Lurasidone

2025-06-23T00:58:29Z

83.32.211.124:

{{Short description|Atypical antipsychotic medication}}
{{Use dmy dates|date=February 2024}}
{{cs1 config|name-list-style=vanc|display-authors=6}}
{{Infobox drug
| image = Lurasidone.svg
| image_class = skin-invert-image
| width = 250
| image2 = Lurasidone ball-and-stick based on xtal 2012.png
| width2 = 250
| alt2 = Ball-and-stick model of the lurasidone molecule


| pronounce = {{IPAc-en|lj|ʊəˈr|æ|s|ɪ|ˌ|d|oʊ|n}}
| tradename = Latuda, others
| Drugs.com = {{drugs.com|monograph|lurasidone-hydrochloride}}
| MedlinePlus = a611016
| DailyMedID = Lurasidone
| pregnancy_AU = B1
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Lurasidone (Latuda) Use During Pregnancy | website=Drugs.com | date=5 February 2020 | url=https://www.drugs.com/pregnancy/lurasidone.html | access-date=12 May 2020 | archive-date=15 October 2020 | archive-url=https://web.archive.org/web/20201015003725/https://www.drugs.com/pregnancy/lurasidone.html | url-status=live }}</ref>
| pregnancy_category =
| routes_of_administration = [[Oral administration|By mouth]]
| class = [[Atypical antipsychotic]]<ref name=AHFS2019/>
| ATC_prefix = N05
| ATC_suffix = AE05
| ATC_supplemental =


| legal_AU = S4
| legal_AU_comment = <ref name = TGA /><ref>{{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2014 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 | access-date=10 April 2023 | archive-date=10 April 2023 | archive-url=https://web.archive.org/web/20230410065838/https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 | url-status=live }}</ref>
| legal_BR = C1
| legal_BR_comment = <ref>{{Cite web |author=Anvisa |author-link=Brazilian Health Regulatory Agency |date=31 March 2023 |title=RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial |trans-title=Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control|url=https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 |url-status=live |archive-url=https://web.archive.org/web/20230803143925/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 |archive-date=3 August 2023 |access-date=16 August 2023 |publisher=[[Diário Oficial da União]] |language=pt-BR |publication-date=4 April 2023}}</ref>
| legal_CA = Rx-only
| legal_CA_comment =
| legal_DE = 
| legal_DE_comment =
| legal_NZ = 
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment = <ref>{{cite web | title=Latuda 18.5mg film-coated tablets - Summary of Product Characteristics (SmPC) | website=(emc) | date=16 January 2019 | url=https://www.medicines.org.uk/emc/product/3299/smpc | access-date=12 May 2020 | archive-date=14 October 2020 | archive-url=https://web.archive.org/web/20201014042307/https://www.medicines.org.uk/emc/product/3299/smpc | url-status=live }}</ref>
| legal_US = Rx-only
| legal_US_comment = <ref name="Latuda label">{{cite web | title=Latuda- lurasidone hydrochloride tablet, film coated | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afad3051-9df2-4c54-9684-e8262a133af8 | access-date=12 May 2020 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828152242/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afad3051-9df2-4c54-9684-e8262a133af8 | url-status=live }}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Latuda EPAR" />
| legal_UN = 
| legal_UN_comment =
| legal_status = Rx-only


| bioavailability = 9–19% (oral)<ref name = TGA>{{cite web|title=Product information Latuda (lurasidone hydrochloride)|work=TGA eBusiness Services|publisher=Therapeutic Goods Administration|date=28 October 2022|access-date=28 October 2022|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-01864-1|format=PDF|archive-date=28 October 2022|archive-url=https://web.archive.org/web/20221028140222/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-01864-1|url-status=live}}</ref>
| protein_bound = ~99%<ref name="EMA" />
| metabolism = Liver ([[CYP3A4]]-mediated)<ref name = TGA/>
| metabolites =
| onset =
| elimination_half-life = 18–40 hours<ref name = TGA/><ref name="EMA" />
| duration_of_action =
| excretion = Faecal (67–80%), renal (9–19%)<ref name = TGA/><ref name="EMA" />


| CAS_number_Ref =
| CAS_number = 367514-87-2
| CAS_supplemental =
| PubChem = 213046
| IUPHAR_ligand = 7461
| DrugBank_Ref =
| DrugBank = DB08815
| ChemSpiderID_Ref =
| ChemSpiderID = 184739
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 22IC88528T
| KEGG_Ref =
| KEGG = D04820
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 70735
| ChEMBL_Ref =
| ChEMBL = 1237021
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = SM-13496


| IUPAC_name = (3a''R'',4''S'',7''R'',7a''S'')-2-<nowiki/>{(1''R'',2''R'')-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2''H''-isoindole-1,3-dione
| C = 28
| H = 36
| N = 4
| O = 2
| S = 1
| SMILES = C1CC[C@H]([C@@H](C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)[C@H]6[C@@H]7CC[C@@H](C7)[C@H]6C5=O
| StdInChI = 1S/C28H36N4O2S/c33-27-24-18-9-10-19(15-18)25(24)28(34)32(27)17-21-6-2-1-5-20(21)16-30-11-13-31(14-12-30)26-22-7-3-4-8-23(22)35-29-26/h3-4,7-8,18-21,24-25H,1-2,5-6,9-17H2/t18-,19+,20-,21-,24+,25-/m0/s1
| StdInChI_comment =
| StdInChIKey = PQXKDMSYBGKCJA-CVTJIBDQSA-N
| density =
| density_notes =
| melting_point = 176
| melting_high = 178
| melting_notes =
| boiling_point =
| boiling_notes =
| solubility = 0.224
| sol_units =
| specific_rotation = [α]20D −59°
}}

'''Lurasidone''', sold under the brand name '''Latuda''' among others, is an [[atypical antipsychotic]] medication used to treat [[schizophrenia]] and [[bipolar disorder|bipolar]] [[major depressive disorder|depression]].<ref name="AHFS2019">{{cite web |title=Lurasidone Hydrochloride Monograph for Professionals |url=https://www.drugs.com/monograph/lurasidone-hydrochloride.html |access-date=21 March 2019 |website=Drugs.com |publisher=American Society of Health-System Pharmacists |archive-date=21 March 2019 |archive-url=https://web.archive.org/web/20190321104507/https://www.drugs.com/monograph/lurasidone-hydrochloride.html |url-status=live }}</ref> It is taken [[by mouth]].


Common side effects include [[Somnolence|sedation]], [[Dyspepsia|indigestion]], [[nausea]], and [[insomnia]]. At higher dosages, there is an increased risk for [[Akathisia|restlessness]] and [[Extrapyramidal symptoms|movement problems]].<ref name=AHFS2019/> Serious side effects are valid for all [[atypical antipsychotic]]s and may include the potentially permanent movement disorder [[tardive dyskinesia]], as well as [[neuroleptic malignant syndrome]], an increased risk of [[suicide]], [[angioedema]], and [[Hyperglycemia|high blood sugar levels]].<ref>{{Cite web |title=IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA |url=https://www.latuda.com/sz/important-safety-information.html |access-date=3 December 2022 |website=Latuda |archive-date=3 December 2022 |archive-url=https://web.archive.org/web/20221203173914/https://www.latuda.com/sz/important-safety-information.html |url-status=live }}</ref> Although lurasidone is less likely to cause high blood sugar levels in most patients, hyperosmolar hyperglycemic syndrome may occur.<ref name=AHFS2019/><ref>{{cite journal | vauthors = Zhang Y, Liu Y, Su Y, You Y, Ma Y, Yang G, Song Y, Liu X, Wang M, Zhang L, Kou C | title = The metabolic side effects of 12 antipsychotic drugs used for the treatment of schizophrenia on glucose: a network meta-analysis | journal = BMC Psychiatry | volume = 17 | issue = 1 | pages = 373 | date = November 2017 | pmid = 29162032 | pmc = 5698995 | doi = 10.1186/s12888-017-1539-0 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Hanyu S, Kojima Y, Murai T, Kawashima H | title = Lurasidone-induced hyperosmolar hyperglycemic syndrome: A case report | journal = Neuropsychopharmacology Reports | volume = 42 | issue = 3 | pages = 377–379 | date = September 2022 | pmid = 35609885 | pmc = 9515717 | doi = 10.1002/npr2.12259 }}</ref> In older people with [[psychosis]] as a result of [[dementia]], it may increase the risk of dying.<ref name=AHFS2019/> Use during [[pregnancy]] is of unclear safety.<ref name=BNF76>{{cite book|title=British national formulary: BNF 76 |date=2018|publisher=Pharmaceutical Press|isbn=978-0-85711-338-2|pages=393–394|edition=76}}</ref><ref>{{cite web |title=Lurasidone (Latuda) tablets for the treatment of schizophrenia in adults |url=https://www.sps.nhs.uk/wp-content/uploads/2015/03/final20draft.pdf |access-date=30 April 2020 |archive-date=27 February 2021 |archive-url=https://web.archive.org/web/20210227005246/https://www.sps.nhs.uk/wp-content/uploads/2015/03/final20draft.pdf |url-status=dead }}</ref> 

Lurasidone was first approved for medical use in the United States in 2010.<ref name=AHFS2019/> In 2013, it was approved in Canada and by the U.S. [[Food and Drug Administration]] (FDA) to treat [[Bipolar disorder|bipolar depression]], either as monotherapy or adjunctively with [[Lithium (medication)|lithium]] or [[valproate]].<ref>{{cite journal | vauthors = Bawa R, Scarff JR | title = Lurasidone: a new treatment option for bipolar depression-a review | journal = Innovations in Clinical Neuroscience | volume = 12 | issue = 1–2 | pages = 21–23 | date = 2015 | pmid = 25852975 | pmc = 4382136 }}</ref><ref>{{cite journal | vauthors = Pikalov A, Tsai J, Mao Y, Silva R, Cucchiaro J, Loebel A | title = Long-term use of lurasidone in patients with bipolar disorder: safety and effectiveness over 2 years of treatment | journal = International Journal of Bipolar Disorders | volume = 5 | issue = 1 | pages = 9 | date = December 2017 | pmid = 28168632 | pmc = 5332323 | doi = 10.1186/s40345-017-0075-7 | doi-access = free }}</ref> It has no effect on [[mania|manic]] symptoms and is more potent for treating [[major depressive disorder]] or depressive episodes associated with bipolar disorder. Generic versions were approved in the United States in 2019, and became available in 2023.<ref name="Generic2019">{{cite web |title=Generic Latuda Availability |url=https://www.drugs.com/availability/generic-latuda.html |website=Drugs.com |access-date=30 April 2020 |archive-date=14 August 2020 |archive-url=https://web.archive.org/web/20200814051621/https://www.drugs.com/availability/generic-latuda.html |url-status=live }}</ref><ref name="WSJ2019" /> In 2021, it was the 193rd most commonly prescribed medication in the United States, with more than 2{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2021 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=14 January 2024 | archive-date=15 January 2024 | archive-url=https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Lurasidone - Drug Usage Statistics | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Lurasidone | access-date = 14 January 2024}}</ref>

==Medical uses==
Lurasidone is used to treat [[schizophrenia]] and [[bipolar disorder]].<ref name=AHFS2019/><ref>{{cite journal | vauthors = Swann AC, Fava M, Tsai J, Mao Y, Pikalov A, Loebel A | title = Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis | journal = CNS Spectrums | volume = 22 | issue = 2 | pages = 228–235 | date = April 2017 | pmid = 28300012 | doi = 10.1017/S1092852917000232 | s2cid = 24653390 | doi-access = free }}</ref> In bipolar disorder, it has been studied both as a monotherapy and adjunctive treatment to lithium or valproate.<ref>{{cite journal | vauthors = Ali Z, Tegin C, El-Mallakh RS | title = Evaluating lurasidone as a treatment option for bipolar disorder | journal = Expert Opinion on Pharmacotherapy | volume = 21 | issue = 3 | pages = 253–260 | date = February 2020 | pmid = 31957501 | doi = 10.1080/14656566.2019.1695777 | s2cid = 210829608 }}</ref>

The European Medicines Agency approved lurasidone for the treatment of schizophrenia for people aged 13 years and older,<ref>{{Cite web |url=https://www.ema.europa.eu/en/documents/overview/latuda-epar-medicine-overview_en.pdf |title=Latuda (lurasidone) An overview. European Medicines Agency, 2020 |access-date=6 October 2022 |archive-date=6 October 2022 |archive-url=https://web.archive.org/web/20221006100102/https://www.ema.europa.eu/en/documents/overview/latuda-epar-medicine-overview_en.pdf |url-status=live }}</ref> but not for bipolar disorder.<ref name="Latuda EPAR" /> In the United States, it is used to treat schizophrenia for people aged 13 years and older, as well as depressive episodes of bipolar disorder age 10 and over as a monotherapy, and in conjunction with lithium or valproate in adults.<ref>{{cite book | via = National Center for Biotechnology Information, U.S. National Library of Medicine | chapter = Key Limitations | chapter-url = https://www.ncbi.nlm.nih.gov/books/NBK195617/ | title = Lurasidone Hydrochloride (Latuda): Management of Manifestations of Schizophrenia | author = Canadian Agency for Drugs and Technologies in Health | access-date = 30 April 2020 | date = 2014 | publisher = Canadian Agency for Drugs and Technologies in Health | archive-date = 28 August 2021 | archive-url = https://web.archive.org/web/20210828152213/https://www.ncbi.nlm.nih.gov/books/NBK195617/ | url-status = live }}</ref>

In July 2013, lurasidone received approval for bipolar I depression.<ref name = Medscape>{{cite web | vauthors = Lowes R | title = Lurasidone Approved for Bipolar Depression | work = Medscape | date = 2013 | url = http://www.medscape.com/viewarticle/807204 | access-date = 1 October 2013 | archive-date = 2 October 2013 | archive-url = https://web.archive.org/web/20131002013831/http://www.medscape.com/viewarticle/807204 | url-status = live }}</ref><ref>{{cite journal | vauthors = Bawa R, Scarff JR | title = Lurasidone: a new treatment option for bipolar depression-a review | journal = Innovations in Clinical Neuroscience | volume = 12 | issue = 1–2 | pages = 21–23 | date = 2015 | pmid = 25852975 | pmc = 4382136 }}</ref><ref name="Latuda approval S1" /><ref name="Latuda approval S2" />

In June 2020, lurasidone was approved in Japan, eight years after its first approval in the United States.<ref>{{Cite web |title=Latuda to Finally Hit Japan Market on June 11 |url=https://pj.jiho.jp/article/242267 |access-date=10 October 2022 |website=PHARMA JAPAN |language=en |archive-date=10 October 2022 |archive-url=https://web.archive.org/web/20221010040006/https://pj.jiho.jp/article/242267 |url-status=live }}</ref> In Japan it is approved for [[bipolar depression]] and [[schizophrenia]].<ref>{{Cite web |title=Sumitomo Dainippon Pharma Announces Approval of Atypical Antipsychotic Agent, LATUDA Tablets in Japan | work = IR News {{!}} Investor Relations | publisher = Sumitomo Pharma |url=https://www.sumitomo-pharma.com/ir/news/2020/20200325-1.html |access-date=10 October 2022 |language=en |archive-date=10 October 2022 |archive-url=https://web.archive.org/web/20221010040007/https://www.sumitomo-pharma.com/ir/news/2020/20200325-1.html |url-status=live }}</ref><ref>{{Cite web |title=Kusuri-no-Shiori(Drug Information Sheet) Latuda tablets |url=https://www.rad-ar.or.jp/siori/english/search/result?n=43474 |access-date=10 October 2022 |language=en |archive-date=10 October 2022 |archive-url=https://web.archive.org/web/20221010040006/https://www.rad-ar.or.jp/siori/english/search/result?n=43474 |url-status=live }}</ref><ref>{{cite journal | vauthors = Okubo R, Hasegawa T, Fukuyama K, Shiroyama T, Okada M | title = Current Limitations and Candidate Potential of 5-HT7 Receptor Antagonism in Psychiatric Pharmacotherapy | journal = Frontiers in Psychiatry | volume = 12 | pages = 623684 | date = 2021 | pmid = 33679481 | doi = 10.3389/fpsyt.2021.623684 | doi-access = free | pmc = 7930824 }}</ref>

Few available atypical antipsychotics are known to possess antidepressant efficacy in bipolar disorder (with the notable exceptions being [[cariprazine]],<ref>{{cite journal | vauthors = Ragguett RM, McIntyre RS | title = Cariprazine for the treatment of bipolar depression: a review | journal = Expert Review of Neurotherapeutics | volume = 19 | issue = 4 | pages = 317–323 | date = April 2019 | pmid = 30753085 | doi = 10.1080/14737175.2019.1580571 }}</ref> [[quetiapine]],<ref>{{cite journal | vauthors = Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M | title = A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I) | journal = The Journal of Clinical Psychiatry | volume = 71 | issue = 2 | pages = 150–162 | date = February 2010 | pmid = 20122369 | doi = 10.4088/JCP.08m04995gre | collaboration = EMBOLDEN I (Trial 001) Investigators }}</ref><ref>{{cite journal | vauthors = Suppes T, Datto C, Minkwitz M, Nordenhem A, Walker C, Darko D | title = Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression | journal = Journal of Affective Disorders | volume = 121 | issue = 1–2 | pages = 106–115 | date = February 2010 | pmid = 19903574 | doi = 10.1016/j.jad.2009.10.007 | author-link1 = Trisha Suppes }}</ref><ref>{{cite journal |doi=10.1111/j.1399-5618.2008.00585.x |title=Corrigendum |year=2008 |journal= Bipolar Disorders |volume=10 |issue=3 |pages= 451|doi-access=free }}</ref><ref>{{cite journal | vauthors = Thase ME | title = Quetiapine monotherapy for bipolar depression | journal = Neuropsychiatric Disease and Treatment | volume = 4 | issue = 1 | pages = 11–21 | date = February 2008 | pmid = 18728771 | pmc = 2515925 | doi = 10.2147/ndt.s1162 | doi-access = free }}</ref> [[olanzapine]]<ref>{{cite journal | vauthors = Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, Mitchell PB, Centorrino F, Risser R, Baker RW, Evans AR, Beymer K, Dube S, Tollefson GD, Breier A | title = Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression | journal = Archives of General Psychiatry | volume = 60 | issue = 11 | pages = 1079–1088 | date = November 2003 | pmid = 14609883 | doi = 10.1001/archpsyc.60.11.1079 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Tohen M, Katagiri H, Fujikoshi S, Kanba S | title = Efficacy of olanzapine monotherapy in acute bipolar depression: a pooled analysis of controlled studies | journal = Journal of Affective Disorders | volume = 149 | issue = 1–3 | pages = 196–201 | date = July 2013 | pmid = 23485111 | doi = 10.1016/j.jad.2013.01.022 }}</ref><ref>{{cite journal | vauthors = Corya SA, Perlis RH, Keck PE, Lin DY, Case MG, Williamson DJ, Tohen MF | title = A 24-week open-label extension study of olanzapine-fluoxetine combination and olanzapine monotherapy in the treatment of bipolar depression | journal = The Journal of Clinical Psychiatry | volume = 67 | issue = 5 | pages = 798–806 | date = May 2006 | pmid = 16841630 | doi = 10.4088/JCP.v67n0514 }}</ref> and possibly [[asenapine]]<ref>{{cite journal | vauthors = Azorin JM, Sapin C, Weiller E | title = Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses | journal = Journal of Affective Disorders | volume = 145 | issue = 1 | pages = 62–69 | date = February 2013 | pmid = 22868059 | doi = 10.1016/j.jad.2012.07.013 }}</ref>) as a monotherapy, even though the majority of atypical antipsychotics are known to possess significant [[Mania|antimanic]] activity,<ref name="LancetM">{{cite journal | vauthors = Cipriani A, Barbui C, Salanti G, Rendell J, Brown R, Stockton S, Purgato M, Spineli LM, Goodwin GM, Geddes JR | title = Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis | journal = Lancet | volume = 378 | issue = 9799 | pages = 1306–1315 | date = October 2011 | pmid = 21851976 | doi = 10.1016/S0140-6736(11)60873-8 | s2cid = 25512763 }}</ref> which is yet to be clearly demonstrated for lurasidone.

In the early post approval period lurasidone-treated patients with bipolar disorder were retrospectively found to have more complex clinical profiles, comorbidities, and prior treatment history compared to patients initiated with other atypical antipsychotics. The study authors suggest this may be due to "the overall clinical profile of lurasidone, the role perceived for lurasidone in the therapeutic armamentarium by practitioners, and the recent introduction of lurasidone into clinical practice during the study period."<ref>{{cite journal | vauthors = Tohen M, Ng-Mak D, Rajagopalan K, Halpern R, Chuang CC, Loebel A | title = Patient Characteristics Associated With Use of Lurasidone Versus Other Atypical Antipsychotics in Patients With Bipolar Disorder: Analysis From a Claims Database in the United States | journal = The Primary Care Companion for CNS Disorders | volume = 19 | issue = 3 | date = June 2017 | pmid = 28590601 | doi = 10.4088/PCC.16m02066 }}</ref>

Lurasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.<ref>{{Cite web|url=https://medlineplus.gov/druginfo/meds/a611016.html|title=Lurasidone| work = MedlinePlus | publisher = U.S. National Library of Medicine |access-date=11 September 2018|archive-date=23 January 2019|archive-url=https://web.archive.org/web/20190123012938/https://medlineplus.gov/druginfo/meds/a611016.html|url-status=live}}</ref>

==Contraindications==
Lurasidone is [[contraindicated]] in individuals who are taking strong inhibitors of the liver enzyme [[CYP3A4]] ([[ketoconazole]], [[clarithromycin]], [[ritonavir]], [[levodropropizine]], etc.) or inducers ([[carbamazepine]], [[St. John's wort]], [[phenytoin]], [[rifampicin]] etc.).<ref>{{cite journal | vauthors = Chiu YY, Ereshefsky L, Preskorn SH, Poola N, Loebel A | title = Lurasidone drug-drug interaction studies: a comprehensive review | journal = Drug Metabolism and Drug Interactions | volume = 29 | issue = 3 | pages = 191–202 | year = 2014 | pmid = 24825095 | doi = 10.1515/dmdi-2014-0005 | doi-access = free }}</ref> The use of lurasidone in pregnant women has not been studied and is not recommended; in animal studies, no risks have been found.<ref>[[Pregnancy category]]</ref> Excretion in breast milk is also unknown; lurasidone is not recommended for breastfeeding women.<ref>{{cite journal | title = ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation | journal = Obstetrics and Gynecology | volume = 111 | issue = 4 | pages = 1001–1020 | date = April 2008 | pmid = 18378767 | doi = 10.1097/AOG.0b013e31816fd910 | author1 = ACOG Committee on Practice Bulletins--Obstetrics }}</ref> In the United States, it is not indicated for use in children.{{CN|date=May 2025}} The enzyme CYP3A4 is involved in the digestion of drugs. Inhibitors such as grapefruit juice block its function resulting in too much drug in the body.<ref>{{Cite web | author = Office of the Commissioner|date=14 July 2021 |title=Grapefruit Juice and Some Drugs Don't Mix |url=https://www.fda.gov/consumers/consumer-updates/grapefruit-juice-and-some-drugs-dont-mix |archive-url=https://web.archive.org/web/20190506062425/https://www.fda.gov/consumers/consumer-updates/grapefruit-juice-and-some-drugs-dont-mix |url-status=dead |archive-date=6 May 2019 | work = FDA |language=en}}</ref>

==Side effects==
{{See also|List of adverse effects of lurasidone}}

Side effects are generally similar to other antipsychotics. The drug has a relatively well tolerated [[side effect]] profile, with low propensity for [[QT interval|QTc interval]] changes,<ref>{{Cite journal | vauthors = Oral H |date=14 September 2018 |title=Lurasidone is not associated with risk of QTc prolongation |url=https://digitalcommons.wayne.edu/crp/vol4/iss2/8 |journal=Clinical Research in Practice: The Journal of Team Hippocrates |volume=4 |issue=2 |doi=10.22237/crp/1536278400 |s2cid=53322344 |issn=2379-4550 |access-date=15 November 2022 |archive-date=15 November 2022 |archive-url=https://web.archive.org/web/20221115033741/https://digitalcommons.wayne.edu/crp/vol4/iss2/8/ |url-status=live }}</ref><ref>{{cite journal | vauthors = Javed A, Arthur H, Curtis L, Hansen L, Pappa S | title = Practical Guidance on the Use of Lurasidone for the Treatment of Adults with Schizophrenia | journal = Neurology and Therapy | volume = 8 | issue = 2 | pages = 215–230 | date = December 2019 | pmid = 31098889 | pmc = 6858892 | doi = 10.1007/s40120-019-0138-z }}</ref> [[weight gain]] and [[lipid]]-related adverse effects.<ref>{{cite press release |title=Lurasidone Demonstrated Efficacy in Treating Patients With Schizophrenia in Pivotal Phase 3 Study |publisher=Dainippon Sumitomo Pharma |date=26 August 2009 |url=http://www.ds-pharma.com/pdf_view.php?id=170 |access-date=3 October 2016 |archive-date=14 May 2015 |archive-url=https://web.archive.org/web/20150514205205/http://www.ds-pharma.com/pdf_view.php?id=170 |url-status=dead }}</ref> In a 2013 meta-analysis of the efficacy and tolerability of 15 antipsychotic drugs, it was found to produce the second least (after [[haloperidol]]) weight gain, the least QT interval prolongation, the fourth ''most'' [[Extrapyramidal symptoms|extrapyramidal side effects]] (after [[haloperidol]], [[zotepine]] and [[chlorpromazine]]), and the sixth least sedation (after [[paliperidone]], [[sertindole]], [[amisulpride]], [[iloperidone]] and [[aripiprazole]]).<ref name="Lancet">{{cite journal | vauthors = Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, Samara M, Barbui C, Engel RR, Geddes JR, Kissling W, Stapf MP, Lässig B, Salanti G, Davis JM | title = Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis | journal = Lancet | volume = 382 | issue = 9896 | pages = 951–962 | date = September 2013 | pmid = 23810019 | doi = 10.1016/S0140-6736(13)60733-3 | s2cid = 32085212 }}</ref>

As with other atypical neuroleptics, lurasidone should be used with caution in the elderly because it puts them at an increased risk for a [[stroke]] or [[transient ischemic attack]];<ref name="PrescribingInfo" /><ref>{{cite web|url=https://www.drugs.com/latuda.html|publisher=Drugs.com|title=Latuda|access-date=17 December 2010|archive-date=5 April 2019|archive-url=https://web.archive.org/web/20190405041927/https://www.drugs.com/latuda.html|url-status=live}}</ref> however, these risks are not likely to be greater than those associated with antipsychotics of other classes.<ref>{{cite journal | vauthors = Herrmann N, Mamdani M, Lanctôt KL | title = Atypical antipsychotics and risk of cerebrovascular accidents | journal = The American Journal of Psychiatry | volume = 161 | issue = 6 | pages = 1113–1115 | date = June 2004 | pmid = 15169702 | doi = 10.1176/appi.ajp.161.6.1113 }}</ref> Similarly, lurasidone should not be used to treat dementia-related psychosis, as evidence has shown increased mortality with antipsychotic use.<ref>{{cite web| work = Sunovion Pharmaceuticals|title=Latuda Prescribing Information|url=http://www.latuda.com/LatudaPrescribingInformation.pdf |access-date=25 March 2014|archive-date=12 July 2018|archive-url=https://web.archive.org/web/20180712172540/http://www.latuda.com/LatudaPrescribingInformation.pdf|url-status=live}}</ref>

Weight gain is reported in up to 15 and 16 percent of users.<ref>{{cite journal | vauthors = Meyer JM, Mao Y, Pikalov A, Cucchiaro J, Loebel A | title = Weight change during long-term treatment with lurasidone: pooled analysis of studies in patients with schizophrenia | journal = International Clinical Psychopharmacology | volume = 30 | issue = 6 | pages = 342–350 | date = November 2015 | pmid = 26196189 | pmc = 4593468 | doi = 10.1097/YIC.0000000000000091 }}</ref><ref>{{cite journal | vauthors = Ketter TA, Sarma K, Silva R, Kroger H, Cucchiaro J, Loebel A | title = Lurasidone in the Long-Term Treatment of Patients with Bipolar Disorder: A 24-Week Open-Label Extension Study | journal = Depression and Anxiety | volume = 33 | issue = 5 | pages = 424–434 | date = May 2016 | pmid = 26918425 | pmc = 5069590 | doi = 10.1002/da.22479 }}</ref> Other possible side effects include vomiting, [[akathisia]], [[dystonia]], [[parkinsonism]], [[somnolence]], dizziness, sedation and nausea.<ref>{{cite journal | vauthors = Zheng W, Cai DB, Yang XH, Li L, Zhang QE, Ng CH, Ungvari GS, Li XB, Ning YP, Xiang YT | title = Short-term efficacy and tolerability of lurasidone in the treatment of acute schizophrenia: A meta-analysis of randomized controlled trials | journal = Journal of Psychiatric Research | volume = 103 | pages = 244–251 | date = August 2018 | doi = 10.1016/j.jpsychires.2018.06.005 | pmid = 29906709 | s2cid = 49227958 }}</ref><ref>{{cite journal | vauthors = Kolli V, Walia A, Kinnan S | title = Food Matters: Reduction of Lurasidone-Induced Nausea With Meals | journal = The Primary Care Companion for CNS Disorders | volume = 21 | issue = 2 | pages = 18l02343 | date = March 2019 | pmid = 30869204 | doi = 10.4088/PCC.18l02343 | s2cid = 76666344 }}</ref>

===Discontinuation===
The [[British National Formulary]] recommends a gradual withdrawal when discontinuing antipsychotics to avoid acute withdrawal syndrome or rapid relapse.<ref name="Group 2009 192">{{cite book | author = BMJ Joint Formulary Committee | title = British National Formulary | edition = 57 | date = March 2009 |publisher=Royal Pharmaceutical Society of Great Britain |location=United Kingdom |isbn=978-0-85369-845-6 |page=192 |chapter=4.2.1 |quote=Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse.}}</ref> Symptoms of withdrawal commonly include nausea, vomiting, and loss of appetite.<ref name=Had2004>{{cite book |veditors=Haddad PM, Dursun S, Deakin B |title=Adverse Syndromes and Psychiatric Drugs: A Clinical Guide |date=2004 |publisher=OUP Oxford |isbn=978-0-19-852748-0 |pages=207–216 |url=https://books.google.com/books?id=CWR7DwAAQBAJ&pg=PA207 |access-date=8 May 2020 |archive-date=10 January 2023 |archive-url=https://web.archive.org/web/20230110164012/https://books.google.com/books?id=CWR7DwAAQBAJ&pg=PA207 |url-status=live }}</ref> Other symptoms may include restlessness, increased sweating, and trouble sleeping.<ref name=Had2004/> Less commonly there may be a feeling of the world spinning, numbness, or muscle pains.<ref name=Had2004/> Symptoms generally resolve after a short period of time.<ref name=Had2004/>

There is tentative evidence that discontinuation of antipsychotics can result in psychosis.<ref>{{cite journal | vauthors = Moncrieff J | title = Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse | journal = Acta Psychiatrica Scandinavica | volume = 114 | issue = 1 | pages = 3–13 | date = July 2006 | pmid = 16774655 | doi = 10.1111/j.1600-0447.2006.00787.x | s2cid = 6267180 }}</ref> It may also result in reoccurrence of the condition that is being treated.<ref>{{cite book |vauthors=Sacchetti E, Vita A, Siracusano A, Fleischhacker W |title=Adherence to Antipsychotics in Schizophrenia |date=2013 |publisher=Springer Science & Business Media |isbn=978-88-470-2679-7 |page=85 |url=https://books.google.com/books?id=odE-AgAAQBAJ&pg=PA85 |access-date=8 May 2020 |archive-date=10 January 2023 |archive-url=https://web.archive.org/web/20230110164029/https://books.google.com/books?id=odE-AgAAQBAJ&pg=PA85 |url-status=live }}</ref> Rarely tardive dyskinesia can occur when the medication is stopped.<ref name=Had2004/>

== Interactions ==

[[Blood plasma]] concentrations may be increased when combined with [[CYP3A4]] inhibitors (e.g. ketoconazole, clarithromycin, ritonavir, and voriconazole) possibly leading to more side effects. This has been clinically verified for [[ketoconazole]], which increases lurasidone exposure by a factor of 9, and is also expected for other 3A4 inhibitors such as [[grapefruit juice]]. Co-administration of CYP3A4 inducers like [[rifampicin]], [[carbamazepine]] or [[St. John's wort]] can reduce plasma levels of lurasidone and its [[active metabolite]], and consequently decrease the effects of the drug. For rifampicin, the reduction was sixfold in a study.<ref name="EMA" />

==Pharmacology==

===Pharmacodynamics===
{{See also|Atypical antipsychotic#Pharmacodynamics|Antipsychotic#Comparison of medications}}

{| class="wikitable floatright" style="font-size:small;"
|+ Lurasidone<ref name="PDSP">{{cite web | title = PDSP Ki Database | work = Psychoactive Drug Screening Program (PDSP) | author1-link = Bryan Roth | vauthors = Roth BL, Driscol J | publisher = University of North Carolina at Chapel Hill and the United States National Institute of Mental Health | access-date = 14 August 2017 | url = https://pdsp.unc.edu/databases/pdsp.php?knowID=0&kiKey=&receptorDD=&receptor=&speciesDD=&species=&sourcesDD=&source=&hotLigandDD=&hotLigand=&testLigandDD=&testFreeRadio=testFreeRadio&testLigand=lurasidone&referenceDD=&reference=&KiGreater=&KiLess=&kiAllRadio=all&doQuery=Submit+Query | archive-date = 28 August 2021 | archive-url = https://web.archive.org/web/20210828152151/https://pdsp.unc.edu/databases/pdsp.php?knowID=0&kiKey=&receptorDD=&receptor=&speciesDD=&species=&sourcesDD=&source=&hotLigandDD=&hotLigand=&testLigandDD=&testFreeRadio=testFreeRadio&testLigand=lurasidone&referenceDD=&reference=&KiGreater=&KiLess=&kiAllRadio=all&doQuery=Submit+Query | url-status = live }}</ref>
|-
! Site !! Ki (nM) !! Action !! Species !! Ref
|-
| {{abbrlink|SERT|Serotonin transporter}} || >1,000 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009">{{cite journal |vauthors=Ishibashi T, Horisawa T, Tokuda K, Ishiyama T, Ogasa M, Tagashira R, Matsumoto K, Nishikawa H, Ueda Y, Toma S, Oki H, Tanno N, Saji I, Ito A, Ohno Y, Nakamura M |date=July 2010 |title=Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity |journal=The Journal of Pharmacology and Experimental Therapeutics |volume=334 |issue=1 |pages=171–181 |doi=10.1124/jpet.110.167346 |pmid=20404009 |s2cid=12893717}}</ref>
|-
| {{abbrlink|NET|Norepinephrine transporter}} || {{abbr|ND|No data}} || {{abbr|ND|No data}} || {{abbr|ND|No data}} || {{abbr|ND|No data}}
|-
| {{abbrlink|DAT|Dopamine transporter}} || >1,000 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009" />
|-
| [[5-HT1A receptor|'''5-HT1A''']] || '''6.7'''|| '''Partial agonist'''|| Human || <ref name="Wróbel_2019">{{cite journal | vauthors = Wróbel MZ, Chodkowski A, Herold F, Marciniak M, Dawidowski M, Siwek A, Starowicz G, Stachowicz K, Szewczyk B, Nowak G, Belka M, Bączek T, Satała G, Bojarski AJ, Turło J | title = Synthesis and biological evaluation of new multi-target 3-(1H-indol-3-yl)pyrrolidine-2,5-dione derivatives with potential antidepressant effect | journal = European Journal of Medicinal Chemistry | volume = 183 | pages = 111736 | date = December 2019 | pmid = 31586817 | doi = 10.1016/j.ejmech.2019.111736 | doi-access = free }}</ref>
|-
| [[5-HT2A receptor|'''5-HT2A''']] || '''0.5-2'''|| '''antagonist'''|| Rat || <ref name="pmid20404009" />
|-
| [[5-HT2B receptor|5-HT2B]] || 24 || {{abbr|ND|No data}} || Human || <ref name="BenderParrLivingston2023">{{cite journal | vauthors = Bender AM, Parr LC, Livingston WB, Lindsley CW, Merryman WD | title = 2B Determined: The Future of the Serotonin Receptor 2B in Drug Discovery | journal = J Med Chem | volume = 66 | issue = 16 | pages = 11027–11039 | date = August 2023 | pmid = 37584406 | pmc = 11073569 | doi = 10.1021/acs.jmedchem.3c01178 | url = }}</ref>
|-
| [[5-HT2C receptor|5-HT2C]] || 415 || {{abbr|ND|No data}} || Pig || <ref name="pmid20404009" />
|-
| [[5-HT3 receptor|5-HT3]] || >1,000 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009" />
|-
| [[5-HT4 receptor|5-HT4]] || >1,000 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009" />
|-
| [[5-HT7 receptor|'''5-HT7''']] || '''0.5'''|| '''Inverse agonist'''|| Human || <ref>{{cite journal | vauthors = Tarazi FI, Riva MA | title = The preclinical profile of lurasidone: clinical relevance for the treatment of schizophrenia | journal = Expert Opinion on Drug Discovery | volume = 8 | issue = 10 | pages = 1297–1307 | date = October 2013 | pmid = 23837554 | doi = 10.1517/17460441.2013.815163 | s2cid = 25838798 }}</ref><ref name="pmid20404009" />
|-
| [[alpha-1 adrenergic receptor|'''α1''']] || 47.9|| {{abbr|ND|No data}} || Rat || <ref name="pmid20404009" />
|-
| [[alpha-2A adrenergic receptor|'''α2A''']] || 41|| Antagonist|| Human || <ref name="pmid20404009" />
|-
| [[alpha-2B adrenergic receptor|α2B]] || {{abbr|ND|No data}} || {{abbr|ND|No data}} || {{abbr|ND|No data}} || {{abbr|ND|No data}}
|-
| [[alpha-2C adrenergic receptor|'''α2C''']] || '''10.8'''|| '''Antagonist'''|| Human || <ref name="pmid20404009" />
|-
| [[Beta-1 adrenergic receptor|β1]] || >1,000 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009" />
|-
| [[Beta-2 adrenergic receptor|β2]] || >1,000 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009" />
|-
| [[D1 receptor|D1]] || 262 || {{abbr|ND|No data}} || {{abbr|ND|No data}} || <ref name="pmid20404009" />
|-
| [[D2 receptor|'''D2s''']] || '''1.2-1.7'''|| '''Antagonist'''|| Human || <ref name="Wróbel_2019" />
|-
| [[D3 receptor|'''D3S''']] || '''15.7'''|| '''Antagonist'''|| {{abbr|ND|No data}} || {{abbr|ND|No data}}
|-
| [[D4 receptor|D4.4L]] || 30 || Positive allosteric modulator || {{abbr|ND|No data}} || {{abbr|ND|No data}}
|-
| [[D5 receptor|D5]] || {{abbr|ND|No data}} || {{abbr|ND|No data}} || {{abbr|ND|No data}} || {{abbr|ND|No data}}
|-
| [[H1 receptor|H1]] || >1,000 || {{abbr|ND|No data}} || Guinea pig || <ref name="pmid20404009" />
|-
| [[Muscarinic acetylcholine receptor M1|M1]] || >1,000 || {{abbr|ND|No data}} || Human || <ref name="pmid20404009" />
|- class="sortbottom"
| colspan="5" style="width: 1px;" | Values are Ki (nM). The smaller the value, the more strongly the drug binds to the site.
|}

Lurasidone ''[(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl) piperazin-1-ylmethyl]-cyclohexylmethyl}-hexahydro-4,7-methano-2Hisoindole-1,3-dione hydrochloride]'' ]<ref>{{Cite web |work=PubChem |publisher=U.S. National Library of Medicine |title=<nowiki>(3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione</nowiki> |url=https://pubchem.ncbi.nlm.nih.gov/compound/50918847 |access-date=2 December 2022 |language=en |archive-date=2 December 2022 |archive-url=https://web.archive.org/web/20221202230335/https://pubchem.ncbi.nlm.nih.gov/compound/50918847 |url-status=live }}</ref> is an azapirone derivative<ref>{{cite journal | vauthors = Amerio A, Giacomini C, Fusar-Poli L, Aguglia A, Costanza A, Serafini G, Aguglia E, Amore M | title = Efficacy and Safety of Lurasidone in Children and Adolescents: Recommendations for Clinical Management and Future Research | journal = Current Pharmaceutical Design | volume = 27 | issue = 39 | pages = 4062–4069 | date = 2021 | pmid = 34348620 | doi = 10.2174/1381612827666210804110853 | s2cid = 236926992 }}</ref> and acts as an [[receptor antagonist|antagonist]] of the [[dopamine receptor|dopamine]] [[D2 receptor|D2]] and [[D3 receptor|D3 receptor]]s,<ref>{{cite journal | vauthors = Fountoulakis KN, Gazouli M, Kelsoe J, Akiskal H | title = The pharmacodynamic properties of lurasidone and their role in its antidepressant efficacy in bipolar disorder | journal = European Neuropsychopharmacology | volume = 25 | issue = 3 | pages = 335–342 | date = March 2015 | pmid = 25596883 | doi = 10.1016/j.euroneuro.2014.11.010 | s2cid = 25628197 }}</ref> and the [[serotonin receptor|serotonin]] [[5-HT2A receptor|5-HT2A]] and [[5-HT7 receptor|5-HT7 receptor]]s, and the [[alpha-2C adrenergic receptor|α2C-adrenergic receptor]], and as a [[partial agonist]] of the serotonin [[5-HT1A receptor|5-HT1A receptor]]. It has moderate-affinity antagonism at α2C-adrenergic receptors; low to very low-affinity [[Antagonism (chemistry)|antagonism]] at α1A-adrenergic α2A-adrenergic receptors.<ref>{{cite journal | vauthors = Franklin R, Zorowitz S, Corse AK, Widge AS, Deckersbach T | title = Lurasidone for the treatment of bipolar depression: an evidence-based review | journal = Neuropsychiatric Disease and Treatment | volume = 11 | pages = 2143–2152 | date = 19 August 2015 | pmid = 26316760 | pmc = 4547662 | doi = 10.2147/NDT.S50961 | doi-access = free }}</ref>

It has only low and likely clinically unimportant [[affinity (pharmacology)|affinity]] for the serotonin [[5-HT2C receptor|5-HT2C receptor]], which may underlie its low propensity for [[appetite stimulant|appetite stimulation]] and [[weight gain]].<ref name="pmid20404009" /><ref name="pmid25453735">{{cite journal | vauthors = Samalin L, Ben Gharbia M, Garnier M, Llorca PM | title = [Short-term efficacy and safety of lurasidone in the treatment of schizophrenia] | language = fr | journal = L'Encephale | volume = 40 | issue = 6 | pages = 507–517 | date = December 2014 | pmid = 25453735 | doi = 10.1016/j.encep.2014.10.009 | trans-title = Short-term efficacy and safety of lurasidone in the treatment of schizophrenia }}</ref><ref>{{cite journal |vauthors=Lincoln J, Tripathi A |year=2011 |title=Lurasidone for Schizophrenia |journal=Current Psychiatry |volume=10 |issue=1 |pages=67–70 |url=http://www.mdedge.com/currentpsychiatry/article/64162/schizophrenia-other-psychotic-disorders/lurasidone-schizophrenia |access-date=2 October 2016 |archive-date=3 October 2016 |archive-url=https://web.archive.org/web/20161003063328/http://www.mdedge.com/currentpsychiatry/article/64162/schizophrenia-other-psychotic-disorders/lurasidone-schizophrenia |url-status=live }}</ref> The drug also has negligible affinity for the [[histamine receptor|histamine]] [[H1 receptor|H1 receptor]] and the [[muscarinic acetylcholine receptor]]s, and hence has no [[antihistamine]] or [[anticholinergic]] effects.<ref name="pmid17662268">{{cite journal | vauthors = Ishiyama T, Tokuda K, Ishibashi T, Ito A, Toma S, Ohno Y | title = Lurasidone (SM-13496), a novel atypical antipsychotic drug, reverses MK-801-induced impairment of learning and memory in the rat passive-avoidance test | journal = European Journal of Pharmacology | volume = 572 | issue = 2–3 | pages = 160–170 | date = October 2007 | pmid = 17662268 | doi = 10.1016/j.ejphar.2007.06.058 }}</ref><ref name="pmid27722855">{{cite journal | vauthors = Greenberg WM, Citrome L | title = Pharmacokinetics and Pharmacodynamics of Lurasidone Hydrochloride, a Second-Generation Antipsychotic: A Systematic Review of the Published Literature | journal = Clinical Pharmacokinetics | volume = 56 | issue = 5 | pages = 493–503 | date = May 2017 | pmid = 27722855 | doi = 10.1007/s40262-016-0465-5 | s2cid = 207485482 }}</ref> Drowsiness (somnolence) side effect is not explained by its antagonist activity to histamine.<ref>{{cite journal | vauthors = Cruz MP | title = Lurasidone HCl (Latuda), an Oral, Once-Daily Atypical Antipsychotic Agent for the Treatment of Patients with Schizophrenia | journal = P & T | volume = 36 | issue = 8 | pages = 489–492 | date = August 2011 | pmid = 21935296 | pmc = 3171824 }}</ref><ref>{{cite journal | vauthors = Corponi F, Fabbri C, Bitter I, Montgomery S, Vieta E, Kasper S, Pallanti S, Serretti A | title = Novel antipsychotics specificity profile: A clinically oriented review of lurasidone, brexpiprazole, cariprazine and lumateperone | journal = European Neuropsychopharmacology | volume = 29 | issue = 9 | pages = 971–985 | date = September 2019 | pmid = 31255396 | doi = 10.1016/j.euroneuro.2019.06.008 | hdl = 11585/714012 | s2cid = 195699303 | url = https://kclpure.kcl.ac.uk/portal/en/publications/bf9947d3-f6a6-486d-9420-771d89443f76 | hdl-access = free }}</ref>

The relationship between dose and [[D2 receptor|D2]] receptor occupancy levels were 41–43% for 10 mg, 51–55% for 20 mg, 63–67% for 40 mg, 77–84% for 60 mg, and 73–79% for 80 mg.<ref>{{cite journal | vauthors = Wong DF, Kuwabara H, Brašić JR, Stock T, Maini A, Gean EG, Loebel A | title = Determination of dopamine D₂ receptor occupancy by lurasidone using positron emission tomography in healthy male subjects | journal = Psychopharmacology | volume = 229 | issue = 2 | pages = 245–252 | date = September 2013 | pmid = 23649882 | doi = 10.1007/s00213-013-3103-z | s2cid = 253737308 }}</ref>

===Pharmacokinetics===
[[File:ID-14283 skeletal.svg|class=skin-invert-image|thumb|ID-14283, the main [[active metabolite]]. The hydroxylation of the [[norbornane]] ring is highlighted.<ref>{{cite journal | vauthors = Katteboina MY, Pilli NR, Mullangi R, Seelam RR, Satla SR | title = LC-MS/MS assay for the determination of lurasidone and its active metabolite, ID-14283 in human plasma and its application to a clinical pharmacokinetic study | journal = Biomedical Chromatography | volume = 30 | issue = 7 | pages = 1065–1074 | date = July 2016 | pmid = 26577488 | doi = 10.1002/bmc.3651 }}</ref> The other active metabolite, ID-14326, has the OH group in [[Endo-exo isomerism|endo position]].<ref name="Caccia">{{cite journal | vauthors = Caccia S, Pasina L, Nobili A | title = Critical appraisal of lurasidone in the management of schizophrenia | journal = Neuropsychiatric Disease and Treatment | volume = 8 | pages = 155–168 | year = 2012 | pmid = 22570547 | pmc = 3346058 | doi = 10.2147/NDT.S18059 | doi-access = free }}</ref>]]

[[File:ID-11614 and 20219 skeletal.svg|class=skin-invert-image|thumb|The main inactivation step by oxidative N-[[dealkylation]] produces the metabolites ID-11614 and ID-20219.<ref name="Caccia" /><ref name="accessdata.fda.gov">{{cite web|url=http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000PharmR.pdf|title=Lurasidone pharmacology review|publisher=Center for Drug Evaluation and Research|date=30 December 2009|access-date=2 October 2016|archive-date=3 October 2016|archive-url=https://web.archive.org/web/20161003115210/http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000PharmR.pdf|url-status=dead}}</ref>]]

Lurasidone is taken by mouth and has an estimated absorption rate of 9 to 19%.<ref name = TGA/> Studies have shown that when lurasidone is taken with food, absorption increases about twofold. Peak blood plasma concentrations are reached after one to three hours. About 99% of the circulating substance are bound to [[plasma protein]]s.<ref name="EMA">{{cite web|url=http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002713/WC500164683.pdf|title=Latuda: EPAR – Product Information|publisher=[[European Medicines Agency]]|date=14 April 2016|access-date=27 February 2017|archive-date=21 August 2016|archive-url=https://web.archive.org/web/20160821085044/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002713/WC500164683.pdf|url-status=live}}</ref> Efficacy data for lurasidone have been evaluated for doses of 20 mg to 120 mg daily.

Lurasidone is extensively metabolised by CYP3A4 leading to contraindication of both strong inhibitors as well as strong inducers of this enzyme,<ref>{{Cite web |url=https://www.ema.europa.eu/en/documents/assessment-report/latuda-epar-public-assessment-report_en.pdf |title=European Medicines Agency Assessment report Latuda International non-proprietary name: LURASIDONE Procedure No. EMEA/H/C/002713/0000 |access-date=14 November 2022 |archive-date=14 November 2022 |archive-url=https://web.archive.org/web/20221114022004/https://www.ema.europa.eu/en/documents/assessment-report/latuda-epar-public-assessment-report_en.pdf |url-status=live }}</ref> but has negligible affinity to other [[cytochrome P450]] enzymes. It is transported by [[P-glycoprotein]] and [[ABCG2]] and also inhibits these carrier proteins ''[[in vitro]]''. It also inhibits the solute carrier protein [[SLC22A1]], but no other relevant transporters.<ref name="EMA" /><ref name="PrescribingInfo">{{cite web|url=http://psychotherapeuticdrugs.com/index.php/new-drug-approvals/latuda-lurasidone-hcl|title=Latuda: Prescribing Information|publisher=Psychotherapeutic Drugs|access-date=17 December 2010|archive-url=https://web.archive.org/web/20110628044842/http://psychotherapeuticdrugs.com/index.php/new-drug-approvals/latuda-lurasidone-hcl|archive-date=28 June 2011|url-status=dead}}</ref>

Main metabolism pathways are oxidative N-[[dealkylation]] between the [[piperazine]] and cyclohexane rings, [[hydroxylation]] of the [[norbornane]] ring, and S-oxidation.<ref name="EMA" /><ref name="accessdata.fda.gov" />:59 Other pathways are hydroxylation of the cyclohexane ring and reductive cleavage of the [[isothiazole]] ring followed by S-[[methylation]].<ref name="Caccia" /> The two relevant active metabolites are the norbornane hydroxylation products called ID-14283 and ID-14326, the former reaching pharmacologically relevant blood plasma concentrations. The two major inactive metabolites are the N-dealkylation products (the [[carboxylic acid]] ID-20219 and the piperazine ID-11614<ref name="Caccia" />), and a norbornane hydroxylated derivative of ID-20219 (ID-20220). Of lurasidone and its metabolites circulating in the blood, the native drug makes up 11%, the main active metabolite 4%, and the inactive carboxylic acids 24% and 11%, respectively.<ref name = TGA/><ref name="EMA" /> Several dozen metabolites have been identified altogether.<ref name="accessdata.fda.gov" />:59–61

[[Biological half-life]] is given as 18 hours or 20 to 40 hours in different sources. 80% or 67% of a [[radiolabelled]] dose was recovered from the feces, and 9% or 19% from the urine.<ref name = TGA/><ref name="EMA" />

==History==
Lurasidone was first synthesised circa 2003.<ref>{{cite web|url=http://www.mmm-online.com/features/leading-latuda-through-the-crowd/article/213096/|title=Leading Latuda through the crowd|date=1 October 2011|quote=Latuda was developed at an R&D facility established in Fort Lee, NJ, about eight years ago by Sunovion's Japanese parent Dainippon Sumitomo Pharma Co. (DSP).|access-date=25 June 2017|archive-date=28 August 2018|archive-url=https://web.archive.org/web/20180828170409/http://www.mmm-online.com/features/leading-latuda-through-the-crowd/article/213096/|url-status=live}}</ref>

Lurasidone is a [[structural analogue]] of [[ziprasidone]]. Lurasidone shows a very close pharmacological profile and has been synthesized similarly to ziprasidone.<ref>{{Cite book|url=https://books.google.com/books?id=A8oHBgAAQBAJ&pg=PA100|title=Synthesis of Best-Seller Drugs|vauthors=Vardanyan R, Hruby V|date=7 January 2016|publisher=Academic Press|via=Google Books|isbn=978-0-12-411524-8|access-date=4 September 2017|archive-date=11 April 2023|archive-url=https://web.archive.org/web/20230411014520/https://books.google.com/books?id=A8oHBgAAQBAJ&pg=PA100|url-status=live}}</ref>

Lurasidone is chemically similar to [[perospirone]] (also a chemical analogue of ziprasidone), as well as [[risperidone]], [[paliperidone]] and [[iloperidone]].<ref>{{cite web|url=http://excli.de/vol13/Mauri_13102014_proof.pdf|date=17 November 2016|archive-url=https://web.archive.org/web/20161117142131/http://excli.de/vol13/Mauri_13102014_proof.pdf|archive-date=17 November 2016|title=EXCLI Journal}}</ref>

It has approval from the US [[Food and Drug Administration]] (FDA) for treating [[schizophrenia]] since 2010, and for treating [[depressive episode]]s in adults with [[bipolar I disorder]] since 2013.<ref name = TGA/>

==Society and culture==
[[File:Image of Latuda (Lurasidone) bottles.png|alt=Latuda 40mg and 80mg bottles with 80mg tablets.|thumb|Latuda 40mg and 80mg bottles with 80mg tablets.]]

===Cost===
In Canada, as of 2014, lurasidone is generally more expensive than [[risperidone]] and [[quetiapine]] but less expensive than [[aripiprazole]].<ref>{{cite book | via = National Center for Biotechnology Information, U.S. National Library of Medicine | chapter = Summary of Pharmacoeconomic Submission | chapter-url = https://www.ncbi.nlm.nih.gov/books/NBK195609/ | title = Lurasidone Hydrochloride (Latuda): Management of Manifestations of Schizophrenia | author = Canadian Agency for Drugs and Technologies in Health | access-date = 30 April 2020 | date = 2014 | publisher = Canadian Agency for Drugs and Technologies in Health | archive-date = 28 August 2021 | archive-url = https://web.archive.org/web/20210828152151/https://www.ncbi.nlm.nih.gov/books/NBK195609/ | url-status = live }}</ref>

In the United States, because a number of doses have the same price per tablet, pill splitting has been used to decrease costs.<ref>{{cite journal | vauthors = Carey H, Fondriest M | title = Cost-Savings From an Antipsychotic Tablet-Splitting Program | journal = P & T | volume = 42 | issue = 6 | pages = 384–393 | date = June 2017 | pmid = 28579725 | pmc = 5440099 }}</ref> In 2019, generic versions were approved in the United States; however, they only became available in 2023 due to drug patents.<ref name=Generic2019/><ref name=WSJ2019>{{cite news |vauthors=Hopkins JS |title=Generic-Drug Approvals Soar, But Patients Still Go Without |url=https://www.wsj.com/articles/many-generic-drugs-havent-hit-market-hindering-cost-control-efforts-11574198448 |access-date=30 April 2020 |work=Wall Street Journal |date=19 November 2019 |archive-date=27 April 2020 |archive-url=https://web.archive.org/web/20200427084114/https://www.wsj.com/articles/many-generic-drugs-havent-hit-market-hindering-cost-control-efforts-11574198448 |url-status=live }}</ref>

===Brand names===
In India, this drug is available under the brand names of Atlura, Lurace, Lurafic, Luramax (Sun Pharma), Lurasid, Lurastar, Latuda, Lurata<ref>{{Cite web|url=http://www.mims.com/india/drug/search?q=Lurasidone|title='Lurasidone' drug search|publisher=CIMS India|access-date=21 April 2018|archive-date=28 August 2021|archive-url=https://web.archive.org/web/20210828152153/https://www.mims.com/india/drug/search?q=Lurasidone|url-status=live}}</ref> and additionally as Alsiva, Emsidon, Lurakem, Luratrend, Tablura, and Unisidon.<ref>{{Cite web|url=https://www.ndrugs.com/?s=lurasidone#substitutes|title=Generic Drugs (ndrugs.com)|access-date=30 April 2018|archive-date=1 May 2018|archive-url=https://web.archive.org/web/20180501092921/https://www.ndrugs.com/?s=lurasidone#substitutes|url-status=live}}</ref>

===Regulatory approval===
Lurasidone was approved in the United States for the treatment of [[schizophrenia]] in October 2010<ref>{{cite web | title=Drug Approval Package: Latuda (lurasidone hydrochloride) Tablets NDA #200603 | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 December 1999 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm | access-date=12 May 2020 | archive-date=25 February 2021 | archive-url=https://web.archive.org/web/20210225053549/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm | url-status=dead }}</ref><ref>{{cite press release | title = FDA approves Latuda to treat schizophrenia in adults | publisher = U.S. [[Food and Drug Administration]] (FDA) | date = 28 October 2010 | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm | archive-url = https://web.archive.org/web/20101030233353/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm | url-status = dead | archive-date = 30 October 2010 | access-date = 29 October 2010}}</ref> and for the treatment of depressive episodes associated with [[bipolar I disorder]] in June 2013.<ref name = Medscape/><ref name="Latuda approval S1">{{cite web | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s010.pdf | title=Latuda Supplement Approval Package 1 | website=U.S. [[Food and Drug Administration]] (FDA) | access-date=12 May 2020 | archive-date=27 July 2020 | archive-url=https://web.archive.org/web/20200727025352/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s010.pdf | url-status=dead }}</ref><ref name="Latuda approval S2">{{cite web | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s011.pdf | title=Latuda Supplement Approval Package 2 | website=U.S. [[Food and Drug Administration]] (FDA) | access-date=12 May 2020 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828152150/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s011.pdf | url-status=live }}</ref> It received regulatory approval in the United Kingdom in September 2014. In October 2014, [[NHS Scotland]] advised use of lurasidone for schizophrenic adults who have not seen improvements with previous antipsychotics due to problems that arise from weight gain or changes in metabolic pathways when taking other medications.<ref>{{cite web|publisher=Scottish Medicines Consortium|year=2014|title=Lurasidone, 18.5mg, 37mg, 74mg film-coated tablets (Latuda) SMC No. (994/14)|url=http://www.scottishmedicines.org.uk/files/advice/lurasidone__Latuda__FINAL_Sept_2014_amended_15.09.14_for_website.pdf|work=scottishmedicines.org.uk|access-date=7 March 2016|archive-date=8 March 2016|archive-url=https://web.archive.org/web/20160308113939/http://www.scottishmedicines.org.uk/files/advice/lurasidone__Latuda__FINAL_Sept_2014_amended_15.09.14_for_website.pdf|url-status=dead}}</ref> The [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) issued a positive opinion for it in January 2014, and it was approved for medical use by the EMA in March 2014.<ref name="Latuda EPAR">{{cite web | title=Latuda EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/latuda | access-date=12 May 2020 | archive-date=11 August 2020 | archive-url=https://web.archive.org/web/20200811111331/https://www.ema.europa.eu/en/medicines/human/EPAR/latuda | url-status=live }} {{PD-notice}}</ref> It was launched in [[Canada]] for the treatment of schizophrenia in September 2012, [[Health Canada]] giving their Summary Basis of Decision (SBD) as favourable on 15 October 2012.<ref>{{cite web|url= http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_latuda_145406-eng.php#a2|work= hc-sc.gc.ca|publisher= Health Canada|title= Summary Basis of Decision (SBD) for Latuda|year= 2012|access-date= 19 June 2013|archive-date= 27 June 2013|archive-url= https://web.archive.org/web/20130627090950/http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_latuda_145406-eng.php#a2|url-status= live}}</ref> The [[European Commission]] has granted a marketing authorization for once-daily oral lurasidone for the treatment of schizophrenia in adults.<ref>{{cite web|url=http://www.tpi.takeda.com/media/news-releases/2014/european-marketing-authorization-for-latuda/|title=European Marketing Authorization for Latuda|work=takeda.com|access-date=25 November 2015|archive-url=https://web.archive.org/web/20171226234708/http://www.tpi.takeda.com/media/news-releases/2014/european-marketing-authorization-for-latuda/|archive-date=26 December 2017|url-status=dead}}</ref> It is approved for use in the EU.<ref name="Latuda EPAR" />

Generic versions of lurasidone were approved for use in the United States in January 2019 and became available in 2023.<ref>{{cite web | title=Lurasidone: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208049 | access-date=12 May 2020 | archive-date=1 October 2020 | archive-url=https://web.archive.org/web/20201001225140/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208049 | url-status=dead }}</ref>

== References ==
{{Reflist}}

== External links ==
* {{cite web | title=FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks | website=U.S. [[Food and Drug Administration]] (FDA) | date=7 January 2021 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-urges-caution-about-withholding-opioid-addiction-medications | archive-url=https://web.archive.org/web/20190914105148/https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-urges-caution-about-withholding-opioid-addiction-medications | url-status=dead | archive-date=14 September 2019 }}

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Lurasidone