Fasoracetam

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Fasoracetam (INNTooltip International Nonproprietary Name) is an experimental drug of the racetam group which was never marketed.[1][2][3] It is a putative nootropic that failed to show sufficient efficacy in clinical trials for vascular dementia.[3] The drug was also subsequently repurposed for treatment of a variety of other conditions, such as attention deficit hyperactivity disorder (ADHD), but effectiveness for ADHD was disappointing[4] and development of fasoracetam for most other conditions has been discontinued as well.[5][6][7][8] In any case, it remains under development for treatment of DiGeorge syndrome.[6]

Pharmacology

Fasoracetam appears to modulate and stimulate all three groups of metabotropic glutamate receptors (mGluRs).[3][1] It has been found to improve certain aspects of cognitive function in rodent studies.[3][1] The drug is orally bioavailable and is excreted mostly unchanged in urine.[1][3]

Chemistry

Fasoracetam is a racetam and a derivative of pyroglutamic acid.[1][2]

History

Fasoracetam was developed in the late 1980s.[3] It was discovered by scientists at the Japanese pharmaceutical company Nippon Shinyaku, which brought it through Phase 3 clinical trials for vascular dementia, and abandoned it due to lack of efficacy.[3][9] Subsequently, fasoracetam was repurposed for treatment of ADHD and other indications.[3][5][6][7]

Scientists at Children's Hospital of Philadelphia led by Hakon Hakonarson have studied fasoracetam's potential use in attention deficit hyperactivity disorder.[3] Hakonarson's company neuroFix tried to bring the drug to market for this use; neuroFix acquired Nippon Shinyaku's clinical data as part of its efforts.[9][10] neuroFix was acquired by Medgenics in 2015.[10] Medgenics changed its name to Aevi Genomic Medicine in 2016.[11]

Clinical trials in adolescents with ADHD who also have mGluR mutations started in 2016.[10] While fasoracetam may be effective in the treatment of ADHD in people with specific mGluR mutations, these represent around 10% of total ADHD cases, and fasoracetam is likely ineffective in all other cases.[12][13] Studies showing improvements in cognitive function from fasoracetam have exclusively been done on rodents.[12]

Society and culture

Legality

Australia

Fasoracetam is a schedule 4 substance in Australia under the Poisons Standard (February 2020).[14] A schedule 4 substance is classified as "Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription."[14]

Research

Fasoracetam was originally developed for treatment of cognitive impairment related to dementia.[3] It reached phase 3 clinical trials for this indication.[3] However, development was discontinued due to lack of effectiveness and fasoracetam was never marketed.[3]

Fasoracetam (developmental code names AFEVI-001, LAM-105, MDGN-001, NFC-1, NS-105) was under development by Avalo Therapeutics (previously Cerecor) for the treatment of attention deficit hyperactivity disorder (ADHD), autistic disorder, cognition disorders, DiGeorge syndrome, and major depressive disorder.[5] However, development for all indications was discontinued by 2018.[5] The drug (developmental code name NB-001) is also under development by Nobias Therapeutics for the treatment of DiGeorge syndrome and is in phase 2 clinical trials for this use as of October 2023.[6] A co-crystallized form of fasoracetam (developmental code name AEVI-004) is under development by Avalo Therapeutics for the treatment of ADHD, autistic disorder, and epilepsy as well.[7] However, no recent development has been reported for these indications as of April 2023.[7]

The results of clinical studies for ADHD with fasoracetam have not shown statistical significance in efficacy.[4]

References

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  7. ↑ a b c d Script error: No such module "citation/CS1".
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  9. ↑ a b Script error: No such module "citation/CS1".
  10. ↑ a b c Script error: No such module "citation/CS1".
  11. ↑ Script error: No such module "citation/CS1".
  12. ↑ a b Script error: No such module "Citation/CS1".
  13. ↑ Script error: No such module "Citation/CS1".
  14. ↑ a b Poisons Standard February 2020. comlaw.gov.au

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