Treprostinil
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Treprostinil, sold under the brand names Remodulin for infusion, Orenitram for oral, and Tyvaso for inhalation, is a vasodilator that is used for the treatment of pulmonary arterial hypertension.[1]
Treprostinil was approved for use in the United States in May 2002.[2]
Medical uses
Treprostinil is indicated for the treatment of pulmonary arterial hypertension in people with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.[3]
Treprostinil inhalation solution and treprostinil inhalation powder are indicated for the treatment of people with pulmonary arterial hypertension (WHO Group 1) to improve exercise ability; and people with pulmonary hypertension associated with interstitial lung disease (WHO Group 3) to improve exercise ability.[4][5]
In the European Union, treprostinil (Trepulmix) is indicated for the treatment of adults with WHO Functional Class III or IV and inoperable chronic thromboembolic pulmonary hypertension;[6] or persistent or recurrent chronic thromboembolic pulmonary hypertension after surgical treatment to improve exercise capacity.[6]
Adverse effects
- Since treprostinil is a vasodilator, its antihypertensive effect may be compounded by other medications that affect the blood pressure, including calcium channel blockers, diuretics, and other vasodilating agents.[7]
- Because of treprostinil's inhibiting effect on platelet aggregation, there is an increased risk of bleeding, especially among patients who are also taking anticoagulants.[7]
Common side effects depending on route of administration:
- 85% of patients report pain or other reaction at the infusion site.[7]
History
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Treprostinil (Remodulin) was approved for medical use in the United States in May 2002,[2] and again in July 2018.[9]
Treprostinil (Tyvaso), as inhalation solution, was approved for medical use in the United States in July 2009,[10] and again in April 2021.[11]
Treprostinil (Orenitram), as extended release tablets, was approved for medical use in the United States in December 2013.[12]
Treprostinil (Trepulmix) was authorized for medical use in the European Union in April 2020.[6] Trepulmix is a hybrid medicine that is similar to the reference medicine Remodulin.[6] It contains the same active substance, but it is used for treating a different form of pulmonary hypertension.[6]
Treprostinil (Tyvaso DPI), as inhalation powder, was approved for medical use in the United States in May 2022.[13][14]
Treprostinil (Yutrepia), as inhalation powder, was approved for medical use in the United States in June 2025.[15][16]
Research
Treprostinil therapy may be effective in treating Degos disease.[17]
References
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- ↑ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213005Orig1s000ltr.pdf
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Further reading
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External links
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- Clinical trial number NCT03399604 for "Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil (INSPIRE)" at ClinicalTrials.gov
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