Drug Type Small molecule drug |
Synonyms Dry powder formulation of treprostinil(MannKind Corporation), TETON, TREPROSTINIL + [22] |
Target |
Action agonists |
Mechanism PGI2 receptor agonists(Prostanoid IP receptor agonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (21 May 2002), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea) |
Molecular FormulaC23H34NaO5 |
InChIKeyRCKWZOAISRYANP-ZSESPEEFSA-N |
CAS Registry289480-64-4 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D06213D08628 | Treprostinil |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hypertension, Pulmonary | United States | 23 May 2022 | |
| Lung Diseases, Interstitial | United States | 31 Mar 2021 | |
| Chronic thromboembolic pulmonary hypertension | European Union | 03 Apr 2020 | |
| Chronic thromboembolic pulmonary hypertension | Iceland | 03 Apr 2020 | |
| Chronic thromboembolic pulmonary hypertension | Liechtenstein | 03 Apr 2020 | |
| Chronic thromboembolic pulmonary hypertension | Norway | 03 Apr 2020 | |
| Pulmonary Arterial Hypertension | United States | 21 May 2002 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pulmonary hypertension due to interstitial lung disease | NDA/BLA | United States | 19 Aug 2024 | |
| Idiopathic Pulmonary Fibrosis | NDA/BLA | United States | - | |
| Progressive fibrotic interstitial lung disease | Phase 3 | United States | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | Argentina | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | Australia | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | Belgium | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | Canada | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | Chile | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | France | 30 Oct 2023 | |
| Progressive fibrotic interstitial lung disease | Phase 3 | Germany | 30 Oct 2023 |
Phase 3 | 593 | xpcinuogrm(ukovrskxcn) = ygkmouqawh bnunlcfzpk (fzhzzzddkg, -79.2 to -19.5) View more | Positive | 09 Jul 2026 | |||
Placebo | xpcinuogrm(ukovrskxcn) = gsmoinuqnd bnunlcfzpk (fzhzzzddkg, -172.5 to -104.0) View more | ||||||
Phase 3 | 598 | dcmqkyjico(ekfksmvtwi) = obttchnwyf zutllhcufn (mdllttsymx ) View more | Positive | 09 Jul 2026 | |||
Placebo | dcmqkyjico(ekfksmvtwi) = znatvlmcmr zutllhcufn (mdllttsymx ) View more | ||||||
Phase 4 | 23 | (Pulmonary Arterial Hypertension) | svcyujgoam(qszvfzxdcx) = vxiuznckpx wdkusovebp (eardxhtseq ) View more | Positive | 15 May 2026 | ||
Not Applicable | 32 | gwsphxpnlt(aimypdqheh) = wtrpnvlfko uomazaypry (ttkxthldwk ) View more | Similar | 15 May 2026 | |||
gwsphxpnlt(aimypdqheh) = ilucgevzdd uomazaypry (ttkxthldwk ) View more | |||||||
Phase 2 | 4 | sefpyrhuqu(fiahgrfefw) = qauovyasnl opmehsnysq (epsjoliqlh ) View more | Positive | 15 May 2026 | |||
Not Applicable | 59 | rizszftkgx(qubetwztqo) = no statistically significant changes were observed at 3, 6, or 12 months masbqldqme (mnducvxrux ) View more | Negative | 15 May 2026 | |||
Phase 3 | 156 | Oral Treprostinil + Background ERA and/or PDE-5i (Background monotherapy) | jqdhywfagw(uziudlcafm) = oeauhoeyoa enksesysnn (ctocyllmxj ) | Positive | 02 Feb 2026 | ||
Oral Treprostinil + Background ERA and/or PDE-5i | jqdhywfagw(uziudlcafm) = disqlvisgp enksesysnn (ctocyllmxj ) | ||||||
Phase 2 | 29 | Right Heart Catheterization (RHC) while exercising+Treprostinil (PAH-ILD Patients) | zpigaskeyn(iazzeuxyel) = sptfatnrld dzvqgowbfz (mwfvkdszlq, 2.1) View more | - | 03 Dec 2025 | ||
Right Heart Catheterization (RHC) while exercising (Healthy Volunteers) | sxitvkqkcc(bnwgztooaf) = pzxymbcfwu lhdmaixibx (dcajbuufuj, tagmkpxavb - gpwzonepgr) View more | ||||||
Phase 3 | 597 | bsxkxlvmni(rtukpkjgiw) = Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. xypahwoqpn (qozywsbeaz ) Met | Positive | 02 Sep 2025 | |||
placebo | |||||||
Not Applicable | - | - | iksrgdqkyc(avkwqejiaq) = cxgzqinmdt pwieybfkai (rjqpcsiipx ) | - | 16 May 2025 |





