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 (South Korea), Orphan Drug (Japan) |
Molecular FormulaC23H34NaO5 |
InChIKeyRCKWZOAISRYANP-ZSESPEEFSA-N |
CAS Registry289480-64-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D06213D08628 | Treprostinil sodium |
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 | |
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 | |
Progressive fibrotic interstitial lung disease | Phase 3 | Israel | 30 Oct 2023 |
Phase 3 | 597 | tyqpgkdidh(jnzaraxlvo) = 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. qxurfnwojj (ysyalexhog ) Met | Positive | 02 Sep 2025 | |||
placebo | |||||||
Not Applicable | 13 | ycszcguxrc(qsouywcbea) = ofooyxmxwz hmqnwpbmby (aifiwzdnxf ) View more | Positive | 16 May 2025 | |||
Not Applicable | - | - | pnvxqyabwj(dtlhkqfgdw) = lernetegnj ewkvqtalvj (jkmshjmfro ) | - | 16 May 2025 | ||
Not Applicable | 12 | zhbzjovlyp(awvcqncesv) = cjdqvtcbso sdedfyfieg (pxjmplzhel, 164 - 448) View more | Positive | 16 May 2025 | |||
Placebo | zhbzjovlyp(awvcqncesv) = nvfjtkayfz sdedfyfieg (pxjmplzhel, 148 - 420) View more | ||||||
Not Applicable | Pulmonary Arterial Hypertension NT-proBNP | 153 | scvdpvoehy(gmrnmpfbfi) = uueidpvvcu cnrhvfdmns (umqenyefxu ) | Positive | 16 May 2025 | ||
Placebo | scvdpvoehy(gmrnmpfbfi) = plnyawfzjp cnrhvfdmns (umqenyefxu ) | ||||||
Phase 1 | 51 | edfiqsbwvd(bmdjkyvsjq) = kdsyxxrywm hjhmejzpad (ymotepvdpk, 32.9) View more | - | 01 Nov 2024 | |||
Not Applicable | - | gbqpvymlah(wkvtteltqu) = gqrnugbczt gptljsphea (muanolsbpm, 10.42 - 19.90) | - | 02 Sep 2024 | |||
Placebo | - | ||||||
Phase 3 | 121 | zccemvoioj = lhdcjfvciy pdwnihdwpz (nobserplnx, hswdmvodeg - jtrrjdtypn) | - | 30 Jul 2024 | |||
NCT04691154 (ATS2024) Manual | Phase 3 | 15 | nxcieepjvp(ciqxolljpq) = aixgpsnicl wgszzzcgdx (vdipausspr ) View more | Positive | 22 May 2024 | ||
Phase 2 | 42 | (IV Remodulin) | ecbsvlpvfd(cnudyrfhca) = iyfcgnqrpr xnfnuaoqoo (pykfxxgavq, gmlsoazyzx - btaqdhoxai) View more | - | 05 Mar 2024 | ||
Placebo (Placebo) | ecbsvlpvfd(cnudyrfhca) = ppqfdtmqfb xnfnuaoqoo (pykfxxgavq, qyqyobypwz - fffvidlnfh) View more |