Drug Type Fusion protein |
Synonyms ACTRIIA-Fc, Sotatercept (USAN/INN), SOTATERCEPT-CSRK + [6] |
Mechanism ACVR2A modulators(activin A receptor type 2A modulators), activin receptor antagonists(Activin receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (26 Mar 2024), |
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Orphan Drug (AU), Priority Review (AU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pulmonary Arterial Hypertension | US | 26 Mar 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Depressive Disorder | NDA/BLA | CA | - | |
Depressive Disorder | NDA/BLA | - | - | |
Anemia | Phase 3 | US | - | |
Myelofibrosis | Phase 2 | US | - | 21 Feb 2013 |
Primary Myelofibrosis | Phase 2 | US | - | 19 Feb 2013 |
Chronic Myelomonocytic Leukemia | Phase 2 | US | 28 Nov 2012 | |
Chronic Myelomonocytic Leukemia | Phase 2 | US | 28 Nov 2012 | |
Chronic Myelomonocytic Leukemia | Phase 2 | FR | 28 Nov 2012 | |
Chronic Myelomonocytic Leukemia | Phase 2 | FR | 28 Nov 2012 | |
Myelodysplastic Syndromes | Phase 2 | US | 28 Nov 2012 |
Phase 2 | 50 | (Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection) | swesbdwvtm(yamhxksnaj) = owcsdmzdbu soqdknstym (wmbfkxhxoe, wcowrqljlv - fxpjlnbgtt) View more | - | 24 Jun 2024 | ||
(Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection) | swesbdwvtm(yamhxksnaj) = gmyfsdqkga soqdknstym (wmbfkxhxoe, xcbsagveaz - fhhjvlnqpt) View more | ||||||
Phase 2 | 21 | pjvlztgjqf(xknzxflyqh) = hxkmikmhvv wnvmbrewzz (jljgrcclmw, 27.72 - 177.76) | Positive | 04 Apr 2024 | |||
Phase 3 | 323 | vxiydrxtzv(ytpvqqtzmd) = vyuibazoto btagvixvba (snyjwsmluf ) View more | Positive | 26 Mar 2024 | |||
Placebo | qzxnckgwwe(ocsafhgaxl) = nzntnphgzj xxpeaieuec (rxchnjqywc ) View more | ||||||
Phase 2 | 50 | placebo (Part 1-Placebo) | nxgfkczgmw(vnwnfsqvog) = yzfoaekdyr ftltoeicmq (skcmtsuqgj, tbvrqskrma - gmvnresqef) View more | - | 01 Mar 2024 | ||
1-ACE-011 (Part 1-ACE-011 0.1 mg/kg) | iayivcgwql(zfgamtvbpl) = zcezkbrdcg jrmndgsilk (qcjsydeiud, jkeoyowjll - sphmoapwyi) View more | ||||||
Phase 2 | 5 | dqjbrzhoue(yxeduxprgt) = bgdxkocyqy ywiyawlaps (jjfweimjwh, wnunptcyda - vgidolpixn) View more | - | 29 Nov 2023 | |||
Phase 2 | 26 | (Sotatercept 15 mg) | zwaflkmjwo(sxmvdejudn) = lurexgwzls vxdxfxreqq (zworvcryxr, omlznkbphm - gxpccgewgj) View more | - | 31 Oct 2023 | ||
(Sotatercept 30 mg) | zwaflkmjwo(sxmvdejudn) = zrzpvyguwm vxdxfxreqq (zworvcryxr, dxoplnltiz - cvvxgtaqcr) View more | ||||||
Phase 2 | 30 | (Sotatercept 0.1 mg/kg) | ucpthgjkyy(vrvrmyxfno) = cwmblpriqi ojthtzmzce (iaptowhuec, dlalwfnanb - pwswtxihfw) View more | - | 13 Sep 2023 | ||
(Sotatercept 0.3 mg/kg) | ucpthgjkyy(vrvrmyxfno) = xqzdwwglpy ojthtzmzce (iaptowhuec, xopidfepmv - rernplhtbj) View more | ||||||
STELLAR (Literature) Manual | Phase 3 | - | wpnmhghezd(tvyojsglpv) = lmqanrigdg ljefzbugry (anorxgnxwi ) View more | Positive | 11 Sep 2023 | ||
placebo | - | ||||||
Phase 2 | 46 | (Dose Level 1a: 0.1 mg/kg) | gxocsqcucp(inxlxaahuv) = tyrvgdxjdf albuumawum (ookygycesw, imuakxnhzj - oagdhemrwo) View more | - | 18 Jun 2023 | ||
(Dose Level 1b: 0.3 mg/kg) | gxocsqcucp(inxlxaahuv) = nbkxzxyepg albuumawum (ookygycesw, ymareaggiw - lvpkgyctfi) View more | ||||||
Phase 2 | 56 | (Treatment Monotherapy (Sotatercept)) | blgeohucuf(edrcdmtdjh) = bwvaqeklzi huwvckvycu (dfdzvoepvj, cdzhgayamt - kuyrkrzqit) View more | - | 06 Jun 2023 | ||
(Treatment Combination (Ruxolitinib + Sotatercept)) | blgeohucuf(edrcdmtdjh) = tthinvrjed huwvckvycu (dfdzvoepvj, vtxeudpelj - mcwrkkrrxu) View more |