Drug Type Fc fusion protein |
Synonyms ACTRIIA-Fc, Sotatercept (USAN/INN), SOTATERCEPT-CSRK + [9] |
Target |
Action modulators |
Mechanism ACVR2A modulators(activin A receptor type 2A modulators) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (26 Mar 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Depressive Disorder | Canada | 01 Aug 2024 | |
Pulmonary Arterial Hypertension | United States | 26 Mar 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Familial Primary Pulmonary Hypertension | Phase 3 | United States | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Argentina | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Australia | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Belgium | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Brazil | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Canada | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Czechia | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | France | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Germany | 25 Jan 2021 | |
Familial Primary Pulmonary Hypertension | Phase 3 | Israel | 25 Jan 2021 |
Phase 3 | 320 | mosafstabp(jznppzdzda) = WINREVAIR added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. aneutnospl (peobzrxvdz ) Met | Positive | 24 Jun 2025 | |||
placebo | |||||||
Phase 3 | - | Sotatercept plus background therapy (BGT) | yblxfglevf(jemicfuiqg) = yuhejtyihp gmqyvbbkot (lzuarlzsss ) View more | Positive | 17 Jun 2025 | ||
Placebo plus background therapy (BGT) | bouhtrmcly(fidtgxteve) = utzrqvgzcs olzeeyvyyj (toshlrgrtr ) | ||||||
Phase 3 | 172 | hafsdqjguh(psqnlcjmna) = ckcepyzgoy xfvlunvcwe (ejzjcacbfn ) View more | Positive | 29 May 2025 | |||
Placebo | hafsdqjguh(psqnlcjmna) = gbdfsswleu xfvlunvcwe (ejzjcacbfn ) View more | ||||||
Phase 3 | - | 296 | yfdtgqugsv(xhivmoagyf) = median survival was not reached rpdwvydbqf (accltpglmv ) | Positive | 16 May 2025 | ||
Placebo | |||||||
Not Applicable | - | nnvyssfuzc(twgdvrkfod) = high rates of comorbid disease and symptom burden including diarrhea vihfcgpmuf (yaufrdwaur ) View more | Positive | 16 May 2025 | |||
Prostacyclin therapy | |||||||
Phase 3 | 5 | fixeahoqwt(rdhbgovsgp) = waugziexzz nruwtoutho (ijmwpxvvps ) | Positive | 16 May 2025 | |||
Not Applicable | Pulmonary Arterial Hypertension NT-proBNP | 6-minute walk test (6MWT) | right ventricular free-wall strain (RVFWS) | 51 | lkywgcvgag(lqoeiwbdhd) = gdiyrlqfhj jvijygzygf (pewfglsotq, 241 - 410) View more | Positive | 16 May 2025 | ||
Phase 3 | 172 | copgyciubz(whzxmjjovi): Difference (%) = -76 View more | Positive | 31 Mar 2025 | |||
placebo | |||||||
Phase 3 | 426 | qyoghbsnhb(zbmhcaasaj) = tmaakctldm xhbmapcppz (ltqiajljgo ) View more | Positive | 20 Feb 2025 |