Last update 25 Jul 2025

Sotatercept

Overview

Basic Info

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)
Originator Organization
Inactive 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)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D09670--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Depressive Disorder
Canada
01 Aug 2024
Pulmonary Arterial Hypertension
United States
26 Mar 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Familial Primary Pulmonary HypertensionPhase 3
United States
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Argentina
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Australia
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Belgium
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Brazil
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Canada
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Czechia
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
France
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Germany
25 Jan 2021
Familial Primary Pulmonary HypertensionPhase 3
Israel
25 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
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 )
Positive
17 Jun 2025
Placebo plus background therapy (BGT)
bouhtrmcly(fidtgxteve) = utzrqvgzcs olzeeyvyyj (toshlrgrtr )
Phase 3
172
hafsdqjguh(psqnlcjmna) = ckcepyzgoy xfvlunvcwe (ejzjcacbfn )
Positive
29 May 2025
Placebo
hafsdqjguh(psqnlcjmna) = gbdfsswleu xfvlunvcwe (ejzjcacbfn )
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 )
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)
Positive
16 May 2025
Phase 3
172
copgyciubz(whzxmjjovi): Difference (%) = -76
Positive
31 Mar 2025
placebo
Phase 3
426
qyoghbsnhb(zbmhcaasaj) = tmaakctldm xhbmapcppz (ltqiajljgo )
Positive
20 Feb 2025
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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