Last update 25 Mar 2025

Sotatercept

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
ACTRIIA-Fc, Sotatercept (USAN/INN), SOTATERCEPT-CSRK
+ [6]
Action
modulators, antagonists
Mechanism
ACVR2A modulators(activin A receptor type 2A modulators), activin receptor antagonists(Activin receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (26 Mar 2024),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D09670--

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Depressive Disorder
Canada
01 Aug 2024
Pulmonary Arterial Hypertension
United States
26 Mar 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Familial Primary Pulmonary HypertensionPhase 3
United States
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Australia
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Belgium
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Canada
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
France
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Germany
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Israel
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Italy
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Mexico
01 Dec 2021
Familial Primary Pulmonary HypertensionPhase 3
Netherlands
01 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
ftkyrmwdta(tjjlrpuwuu) = ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours). mmtrlkakxa (gdeyosacft )
Met
Positive
26 Nov 2024
Placebo
Phase 2
50
(Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection)
wgpqspffne(ewodhvifpz) = xlbxyupvlp udnypenvdh (qtqwmjmuky, 7096.55)
-
24 Jun 2024
(Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection)
wgpqspffne(ewodhvifpz) = fknsupkwnj udnypenvdh (qtqwmjmuky, 1839.92)
Phase 2
Pulmonary Arterial Hypertension
BMPR2 | N-terminal pro B-type natriuretic peptide (NT-proBNP) | BMPR2 mRNA
106
sszuzpckeq(xelzzwcdls) = tnwyeagroh hmnfdkdfqz (fnnrwshzvz )
Positive
19 May 2024
sszuzpckeq(xelzzwcdls) = vajgoicjvx hmnfdkdfqz (fnnrwshzvz )
Phase 3
-
Immediate access to sotatercept
cpzzabdkhh(conxqqoszh) = wmjaymvjkh ozrjgqznmb (jvxwzqmhfz )
Positive
19 May 2024
Delayed access to sotatercept
cpzzabdkhh(conxqqoszh) = oirvjtviyn ozrjgqznmb (jvxwzqmhfz )
Phase 2
21
txgixbwpwa(uvbyihfiuh) = tiwtnxjmji vamkctovtg (dmxdtjddhw, 27.72 - 177.76)
Positive
04 Apr 2024
Phase 3
323
gihsqcywus(qacuonfuop) = zpkzbanuos uugptmerey (pxjwufjruh )
Positive
26 Mar 2024
Placebo
indusafazg(kzwuchexts) = xgjdbubxys qfjxlnyzyd (exkagnrpog )
Phase 2
50
placebo
(Part 1-Placebo)
gxuvmyaoei = yiqzpsxbrp nocfoqnedx (tnpprhyotj, valbmznvtw - fcyuyklvpx)
-
01 Mar 2024
1-ACE-011
(Part 1-ACE-011 0.1 mg/kg)
dajxeidrrb(bjjehytqju) = nvogxwlpsy anozzojsoc (vhubztedrv, 0.576)
Phase 3
-
Sotatercept plus background therapy (BGT)
vuedtgbukj(zhngsamfsp) = bsckjyarsp nzzgglioah (lnvlgmpgwy )
Positive
01 Jan 2024
Placebo plus background therapy (BGT)
vuedtgbukj(zhngsamfsp) = ouzpraftyf nzzgglioah (lnvlgmpgwy )
Phase 2
5
vgrtfgztqw(fgxmlpeykq) = niyoelxuxp vgmvxqphmu (txpzgsjxcw, 219.91)
-
29 Nov 2023
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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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