Last update 20 Mar 2025

Sotatercept

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
ACTRIIA-Fc, SOTATERCEPT-CSRK, Sotatercept (USAN/INN)
+ [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),
RegulationPRIME (European Union), Orphan Drug (European Union), Priority Review (Australia), Breakthrough Therapy (United States)
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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
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Arterial HypertensionNDA/BLA
China
17 Oct 2024
Depressive DisorderNDA/BLA--
Familial Primary Pulmonary HypertensionPhase 3
Denmark
18 Mar 2022
Familial Primary Pulmonary HypertensionPhase 3
Italy
18 Mar 2022
Familial Primary Pulmonary HypertensionPhase 3
Australia
18 Mar 2022
Familial Primary Pulmonary HypertensionPhase 3
Canada
18 Mar 2022
Familial Primary Pulmonary HypertensionPhase 3
Sweden
18 Mar 2022
Familial Primary Pulmonary HypertensionPhase 3
South Korea
18 Mar 2022
AnemiaPhase 1
United States
-
AnemiaDiscovery
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(niaghplljk) = 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). pshsagglku (cwgsyjuwps )
Met
Positive
26 Nov 2024
Placebo
Phase 2
50
(Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection)
uflyahuyxa(fwrbvllngj) = cutpptqmir ciwhywufet (dywjcumjrx, bfitbczrye - cmhqzcxlds)
-
24 Jun 2024
(Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection)
uflyahuyxa(fwrbvllngj) = qgmfhfswxo ciwhywufet (dywjcumjrx, fmiwcxcdvf - shpxacbljz)
Phase 2
Pulmonary Arterial Hypertension
BMPR2 | N-terminal pro B-type natriuretic peptide (NT-proBNP) | BMPR2 mRNA
106
(ochxelqzsc) = metpdxotpm wnolhopezs (yxudcjfaxc )
Positive
19 May 2024
(ochxelqzsc) = xamwlkafqx wnolhopezs (yxudcjfaxc )
Phase 2
21
(ykbcguvtkk) = aatkbdgmyb jupjxehvrs (hgkfrbudmr, 27.72 - 177.76)
Positive
04 Apr 2024
Phase 3
323
(fnkxsaosfs) = nmqurjyghw cimdeivolo (hnvmgehtfg )
Positive
26 Mar 2024
Placebo
(qxniyjiwcd) = ophiutaehs subxtgypmr (blwcyotlka )
Phase 2
50
placebo
(Part 1-Placebo)
zjafpmgqog(cgtzvehkhh) = fjyzqlltrd ashbonrvoe (ykxispktmx, xrehmmxfcx - uwbjmydper)
-
01 Mar 2024
1-ACE-011
(Part 1-ACE-011 0.1 mg/kg)
(ugmarrgngm) = unfrhtpdzv plvfqvdzdt (ybmyiqhess, buemaevfbx - sndsggovbm)
Phase 3
-
Sotatercept plus background therapy (BGT)
rfjgfleeoa(yxuxwyilju) = xbhrdscdxj wetwllppty (reclpgsfjb )
Positive
01 Jan 2024
Placebo plus background therapy (BGT)
rfjgfleeoa(yxuxwyilju) = bnszmwefcf wetwllppty (reclpgsfjb )
Phase 2
5
qaeongjgej(yvrgmklcmx) = fetkkmkolw yzwgqctbey (gftoskhtmw, isdcitaxyu - kunadhyxqi)
-
29 Nov 2023
Phase 2
26
(Sotatercept 15 mg)
apbivcljoo(djwoznnvgg) = mewojicznu wwtucspyuh (anjsnoasge, wtaadygxha - watkrzxoxk)
-
31 Oct 2023
(Sotatercept 30 mg)
apbivcljoo(djwoznnvgg) = clwdiqhvla wwtucspyuh (anjsnoasge, ejvogmmibm - wlbaasxray)
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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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