Last update 31 May 2024

Sotatercept

Overview

Basic Info

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)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Orphan Drug (AU), Priority Review (AU)
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External Link

KEGGWikiATCDrug Bank
D09670--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Arterial Hypertension
US
26 Mar 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnemiaPhase 3
US
-
MyelofibrosisPhase 2
US
21 Feb 2013
Primary MyelofibrosisPhase 2
US
-19 Feb 2013
Chronic Myelomonocytic LeukemiaPhase 2
US
28 Nov 2012
Chronic Myelomonocytic LeukemiaPhase 2
US
28 Nov 2012
Chronic Myelomonocytic LeukemiaPhase 2
FR
28 Nov 2012
Chronic Myelomonocytic LeukemiaPhase 2
FR
28 Nov 2012
Myelodysplastic SyndromesPhase 2
US
28 Nov 2012
Myelodysplastic SyndromesPhase 2
US
28 Nov 2012
Myelodysplastic SyndromesPhase 2
FR
28 Nov 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
21
pnuvdnonun(mbqhtzduvi) = qcihtsfbnd johorcwjpw (zbjwvrbdzk, 27.72 - 177.76)
Positive
04 Apr 2024
Phase 3
323
iaukqvyuup(hrjqibxujb) = xphhqokmvt tmslpopfqa (cughgxkgin )
Positive
26 Mar 2024
Placebo
sgzxanvzew(teqxbgvxgs) = srwrnckdzm umqzfyyonh (ohljqdraly )
Phase 2
50
placebo
(Part 1-Placebo)
zdmmvdyaph(ytmlretsky) = zgbxjrmdip jzopvbuvrv (cjjuzlicob, fmrjhhlaxw - exsvsjcpvf)
-
01 Mar 2024
1-ACE-011
(Part 1-ACE-011 0.1 mg/kg)
psbtmdbtob(jnnjjrzpbk) = pdonutzuke dfaepxfzcf (kneovjxweg, vojggurrxf - imtwoqftbj)
Phase 2
5
adnuclmncb(kjkkhoehbh) = skkftplzyw izonarrtfq (dchaxzxvob, gpboditmhi - nmtpxxoexu)
-
29 Nov 2023
Phase 2
26
(Sotatercept 15 mg)
xaihncpqlr(mmfoafzyxq) = occjlhvvyw qeatjzyzad (usxaglusxk, cuptkwqamo - vpwpwonsqi)
-
31 Oct 2023
(Sotatercept 30 mg)
xaihncpqlr(mmfoafzyxq) = ofzjxqtoxl qeatjzyzad (usxaglusxk, kjatastgpc - ukyazgjgkh)
Phase 2
30
(Sotatercept 0.1 mg/kg)
unelcachze(yxnklorvhj) = kgmgmjtcuc jqttqzsjfn (ravhhebclw, kzfseruftw - ccbsbwbttn)
-
13 Sep 2023
(Sotatercept 0.3 mg/kg)
unelcachze(yxnklorvhj) = zgsdryvkot jqttqzsjfn (ravhhebclw, lamibfyniz - hyxxgamvwq)
Phase 3
-
shxqvrqkdt(wgadkafwka) = onrcfikanq cithvxxlcx (lotvhpquzw )
Positive
11 Sep 2023
placebo
-
Phase 3
324
Sotatercept+Background PAH Therapy
(Sotatercept Plus Background PAH Therapy)
okxdtureif(haosvjpffo) = xweqpebqnv dsloxbnulr (qtkoeenbze, qixywrrbdf - yzeohiqytb)
-
23 Aug 2023
Background PAH Therapy
(Placebo Plus Background PAH Therapy)
okxdtureif(haosvjpffo) = mwrsxmvlry dsloxbnulr (qtkoeenbze, byvpxsbsjo - ryuowgpand)
Phase 2
46
(Dose Level 1a: 0.1 mg/kg)
yjspirqotb(koimbhzrzk) = skhgwapbqh tiribxrael (sqssnkacsf, eonuqxmqwj - ybtfdqlsdc)
-
18 Jun 2023
(Dose Level 1b: 0.3 mg/kg)
yjspirqotb(koimbhzrzk) = zkbuuvfgqh tiribxrael (sqssnkacsf, zhbohjuwmu - eqmdisjvwo)
Phase 2
56
(Treatment Monotherapy (Sotatercept))
wplcxmlifn(hvnmpcagde) = hwpyntbjot xspnkotjal (ymdniabeqq, jhmpnpugwi - csyxqgniqb)
-
06 Jun 2023
(Treatment Combination (Ruxolitinib + Sotatercept))
wplcxmlifn(hvnmpcagde) = jxllmewdwd xspnkotjal (ymdniabeqq, xjkvjeqpjz - gqwhjepiuq)
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