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DRUG:

Winrevair (sotatercept-csrk)

i
Other names: RAP-011, hActRIIA-IgG1, ActRIIA-IgG1, MK-7962, ACE-011, human ACTRIIA-IgG-Fc, RAP 011
Associations
Trials
Company:
BMS, Merck (MSD)
Drug class:
TGFβ inhibitor
Associations
Trials
10d
SOTERIA: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (clinicaltrials.gov)
P3, N=815, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting
Enrollment open • Trial initiation date
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Winrevair (sotatercept-csrk)
12d
HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov)
P3, N=321, Terminated, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Completed --> Terminated; Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.
Trial termination
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Winrevair (sotatercept-csrk)
13d
SOTERIA: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (clinicaltrials.gov)
P3, N=815, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
Enrollment closed
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Winrevair (sotatercept-csrk)
19d
Trial initiation date
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Winrevair (sotatercept-csrk)
23d
Trial completion
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Winrevair (sotatercept-csrk)
25d
CADENCE: A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (clinicaltrials.gov)
P2, N=164, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Active, not recruiting --> Completed
Trial completion
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Winrevair (sotatercept-csrk)
1m
Real World Observational Study of Sotatercept for Pulmonary Hypertension (clinicaltrials.gov)
P=N/A, N=120, Recruiting, Mayo Clinic | Enrolling by invitation --> Recruiting | Trial completion date: Jan 2035 --> Mar 2027 | Trial primary completion date: Jan 2035 --> Mar 2027
Enrollment status • Trial completion date • Trial primary completion date • Real-world evidence
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Winrevair (sotatercept-csrk)
1m
New P2 trial
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Winrevair (sotatercept-csrk)
1m
Trial initiation date
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Winrevair (sotatercept-csrk)
2ms
Trial initiation date
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Winrevair (sotatercept-csrk)
3ms
New P2/3 trial
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Winrevair (sotatercept-csrk)
4ms
New P1/2 trial
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Winrevair (sotatercept-csrk)