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    DRUG:

    Winrevair (sotatercept-csrk)

    i
    Other names: MK-7962, ACE-011, human ACTRIIA-IgG-Fc, RAP 011, RAP-011, hActRIIA-IgG1, ActRIIA-IgG1
    Associations

    News

    Trials
    Company:
    BMS, Merck (MSD)
    Drug class:
    TGFβ inhibitor
    Related drugs:
    Associations

    News

    Trials
    2d
    SOFAPI: Impact of Sotatercept on Pulmonary Artery and Right Ventricle Remodeling Imaging Assessed With 68Ga-FAPI PET/CT in Patients With PAH (clinicaltrials.gov)
    P1/2, N=15, Not yet recruiting, University Hospital, Brest | Trial completion date: Dec 2028 --> Jan 2028 | Initiation date: Jan 2026 --> Jul 2026 | Trial primary completion date: Jan 2027 --> Jan 2028
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    3d
    A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032) (clinicaltrials.gov)
    P2, N=6, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2 trial
    |
    Winrevair (sotatercept-csrk)
    10d
    HARMONIZE: Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) (clinicaltrials.gov)
    P2, N=130, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Winrevair (sotatercept-csrk)
    23d
    HARMONIZE: Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) (clinicaltrials.gov)
    P2, N=130, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Mar 2029 --> Aug 2035 | Trial primary completion date: Mar 2029 --> Aug 2035
    Trial completion date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    27d
    A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037) (clinicaltrials.gov)
    P4, N=30, Not yet recruiting, Merck Sharp & Dohme LLC
    New P4 trial
    |
    Winrevair (sotatercept-csrk)
    2ms
    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
    |
    Winrevair (sotatercept-csrk)
    2ms
    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
    |
    Winrevair (sotatercept-csrk)
    2ms
    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
    |
    Winrevair (sotatercept-csrk)
    2ms
    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
    Trial initiation date
    |
    Winrevair (sotatercept-csrk)
    2ms
    Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension (clinicaltrials.gov)
    P4, N=30, Completed, Mayo Clinic | Active, not recruiting --> Completed
    Trial completion
    |
    Winrevair (sotatercept-csrk)
    2ms
    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
    |
    Winrevair (sotatercept-csrk)
    2ms
    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
    |
    Winrevair (sotatercept-csrk)