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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
    3d
    A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) (clinicaltrials.gov)
    P3, N=172, Active, not recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: Nov 2025 --> Feb 2025 | Trial primary completion date: Sep 2025 --> Jul 2024
    Trial completion date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    1m
    SOTERIA: A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (clinicaltrials.gov)
    P3, N=700, Recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: Nov 2027 --> Feb 2031 | Trial primary completion date: Sep 2027 --> Feb 2031
    Trial completion date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    1m
    LIGHTRAY: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) (clinicaltrials.gov)
    P2, N=160, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Winrevair (sotatercept-csrk)
    1m
    Sox-PH: 129 Xenon Imaging in Patients Treated with Sotatercept (clinicaltrials.gov)
    P2, N=14, Not yet recruiting, Bastiaan Driehuys | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    Winrevair (sotatercept-csrk)
    2ms
    LIGHTRAY: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2 trial
    |
    Winrevair (sotatercept-csrk)
    2ms
    Right Ventricular Compensation with Sotatercept: a Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE) (clinicaltrials.gov)
    P4, N=20, Not yet recruiting, Amsterdam UMC, location VUmc
    New P4 trial
    |
    Winrevair (sotatercept-csrk)
    3ms
    A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma (clinicaltrials.gov)
    P2, N=30, Completed, Celgene | Phase classification: P2a --> P2
    Phase classification
    |
    Winrevair (sotatercept-csrk)
    4ms
    To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=26, Terminated, Merck Sharp & Dohme LLC | Phase classification: P2a --> P2
    Phase classification
    |
    Winrevair (sotatercept-csrk)
    4ms
    SPECTRA: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (clinicaltrials.gov)
    P2, N=21, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Phase classification: P2a --> P2
    Phase classification
    |
    Winrevair (sotatercept-csrk)
    5ms
    Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension (clinicaltrials.gov)
    P4, N=21, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Winrevair (sotatercept-csrk)
    5ms
    Sox-PH: 129 Xenon Imaging in Patients Treated With Sotatercept (clinicaltrials.gov)
    P2, N=14, Not yet recruiting, Bastiaan Driehuys | Initiation date: Jun 2024 --> Sep 2024
    Trial initiation date
    |
    Winrevair (sotatercept-csrk)
    8ms
    Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension (clinicaltrials.gov)
    P4, N=21, Not yet recruiting, Mayo Clinic
    New P4 trial
    |
    Winrevair (sotatercept-csrk)
    8ms
    Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Jun 2022 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • pomalidomide • Winrevair (sotatercept-csrk)
    9ms
    Sox-PH: 129 Xenon Imaging in Patients Treated With Sotatercept (clinicaltrials.gov)
    P2, N=14, Not yet recruiting, Bastiaan Driehuys
    New P2 trial
    |
    Winrevair (sotatercept-csrk)
    9ms
    A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) (clinicaltrials.gov)
    P3, N=46, Active, not recruiting, Merck Sharp & Dohme LLC | N=35 --> 46
    Enrollment change
    |
    Winrevair (sotatercept-csrk)
    9ms
    A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) (clinicaltrials.gov)
    P3, N=166, Active, not recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Winrevair (sotatercept-csrk)
    10ms
    A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis. (clinicaltrials.gov)
    P2, N=50, Completed, Celgene | Phase classification: P2a --> P2
    Phase classification
    |
    Winrevair (sotatercept-csrk)
    11ms
    HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov)
    P3, N=444, Recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial primary completion date: Nov 2029 --> Aug 2026
    Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    12ms
    CADENCE: A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (clinicaltrials.gov)
    P2, N=150, Recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: May 2026 --> Feb 2027 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    12ms
    HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov)
    P3, N=444, Recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: Aug 2028 --> Jan 2030 | Trial primary completion date: Jun 2028 --> Nov 2029
    Trial completion date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    12ms
    A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) (clinicaltrials.gov)
    P3, N=166, Recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: Dec 2026 --> Nov 2025
    Trial completion date
    |
    Winrevair (sotatercept-csrk)
    1year
    HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov)
    P3, N=444, Recruiting, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | N=662 --> 444
    Enrollment change
    |
    Winrevair (sotatercept-csrk)
    1year
    A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) (clinicaltrials.gov)
    P3, N=35, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Aug 2025 | Trial primary completion date: Jan 2025 --> Mar 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Winrevair (sotatercept-csrk)
    over1year
    From bench to bedside: The promise of sotatercept in hematologic disorders. (PubMed, Biomed Pharmacother)
    In this review, we provide a detailed overview of TGF-β pathways in physiological and hematologic disorder contexts, outline the potential mechanism of sotatercept, and delve into its pharmacokinetics and clinical research advancements in various hematologic diseases. A particular emphasis is given to the relationship between sotatercept dosage and its efficacy or associated adverse reactions.
    Review • Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1) • ACVR2A (Activin A Receptor Type 2A)
    |
    Winrevair (sotatercept-csrk)
    3years
    Final Results of a Phase 2 Study of Sotatercept (ACE-011) for Anemia of MPN-Associated Myelofibrosis (ASH 2021)
    Furthermore, anemia is an on-target effect of therapeutic Janus kinase 2 (JAK2) inhibition, and is a frequent cause of ruxolitinib (rux) discontinuation (d/c) in clinical practice (Kuykendall, Ann Hematol 2018). Current therapies for anemia of MF (erythropoietin and analogs, danazol, IMiDs®) are unsatisfactory...All responses in the rux cohort occurred in non-TD pts. The trial (NCT01712308) has been closed to new pt enrollment.
    Clinical • P2 data
    |
    JAK2 (Janus kinase 2) • ACVR2A (Activin A Receptor Type 2A)
    |
    Jakafi (ruxolitinib) • Winrevair (sotatercept-csrk)
    over4years
    RAP-011 Rescues the Disease Phenotype in a Cellular Model of Congenital Dyserythropoietic Anemia Type II by Inhibiting the SMAD2-3 Pathway. (PubMed, Int J Mol Sci)
    We demonstrate that treatment of these SEC23B-silenced K562 cells with RAP-011, a "murinized" ortholog of sotatercept, rescues the disease phenotype by restoring gene expression of erythroid markers through inhibition of the phosphorylated SMAD2 pathway. Our data also demonstrate the effect of RAP-011 treatment in reducing the expression of erythroferrone in vitro, thus suggesting a possible beneficial role of the use of sotatercept in the management of iron overload in patients with CDA II.
    Journal
    |
    GATA1 (GATA Binding Protein 1)
    |
    Winrevair (sotatercept-csrk)