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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
Trials
Company:
BMS, Merck (MSD)
Drug class:
TGFβ inhibitor
Associations
Trials
2d
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
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Winrevair (sotatercept-csrk)
3d
Enrollment open
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Winrevair (sotatercept-csrk)
4d
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
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Winrevair (sotatercept-csrk)
23d
New P2 trial
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Winrevair (sotatercept-csrk)
2ms
Phase classification
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Winrevair (sotatercept-csrk)
3ms
Phase classification
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Winrevair (sotatercept-csrk)
3ms
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
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Winrevair (sotatercept-csrk)
4ms
Enrollment open
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Winrevair (sotatercept-csrk)
4ms
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
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Winrevair (sotatercept-csrk)
7ms
New P4 trial
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Winrevair (sotatercept-csrk)
7ms
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
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lenalidomide • pomalidomide • Winrevair (sotatercept-csrk)
8ms
New P2 trial
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Winrevair (sotatercept-csrk)
8ms
Enrollment change
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Winrevair (sotatercept-csrk)
8ms
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
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Winrevair (sotatercept-csrk)
10ms
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
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Winrevair (sotatercept-csrk)
11ms
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
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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 completion date: Aug 2028 --> Jan 2030 | Trial primary completion date: Jun 2028 --> Nov 2029
Trial completion date • Trial primary completion date
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Winrevair (sotatercept-csrk)
11ms
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
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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
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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
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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
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TGFB1 (Transforming Growth Factor Beta 1) • ACVR2A (Activin A Receptor Type 2A)
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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
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JAK2 (Janus kinase 2) • ACVR2A (Activin A Receptor Type 2A)
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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
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GATA1 (GATA Binding Protein 1)
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Winrevair (sotatercept-csrk)