Sotatercept

Overview

Sotatercept has been used in trials studying the supportive care and treatment of Anemia, Leukemia, Solid Tumors, Bladder Cancer, and multiple myeloma, among others.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)	2025/04/16	NCT06930664	Phase 1	Recruiting	Merck Sharp & Dohme LLC
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)	2025/04/13	NCT06925750	Phase 2	Recruiting	Merck Sharp & Dohme LLC
A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)	2025/02/25	NCT06843460	Phase 1	Completed	Merck Sharp & Dohme LLC
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)	2025/02/07	NCT06814145	Phase 2	Recruiting	Merck Sharp & Dohme LLC
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)	2024/10/30	NCT06664801	Phase 2	Active, not recruiting	Merck Sharp & Dohme LLC
RECOMPENSE: Right vEntricular COMPENsation with SotatercEpt. A prospective single arm open label phase IV study to evaluate the effects of sotatercept on right ventricular function in pulmonary arterial hypertension	2025/04/14	2024-512543-23-00	Phase 4	Recruiting	Amsterdam UMC Stichting
Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension	2024/05/10	NCT06409026	Phase 4	Recruiting	Mayo Clinic
A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)	2023/04/18	NCT05818137	Phase 3	Active, not recruiting	Merck Sharp & Dohme LLC
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)	2022/10/20	NCT05587712	Phase 2	Recruiting	Merck Sharp & Dohme LLC
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)	2021/06/30	NCT04945460	Phase 2	Active, not recruiting	Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Winrevair	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Harlem,The Netherlands	Authorised	8/22/2024

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG (VIAL ONLY)	Patheon Italia S.p.A	SIN17094P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	60mg	9/20/2024
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)	Patheon Italia S.p.A	SIN17093P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	45mg	9/20/2024
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG	Patheon Italia S.p.A, Vetter Pharma-Fertigung GmbH & Co. KG	SIN17092P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	60mg	9/20/2024
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG	Patheon Italia S.p.A, Vetter Pharma-Fertigung GmbH & Co. KG	SIN17091P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	45mg	9/20/2024

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
WINREVAIR sotatercept 45 mg powder for injection vial	433670	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	11/8/2024
WINREVAIR sotatercept 60 mg powder for injection vial	433671	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	11/8/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
WINREVAIR	Merck Canada Inc	02551284	Powder For Solution - Subcutaneous	45 MG / VIAL	N/A
WINREVAIR	Merck Canada Inc	02551314	Kit , Powder For Solution - Subcutaneous	60 MG / VIAL	2/12/2025
WINREVAIR	Merck Canada Inc	02551306	Kit , Powder For Solution - Subcutaneous	45 MG / VIAL	2/12/2025
WINREVAIR	Merck Canada Inc	02551292	Powder For Solution - Subcutaneous	60 MG / VIAL	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
WINREVAIR 60 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Merck Sharp & Dohme B.V.	1241850003	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
WINREVAIR 45 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Merck Sharp & Dohme B.V.	1241850001	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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