Winrevair (sotatercept-csrk)

P1/2, N=15, Not yet recruiting, University Hospital, Brest

P4, N=30, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | N=21 --> 30

P3, N=46, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | Trial completion date: Feb 2026 --> Nov 2025

P1, N=33, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Jun 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026

Two peptide-based ligand traps have recently received clinical approval: luspatercept [ActRIIB-Fc], an erythroid maturation agent, and sotatercept [ActRIIA-Fc], a novel therapeutic agent for pulmonary arterial hypertension [PAH]. Although both agents have failed to increase skeletal muscle mass in clinical trials consistently, they represent significant advances in the treatment of hematopoietic and vascular disorders. Future studies should focus on optimal dosing strategies, long-term safety, and potential synergistic effects when combined with other therapeutic modalities.

P3, N=815, Recruiting, Merck Sharp & Dohme LLC | Initiation date: Nov 2025 --> May 2021

P1, N=146, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed

Targeting these pathways, including BMPR2 restoration, TGF-β inhibition, and tyrosine kinase blockade, has shown encouraging results beyond the vasodilator-focused standard of care. These innovations may reshape PAH management by improving outcomes, and potentially altering disease progression.

P2, N=25, Not yet recruiting, Philipps University Marburg

P3, N=815, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

P2, N=130, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting | Trial completion date: Sep 2027 --> Jun 2028 | Trial primary completion date: Sep 2027 --> Jun 2028

P2, N=164, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed