Winrevair (sotatercept-csrk) / BMS, Merck (MSD) - LARVOL DELTA

The Evidence Base for Adding Sotatercept to the Treatment Regimen (AHA 2025) - No abstract available

Cardiovascular

Sotatercept: A novel therapeutic approach for pulmonary arterial hypertension through transforming growth factor-β signaling modulation. (PubMed, World J Methodol) - "Among these, sotatercept, a fusion protein that targets the transforming growth factor-β superfamily signaling pathway, has emerged as a promising therapeutic option. In this review, we examine the available evidence from clinical trials to assess the potential of sotatercept as a treatment for PAH."

Journal • Review • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Sotatercept: A New Frontier in Pulmonary Arterial Hypertension Treatment. (PubMed, Ann Pharmacother) - "Sotatercept offers a novel and effective approach to management of patients with PAH on background therapy. Additional data regarding long-term outcomes is needed-studies evaluating this are in progress."

Journal • Review • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Transplantation

Sotatercept in Pulmonary Arterial Hypertension - Revolution, Risk, and the Road Ahead. (PubMed, Eur Respir J) - No abstract available

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Comprehensive approach to personalized treatment in pulmonary arterial hypertension (MTS 2025) - "Novel agents and pathways: Incorporation of sotatercept (activin signaling modulator) in specific patient populations showing promising outcome benefits...How Cardiopulmonary Exercise Testing (CPET) can help not only to risk stratify but also, to guide treatment options in PHT Risk factor modification and Holistic management: What are the treatments options to address associated risk factors and disease-targeted treatments. Integration of supportive measures (oxygen therapy, and pulmonary rehabilitation)"

Cardiovascular • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Significant Stagnancy in the Search and Use of New Antiarrhythmic Agents With Some Recent Beams of Hope. (PubMed, Curr Vasc Pharmacol) - "In this review of new antiarrhythmic agents, the advantages of sodium-glucose co-transporter inhibitors, and also those of pirfenidone, ranolazine, sotatercept, mirabegron, nintedanib, and melatonin are discussed. Some of these agents have been approved for other indications and repurposed for use in managing arrhythmias. Finding novel antiarrhythmic therapeutic approaches may be challenging for further research."

Journal • Atrial Fibrillation • Cardiovascular • Fibrosis • Immunology • Pain • Ventricular Tachycardia

Sotatercept and the Development of Pericardial Effusions: An Emerging Safety Signal. (PubMed, Chest) - No abstract available

Journal • Cardiovascular

Sotatercept in Pulmonary Arterial Hypertension (clinicaltrials.gov) - P4 | N=27 | Not yet recruiting | Sponsor: University of Alberta

New P4 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Clinical data into context: effect of sotatercept on right ventricular (RV) function and structure (ESC-WCC 2025) - "Sponsored by Merck (MSD)"

Clinical data • Cardiovascular • Hypertension

A new way to treat pulmonary arterial hypertension (PAH) by reverse remodeling and right ventricular (RV) function improvement (ESC-WCC 2025) - "Enhance their understanding on the novel pathophysiological pathway targeted by sotatercept. Provide clinical data of the effect of sotatercept on hemodynamics and echo in a way that helps the audience understand it with a clinical context."

Cardiovascular

Rationale and design of the CADENCE trial: evaluating sotatercept in Cpc-PH secondary to HFpEF (ESC-WCC 2025) - "The ongoing CADENCE trial aims to demonstrate whether sotatercept improves pulmonary hemodynamics, exercise capacity, and reduces risk of fatal and non-fatal clinical worsening events in patients with Cpc-PH associated with HFpEF, potentially addressing a need for effective treatments in this high-risk population."

Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension

Hemodynamic effects of add-on therapies in pulmonary arterial hypertension: an additive component network meta-analysis. (ESC-WCC 2025) - "Out of 1,974 identified studies, 12 RCTs (1,312 patients with baseline and follow-up right heart catheterization) met inclusion criteria. Most patients were WHO functional class II or III, with a baseline 6MWD of 375±85 meters. The effect of add-on therapies on PVR was -3.2 WU for ERA, -2.9 WU for sotatercept, -2.3 WU for riociguat, -2.1 WU for oral prostanoids, -2.0 WU for PDE5i, -1.2 WU for seralutinib, and -0.3 WU for inhaled prostanoids."

Retrospective data • Cardiovascular • Congestive Heart Failure • Heart Failure

Sotatercept Improves Hemodynamics and Right Heart Function in High-Risk Pulmonary Arterial Hypertension (PAH): Results from ZENITH Trial (ESC-WCC 2025) - No abstract available

Cardiovascular

Targeting alpha 5 beta 1 integrin as a therapeutic strategy to combat right ventricular dysfunction in pulmonary arterial hypertension (ESC-WCC 2025) - "In pulmonary artery banding rats, α5β1-neutralizing antibody (mAB4) alone or in combination with sotatercept improves RV dysfunction (CO, TAPSE, RV strain; assessed by echocardiography, RHC and cardiac MRI) and diminished RV hypertrophy and fibrosis (Fulton index, H&E and Masson's trichrome staining). Our results suggest that integrin α5β1 plays a key role in pathological RV remodeling in PAH."

Cardiovascular • Heart Failure • PCNA • TGFB1

CADENCE: A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Sotatercept in pulmonary arterial hypertension (PAH): long-term follow-up in SOTERIA (ERS 2025) - No abstract available

Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

SFDA approves 'Winrevair' for rare pulmonary hypertension treatment (Saudi Gazette) - "The Saudi Food and Drug Authority (SFDA) has approved the registration of Winrevair (sotatercept) for the treatment of adult patients with World Health Organization (WHO) Functional Class II to III pulmonary arterial hypertension (PAH)....The SFDA confirmed that the drug’s approval followed a comprehensive evaluation of its efficacy, safety, and quality, meeting all regulatory requirements."

Approval • Pulmonary Arterial Hypertension

Sotatercept for Connective Tissue Disease-Associated Pulmonary Arterial Hypertension with Concomitant Interstitial Lung Disease: Efficacy and Safety Insights. (PubMed, J Clin Med) - "When added to foundational PAH therapy, sotatercept resulted in significant improvements across multiple parameters. These findings suggest that sotatercept may be a promising therapeutic option as an adjunctive treatment in this patient population."

Journal • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology

RCT Abstract - Efficacy and safety of sotatercept in patients with newly diagnosed pulmonary arterial hypertension at intermediate-to-high risk of mortality: Results from Phase 3 HYPERION study (ERS 2025) - No abstract available

Clinical • P3 data • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

Pre-license patient access Program of Sotatercept in high-risk PAH patients under triple combination therapy, in a greek PAH centre (ERS 2025) - No abstract available

Clinical • Combination therapy • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

LIGHTRAY: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jul 2026 ➔ Nov 2025 | Trial primary completion date: Jul 2026 ➔ Nov 2025

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Long-Term Follow-Up Study of Sotatercept for Treatment of Pulmonary Arterial Hypertension: Interim Results of SOTERIA. (PubMed, Eur Respir J) - P3 | "Interim results of SOTERIA support the favourable benefit-risk of add-on sotatercept treatment in adults with PAH. Follow-up reports from this study will provide additional information on benefit-risk."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - StratosPHere 1 study - a novel BMP target engagement biomarker panel for use in clinical trials demonstrates sotatercept alters gene expression in pulmonary arterial hypertension (ERS 2025) - No abstract available

Biomarker • Clinical • Late-breaking abstract • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

A 2-Decade Cardiac Magnetic Resonance Imaging Journey in Heritable Pulmonary Arterial Hypertension: Reversal With Sotatercept. (PubMed, JACC Case Rep) - "Regular CMR examinations allow detailed monitoring of the disease course in PAH. Sotatercept can achieve impressive benefits even in late-stage PAH."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Pericardial effusion in sotatercept phase 3 trials: insights from STELLAR and ZENITH. (PubMed, Eur Respir J) - No abstract available

Journal • P3 data • Cardiovascular