PharmaRadar360

PharmaRadar360

CardiovascularDrug intelligence

Winrevair

Sotatercept

Activin signaling inhibitor (ActRIIA-Fc fusion protein). Developed by Merck. Clinical, regulatory, and source evidence are connected below.

Company
Merck
Target / MOA
Activin A
Aliases
Winrevair
Signals
20
Clinical trials
19
Approvals
0
Evidence sources
20

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Phase 3 · ACTIVE_NOT_RECRUITING · Merck Sharp & Dohme LLC

clinical trialClinicalTrials.gov

A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

Phase 2 · RECRUITING · Merck Sharp & Dohme LLC

clinical trialClinicalTrials.gov

A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)

Phase 3 · NOT_YET_RECRUITING · Merck Sharp & Dohme LLC

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Winrevair · BLA761363 · label version 13, effective Sep 21, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1) ] .

European Union (EMA)

Winrevair · EMEA/H/C/005647 · Authorised, authorised Aug 22, 2024 (Commission decision C(2024) 6049) · EPAR

Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA761363 · MERCK SHARP DOHME · first approved Mar 26, 2024

2 efficacy supplements approved

European Union

  • Winrevair: Authorised since Aug 22, 2024

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA761363 (Purple Book)

Orphan exclusivity until Mar 26, 2031

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 19 linked records.

Phase 3ACTIVE NOT RECRUITINGNCT07218029

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Merck Sharp & Dohme LLC · Updated Oct 8, 2026

Phase 2RECRUITINGNCT07646860

A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

Merck Sharp & Dohme LLC · Updated Oct 6, 2026

Phase 3NOT YET RECRUITINGNCT07839585

A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)

Merck Sharp & Dohme LLC · Updated Oct 6, 2026

NANOT YET RECRUITINGNCT07700303

Withdrawal of Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept (WATERLOO)

University of Alberta · Updated Sep 23, 2026

Phase 2COMPLETEDNCT04945460

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Updated Sep 23, 2026

Phase 4NOT YET RECRUITINGNCT07600723

A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037)

Merck Sharp & Dohme LLC · Updated Aug 7, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 16, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.