How many clinical trials are studying Sotatercept?

6 recruiting trials in our tracked data involve Sotatercept.

What conditions is Sotatercept being studied for?

In our tracked recruiting trials, Sotatercept is being studied in trials for Hypertension, Pulmonary Arterial Hypertension, Eisenmenger Syndrome.

Sotatercept: clinical trials recruiting now

Q: Is Sotatercept FDA-approved?

Yes. According to the FDA drug label available through openFDA, Sotatercept is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Sotatercept appears in the FDA drug-label database. Marketed as WINREVAIR.

FDA-approved use

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) ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. ( 1 )

FDA label via openFDA

Phase breakdown

Phase 2 2 Phase 3 1 Phase 4 3

Conditions being studied

Condition	Trials
Hypertension · Sotatercept for Hypertension	6
Pulmonary Arterial Hypertension · Sotatercept for Pulmonary Arterial Hypertension	4
Eisenmenger Syndrome	1
Pulmonary Arterial Hypertension PAH	1
Pulmonary Arterial Hypertension WHO Group I	1
Pulmonary Arterial Hypertension of Congenital Heart Disease	1
Pulmonary Artery Hypertension	1

Recruiting trials involving Sotatercept

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
NCT07218029 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 135 locations
A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
NCT07646860 · Phase: Phase 2 · Ages: 1 Year to 17 Years · Sex: All (male and female) · 3 locations
A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy
NCT07356778 · Phase: Phase 4 · Ages: 18 Years and older · Sex: All (male and female) · 10 locations
Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)
NCT06658522 · Phase: Phase 4 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location
Sotatercept in Pulmonary Arterial Hypertension
NCT07140484 · Phase: Phase 4 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
NCT05587712 · Phase: Phase 2 · Ages: 1 Year to 17 Years · Sex: All (male and female) · 35 locations

Common questions

Is Sotatercept FDA-approved?

Yes, marketed as WINREVAIR.

How many recruiting trials involve Sotatercept?

6 recruiting trials across 7 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.