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Drugs in development · updated 30 October 2026

Sotatercept: clinical trials and development status

Other names and codes: ACE-011, Winrevair

NLM verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 22 August 2024

As of 30 October 2026 Sotatercept is in 9 active clinical trials (recruiting or ongoing, phases I–III) for 5 diseases. The most advanced phase is III.

9Active trials
IIIMost advanced phase
5Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Sotatercept and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Arterial pulmonary hypertensionIII5NCT07218029
Pulmonary hypertensionIII2NCT07839585
Congenital heart diseaseII1NCT07498803
Eisenmenger complexII1NCT07498803
Multiple myelomaI1NCT01562405

Everything on Sotatercept

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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