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Drugs in development · updated 30 October 2026

Setmelanotide: clinical trials and development status

Other names and codes: Imcivree

NLM verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 16 July 2021

As of 30 October 2026 Setmelanotide is in 4 active clinical trials (recruiting or ongoing, phases I–III) for 7 diseases. The most advanced phase is III.

4Active trials
IIIMost advanced phase
7Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Setmelanotide 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
Optic nerve hypoplasiaIII1NCT06760546
Septo-optic dysplasiaIII1NCT06760546
Sexual infantilismIII1NCT05774756
ObesityII2NCT07496463
HyperphagiaII1NCT06772597
Prader–Willi syndromeII1NCT06772597
PseudohypoparathyroidismII1NCT07496463

Everything on Setmelanotide

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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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