melanocortin-4 receptor agonist
Setmelanotide
Answer
Setmelanotide is authorised or registered in the US, the EU, the UK, Canada and Switzerland: 5 of the 10 registers read. Highest trial phase: Phase 4 (after approval). It has 29 registered trials, 5 of them running. Brand names on the FDA label register: Imcivree.
RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03
Not medical, legal or regulatory advice.
29 trials by status
Trial registerClinicalTrials.gov and EU CTIS · read 2026-10-03 · 14 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 8 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Authorised | EMA, ema | 2026-10-03 |
| United Kingdom | Authorised | MHRA, uk-mhra | 2026-10-03 |
| Canada | Authorised | Health Canada, ca-dpd | 2026-10-03 |
| Australia | Status unknown | TGA, au-artg | not read |
| Switzerland | Authorised | Swissmedic, ch-swissmedic | 2026-10-03 |
| Brazil | Not on the register | ANVISA, br-anvisa | 2026-09-03 |
| Serbia | Not on the register | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Not on the register | HSA, sg-hsa | 2026-09-03 |
| Turkey | Not on the register | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
Get an email when this changes
One email when the status of Setmelanotide changes on the register. You confirm your address first.
REGISTERED TRIALS
Newest 10 of 29 trials
| NCT05774756 | A Trial of Setmelanotide in Acquired Hypothalamic Obesity running, but no longer enrolling · register updated 2026-08-10 |
|---|---|
| NCT05093634 | EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway completed · register updated 2026-08-06 |
| NCT07496463 | Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) enrolling by invitation only · register updated 2026-07-23 |
| NCT06596135 | Open-Label Extension Study of Setmelanotide completed · register updated 2026-07-15 |
| NCT07674290 | Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity currently recruiting participants · register updated 2026-06-29 |
| NCT06760546 | A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) currently recruiting participants · register updated 2026-02-12 |
| NCT06772597 | A Study of Setmelanotide in Patients With Prader-Willi Syndrome running, but no longer enrolling · register updated 2026-02-12 |
| 2023-507634-24-00 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients with no status recorded · register updated 2025-11-28 |
| NCT04963231 | DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway completed · register updated 2025-07-02 |
| NCT03651765 | Long Term Extension Trial of Setmelanotide completed · register updated 2025-05-31 |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.