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setmelanotide · Imcivree

Peptide

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Approvedregulatory verdict

Evidence outlook

Approved: Obesity (label: acquired hypothalamic obesity, Bardet-Biedl syndrome, and POMC, PCSK1 or LEPR deficiency obesity), Bardet-Biedl Syndrome

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Weak signal

Also in development:Hypothalamic Obesity · Phase 3

How the evidence outlook works ↗

Competitive landscape

62 competitors in this universe: 2 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Setmelanotide (Imcivree): this drugApprovedPeptideMC4R
BivamelagonPhase 2Small moleculeMC4R
LB54640Phase 2PeptideMC4R
Liraglutide (Saxenda / Victoza)ApprovedPeptideGLP-1 receptor
Naltrexone / Bupropion (Contrave)ApprovedSmall moleculeOpioid receptor / dopamine (combination)
Orforglipron (Foundayo)ApprovedSmall moleculeGLP-1 receptor
Orlistat (Xenical / Alli)ApprovedSmall moleculePancreatic/gastric lipase
Phentermine / Topiramate (Qsymia)ApprovedSmall moleculeNoradrenergic/anticonvulsant (combination)
Semaglutide (Wegovy / Ozempic / Rybelsus)ApprovedPeptideGLP-1 receptor
Tirzepatide (Zepbound / Mounjaro)ApprovedPeptideGLP-1/GIP receptor (dual)
AleniglipronPhase 3Small moleculeGLP-1 receptor
AmycretinPhase 3PeptideGLP-1 receptor, Amylin receptor
ApitegromabPhase 3Monoclonal antibodyActivin/myostatin type II receptor
ARD-101Phase 3Small moleculeBitter taste receptor (gut)
ASC30Phase 3Small moleculeGLP-1 receptor
AZD6234Phase 3PeptideAmylin receptor

…and 47 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(4 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
October 2026 (1)
Phase 2ObesityActive not recruiting
Est. primary completion 2026-10-31 · NCT06772597 · CT.gov ↗
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2027 (2)
March 2027 (1)
Phase 3ObesityRecruiting
Est. primary completion 2027-03-13 · NCT06760546 · CT.gov ↗
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April 2027 (1)
Phase 2ObesityEnrolling by invitation
Est. primary completion 2027-04-30 · NCT07496463 · CT.gov ↗
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2030 (1)
December 2030 (1)
Phase 4Bardet-Biedl SyndromeRecruiting
Est. primary completion 2030-12-31 · NCT07674290 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (9)
Phase 2/3 (1)
Phase 2 (9)
Phase 1/2 (1)
Phase 1 (3)
Phase 4 (2)