Asset profile

metreleptin · Myalept

Protein / enzyme therapeutic

Phase 3LeptinNo featureable registry evidence
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Approvedregulatory verdict

Evidence outlook

Approved: Complications of leptin deficiency in congenital or acquired generalized lipodystrophy (FDA)

This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

Source for the program status

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Competitive landscape

61 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 60 same-indication; 8 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Metreleptin (Myalept): this drugPhase 3Protein / enzyme therapeuticLeptin
ERX1000Phase 2Small moleculeLeptin
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
Setmelanotide (Imcivree)ApprovedPeptideMC4R
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 46 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.

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Upcoming events

(5 total)

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

2026 (1)
December 2026 (1)
Phase 2Anorexia NervosaRecruiting
Est. primary completion 2026-12-31 · NCT06305182 · CT.gov ↗
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2027 (2)
July 2027 (2)
Phase 2Diabetes, Lipodystrophy, HyperlipidemiaActive not recruiting
Est. primary completion 2027-07-31 · NCT02262806 · CT.gov ↗
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Phase 3Lipodystrophy, Diabetes, HyperlipidemiaActive not recruiting
Est. primary completion 2027-07-31 · NCT02262832 · CT.gov ↗
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2028 (2)
February 2028 (1)
Phase 4Partial LipodystrophyRecruiting
Est. primary completion 2028-02 · NCT06484868 · CT.gov ↗
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March 2028 (1)
Phase 3Familial Partial LipodystrophyRecruiting
Est. primary completion 2028-03 · NCT06679270 · CT.gov ↗
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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 (6)
Phase 2/3 (1)
Phase 2 (22)
Phase 1/2 (2)
Phase 1 (4)
Phase 4 (6)
Early phase / not applicable (26)
Appears in other studies (11)