Hormone FDA Approved

Metreleptin

An FDA-approved leptin analog used in rare metabolic disease, best known in the United States as Myalept.

Leptin AnalogFDA ApprovedRare DiseaseMetabolic

Also referenced as: Myalept

Status
FDA Approved

This peptide maps to at least one regulated medical product or label context in the United States.

Category
Hormone

This profile is grouped by its dominant research and market lane, not by vendor shelf placement.

Aliases
1

Myalept

Signal depth
High

FDA label signal · 41 trials · 247 PubMed results

Established
Research evidence

Metreleptin is an FDA-approved medicine with substantial published trial evidence. Note that research-market products sold under this name are not the approved medicine and are not held to the same manufacturing or labeling standards.

Metreleptin has 22 name-matched clinical trials (highest phase: Phase 4) and 247 PubMed-indexed publications and holds an FDA drug label. 9 trials have posted results.

FAERS (approved drug): 416
Human data
Approved drug
Trial quality
Large RCT
Outcomes
Clinical outcomes
Replication
Multiple trials
Literature
High-impact
PHASE4 Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy PHASE4 Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy PHASE3 · Randomized Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL Obesity · 329 citations Enhanced Weight Loss With Pramlintide/Metreleptin: An Integrated Neurohormonal Approach to Obesity Pharmacotherapy The Journal of Clinical Endocrinology & Metabolism · 180 citations Partial and Generalized Lipodystrophy: Comparison of Baseline Characteristics and Response to Metreleptin Metabolism · 168 citations Long-term metreleptin treatment increases bone mineral density and content at the lumbar spine of lean hypoleptinemic women
Evidence history

Re-checked nightly against the registries — tracked since 2026-07-09. No band changes yet.

Grades evidence strength, not efficacy or safety. Research-use context; not medical advice. Graded 2026-07-13 from PubMed, ClinicalTrials.gov, ISRCTN, openFDA, Health Canada, and OpenAlex — computed deterministically and refreshed nightly, with a retraction check. How we grade →

What metreleptin is

Metreleptin is a leptin analog marketed in the United States as Myalept.

Why it matters

It expands the library’s hormone and metabolic coverage beyond incretins and growth-related peptides into rare-disease endocrine therapeutics.

Regulatory context

Metreleptin is FDA approved in the United States for specific rare-disease use.

Practical reading note

Metreleptin is a good example of how a peptide can be clinically important without ever becoming a mainstream consumer-market name.