BLAINJECTIONINJECTABLEPriority Review
Approved
Feb 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
MYALEPT (metreleptin) by Chiesi is non-adipose tissues during fasting. First approved in 2014.
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYALEPT (metreleptin) is a leptin analog injectable biologic approved in 2014 for generalized lipodystrophy, a rare metabolic disorder characterized by absence or severe deficiency of adipose tissue. It works by binding to and activating the human leptin receptor (ObR), signaling through the JAK/STAT pathway to restore metabolic homeostasis and reduce ectopic fat deposition in liver and muscle. The drug addresses leptin deficiency that drives hypertriglyceridemia, insulin resistance, and metabolic complications in lipodystrophy patients.
$0.017BPart D
PeakProduct is at peak lifecycle stage with modest Part D spending ($17M) and small patient population (110 claims in 2023), suggesting stable but limited commercial scale and team size.
Mechanism of Action
non-adipose tissues during fasting. In patients with generalized lipodystrophy, the deficiency of adipose tissue leads to hypertriglyceridemia and ectopic deposition of fat in non-adipose tissues such as liver and muscle, contributing to metabolic abnormalities including insulin resistance. Native…
Pharmacologic Class:
Leptin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Started May 2025
1 enrolled
Generalized Lipodystrophy
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
Started Dec 2024
9 enrolled
Generalized Lipodystrophy
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Started Oct 2024
24 enrolled
Familial Partial Lipodystrophy
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Started Feb 2024
12 enrolled
Partial Lipodystrophy
Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)
Started Aug 2023
4 enrolled
Lipomatosis, Multiple Symmetrical
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.