Quick answers
- What is Metreleptin used for?
- The FDA-approved label (Myalept, Chiesi USA, Inc., March 25, 2024) says: “MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Limitations of Use The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metreleptin have a boxed warning?
- Yes. The FDA label for Myalept has a boxed warning (“WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Metreleptin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Metreleptin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Metreleptin?
- 1 company lists prescription products of Metreleptin in the FDA NDC Directory, including Chiesi USA, Inc..
What Metreleptin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Limitations of Use The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. …
— FDA label: Myalept, Chiesi USA, Inc., effective March 25, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Myalept |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Chiesi USA, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125390 MYALEPT | Chiesi Farmaceutici Spa | February 24, 2014 | 12, latest September 17, 2025 2025: REMS · 2023: REMS · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1491629, 1491634 |
|---|---|
| SPL set ID of the quoted label | d3b50bbd-140b-425c-b5ec-d4682aad62bc |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125390 |
| Active ingredients (FDA) | METRELEPTIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Myalept, Chiesi USA, Inc., effective March 25, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →