Enfuvirtide regulatory status
Current status of Enfuvirtide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of Enfuvirtide?
Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 23, 2026
- FDA and compounding
- FDA approved prescription drug (Fuzeon, approved March 13, 2003, the first HIV fusion inhibitor). Drugs@FDA lists the Fuzeon product's marketing status as discontinued as of the last verified date; the approval itself has not been withdrawn. It is not on any 503A bulks list and is not a research chemical.
- WADA
- Not WADA prohibited
- Access path
- Prescription from an HIV specialist, filled by a specialty pharmacy as Fuzeon.
- Not available through compounding pharmacies, telehealth peptide clinics, or research chemical sellers.
Full Enfuvirtide page: evidence, dosing in the literature, and sources
How has the status of Enfuvirtide changed over time?
- FDA
FDA approves Fuzeon (enfuvirtide), the first HIV fusion inhibitor
FDA approved enfuvirtide injection (Fuzeon), a 36-amino-acid peptide that blocks HIV-1 fusion with host cells, for treatment-experienced patients with HIV-1.
Regulatory: FDA approvedSource: Drugs@FDA: Fuzeon (enfuvirtide) NDA 021481
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Enfuvirtide and the source of each dated event.