Peptide Graded

Enfuvirtide

Is Enfuvirtide legal in the US?

Yes, FDA approved for HIV, but the maker stopped selling it in the US in 2025.

AStrong human evidenceFDA approvedas of 2026-10-26

Approved but discontinued. Enfuvirtide was approved by the FDA in March 2003 as Fuzeon (Roche/Genentech) for HIV-1 infection in treatment-experienced patients with ongoing viral replication despite antiretroviral therapy. Genentech discontinued Fuzeon in the US effective February 28, 2025, citing declining need; the approval stands but the product is no longer sold. 2

The 2003 approval for treatment-experienced HIV-1 infection remains on the books. But Genentech stopped selling Fuzeon in the US on February 28, 2025. 2

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More on Enfuvirtide

Citations

  1. Lalezari 2003, NEJM: enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America (TORO 1) doi.org
  2. Genentech 2024: statement on discontinuation of Fuzeon (enfuvirtide) in the US gene.com

Reference information only, not medical advice. Drawn from the Enfuvirtide article, fact-checked against the cited sources. No dosing anywhere on this site.