ApprovedClinical / approved drugSubcutaneousEvidence 4/5

Enfuvirtide

Also known as: Fuzeon, T-20

Enfuvirtide binds the HR1 region of the HIV-1 gp41 envelope subunit and blocks the six-helix bundle conformational change required for fusion of the viral and host cell membranes.

Enfuvirtide
Drug class
HIV-1 gp41 fusion inhibitor (antiretroviral)
Primary targets
HIV-1 gp41 HR1 (N-terminal heptad repeat), viral envelope glycoprotein gp41
Dose reference
Per FDA label (reference only, not a recommendation): adults 90 mg subcutaneously twice daily; pediatric patients 2 mg/kg twice daily up to a 90 mg maximum.
Half-life
Approximately 3.8 hours (mean 3.8 ± 0.6 h after a single 90 mg subcutaneous dose, per FDA label)
Developer / origin
Discovered at Trimeris; co-developed with Hoffmann-La Roche; marketed by Genentech (Roche Group) and Roche
Reference year
2003
Evidence score
4/5 - Strong randomized-trial evidence for the approved indication

Approved uses

  • Treatment of HIV-1 infection in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
Evidence 4/5

Strong randomized-trial evidence for the approved indication

Two pivotal 24-week randomized controlled trials (TORO 1 and TORO 2, ~1,000 treatment-experienced patients) showed adding enfuvirtide to an optimized background regimen roughly doubled the odds of achieving undetectable HIV-1 RNA and improved CD4 gains, supporting its 2003 FDA accelerated approval; evidence is limited to add-on use in treatment-experienced populations over short follow-up, and resistance arises rapidly without a suppressive companion regimen.

Investigational compound with human randomized or phase 2/3 evidence.

Evidence basis

  • FDA-approved label with defined indication and pharmacokinetics
  • TORO 1 randomized controlled trial published in NEJM 2003
  • TORO 2 randomized controlled trial
  • Peer-reviewed pharmacokinetic study establishing 3.8 h half-life
  • Independent review articles and NIH resources

How to read this entry

Dose references and half-life values are pulled from trial protocols, labels, reviews, or published summaries where available. They are context for research and comparison, not a personal dosing recommendation.

Status matters: approved drugs have regulated indications; investigational compounds are still being studied; research-only peptides do not have established human dosing, safety, or efficacy for consumer use.

Enfuvirtide guides

Read the matching guide or adjacent research pages for more context.

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