Immune

Enfuvirtide

Also known as: Fuzeon, T-20

FDA Approved
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Key Facts: Enfuvirtide

Category
Immune
FDA Status
FDA Approved
Clinical Status
FDA Approved but Commercially Discontinued (Feb 2025) - HIV salvage therapy. Withdrawn from US, UK, and Canadian markets due to availability of superior alternatives.
Administration
Subcutaneous injection twice daily
Typical Dose
Limited community data available
Frequency
See research protocols
Duration
Ongoing as part of HIV regimen
Also Known As
Fuzeon, T-20

Mechanism of Action

HIV gets into a cell using a surface protein called gp41, which works like a folding grappling hook. Two stretches of that protein, called heptad repeat 1 and heptad repeat 2, snap together to pull the virus and the cell membrane close enough to fuse. Enfuvirtide is a copy of the HR2 stretch, so it slides in and binds HR1 first, jamming the hinge before it can collapse. With the hinge stuck open, the membranes never fuse and the virus is locked outside the cell. Because it acts on the outside of the cell, it works against HIV that is already resistant to drugs targeting the virus's internal machinery.

Research Summary

This is one of the better-evidenced antiretrovirals, with real randomized human trials behind it. The pivotal TORO 1 and TORO 2 phase 3 trials, published in the New England Journal of Medicine in 2003, enrolled heavily treatment-experienced patients and showed that adding enfuvirtide to an optimized background regimen roughly doubled the drop in viral load compared with the background regimen alone, with mean HIV RNA reductions on the order of 1.5 log10 copies per mL. Earlier dose-ranging work documented its subcutaneous pharmacokinetics and antiviral activity in HIV-infected adults. The main real-world drawbacks are practical, not theoretical: nearly all patients get injection-site reactions, and twice-daily injections are a burden, which is why newer oral salvage options have largely displaced it. Resistance does develop, usually through mutations in the gp41 HR1 region, so it is always used as part of a combination regimen. It remains an approved drug rather than a speculative peptide, but it is now a niche, last-resort option.

Trial Progress:FDA Approved
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II
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IV
FDA

Dosing Information

FDA Approved·Human clinical trials completed, FDA approved

Typical Dosing

Community experience

Common Dose

Limited community data available

Range

See research dosing

Frequency

See research protocols

Research Dosing

Scientific studies

FDA-approved dosing

Doses from Studies

90 mg subcutaneous twice daily

FDA Approved Labeling - Prescribed dose

Duration

Ongoing as part of HIV regimen

Administration

Subcutaneous injection twice daily

Timing & Administration

Best Time to Take

Morning or as directed

Follow recommended protocol

Food Recommendation

With or without food

Why This Timing?

Timing may vary based on individual response and goals. Consistency is generally more important than specific timing.

Possible Side Effects

Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.

  • Injection site reactions (98%)
  • Diarrhea
  • Nausea
  • Fatigue
  • Pneumonia (higher incidence)
  • Hypersensitivity reactions
  • FDA approved (Fuzeon)

References

Research This Peptide Further

Frequently Asked Questions

What does Enfuvirtide do?

Enfuvirtide (brand name Fuzeon, originally T-20) is a 36-amino-acid synthetic peptide and the first HIV fusion inhibitor, FDA-approved in March 2003. It is a genuine prescription antiretroviral, not a research-only compound, and it is given as a twice-daily subcutaneous injection. Its job is narrow but important: it blocks HIV from entering a host cell in the first place, and it is reserved for people whose virus has stopped responding to other drugs.

How does Enfuvirtide work?

HIV gets into a cell using a surface protein called gp41, which works like a folding grappling hook. Two stretches of that protein, called heptad repeat 1 and heptad repeat 2, snap together to pull the virus and the cell membrane close enough to fuse. Enfuvirtide is a copy of the HR2 stretch, so it slides in and binds HR1 first, jamming the hinge before it can collapse. With the hinge stuck open, the membranes never fuse and the virus is locked outside the cell. Because it acts on the outside of the cell, it works against HIV that is already resistant to drugs targeting the virus's internal machinery.

Is Enfuvirtide FDA approved?

Yes, Enfuvirtide is FDA approved. FDA Approved but Commercially Discontinued (Feb 2025) - HIV salvage therapy. Withdrawn from US, UK, and Canadian markets due to availability of superior alternatives.

What are the side effects of Enfuvirtide?

Reported side effects include: Injection site reactions (98%), Diarrhea, Nausea, Fatigue, Pneumonia (higher incidence). Individual responses vary based on dosage, duration, and personal health factors.

What is the typical dose of Enfuvirtide?

Community-reported common dose: Limited community data available (See research protocols). Range: See research dosing. Administration: Subcutaneous injection twice daily. Community-reported doses. Not medical advice. Consult healthcare provider.

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Peptides commonly compared with Enfuvirtide or used in similar applications.

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VIP

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Immune

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