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Fuzeon (ENFUVIRTIDE)
Fuzeon (generic name: ENFUVIRTIDE) is a Human Immunodeficiency Virus 1 Fusion Inhibitor Recombinant protein drug developed by Roche. It is currently FDA-approved (first approved 2003) for Human immunodeficiency virus infection.
Fuzeon (enfuvirtide) is a small molecule human immunodeficiency virus 1 (HIV-1) fusion inhibitor developed by Roche. It was approved by the FDA in 2003 for the treatment of HIV infection. As a fusion inhibitor, Fuzeon works by blocking the fusion of HIV with host cells, preventing the virus from entering and infecting cells. Despite being off-patent, Fuzeon remains a commercial product due to its unique mechanism of action and limited generic competition. Key safety considerations include its short half-life requiring multiple daily injections.
At a glance
| Generic name | ENFUVIRTIDE |
|---|---|
| Sponsor | Roche |
| Drug class | Human Immunodeficiency Virus 1 Fusion Inhibitor |
| Modality | Recombinant protein |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2003 |
Approved indications
- Human immunodeficiency virus infection
Common side effects
Drug interactions
- maraviroc
Key clinical trials
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2,PHASE3)
- Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals (EARLY_PHASE1)
- Optimizing Treatment for Treatment-Experienced, HIV-Infected People (PHASE3)
- Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults (NA)
- Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children (PHASE1)
- Adding New Drugs for HIV Infected Patients Failing Current Therapy (PHASE1,PHASE2)
- A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fuzeon CI brief — competitive landscape report
- Fuzeon updates RSS · CI watch RSS
- Roche portfolio CI
Frequently asked questions about Fuzeon
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Related
- Drug class: All Human Immunodeficiency Virus 1 Fusion Inhibitor drugs
- Manufacturer: Roche — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Human immunodeficiency virus infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing