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Home/Compounds/Enfuvirtide
OtherFDA approvedRx required

Enfuvirtide

Also known as: Fuzeon · T-20
Brands: Fuzeon

36-amino-acid HIV fusion inhibitor; the first and only approved peptide drug that blocks HIV entry.

A
Grade A
Multiple human RCTs
Human studies28
PubMed citations28
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Binds gp41 of HIV-1 and prevents conformational change required for fusion of viral and host-cell membranes.

Evidence summary

28
Human studies
28
PubMed citations
25
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

No FDA label or editorial side-effect profile is on file for this compound yet. See the clinical trials and citations sections for study-reported safety data.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for HIV-1 infection in treatment-experienced patients (Fuzeon)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT00302822Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLOCompleted · Phase 3 · HIV Infections · n=195NCT00454337Randomized Non-inferiority Study Comparing a Strategy Maintaining Current Enfuvirtide-based Antiretroviral Therapy to a Strategy Replacing Enfuvirtide by an Integrase Inhibitor (Raltegravir) in HIV-1 Infected Subjects With Plasma Hiv-1 RNA Levels Below 400 Copies Per ml.ANRS 138 EASIERCompleted · Phase 3 · HIV Infections · n=170NCT01022476A Pilot Study of Pharmacokinetics, Tolerance and Efficacy of Raltegravir Combined to Two Fully Active Molecules Among Nucleosi(ti)de Analogs and Enfuvirtide Before and After Liver Transplant in HIV Infected Patients With End Stage Liver Disease (ANRS 148 LIVERAL)Completed · Phase 1 · HIV Infection · n=14NCT00120367Early Intensification of Combination Antiretroviral Therapy Including FUZEON® in the Treatment of Progressive Multifocal Leucoencephalopathy During HIV-1 Infection ANRS 125 TrialCompleted · Phase 2 · Leukoencephalopathy, Progressive Multifocal · n=30NCT02302547Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to ModerateCompleted · Phase 3 · HIV · n=224NCT05502341An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment RegimensActive Not Recruiting · Phase 2 · HIV-1-infection · n=689NCT01836068Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected IndividualsCompleted · Phase 1 · HIV · n=11NCT00537394The Optimized Treatment That Includes or Omits NRTIs Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective RegimenCompleted · Phase 3 · HIV Infections · n=517NCT00031044A Randomized Phase I/II Placebo-controlled Study of Amdoxovir (DAPD) Versus Placebo Together With Enfuvirtide (T-20) Plus Optimized Background Therapy for HIV-Infected Subjects Failing Current TherapyCompleted · Phase 1 · HIV Infections · n=50NCT00051831A Pilot Study to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4+ Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral TherapyCompleted · N/A · HIV Infections · n=19NCT00001118A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected ChildrenCompleted · Phase 1 · HIV Infections · n=24NCT00344760Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIVCompleted · Phase 4 · HIV Infections · n=2

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40718095Raj A, Sharmin S et al. · Harnessing Antiviral Peptides: From Molecular Mechanisms to Clinical Translation.Current research in pharmacology and drug discovery (2025)HumanPMID 36982978Moranguinho I, Taveira N et al. · Antiretroviral Treatment of HIV-2 Infection: Available Drugs, Resistance Pathways, and Promising New Compounds.International journal of molecular sciences (2023)HumanPMID 35412132Pu J, Wang Q et al. · Peptide-Based HIV Entry Inhibitors.Advances in experimental medicine and biology (2022)HumanPMID 35412131Su S, Xu W et al. · Virus Entry Inhibitors: Past, Present, and Future.Advances in experimental medicine and biology (2022)HumanPMID 33166562Chang L, Zhao J et al. · HIV-1 gp41 genetic diversity and enfuvirtide resistance-associated mutations among enfuvirtide-naïve patients in southern China.Virus research (2021)HumanPMID 33844613Mousavi Maleki MS, Rostamian M et al. · Antimicrobial peptides and other peptide-like therapeutics as promising candidates to combat SARS-CoV-2.Expert review of anti-infective therapy (2021)HumanPMID 31374953Pu J, Wang Q et al. · Development of Protein- and Peptide-Based HIV Entry Inhibitors Targeting gp120 or gp41.Viruses (2020)HumanPMID 30867304Zhu Y, Chong H et al. · Design and Characterization of Cholesterylated Peptide HIV-1/2 Fusion Inhibitors with Extremely Potent and Long-Lasting Antiviral Activity.Journal of virology (2020)HumanPMID 30811933Ikeda T, Tennyson RL et al. · Evolved Proteins Inhibit Entry of Enfuvirtide-Resistant HIV-1.ACS infectious diseases (2020)HumanPMID 21182341Boyd MA, Hill AM · Clinical management of treatment-experienced, HIV/AIDS patients in the combination antiretroviral therapy era.PharmacoEconomics (2011)HumanPMID 21762676Ashkenazi A, Wexler-Cohen Y et al. · Multifaceted action of Fuzeon as virus-cell membrane fusion inhibitor.Biochimica et biophysica acta (2011)HumanPMID 19223380Sidhu HK, Chaffee BH et al. · Fuzeon-induced collagenophagic granuloma: a peculiar granulomatous injection site reaction to Fuzeon--a case report and review of literature.International journal of surgical pathology (2011)HumanPMID 19619009Garg H, Joshi A et al. · Altered bystander apoptosis induction and pathogenesis of enfuvirtide-resistant HIV type 1 Env mutants.AIDS research and human retroviruses (2009)HumanPMID 17617275Esté JA, Telenti A · HIV entry inhibitors.Lancet (London, England) (2007)HumanPMID 16927284Bienvenu B, Krivine A et al. · A cohort study of enfuvirtide immunological and virological efficacy in clinical practice.Journal of medical virology (2006)HumanPMID 15934866De Clercq E · Emerging anti-HIV drugs.Expert opinion on emerging drugs (2006)HumanPMID 15656696Patel IH, Zhang X et al. · Pharmacokinetics, pharmacodynamics and drug interaction potential of enfuvirtide.Clinical pharmacokinetics (2005)HumanPMID 15675339Hayashi T · [Fuzeon, first of the so-called "fusion inhibitor" drug in new class of AIDS treatments and its warnings].Nihon rinsho. Japanese journal of clinical medicine (2005)HumanPMID 15044424Rockstroh JK, Mauss S · Clinical perspective of fusion inhibitors for treatment of HIV.The Journal of antimicrobial chemotherapy (2004)HumanPMID 15110129Fung HB, Guo Y · Enfuvirtide: a fusion inhibitor for the treatment of HIV infection.Clinical therapeutics (2004)Human

Showing 20 of 28 papers. View all on PubMed →