Enfuvirtide

Also known as: Fuzeon

Approved, discontinued

Last verified: October 30, 2026

At a glance

FDA approval Approved, discontinued 1 application

Randomized controlled trials 64 of 866 publications on PubMed

Registered clinical trials 54 1 active

Adverse event reports 3,751 3,443 classified as serious

Enfuvirtide was approved by the FDA (Fuzeon, March 13, 2003), but the products are no longer marketed.
PubMed lists 866 publications mentioning it, including 64 randomized controlled trials and 20 animal-only studies.
ClinicalTrials.gov lists 54 registered studies testing it (1 active).
FDA's adverse event system (FAERS) holds 3,751 reports mentioning it; 3,443 classified as serious. Reports do not prove causation.

Research topics

HIV-1 111
HIV Infections 91
HIV Envelope Protein gp41 90
HIV Fusion Inhibitors 72
Anti-HIV Agents 58
Drug Resistance, Viral 48
Virus Internalization 43
Antiviral Agents 22
Virus Replication 17
Anti-Retroviral Agents 16

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application	Product	Status	First approval	Sponsor
NDA021481	FUZEON	Approved, discontinued	March 13, 2003	ROCHE

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 866
Human (MeSH) 750
Animal only 20
Clinical trials 108
Randomized controlled trials 64
Systematic reviews & meta-analyses 2
Case reports 52
Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

A four-amino-acid deletion in gp41 enhances HIV-1 CRF01_AE Cluster 4 pathogenicity and fusion inhibitor resistance. Unclassified 2026 Journal of virology
Insulin-derived nodular amyloidosis at sites of injection. Unclassified 2026 Proceedings (Baylor University. Medical Center)
Design of Artificial Peptide Against HIV-1 Based on the Heptad-Repeat Rules and Membrane-Anchor Strategies. Unclassified 2025 Pharmaceuticals (Basel, Switzerland)
HIV-1 Entry Mechanisms: Protein-Host Receptor Interactions and Membrane Fusion Dynamics. Review 2025 Frontiers in bioscience (Landmark edition)
Correction to "Quality by Design-Guided Development of Hydrogel-Forming Microneedles for Transdermal Delivery of Enfuvirtide". Unclassified 2025 ACS applied materials & interfaces
Next-generation antiviral peptides: AI-driven design, translational delivery platforms, and future therapeutic directions. Review 2025 Virus research
Harnessing Antiviral Peptides: From Molecular Mechanisms to Clinical Translation. Review 2025 Current research in pharmacology and drug discovery
Utilizing Machine Learning to Improve Neutralization Potency of an HIV-1 Antibody Targeting the gp41 N-Heptad Repeat. Human study 2025 ACS chemical biology
Transdermal delivery of enfuvirtide using dissolving microneedles integrated with novel insertion and removal indicator. Animal study 2025 Journal of controlled release : official journal of the Controlled Release Society
Research strategies of the N-peptide fusion inhibitor: a promising direction for discovering novel antivirals. Review 2025 Journal of virology

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 54
Active: 1
With posted results: 16

Conditions studied

HIV Infections 41
HIV Infection 4
HIV 3
AIDS 2
HIV-1-infection 1
HER2-positive Breast Cancer 1
Liver Failure 1
Evidence of Liver Transplantation 1
HIV1 Infection 1
HIV-1 1
Human Immunodeficiency Virus Type 1 1
Human Immunodeficiency Virus 1

Study	Status	Phase	Start
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1) NCT05502341 Gilead Sciences Results posted	Active, not recruiting	Phase 2, Phase 3	August 16, 2022
Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy NCT02302547 University Hospital, Tours	Completed	Phase 3	Dec 2014
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals NCT01836068 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Completed	Early phase 1	Jun 2013
Fasting on Newly Diagnosed Breast Cancer NCT02379585 Western Regional Medical Center Results posted	Terminated	Phase 1, Phase 2	Jan 2013
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients NCT01022476 ANRS, Emerging Infectious Diseases	Completed	Phase 1, Phase 2	May 2010
Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules NCT00937729 University Hospital, Rouen	Terminated	—	Jun 2009
CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery NCT00925756 University of California, San Diego Results posted	Completed	Phase 4	October 20, 2008
Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir NCT00708162 Gilead Sciences Results posted	Completed	Phase 3	Jul 2008
Optimizing Treatment for Treatment-Experienced, HIV-Infected People NCT00537394 National Institute of Allergy and Infectious Diseases (NIAID) Results posted	Completed	Phase 3	Jan 2008
INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure. NCT00615134 Hoffmann-La Roche	Completed	Phase 2	Jan 2008

Show 40 more studies

Study	Status	Phase	Start
RAL-eve Study: Raltegravir Substitution Study NCT00523237 Stanford University Results posted	Completed	N/A	Oct 2007
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects NCT00529243 Kaiser Permanente Results posted	Completed	Phase 3	Sep 2007
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients NCT00488059 Hoffmann-La Roche Results posted	Terminated	Phase 4	Jun 2007
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load NCT00454337 French National Agency for Research on AIDS and Viral Hepatitis	Completed	Phase 3	May 2007
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses NCT00460382 French National Agency for Research on AIDS and Viral Hepatitis	Completed	Phase 2	May 2007
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects. NCT00460746 Tibotec, Inc Results posted	Completed	Phase 3	May 2007
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression. NCT00461266 Hoffmann-La Roche	Withdrawn	Phase 4	Apr 2007
Clinical Trial of CNS-targeted HAART (CIT2) NCT00624195 University of California, San Diego Results posted	Completed	Phase 2, Phase 3	Mar 2007
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC NCT00440271 Boehringer Ingelheim Results posted	Terminated	Phase 3	Feb 2007
Study of Valproic Acid to Treat HIV Infected Adults NCT00312546 University of North Carolina, Chapel Hill	Terminated	Phase 1	Jun 2006
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection NCT00337701 Hoffmann-La Roche	Completed	Phase 4	Jun 2006
Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130) NCT00302822 French National Agency for Research on AIDS and Viral Hepatitis	Completed	Phase 3	Apr 2006
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1. NCT00326963 Hoffmann-La Roche Results posted	Completed	Phase 4	Mar 2006
Fuzeon Viral Decay Pilot Study NCT00334022 Canadian Immunodeficiency Research Collaborative	Completed	N/A	Feb 2006
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience NCT00487188 Hoffmann-La Roche Results posted	Completed	Phase 4	Nov 2005
Metabolic Effects of Enfuvirtide in Healthy Volunteers NCT00657761 Hospital Clinic of Barcelona	Completed	Phase 4	Sep 2005
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV. NCT00233883 Hoffmann-La Roche	Completed	Phase 4	Aug 2005
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study NCT00128830 Tibotec Pharmaceuticals, Ireland Results posted	Completed	Phase 2	Jun 2005
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration NCT00333736 Canadian Immunodeficiency Research Collaborative	Completed	Phase 2	May 2005
Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125) NCT00120367 French National Agency for Research on AIDS and Viral Hepatitis	Completed	Phase 2	Apr 2005
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection NCT02569502 Hoffmann-La Roche	Completed	Phase 4	Apr 2005
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy NCT00344760 University of Maryland, Baltimore	Completed	Phase 4	Jan 2005
Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection NCT02733419 Hoffmann-La Roche	Completed	Phase 3	Dec 2004
A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1 NCT00100984 Hoffmann-La Roche	Terminated	Phase 4	July 21, 2004
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients NCT00089492 Hoffmann-La Roche	Completed	Phase 2	Jul 2004
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection NCT00232908 Hoffmann-La Roche	Completed	Phase 4	Jun 2004
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection NCT02582983 Hoffmann-La Roche Results posted	Completed	Phase 4	Feb 2004
Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults NCT00051831 National Institute of Allergy and Infectious Diseases (NIAID)	Completed	N/A	Oct 2003
Cohort Study for Patients Using Fuzeon (Enfuvirtide) NCT00216359 Institute for Interdisciplinary Infectiology	Unknown status	—	May 2003
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus NCT00102934 National Institute of Allergy and Infectious Diseases (NIAID)	Unknown status	N/A	Mar 2003
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) NCT00192660 Kirby Institute	Completed	Phase 4	Feb 2003
Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection NCT00050856 National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Phase 3	Nov 2002
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents NCT00022763 Hoffmann-La Roche Results posted	Completed	Phase 2	Aug 2001
HIV Maintenance Therapy With T-20 During HAART Interruption NCT00013884 National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Phase 2	Mar 2001
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection NCT01902615 Hoffmann-La Roche	Completed	—	Jan 2001
Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance NCT00187551 University of California, San Francisco	Completed	Phase 4	May 2000
The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV NCT00004735 National Institute of Allergy and Infectious Diseases (NIAID)	Completed	N/A	Feb 2000
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults NCT00002239 Hoffmann-La Roche	Completed	Phase 2	May 1999
T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs NCT00008528 Hoffmann-La Roche	Completed	Phase 3	—
Study of Enfuvirtide in HIV-Positive Subjects NCT00086710 Trimeris	Completed	Phase 1	—

All 54 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 3,751
Serious: 3,443
With death outcome: 514

Most reported reactions

Depression 555
Drug interaction 551
Psychotic disorder 307
Nausea 294
Vomiting 290
Pneumonia 273
Injection site reaction 231
Loss of personal independence in daily activities 227
Anxiety 215
Cholelithiasis 209
Schizophrenia 209
Lipodystrophy acquired 192

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.