U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Enfuvirtide is a linear 36-amino acid synthetic peptide that inhibits the fusion of HIV-1 with CD4 cells. Enfuvirtide works by disrupting the HIV-1 molecular machinery at the final stage of fusion with the target cell, preventing uninfected cells from becoming infected. Enfuvirtide interferes with the entry of HIV-1 into cells by inhibiting fusion of viral and cellular membranes. Enfuvirtide binds to the first heptad-repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational changes required for the fusion of viral and cellular membranes. Enfuvirtide is indicated for the treatment of HIV-1 infection, in combination therapy with other antiretrovirals, in patients where all other treatments have failed. Common adverse drug reactions associated with enfuvirtide therapy include: injection site reactions (pain, hardening of skin, erythema, nodules, cysts, itch; experienced by nearly all patients, particularly in the first week), peripheral neuropathy, insomnia, depression, cough, dyspnoea, anorexia, arthralgia, infections (including bacterial pneumonia) and/or eosinophilia.

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
FUZEON

Approved Use

FUZEON is an HIV-1 fusion inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment experienced patients with HIV-1 replication despite ongoing antiretroviral therapy.

Launch Date

2003
PubMed

PubMed

TitleDatePubMed
[T-20: a fusion inhibitor].
2002
Five new drugs enter the homestretch.
2002 Dec
New drugs show promise in attacking HIV.
2002 Dec
HIV medicine after Barcelona conference: interview with Howard Grossman, M.D. Interview by John S. James.
2002 Sep 6
ConFuzeon reigns.
2003 Apr
Anti-HIV-1 activity of enfuvirtide (T-20) by inhibition of bystander cell death.
2003 Apr
The LLSGIV stretch of the N-terminal region of HIV-1 gp41 is critical for binding to a model peptide, T20.
2003 Apr
Drug cost. States concerned about Fuzeon.
2003 Apr 11
Stopping HIV fusion with enfuvirtide: the first step to extracellular HAART.
2003 Feb
Anti-HIV drug updates--three drugs on the near horizon.
2003 Jan
Projecting future drug expenditures--2003.
2003 Jan 15
First fusion inhibitor for advanced HIV.
2003 Jul
Large-scale manufacture of peptide therapeutics by chemical synthesis.
2003 Jul
[HIV infections: further options for combination therapy].
2003 Jul 11
FDA notifications. FDA approves Fuzeon, the first fusion inhibitor.
2003 Jun
Antiviral Research--16th Annual International Conference. Satellite symposium: clinical update on antiviral drugs. 27 April-1 May 2003, Savannah, GA, USA.
2003 Jun
Gateways to clinical trials.
2003 Jun
Uncommon mutations at residue positions critical for enfuvirtide (T-20) resistance in enfuvirtide-naive patients infected with subtype B and non-B HIV-1 strains.
2003 Jun 1
[First fusion inhibitor is available. No entry for HIV-1 viruses].
2003 Jun 19
Enfuvirtide (Fuzeon) for HIV Infection.
2003 Jun 23
Treatment with a new fusion inhibitor: patient issues with enfuvirtide (T-20). A review of the presentation at the satellite symposium "New hope: advancing care in HIV infection" at the 15th annual Association of Nurses in AIDS Care conference, November 2002.
2003 Mar
Clinical safety and efficacy of enfuvirtide (T-20), a new fusion inhibitor. A review of the presentation at the satellite symposium "New hope: advancing care in HIV infection" at the 15th annual Association of Nurses in AIDS Care conference, November 2002.
2003 Mar
New classes of HIV drugs on the horizon. A review of the presentation at the satellite symposium "New hope: advancing care in HIV infection" at the 15th annual Association of Nurses in AIDS Care conference, November 2002.
2003 Mar
Gateways to clinical trials. March 2003.
2003 Mar
FUZEON (enfuvirtide, T-20). Breaking barriers or breaking the bank?
2003 Mar
Fuzeon data review.
2003 Mar
Long path to approval. A look back at the road to Fuzeon.
2003 Mar
Entry inhibitors SCH-C, RANTES, and T-20 block HIV type 1 replication in multiple cell types.
2003 Mar
New antiretroviral drugs.
2003 Mar
T-20: most expensive AIDS drug ever at $25,000 per year?
2003 Mar 14
A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy.
2003 Mar 28
Fusion inhibitor approved.
2003 May
Drug profile: enfuvirtide (Fuzeon, ENF, T-20).
2003 May
The optimal use of enfuvirtide.
2003 May
Enfuvirtide access, administration, and patient education.
2003 May
Enfuvirtide.
2003 May
FDA news. Price criticized for new anti-HIV drug.
2003 May
Enfuvirtide approved for defusing HIV.
2003 May
US FDA approves new class of HIV therapeutics.
2003 May
Enfuvirtide, a new drug for HIV infection.
2003 May 10
Primary resistance mutations to fusion inhibitors and polymorphisms in gp41 sequences of HIV-1 non-B subtypes and recombinants.
2003 May 2
Fusion inhibition--a major but costly step forward in the treatment of HIV-1.
2003 May 29
Novel therapies based on mechanisms of HIV-1 cell entry.
2003 May 29
Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia.
2003 May 29
HIV infection--a new drug and new costs.
2003 May 29
Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America.
2003 May 29
[HIV-1 fusion inhibitor improves treatment in HIV-1-resistant patients].
2003 May 9
New class of medications approved for advance HIV.
2003 May-Jun
Inhibiting HIV-1 entry with fusion inhibitors.
2003 Sep
Virus entry as a target for anti-HIV intervention.
2003 Sep

Sample Use Guides

Adults: Recommended dosage of Enfuvirtide is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh, or abdomen. Pediatric Patients (weighing at least 11kg): Recommended dose of 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously.
Route of Administration: Other
Name Type Language
ENFUVIRTIDE
EMA EPAR   HSDB   INN   MART.   MI   ORANGE BOOK   USAN   VANDF   WHO-DD  
INN   USAN  
Official Name English
ENFUVIRTIDE [VANDF]
Common Name English
DP-178
Code English
T-20
Code English
FUZEON
Brand Name English
DP178
Code English
enfuvirtide [INN]
Common Name English
ENFUVIRTIDE [EMA EPAR]
Common Name English
ENFUVIRTIDE [USAN]
Common Name English
Enfuvirtide [WHO-DD]
Common Name English
T20
Code English
ENFUVIRTIDE [MART.]
Common Name English
ENFUVIRTIDE [MI]
Common Name English
ENFUVIRTIDE [ORANGE BOOK]
Common Name English
ENFUVIRTIDE [HSDB]
Common Name English
Classification Tree Code System Code
NDF-RT N0000175616
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
NCI_THESAURUS C1660
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
NDF-RT N0000175615
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
WHO-ATC J05AX07
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
WHO-VATC QJ05AX07
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
EMA ASSESSMENT REPORTS FUZEON (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
LIVERTOX NBK548862
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
Code System Code Type Description
DRUG CENTRAL
1010
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PRIMARY
EVMPD
SUB12496MIG
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PRIMARY
CAS
159519-65-0
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PRIMARY
SMS_ID
100000089287
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PRIMARY
CHEBI
608828
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
NCI_THESAURUS
C2105
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PRIMARY
EPA CompTox
DTXSID20166672
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
USAN
LL-10
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PRIMARY
HSDB
7341
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
ChEMBL
CHEMBL525076
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PRIMARY
INN
8063
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PRIMARY
DRUG BANK
DB00109
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
RXCUI
139896
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY RxNorm
MERCK INDEX
m4906
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY Merck Index
WIKIPEDIA
ENFUVIRTIDE
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
DAILYMED
19OWO1T3ZE
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
LACTMED
Enfuvirtide
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
MESH
C105196
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY
FDA UNII
19OWO1T3ZE
Created by admin on Sat Dec 16 16:21:25 GMT 2023 , Edited by admin on Sat Dec 16 16:21:25 GMT 2023
PRIMARY