Enfuvirtide - PharmaKB

Fuzeon(enfuvirtide)

Fuzeon (enfuvirtide) is a protein pharmaceutical. Enfuvirtide was first approved as Fuzeon on 2003-03-13. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

FDA

EMA

Fuzeon

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Enfuvirtide

Tradename	Company	Number	Date	Products
FUZEON	Roche	N-021481 RX	2003-03-13	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
fuzeon	New Drug Application	2020-05-05

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AX: Other antivirals in atc

— J05AX07: Enfuvirtide

HCPCS

Code	Description
J1324	Injection, enfuvirtide, 1 mg

Clinical

Clinical Trials

60 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	5	14	12	14	7	48
Infections	D007239	EFO_0000544	—	—	1	2	4	2	9
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	2	1	1	—	5
Communicable diseases	D003141	—	—	—	—	—	4	1	5
Cardiovascular diseases	D002318	HP_0001626	—	—	—	—	1	—	1
Lipodystrophy	D008060	HP_0009125	E88.1	—	—	—	1	—	1
Hiv-associated lipodystrophy syndrome	D039682	EFO_1001348	—	—	—	—	1	—	1
Atrioventricular block	D054537	—	I44.3	—	—	—	1	—	1
Atrial fibrillation	D001281	EFO_0000275	I48.0	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv	D006678	—	—	1	1	2	—	—	4

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv-1	D015497	—	—	—	1	—	—	1	2
Breast neoplasms	D001943	EFO_0003869	C50	1	1	—	—	—	1
Liver diseases	D008107	HP_0002910	K70-K77	1	1	—	—	—	1
End stage liver disease	D058625	EFO_1001311	K72.1	1	1	—	—	—	1
Liver failure	D017093	HP_0001399	K72.9	1	1	—	—	—	1
Immunologic deficiency syndromes	D007153	HP_0002721	D84.9	—	1	—	—	—	1
Leukoencephalopathies	D056784	HP_0002352	—	—	1	—	—	—	1
Progressive multifocal leukoencephalopathy	D007968	EFO_0007455	A81.2	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv seropositivity	D006679	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphedema	D008209	HP_0001004	—	—	—	—	—	1	1
Diabetes mellitus	D003920	HP_0000819	E08-E13	—	—	—	—	1	1
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	—	—	—	1	1
Septic shock	D012772	—	A48.3	—	—	—	—	1	1
Shock	D012769	—	R57.1	—	—	—	—	1	1
Colorectal neoplasms	D015179	—	—	—	—	—	—	1	1
Multiple pulmonary nodules	D055613	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Enfuvirtide
INN	enfuvirtide
Description	Enfuvirtide is a synthetic 36-amino acid peptide consisting of N-acetyltyrosyl, threonyl, seryl, leucyl, isoleucyl, histidyl, seryl, leucyl, isoleucyl, alpha-glutamyl, alpha-glutamyl, seryl, glutaminyl, asparaginyl, glutaminyl, glutaminyl, alpha-glutamyl, lysyl, asparaginyl, alpha-glutamyl, alpha-glutamyl, alpha-glutamyl, leucyl, leucyl, alpha-glutamyl, leucyl, alpha-aspartyl, lysyl, tryptophyl, alanyl, seryl, leucyl, tryptophyl, asparaginyl, tryptophyl, and phenylalaninamide residues joined in sequence. An HIV fusion inhibitor, it was the first of a novel class of antiretroviral drugs used in combination therapy for the treatment of HIV-1 infection. It interferes with entry of HIV into cells by binding to the gp41 sub-unit of the viral envelope glycoprotein, so inhibiting fusion of viral and cellular membranes. It has a role as a HIV fusion inhibitor.
Classification	Protein
Drug class	peptides: antiviral peptides; antivirals
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC[C@H](C)[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(C)=O)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](Cc1ccccc1)C(N)=O