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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Therapeutic Areas

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

Trade Name

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EMA

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Drug Products

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New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Enfuvirtide

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

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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

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Patent Expiration

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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

62 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
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	—	1	—	1
Lipodystrophy	D008060	—	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
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	2	2	—	—	5
Hiv	D006678	—	O98.7	1	1	2	—	—	4
Infections	D007239	EFO_0000544	—	—	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	EFO_0001421	K70-K77	1	1	—	—	—	1
End stage liver disease	D058625	EFO_1001311	K72.1	1	1	—	—	—	1
Liver failure	D017093	—	K72.9	1	1	—	—	—	1
Immunologic deficiency syndromes	D007153	—	D84.9	—	1	—	—	—	1
Leukoencephalopathies	D056784	—	R90.82	—	1	—	—	—	1
Progressive multifocal leukoencephalopathy	D007968	EFO_0007455	A81.2	—	1	—	—	—	1

Indications Phases 1

No data

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Communicable diseases	D003141	—	—	—	—	—	—	1	1
Lymphedema	D008209	—	Q82.0	—	—	—	—	1	1
Diabetes mellitus	D003920	EFO_0000400	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
Smoking cessation	D016540	EFO_0004319	—	—	—	—	—	1	1
Knee osteoarthritis	D020370	EFO_0004616	M17	—	—	—	—	1	1
Osteoarthritis	D010003	EFO_0002506	M15-M19	—	—	—	—	1	1
Colorectal neoplasms	D015179	—	—	—	—	—	—	1	1

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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