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Enfuvirtide

Generic Name
Enfuvirtide
Brand Names
Fuzeon
Drug Type
Biotech
CAS Number
159519-65-0
Unique Ingredient Identifier
19OWO1T3ZE

Overview

Enfuvirtide is a 36 amino acid biomimetic peptide that is structurally similar to the HIV proteins that are responsible for the fusion of the virus to cell membranes and subsequent intracellular uptake. The first agent in the novel class of antiretroviral drugs called HIV fusion inhibitors, enfuvirtide works by inhibiting HIV-1 fusion with CD4 cells.

Indication

Enfuvirtide is an antiretroviral drug used in combination therapy for the treatment of HIV-1/AIDS.

Associated Conditions

  • Human Immunodeficiency Virus Type 1 (HIV-1)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2016/04/11
Phase 3
Completed
2015/10/21
Phase 4
Completed
2015/10/06
Phase 4
Completed
2013/04/19
Early Phase 1
Completed
2008/04/14
Phase 4
Completed
2008/02/14
Phase 2
Completed
2007/10/01
Phase 3
Completed
2007/06/19
Phase 4
Terminated
2007/06/15
Phase 4
Completed
2007/04/17
Phase 4
Withdrawn

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
5/27/2003

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
FUZEON
Hoffmann-La Roche Limited
02247725
Powder For Solution - Subcutaneous
108 MG / VIAL
8/18/2003

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
FUZEON 90 mg/ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
03252001
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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