MedPath

Stavudine

Generic Name
Stavudine
Brand Names
Zerit
Drug Type
Small Molecule
Chemical Formula
C10H12N2O4
CAS Number
3056-17-5
Unique Ingredient Identifier
BO9LE4QFZF

Overview

A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.

Indication

For the treatment of human immunovirus (HIV) infections.

Associated Conditions

  • Human Immunodeficiency Virus (HIV) Infections

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2016/02/02
Phase 3
Completed
Willem Daniel Francois Venter
2014/09/25
Phase 2
Completed
2012/05/18
Phase 4
Terminated
University of Witwatersrand, South Africa
2010/06/22
Phase 3
Completed
2008/02/18
Phase 4
Completed
Peking Union Medical College
2007/09/14
Phase 3
Completed
2006/06/21
Phase 4
Completed
2006/04/07
Phase 1
Completed
2005/11/21
Not Applicable
Completed
CIPRA SA
2005/10/10
Phase 4
UNKNOWN
Groupe Hospitalier Pitie-Salpetriere

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
State of Florida DOH Central Pharmacy
53808-0594
ORAL
40 mg in 1 1
6/8/2010
State of Florida DOH Central Pharmacy
53808-0795
ORAL
40 mg in 1 1
8/12/2010
State of Florida DOH Central Pharmacy
53808-0656
ORAL
20 mg in 1 1
8/12/2010
State of Florida DOH Central Pharmacy
53808-0595
ORAL
40 mg in 1 1
6/8/2010
Cipla Ltd.
53104-0111
ORAL
1 mg in 1 mL
1/16/2019
State of Florida DOH Central Pharmacy
53808-0657
ORAL
30 mg in 1 1
8/12/2010
State of Florida DOH Central Pharmacy
53808-0852
ORAL
20 mg in 1 1
9/30/2013

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

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
STAVUDINE CAPSULES 40MG
N/A
i & c (hong kong) limited
N/A
N/A
8/25/2014

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
ZERIT - CAP 20MG
bristol-myers squibb canada
02216094
Capsule - Oral
20 MG
7/30/1996
ZERIT - CAP 15MG
bristol-myers squibb canada
02216086
Capsule - Oral
15 MG
7/30/1996
ZERIT
bristol-myers squibb canada
02237009
Powder For Solution - Oral
1 MG / ML
N/A
ZERIT - CAP 40MG
bristol-myers squibb canada
02216116
Capsule - Oral
40 MG
7/30/1996
ZERIT - CAP 30MG
bristol-myers squibb canada
02216108
Capsule - Oral
30 MG
7/30/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
ZERIT 20 mg CAPSULA DURA
96009004
CÁPSULA DURA
Uso Hospitalario
Not Commercialized
ZERIT 30 mg CAPSULA DURA
96009006
CÁPSULA DURA
Uso Hospitalario
Not Commercialized
ZERIT 40 mg CAPSULA DURA
96009008
CÁPSULA DURA
Uso Hospitalario
Not Commercialized
ZERIT 200 mg POLVO PARA SOLUCION ORAL
96009009
POLVO PARA SOLUCIÓN ORAL
Uso Hospitalario
Not Commercialized
ZERIT 15 mg CAPSULA DURA
96009002
CÁPSULA DURA
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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