Stavudine

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
Dose Optimisation of Stavudine for the Treatment of HIV Infection	2016/02/02	NCT02670772	Phase 3	Completed	Willem Daniel Francois Venter
Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir	2014/09/25	NCT02249130	Phase 2	Completed	Boehringer Ingelheim
Differences Between Stavudine and Tenofovir Each Combined With Lamivudine and Efavirenz in SA HIV-infected Patients	2012/05/18	NCT01601899	Phase 4	Terminated	University of Witwatersrand, South Africa
Treatment Options for Protease Inhibitor-exposed Children	2010/06/22	NCT01146873	Phase 3	Completed	Columbia University
Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort	2008/02/18	NCT00618176	Phase 4	Completed	Peking Union Medical College
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children	2007/09/14	NCT00528957	Phase 3	Completed	Gilead Sciences
Antiretroviral Therapy for Advanced HIV Disease in South Africa	2006/06/21	NCT00342355	Phase 4	Completed	National Institutes of Health Clinical Center (CC)
Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children	2006/04/07	NCT00312091	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities	2005/11/21	NCT00255840	Not Applicable	Completed	CIPRA SA
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY	2005/10/10	NCT00235222	Phase 4	UNKNOWN	Groupe Hospitalier Pitie-Salpetriere

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Stavudine	State of Florida DOH Central Pharmacy	53808-0594	ORAL	40 mg in 1 1	6/8/2010
ZERIT	State of Florida DOH Central Pharmacy	53808-0795	ORAL	40 mg in 1 1	8/12/2010
ZERIT	State of Florida DOH Central Pharmacy	53808-0656	ORAL	20 mg in 1 1	8/12/2010
Stavudine	State of Florida DOH Central Pharmacy	53808-0595	ORAL	40 mg in 1 1	6/8/2010
stavudine	Cipla Ltd.	53104-0111	ORAL	1 mg in 1 mL	1/16/2019
ZERIT	State of Florida DOH Central Pharmacy	53808-0657	ORAL	30 mg in 1 1	8/12/2010
Stavudine	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	Bristol-Myers Squibb Pharma Eeig	96009004	CÁPSULA DURA	Uso Hospitalario	Not Commercialized
ZERIT 30 mg CAPSULA DURA	Bristol-Myers Squibb Pharma Eeig	96009006	CÁPSULA DURA	Uso Hospitalario	Not Commercialized
ZERIT 40 mg CAPSULA DURA	Bristol-Myers Squibb Pharma Eeig	96009008	CÁPSULA DURA	Uso Hospitalario	Not Commercialized
ZERIT 200 mg POLVO PARA SOLUCION ORAL	Bristol-Myers Squibb Pharma Eeig	96009009	POLVO PARA SOLUCIÓN ORAL	Uso Hospitalario	Not Commercialized
ZERIT 15 mg CAPSULA DURA	Bristol-Myers Squibb Pharma Eeig	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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