ZIDOVUDINE

Post-LOE

zidovudine

Aurobindo Pharma

ANDAORALSOLUTION

Approved

Sep 2005

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

ZIDOVUDINE (zidovudine) by Aurobindo Pharma is nucleoside reverse transcriptase inhibitors [moa]. Approved for maternal-fetal hiv-1 transmission [see ], combination with other antiretroviral agents for the treatment of hiv-1 infection. First approved in 2005.

Drug data last refreshed 6h ago

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Pharmacologic Class:

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

Indications (1)

combination with other antiretroviral agents for the treatment of HIV-1 infection

Clinical Trials (20)

NCT00000969N/ACompleted

A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy

400 enrolled

HIV Infections

NCT00002274N/ACompleted

A Study of ddI in Patients With AIDS Who Become Sicker While Taking Zidovudine

HIV InfectionsLeukoencephalopathy, Progressive Multifocal

NCT00000649Phase 1Completed

An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection (CD4+ Cell Count < 400/mm3)

30 enrolled

HIV Infections

NCT00000628Phase 1Completed

A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine

27 enrolled

HIV Infections

NCT00000990Phase 2Completed

The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms

224 enrolled

HIV Infections

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.