NDAINJECTIONINJECTABLEPriority Review
Approved
Feb 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
RETROVIR (zidovudine) by GSK is nucleoside reverse transcriptase inhibitors [moa]. Approved for human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 1990.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RETROVIR (zidovudine) is a nucleoside reverse transcriptase inhibitor (NRTI) approved in 1990 for HIV treatment. It works by blocking the reverse transcriptase enzyme that HIV uses to replicate. This foundational antiretroviral was the first FDA-approved HIV therapy and remains part of combination regimens.
LOE Approaching
Declining market presence with minimal linked job opportunities reflects mature product status and limited growth trajectory at GSK.
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
5 enrolled
HIV Infections
A Phase I Concentration-Controlled Trial to Assess the Safety, Tolerance, Pharmacokinetics and Development of Decreased HIV-1 Susceptibility to the Combination of Atevirdine Mesylate (U-87201E), Zidovudine (AZT), and Didanosine (ddI)
15 enrolled
HIV Infections
Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
3,200 enrolled
HIV Infections
Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
25 enrolled
HIV Infections
Evaluation of the Interaction Between Acetaminophen and Zidovudine
10 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.