NDAORALSOLUTIONPriority Review
Approved
Sep 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
RETROVIR (zidovudine) by GSK is nucleoside reverse transcriptase inhibitors [moa]. First approved in 1989.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RETROVIR (zidovudine) is a nucleoside reverse transcriptase inhibitor (NRTI) approved in 1989 for HIV infection and AIDS dementia complex. It works by blocking the reverse transcriptase enzyme that HIV uses to replicate, slowing disease progression. This was the first antiretroviral drug approved for HIV treatment, marking a watershed moment in infectious disease therapy.
LOE Approaching
Declining
Product is in advanced lifecycle decline with minimal active commercial investment; teams are typically skeleton crews managing legacy business and generic transitions.
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)
Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
60 enrolled
HIV InfectionsCytopenias
A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)
HIV Infections
The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
112 enrolled
HIV Infections
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
230 enrolled
HIV Infections
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
200 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.