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 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RETROVIR (zidovudine) is a nucleoside reverse transcriptase inhibitor (NRTI) that treats HIV infection by blocking the enzyme reverse transcriptase, which the virus uses to replicate. It was the first FDA-approved antiretroviral therapy and is administered via injection. Zidovudine is now typically used in combination regimens rather than as monotherapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure; expect downsizing of dedicated brand teams and consolidation into legacy portfolio management units.
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 of Different Dose Levels of Zidovudine in HIV-Infected Children
400 enrolled
HIV Infections
A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
471 enrolled
HIV Infections
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 Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
1,710 enrolled
HIV Infections
A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease
72 enrolled
AnemiaAcquired Immunodeficiency Syndrome
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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.