RETROVIR
LOE ApproachingNDAORALTABLET
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
RETROVIR by GSK is [see microbiology ()] . Approved for maternal-fetal hiv-1 transmission [see dosage, administration ()], combination with other antiretroviral agents for the treatment of hiv-1 infection. First approved in 1995.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RETROVIR (zidovudine) is an oral nucleoside reverse transcriptase inhibitor (NRTI) approved in 1995 for HIV-1 treatment and prevention of maternal-fetal transmission. It works by inhibiting HIV-1 reverse transcriptase, blocking viral replication. RETROVIR is typically used in combination with other antiretroviral agents as part of highly active antiretroviral therapy (HAART).
LOE Approaching
As LOE approaches, the RETROVIR team is likely consolidating and focusing on lifecycle management and generic mitigation strategies rather than growth initiatives.
Mechanism of Action
[see Microbiology ()] .
Clinical Trials (20)
A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
399 enrolled
HIV Infections
A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone
200 enrolled
HIV Infections
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
16 enrolled
HIV Infections
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
Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315
34 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.