RETROVIR (zidovudine)
RETROVIR is indicated for the treatment of Human Immunodeficiency Virus.
How RETROVIR Works
Zidovudine is a structural analogue of thymidine. It is phosphorylated by cellular enzymes to the active metabolite zidovudine triphosphate (ZDV-TP). ZDV-TP inhibits the replication of HIV-1 by competing with the natural substrate dTTP for incorporation into viral DNA via the reverse transcriptase enzyme. Once incorporated, the absence of a 3'-OH group on the zidovudine molecule prevents the formation of further 5' to 3' phosphodiester linkages, resulting in viral DNA chain termination.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1987-03-19
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, SOLUTION, CAPSULE, TABLET
RETROVIR Approval History
What RETROVIR Treats
1 indicationsRETROVIR is approved for 1 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus
RETROVIR Boxed Warning
RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS RETROVIR (zidovudine) capsules, oral solution, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease [see Warnings and Precautions ( 5.1 )] . Prolonged use of RETROVIR has been associated with symptomatic myopathy [see Warnings and Precautions ( 5. 2)] . Lactic acidosis and severe hepatomegaly with st...
WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS RETROVIR (zidovudine) capsules, oral solution, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease [see Warnings and Precautions ( 5.1 )] . Prolonged use of RETROVIR has been associated with symptomatic myopathy [see Warnings and Precautions ( 5. 2)] . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including RETROVIR and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ( 5. 3)] . WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS See full prescribing information for complete boxed warning. • Hematologic toxicity including neutropenia and severe anemia have been associated with the use of zidovudine. ( 5.1 ) • Symptomatic myopathy associated with prolonged use of zidovudine. ( 5.2 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including RETROVIR. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. ( 5.3 )
RETROVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RETROVIR
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01419561 | 110220 11-C-0220 | Ph 2 | recruiting | Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) |
| NCT02737046 results posted | 20150567 | Ph 2 | completed | Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma |
| NCT02369406 EIT | U01AI114235 | Ph 2, Ph 3 | active not recruiting | Early Infant HIV Treatment in Botswana |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT02712801 | 2015ZX10001001 | Ph 4 | completed | Antiretroviral Regime for Viral Eradication in Newborns |
| NCT03088410 | IRB 2019-2922 R01DK109881, HRDC 00781 | Ph 4 | completed | Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana |
| NCT00672412 | P1069 10620, IMPAACT P1069 | Ph 1, Ph 2 | completed | Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand |
| NCT01352715 SELECT results posted | ACTG A5273 1U01AI068636, 5UM1AI068634 | Ph 3 | completed | Study of Options for Second-Line Effective Combination Therapy (SELECT) |
| NCT01441063 results posted | 110233 11-C-0233 | Ph 2 | completed | Tocilizumab for KSHV-Associated Multicentric Castleman Disease |
| NCT02431975 LEOPARD | AAAO5011 U01HD080441 | Ph 4 | completed | Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial |
| NCT01964755 results posted | 20090166 | Ph 2 | terminated | Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma |
| NCT00993031 PROMOTE-PIs results posted | H5741-34342 P01HD059454, 2009-141 | Ph 3 | completed | Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women |
| NCT01516970 PEPDar results posted | CR018349 TMC114IFD3004, 2011-001303-13 | Ph 3 | completed | Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) |
| NCT00409591 PHPT-5 | PHPT-5 First Phase R01HD052461, R01HD056953 | Ph 3 | terminated | Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand |
| NCT01694017 | 10465 | Ph 4 | completed | Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy |
| NCT00915655 DIONE results posted | CR016312 TMC114-TiDP29-C230, 2008-004631-37 | Ph 2 | completed | A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RETROVIR FDA Label Details
Indications & Usage
FDA Label (PDF)RETROVIR is indicated for the treatment of Human Immunodeficiency Virus.
WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS RETROVIR (zidovudine) capsules, oral solution, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment