Retrovir, Combivir(zidovudine)
Combivir, Retrovir, Trizivir (zidovudine) is a small molecule pharmaceutical. Zidovudine was first approved as Retrovir on 1987-03-19. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Retrovir (generic drugs available since 2005-09-19)
CombinationsCombivir, Trizivir (generic drugs available since 2005-09-19)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Abacavir sulfate
+
Lamivudine
+
Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIZIVIR | ViiV Healthcare | N-021205 RX | 2000-11-14 | 1 products, RLD, RS |
Lamivudine
+
Nevirapine
+
Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE | Micro Laboratories | N-205626 DISCN | 2018-08-13 | 1 products, RLD |
Hide discontinued
Lamivudine
+
Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COMBIVIR | ViiV Healthcare | N-020857 RX | 1997-09-26 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
| hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
— J05AF01: Zidovudine
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR01: Zidovudine and lamivudine
— J05AR04: Zidovudine, lamivudine and abacavir
— J05AR05: Zidovudine, lamivudine and nevirapine
Clinical
Clinical Trials
399 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 70 | 86 | 73 | 26 | 89 | 340 |
| Hiv | D006678 | O98.7 | 3 | 4 | 3 | 10 | 1 | 19 | |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | 4 | 2 | — | 8 |
| Lymphoma | D008223 | C85.9 | — | 6 | — | 1 | — | 7 | |
| Infections | D007239 | EFO_0000544 | 1 | 1 | — | 2 | — | 4 | |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | 1 | 1 | 1 | 4 |
| Hiv-1 | D015497 | — | 1 | 1 | 1 | — | 3 | ||
| Lipodystrophy | D008060 | E88.1 | — | 1 | — | 2 | — | 3 | |
| Hemophilia a | D006467 | EFO_0007267 | D66 | 1 | — | — | 1 | 1 | 3 |
| Hiv-2 | D015498 | — | — | 1 | 1 | — | 2 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 7 | — | 6 | — | — | 13 |
| Aids dementia complex | D015526 | EFO_0002608 | 1 | 1 | 2 | — | 1 | 5 | |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | — | — | 2 | — | 1 | 3 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | — | 1 | — | — | 2 |
| Tropical spastic paraparesis | D015493 | EFO_0007527 | G04.1 | 1 | 1 | 1 | — | — | 2 |
| Breast feeding | D001942 | — | — | 1 | — | — | 1 | ||
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | 1 | 1 | — | — | 1 | |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | 1 | — | — | 1 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kaposi sarcoma | D012514 | C46 | 6 | 1 | — | — | — | 7 | |
| Human herpesvirus 8 | D019288 | — | 2 | — | — | — | 2 | ||
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | 2 | — | — | — | 2 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | 1 | — | — | 1 | 2 |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 1 | — | — | — | 1 |
| Hodgkin disease | D006689 | C81 | — | 1 | — | — | — | 1 | |
| Adult t-cell leukemia-lymphoma | D015459 | C91.5 | — | 1 | — | — | — | 1 | |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | 2 | 6 | ||
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 1 | — | — | — | 1 | 2 |
| Htlv-i infections | D015490 | EFO_0007316 | 1 | — | — | — | — | 1 | |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | 1 | — | — | — | — | 1 | |
| Cerebral toxoplasmosis | D016781 | EFO_0007200 | B58.2 | 1 | — | — | — | — | 1 |
| Severe combined immunodeficiency | D016511 | D81.0 | 1 | — | — | — | — | 1 | |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | — | — | — | — | 3 | 3 | |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | — | — | — | 3 | 3 | |
| Meningeal tuberculosis | D014390 | A17.0 | — | — | — | — | 1 | 1 | |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 1 | 1 |
| Protein-energy malnutrition | D011502 | EFO_0009563 | E41 | — | — | — | — | 1 | 1 |
| Kwashiorkor | D007732 | EFO_1001009 | E40 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Lymphatic diseases | D008206 | HP_0100763 | — | — | — | — | 1 | 1 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ZIDOVUDINE |
| INN | zidovudine |
| Description | Zidovudine is a pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase. It has a role as an antiviral drug, an antimetabolite and a HIV-1 reverse transcriptase inhibitor. It is a pyrimidine 2',3'-dideoxyribonucleoside and an azide. |
| Classification | Small molecule |
| Drug class | antineoplastics; antivirals (zidovudine group) (exception: edoxudine) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O |
Identifiers
| PDB | — |
| CAS-ID | 30516-87-1 |
| RxCUI | 11413 |
| ChEMBL ID | CHEMBL129 |
| ChEBI ID | 10110 |
| PubChem CID | 35370 |
| DrugBank | DB00495 |
| UNII ID | 4B9XT59T7S (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Combivir, Retrovir, Trizivir
Adverse Events
Top Adverse Reactions
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2,342 adverse events reported
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