Retrovir, Combivir(zidovudine)
/ Lamivudine / Zidovudine, Combivir, Lamivudine / Zidovudine, Retrovir, Trizivir, Zidovudine (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, Zidovudine (discontinued: Retrovir, Zidovudine)
CombinationsAbacavir sulfate, lamivudine zidovudine, Lamivudine zidovudine (discontinued: Combivir, Lamivudine zidovudine, Lamivudine, nevirapine zidovudine, Trizivir)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RETROVIR | ViiV Healthcare | N-019655 RX | 1987-03-19 | 1 products, RLD, RS |
| RETROVIR | ViiV Healthcare | N-019910 RX | 1989-09-28 | 1 products, RLD, RS |
| RETROVIR | ViiV Healthcare | N-019951 RX | 1990-02-02 | 1 products, RLD, RS |
Show 3 discontinued
Lamivudine
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Nevirapine
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Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE | Micro Laboratories | N-205626 DISCN | 2018-08-13 | 1 products, RLD |
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Lamivudine
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Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LAMIVUDINE AND ZIDOVUDINE | PharmaCare | N-022018 DISCN | 2017-03-17 | 1 products |
| COMBIVIR | ViiV Healthcare | N-020857 DISCN | 1997-09-26 | 1 products, RLD |
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Abacavir sulfate
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Lamivudine
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Zidovudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIZIVIR | ViiV Healthcare | N-021205 DISCN | 2000-11-14 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abacavir sulfate, lamivudine and zidovudine | ANDA | 2016-05-04 |
| abacavir, lamivudine and zidovudine | ANDA | 2023-10-31 |
| combivir | New Drug Application | 2023-08-22 |
| compound w | C200263 | 2024-10-25 |
| compound w for kids one step strips | C200263 | 2024-10-25 |
| compound w one step pads | C200263 | 2024-10-25 |
| compound w one step plantar foot pads | C200263 | 2024-10-25 |
| compound w total care wart and skin kit | C200263 | 2023-10-27 |
| danil | unapproved drug other | 2024-05-16 |
| direct rx | ANDA | 2015-08-04 |
Show 11 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
| hepatitis b | — | D006509 | — |
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
569 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 | 77 | 119 | 98 | 49 | 121 | 453 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 22 | 33 | 30 | 12 | 29 | 125 |
| Infections | D007239 | EFO_0000544 | — | 22 | 28 | 24 | 7 | 29 | 110 |
| Communicable diseases | D003141 | — | — | 14 | 12 | 11 | 3 | 15 | 55 |
| Hiv | D006678 | — | — | 6 | 10 | 6 | 16 | 5 | 39 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 3 | 8 | 9 | 4 | 5 | 28 |
| Lymphoma | D008223 | — | C85.9 | 1 | 11 | 1 | 1 | 3 | 17 |
| Dementia | D003704 | EFO_0003862 | F03 | 2 | 2 | 3 | 1 | 1 | 9 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | 2 | — | 7 | — | 9 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 2 | 2 | — | 3 | 2 | 8 |
Show 40 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 | 1 | 7 | — | 2 | 17 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | 6 | 2 | 2 | — | 7 | 17 |
| Sarcoma | D012509 | — | — | 6 | 2 | 2 | — | — | 9 |
| Kaposi sarcoma | D012514 | — | C46 | 6 | 2 | 2 | — | — | 9 |
| Aids dementia complex | D015526 | EFO_0002608 | — | 2 | 2 | 3 | — | 1 | 8 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | 3 | 3 | — | 1 | 7 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 3 | 1 | — | 3 | 7 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | 1 | 2 | — | — | 4 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | 2 | 1 | — | — | 3 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 1 | 2 | 1 | — | — | 3 |
Show 17 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | — | 5 | — | — | 6 | 11 |
| Syndrome | D013577 | — | — | 1 | 6 | — | — | 1 | 8 |
| Neoplasms | D009369 | — | C80 | 3 | 1 | — | — | — | 4 |
| Lymphadenopathy | D000072281 | HP_0002716 | R59.1 | 1 | 1 | — | — | 1 | 3 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 3 | — | — | — | 3 |
| Leukoencephalopathies | D056784 | HP_0002352 | — | — | 1 | — | — | 2 | 3 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | 1 | — | — | 2 | 3 |
| Disease progression | D018450 | — | — | — | 3 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 2 | 1 | — | — | — | 2 |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | — | 2 | — | — | — | 2 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancytopenia | D010198 | HP_0001876 | D61.81 | 2 | — | — | — | 10 | 12 |
| Cytopenia | D000095542 | — | — | 2 | — | — | — | 10 | 12 |
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | 2 | 8 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 1 | — | — | — | 1 | 2 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | 1 | 2 |
| Leukopenia | D007970 | EFO_0004233 | D72.819 | 1 | — | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | 1 | 2 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | — | — | — | — | 1 |
| Hiv seronegativity | D018023 | — | — | 1 | — | — | — | — | 1 |
| Muscle spasticity | D009128 | HP_0001257 | — | 1 | — | — | — | — | 1 |
Show 19 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | — | — | — | — | 4 | 4 |
| Retinitis | D012173 | — | H30.9 | — | — | — | — | 4 | 4 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | — | — | 1 | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Meningeal tuberculosis | D014390 | — | A17.0 | — | — | — | — | 1 | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | — | 1 | 1 |
Show 20 more
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 | — |
| ChEMBL ID | CHEMBL129 |
| ChEBI ID | 10110 |
| PubChem CID | 35370 |
| DrugBank | DB00495 |
| UNII ID | 4B9XT59T7S (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Zidovudine
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Lamivudine
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Abacavir
Total medical expenditures per year (USD, in millions)
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Zidovudine
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Lamivudine
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Zidovudine
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Trends
PubMed Central
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Additional graphs summarizing 1,277,293 documents
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Safety
Black-box Warning
Black-box warning for: Abacavir sulfate, lamivudine and zidovudine, Abacavir, lamivudine and zidovudine, Combivir, Direct rx, Lamivudine and zidovudine, Lamivudine zidovudine, Retrovir, Trizivir, Zidovudine
Adverse Events
Top Adverse Reactions
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22,239 adverse events reported
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