Ziagen(abacavir)
Abacavir, Abacavir / Lamivudine, Abacavir / Lamivudine /, Kivexa, Triumeq, Ziagen (abacavir) is a small molecule pharmaceutical. Abacavir was first approved as Ziagen on 1998-12-17. 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
Abacavir, Ziagen (discontinued: Abacavir, Ziagen)
CombinationsAbacavir lamivudine, Abacavir sulfate, lamivudine zidovudine, Triumeq (discontinued: Abacavir lamivudine, Epzicom, Trizivir)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Abacavir sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZIAGEN | ViiV Healthcare | N-020978 RX | 1998-12-17 | 1 products, RLD, RS |
Show 1 discontinued
Abacavir sulfate
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Dolutegravir sodium
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Lamivudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIUMEQ PD | ViiV Healthcare | N-215413 RX | 2022-03-30 | 1 products, RLD, RS |
| TRIUMEQ | ViiV Healthcare | N-205551 RX | 2014-08-22 | 1 products, RLD, RS |
Abacavir sulfate
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Lamivudine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | Mylan | N-204311 DISCN | 2023-12-22 | 1 products, RLD |
| EPZICOM | ViiV Healthcare | N-021652 DISCN | 2004-08-02 | 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 | ANDA | 2024-08-01 |
| abacavir and lamivudine | ANDA | 2024-05-19 |
| abacavir sulfate | ANDA | 2022-06-14 |
| abacavir sulfate, lamivudine and zidovudine | ANDA | 2016-05-04 |
| abacavir, lamivudine and zidovudine | ANDA | 2023-10-31 |
| epzicom | New Drug Application | 2022-12-14 |
| triumeq | New Drug Application | 2021-03-23 |
| triumeq triumeq pd | New Drug Application | 2024-07-08 |
| trizivir | New Drug Application | 2024-03-26 |
| ziagen | New Drug Application | 2023-09-29 |
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
Expiration | Code | ||
|---|---|---|---|
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ, VIIV HLTHCARE | |||
| 2026-12-15 | PED | ||
| 2026-06-15 | M-294 | ||
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ PD, VIIV HLTHCARE | |||
| 2026-12-15 | PED | ||
| 2026-06-15 | NPP | ||
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
— J05AF06: Abacavir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR02: Lamivudine and abacavir
— J05AR04: Zidovudine, lamivudine and abacavir
— J05AR13: Lamivudine, abacavir and dolutegravir
HCPCS
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Clinical
Clinical Trials
255 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 | 23 | 39 | 65 | 42 | 37 | 201 |
| Infections | D007239 | EFO_0000544 | — | 8 | 14 | 20 | 7 | 17 | 66 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 8 | 10 | 23 | 9 | 12 | 61 |
| Hiv | D006678 | — | — | 4 | 5 | 7 | 18 | 3 | 35 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 11 | 4 | 5 | 24 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 1 | 4 | 5 | 3 | 2 | 14 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | 2 | — | 8 | 1 | 11 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | — | 4 | 3 | 8 |
| Hiv-1 | D015497 | — | — | — | 1 | 1 | 3 | — | 5 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | — | 4 | — | 4 |
Show 20 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | 1 | — | 2 | 4 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | 1 | — | 2 | 4 |
| Hepatitis c | D006526 | — | B19.2 | 1 | — | 1 | — | 1 | 3 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | — | 1 | 2 | — | — | 3 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 1 | 2 | — | — | 3 |
| Sclerosis | D012598 | — | — | — | 1 | 2 | — | — | 3 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | 1 | — | 1 | 2 |
| Malaria | D008288 | EFO_0001068 | B54 | — | — | 1 | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | 1 | — | — | 1 |
| Kaposi sarcoma | D012514 | — | C46 | — | 1 | 1 | — | — | 1 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Highly active antiretroviral therapy | D023241 | — | — | — | 1 | — | — | 1 | 2 |
| Autoimmune diseases of the nervous system | D020274 | — | — | — | 2 | — | — | — | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Nervous system malformations | D009421 | HP_0000707 | Q00-Q07 | — | 2 | — | — | — | 2 |
| Htlv-ii infections | D015491 | EFO_1001349 | — | — | 1 | — | — | — | 1 |
| Aicardi syndrome | D058540 | Orphanet_50 | Q04.0 | — | 1 | — | — | — | 1 |
| Disease progression | D018450 | — | — | — | 1 | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Hiv seronegativity | D018023 | — | — | 1 | — | — | — | — | 1 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | — | — | — | — | 2 | 2 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Wasting syndrome | D019282 | — | — | — | — | — | — | 1 | 1 |
| Cachexia | D002100 | HP_0004326 | R64 | — | — | — | — | 1 | 1 |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | — | — | — | — | 1 | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | — | 1 | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
| Platelet aggregation | D010974 | GO_0070527 | — | — | — | — | — | 1 | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | — | — | — | 1 | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 1 | 1 |
Show 3 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Abacavir |
| INN | abacavir |
| Description | Abacavir is a 2,6-diaminopurine that is (1S)-cyclopent-2-en-1-ylmethanol in which the pro-R hydrogen at the 4-position is substituted by a 2-amino-6-(cyclopropylamino)-9H-purin-9-yl group. A nucleoside analogue reverse transcriptase inhibitor (NRTI) with antiretroviral activity against HIV, it is used (particularly as the sulfate) with other antiretrovirals in combination therapy of HIV infection. It has a role as a HIV-1 reverse transcriptase inhibitor, an antiviral drug and a drug allergen. |
| Classification | Small molecule |
| Drug class | antivirals: carbocyclic nucleosides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc(NC2CC2)c2ncn([C@H]3C=C[C@@H](CO)C3)c2n1 |
Identifiers
| PDB | — |
| CAS-ID | 136470-78-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1380 |
| ChEBI ID | 421707 |
| PubChem CID | 441300 |
| DrugBank | DB01048 |
| UNII ID | WR2TIP26VS (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Abacavir
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Abacavir
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Lamivudine
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Abacavir
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Lamivudine
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Zidovudine
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Abacavir, Abacavir and lamivudine, Abacavir sulfate, Abacavir sulfate, lamivudine and zidovudine, Abacavir, lamivudine and zidovudine, Epzicom, Triumeq, Triumeq triumeq pd, Trizivir, Ziagen
Adverse Events
Top Adverse Reactions
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18,877 adverse events reported
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