Overview
Abacavir (ABC) is a powerful nucleoside analog reverse transcriptase inhibitor (NRTI) used to treat HIV and AIDS. Chemically, it is a synthetic carbocyclic nucleoside and is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. In vivo, abacavir sulfate dissociates to its free base, abacavir.
Indication
Abacavir is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection. It is available in a combination product alongside dolutegravir and lamivudine for the treatment of adult and pediatric patients with HIV-1 who weigh ≥10 kg.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/26 | Phase 3 | Terminated | Macquarie University, Australia | ||
2024/05/24 | Phase 1 | Recruiting | |||
2022/10/21 | Phase 4 | Withdrawn | |||
2022/05/26 | Phase 4 | Active, not recruiting | Harvard School of Public Health (HSPH) | ||
2021/01/29 | Phase 2 | Completed | |||
2018/11/30 | Phase 1 | Completed | |||
2017/12/04 | Phase 4 | Completed | Fundacion Clinic per a la Recerca Biomédica | ||
2017/09/15 | N/A | Completed | |||
2016/11/08 | Phase 4 | UNKNOWN | |||
2016/09/08 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ViiV Healthcare Company | 49702-231 | ORAL | 600 mg in 1 1 | 6/15/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1049 | ORAL | 600 mg in 1 1 | 5/15/2023 | |
| Major Pharmaceuticals | 0904-6874 | ORAL | 300 mg in 1 1 | 12/4/2019 | |
| State of Florida DOH Central Pharmacy | 53808-0811 | ORAL | 300 mg in 1 1 | 4/13/2010 | |
| Rising Pharmaceuticals, Inc. | 64980-405 | ORAL | 20 mg in 1 mL | 12/3/2022 | |
| ViiV Healthcare Company | 49702-221 | ORAL | 300 mg in 1 1 | 6/3/2019 | |
| Cipla USA Inc. | 69097-362 | ORAL | 600 mg in 1 1 | 1/18/2022 | |
| Aurobindo Pharma Limited | 65862-073 | ORAL | 300 mg in 1 1 | 4/17/2023 | |
| Macleods Pharmaceuticals Limited | 33342-440 | ORAL | 600 mg in 1 1 | 3/3/2025 | |
| ViiV Healthcare Company | 49702-206 | ORAL | 600 mg in 1 1 | 4/27/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/16/2004 | ||
Authorised | 7/8/1999 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Kivexa | SIN13230P | TABLET | 600 mg | 1/11/2007 | |
| ABACAR ABACAVIR TABLETS USP 300 MG | SIN16114P | TABLET, FILM COATED | 300.00mg | 3/3/2021 | |
| ZIAGEN TABLETS 300 mg | SIN11098P | TABLET, FILM COATED | 300 mg | 9/1/1999 | |
| ABALAM ABACAVIR SULFATE & LAMIVUDINE TABLETS 600/300 MG | SIN15864P | TABLET, FILM COATED | 600.0 mg | 12/2/2019 | |
| TRIUMEQ FILM COATED TABLET 50mg/600mg/300mg | SIN15100P | TABLET, FILM COATED | 600 mg | 10/14/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ABACAVIR ZENTIVA 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 86115 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized | |
| ABACAVIR/LAMIVUDINA TEVA 600 MG/300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 81176 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| ABACAVIR TARBIS 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 84740 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| ABACAVIR/LAMIVUDINA STADA 600 MG/300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 82913 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
| ABACAVIR/LAMIVUDINA DR. REDDYS 600 MG/300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Reddy Pharma Iberia S.A. | 81012 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| ABACAVIR/LAMIVUDINA KERN PHARMA 600 MG/300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 84182 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| ABACAVIR ACCORD 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 85319 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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