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2022/10/21 | Phase 4 | Withdrawn | |||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 | UNKNOWN | 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 |
|---|---|---|---|---|---|
| Abacavir Sulfate Oral Solution | 国药准字HJ20150202 | 化学药品 | 口服溶液剂 | 6/8/2021 | |
| Abacavir Sulfate Tablets | 国药准字HJ20160636 | 化学药品 | 片剂 | 10/22/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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