Overview
Atazanavir (formerly known as BMS-232632) is an antiretroviral drug of the protease inhibitor (PI) class. Like other antiretrovirals, it is used to treat infection of human immunodeficiency virus (HIV). Atazanavir is distinguished from other PIs in that it can be given once daily (rather than requiring multiple doses per day) and has lesser effects on the patient's lipid profile (the amounts of cholesterol and other fatty substances in the blood). Like other protease inhibitors, it is used only in combination with other HIV medications. The U.S. Food and Drug Administration (FDA) approved atazanavir on June 20, 2003.
Background
Atazanavir (formerly known as BMS-232632) is an antiretroviral drug of the protease inhibitor (PI) class. Like other antiretrovirals, it is used to treat infection of human immunodeficiency virus (HIV). Atazanavir is distinguished from other PIs in that it can be given once daily (rather than requiring multiple doses per day) and has lesser effects on the patient's lipid profile (the amounts of cholesterol and other fatty substances in the blood). Like other protease inhibitors, it is used only in combination with other HIV medications. The U.S. Food and Drug Administration (FDA) approved atazanavir on June 20, 2003.
Indication
Atazanavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 3 months of age and older weighing at least 5kg. Atazanavir is also indicated in combination with cobicistat and other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35kg.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/02/11 | Phase 1 | Completed | |||
2020/07/13 | Phase 2 | Completed | |||
2020/02/10 | Phase 1 | Completed | |||
2019/12/04 | Phase 1 | Completed | |||
2019/07/17 | Phase 3 | Active, not recruiting | |||
2019/04/22 | N/A | Completed | |||
2017/01/13 | Phase 2 | Completed | |||
2016/03/03 | Phase 1 | Terminated | St Stephens Aids Trust | ||
2016/01/12 | Not Applicable | Completed | Judit Pich | ||
2015/10/28 | Phase 1 | Completed | St Stephens Aids Trust |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 70771-1592 | ORAL | 200 mg in 1 1 | 10/13/2022 | |
| Zydus Lifesciences Limited | 70771-1593 | ORAL | 300 mg in 1 1 | 10/13/2022 | |
| E.R. Squibb & Sons, L.L.C. | 0003-3622 | ORAL | 300 mg in 1 1 | 9/24/2020 | |
| Laurus Labs Limited | 42385-920 | ORAL | 150 mg in 1 1 | 11/21/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-654 | ORAL | 200 mg in 1 1 | 2/2/2022 | |
| NorthStar Rx LLC | 16714-862 | ORAL | 300 mg in 1 1 | 2/20/2024 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1050 | ORAL | 150 mg in 1 1 | 5/15/2023 | |
| Amneal Pharmaceuticals NY LLC | 69238-1135 | ORAL | 100 mg in 1 1 | 9/25/2023 | |
| Zydus Lifesciences Limited | 70771-1591 | ORAL | 150 mg in 1 1 | 10/13/2022 | |
| Laurus Labs Limited | 42385-921 | ORAL | 200 mg in 1 1 | 11/21/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/13/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REYATAZ CAPSULE 200 mg | SIN12520P | CAPSULE | 200 mg | 3/8/2004 | |
| REYATAZ CAPSULE 300MG | SIN13560P | CAPSULE | 300 mg | 10/8/2008 |
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
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ATAZANAVIR APOTEX atazanavir 200 mg (as sulfate) capsule bottle | 289525 | Medicine | A | 5/14/2018 | |
| ATAZANAVIR ALPHAPHARM atazanavir (as sulfate) 150 mg capsule bottle | 255298 | Medicine | A | 8/28/2018 | |
| ATAZANAVIR APOTEX atazanavir 300 mg (as sulfate) capsule blister pack | 289524 | Medicine | A | 5/14/2018 | |
| ATAZANAVIR CIPLA atazanavir 300 mg capsule bottle pack | 276193 | Medicine | A | 8/30/2017 | |
| ATAZANAVIR APOTEX atazanavir 150 mg (as sulfate) capsule blister pack | 289518 | Medicine | A | 5/14/2018 | |
| ZANAVIR CA atazanavir 200 mg capsule bottle pack | 276197 | Medicine | A | 8/30/2017 | |
| ATAZANAVIR ALPHAPHARM atazanavir (as sulfate) 300 mg capsule bottle | 255300 | Medicine | A | 8/28/2018 | |
| REYATAZ atazanavir 200mg capsule bottle | 99056 | Medicine | A | 1/12/2004 | |
| ATAZANAVIR CIPLA atazanavir 200 mg capsule bottle pack | 276191 | Medicine | A | 8/30/2017 | |
| APO-ATAZANAVIR atazanavir 150 mg (as sulfate) capsule bottle | 289527 | Medicine | A | 5/14/2018 |