Overview
Efavirenz (brand names Sustiva® and Stocrin®) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. For HIV infection that has not previously been treated, efavirenz and lamivudine in combination with zidovudine or tenofovir is the preferred NNRTI-based regimen. Efavirenz is also used in combination with other antiretroviral agents as part of an expanded postexposure prophylaxis regimen to prevent HIV transmission for those exposed to materials associated with a high risk for HIV transmission.
Indication
For use in combination treatment of HIV infection (AIDS)
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/06 | Phase 1 | Completed | |||
2025/02/12 | Not Applicable | Recruiting | |||
2025/01/28 | Phase 1 | Active, not recruiting | |||
2024/11/20 | Phase 1 | Completed | |||
2023/08/16 | Phase 1 | Completed | |||
2023/06/18 | Phase 1 | Completed | |||
2022/09/29 | Phase 1 | Completed | |||
2022/04/15 | Phase 1 | Completed | |||
2021/10/13 | Phase 2 | Recruiting | |||
2021/10/05 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Strides Pharma Science Limited | 64380-705 | ORAL | 600 mg in 1 1 | 12/13/2023 | |
| Mylan Specialty L.P. | 49502-425 | ORAL | 400 mg in 1 1 | 9/9/2019 | |
| Laurus Labs Limited | 42385-929 | ORAL | 400 mg in 1 1 | 1/16/2019 | |
| Exelan Pharmaceuticals, Inc. | 76282-678 | ORAL | 600 mg in 1 1 | 3/12/2021 | |
| Physicians Total Care, Inc. | 54868-5643 | ORAL | 600 mg in 1 1 | 5/3/2013 | |
| Physicians Total Care, Inc. | 54868-4668 | ORAL | 600 mg in 1 1 | 1/2/2013 | |
| Strides Pharma Inc. | 42543-889 | ORAL | 600 mg in 1 1 | 1/23/2023 | |
| Mylan Specialty L.P. | 49502-475 | ORAL | 600 mg in 1 1 | 10/15/2019 | |
| Aurobindo Pharma Limited | 65862-049 | ORAL | 600 mg in 1 1 | 12/29/2023 | |
| Cipla USA Inc. | 69097-301 | ORAL | 600 mg in 1 1 | 3/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/5/2017 | ||
Authorised | 7/17/2017 | ||
Authorised | 2/8/2018 | ||
Authorised | 1/9/2012 | ||
Authorised | 5/28/1999 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| STOCRIN TABLET 600 mg | SIN12064P | TABLET, FILM COATED | 600 mg | 9/5/2002 | |
| EFAVIRENZ SANDOZ FILM COATED TABLET 600MG | SIN15719P | TABLET, FILM COATED | 600mg | 6/18/2019 | |
| STOCRIN® 200mg TABLET | SIN13509P | TABLET | 200.0 mg | 7/31/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Efavirenz Tablets | 国药准字H20184016 | 化学药品 | 片剂 | 6/17/2021 | |
| Efavirenz Tablets | 国药准字H20143153 | 化学药品 | 片剂 | 2/28/2023 | |
| Efavirenz Tablets | 国药准字H20184015 | 化学药品 | 片剂 | 6/17/2021 | |
| Efavirenz Tablets | 国药准字H20213208 | 化学药品 | 片剂 | 3/23/2021 | |
| Efavirenz Tablets | 国药准字H20193132 | 化学药品 | 片剂 | 1/26/2024 | |
| Efavirenz Tablets | 国药准字H20237058 | 化学药品 | 片剂 | 1/26/2024 | |
| Efavirenz Tablets | 国药准字H20133265 | 化学药品 | 片剂 | 2/28/2023 | |
| Efavirenz Tablets | 国药准字H20143154 | 化学药品 | 片剂 | 2/28/2023 | |
| Efavirenz Tablets | 国药准字H20163464 | 化学药品 | 片剂 | 6/15/2021 |
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 |
|---|---|---|---|---|---|
| EFAVIRENZ ALPHAPHARM efavirenz 600 mg tablet blister pack | 183898 | Medicine | A | 4/17/2013 | |
| EFAVIRENZ ALPHAPHARM efavirenz 600 mg tablet bottle | 183899 | Medicine | A | 4/17/2013 | |
| TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ Viatris 300/200/600 tenofovir disoproxil maleate 300mg/emtricitabine 200mg/efavirenz 600mg tablet bottle | 280721 | Medicine | A | 5/17/2018 |
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