Overview
Darunavir is a protease inhibitor used with other HIV protease inhibitor drugs as well as ritonavir for the effective management of HIV-1 infection. As a second-generation protease inhibitor, darunavir is designed to combat resistance to standard HIV therapy. It was initially approved by the FDA in 2006. Darunavir is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection. Clinical trials are underway and are expected to conclude in August 2020.
Background
Darunavir is a protease inhibitor used with other HIV protease inhibitor drugs as well as ritonavir for the effective management of HIV-1 infection. As a second-generation protease inhibitor, darunavir is designed to combat resistance to standard HIV therapy. It was initially approved by the FDA in 2006. Darunavir is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection. Clinical trials are underway and are expected to conclude in August 2020.
Indication
Darunavir, co-administered with ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/06/26 | N/A | Completed | Southern Illinois Healthcare Foundation | ||
2017/04/05 | Phase 4 | Completed | |||
2017/03/29 | Phase 1 | Completed | St Stephens Aids Trust | ||
2017/01/11 | Phase 4 | Active, not recruiting | |||
2016/12/07 | Phase 1 | Completed | |||
2016/04/14 | Phase 2 | Completed | |||
2016/02/02 | Phase 3 | Completed | Willem Daniel Francois Venter | ||
2015/10/28 | Phase 1 | Completed | St Stephens Aids Trust | ||
2015/10/19 | Phase 1 | Completed | |||
2015/07/21 | Phase 4 | Terminated | University Hospital, Basel, Switzerland |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
EXELAN PHARMACEUTICALS INC. | 76282-738 | ORAL | 800 mg in 1 1 | 1/22/2024 | |
Camber Pharmaceuticals, Inc. | 31722-567 | ORAL | 400 mg in 1 1 | 10/5/2023 | |
Novadoz Pharmaceuticals LLC | 72205-185 | ORAL | 800 mg in 1 1 | 11/29/2023 | |
Janssen Products LP | 59676-566 | ORAL | 800 mg in 1 1 | 8/15/2023 | |
Teva Pharmaceuticals, Inc. | 0480-7736 | ORAL | 600 mg in 1 1 | 6/1/2023 | |
State of Florida DOH Central Pharmacy | 53808-0672 | ORAL | 400 mg in 1 1 | 8/23/2010 | |
Dr.Reddys Laboratories Inc | 43598-704 | ORAL | 600 mg in 1 1 | 11/25/2023 | |
Cipla USA Inc. | 69097-244 | ORAL | 800 mg in 1 1 | 11/10/2023 | |
Novadoz Pharmaceuticals LLC | 72205-184 | ORAL | 600 mg in 1 1 | 11/29/2023 | |
Janssen Products LP | 59676-565 | ORAL | 100 mg in 1 mL | 8/15/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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SYMTUZA 800/150/200/10 darunavir/cobicistat/emtricitabine/tenofovir alafenamide 800/150/200/10 mg film-coated tablets | 312623 | Medicine | A | 11/22/2019 |