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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/01/22 | Phase 1 | Completed | |||
2020/12/10 | Phase 1 | Completed | |||
2020/02/13 | Not Applicable | Completed | Geropharm | ||
2020/02/05 | Phase 3 | UNKNOWN | |||
2020/01/22 | Phase 1 | Terminated | Janssen Pharmaceutica N.V., Belgium | ||
2019/12/23 | Phase 1 | Completed | |||
2019/12/03 | Phase 4 | Withdrawn | |||
2019/06/17 | Phase 3 | UNKNOWN | |||
2018/09/18 | Phase 4 | Completed | |||
2018/07/17 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Products LP | 59676-564 | ORAL | 150 mg in 1 1 | 8/15/2023 | |
| Amneal Pharmaceuticals NY LLC | 60219-1145 | ORAL | 800 mg in 1 1 | 12/15/2023 | |
| Janssen Products LP | 59676-800 | ORAL | 800 mg in 1 1 | 8/18/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-346 | ORAL | 800 mg in 1 1 | 1/3/2024 | |
| State of Florida DOH Central Pharmacy | 53808-0773 | ORAL | 600 mg in 1 1 | 8/23/2010 | |
| Janssen Products LP | 59676-562 | ORAL | 600 mg in 1 1 | 8/15/2023 | |
| Dr.Reddys Laboratories Inc | 43598-705 | ORAL | 800 mg in 1 1 | 11/25/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-568 | ORAL | 600 mg in 1 1 | 10/5/2023 | |
| Janssen Products LP | 59676-575 | ORAL | 800 mg in 1 1 | 8/15/2023 | |
| EXELAN PHARMACEUTICALS INC. | 76282-737 | ORAL | 600 mg in 1 1 | 1/22/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Viatris LimitedDamastown Industrial Park Dublin 15Ireland | Authorised | 1/3/2017 | |
Authorised | 1/3/2017 | ||
Authorised | 1/26/2018 | ||
Authorised | 2/11/2007 | ||
Authorised | 11/19/2014 | ||
Authorised | 9/21/2017 | ||
Authorised | 1/26/2018 | ||
Viatris LimitedDamastown Industrial Park Dublin 15Ireland | Authorised | 1/3/2017 | |
Authorised | 1/3/2017 | ||
Authorised | 2/11/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PREZISTA™ TABLET 400MG | SIN13855P | TABLET, FILM COATED | 400mg | 8/26/2010 | |
| PREZISTA™ TABLET 75MG | SIN13853P | TABLET, FILM COATED | 75mg | 8/26/2010 | |
| PREZISTA™ TABLET 150MG | SIN13854P | TABLET, FILM COATED | 150mg | 8/26/2010 | |
| PREZISTA™ TABLET 800MG | SIN14595P | TABLET, FILM COATED | 800 mg | 8/28/2014 | |
| PREZISTA™ TABLET 600MG | SIN13856P | TABLET, FILM COATED | 600mg | 8/26/2010 | |
| PREZISTA™ TABLET 600MG | SIN13856P | TABLET, FILM COATED | 600mg | 8/26/2010 |
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 |
|---|---|---|---|---|---|
| PROTOMUNE TABLETS 400MG | N/A | N/A | N/A | 8/14/2024 | |
| DARUNAVIR SANDOZ TABLETS 600MG | N/A | N/A | N/A | 6/24/2020 | |
| PROTOMUNE TABLETS 600MG | N/A | N/A | N/A | 8/14/2024 | |
| PROTOMUNE TABLETS 800MG | N/A | N/A | N/A | 8/14/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DARUNAVIR MYLAN darunavir 600 mg tablet bottle | 271132 | Medicine | A | 5/26/2017 | |
| PREZISTA darunavir 400mg tablets bottle | 153627 | Medicine | A | 7/30/2009 | |
| PREZCOBIX darunavir/cobicistat 800 mg/150 mg film coated tablet bottle | 231198 | Medicine | A | 9/24/2015 | |
| PREZISTA darunavir 600mg tablets bottle | 153628 | Medicine | A | 7/30/2009 | |
| DARUNAVIR MYLAN darunavir 800 mg tablet bottle | 271133 | Medicine | A | 5/26/2017 | |
| PREZISTA darunavir 800 mg tablet bottle | 199320 | Medicine | A | 4/8/2013 | |
| DARUNAVIR JUNO darunavir 600 mg film coated tablet bottle | 318765 | Medicine | A | 4/22/2020 | |
| DARUNAVIR JUNO darunavir 400 mg film coated tablet bottle | 318764 | Medicine | A | 4/22/2020 | |
| DARUNAVIR JUNO darunavir 800 mg film coated tablet bottle | 318766 | Medicine | A | 4/22/2020 | |
| PREZISTA darunavir 75mg tablets bottle | 156280 | Medicine | A | 2/4/2010 |