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Darunavir

Generic Name
Darunavir
Brand Names
Prezcobix, Prezista, Rezolsta, Darunavir Viatris (previously Darunavir Mylan), Darunavir Krka, Symtuza
Drug Type
Small Molecule
Chemical Formula
C27H37N3O7S
CAS Number
206361-99-1
Unique Ingredient Identifier
YO603Y8113

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
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
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TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
SYMTUZA 800/150/200/10 darunavir/cobicistat/emtricitabine/tenofovir alafenamide 800/150/200/10 mg film-coated tablets
312623
Medicine
A
11/22/2019
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