Darunavir
- Generic Name
- Darunavir
- Brand Names
- Prezcobix, Prezista, Rezolsta, Darunavir Viatris (previously Darunavir Mylan), Darunavir Krka
- Drug Type
- Small Molecule
- Chemical Formula
- C27H37N3O7S
- CAS Number
- 206361-99-1
- Unique Ingredient Identifier
- YO603Y8113
- 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
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
- Conditions
- HIV Infections
- First Posted Date
- 2005-10-28
- Last Posted Date
- 2014-04-11
- Lead Sponsor
- Tibotec Pharmaceuticals, Ireland
- Registration Number
- NCT00245739
TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options
- Conditions
- HIV Infections
- First Posted Date
- 2005-06-21
- Last Posted Date
- 2011-06-10
- Lead Sponsor
- Tibotec Pharmaceuticals, Ireland
- Target Recruit Count
- 260
- Registration Number
- NCT00115050
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
- First Posted Date
- 2004-04-19
- Last Posted Date
- 2014-06-20
- Lead Sponsor
- Tibotec Pharmaceuticals, Ireland
- Target Recruit Count
- 555
- Registration Number
- NCT00081588
Drug Development Updates
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