Depicted as darunavir ethanolate

Darunavir is marketed under the trade name PREZISTA® for use in combination with ritonavir (PREZISTA®/r) and other ARVs as an oral treatment for adults with HIV.

How does darunavir work?

Darunavir is a second-generation protease inhibitor that targets HIV inside infected cells to prevent the formation of new virus capable of infecting healthy cells.

Darunavir is a promising addition to IPM’s product development portfolio as the first protease inhibitor to be licensed for development as a microbicide. Because this mechanism of action has not yet been employed in existing HIV prevention products, it may increase the chance that it is active against drug-resistant HIV.

What is darunavir’s clinical history?

IPM is developing darunavir as a microbicide through an exclusive, royalty-free license obtained in 2015 from Janssen Sciences Ireland UC, one of the pharmaceutical companies of Johnson & Johnson. Because darunavir is a licensed, FDA-approved drug, its safety profile and efficacy as a therapeutic has been well-established through comprehensive preclinical and clinical studies.

In what stage of development is darunavir, and what forms will it take as a microbicide? 

IPM supported a University of York-led Phase I trial of a dapivirine-darunavir vaginal gel and preclinical studies of a monthly dapivirine-darunavir vaginal ring, both developed by the European Commission-funded CHAARM project.

IPM is also exploring the development of darunavir-based vaginal rings that combine darunavir with ARVs that have different mechanisms of action such as dapivirine or DS003. Combination products using multiple ARVs that attack the virus at different stages of the HIV life cycle may offer greater protection than using a single ARV.

Where can I get more information?

For a bibliography of scientific papers and articles on IPM-supported research on darunavir, visit our Publications & Media page.