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 has been developing darunavir as a microbicide through an exclusive, royalty-free license obtained in 2015 from Janssen Sciences Ireland Unlimited Company, 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 also conducted pre-formulation studies of the drug to inform potential development of darunavir-based vaginal rings.

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.