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Darunavir · Prezista, DRV

Small molecule · Inhibitor of HIV-1 protease · developed by Janssen Prods

Approved FDA, Jun 2006

1 Registered trials

What is Darunavir?

Darunavir is an HIV-1 protease inhibitor that selectively inhibits cleavage of HIV-1 encoded Gag-Pol polyproteins in infected cells, preventing formation of mature virus particles.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Prezista, DRV, TMC-114, TMC-41629
Drug type: Small molecule
Targets: HIV-1 protease
Mechanism: Inhibitor of HIV-1 protease
Therapy area: Infectious disease
Developer: Janssen Prods
In trials of: GILD
FDA status: Approved as Prezista (June 23, 2006), NDA021976 · FDA label
UNII: YO603Y8113

✅ FDA-approved uses

HIV-1 infection

From the indications section of the FDA label (version of Aug 29, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06337032	Phase 4	HIV-1-infection	Recruiting	GILD

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

HIV-1-infection

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z