18 June 2025 - Approval based on Phase 3 PURPOSE 1 and PURPOSE 2 data that showed ≥99.9% of participants remained HIV negative on twice yearly injectable Yeztugo.
Gilead Sciences today announced that the US FDA has approved Yeztugo (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg, making it the first and only twice yearly option available in the US for people who need or want PrEP.