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# FDA Approves Gilead’s Yeztugo for HIV Prevention
- URL: https://www.fdaweb.com/fda-approves-gileads-yeztugo-for-hiv-prevention/
- Published: 2025-06-18T12:00:00.000Z
- Updated: 2026-09-14T15:14:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159380

FDA has approved Gilead’s Yeztugo (lenacapair), an injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV in some adults and adolescents. A company [statement](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.businesswire.com/news/home/20250520465880/en/Yeztugo-Lenacapavir-Is-Now-the-First-and-Only-FDA-Approved-HIV-Prevention-Option-Offering-6-Months-of-Protection&ved=2ahUKEwiE8e2Y2fuNAxW2w%5FACHdmyM5MQxfQBKAB6BAgLEAE&usg=AOvVaw2gMaFTNyZYW9iA7JN7Pm5a) says Yeztugo is the only twice-yearly option available in the U.S. for people who need or want pre-exposure prophylaxis. “Data show that ≥ 99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative,” Gilead says.

Yeztugo was granted FDA breakthrough therapy designation and received approval under priority review.