The FDA has approved Gilead's lenacapavir, marketed as Yeztugo, as the first twice-yearly injectable HIV prevention medication in the United States134.
Yeztugo provides six months of protection from HIV with a single injection, significantly reducing the frequency of medication compared to daily pills or other PrEP options134.
Lenacapavir was previously approved for treating drug-resistant HIV in 2022; its long-acting nature and efficacy have now been leveraged for prevention in people at high risk of HIV1.
The approval was based on strong evidence from the PURPOSE 1 and PURPOSE 2 clinical trials, which demonstrated efficacy and safety of lenacapavir in diverse populations4.
The World Health Organization (WHO) has welcomed the FDA’s decision and will issue new global guidelines for lenacapavir as an HIV prevention tool in July 20254.
Advocates and global health organizations are monitoring access issues, especially outside the U.S., amid concerns over funding cuts for HIV programs and the need for equitable access to this innovation12.
FDA approval may accelerate regulatory processes worldwide, with WHO and partners working to expand access through international mechanisms and upcoming guidelines4.
Sources:
1. https://time.com/7295343/fda-hiv-shot-lenacapavir-yeztugo/
2. https://www.gilead.com/company/company-statements/2025/gilead-statement-on-access-planning-for-lenacapavir-for-hiv-prevention-in-low--and-middle-income-countries
3. https://www.statnews.com/2025/06/18/fda-approves-gilead-hiv-prevention-drug-lenacapavir-yeztugo-next-best-thing-to-vaccine/
4. https://www.who.int/news/item/19-06-2025-fda-approval-of-injectable-lenacapavir-marks-progress-for-hiv-prevention