FDA Approves First-Ever Twice-Yearly Injection to Prevent HIV Infection

 

June 19, 2025 — Washington, D.C.

In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved the first twice-yearly injectable medication for HIV prevention. The drug, called lenacapavir and marketed under the brand name Yeztugo, is developed by Gilead Sciences and offers a groundbreaking new option for pre-exposure prophylaxis (PrEP).

Administered just twice a year, Yeztugo is designed to prevent HIV infection in individuals at high risk. It becomes the first capsid inhibitor approved for PrEP, adding a long-acting alternative to current daily pills and every-two-month injections. Clinical trials have shown striking results: Yeztugo reduced HIV infections by 100% in men who have sex with men and transgender women, and by 96% in cisgender women.

“This is a major step forward in our efforts to end the HIV epidemic,” said Dr. Demetre Daskalakis of the CDC. “By dramatically reducing the number of doses required each year, this product could improve adherence and reach more people in need.”

Yeztugo is expected to carry an annual list price of about $28,218, though Gilead says insurance coverage and patient assistance programs will help reduce costs for many. The company has also agreed to license generic versions royalty-free in 120 low- and middle-income countries.

Despite the medical breakthrough, experts caution that access challenges remain. Advocacy groups point to global funding shortfalls and logistical barriers in rural and underserved regions. Still, optimism is high that Yeztugo will become a vital tool in the global fight against HIV.

The approval comes amid growing momentum for long-acting PrEP options and may influence the direction of future vaccine trials. For now, Yeztugo marks a significant milestone—both for science and for the communities most affected by HIV.