The U.S. Food and Drug Administration (FDA) on June 18, 2025, approved Gilead Sciences’ lenacapavir, the world’s first injectable HIV prevention drug that is administered only twice a year.
Branded as Yeztugo, lenacapavir is an HIV capsid inhibitor that has demonstrated nearly 100% efficacy in large clinical trials. The drug is the first twice-yearly injectable PrEP regimen.
Gilead says Yeztugo is a revolution in HIV prevention: it significantly simplifies therapy by eliminating the need for patients to take daily pills or receive monthly injections. Clinical trials have shown that more than 99.9% of participants remained HIV-negative — including 100% among men who have sex with men and 96% among women.
“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a real opportunity to end the HIV epidemic,” said Daniel O’Day, chairman and CEO of Gilead Sciences. “It’s a medicine that needs to be taken only twice a year and has shown remarkable results in clinical trials, meaning it has the potential to transform HIV prevention. Gilead scientists have dedicated their lives to fighting HIV, and now, with the FDA approval of Yeztugo and our collaboration with our many partners, we can help make that goal a reality.”
Gilead already sells lenacapavir as a treatment called Sunlenca, and its use for prevention shares the same active ingredient.
The company estimates that the annual cost of Yeztugo in the United States is more than $28,000, but it expects most patients to cover the cost through insurance and also provides financial assistance. Gilead says it plans to make the drug available to countries with high HIV prevalence, primarily in Africa, through agreements with six generic manufacturers — covering 120 low-income countries.
The U.S. Centers for Disease Control and Prevention (CDC) notes that of the more than 1.2 million people in the U.S. who need PrEP, only about 36% actually receive it — underscoring the importance of more convenient drugs. Analysts say the Yeztugo formula is particularly appealing to patients who have difficulty taking their pills daily, have inconsistent access to health care, or face stigma.
As a reminder, Australian researchers have made a major breakthrough in HIV research by using mRNA delivery technology — the same one that underlies COVID-19 vaccines. However, instead of preventing infection, they have aimed it at bringing the virus out of a latent state for the purpose of a potential treatment.