A hope renewed: Gilead’s Yeztugo approved by FDA, marking a turning point in HIV prevention

On 18 June 2025, Gilead Sciences—the pharmaceutical company behind the groundbreaking new treatment—announced that the U.S. FDA had officially approved its latest drug. Named Yeztugo (lenacapavir), this innovative medication is now the first and only HIV prevention drug available that requires just two doses a year.

unotv.com

unotv.com

The Human Immunodeficiency Virus (HIV), which swept across the world in the 1980s and 1990s, has taken the lives of millions and left deep scars in communities across the globe. For decades, those affected by the virus have waited—often in silence and sorrow—for a breakthrough. Now, in a long-overdue moment of hope, the U.S. Food and Drug Administration (FDA) has approved a new preventative HIV drug. This milestone brings renewed promise to those still fighting and serves as a powerful tribute to the countless lives lost to the virus.

The FDA approval for a drug that might finally change how HIV is treated comes almost 41 years since researchers identified HIV as the cause of AIDS. The initial discovery, made in 1984, led to the FDA licensing the first commercial blood test for HIV in 1985. It was two years later, in 1987 that the first antiretroviral medication for HIV became available. Since then, with the advancements in the medical field, researchers have managed to produce numerous other medicines for HIV, including the widely known prep-exposure prophylaxis (PrEP).

On 18 June 2025, Gilead Sciences—the pharmaceutical company behind the groundbreaking new treatment—announced that the U.S. FDA had officially approved its latest drug. Named Yeztugo (lenacapavir), this innovative medication is now the first and only HIV prevention drug available that requires just two doses a year.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (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 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.
 Statement by Gilead Sciences, Inc.

Until now, individuals at risk of HIV have had to depend on daily pills or frequent injections, making long-term adherence to preventative care a constant challenge. With Yeztugo, hope takes a new form—offering a simpler, more sustainable way to protect against HIV and bringing us one step closer to ending the epidemic.

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 very real opportunity to help end the HIV epidemic. 
Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.

This is also a big moment for Gilead, the creators of the first PrEP medication approved in the U.S. in 2012, as they are finally able to offer a next-generation solution that not only builds on over a decade of progress but also redefines what long-term HIV prevention can look like. For Gilead and the millions impacted by HIV, this marks a powerful step forward—one grounded in science, shaped by compassion, and driven by the promise of a future free from fear.

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