FDA Approves New HIV Preventive Drug Developed from University of Utah Research

SALT LAKE CITY — A significant achievement took place last week as the FDA gave the green light to an antiviral drug aimed at preventing HIV, rooted in the research of biochemist Wesley Sundquist from the University of Utah.

Sundquist’s laboratory laid the groundwork for this innovative prophylactic against HIV, the virus linked to AIDS. The medication—lenacapavir—was developed by Gilead Sciences, a California-based pharmaceutical company, and has been recognized as the “Breakthrough of the Year” by the esteemed journal Science.

With the FDA’s approval, lenacapavir, marketed as Yeztugo, will now be accessible in the U.S., where around 31,000 new HIV infections occur each year.

The journey to this moment started in the late 1990s. Sundquist’s team worked on purifying and examining the protein shell encasing the virus’s genetic material. They uncovered the structure of this shell and its assembly process.

In a pivotal finding, the researchers discovered that the virus’s shell has a heightened sensitivity to alterations. Even minor changes to the proteins that form the shell significantly slowed down the virus’s replication, indicating that targeting these proteins could lead to effective treatments.

This breakthrough caught the eye of Gilead Sciences, which began exploring medications that would affect HIV’s protein shell, or capsid, and brought Sundquist on board as a consultant, ultimately resulting in the creation of lenacapavir.

Lenacapavir works by binding to the viral protein shell of HIV, stopping it from assembling correctly and entering host cell nuclei.

“It’s more potent than any existing drug, and importantly, it has lasting effects,” Sundquist explained. “Phase 3 clinical trials showed full protection against transmission for six months. With 1.3 million new infections globally, this could really shift the landscape. Sure, the rollout needs funding and effective implementation, but there’s a strong chance it will have significant positive effects.”

This drug stands out from other HIV medications primarily due to its ability to potentially prevent HIV altogether.

According to the World Health Organization, around 40 million individuals worldwide are living with HIV, with the virus causing 600,000 deaths each year.

In large clinical trials in South Africa and Uganda—areas heavily affected by HIV—not a single one of the over 2,000 women who received lenacapavir contracted the virus during the study.

“Lenacapavir nearly eliminates the transmission of HIV in at-risk populations,” Sundquist noted. “It’s truly an incredible outcome.”

This FDA approval is yet another notable achievement for Sundquist, who was also awarded the 2025 Warren Alpert Prize from Harvard last week. Earlier in April, Time magazine included him in its list of the 100 most influential people worldwide.

“We see ourselves as contributors to innovative medical approaches,” Sundquist remarked. “Our curiosity drives us to explore the unknown, similar to how adventurers feel drawn to discover new heights or places. It’s about figuring out how this molecular machinery operates.”

Even with these recent successes, Sundquist emphasizes that the fight against HIV is not over.

“We still need a vaccine, which would be even better, allowing us to protect everyone, not just those at risk,” he stated. “That remains a challenging puzzle.”