By Fineline Cube 
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that it has received market approval from the US Food and Drug Administration (FDA) for its Yeztugo (lenacapavir). The injectable HIV-1 capsid inhibitor can now be used as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. This makes it the first and only HIV prevention regimen administered via subcutaneous injection every six months.
Mechanism of Action
Lenacapavir’s multi-stage mechanism of action sets it apart from other approved antiviral drugs. While most antivirals target a single stage of viral replication, lenacapavir is designed to inhibit multiple phases of the HIV lifecycle. No cross-resistance has been observed in vitro with existing drug classes.
Clinical Trial Results
The FDA approval is based on results from the global pivotal Phase III PURPOSE 1 and PURPOSE 2 studies. PURPOSE 1, conducted in sub-Saharan Africa, enrolled HIV-negative women aged 16–25. The trial showed zero HIV infections among 2,134 participants receiving twice-yearly Yeztugo, demonstrating 100% efficacy and superiority over daily oral Truvada in preventing HIV. PURPOSE 2 further confirmed Yeztugo’s efficacy and safety in a broader high-risk population.
Global Expansion
Gilead has filed for marketing approval in multiple regions, including Europe, Australia, Brazil, Canada, and South Africa, and plans to pursue registrations in additional FDA-reliant countries.-Fineline Info & Tech