FEB 2 2027
Gilead Sciences — Yeztugo (lenacapavir) $GILD
for HIV-1 pre-exposure prophylaxis (PrEP) — once-weekly oral formulation
Accepted JUN 15 2026.
About
HIV pre-exposure prophylaxis (PrEP) is a highly effective strategy to prevent HIV acquisition, but current daily oral options can be challenging to adhere to consistently. Yeztugo (lenacapavir) is a long-acting drug that works by blocking the HIV capsid, a critical protein shell the virus needs to replicate. A once-weekly oral version could offer a convenient middle ground, potentially providing strong protection with less frequent dosing than daily pills.
Pivotal trial
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrE...
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Yeztugo
- Is Gilead Sciences (GILD) Cheap With Trodelvy And Yeztugo In Focus? - Yahoo Finance
- Gilead Sciences (GILD) Reiterated at Overweight by Cantor Fitzgerald: Yeztugo Total TRx Down - StreetInsider
- [Press release] FDA accepts Gilead’s application for investigational once-weekly oral Yeztugo, potentially the first long-acting pill for HIV prevention - European AIDS Treatment Group
- Once-Weekly Oral Lenacapavir for HIV PrEP Under FDA Review - Medical Professionals Reference
- FDA Accepts Gilead's Filing for Weekly Oral Yeztugo for HIV Prevention - Yahoo Finance