Gilead Sciences Advances HIV Prevention with Lenacapavir Study

Gilead Sciences ((GILD)), Gilead Sciences (($CC:GILD.CUR)) announced an update on their ongoing clinical study.

Gilead Sciences has announced a new clinical study titled ‘A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP.’ The study aims to assess the safety, tolerability, and pharmacokinetics of lenacapavir, a drug administered once yearly via intramuscular injection, for individuals requiring HIV PrEP.

The intervention being tested is lenacapavir, available as both an injection and a tablet. It is designed to provide a long-term preventive treatment option for HIV, with the primary objective of evaluating its pharmacokinetics and safety when administered annually.

This Phase 3 study follows a single-group, non-randomized design where all participants receive lenacapavir. The study’s primary purpose is prevention, and it does not involve any masking, meaning all participants and researchers are aware of the treatment being administered.

The study is set to begin in July 2025, with primary completion estimated for a later date. The last update to the study was submitted in July 2025, indicating the study is not yet recruiting participants.

For investors, this study could signal potential growth for Gilead Sciences if lenacapavir proves effective, as it may offer a competitive edge in the HIV prevention market. The success of this study could positively influence Gilead’s stock performance and investor sentiment, especially given the increasing focus on long-term HIV prevention solutions.

The study is ongoing, and further details can be accessed on the ClinicalTrials portal.