Gilead Advances Once-Yearly Lenacapavir for HIV Prevention Directly to Phase III Trial, Aiming for NDA Submission in 2027

Recently, Gilead Sciences announced that its newly developed once-a-year HIV prevention drug, lenacapavir, has achieved positive results in Phase I clinical trials and is planned to directly advance to Phase III clinical trials.

At the recently concluded Conference on Retroviruses and Opportunistic Infections, Gilead Sciences presented Phase I clinical trial data, which was simultaneously published in The Lancet. In the trial, two different formulations of lenacapavir were administered via intramuscular injection. Results showed that the drug's plasma concentration in participants remained above the effective level throughout 52 weeks, with the minimum concentrations at Week 52 (57.0 ng/mL and 65.6 ng/mL) being higher than those observed in previous trials where dosing occurred every six months.

In addition, safety data from the phase I trial showed that both formulations of lenacapavir were well tolerated, with the main adverse reaction being injection site pain, which was mostly mild and self-resolved within a week.

Previous studies have shown that lenacapavir, injected once every six months, is superior to daily oral medications in reducing HIV infections. Additionally,Patient preference surveys indicate that approximately two-thirds of subjects prefer injectable medications over daily oral medications.A once-a-year dosing regimen is expected to further improve patient acceptance and adherence.

Gilead Plans to Launch Phase III Clinical Trial of Lenacapavir with Once-a-Year Dosing in the Second Half of 2025. If the Trial Proceeds Smoothly, a Regulatory Submission is Expected by 2027.

Conclusion:

If approved, the once-a-year lenacapavir will become an important new option for HIV prevention, helping to address current challenges related to adherence and persistence in pre-exposure prophylaxis (PrEP). This innovative move by Gilead Sciences not only provides a more convenient choice for HIV prevention but also sets a new benchmark for the future development of long-acting antiviral drugs.

Disclaimer:

The content of the article is for reference only and does not constitute investment advice. Investors who take actions based on this information bear their own risks. The article maintains a neutral stance on the statements and viewpoints presented, and does not provide any explicit or implicit guarantees regarding the accuracy, reliability, or completeness of the content included. Readers are advised to use it solely as a reference and assume full responsibility for their own decisions.