Mexico’s Federal Commission for the Protection against Sanitary Risks (Cofepris) authorized the sanitary registration of lenacapavir on Thursday, September 24, 2026. The authorization establishes the twice-yearly injectable medication as a pre-exposure prophylaxis (PrEP) option to prevent human immunodeficiency virus (HIV) infection, following a regulatory review of data concerning the drug’s quality, safety, and efficacy.
Mexico Approves Twice-Yearly Lenacapavir for HIV Pre-Exposure Prophylaxis
With this approval, Mexico joins a group of jurisdictions that authorize lenacapavir for HIV prevention, alongside the United States, Brazil, and member states of the European Union. The regulatory decision follows local investigative steps that began in 2023, when Cofepris authorized a phase 3 clinical trial protocol to evaluate the long-acting injectable regimen in populations at risk for HIV.
Mechanisms and Function of Lenacapavir
Lenacapavir represents a distinct class of antiretroviral agents known as capsid inhibitors. Rather than targeting viral enzymes after entry, the drug binds directly to the viral capsid—the protein shell that protects the genetic material and essential enzymes of HIV—to disrupt multiple stages of the viral lifecycle.
https://x.com/COFEPRIS/status/2103182679097147479
The compound interferes with the transport of viral genetic material into host cells and disrupts the assembly and maturation of new viral particles, preventing replication and propagation. Regulatory filings clarify that lenacapavir functions as an antiviral agent rather than a vaccine. It does not induce an active immunological response to recognize the pathogen; instead, it persists in the body to inhibit viral replication directly.
Comparison: Twice-Yearly Dosing Versus Daily Oral PrEP Regimens
Traditional pre-exposure prophylaxis relies on daily oral antiretroviral tablets, which require strict daily adherence to maintain protective drug concentrations. Lenacapavir shifts this schedule to two subcutaneous injections administered every six months.
This biannual administration schedule aims to address adherence barriers associated with daily regimens. Clinical trials supporting international authorizations demonstrated high levels of preventive efficacy. For instance, the PURPOSE 1 trial reported no new HIV infections among participants assigned to the lenacapavir arm during the primary follow-up window. Consequently, the World Health Organization (OMS/WHO) includes long-acting lenacapavir among its recommended PrEP alternatives.
Clinical Research Precedents in Mexico
Mexico’s regulatory pathway for the drug included local evaluation under clinical trial protocol GS-US-528-9023, initiated following Cofepris clearance granted in 2023. The trial was structured as a phase 3, double-blind, multicenter, randomized study.
Researchers evaluated the safety and efficacy of the biannual subcutaneous regimen in cisgender men, transgender women, transgender men, and non-binary individuals aged 16 years and older who report sexual activity with male partners and face ongoing risk of HIV acquisition.