Merck (NYSE: MRK) has unveiled a sweeping access strategy for alimatravir, an investigational once-monthly oral pill designed to prevent HIV-1 infection.
The drug, also known as MK-8527, is being positioned as a pre-exposure prophylaxis option that could offer a full month of HIV protection in a single dose.
Merck says the pill is predicted to begin protecting users within one hour of being taken, which would mark a significant shift in how PrEP is administered globally.
The company has signed seven royalty-free, non-exclusive voluntary licensing agreements with generic manufacturers, covering 129 low- and middle-income countries.
Licensing partners include three manufacturers based in sub-Saharan Africa: Aspen Pharmacare, Quality Chemical Industries, and UCL Kenya.
Four Indian manufacturers are also part of the agreement: Aurobindo, Cipla, Emcure, and Viatris, giving the programme substantial production capacity across two continents.
The strategy is notable because the licensing agreements have been established before the completion of Phase 3 clinical trials, which is described as a pioneering move in the pharmaceutical industry.
Merck announced the access strategy ahead of the 26th International AIDS Conference, which is being held in Rio de Janeiro, Brazil.
Two ongoing trials, EXPrESSIVE-10 and EXPrESSIVE-11, are currently studying alimatravir’s safety and efficacy, with EXPrESSIVE-10 running in partnership with the Gates Foundation and focusing on women and adolescent girls in sub-Saharan Africa.
EXPrESSIVE-11 is enrolling participants likely to be exposed to HIV across 16 countries, broadening the evidence base for the drug’s potential approval.
Researchers have noted that alimatravir may provide what they describe as a “cushion of forgiveness,” with drug levels remaining high enough to prevent HIV for approximately one week even if a dose is taken late.
Globally, 1.2 million people acquired HIV in 2025, equating to roughly 3,300 new infections every single day, underscoring the scale of the ongoing epidemic.
According to the 2024 UNAIDS report, only 3.5 million people were using oral PrEP in 2023, far short of the global target of 20 million people receiving PrEP by 2030.
“Merck’s early and proactive efforts to enable quick access to its new PrEP option, if approved, are important to help protect the communities most affected by HIV,” said Mark Suzman, CEO of the Gates Foundation.
Merck is already scaling production in anticipation of approval so that generic manufacturers can move quickly once regulatory clearance is granted.
Trial results are expected in the second half of next year, at which point the company hopes to convert its access infrastructure into rapid real-world distribution.