Seventeen countries are hosting sites for the Phase III efficacy trials of a monthly PrEP pill, called MK-8527, now known as alimatravir, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase III trials at IAS 2025 in Kigali. Alimatravir (AMI) was found to be safe and well-tolerated in Phase II clinical trials.
EXPrESSIVE Phase III Program Countries of Alimatravir
Years Ahead in HIV Prevention Research: Time to Market
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
HIV Prevention Pipeline: Products to Watch
From the People’s Research Agenda, this graphic tracks the pipeline of potential new HIV prevention options across broadly neutralizing antibodies, preventive vaccines, pre-exposure prophylaxis, and multipurpose technologies.
People’s Research Agenda 2025 Update Summary Table
The People’s Research Agenda sets out a people-centered framework for equitable and accelerated R&D and product introduction. It tracks the science, shows where investments align—or fail to align—with community-defined priorities, and spotlights critical gaps in the pipeline of prevention options needed to meet the diverse realities of all populations. View this summary table or see the full report and dashboard.
Alimatravir (AMI) Licensing Timeline
This timeline demonstrates the speed of generic licensing for alimatravir (AMI) compared to lenacapavir (LEN) and cabotegravir (CAB).
ARV-Based and Multipurpose Prevention Technology R&D Pipeline
The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
An “Innovation Pile-Up” in Next-Generation LA-PrEP is Possible
The HIV prevention market is headed toward a period of significant opportunity—and possible congestion—as a slate of new products are on track for continued development and potential introduction to the market in 2027 and 2028. Markets and policies must be built to support the products in the market already, so that new options can be rapidly deployed and deliver impact. Otherwise, the field will squander time and money, with epidemic control slipping further out of reach.
Merck’s alimatravir licensing deal receives mixed response
In July, Merck announced licensing agreements with seven manufacturers for generic production of its HIV drug alimatravir, though access and equity concerns remain. As AVAC’s Executive Director Mitchell Warren explained, AVAC hopes to see Merck pledge to reach at least 2 million people with alimatravir within the first year of product launch and 5 million within the first 2 years, and guarantee it will be available in LMICs within 3 months of first approval. “These targets are a bare minimum and entirely feasible. We need this to jump-start the scale of the market, drive down prices and, most importantly, deliver impact”, Warren said.
INCLUSION Global Study Details
Gilead, Unitaid and the US National Institutes of Health are funding 36 ongoing studies to investigate implementation outcomes, rapid initiation and real-life use of injectable lenacapavir (LEN) for PrEP in 9 countries. Gilead’s INCLUSION program (INCLUSION Global in Africa and Asia and INCLUSION-US in the United States) accounts for 26 of these studies. This table provides details on the INCLUSION Global projects planned for 2026-2028 in 7 LEN early adopter countries. For more details on all ongoing LEN implementation studies, see our map and visit the integrated study dashboard.