Regulatory approvals, pending decisions, and appeals as of August 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Lenacapavir Regulatory Approval
From Research to Access: The Community Statement from the Global Community Advisory Group (GCAG) on the Future of Alima (Alimatravir) for HIV Prevention
The EXPrESSIVE-10 Global Community Advisory Group (GCAG) released a statement on the future of alimatravir and HIV prevention. The statement reflects community perspectives and priorities around prevention choice, meaningful community engagement, equitable access, and ensuring that communities have a voice as research progresses toward potential introduction. As the GCAG writes, “The test is now whether early planning can translate into faster, more equitable action. An access plan is valuable not because it is announced, but because it creates a pathway that can be tracked, challenged, and delivered.”
Avac Event
Evolving Oral PrEP Guidance for Cis Women: What do we know, and what will it take?
Scientific consensus is evolving, but PrEP clinical equity remains unachieved. Recent data has challenged the “conventional wisdom” surrounding vaginal PrEP tissue concentrations, proving oral PrEP (TDF/FTC, TAF/FTC) is significantly more forgiving than historic messaging for cis women suggested. This has implications for what we understand as “time to protection” as well as “on-demand” PrEP, and may impact trans and non-binary people as well.
What will it take to update the discordant guidelines for women? Can better, more accurate alignment advance equity for cis women, trans folks and non-binary people?
Speakers:
- Heather-Marie Anne Schmidt, UNAIDS
- Simon Collins, HIV i-Base
- Dr. Jenell Stewart, University of Minnesota
- Dr. Raphael Landovitz, University of California Los Angeles
EXPrESSIVE Phase III Program Countries of Alimatravir
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.
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.