Regulatory approvals, pending decisions, and appeals as of August 2025, including US Food and Drug Administration approval. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Lenacapavir Regulatory Approval
Where We Are Now with LEN for PrEP
The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.
In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain.
Global Advocates Welcome the Launch of Merck’s EXPrESSIVE Program
Known as the EXPrESSIVE program, the drug maker Merck has two trials testing a monthly pill for PrEP. Merck is committed to stakeholder engagement, putting global advocates at the forefront of planning for the program. Numerous organizations and advocates commend Merck’s dedication to hearing from the community and shared this statement.
The EXPrESSIVE Trials Test a Monthly Pill for PrEP: Advocates speak
The drug maker Merck’s recent announcement at IAS 2025 of two new efficacy trials of a monthly PrEP pill, known as the EXPrESSIVE program, is welcome news. A long-acting PrEP pill would offer a unique new option that could transform the field, contributing significantly to expanding use of HIV prevention, especially to young women, key populations, and those navigating stigma, clinic fatigue, or other barriers to health services.
In addition, Merck’s robust commitment to stakeholder engagement to date contributes an important model of Good Participatory Practice (GPP) to the field, by putting global advocates at the forefront of planning for the program. Merck has expressed a commitment to sustain this vital engagement throughout the program and next steps, and advocates will be holding them to it. AVAC is pleased to share this statement, Global Advocates Welcome the Launch of Merck’s EXPrESSIVE Program, from numerous organizations and advocates who commend Merck “for this important investment in innovation, equity, and choice.”
“This is not just another trial; it’s a signal that the needs of young women and other key groups most affected by HIV really matter,” said Chilufya Kasanda Hampongo, Chair of the Young Women’s HIV Prevention Council (YWHPC). “A monthly pill will offer a new kind of freedom—something discreet, something manageable, something we can own on our terms.”
AVAC has produced several resources to explain and contextualize the EXPrESSIVE program and the monthly PrEP pill.
- Next Up: A monthly pill for PrEP?: This new episode of AVAC’s PxPulse podcast features MSD’s Distinguished Scientist Rebeca Plank and AVAC’s Regional Manager for Research Engagement Grace Kumwenda. They explain the trials’ design, why a monthly pill could be so important to HIV prevention and how GPP is shaping both R&D and rollout of the trials.
- EXPrESSIVE Phase 3 Trials is a new infographic showing the 17 countries hosting trial sites for the two efficacy trials.
- Go to PrEPWatch.org’s dedicated page on MK-8527 for background information on the product and details on the EXPrESSIVE trials.
Now is the time for advocates to serve as both watchdogs and champions for the EXPrESSIVE program and additional options! Join AVAC in tracking this important development in prevention research.
Next Up: A monthly pill for PrEP?
The drug maker Merck has just announced their plans to start two new trials, known as the EXPrESSIVE program, testing a monthly pill for PrEP. A once-a-month PrEP pill holds great potential for the field. Even with daily pills, a monthly ring, or long acting injectables such as cabotegravir and recently FDA-approved lenacapavir, there’ll be people who can’t find what they really need for prevention.
For advocates who follow prevention, there’s a lot to know about these trials, and powerful lessons to learn about Good Participatory Practice (GPP) and impactful involvement of stakeholders—especially community—in research. GPP has been a cornerstone of the process of design and protocol development for the EXPrESSIVE trials, and it doesn’t stop there.
This episode features MSD Distinguished Scientist Rebeca Plank and AVAC’s Regional Manager for Research Engagement Grace Kumwenda. They explain why a monthly pill could be so important to HIV prevention and how GPP is shaping the design and rollout of the trials.
Watch or Listen
Resources
- Global Advocates Welcome the Launch of Merck’s EXPrESSIVE Program, Community Statement
- People’s Research Agenda: Community-Driven Priorities for HIV Prevention Research & Development, AVAC
- Good Participatory Practice (GPP) Guidelines, AVAC
- GPP Body of Evidence: Advocating for Good Participatory Practice (GPP) to become an international standard that makes clinical trials more equitable, just and actionable, AVAC
- Better Engagement, Better Evidence, Lancet
- Learn more about MK-8527 on PrEPWatch.org, AVAC
EXPrESSIVE Phase 3 Trials
Seventeen countries are hosting sites for Merck’s trials of a monthly pill for PrEP. Launch is expected in Q3 2025. This graphic shows where these trials are taking place.
This file is also available to download as a PowerPoint file.
Moving a Product to the Real World
The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.
Download this as a PowerPoint file. And for the latest on lenacapavir, visit here.
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.
This file is also available to download as a PowerPoint file.
Now What with Injectable LEN for PrEP?
How to Translate Ambition into Accelerated Delivery and Impact
The announcements on 9 July 2025 from Global Fund and Gilead about their next steps for injectable lenacapavir (LEN) for PrEP are welcome, as one more part of the process. But they raise as many questions as they answer. This brief summary is intended to help outline what is actually known – and not – and what needs to happen next.
Avac Event
Re-Imagining Prevention: Ensuring sustainable PrEP access in an evolving funding context
If you are attending the International AIDS Society Conference (IAS), be sure to join AVAC and the Ministry of Health, Zambia for this vital conversation.
