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.
Addressing Transgender Erasure in HIV Clinical Trials
The scorecard for transgender and gender-diverse inclusion
Scorecard indicators reveal a dearth of HIV research responsive to the needs of transgender and gender-diverse (TGD) communities. The lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences. The scorecard might guide future HIV research to be more responsive to the needs of TGD people. Published in the American Journal of Public Health.
HIV Prevention Product Overview
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.
This file is also available to download as a PowerPoint file.
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.
HIV Research on Pause
Impacts of US government cuts on HIV R&D
This presentation, delivered by AVAC’s Executive Director, Mitchell Warren at IAS 2025, shares a sobering picture of the sweeping changes to science, global health and particularly, HIV R&D since January 20, 2025. It outlines the impact of foreign aid cuts, NIH grant terminations, and policy shifts and shares a vision for the future.
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.
Enhancing Community Engagement in HIV Prevention Clinical Trial Design
Insights from AVAC's clinical trial design academy
Presented at IAS 2025, this poster discusses the goals and lessons learned from the Clinical Trial Design Academy.
Designing for the Future
Community perspectives for HIV prevention trials
Presented by AVAC’s Regional Program Manager for Research Engagement Grace Kumwenda at IAS 2025, this presentation summarizes community demands that future HIV prevention trials be ethical, acceptable, inclusive, feasible, and efficient.