Regulatory approvals, pending decisions, and appeals as of October 2025. 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 is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal and are making progress, but major questions remain.
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.
And for the latest on lenacapavir, visit here.
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
PxWire Volume 15, Issue 4
This issue provides a range of maps to help orient the field on critical HIV prevention activities: the status of delivering injectable cabotegravir (CAB for PrEP); funders and countries on track for early introduction of injectable lenacapavir (LEN for PrEP); and where new Phase 3 efficacy trials testing MK-8527 as a monthly pill for PrEP are taking place.
Read below or download a PDF version of this issue.
Progress in PrEP Uptake
- The first supplies of CAB for programmatic use (as opposed to use in implementation studies) began to arrive in countries in 2024.
- Currently, 16 countries are rolling out CAB for programmatic use, with the majority of supply provided by PEPFAR, and some additional quantities procured by the Global Fund.
- Stop work orders for PEPFAR programming, issued in January 2025 by the new US administration, led to the cancellation of planned programs to offer CAB before they could start in Namibia and South Africa. Ethiopia’s CAB program was able to move forward with supplies supported by Global Fund.
- Stop work orders disrupted ongoing CAB programs in other PEPFAR supported countries, too. They were able to resume, though in some cases at a reduced level. Global Fund supported programs were unaffected by stop work orders and are ongoing.
- The future of PEPFAR and Global Fund supported CAB programs remains uncertain in the context of multiple forms of injectable PrEP entering the market. But lessons and insights being gathered now on delivery of injectable PrEP via these programs can be leveraged to help countries prepare for the introduction of LEN.
- In the past quarter, CAB for PrEP received additional regulatory approval in Argentina, Chile, Mexico, and Rwanda.
PrEParing for New Products
- The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with LEN for PrEP over three years.
- Supply of LEN is due to begin arriving in countries in late 2025 with service delivery planned to start in early 2026.
- Ministries of Health, implementing partners and communities are now preparing for LEN introduction, and CIFF, Unitaid and PEPFAR are funding technical support efforts. PrEPWatch.org hosts updated tools to support developing guidelines, training providers, preparing delivery sites and developing demand generation campaigns.
- In addition, Unitaid, the Gates Foundation, and Gilead are supporting LEN implementation research:
- Two Unitaid-funded PrEP implementation projects – ImPrEP in Brazil (led by Fiocruz) and Project PrEP in South Africa (led by Wits RHI) – will be adding LEN.
- Gates is providing support to the Desmond Tutu Health Foundation for a new LEN implementation study, ALIGN, in South Africa.
- Gilead is funding a Phase 4 study, PROPEL, in the United States that will assess real world implementation of LEN and effectiveness outcomes.
- The supply for LEN for these projects is being provided by Gilead.
- The Elton John AIDS Foundation is providing support to Global Fund LEN programming in Kenya, Nigeria, Uganda, and South Africa.
- In September, the Gates Foundation and Unitaid announced partnerships with Hetero Labs and Dr Reddy’s Laboratories, respectively, to achieve a price of $40 USD/person/year for generic injectable LEN. Generic LEN is expected to become available in 2027 in up to 120 countries.
- LEN received WHO prequalification in October, becoming the first product to be prequalified using an expedited process which took just 36 days from the date of submission.
- In the past quarter, LEN has been approved by the European Medicines Agency and submitted in Australia, Canada, and Switzerland.
The Latest R&D in the Prevention Pipeline
- Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
- A long-acting PrEP pill would offer a unique new option to the existing range of PrEP options and could significantly expand use of HIV prevention, especially among young women, key populations, those facing stigma or access barriers, and those that prefer an oral PrEP option over an injectable.
- EXPrESSIVE-10, with funding from the Gates Foundation, is expected to launch in Q4. It will enroll about 4,600 cisgender adolescent girls, young women, and other women who could benefit from PrEP across three countries in Eastern and Southern Africa.
- EXPrESSIVE-11 launched in August 2025, and will enroll about 4,400 cisgender men, MSM, transgender men and women, and gender non-binary persons who could benefit from PrEP in 16 countries. So far, EXPrESSIVE-11 has launched at sites in Dominican Republic, Guatemala, Switzerland, and the US.
- Merck’s 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 and trial design. Merck has expressed a commitment to sustain this vital engagement throughout the program and next steps.
Prevention Playlist
Join
- Do Not Check That Box – Impacts From the Assault on Transgender Communities and DEI + Strategies to Sustain and Rebuild, webinar
- From Courtrooms to Communities: Funding Advocacy to Protect HIV Responses, webinar
- We Declare—Turning The People’s Declaration Demands into Actions and Accountability, webinar
- International Conference on AIDS and STIs in Africa (ICASA 2025), conference
- Subscribe to Global Health Watch
Use
- Now What with Injectable LEN for PrEP?, factsheet
- Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis, guidelines
- Potential Demand for LEN for PrEP, infographic
- Where We Are Now with LEN for PrEP, infographic
- PrEP Price Comparison, infographic
- HIV Prevention Product Overview, infographic
Watch/Listen
- 24 Hours to Save AIDS Research, website & videos
- New WHO Guidance on Lenacapavir for Prevention & HIV Testing for Long-Acting PrEP, webinar
- Next Up: A monthly pill for PrEP?, podcast
- PrEP Implementation — What’s worked and what are we learning, webinar
Read
- AVAC Applauds Agreements to Accelerate Market Development for Lenacapavir for PrEP, statement
- Global Advocates Welcome the Launch of Merck’s EXPrESSIVE Program, statement
- Getting Rollout Right This Time, report
- Key Messages from IAS 2025, newsletter
- Addressing Transgender Erasure in HIV Clinical Trials, publication
- Global Forecast of Long-Acting PrEP Need for Key Populations (2025–2030), report
EXPrESSIVE Phase 3 Trials Countries of MK-8527
Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with injectable lenacapavir for PrEP over three years. Supply of LEN is due to begin arriving in countries in late 2025 with service delivery planned to start in early 2026.
Source of Programmatic Cabotegravir for PrEP Supply
The first supplies of injectable cabotegravir for programmatic use (as opposed to use in implementation studies) began to arrive in countries in 2024. Currently, 16 countries are rolling out CAB for programmatic use, with the majority of supply provided by PEPFAR, and some additional quantities procured by the Global Fund.
Lenacapavir Implementation Studies
Ongoing and planned implementation studies for the lenacapavir as of October 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
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.