The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.
Speeding Up Access to PrEP
Time from efficacy results to key milestones
HIV Vaccine Clinical Trials Pipeline
This graphic summarizes the state of HIV vaccine research, detailing the different immunological approaches in clinical trials, the specific candidates being studied, and the collaborative networks of funders and developers working toward an effective vaccine.
Change in PrEP Initiations from 2024 to 2025 in Five Countries
Between the period January-September 2024 to January-September 2025, PrEP initiations fell between 13% and 66% in selected high-volume PrEP countries where ministries of health (MoH) were able to provide data. Among the five countries depicted, four saw significant decline in PrEP uptake. All four relied on PEPFAR PrEP programs and were disrupted by stop work orders (SWO).
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.
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
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 began arriving in countries in late 2025 with service delivery planned to start in early 2026.
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.
Dapivirine Vaginal Ring Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Lenacapavir Implementation Studies
Ongoing and planned implementation studies for the lenacapavir as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
HIV Prevention Product Overview
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.