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 starting in early 2026.
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
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.
Speeding Up Access to PrEP
Time from efficacy results to key milestones
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.
What Does It Take to Conduct HIV Cure Research?
Progress towards an HIV cure depends on strengthening four critical systems: lab equipment, sustainable funding, policy & programs, and training.
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of May 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
EXPrESSIVE Phase III Program Countries of MK-8527
Seventeen countries are hosting sites for the Phase III 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 III trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase II clinical trials.
Long-Acting HIV Treatment Pipeline
AVAC has begun to track the research pipeline for long-acting HIV treatment (LA-ART). A rapidly expanding pipeline for LA-ART has the potential to introduce new regimens with dosing frequencies that range from weeks to months to, eventually, years. The benefits of LA-ART include reduced drug dosing, frequency, and number of drugs, with the potential for associated decreases in the cost of medications and the burden on health systems. New drug classes could close treatment gaps in children, adolescents, and those with high viremia, comorbidities and resistance. Ongoing clinical research will hopefully further demonstrate whether there are trade-offs (treatment failures or resistance) between LA-ART and highly effective daily oral ART. In addition to the new long-acting products, simplified single-tablet daily regimens are also in development.
Where We Are Now with LEN for PrEP
This timeline tracks the regulatory approval process for lenacapavir (LEN) for HIV prevention from late 2024 through early 2026. Key milestones include FDA Priority Review status, FDA approval in June 2025, expected subsequent approvals from European regulators and WHO, and Global Fund and PEPFAR commitment to roll out LEN to three million people over the next three years.
Decline in PEPFAR Supported PrEP
Official characterizations of the HIV response as “doing very good” warrant a closer look at the data. AVAC’s analysis of PEPFAR prevention figures shows PrEP initiations declined 41% in one year, with women and men each seeing drops exceeding 50%. Data on key populations remains unavailable.
Potential Lenacapavir Supply, 2026-28
Lenacapavir has the potential to reach millions — and the momentum is building. Using the current oral PrEP market as a baseline, this graphic estimates what demand for LEN could look like through 2028 and shows how current donor commitments stack up against that opportunity.