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.
Potential Lenacapavir Supply, 2026-28
HIV Prevention Pipeline: Products to Watch
From the People’s Research Agenda, this graphic tracks the pipeline of potential new HIV prevention options across broadly neutralizing antibodies, preventive vaccines, pre-exposure prophylaxis, and multipurpose technologies.
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of July 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 starting in early 2026.
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
ARV-Based and Multipurpose Prevention Technology R&D Pipeline
The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.
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.
Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group
Approximately one-quarter of vertical HIV transmissions are linked to infections during pregnancy and lactation, yet data on PrEP use in these populations remains generally limited due to their exclusion from clinical trials. A multisectoral working group, including AVAC’s Executive Director Mitchell Warren and former AVACer Manju Chitani Gada collaborated to develop evidence-based strategies to improve the inclusion of pregnant and lactating women in PrEP trials. The group recommended reframing pregnant and lactating women as needing protection through research, alongside standardized data systems, stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts.
Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group
Approximately one-quarter of vertical HIV transmissions are linked to infections during pregnancy and lactation, yet data on PrEP use in these populations remains generally limited due to their exclusion from clinical trials. A multisectoral working group, including AVAC’s executive director Mitchell Warren, held meetings and a scientific symposium to inform evidence-based strategies for improving the inclusion of pregnant and lactating women in PrEP trials. They recommend reframing pregnant and lactating women as needing protection through research, alongside standardized data systems, stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts.
From Anticipation to Action: The Civil Society Advocates’ Checklist for Lenacapavir for PrEP
By Co-Chairs of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP Chilufya Kasanda, Kenneth Mwehonge, Numan Afifi and AVAC staff supporting the Caucus Navita Jain & Bridget Jjuuko
The landscape of HIV prevention is shifting beneath our feet. We have officially moved from the anticipation of long-acting options to the gritty, urgent work of early implementation, and translating biomedical options into actual choices for people.
The most recent new option is injectable lenacapavir (LEN) for PrEP – a six-monthly subcutaneous injection that offers near perfect protection from HIV. With LEN implementation ongoing in nine African countries as part of Global Fund and PEPFAR support to 24 “Early Adopter” countries, the question is no longer if LEN will arrive, but how fast we can get it to the communities who need it most and build a sustainable, scalable market.
To ensure community leadership sits at the center of this rollout, the Advocates’ Checklist for Lenacapavir for PrEP Introduction was designed as an immediate, actionable blueprint to help civil society organizations (CSOs) and global health advocates pressure-test government commitments, map implementation bottlenecks and demand equitable access. Whether your country is currently on the early adopter list or you are fiercely campaigning for its inclusion, this checklist outlines the essential questions we all need to be asking our Ministries of Health, technical partners and funders.
Why This Checklist? Why Now?
While the field eagerly prepares for the entry of generic LEN supplies into the market in 2027, we cannot afford to simply wait for that eventuality. The demand and need for LEN is immediate – and the sooner we create demand, the sooner generics will make larger volumes at lower prices. Advancing LEN rollout now, as quickly and as large as possible, translates directly into preventable HIV infections and signals strong demand to generic manufacturers as they prepare to enter the market and to donors as they plan for larger-scale procurement. Advocates need to push for speedy and equitable access to LEN right now, while simultaneously preparing national systems for a multi-producer generic market tomorrow.
The checklist breaks down advocacy targets into five critical pillars:
- Regulatory & Policy Alignment: Moving LEN from regulatory approval to formal integration into National HIV Prevention Guidelines alongside oral PrEP, long-acting injectable cabotegravir (CAB-LA) and the Dapivirine Vaginal Ring (DVR).
- Financing & Procurement: Holding funders accountable to the “3 Million in 3 Years” target for providing access to LEN for prevention, and treating that commitment as a floor, not a ceiling. Ensuring robust demand forecasts are developed and financing plans reflect both procurement and program needs.
- Supply Chain & Site Readiness: Using technical tools to track whether orders sitting at the Global Fund are actually reaching central warehouses and frontline clinics.
- Demand Generation & Community Leadership: Fighting back against the “slow rollout” narrative and embedding LEN into comprehensive, integrated choice campaigns rather than letting it be siloed.
- Accountability & Monitoring: Securing dedicated civil society seats on National Technical Working Groups and deploying Community-Led Monitoring (CLM) to track stock-outs and document real-world access barriers.
Working together, partners from Ascend Futures Foundation, APCOM, HEPS Uganda and AVAC, representing members of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, lent their expertise and localized insights to create this tool for the global community. It is the newest in a suite of resources available on PrEPWatch to support LEN rollout, including the LEN Resource Toolkit and the Long-Acting PrEP Status Dashboard.
With this tool in hand, now is the time to turn high-level commitments into real choices at the clinic level. For questions or comments about the checklist, contact us at [email protected].
Get Involved: Download and Share the Checklist: Access the full PDF tool to start auditing your country’s readiness.
Track Progress Live: Keep an eye on global efforts and view continuously updated, country-specific progress trackers on PrEPWatch.
“Lenacapavir has the potential to transform HIV prevention, but its true impact will depend on whether it expands choice rather than replaces it. No single prevention method will work for everyone. Ending new HIV infections requires a prevention ecosystem where every individual can choose the option that best fits their needs, preferences and circumstances.”
“Asia and the Pacific account for nearly one in six people living with HIV globally. For us, global access is about ensuring that new prevention tools do not remain available only in a handful of countries but can reach the millions of people across our region who could benefit from them. That’s how scientific innovation translates into public health impact.”
“Lenacapavir has the potential to transform HIV prevention in high-burden countries. For governments, it is more than a new product—it is an opportunity to prevent infections more effectively, expand choice, reach underserved populations, and reduce the long-term social and economic costs of HIV. If introduced equitably and at scale, LEN could become one of the most important tools in accelerating progress towards ending AIDS as a public health threat.”