Now What with Injectable LEN for PrEP

How to Translate Ambition into Accelerated Delivery and Impact

Since results of the PURPOSE efficacy trials were announced in 2024, injectable lenacapavir for PrEP (LEN) has generated enormous excitement and opportunity – and frustration. By the end of 2024, Gilead Sciences provided six voluntary licenses to generic manufacturers and submitted multiple regulatory filings, and the Global Fund and PEPFAR committed to an ambition to reach two million people over three years, pending regulatory approvals and WHO guidelines. It seemed like bold ambition – and it was, compared to the previous launches of oral PrEP, vaginal ring and CAB.

But this ambition was always defined as a floor, not a ceiling. In April 2026, the collaboration increased the goal to reach three million people over three years with LEN for PrEP.

In July 2025, AVAC published a first edition of Now What with Injectable LEN for PrEP, outlining priorities to ensure introduction moved swiftly. Now, in this update, AVAC is calling for a new minimum floor: reach three million in two years (2026-2027). No less and no slower, with a push for more and faster.

Without speed, scale and equity, LEN is simply exciting science; but, with them, LEN can be a transformational moment in the HIV/AIDS response.

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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.

Going Faster with LEN Generics

The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.

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.

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 late 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.

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.

Injectable PrEP Regulatory Approvals

This graphic tracks regulatory approvals for injectable cabotegravir and lenacapavir for PrEP as of October 2026. For additional details on product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of October 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 in Africa

Lenacapavir for PrEP has now reached seventeen countries in Africa. This map offers more detail on the LEN rollout as of October 2026.

Long-Acting PrEP Generic Manufacturers

Licenses have been granted to manufacturers across multiple low- and middle-income countries to produce generic long-acting PrEP products. Cabotegravir (CAB) and Lenacapavir (LEN) are approved and rolling out, while alimatravir (AMI) is in Phase 3 efficacy trials. Generic manufacturing can play an important role in expanding access to PrEP, and licensing to three African manufacturers for AMI is a notable step toward strengthening regional supply and affordability.