This wide-ranging slide deck gives a complete overview of lenacapavir — showing the overall prevention product pipeline, describes lenacapavir, compares it to other options, discusses the trials testing the product, next steps, and links to advocacy resources.
Advocates’ Guide to Lenacapavir
Trial results and steps toward ensuring access
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
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, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, 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.
For the latest on lenacapavir, visit here.
LEN Generics — Can we go faster?
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.
An Overview of Lenacapavir for PrEP Trials
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of June 2025, including US Food and Drug Administration approval. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Press Release
FDA Approves Injectable Lenacapavir for PrEP
A Historic Milestone Must Now Be Matched by Urgent Action
Contact: [email protected]
New York, NY, June 18, 2025 — AVAC welcomes the U.S. Food and Drug Administration (FDA) approval of injectable lenacapavir (LEN) for the prevention of HIV as pre-exposure prophylaxis (PrEP). LEN, developed by Gilead Sciences, is a twice-yearly injectable PrEP option that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials. Science Magazine named LEN the “Breakthrough of the Year” in 2024, a recognition that reflects its enormous potential. But that promise will only be realized if it is rolled out with speed, scale, and equity.
“The approval of LEN is a much-needed boost for HIV prevention, given the strength of the science and the simultaneous disruption in HIV programs globally,” said Mitchell Warren, executive director of AVAC. “But US FDA approval is just one in a series of steps needed to ensure that injectable LEN can help reduce the 1.3 million new HIV infections that occur each year. Scientific progress only matters if innovation actually reaches people. LEN for PrEP is poised to re-shape the HIV response, but only if today’s approval is accompanied by bold, strategic, effective and equitable rollout that reaches the populations that need access. Otherwise, the world risks squandering this PrEP opportunity, as it has with other PrEP options too often over the past 12 years.”
In December, PEPFAR and the Global Fund announced a coordinated ambition to reach two million people within three years of product launch. This commitment signals an unprecedented opportunity to make PrEP access a reality. But translating this ambition into impact, especially now amid the current political environment, is not without considerable challenges.
“Political will, programmatic implementation, and sustainable funding are needed to truly accelerate equitable and impactful introduction of LEN worldwide,” said Wawira Nyagah, AVAC’s director of product introduction & access. “We have over a decade of hard-won lessons on what it takes to rollout PrEP effectively, and the field cannot afford the delays we have seen with the past launches of daily oral PrEP, the monthly dapivirine vaginal ring (DVR), and every-two-month injectable cabotegravir (CAB). Lives depend on speed, scale and equity.”
The World Health Organization (WHO) is expected to release updated PrEP guidelines for LEN in July, and regulatory agencies in Brazil, Europe and South Africa are simultaneously reviewing the product. But the current political context, including a shuttered USAID and further disruptions across global health, demands an urgent and courageous response. In January, the US Administration issued a stop-work on all USAID-funded grants, nearly paralyzing HIV treatment and prevention by PEPFAR, the primary funder of programs in HIV-burdened countries (and administered by USAID). In February, PrEP was broadly excluded from a waiver that allowed HIV treatment to continue and allowed PrEP only for pregnant and breastfeeding women. These policies could not only undercut LEN’s promise but roll back years of progress in HIV prevention.
It will take new, re-vitalized and committed partnerships to work together to sustain past progress and advance HIV prevention to deliver on the UN targets for epidemic control. AVAC’s The Gears of Lenacapavir for PrEP Rollout outlines the steps needed from national governments, funders, researchers, drug-makers including generic manufacturers, and civil society to ensure LEN reaches those who need it most. In the near term, these stakeholders each have vital work to do to complement the initial announcement from the Global Fund and The Children’s Investment Fund Foundation (CIFF) in their pledged collaboration to significantly expand access to LEN for PrEP.
“No one donor, national government or manufacturer can realize this ambition alone,” said Warren. “All stakeholders—including Gilead, PEPFAR, and the Gates Foundation—must act decisively to seize this opportunity, ensuring that all populations—regardless of geography, income, or identity—benefit from this innovative prevention option.”
Meeting this moment requires funders, Ministries of Health, implementers and civil society partners to collaboratively design a comprehensive introduction strategy that breaks the sequential nature of traditional approaches to scaling up interventions. Instead, to speed up introduction, stakeholders must move toward a parallel approach where research, implementation science, and programs at scale are designed, funded and implemented simultaneously. This introduction strategy should entail:
- Other funders and national governments to join the Global Fund and CIFF and commit to procure at least enough LEN from Gilead for two million person years of protection beginning this year through 2027.
- Gilead to set a cost-effective price that compares to generic daily oral TDF/FTC. Achieving this will require a low launch price from Gilead, significant volume procurement from donors, and the entry of multiple generic manufacturers into a competitive, multi-million-user market. While this low price is not expected at launch, stakeholders must act now to reach this price point as quickly as possible by building volume with supplies from Gilead at no more than $100 per person per year and to support multiple generic manufacturers to enable production at larger scale and lower prices as quickly as possible.
- A mobilized civil society in high-burden countries pushing national governments to expedite regulatory approvals, integrate LEN into HIV and national health programs with domestic resources, and develop national guidelines without delay.
- Civil society also demanding transparent pricing and a clear, accelerated pathway to sustainable PrEP programs—so that by the time generic LEN becomes available around 2028, the market is primed for rapid scale-up, with multiple producers driving down prices through competition.
- Gilead working with their generic license holders to accelerate production and expand generic availability in middle-income countries.
- The US Administration, via the State Department, releasing all appropriated funds, negotiate best prices at scale and provide LEN to all who need it. These actions are essential to achieve a strategic transition and sustainability against the global HIV epidemic.
“This is the moment to build on the momentum of science, which has brought the field to this day, when LEN for PrEP is speeding through regulatory review faster than any prevention product to date,” said Nyagah. “Translating this success into real impact on the epidemic, led by communities around the world, must be a top priority among all stakeholders.”
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About AVAC: Founded in 1995, AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org.
The Scientific Journey of Lenacapavir — and the Urgency to Defend HIV Prevention Science
On June 11, AVAC hosted a conversation, The Scientific Journey of Lenacapavir: From basic science to clinical development to impact, to explore how US support from NIH for basic science and South Africa’s clinical research infrastructure made possible the development of lenacapavir for PrEP (LEN), a discovery in HIV prevention that went on to be named Science magazine’s 2024 Breakthrough of the Year.
As the field anticipates initial regulatory approval from the US FDA by June 19 and a WHO recommendation in July, Linda-Gail Bekker of the Desmond Tutu Health Foundation, Wes Sundquist of the University of Utah and Mitchell Warren of AVAC underscored how this moment of promise is threatened by sweeping attacks on science, research and the very systems that made the development of LEN possible.
Getting PrEP Rollout Right This Time
Lessons from the Field
Thirteen years after oral PrEP’s introduction, global uptake remains slow, with just over 9 million initiations—falling short of UNAIDS’ 2025 targets. While HIV infections are declining in some regions, others are experiencing increasing epidemics. Despite challenges, lessons from oral PrEP and CAB rollout have strengthened health systems for scaling up longer-acting PrEP.
AVAC undertook a qualitative landscaping analysis to identify actionable lessons and recommendations across seven countries—Brazil, Kenya, Nigeria, South Africa, Vietnam, Zambia, and Zimbabwe—exploring themes of:
- Successes and challenges with daily oral PrEP introduction and scale-up and what can be done differently for new PrEP products.
- Public health system readiness for the introduction and scale-up of new PrEP products.
- Considerations for improving and accelerating PrEP regulatory approval, normative guidance, demand generation, stakeholder engagement, and health systems strengthening.
This analysis, conducted across seven countries before the January 2025 US foreign aid freeze, identifies urgent actions to sustain momentum. US foreign aid cuts are severely impairing PrEP delivery, jeopardizing remarkable progress made in the last 20 years. In the wake of this disruption, it is vital that efforts to mobilize and sustain an effective HIV response learn from the past and reach UNAIDS’ targets for 2030 by incorporating these insights into future planning.
Visit PrEPWatch for the full report and individual country profiles.