Initial access plans as part of Merck’s broader strategy include establishing early generic licensing covering 129 LMICs; supporting targeted, regional manufacturing capabilities in Africa and Latin America; and investing early in product manufacturing to enable timely access and availability in regions of high unmet need. The first steps of this strategy are being announced in the lead up to the 26th International AIDS Conference in Rio de Janeiro, Brazil.

Key Highlights:

Planning early for rapid, broad and sustainable access in LMICs: By initiating a multi-faceted access strategy while Phase 3 trials are ongoing and before enrollment is complete, Merck aims to make alimatravir available in LMICs as broadly and as quickly as possible, if approved.
Community-guided access strategy: Merck’s access plans have been shaped by years of engagement with the HIV community, advocates and global health stakeholders, and that collaboration will continue as Phase 3 trials progress.
A potential new oral PrEP option: If approved, alimatravir would provide an important new option, with the potential to offer one month of protection from HIV-1 in one pill, predicted to be protective starting within one hour after dosing.
Globally, 1.2 million people acquired HIV in 2025, approximately 3,300 each day. Today, multiple HIV prevention options are available, including daily oral PrEP, long-acting injectable PrEP, and other evidence-based prevention tools. Yet, according to the 2024 UNAIDS report, only 3.5 million people were using oral PrEP in 2023, demonstrating the urgent need to expand access and uptake to reach the global goal of 20 million people receiving PrEP by 2030. New access programs should enable rapid, broad and sustainable scale-up, and focus on the persistent barriers that may be limiting PrEP use, including stigma and affordability.

"Scientific innovation only has impact when it reaches those who need it most," said Robert M. Davis, chairman and chief executive officer, Merck. "Merck has a deep legacy in HIV and a longstanding commitment to public health. Recognizing the urgent, unmet needs in HIV prevention, we are acting early to enable rapid, broad and sustainable access to alimatravir, an investigational once-monthly oral PrEP option, in low- and middle-income countries. These important first steps reflect years of engagement with advocates and global health stakeholders. As Phase 3 trials progress, we remain committed to advancing our efforts in partnership with the HIV community to help maximize the public health impact of alimatravir, if approved."

Establishing early voluntary licensing agreements

Merck has signed seven non-exclusive voluntary licensing agreements* with generic manufacturers, including three in sub-Saharan Africa (Aspen Pharmacare Holdings, Ltd (Aspen), Quality Chemical Industries Limited (Qcil) and UCL Kenya) and four in India (Aurobindo, Cipla, Emcure and Viatris). The royalty-free agreements with these companies cover both the public and private sectors and will enable supply of generic alimatravir in 129 LMICs that account for a substantial majority of new HIV diagnoses globally.

Entering into licensing agreements before Phase 3 trial enrollment is complete represents a first in HIV prevention. This early action should help stakeholders across the HIV response begin planning for ambitious scale-up. It will also facilitate the acceleration of developmental and regulatory activities by the licensed generic manufacturers to help them bring generic alimatravir that meets internationally recognized standards to market in licensed territories, if approved.

"Merck's early and proactive efforts to enable quick access to its new PrEP option, if approved, are important to help protect the communities most affected by HIV," said Mark Suzman, chief executive officer of the Gates Foundation, which aims to end or significantly reduce preventable infectious diseases, including HIV, in the next two decades. "We look forward to continuing to work with Merck and other partners who will help advance these plans and expand access to HIV prevention options."

Supporting targeted, regional manufacturing

Sustainable access for HIV prevention requires reliable supply chains, strong local partnerships and country ownership and prioritization. The voluntary licensing strategy for alimatravir is designed to help support sustainable access across Africa and other high-burden geographies by enabling regional manufacturing, strengthening supply resilience and supporting long-term availability following approval.

Africa has the highest burden of HIV worldwide. With this announcement, for the first time in HIV, generic manufacturers in sub-Saharan Africa have been included in the initial voluntary licenses granted, alongside generic manufacturers in India, enabling planning for introduction and scale-up by local manufacturers.

"People across Africa need more options to prevent HIV. A once-monthly pill could provide a different choice for people in how to protect themselves, subject to successful trials and regulatory approval," said Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention. "We welcome this decision to engage African manufacturers early. Africa must continue to expand its role across the health innovation value chain, from supporting research ecosystems and clinical trial capacity to manufacturing and access. This is how we strengthen health sovereignty and bring new HIV prevention options closer to our people."

HIV incidence remains a pressing public health challenge in Latin America, and specifically in Brazil, where approximately 55,000 people acquired HIV in 2024. In recognition of this significant unmet need, Merck is in active discussions with organizations, including Fiocruz, with a goal to enable rapid availability and broad supply of alimatravir in the region.

Investing early in product manufacturing

To reduce the time between potential regulatory approval of alimatravir and its availability in LMICs, Merck is investing early in its product manufacturing capacity as Phase 3 trials continue. These efforts are intended to help ensure that sufficient product supply is made available, if approved, in areas of high unmet need following the anticipated U.S. approval to enable early program implementation and ambitious scale-up.

Merck expects to provide initial supply and continue supplying product as neededwhile licensed generic manufacturers complete development, obtain the necessary regulatory approvals and prepare to provide supply in the licensed territories. The goal is to help avoid delays in access by providing an initial supply pathway until generic manufacturing capacity is established and brought online.

These actions represent important early steps to help support the future availability and supply of alimatravir in countries with a high burden of HIV, subject to applicable regulatory approvals and requirements. Merck is committed to continuing to advance its access plans, working in close collaboration with communities and global health stakeholders, as Phase 3 trials continue.