RAHWAY, N.J., July 24, 2026
Merck has announced an ambitious global access strategy for alimatravir (MK-8527), its investigational once-monthly oral HIV-1 pre-exposure prophylaxis (PrEP) candidate currently in Phase 3 clinical development. The company revealed plans to accelerate access in low- and middle-income countries (LMICs) through early voluntary licensing agreements, regional manufacturing initiatives, and expanded manufacturing investments ahead of potential regulatory approvals. The strategy is designed to ensure rapid, broad, and sustainable availability of alimatravir if approved, while addressing the urgent need for improved HIV prevention options worldwide. Merck emphasized that these access initiatives were developed in collaboration with the global HIV community, public health organizations, and advocacy groups, marking one of the earliest large-scale access commitments ever announced for an investigational HIV prevention therapy.
Early Licensing Agreements to Accelerate Global Access
As part of its access strategy, Merck has signed seven royalty-free, non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers, including Aspen Pharmacare, Quality Chemical Industries Limited, UCL Kenya, Aurobindo Pharma, Cipla, Emcure, and Viatris. These agreements cover 129 low- and middle-income countries, representing regions where the majority of new HIV infections occur globally. The licensing framework allows participating manufacturers to prepare regulatory submissions, development activities, and commercial production before Phase 3 enrollment is completed, helping reduce the delay between approval and patient access. Merck noted that this represents a first-of-its-kind approach in HIV prevention, enabling governments and healthcare organizations to prepare for large-scale implementation well before commercialization.
Regional Manufacturing and Phase 3 Development Progress
Beyond licensing, Merck plans to strengthen regional manufacturing capabilities across Africa and Latin America, supporting long-term supply resilience and improving local access. The company is also investing in its own manufacturing capacity to provide initial product supplies until licensed manufacturers begin commercial production. Alimatravir is currently being evaluated in the global Phase 3 EXPrESSIVE-10 and EXPrESSIVE-11 clinical trials, which are enrolling participants across multiple countries. The investigational medicine is designed as a once-monthly oral PrEP tablet, with research suggesting it may provide protection against HIV-1 infection within one hour after dosing. Previous Phase 2 clinical data demonstrated a favorable safety profile with adverse event rates comparable to placebo while supporting the drug’s once-monthly dosing strategy. Merck also confirmed its commitment to ensuring continued access to alimatravir for participants enrolled in ongoing clinical trials following regulatory approval.
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Global Effort to Expand HIV Prevention Options
According to global estimates, approximately 1.2 million people acquired HIV in 2025, despite the availability of multiple prevention strategies. Merck believes once-monthly oral PrEP could help address barriers associated with daily medications, including adherence, affordability, accessibility, and social stigma. The company will continue working alongside international health organizations, governments, advocacy groups, and local manufacturers to maximize future access if alimatravir receives regulatory approval. By combining innovative pharmaceutical research, early licensing partnerships, regional manufacturing, and global public health collaboration, Merck aims to support broader HIV prevention efforts and contribute toward international goals of significantly expanding PrEP adoption in high-burden regions over the coming decade.
Source: Merck press release
