Merck announced on Friday it will license seven generic drug manufacturers to produce a low-cost version of a new monthly HIV prevention pill, alimatravir, aiming to expand access in developing countries ahead of final clinical trial results expected next year. The move, timed with the start of a major international AIDS conference in Rio de Janeiro, reflects growing optimism about the drug’s potential role in reducing HIV transmission, particularly in regions with high infection rates.

Alimatravir is designed as a pre-exposure prophylaxis (PrEP) medication taken once monthly to help prevent HIV infection. It is currently under late-stage clinical trials involving young women in three sub-Saharan African countries, and a separate trial including transgender individuals and men who have sex with men in countries across Latin America, Asia, Europe, and Africa.

According to UNAIDS, there were 1.2 million new HIV infections worldwide in 2025, underscoring an ongoing need for effective prevention tools. Despite existing options, many vulnerable populations remain underserved, a situation exacerbated by sharp funding cuts from major donors, including the United States, over the past 18 months. A recent report by the Clinton Health Access Initiative indicated a 42 percent decline in new oral PrEP starts in ten high-prevalence countries in sub-Saharan Africa and Asia during 2025.

Merck’s licensing deal covers 129 low- and middle-income countries and grants royalty-free licenses to four generic manufacturers in India and three in sub-Saharan Africa—including companies based in Uganda, Kenya, and South Africa. The company will also produce an initial supply of the drug to be sold at no profit in these markets until generic versions receive regulatory approval. Merck did not disclose pricing details but indicated that generic production could reduce costs to about $5 per person per year.

The approach aligns with broader efforts to boost regional pharmaceutical manufacturing, particularly in Africa, where the continent’s limited access to COVID-19 vaccines underscored the need for local production capacity. Advocates emphasize the potential for a monthly oral PrEP pill to overcome delivery challenges associated with longer-acting injectable options like lenacapavir, which requires biannual clinic visits and has seen limited uptake amid dwindling funding and weak health infrastructure.

Researchers remain cautiously optimistic about alimatravir’s efficacy. The drug’s active molecule is structurally related to other effective HIV medications, and preclinical studies have demonstrated strong protective effects. Notably, alimatravir starts offering protection within an hour of ingestion and provides a weeklong grace period if doses are missed early in the cycle, potentially improving adherence.

The licensing agreement excludes several Latin American countries with ongoing clinical trials, such as Brazil, Colombia, Mexico, Peru, and Chile. Merck is reportedly negotiating with Brazil’s Oswaldo Cruz Foundation to establish supply arrangements for the region. Access remains a significant hurdle in Latin America, where middle-income countries often fall outside licensing deals despite relying on public health systems to serve vulnerable populations.

Brazil’s health minister, Dr. Alexandre Padilha, highlighted ongoing challenges in securing affordable pricing for lenacapavir, which has been unavailable in the country despite trial participation. Brazil has offered to pay $400 annually per patient—far above the generic prices available in other countries but significantly below the $28,000 U.S. price. Padilha emphasized the need for innovative treatments to reach diverse risk groups, such as sex workers, but noted the public health system cannot sustain prohibitive costs.

A Gilead spokesperson, the maker of lenacapavir, stated the company is engaged in multiple initiatives to broaden access across Latin America and the Caribbean, including collaborations with the Pan American Health Organization.

As funding fluctuations and access issues continue to limit the effectiveness of existing HIV prevention strategies, Merck’s forward-leaning licensing approach for alimatravir may offer a critical new tool—provided trial results meet expectations and equitable distribution mechanisms are successfully implemented.