Keypoints:
- Three African manufacturers receive early licences
- Both phase three trials remain in recruitment
- Pricing and procurement will determine access
THREE African pharmaceutical manufacturers have secured early licences to produce an experimental once-monthly HIV prevention pill if ongoing phase three trials succeed and the medicine receives regulatory approval.
The candidate, known as alimatravir or MK-8527, is being developed by Merck Sharp & Dohme as an oral form of pre-exposure prophylaxis, commonly called PrEP. It could eventually provide a monthly alternative to daily tablets and long-acting injections, although its safety and effectiveness have not yet been established.
The development matters for Africa because MSD has included manufacturers in South Africa, Uganda and Kenya in its initial generic licensing programme. Early participation could reduce the long delays that have often separated medical innovation from affordable access in lower-income countries.
African manufacturers enter early
The three companies are Aspen Pharmacare in South Africa, Quality Chemical Industries Limited in Uganda and Universal Corporation Limited in Kenya.
They form part of a group of seven generic manufacturers covered by non-exclusive, royalty-free licensing agreements. Four manufacturers in India have also been selected.
MSD said the agreements would support supply to public and private markets in 129 low- and middle-income countries if alimatravir completes clinical development and obtains the necessary regulatory approvals.
The company said granting licences before phase three enrolment is complete would allow manufacturers to begin product development, regulatory preparation and production planning earlier than would usually be possible.
The move also supports Africa’s wider push to expand pharmaceutical production, strengthen regional supply chains and reduce dependence on imported medicines.
What a monthly pill could offer
PrEP involves the use of antiretroviral medication by people who do not have HIV to reduce their likelihood of acquiring the virus.
Available options include daily oral tablets, the dapivirine vaginal ring and long-acting injectable medicines. In July 2025, the WHO also recommended twice-yearly injectable lenacapavir as an additional HIV prevention option.
A once-monthly oral pill could broaden that range, particularly for people who find it difficult to take medication every day but do not want an injection.
Choice alone, however, will not guarantee wider access. Stigma, testing requirements, clinic availability, pricing and reliable supply will continue to influence whether people can use new prevention technologies consistently.
African countries are already beginning to introduce newer products. Eswatini has started rolling out twice-yearly injectable HIV prevention, illustrating how longer-acting options could reshape national programmes.
Trials remain unfinished
Alimatravir remains an investigational medicine and should not be presented as an approved or proven HIV prevention pill.
Two large phase three studies are currently recruiting participants.
The EXPrESSIVE-10 trial plans to enrol about 4,580 adolescent girls and young women in Kenya, South Africa and Uganda. Its estimated completion date is in October 2027.
EXPrESSIVE-11 is expected to involve about 4,390 participants across 16 countries and is estimated to be completed in July 2027.
Researchers are comparing monthly alimatravir with established daily oral PrEP while assessing safety, tolerability and HIV incidence. No phase three results have yet been posted.
The licensing agreements therefore prepare for a possible future product. They do not demonstrate that alimatravir is effective, guarantee regulatory approval or establish when it could become commercially available.
Affordable access will be decisive
UNAIDS welcomed MSD’s early manufacturing arrangements but warned that scientific innovation would matter only if successful products reached the people who needed them.
‘If alimatravir proves to be safe and effective and receives regulatory approval, manufacturing must be rapidly scaled up and the product made affordable and accessible in low- and middle-income countries from day one,’ said UNAIDS Deputy Executive Director Angeli Achrekar.
The agency said governments, pharmaceutical companies and global health partners should begin planning financing, demand forecasts, procurement and regulatory readiness before the clinical programme is completed.
Without those preparations, a future approval could still be followed by years of limited supplies, unaffordable prices or slow national adoption.
The access debate comes amid continued uncertainty over international HIV financing. South Africa received a temporary $115m US bridge package for HIV services in October 2025, but that six-month arrangement expired at the end of March 2026.
Local production needs firm demand
For African manufacturers, the licences could support technology transfer, regulatory experience and additional production capacity.
Licensing alone, however, will not create a sustainable pharmaceutical industry. Manufacturers will need predictable orders, affordable financing, capable national regulators and coordinated regional procurement.
Those requirements reflect the goals of the AfDB’s $6bn health and pharmaceutical initiative, which seeks to expand local medicine production alongside stronger health infrastructure.
UNAIDS estimates that 1.2 million people acquired HIV in 2025, while 570,000 died from AIDS-related illnesses. About 3,100 adolescent girls and young women acquire HIV every week in sub-Saharan Africa.
Alimatravir could eventually become an important addition to the HIV prevention toolbox. For now, the central story is one of preparation: testing the medicine rigorously while building an African manufacturing, regulatory and financing pathway capable of delivering it rapidly and affordably if it succeeds.
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