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The South African Health Products Regulatory Authority officially approved Lenacapavir, branded as Sunlenca, on October 27, 2025, making South Africa the first African country to authorize this innovation.

SOUTH AFRICA—South Africa has received its first shipment of Lenacapavir of 37,920 doses, a twice-yearly injectable that prevents HIV infections, marking a transformative moment for HIV prevention across the African continent.
This comes just a few days after Nigeria rolled out Lenacapavir, across its eight states, including Anambra, Ebonyi, Gombe, Kwara, Akwa Ibom, Cross River, Benue, and the Federal Capital Territory, to provide its citizens with more innovative HIV prevention options.
A game-changing prevention tool
Unlike daily oral medications, Lenacapavir offers a long-acting alternative designed for individuals weighing over 35 kilograms who face high risk of HIV infection.
Clinical trials show the drug is remarkably effective, nearly eliminating new infections among users.
In the announcement made by the Department of Health last week, Health Department spokesperson Foster Mohale described it as one of the most exciting HIV prevention advances in recent years, emphasizing that it is preventive medicine, not a vaccine.
The South African Health Products Regulatory Authority officially approved Lenacapavir, branded as Sunlenca, on October 27, 2025, making South Africa the first African country to authorize this innovation.
This regulatory achievement paved the way for the drug’s arrival and sets a precedent for other nations across the continent.
Addressing prevention barriers
The new injectable addresses critical gaps in existing HIV prevention methods, particularly for vulnerable groups who struggle with adherence to daily medication regimens.
The strategy prioritizes adolescent girls and young women, sex workers, and men who have sex with men—populations that have historically faced barriers to consistent prevention options.
According to Mohale, the drug is central to South Africa’s integrated, people-centered HIV prevention approach.
It supports the government’s objective to eliminate HIV as a public health threat by 2030 and maintain momentum beyond that deadline in line with the Global AIDS Strategy for 2026-2030.
Manufacturing and regional expansion
South Africa’s National AIDS Council (SANAC) views this arrival as more than immediate prevention relief.
The organization is actively collaborating with stakeholders to establish local manufacturing capabilities through voluntary licensing agreements.
Dr. Thembisile Xulu, the CEO of SANAC and chair of the committee on Lenacapavir Voluntary Licensing, emphasized that making the drug locally would help the region have a steady supply and allow South Africa to assist nearby countries that need it the most.
This manufacturing initiative reflects a broader commitment to self-reliance and equity across the African continent.
International partnership
The successful delivery represents a collaborative effort between multiple stakeholders.
Gilead Sciences, the American biotechnology company that developed Lenacapavir, coordinated closely with the Global Fund to Fight AIDS, Tuberculosis and Malaria to facilitate delivery.
U.S. Ambassador L. Brent Bozell III highlighted America’s role, noting that the United States has contributed more than USD 28.19 billion to the Global Fund to date, with a commitment of USD 4.6 billion for the Eighth Replenishment.
Next steps
The Department of Health and the Presidency plan to announce the official launch date and implementation timeline in the coming weeks.
Minister of Health Dr. Aaron Motsoaledi will lead this announcement in consultation with the president, outlining how the phased rollout will proceed across the country.
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