NDA says approved HIV-prevention drug Lenacapavir

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The Uganda National Drug Authority (NDA) says it has today, January 5, 2026, approved HIV-prevention drug Lenacapavir.

The approval means that data on the drug’s effects have been reviewed and prove that the drug provides benefits that outweigh its known and potential risks for the intended population. It also means that the drug can legally be marketed, distributed and sold in Uganda.

The development comes barely six months after the World Health Organisation (WHO) recommended the drug as an additional HIV prevention choice as part of combination HIV-prevention approaches. The WHO recommendation also came after the United States Food and Drug Administration (FDA) approved lenacapavir for HIV prevention in mid-June 2025.  

The life-saving drug lenacapavir is expected to be marketed in Uganda and distributed through the US President’s Emergency Plan for AIDS Relief (PEPFAR). 

Since Uganda is among the 10 high-burden HIV countries around the world, it is set to benefit from the subsidised HIV-prevention drug this year through a US government initiative.

Taken only twice a year, lenacapavir offers a highly effective and convenient HIV prevention option for individuals at high risk of HIV acquisition. Clinical trials show more than 99% of people on lenacapavir remained HIV negative.

NDA says the approval is expected to be a game-changer for HIV prevention, especially for those at high risk. 

"This is a great step towards ending AIDS by 2030," NDA said in a social media post. 

Late last year, the US embassy in Uganda said the PEPFAR intervention of Uganda, being among the 10 countries benefitting from the subsidised drug, will advance its fight against HIV/AIDS, particularly for pregnant and breastfeeding mothers. 

"The US government and the Global Fund, of which the US government is the largest donor, are co-funding this advanced market commitment to purchase lenacapavir for up to two million individuals by 2028 in countries with the largest HIV/AIDS epidemics. Gilead has agreed to provide the drug at cost". 

The embassy also said drug manufacturer Gilead has agreed to provide its intellectual property to generic manufacturers who can produce the drug at scale and help bring down the price so that future purchases can be sustained by local governments.

US Ambassador to Uganda William W. Popp said: "Collaboration between an American company and researchers right here in Uganda led to a medical breakthrough to reduce new HIV infections in the communities that need it most. This exciting development will accelerate our progress toward ending HIV as a public health threat, building a healthier future for America, Uganda, and the world.”

Lenacapavir to be available for sh140,000 a year  

Generic versions of the injectable HIV-prevention drug should be available for $40 (about sh140,0000) a year in more than 100 countries from 2027, Unitaid and the Gates Foundation said last year.

The two organisations entered into separate agreements with Indian pharmaceutical companies to produce cheaper generic versions of lenacapavir for low- and middle-income countries.

Marketed under the brand name Yeztugo by California-based Gilead Sciences, lenacapavir currently costs about $28,000 (about shillings 97.9 million) a year in the US.

Far cheaper generic versions are therefore "really critical for the scale-up of prevention of HIV," Carmen Perez Casas, Unitaid's strategic lead for HIV, told AFP in an interview.

HIV burden in Uganda

As of December 2023, the estimated number of people living with HIV in Uganda stood at 1.492 million. While the HIV prevalence has declined to 5.1%, women remain disproportionately affected. Additionally, 38,000 new infections are recorded annually, with a third occurring among youth aged 15 to 24 years.

Despite progress, Uganda’s HIV epidemic remains severe.

“The estimated number of people living with HIV is 1.492million, and this is as of December 2023. The burden of HIV is still higher in females than males. The HIV prevalence is coming down, currently averaging at 5.1 per cent, but still higher among women than men, and new HIV infections are now 38,000. Again, the bulk of HIV infections occurs in women compared to men,” Dr Vincent Bagambe, the Uganda AIDS Commission director in charge of planning and strategic information, said recently.

Youth aged 15-24 years account for a third of new HIV infections.

“To give you an example, out of 100 people living with HIV in the world, four are Ugandans. We derive this considering the fact that Uganda has a population of only 46 million people and it has 3.8 % of people living with HIV in the world,” he said.

Moreover, an estimated 200,000 people remain undiagnosed and untreated each year.

Dr Flavia Kiweewa Kiwanuka, the principal investigator of the trials in Uganda, in an X (formerly Twitter) space hosted by New Vision Online on July 15, 2025, noted that the FDA’s approval, WHO’s recommendation, and the Global Fund’s commitment to purchase the drug for low- and middle-income countries, including Uganda, is a significant opportunity.

“The Ministry of Health has been allocated shillings 40,840,500,000 (approximately $1.14 million) from the Global Fund to procure drugs for 17,000 people as the first doses. It’s a procurement process, but we hope by 2027 we will have them available,” Dr Kiweewa said.

She added that these 17,000 individuals will receive the drug for one year. “We have gotten support to start us off.”