Zimbabwe has fast-tracked the approval of Lenacapavir, a long-acting injectable medicine that could reshape HIV prevention efforts nationwide.
The Medicines Control Authority of Zimbabwe (MCAZ) announced the authorization on Saturday, completing its regulatory review in only 23 days, one of the swiftest timelines for a major public health product in the country.
The drug, submitted by Gilead Sciences on October 29, is designed for pre-exposure prophylaxis (PrEP) and is administered as a six-monthly injection after an initial dose and two days of oral tablets.
It is approved for adults and adolescents weighing at least 35 kilograms who are HIV-negative and at substantial risk of infection.
Officials say its extended dosing schedule may help people who struggle with adherence to daily oral PrEP.
MCAZ Director-General Richard T. Rukwata described the decision as a major step forward in expanding prevention options.
“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products,” he said.
“This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health.”
Lenacapavir’s registration comes as Zimbabwe continues efforts to curb new HIV infections, particularly among young people and key populations where transmission rates remain high.
Health experts have long argued that more flexible prevention tools are essential to meeting global HIV targets.
To evaluate the drug, MCAZ used a regulatory reliance model, drawing on scientific assessments from the World Health Organization Prequalification Programme.
Officials said the approach allowed for an efficient but thorough review of the drug’s safety, efficacy, and quality.
Public health advocates say access to long-acting PrEP could help reduce barriers including stigma, pill fatigue, and challenges with consistent clinic visits.
The new injection, taken only twice per year after initiation, offers a discreet alternative that may reach users who have been left out of existing prevention programs.
MCAZ emphasized that the medicine must be paired with safer sex practices, including condom use and behavior-change strategies.
It also reiterated its mandate to ensure that all medical products on the market meet strict quality and safety standards.
With the approval now in place, Zimbabwe joins a growing list of countries advancing long-acting HIV prevention tools.
The Authority said updates on registration and rollout information will be shared through its public portal.
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