The Medicines Control Authority of Zimbabwe has approved Lenacapavir, a long-acting pre-exposure prophylaxis medicine for HIV-1 prevention, following an expedited 23-day review process.
The application, submitted by Gilead on October 29, 2025, underwent what MCAZ described as a rigorous evaluation under the Authority’s accelerated review framework.
MCAZ said the product was prioritised because of its significant public health importance in Zimbabwe and globally, and due to the need to ensure timely access to essential, life-saving medicines.
Lenacapavir is recommended for PrEP in adults and adolescents weighing at least 35kg. It is administered as a six-monthly subcutaneous injection after an initiation phase consisting of one injection and oral tablets taken on Days 1 and 2.
According to MCAZ, the medicine is intended for individuals who are HIV-negative and at substantial risk of infection, and must be used alongside safer sex practices, including condom use and behavioural risk-reduction measures.
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The Authority said the registration of Lenacapavir marks a significant step in Zimbabwe’s HIV prevention efforts, offering a long-acting option for populations that struggle with adherence to daily oral PrEP.
MCAZ Director-General Richard Rukwata said the rapid approval demonstrates the Authority’s commitment to accelerating access to trusted, high-quality medical products.
“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.”
Rukwata said MCAZ conducted a detailed assessment of the medicine’s safety, efficacy and quality, applying a regulatory-reliance approach that incorporated scientific assessments from the World Health Organization Prequalification Programme to support a robust review.
MCAZ said it remains committed to ensuring access to safe, effective and high-quality medical products that strengthen public health and advance national efforts against HIV and AIDS.
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