Breakthrough PrEP Injection Lenacapavir Gets Fast-Track Approval in Zimbabwe

Zimbabwe Fast-Tracks Approval of Lenacapavir in Just 23 Days

Zimbabwe has moved swiftly to strengthen the country’s HIV prevention strategy by fast-tracking the approval of Lenacapavir, a breakthrough long-acting PrEP injection.

The Medicines Control Authority of Zimbabwe (MCAZ) cleared the drug after completing its assessment in just 23 days.

In a statement, MCAZ confirmed that the application, submitted on 29 October 2025, was fully assessed and approved within just 23 days.

Also Read: Zimbabwe Selected As One Of Ten Countries To Introduce The 6-Month HIV Prevention Injection

A Six-Month HIV Prevention Option

Lenacapavir is a long-acting pre-exposure prophylaxis (PrEP) drug designed for adults and adolescents weighing at least 35kg who are HIV-negative but at substantial risk of infection.

The product is administered as a six-monthly subcutaneous injection, following an initiation phase that includes one injection and oral tablets taken on Days 1 and 2.

MCAZ stressed that the medicine must be used alongside safer sex practices, including condom use and behavioural risk-reduction measures.

Also Read: Zimbabwe Becomes First African Country To Approve Long-Acting Drug For HIV Prevention

A Major Step Forward for HIV Prevention

Authorities say the newly approved drug has the potential to significantly improve PrEP adherence, especially among populations who struggle with daily pill regimens. By introducing a long-acting alternative, Zimbabwe hopes to strengthen its HIV prevention strategy and expand options for vulnerable communities.

MCAZ Director-General Richard T. Rukwata said the rapid review reflects the organisation’s commitment to public health.

“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products. This milestone brings new hope for HIV prevention,” he said.

Assessment Supported by WHO Prequalification

To ensure both speed and scientific rigour, MCAZ applied a regulatory reliance approach, drawing from the World Health Organization Prequalification (WHO PQ) programme.

The authority conducted a full evaluation of the drug’s safety, efficacy and quality, confirming that it meets international standards.

Commitment to Strengthening Public Health

MCAZ said it remains committed to ensuring Zimbabweans have access to safe, effective, and high-quality medical products.

The approval of Lenacapavir marks another step in strengthening national efforts to curb HIV infections and expand prevention tools across the country.