Breakthrough PrEP Injection Lenacapavir Gets Fast-Track Approval in Zimbabwe

Breakthrough PrEP Injection Lenacapavir Gets Fast-Track Approval in Zimbabwe

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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.

In a statement, the Medicines Control Authority of Zimbabwe (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

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