As with any medicine, the MHRA will keep the safety and effectiveness of lenacapavir under close review.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (19 December 2025) approved lenacapavir (Yeytuo) for the prevention of sexually transmitted HIV-1 infection in adults and adolescents.
Lenacapavir works by reducing the risk of the HIV-1 virus multiplying and spreading throughout the body if a person is exposed to the virus.
Lenacapavir binds to the HIV-1 virus's outer layer, interfering with the virus' ability to multiply and spread. It is recommended to be used alongside safer sex practices, such as condoms.
Lenacapavir is administered via a combination of tablets and injections. It is given as an injection once every six months. For the first dose only, people also take two days of tablets by mouth.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said:
"The approval of lenacapavir marks the introduction of a 6-monthly long-acting preventative option for sexually transmitted HIV-1 infection.
"Blocking the virus from multiplying if exposure occurs, lenacapavir offers an additional choice alongside existing safer sex practices.
"As with all licensed medicines, we will continue to monitor its safety and effectiveness closely as it becomes more widely used."
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within 7 days of approval.
Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Report any suspected adverse reactions to the MHRA Yellow Card scheme, either through the website ( https://yellowcard.mhra.gov.uk ) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes
The approval was granted on 19 December 2025 to Gilead Sciences LTD
