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A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

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Trial Profile

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2025

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At a glance

Most Recent Events

  • 25 Jul 2025 According to a Gilead Sciences media release, based on PURPOSE-1 and PURPOSE-2 studies, the CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs). Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication.
  • 25 Jul 2025 According to a Gilead Sciences media release, based in part on the trial results from PURPOSE-1 and PURPOSE-2 studies, in December 2024 the journal Science named lenacapavir its 2024 "Breakthrough of the Year."
  • 25 Jul 2025 According to a Gilead Sciences media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion under accelerated review recommending lenacapavir as pre-exposure prophylaxis (PrEP) against sexually acquired HIV-1 in adults and adolescents. The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead.

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