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Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill
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July 14, 2025
In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and efficacy of MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) for HIV pre-exposure prophylaxis (PrEP). The EXPrESSIVE-11 (MK-8527-011, NCT 07044297) trial will evaluate the safety and efficacy of MK-8527 among people with greater likelihood of HIV-1 exposure in 16 countries and will begin enrolling in August 2025. In collaboration with the Gates Foundation, the EXPrESSIVE-10 (MK-8527-010) trial will evaluate the safety and efficacy of MK-8527 in women and adolescent girls in sub-Saharan Africa and will begin enrolling in the next few months.
About the EXPrESSIVE MK-8527 Phase 3 Clinical Trial Program
The EXPrESSIVE-11 trial (MK-8527-011, NCT 07044297) is a randomized, active-controlled study enrolling 4,390 sexually active people who could benefit from PrEP across trial sites in 16 countries. The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as assessed by the incidence rate per year of adjudicated HIV-1 infections. The trial will begin enrolling in August 2025.
The EXPrESSIVE-10 trial (MK-8527-010) is a randomized, active-controlled study enrolling 4,580 sexually active women aged 16 to 30 in Kenya, South Africa, and Uganda. The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as assessed by the incidence rate per year of adjudicated HIV-1 infections. The study will begin enrolling in the next few months.
https://www.merck.com/news/merck-to-initiate-phase-3-trials-for-investigational-once-monthly-hiv-prevention-pill/
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