Back to MK-8527
MK-8527
MK-8527 is an investigational antiretroviral (ARV) drug that is being studied as a potential PrEP product. Below are details on its distinct characteristics and imminent Phase III clinical trial, as well as resources to learn more.
The Basics
- Given once a month.
- An oral pill.
- Developed by Merck.
- Found to be safe and well-tolerated in a Phase II clinical trial.
- Two Phase III clinical trials, due to start enrolling in August 2025, will investigate efficacy for use as HIV prevention.
- Also under investigation as a once-weekly pill for treatment.
The Trials
EXPrESSIVE 10
- Will be conducted amongst approximately 4,580 cisgender women aged 16-30 in Kenya, South Africa, and Uganda.
- Will evaluate the efficacy, safety, and tolerability of MK-8527 compared to daily oral PrEP (TDF/FTC).
- Due to begin enrolling participants in the second half of 2025.
EXPrESSIVE 11
- Will be conducted amongst 4,390 cisgender men who have sex with men, transgender men, transgender women, and gender non binary individuals in Argentina, Brazil, Chile, Colombia, the Dominican Republic, France, Guatemala, Kenya, Malaysia, Peru, the Philippines, South Africa, Switzerland, Thailand, the USA, and Vietnam.
- Will evaluate the efficacy, safety, and tolerability of MK-8527 compared to daily oral PrEP (TDF/FTC).
- Due to begin enrolling participants in August 2025.
Further Resources
- Study Overview of EXPrESSIVE-11 (EXPrESSIVE-10 overview coming soon)
- Safety and pharmacokinetics of MK-8527 oral once-monthly: a phase 2 study in adults at low risk of HIV-1 exposure– Abstract from IAS 2025
- Safety and Pharmacokinetics of MK-8527, a Novel nRTTI, in Adults Without HIV– Abstract from CROI 2024
- MK-8527 details on the Long-Acting Patents and Licenses Database