Drug name
MK-8527
Developer(s)
Drug information
Not provided
MK-8527
investigational
Small molecule
MK-8527 is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently in clinical development for the prevention of HIV-1 by oral route. Ongoing trials are assessing MK-8257 as a once-monthly oral PrEP option. MK-8257 is a similar compound to islatravir. MK-8527 is a 7-deaza-deoxyadenosine analog and is phosphorylated intracellularly to its active triphosphate (TP) form, which is a potent inhibitor of HIV-1 replication. MK-8527 functions by preventing the translocation of the HIV reverse transcriptase enzyme, thereby disrupting viral replication. Pre-clinical studies suggest that MK-8527 has a sub-nanomolar potency and no off-target activity. Apparent terminal half-life of MK-8527 triphosphate was 216-291 hrs. Observed reduced viral load by at least –1.0 log after 7 days.
MK-8527 is currently in clinical development and not yet approved in any jurisdiction.
MK-8527 is currently in clinical development and not yet approved in any jurisdiction.
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Prevention
Administration route
Oral
Associated long-acting platforms
Oral solid form
Use of drug
- Self-administered
A monthly oral PrEP option would probably fit well in many settings and be convenient for a number of clients. This will be further investigated. In safety and tolerability trials, in healthy male and female adult populations, MK-8527 was well tolerated. In Phase 1 studies, AEs were reported by the majority of participants (79 -90%), with top AEs being headache, influenza-like illness, cough, abdominal pain, nausea. No serious AEs or events of clinical interest were reported. There seemed to be no difference in meal fat content on the drug levels.
Dosage
Doses of 0.25 mg, 0.5mg, 1mg, 3mg, 10 mg and 12 mg are being evaluated in clinical programs.
Investigated for once monthly oral dosing for HIV PrEP
Doses of 0.25 mg, 0.5mg, 1mg, 3mg and 10 mg are being evaluated in clinical programs.
Doses of 0.25 mg, 0.5mg, 1mg, 3mg and 10 mg are being evaluated in clinical programs as once monthly oral dosing
MK-8527 is on the priority list of MPP since March 2025, as a candidate for which voluntary licensing and technology transfer through MPP would lead to expanded access, significant health benefits, and substantial public health impact compared to available standards of care (https://medicinespatentpool.org/progress-achievements/prioritisation#pills-hiv)
Not provided
Associated technologies
Not provided
Comment & Information
Developer(s)
Merck & Co., Inc. is an American multinational pharmaceutical company known as Merck Sharp & Drone (MSD) in territories outside of the USA and Canada. Merck was originally established in 1891, and is currently headquartered in Rahway, New Jersey. The company is particularly well known for developing and manufacturing biologic therapies, vaccines, medicines and animal health products.
Drug structure
Scale-up and manufacturing prospects
Detailed manufacturing information is not currently available for this compound.
Detailed manufacturing information is not currently available for this compound.
Detailed manufacturing information is not currently available for this compound.
Detailed manufacturing information is not currently available for this compound.
Excipients
Not provided
Not provided
Not provided
Delivery device(s)
No delivery device
Publications
There are no publication
Additional documents
Useful links
Collaborate for development
Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology
Share technical information for match-making assessment
Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit
Work with MPP to expand access in LMICs
In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing