Drug name
Last update: Jul 2026Alimatravir (MK-8527)
Developer(s)
Drug information
Not provided
MK-8527
investigational
Small molecule
nucleoside reverse transcriptase translocation inhibitor (NRTTI)
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 is 216-291 hrs. Observed reduced viral load by at least –1.0 log after 7 days.
MK-8527 is currently in clinical development (phase 3) and not yet approved in any jurisdiction.
MK-8527 is currently in clinical development (phase 3) 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
- Monthly
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
Oral tablet of 11mg is being evaluated in clinical programs in phase 3 clinical trials as once monthly dosing.
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MK-8527 is currently in clinical development.
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 compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
Merck / MSD
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
Manufacturing process is not publicly known. Capsule formulation is used in phase 3 clinical trials, 11 mg dose is under evaluation.
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Since this is an oral formulation, sterile facility will not be required.
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Excipients & delivery device(s)
Not provided
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No delivery device
Safety, Efficacy and Evidence Summary
Not provided
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