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Developed by 
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Supported by 
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MK-8527
Developer(s)
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Merck Originator
https://www.merck.com/
United States 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
MK-8527 Compound (4'-ethynyl-2-fluoro-2'-deoxyadenosine)
Drug information
Associated long-acting platforms
Oral solid form
Administration route
Oral
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
User acceptance
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
Available dose and strength
Doses of 0.25 mg, 0.5mg, 1mg, 3mg, 10 mg and 12 mg are being evaluated in clinical programs.
Frequency of administration
Investigated for once monthly oral dosing for HIV PrEP
Maximum dose
Doses of 0.25 mg, 0.5mg, 1mg, 3mg and 10 mg are being evaluated in clinical programs.
Recommended dosing regimen
Doses of 0.25 mg, 0.5mg, 1mg, 3mg and 10 mg are being evaluated in clinical programs as once monthly oral dosing
Additional comments
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)
Dosage link(s)
Not provided
Drug information
Drug's link(s)
Not provided
Generic name
Brand name
Compound type
Summary
Approval status
Regulatory authorities
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
Detailed manufacturing information is not currently available for this compound.
Tentative equipment list for manufacturing
Detailed manufacturing information is not currently available for this compound.
Manufacturing
Detailed manufacturing information is not currently available for this compound.
Specific analytical instrument required for characterization of formulation
Detailed manufacturing information is not currently available for this compound.
Clinical trials
MK-8527-007 - QM PrEP
Identifier
NCT06045507
Link
https://clinicaltrials.gov/study/NCT06045507
Phase
Phase II
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
Purpose
Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection.
Interventions
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-11-08
Anticipated Date of Last Follow-up
2025-03-11
Estimated Primary Completion Date
2025-02-18
Estimated Completion Date
2025-02-18
Actual Primary Completion Date
2024-12-12
Actual Completion Date
2025-02-12
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied populations
Participants aged 18 to 65 years who are confirmed HIV-uninfected with low-risk of acquiring HIV. Participants are excluded if they have prior use of either islatravir (MK-8591) or MK-8527.
Health status
Study type
Interventional (clinical trial)
Enrollment
352
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Participants receive the intervention for 6 months and are then followed-up for 8 weeks blinded safety period.
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
| Type | Title | Content | Link |
|---|---|---|---|
| Link | South African National Clinical Trials Registry | https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=9389 | |
| Link | MK-8527 PK/PD Threshold and Phase II Dose Selection for Monthly Oral HIV-1 Preexposure Prophylaxis - CROI2025- abstract 1232 | https://www.croiconference.org/abstract/3704-2025/ |
MK-8527-002 - monotherapy antiviral
Identifier
NCT03615183
Link
https://clinicaltrials.gov/study/NCT03615183
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Purpose
Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants.
Interventions
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Intervention 5
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-02-11
Anticipated Date of Last Follow-up
2020-09-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-09-26
Actual Completion Date
2019-09-26
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied populations
Participants are ART-naïve HIV-1 positive individuals with a Body Mass Index (BMI) ≤35 kg/m^2, inclusive.
Health status
Study type
Interventional (clinical trial)
Enrollment
17
Allocation
Randomized
Intervention model
Sequential assignment
Intervention model description
Not provided
Masking
Open label
Masking description
None (Open Label)
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
| Type | Title | Content | Link |
|---|---|---|---|
| Link | Single Dose Administration of MK-8527, a Novel nRTTI, in Adults With HIV-1 | https://www.croiconference.org/abstract/single-dose-administration-of-mk-8527-a-novel-nrtti-in-adults-with-hiv-1/ | |
| Link | Clinical trial results of MK-8527-002 on clinicaltrials.gov | https://clinicaltrials.gov/study/NCT03615183?intr=mk-8527&rank=6&tab=results |
MK-8527-004 - monotherapy antiviral
Identifier
NCT05494736
Link
https://clinicaltrials.gov/study/NCT05494736
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
Purpose
Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of a Single Dose of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants.
Interventions
Intervention 1
Intervention 2
Intervention 3
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-11-17
Anticipated Date of Last Follow-up
2025-03-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-01-31
Actual Completion Date
2024-01-31
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied populations
Participants are ART-naïve HIV-1 positive individuals aged 18-60 years.
Health status
Study type
Interventional (clinical trial)
Enrollment
20
Allocation
Non-randomized
Intervention model
Sequential assignment
Intervention model description
Not provided
Masking
Open label
Masking description
None (Open Label)
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
| Type | Title | Content | Link |
|---|---|---|---|
| Link | Single Dose Administration of MK-8527, a Novel nRTTI, in Adults With HIV-1 | https://www.croiconference.org/abstract/single-dose-administration-of-mk-8527-a-novel-nrtti-in-adults-with-hiv-1/ | |
| Link | AVAC trial entry | https://avac.org/trial/mk-8527-004/ | |
| Link | Study Protocol | https://cdn.clinicaltrials.gov/large-docs/36/NCT05494736/Prot_SAP_000.pdf | |
| Link | Safety and Pharmacokinetics of MK-8527, a Novel nRTTI, in Adults Without HIV | https://www.croiconference.org/abstract/safety-and-pharmacokinetics-of-mk-8527-a-novel-nrtti-in-adults-without-hiv/ | |
| Link | Key results on Clinicaltrials.gov | https://clinicaltrials.gov/study/NCT05494736?intr=mk-8527&rank=1&tab=results |
MK-8527-008 - renal impairment
Identifier
NCT06295796
Link
https://clinicaltrials.gov/study/NCT06295796
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.
Purpose
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-06-20
Anticipated Date of Last Follow-up
2025-02-05
Estimated Primary Completion Date
2024-03-06
Estimated Completion Date
2024-03-06
Actual Primary Completion Date
2025-01-31
Actual Completion Date
2025-01-31
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Moderate and Severe RI * With the exception of RI, is in sufficient health for study participation. * Has stable renal function. Healthy * Matches mean age to participants with moderate and severe RI. * Has normal renal function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants * History of cancer (malignancy). * Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV). * Had a major surgery or lost significant volume of blood within 56 days prior to dosing. * Donated plasma within 7 days prior to dosing. Moderate and Severe RI * Failed renal transplant or h
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Non-randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
MK-8527-012 - CBZ
Identifier
NCT06893081
Link
https://clinicaltrials.gov/study/NCT06893081
Phase
Phase I
Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ. Carbamazepine, sold under the brand name Tegretol among others, is an anticonvulsant medication used in the treatment of epilepsy and neuropathic pain. It is used as an adjunctive treatment in schizophrenia along with other medications and as a second-line agent in bipolar disorder.
Purpose
A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
Interventions
Intervention 1
Intervention 2
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-04-28
Actual Start Date
2025-04-28
Anticipated Date of Last Follow-up
2025-07-03
Estimated Primary Completion Date
2025-06-19
Estimated Completion Date
2025-07-11
Actual Primary Completion Date
2025-06-19
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: Inclusion criteria include, but are not limited to: * Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive * Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior Exclusion Criteria: Exclusion criteria include, but are not limited to: * Has a history or presence of: * Seizures (except for febrile seizure), or is at an increased risk for seizures * Family history of severe dermatologic reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome * Clinically meaningful hematologic diseases, bone marrow disorders, or hematologic adverse reactions to other medications * Depression, unusual changes in mood or behavior or suicidal thoughts
Health status
Study type
Interventional (clinical trial)
Enrollment
16
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
MK-8527-005 - multiple dose PK
Identifier
EUCT2022-502081-24-00
Link
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2022-502081-24-00
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
A Multiple-Dose Clinical Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-8527 in Healthy Participants
Purpose
A Multiple-Dose Clinical Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-8527 in Healthy Participants
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2022-12-07
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2023-06-14
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- Male
- Female
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
18-64 years
Health status
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
| Type | Title | Content | Link |
|---|---|---|---|
| Link | Safety and Pharmacokinetics of MK-8527, a Novel nRTTI, in Adults Without HIV | https://www.croiwebcasts.org/console/player/52100?mediaType=slideVideo& |
MK-8527-013 - PK/PD
Identifier
NCT06826989
Link
https://clinicaltrials.gov/study/NCT06826989
Phase
Phase I
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn how MK-8527 moves through a healthy person's body over time. Researchers will study how MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.
Purpose
A Study of MK-8527 in Healthy Adult Participants (PK PD) (MK-8527-013)
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-03-19
Anticipated Date of Last Follow-up
2025-04-07
Estimated Primary Completion Date
2025-05-07
Estimated Completion Date
2025-05-21
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
Genders
- Male
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: * Is in good health * Has a body mass index (BMI) of 18 to 32 kg/m\^2 Exclusion Criteria: * Has a history of cancer * Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
Health status
Study type
Interventional (clinical trial)
Enrollment
8
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
MK-8527-009 - Breast Milk
Identifier
NCT06580587
Link
https://clinicaltrials.gov/study/NCT06580587
Phase
Phase I
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
Purpose
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-04-15
Anticipated Date of Last Follow-up
2025-04-21
Estimated Primary Completion Date
2025-12-19
Estimated Completion Date
2025-12-19
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- Female
Accepts pregnant individuals
No
Accepts lactating individuals
Yes
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate * Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment * Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrit
Health status
Study type
Interventional (clinical trial)
Enrollment
12
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
MK-8527-006 - LNG/EE
Identifier
NCT06783192
Link
https://clinicaltrials.gov/study/NCT06783192
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
Purpose
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
Interventions
Intervention 1
Intervention 2
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-08-14
Anticipated Date of Last Follow-up
2025-01-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-10-11
Actual Completion Date
2023-10-11
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- Female
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: 18 Years to 70 Years (Adult, Older Adult ) * is in good overall health * assigned female at birth Exclusion Criteria: * has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years * has a history of cancer (malignancy)
Health status
Study type
Interventional (clinical trial)
Enrollment
14
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
| Type | Title | Content | Link |
|---|---|---|---|
| Link | Phase 1, open-label study to evaluate the drug interaction between MK-8527, an HIV-1 nucleoside reverse transcriptase translocation inhibitor, and the oral contraceptive levonorgestrel/ethinyl estradi | https://www.natap.org/2024/IAS/IAS_115.htm |
MK-8527-016 - TDF/FTC
Identifier
NCT06816043
Link
https://clinicaltrials.gov/study/NCT06816043
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).
Purpose
A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants
Interventions
Intervention 1
Intervention 2
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-02-21
Anticipated Date of Last Follow-up
2025-06-25
Estimated Primary Completion Date
2025-06-05
Estimated Completion Date
2025-06-05
Actual Primary Completion Date
2025-06-05
Actual Completion Date
2025-06-17
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior * Has body mass index (BMI) ≥18 and ≤32.0 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease * History of cancer (malignancy) * Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Health status
Study type
Interventional (clinical trial)
Enrollment
20
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
MK-8527-011 -EXPrESSIVE-11
Identifier
NCT07044297
Link
https://clinicaltrials.gov/study/NCT07044297
Phase
Phase III
Status
Not yet recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
Purpose
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Interventions
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-07-31
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-07-14
Estimated Primary Completion Date
2027-10-20
Estimated Completion Date
2027-10-20
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Children
- Adults
- Older Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results * Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person * Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening * Weighs ≥35 kg
Health status
Study type
Interventional (clinical trial)
Enrollment
4390
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
| Type | Title | Content | Link |
|---|---|---|---|
| Link | In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally | https://www.merck.com/news/merck-to-initiate-phase-3-trials-for-investigational-once-monthly-hiv-prevention-pill/ |
MK-8527-015 -Hepatic Impairment
Identifier
NCT07025551
Link
https://clinicaltrials.gov/study/NCT07025551
Phase
Phase I
Status
Not yet recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
Purpose
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-08-11
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-06-09
Estimated Primary Completion Date
2026-02-05
Estimated Completion Date
2026-02-25
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: All participants: * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing * Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\^2 * Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology Participants with Mild HI (Group 1) and Moderate HI (Group 2): * Has mild or moderate hepatic impairment * Is generally in good health with the exception of HI Healthy Control Participants (Group 3): - Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs Exclusion Criteria: The main exclusion criteria include but
Health status
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
MK-8527-014 -Moxifloxacin -QT
Identifier
NCT07063238
Link
https://clinicaltrials.gov/study/NCT07063238
Phase
Phase I
Status
Not yet recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often. MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet. The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
Purpose
A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
Interventions
Intervention 1
Intervention 2
Intervention 3
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-07-22
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-07-03
Estimated Primary Completion Date
2025-09-09
Estimated Completion Date
2025-09-09
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases. * Has history of cancer (malignancy). * Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Health status
Study type
Interventional (clinical trial)
Enrollment
42
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
MK-8527-010 -EXPrESSIVE-10
Identifier
NCT07071623
Link
https://clinicaltrials.gov/study/NCT07071623
Phase
Phase III
Status
Not yet recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
Purpose
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Interventions
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-10-31
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-07-08
Estimated Primary Completion Date
2028-01-14
Estimated Completion Date
2028-01-14
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Children
- Adults
Genders
- Female
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results * Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months) * Was assigned female sex at birth and is cisgender. * Weighs ≥35 kg Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has hypersensitivity or other contraindication to any component of the study interventions * Has evidence of acute or chronic hepatitis B infection * Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * Has t
Health status
Study type
Interventional (clinical trial)
Enrollment
4580
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
Excipients
Proprietary excipients used
Not provided
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Not provided
Residual solvents used
Not provided
Patent info
Formulation patent families
Patent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
|---|---|---|---|---|---|
|
MK-8527 compound and analogues
Expiry date: 2034-03-28 Provided is 4'-substituted nucleoside derivatives of Formula I and their use in the inhibition of HIV reverse transcriptase, the prophylaxis of infection by HIV, the treatment of infection by HIV, and the prophylaxis, treatment, and delay in the onset or progression of AIDS and/or ARC. |
WO2015143712 | Compound | Merck Sharp & Dohme Corp. | No |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | Argentina, Brazil, China, Dominican Republic, Belarus, Azerbaijan, Armenia, Kazakhstan, Morocco, Albania, Serbia, Bosnia and Herzegovina, Montenegro, Türkiye, North Macedonia, Georgia, Jordan, Moldova, Republic of, Mexico, Malaysia, Peru, Philippines, El Salvador, Ukraine, South Africa, India, Namibia, Ghana, Botswana, Kenya, Colombia, Algeria, Honduras, Indonesia, Iran (Islamic Republic of), Lebanon, Mongolia, Nigeria, Pakistan, Tunisia, Venezuela (Bolivarian Republic of), Viet Nam | Australia, Canada, Chile, Costa Rica, Russian Federation, Liechtenstein, Italy, Norway, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Bulgaria, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Lithuania, Sweden, Israel, Japan, Korea, Republic of, New Zealand, Singapore, Taiwan, Province of China, United States of America, Gibraltar, Guyana, Panama, Seychelles, Trinidad and Tobago |
| Filed | World Intellectual Property Organization (WIPO), Argentina, Ecuador, Guatemala, Nicaragua, Belize, Egypt, Jamaica, Sri Lanka, Thailand | World Intellectual Property Organization (WIPO), Croatia, Barbados, Brunei Darussalam, Kuwait, United Arab Emirates, Bahrain, Saudi Arabia, Oman, Qatar |
| Not in force | World Intellectual Property Organization (WIPO), Tajikistan, Turkmenistan, Kyrgyzstan, Sierra Leone, Eswatini, Liberia, Sao Tome and Principe, Mozambique, Uganda, Zambia, Zimbabwe, Tanzania, United Republic of, Malawi, Rwanda, Sudan, Lesotho, Gambia (the) | World Intellectual Property Organization (WIPO), San Marino, Monaco, United States of America |
Supporting material
Publications
There are no publication
Additional documents
Useful links
Access principles
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Collaborate for developmentConsider 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 Not provided |
|
Share technical information for match-making assessmentProvide 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 Not provided |
|
Work with MPP to expand access in LMICsIn 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 Not provided |
Comment & Information
MK-8527 is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) being developed for the prevention of HIV as once-monthly oral capsule. It is prioritised by the Medicines Patent Pool (MPP) for public health oriented voluntary licensing since 2025. See more details here: https://medicinespatentpool.org/progress-achievements/prioritisation#pills-hiv