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Alimatravir

Phase 2

HIV | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Sep 30, 2026

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Alimatravir · 1 trial · 1 indication

Phase 2 1
NCT07850609A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018)HIV
NOT YET_RECRUITING80 Analytics
PHASE2NOT YET_RECRUITING
A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018)
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Study Endpoints

Primary Endpoints

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 4 months

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 2 months

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary Endpoints

Maximum Plasma Concentration (Cmax) of Alimatravir in Plasma
At designated time points (up to approximately 3 months)
Time to Maximum Plasma Concentration (Tmax) of Alimatravir in Plasma
At designated time points (up to approximately 3 months)
Plasma Trough Concentration (Ctrough) of Alimatravir
At designated time points (up to approximately 3 months)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
AlimatravirEXPERIMENTALAlimatravir 11 mg will be taken once monthly (qm)

Interventions

NameTypeDescription
AlimatravirDRUG11 mg tablets taken orally once monthly (qm) for a total of 3 doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed human immunodeficiency virus (HIV)-uninfected * Is a transgender or gender diverse (TGD) person, ie, a person whose gender identity differs from the sex that was assigned at birth * Is on s...

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Recent Changes (Last 90 Days)

LOWSep 30, 2026NCT07850609NEW_TRIAL: changed
LOWSep 30, 2026NCT07850609NEW_TRIAL: changed

Frequently asked questions about Alimatravir

What is Alimatravir?

Alimatravir is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for HIV. It is currently in Phase 2 clinical development and has not been approved by the FDA. Merck is evaluating it in a study population of transgender and gender diverse individuals on gender-affirming hormone therapy.

What is Alimatravir used for in HIV?

Alimatravir is being studied for HIV in transgender and gender diverse individuals who are on gender-affirming hormone therapy and at low likelihood of HIV-1 exposure. It is an investigational agent in Phase 2 testing, so its use remains limited to clinical research rather than routine clinical care.

Who makes Alimatravir?

Alimatravir is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical program for the drug, including the Phase 2 study identified as MK-8527-018. The compound is also referred to in that study by the code MK-8527.

What phase is Alimatravir in?

Alimatravir is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. One Phase 2 trial is registered for the drug, and it is listed as not yet recruiting, with a planned enrollment of 80 participants.

What clinical trials is Alimatravir in?

Alimatravir is being evaluated in the Phase 2 trial NCT07850609, titled a clinical study of Alimatravir (MK-8527) in transgender and gender diverse individuals on gender-affirming hormone therapy and at low likelihood of HIV-1 exposure. The trial is not yet recruiting and plans to enroll 80 participants aged 18 years and older.

Is Alimatravir the same as MK-8527?

Yes, Alimatravir is also known as MK-8527. The Phase 2 trial NCT07850609 lists the drug under both names, Alimatravir (MK-8527), so searches for either term refer to the same Merck investigational compound being studied in HIV.