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Mirdametinib

Phase 2

Undisclosed | Small Molecules | Other |Merck KGaA|Trials Updated: Nov 4, 2026

Mirdametinib development status

Highest phase Phase 2 run by Murdoch Childrens Research Institute (NCT05983159)
Phase scored for MKGAFPhase 1
Registered trials 9 across 7 sponsors since Apr 2019

Mirdametinib target and mechanism

Molecular targetMAP2K1, MAP2K2
Target classInhibitor
ModalitySmall Molecules

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Mirdametinib clinical trials

Mirdametinib · 1 trial · 1 indication

Phase 1 1
NCT07840612A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy ParticipantsHealthy
RECRUITING17 Analytics
PHASE1RECRUITING
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Ratios of Mirdametinib Pharmacokinetic Plasma Concentration in Presence and Absence of Probenecid
Day 1 up to Day 26

Secondary Endpoints

Number of Participants with Adverse Events (AEs)
Screening up to Day 26
Number of Participants with Clinically Significant Findings in Clinical Laboratory Tests, 12-lead Electrocardiograms (ECGs), Vital Signs, Ophthalmic and Physical Examinations
Screening up to Day 26
Pharmacokinetic Plasma Concentration of Mirdametinib Alone and Following Probenecid
Day 1 up to Day 26
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
MirdametinibEXPERIMENTAL -
Mirdametinib and ProbenecidEXPERIMENTAL -

Interventions

NameTypeDescription
MirdametinibDRUGMirdametinib capsules administered orally.
ProbenecidDRUGProbenecid tablets administered orally.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Participant has a body mass index greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilograms per meter square (kg/m\^²) (inclusive) at Screening. 2. Participant is in good health in the judgement of the investigator on the basis of a medical evaluation per...

Countries:Germany
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Recent Changes (Last 90 Days)

LOWNov 4, 2026NCT07840612lastUpdatePostDate: changed
LOWNov 4, 2026NCT07840612lastUpdatePostDate: changed
LOWOct 9, 2026NCT07840612Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 9, 2026NCT07840612Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 25, 2026NCT07840612NEW_TRIAL: changed
LOWSep 25, 2026NCT07840612NEW_TRIAL: changed

Frequently asked questions about Mirdametinib

What is Mirdametinib?

Mirdametinib is an investigational small molecule drug being developed by Merck KGaA. It is a MAP2K1 and MAP2K2 inhibitor that is currently in Phase 1 clinical development. Its therapeutic indications have not been disclosed.

What does Mirdametinib target?

Mirdametinib targets MAP2K1 and MAP2K2, also known as MEK1 and MEK2. It is classified as an inhibitor of these kinases. By inhibiting MAP2K1 and MAP2K2, mirdametinib acts on the MAP kinase signaling pathway.

Who makes Mirdametinib?

Mirdametinib is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is the sponsor of the clinical program evaluating this investigational small molecule.

What phase is Mirdametinib in?

Mirdametinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The only listed trial is a Phase 1 study, and no completed trials are recorded for this asset.

What clinical trials is Mirdametinib in?

Mirdametinib is being studied in one active clinical trial, NCT07840612. This Phase 1 study is recruiting and is titled "A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants." It is being conducted in Germany and plans to enroll 17 healthy volunteers.