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Mirdametinib

Phase 2

Healthy | Small molecule | Other |Merck KGaA|Last Updated: Sep 25, 2026

Development status

Highest phase Phase 2 run by Murdoch Childrens Research Institute (NCT05983159)
Phase scored for MKGAFPhase 1
Registered trials 8 across 7 sponsors since Apr 2019

Target and mechanism

Molecular targetMAP2K1, MAP2K2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL507361

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

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
NOT YET_RECRUITING17 Analytics
PHASE1NOT YET_RECRUITING
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
NCT0784061217
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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)

LOWSep 25, 2026NCT07840612NEW_TRIAL: changed
LOWSep 25, 2026NCT07840612NEW_TRIAL: changed

Other drugs targeting MAP2K1

Selumetinib AZN· PHASE3 AZD8330 AZN· PHASE1 Refametinib BAYRY· PHASE2 Trametinib pediatric formulation GSK· PHASE1 Pimasertib MKGAF· PHASE1 trametinib NVS· PHASE3 binimetinib PFE· PHASE3 CI-1040 PFE· PHASE2 Cobimetinib RHHBY· PHASE3 Avutometinib (RO5126766) RHHBY· PHASE1 RO4987655 RHHBY· PHASE1 Avutometinib VSTM· PHASE3

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