MEK inhibitor · small molecule

mirdametinib

2 active trials across 5 of our biomarkers, targeting MEK1/2. Not approved for any biomarker on marked.bio yet.

Also known as PD-0325901, Gomekli.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRAF V600E 1 2 Phase 1/2
FGFR2 fusion or rearrangement 1 1 Phase 1/2
FGFR3 alteration (mutation or fusion) 1 1 Phase 1/2
KRAS G12C 0 6 –
KRAS G12D 0 6 –

Trials

Status

2 of 8 trials shown

  1. Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK

    Recruiting Phase 1/2 St. Justine's Hospital Started 2026Primary completion 2030-04 NCT06666348

    mirdametinibvinblastine

    …mor) or PLGG with evidence of MAPK pathway alteration with the exception of patients with BRAF V600E mutation (based on molecular analysis of the tumor).

    BRAF V600EPediatric Low-grade Glioma

  2. SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

    Recruiting Phase 1/2 St. Jude Children's Research Hospital Started 2021Primary completion 2031-06 NCT04923126

    mirdametinib

    BRAF fused or rearranged, FGFR1/2/3 aberration, NF1, NF2, PTPN11, SOS1, RAF1 mutations, MYB or MYBL1 fused or rearranged, etc.) or occur…

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementLow-Grade Glioma, Recurrent Low-Grade Glioma, Progressive Low-Grade Glioma