Drug

Mirdametinib

Approved · EMA

Early-to-mid development

Also known as Gomekli, (-)-N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDE, Benzamide, N-((2R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)-, N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDE+1 more

Gomekli, (-)-N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDE, Benzamide, N-((2R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)-, N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDE, N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDE N-((2R)-2,3-DIHYDROXYPROPOXY)-3,4-DIFLUORO-2-(2-FLUORO-4-IODOANILINO)BENZAMIDE.

RxNorm2705551 ChEMBLCHEMBL507361UNII86K0J5AK6M

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1 Open-Label Study to Assess the Pharmacokinetics of Mirdametinib and Its Metabolite PD-0315209 in Participants With Impaired Hepatic Function and Participants With Normal Hepatic Function

Clinical trial2026-07-07Results expected Q3 2026 · ClinicalTrials.gov

A Phase 2 Pilot Study of Mirdametinib in Relapsed Refractory Chronic Lymphocytic Leukemia

Clinical trial2026-06-18Results expected Q1 2030 · ClinicalTrials.gov

A Phase 1/2 Study of Mirdametinib and Vinblastine for Newly Diagnosed or Previously Untreated Patients With Pediatric Low-grade Glioma and Activation of the MAPK Pathway

Clinical trial2026-06-11Results expected Q2 2030 · ClinicalTrials.gov

A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma

Clinical trial2026-05-22Results expected Q3 2028 · ClinicalTrials.gov

Phase 1/2 Trial of Mirdametinib in Patients With MAPK Pathway Mutant Central Nervous System Tumors

Clinical trial2026-05-13Results expected Q4 2029 · ClinicalTrials.gov

A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)

Clinical trial2026-05-05Results expected Q1 2027 · ClinicalTrials.gov

A Phase 1/2a Open-label, Multicenter Dose Finding Study to Evaluate the Safety and Anti-tumor Activity of Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).

Clinical trial2026-04-13Results expected Q4 2027 · ClinicalTrials.gov

Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma

Clinical trial2026-04-13Results expected Q3 2030 · ClinicalTrials.gov

A Phase 1, Open-Label Study to Assess the Enzyme Inducing Effects of Carbamazepine on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants

Clinical trial2026-02-27Completed · ClinicalTrials.gov

SJ901: Phase 1/2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1/2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma

Clinical trial2026-02-04Results expected Q2 2031 · ClinicalTrials.gov

A Pilot Study of Mirdametinib in Patients With Advanced Melanoma With an NF1 Mutation

Clinical trial2025-11-19Results expected Q4 2027 · ClinicalTrials.gov

Approval: Ezmekly (EMA)

Regulatory2025-07-17EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Mirdametinib

Aliases & brands

Gomekli(-)-N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDEBenzamide, N-((2R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)-N-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDEN-(((R)-2,3-DIHYDROXYPROPYL)OXY)-3,4-DIFLUORO-2-((2-FLUORO-4-IODOPHENYL)AMINO)BENZAMIDE N-((2R)-2,3-DIHYDROXYPROPOXY)-3,4-DIFLUORO-2-(2-FLUORO-4-IODOANILINO)BENZAMIDE

RxNorm CUI

2705551

ChEMBL ID

CHEMBL507361

UNII

86K0J5AK6M

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2025-07-17

Latest approval

2025-07-17

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2025-07-17Approval

Approval: Ezmekly (EMA)

Indication: Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1)… Show full indication

Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.

Evidence ↗