Gomekli

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

MelanomaHepatic ImpairmentLow Grade GliomaRecurrent Chronic Lymphocytic LeukemiaVascular MalformationNeurofibromatosisCentral Nervous System TumorNeurofibromatosis 1 (NF1)Langerhans Cell Histiocytosis (LCH)

177 competitors in Melanoma

#DrugCompanyPhaseTrials

1

Opdivo

Bristol-Myers Squibb

Phase 3

1112

Keytruda

Merck & Co.

Phase 3

933

Cotellic

Roche

Phase 3

214

Zelboraf

CConrado Roberto Hoffmann Filho

Phase 3

395

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

356

Taxol

Teva

Phase 3

137

Mektovi

Pfizer

Phase 3

128

Tecentriq

Roche

Phase 3

119

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

2710

Lenvima

Eisai

Phase 3

9Show 34 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

14 more indications

Refractory Solid Tumors1 trial

Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors

Completed·BeiGene·Phase 1·NCT03905148·91 enrolled

CAR1 trial

To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants

Not yet recruiting·SSpringWorks Therapeutics, Inc.·Phase 1·NCT07279233·36 enrolled

Multiple Myeloma1 trial

A Phase 1b/2 Study of Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma (RRMM)

Suspended·NNational Cancer Institute (NCI)·Preclinical·NCT06876142·54 enrolled

LGCMN1 trial

A Phase II Study to Evaluate the Use of the MEK Inhibitor Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07891286·15 enrolled

Pediatric Low-grade Glioma1 trial

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

Recruiting·SSt. Justine's Hospital·Preclinical·NCT06666348·50 enrolled

Hepatic Impairment1 trial

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

Recruiting·SSpringWorks Therapeutics, Inc.·Phase 1·NCT06997276·32 enrolled

Recurrent Chronic Lymphocytic Leukemia1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07061951·20 enrolled

Neurofibromatosis 1 (NF1)1 trial

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

Not yet recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT07521657·55 enrolled

Langerhans Cell Histiocytosis (LCH)1 trial

A Phase II Trial of the MEK Inhibitor Mirdametinib in Histiocytic Disorders

Recruiting·CChildren's Hospital Medical Center, Cincinnati·Phase 2·NCT06153173·40 enrolled

Liposarcoma1 trial

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

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT06843967·54 enrolled

Low Grade Glioma1 trial

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

Recruiting·SSt. Jude Children's Research Hospital·Preclinical·NCT04923126·132 enrolled

Central Nervous System Tumor1 trial

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

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT07539441·26 enrolled

Solid Tumor1 trial

A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors

Terminated·SSpringWorks Therapeutics, Inc.·Preclinical·NCT05580770·23 enrolled

Unspecified1 trial

A Phase 1, Open-Label, Drug Interaction Study to Assess the Effects of Probenecid, a Probe UGT Enzyme Inhibitor, on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants

Recruiting·Merck & Co.·Phase 1·NCT07840612·17 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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