Gomekli

(mirdametinib)

Phase 2Small molecule

SSpringWorks Therapeutics, Inc.

Gomekli is one of 91 small molecule programs targeting Low Grade Glioma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Low Grade GliomaRecruiting

Recurrent Chronic Lymphocytic LeukemiaRecruiting

Pediatric Low-Grade GliomaRecruiting

Central Nervous System TumorRecruiting

Tic DisorderRecruiting

Vascular MalformationRecruiting

MelanomaRecruiting

NeurofibromatosisRecruiting

Low Grade GliomaPreclinical

Recruiting

Recurrent Chronic Lymphocytic LeukemiaPhase 2

Recruiting

Pediatric Low-Grade GliomaPreclinical

Recruiting

Central Nervous System TumorPreclinical

Recruiting

Tic DisorderPhase 2

Recruiting

Vascular MalformationPhase 2

Recruiting

MelanomaPhase 2

Recruiting

NeurofibromatosisPhase 2

Recruiting

Competition

Competitive Landscape

191 competitors in Melanoma

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

95 2

Opdivo

Cotellic

21 4

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

28 5

Libtayo

Regeneron

Phase 3

6 6

Intron a

Merck & Co.

Phase 3

4 7

Opdualag

Bristol-Myers Squibb

Phase 3

4 8

Paraplatin

AAvyxa

Phase 3

11 9

Tuoyi

SSun Yat-sen University

Phase 3

4 10

Rhuph20

Bristol-Myers Squibb

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

CAR

NCT07279233

Phase 1Recruiting

Hepatic Impairment

NCT06997276

Phase 2Recruiting

Vascular Malformation

NCT05983159

Q3 2028

PreclinicalRecruiting

Liposarcoma

NCT06843967

Q4 2028

Phase 1/2Recruiting

Neurofibromatosis

NCT06159166

Q4 2029

PreclinicalRecruiting

Central Nervous System Tumor

NCT07539441

Clinical

Trials by Indication[1]

Tic Disorder1 trial

Mirdametinib in Histiocytic Disorders

Recruiting·—·Phase 2·NCT06153173·40 enrolled

Solid Tumor Cancer1 trial

A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT05054374·6 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

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 logo

BeiGene·Phase 1·NCT03905148·91 enrolled

Neurofibromatosis1 trial

Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).

Recruiting·JJohns Hopkins University·Phase 1/2·NCT06159166·24 enrolled

11 more indications

MPA1 trial

Individual Patient Compassionate Use of Mirdametinib

Available·SSpringWorks Therapeutics, Inc.··NCT05028166

Vascular Malformation1 trial

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

Recruiting·MMurdoch Childrens Research Institute·Phase 2·NCT05983159·50 enrolled

Melanoma1 trial

Mirdametinib in Patients With Advanced NF1-mutant Melanoma

Recruiting·—·Phase 2·NCT07237100·10 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

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

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

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

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

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

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

Regulatory

FDA Approval Timeline[4]

Feb 11, 2025

GOMEKLI

NDA NDA219389

Feb 11, 2025

GOMEKLI

NDA NDA219379

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for mirdametinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — mirdametinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for mirdametinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219389). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gomekli. U.S. Food & Drug Administration.
[6]
SEC EDGAR — SpringWorks Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSpringWorks Therapeutics, Inc.

Patent Landscape[5]

Patent Cliff

Feb 17, 2041

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12295925Feb 17, 2041

12357597Feb 17, 2041

11819487Feb 17, 2041

11806321Feb 17, 2041

11453641Feb 17, 2041

18 more patents

12090128Feb 17, 2041

12037306Feb 17, 2041

12263146Feb 17, 2041

12275688Feb 17, 2041

11084780Feb 17, 2041

11066358Feb 17, 2041

11571402Feb 17, 2041

12011424Feb 17, 2041

11883375Mar 16, 2043

12324791Mar 16, 2043

12220390Mar 16, 2043

11839595Mar 16, 2043

12257215Mar 16, 2043

11806322Apr 9, 2043

12661330Feb 4, 2044

12383517Mar 15, 2044

12029711Mar 15, 2044

12390430Oct 10, 2044

Gomekli

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2028

Q4 2028

Q4 2029

Trials by Indication[1]

Tic Disorder1 trial

Solid Tumor Cancer1 trial

CAR1 trial

Refractory Solid Tumors1 trial

Neurofibromatosis1 trial

MPA1 trial

Vascular Malformation1 trial

Melanoma1 trial

Multiple Myeloma1 trial

Liposarcoma1 trial

Low Grade Glioma1 trial

Recurrent Chronic Lymphocytic Leukemia1 trial

Central Nervous System Tumor1 trial

Hepatic Impairment1 trial

Solid Tumor1 trial

Pediatric Low-grade Glioma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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