Gomekli

(mirdametinib)

Phase 2Small molecule

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Gomekli is one of 223 small molecule programs targeting Glioma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

222

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

NeurofibromatosisActive, not recruiting

Tic DisorderActive, not recruiting

LiposarcomaActive, not recruiting

Vascular MalformationActive, not recruiting

MelanomaActive, not recruiting

Multiple MyelomaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

Hepatic ImpairmentRecruiting

GliomaPhase 1/Phase 2

Active, not recruiting

NeurofibromatosisPhase 1/Phase 2

Active, not recruiting

Tic DisorderPhase 2

Active, not recruiting

LiposarcomaPhase 1/Phase 2

Active, not recruiting

Vascular MalformationPhase 2

Active, not recruiting

MelanomaPhase 2

Active, not recruiting

Multiple MyelomaPhase 1/Phase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 2

Active, not recruiting

Hepatic ImpairmentPhase 1

Recruiting

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Gomekli

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Phase 2

1 2

Ninlaro

Takeda

Preclinical

18 3

Prolia

Amgen

Preclinical

5 4

Eliquis

Bristol-Myers Squibb

Preclinical

3 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

2 6

Adriamycin

GGynecologic Oncology Group

Preclinical

9 7

Nolvadex

AstraZeneca

Preclinical

1 8

Oncovin

EEastern Cooperative Oncology Group

Preclinical

8 9

Intron a

Systemic Therapy

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Hepatic Impairment

NCT06997276

Q4 2026

Phase 1Not yet recruiting

CAR

NCT07279233

Phase 2Recruiting

Vascular Malformation

NCT05983159

Q3 2028

Phase 1/2Recruiting

Liposarcoma

NCT06843967

Q4 2028

Phase 1/2Recruiting

Neurofibromatosis

NCT06159166

Clinical

Trials by Indication[1]

Advanced Solid Tumors1 trial

Mirdametinib + BGB-3245 in Advanced Solid Tumors

Terminated·SSpringWorks Therapeutics, Inc.·Phase 1/2·NCT05580770·23 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

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

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

Tic Disorder1 trial

Mirdametinib in Histiocytic Disorders

Recruiting·—·Phase 2·NCT06153173·40 enrolled

10 more indications

MPA1 trial

Individual Patient Compassionate Use of Mirdametinib

Available·SSpringWorks Therapeutics, Inc.··NCT05028166

Newly Diagnosed1 trial

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

Recruiting·SSt. Justine's Hospital·Phase 1/2·NCT06666348·50 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

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

Liposarcoma1 trial

A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT06843967·54 enrolled

Melanoma1 trial

Mirdametinib in Patients With Advanced NF1-mutant Melanoma

Recruiting·—·Phase 2·NCT07237100·10 enrolled

Glioma1 trial

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

Recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT04923126·132 enrolled

Chronic Lymphocytic Leukemia1 trial

Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia

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

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

Regulatory

FDA Approval Timeline[4]

Feb 11, 2025

GOMEKLI

NDA NDA219389

Feb 11, 2025

GOMEKLI

NDA NDA219379

Sources

References

[1]
ClinicalTrials.gov — 15 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., a healthcare company of Merck KGaA, Darmstadt, Germany 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., a healthcare company of Merck KGaA, Darmstadt, Germany

Patent Landscape[5]

Patent Cliff

Feb 17, 2041

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11571402Feb 17, 2041

12357597Feb 17, 2041

11806321Feb 17, 2041

11453641Feb 17, 2041

12090128Feb 17, 2041

17 more patents

12037306Feb 17, 2041

12263146Feb 17, 2041

12275688Feb 17, 2041

11084780Feb 17, 2041

11066358Feb 17, 2041

12295925Feb 17, 2041

12011424Feb 17, 2041

11819487Feb 17, 2041

11883375Mar 16, 2043

12324791Mar 16, 2043

12257215Mar 16, 2043

11839595Mar 16, 2043

12220390Mar 16, 2043

11806322Apr 9, 2043

12029711Mar 15, 2044

12383517Mar 15, 2044

12390430Oct 10, 2044

Gomekli

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2028

Q4 2028

Trials by Indication[1]

Advanced Solid Tumors1 trial

Neurofibromatosis1 trial

Solid Tumor Cancer1 trial

Refractory Solid Tumors1 trial

Tic Disorder1 trial

MPA1 trial

Newly Diagnosed1 trial

CAR1 trial

Vascular Malformation1 trial

Liposarcoma1 trial

Melanoma1 trial

Glioma1 trial

Chronic Lymphocytic Leukemia1 trial

Multiple Myeloma1 trial

Hepatic Impairment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News