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mirdametinib

Generic: MIRDAMETINIB·Brand: GOMEKLI, Gomekli

mirdametinib: sourced relationships with 1 company · 12 clinical trials tracked.

mirdametinib evidence translation

What we can confirm

What it means

Source-backed records connect mirdametinib to SWTX; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could mirdametinib → SWTX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 0 study sponsors

Related indications

Treatment of solid tumors harboring MAPK pathway aberrations, including pediatric low-grade gliomaAdvanced Solid TumorDedifferentiated LiposarcomaGliomaHealthyHepatic ImpairmentLiposarcomaVascular Anomalies

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
SpringWorks Therapeutics, Inc. (SWTX)
developer · Reported 2025-02-20 · Current development: unknownSource
Treatment of solid tumors harboring MAPK pathway aberrations…
Phase 2
Clinical Trial Registry Records (12)showing 10 most recent

Individual Patient Compassionate Use of Mirdametinib

NCT05028166Registry updated 2026-10-05
Available
Expanded Access2 sites · Germany, United StatesSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

A Phase 1b, Open-Label Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

NCT07850635Registry updated 2026-09-30·Phase 1
Not yet recruiting

Primary endpoint: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Interventionalopen6 targetStarted 2026-12Completion 2032-101 site · GermanySpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

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

NCT07840612Registry updated 2026-10-09·Phase 1
Recruiting

Primary endpoint: Geometric Mean Ratios of Mirdametinib Pharmacokinetic Plasma Concentration in Presence and Absence of Probenecid

Interventionalopen17 targetStarted 2026-09Completion 2026-111 site · GermanyMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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

NCT07539441Registry updated 2026-09-03·Phase 1/Phase 2
Recruiting

Primary endpoint: Best overall neurologic response rate

InterventionalRandomizedopen26 targetStarted 2026-04Completion 2029-107 sites · United StatesMemorial Sloan Kettering Cancer Center

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

NCT07279233Registry updated 2026-04-01·Phase 1·SWTX
Completed

Primary endpoint: The geometric mean ratio of mirdametinib plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) of Mirdametinib

Interventionalopen36 enrolledStarted 2025-12Completion 2026-021 site · United StatesSpringWorks Therapeutics, Inc.

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

NCT06997276Registry updated 2026-08-24·Phase 1
Recruiting

Primary endpoint: Maximum plasma concentration (Cmax) of mirdametinib

Interventionalopen32 targetStarted 2025-05Completion 2026-103 sites · United StatesSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

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

NCT06843967Registry updated 2026-05-22·Phase 1/Phase 2
Recruiting

Primary endpoint: Maximum tolerated dose (Phase I)

Interventionalopen54 targetStarted 2025-02Completion 2028-087 sites · United StatesMemorial Sloan Kettering Cancer Center

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

NCT05983159Registry updated 2026-02-19·Phase 2
Recruiting

Primary endpoint: The number of participants who achieve or exceed a predetermined threshold of improvement in their most significant symptom at 48 weeks based on the Vascular Malformation Patient Specific Outcome Measure (VM-PSOM).

Interventionalopen50 targetStarted 2024-09Completion 2026-122 sites · AustraliaMurdoch Childrens Research Institute

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).

NCT06159166Registry updated 2026-04-13·Phase 1/Phase 2
Recruiting

Primary endpoint: Assess the safety of continuous and three week on-one week off dosing of mirdametinib in adults with NF1 and cutaneous neurofibromas (cNFs).

Interventionalopen24 targetStarted 2024-02Completion 2028-111 site · United StatesJohns Hopkins University

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

NCT05580770Registry updated 2026-08-20·Phase 1/Phase 2
Terminated

Primary endpoint: Incidence of Treatment Emergent Adverse Events

Interventionalopen23 enrolledStarted 2023-02Completion 2025-018 sites · Australia, United StatesSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Frequently asked questions

Which companies have sourced relationships with mirdametinib?

mirdametinib has dated SEC/FDA relationship records for SpringWorks Therapeutics, Inc..

How many clinical trials involve mirdametinib?

BioSniper tracks 12 clinical trials involving mirdametinib.