PD0325901 (Mirdametinib) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 377

Clinical Trials

PD0325901 (mirdametinib) has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 2 studies for diverse indications, including solid tumors, KRAS-mutant non-small cell lung cancer, neurofibromatosis type 1 with plexiform neurofibromas, vascular malformations, and relapsed or refractory hematologic malignancies. Supported by pharmaceutical companies and prominent research institutions, these studies reflect varied recruitment statuses, encompassing completed, terminated, and actively recruiting protocols investigating targeted therapeutic strategies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06876142	SUSPENDED	Multiple Myeloma; Relapsed and/or Refractory Multiple Myeloma (RRMM)	National Cancer Institute (NCI)	2026-09-09	PHASE1; PHASE2
NCT04923126	RECRUITING	Low-Grade Glioma; Recurrent Low-Grade Glioma; Progressive Low-Grade Glioma	St. Jude Children's Research Hospital	2021-06-21	PHASE1; PHASE2
NCT07521657	NOT_YET_RECRUITING	Neurofibromatosis 1 (NF1)	University of Alabama at Birmingham	2026-08-01	PHASE2
NCT06666348	RECRUITING	Pediatric Low-grade Glioma	St. Justine's Hospital	2026-01-12	PHASE1; PHASE2
NCT06153173	RECRUITING	Langerhans Cell Histiocytosis (LCH); Juvenile Xanthogranuloma (JXG); Rosai-Dorfman Disease (RDD); Histiocytic Disorders	Children's Hospital Medical Center, Cincinnati	2024-02-05	PHASE2
NCT07061951	RECRUITING	Recurrent Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Small Lymphocytic Lymphoma	National Cancer Institute (NCI)	2026-05-27	PHASE2
NCT07539441	RECRUITING	Central Nervous System Tumors; Glioma	Memorial Sloan Kettering Cancer Center	2026-04-10	PHASE1; PHASE2
NCT06843967	RECRUITING	Well Differentiated Liposarcoma; Dedifferentiated Liposarcoma; Liposarcoma; Myxoid Liposarcoma; Round Cell Liposarcoma; Myxoid Pleomorphic Liposarcoma; Pleomorphic Liposarcoma; Unresectable Liposarcoma; Unresectable Dedifferentiated Liposarcoma	Memorial Sloan Kettering Cancer Center	2025-02-19	PHASE1; PHASE2
NCT05937906	RECRUITING	Non-Small Cell Lung Cancer	Centre Georges Francois Leclerc	2026-07-07	PHASE1; PHASE2
NCT06159166	RECRUITING	NF1; Cutaneous Neurofibroma; Monotherapy	Johns Hopkins University	2024-02-12	PHASE1; PHASE2
NCT07237100	RECRUITING	Advanced Unresectable Melanoma; Metastatic Melanoma	Kevin Kim, MD	2025-10-13	PHASE2
NCT06693284	RECRUITING	Primary Malignant Peripheral Nerve Sheath Tumors	University of Minnesota	2025-11-20	EARLY_PHASE1
NCT05983159	RECRUITING	Slow-Flow Vascular Malformation; Fast-Flow Vascular Malformation; Vascular Malformations; Venous Malformation; Lymphatic Malformation, Low Flow; Lymphatic Malformation; Lymphangioma; Arteriovenous Malformations; Venous Malformation, Low Flow; Cystic Hygroma; Vascular Anomaly; Vascular Anomalies; PI3K Gene Mutation; MAP2K1 Gene Mutation; PIK3CA-related Overgrowth Spectrum; Arteriovenous Malformation (AVM); KRAS G12C; KRAS G12D	Murdoch Childrens Research Institute	2024-09-13	PHASE2
NCT06997276	RECRUITING	Healthy; Hepatic Impairment	SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany	2025-05-07	PHASE1
NCT07279233	COMPLETED	Healthy; Volunteer	SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany	2025-12-15	PHASE1
NCT05580770	TERMINATED	Advanced Solid Tumor	SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany	2023-02-03	PHASE1; PHASE2
NCT03905148	COMPLETED	Solid Tumor, Adult	BeiGene	2019-05-01	PHASE1
NCT05054374	COMPLETED	Breast Cancer; Breast Cancer Stage IV; HER2-negative Breast Cancer; Solid Carcinoma; MEK1 Gene Mutation; MEK2 Gene Mutation; Metastatic Breast Cancer	Memorial Sloan Kettering Cancer Center	2021-09-14	PHASE1; PHASE2
NCT03962543	ACTIVE_NOT_RECRUITING	Plexiform Neurofibroma; Neurofibromatosis Type 1 (NF1)	SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany	2019-09-29	PHASE2
NCT02510001	COMPLETED	Solid Tumor; Colorectal Cancer	University of Oxford	2014-11	PHASE1
NCT02039336	COMPLETED	Colorectal Cancer	The Netherlands Cancer Institute	2014-04-02	PHASE1; PHASE2
NCT02022982	COMPLETED	KRAS Mutant Non-Small Cell Lung Cancer; Solid Tumors	Dana-Farber Cancer Institute	2014-01	PHASE1
NCT02096471	COMPLETED	Neurofibromatosis Type 1 and Growing or Symptomatic, Inoperable PN	University of Alabama at Birmingham	2014-06	PHASE2
NCT01347866	TERMINATED	Advanced Cancer	Pfizer	2011-10	PHASE1
NCT02510001	Completed	Solid Tumor\|Colorectal Cancer	University of Oxford\|Queen''s University Belfast\|Oxford University Hospitals NHS Trust\|Velindre NHS Trust\|University Hospital Antwerp\|Hospital Vall d''Hebron\|Saint Antoine University Hospital\|European Georges Pompidou Hospital\|Pfizer\|University of Turin Italy\|Belfast Health and Social Care Trust\|Beaumont Hospital\|European Commission\|Array BioPharma\|University of Paris 5 - Rene Descartes	2014-11	Phase 1
NCT02096471	Completed	Neurofibromatosis Type 1 and Growing or Symptomatic Inoperable PN	University of Alabama at Birmingham	2014-06	Phase 2
NCT02022982	Completed	KRAS Mutant Non-Small Cell Lung Cancer\|Solid Tumors	Dana-Farber Cancer Institute	2014-01	Phase 1
NCT01347866	Terminated	Advanced Cancer	Pfizer	2011-10	Phase 1
NCT00174369	TERMINATED	Carcinoma, Non-Small-Cell Lung	Pfizer	2005-11	PHASE2
NCT00147550	TERMINATED	Melanoma; Colonic Neoplasms; Breast Neoplasms	Pfizer	2004-02	PHASE1; PHASE2
NCT00174369	Terminated	Carcinoma Non-Small-Cell Lung	Pfizer	2005-11	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the PD0325901 (Mirdametinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PD0325901 is a selective, non-ATP-competitive inhibitor that binds to activated MEK1 and MEK2, thereby blocking the downstream phosphorylation of ERK1 and ERK2 to potently shut down MAPK pathway signaling and suppress cell proliferation. By inhibiting these hyperactive downstream proliferative signals, the compound prevents tumor growth and pathological cellular proliferation, underlying its therapeutic investigation in clinical conditions such as KRAS-mutant solid tumors, neurofibromatosis type 1, and vascular malformations.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).