Pexmetinib Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

Multiple Phase I and Phase II clinical trials have evaluated pexmetinib across various oncological indications, including myelodysplastic syndromes, advanced solid tumors, renal cell carcinoma, melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Sponsored by individual investigators as well as industry entities such as Array Biopharma, a subsidiary of Pfizer, the recruitment status across these studies includes both completed and active, not recruiting trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04074967	ACTIVE_NOT_RECRUITING	Renal Cell Carcinoma; Melanoma; Solid Tumor; Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma	Dan Zandberg	2020-06-11	PHASE1; PHASE2
NCT01496495	COMPLETED	Myelodysplastic Syndromes	Array Biopharma, now a wholly owned subsidiary of Pfizer	2012-01	PHASE1
NCT00916227	COMPLETED	Myelodysplastic Syndromes	Array Biopharma, now a wholly owned subsidiary of Pfizer	2009-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-06)

Check the Pexmetinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pexmetinib selectively binds to and inhibits p38 MAPK and Tie-2 kinases, blocking downstream intracellular phosphorylation cascades involved in inflammatory cytokine production and angiogenic signaling. This dual inhibition suppresses pro-inflammatory signaling and tumor vascularization, ultimately inducing cell apoptosis and limiting disease progression in clinical conditions such as myelodysplastic syndromes and advanced solid tumors.

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>).