PLX8394 (Plixorafenib, FORE8394) Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 927

Clinical Trials

Sponsored by Fore Biotherapeutics, several Phase 1 clinical trials evaluated the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of PLX8394 (plixorafenib) in patients with advanced solid tumors and unresectable lesions, including melanoma, thyroid cancer, colorectal cancer, non-small cell lung cancer, cholangiocarcinoma, histiocytosis, and hairy cell leukemia. Participant recruitment for these early-phase trials has officially been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02012231	TERMINATED	Melanoma; Thyroid Cancer; Colorectal Cancer; Non-small Cell Lung Cancer; Cholangiocarcinoma; Histiocytosis; Hairy Cell Leukemia	Fore Biotherapeutics	2014-02	PHASE1
NCT02012231	Terminated	Melanoma\|Thyroid Cancer\|Colorectal Cancer\|Non-small Cell Lung Cancer\|Cholangiocarcinoma\|Histiocytosis\|Hairy Cell Leukemia	Fore Biotherapeutics	2014-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-10-19)

Check the PLX8394 (Plixorafenib, FORE8394) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PLX8394 (Plixorafenib) selectively binds to and inhibits wild-type BRAF, mutant BRAF(V600E), and CRAF with IC50 values of 14 nM, 3.8 nM, and 23 nM, respectively, thereby blocking downstream mitogen-activated protein kinase (MAPK) signaling cascade activation. This potent target inhibition suppresses tumor cell proliferation and drives apoptotic cell death, demonstrating therapeutic potential across BRAF-mutated solid tumors and hematologic malignancies such as melanoma, colorectal cancer, and non-small cell lung cancer.

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>).