Fisogatinib (BLU-554) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple clinical trials across Phase 1 and Phase 1/2 stages have evaluated fisogatinib (BLU-554) for the treatment of hepatocellular carcinoma (HCC). Sponsored by pharmaceutical organizations including Blueprint Medicines Corporation and CStone Pharmaceuticals, these completed investigations assessed the drug's safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy. Together, these clinical efforts highlight the therapeutic exploration of fisogatinib as a targeted agent in liver cancer management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04194801	COMPLETED	Hepatocellular Carcinoma	CStone Pharmaceuticals	2019-12-16	PHASE1; PHASE2
NCT02508467	COMPLETED	Hepatocellular Carcinoma (HCC)	Blueprint Medicines Corporation	2015-07-31	PHASE1
NCT02508467	Completed	Hepatocellular Carcinoma (HCC)	Blueprint Medicines Corporation	2015-07-31	Phase 1

(data from https://clinicaltrials.gov, updated on 2023-02-06)

Check the Fisogatinib (BLU-554) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fisogatinib (BLU-554) selectively binds to and inhibits fibroblast growth factor receptor 4 (FGFR4) with nanomolar potency, thereby disrupting downstream oncogenic signaling pathways and suppressing aberrant cellular proliferation. By targeted blockade of FGFR4 activation, this small molecule impairs tumor growth and cell survival, providing direct mechanistic relevance to the treatment of hepatocellular carcinoma evaluated in clinical trials.

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>).