H3B-6527 Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple clinical trials sponsored by H3 Biomedicine Inc. and Eisai Inc. have evaluated the drug candidate H3B-6527 in healthy volunteers and patients with advanced hepatocellular carcinoma or liver neoplasms. These early-stage Phase I studies included open-label evaluations of safety, pharmacokinetics, and pharmacodynamics as well as randomized food-effect protocols. All of the recorded trials have completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02834780	COMPLETED	Advanced Hepatocellular Carcinoma; Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Hepatic Cancer; Hepatic Carcinoma	H3 Biomedicine Inc.	2016-12-28	PHASE1
NCT03424577	COMPLETED	Healthy Participants	Eisai Inc.	2017-12-27	PHASE1
NCT03424577	Completed	Healthy Participants	Eisai Inc.\|H3 Biomedicine Inc.	2017-12-27	Phase 1
NCT02834780	Completed	Advanced Hepatocellular Carcinoma\|Hepatocellular Carcinoma\|Liver Cancer\|Liver Neoplasms\|Hepatic Cancer\|Hepatic Carcinoma	H3 Biomedicine Inc.\|Eisai Inc.	2016-12-28	Phase 1

(data from https://clinicaltrials.gov, updated on 2023-11-13)

Check the H3B-6527 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

H3B-6527 acts as a highly potent and selective covalent inhibitor of fibroblast growth factor receptor 4 (FGFR4), blocking oncogenic receptor activation and suppressing downstream oncogenic signaling cascades. By selectively disrupting FGFR4-mediated signaling in target cells, this targeted inhibition halts cell proliferation and tumor progression, providing therapeutic rationale for its clinical evaluation in advanced hepatocellular carcinoma.

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>).