Clemizole Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by industry entities, including Eiger BioPharmaceuticals, have evaluated the therapeutic potential of clemizole across viral and oncological indications. Specifically, a completed Phase 1b trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral clemizole hydrochloride in hepatitis C patients. In addition, a Phase 2a pilot study with an unknown recruitment status was initiated to evaluate the compound in hepatocellular carcinoma, underscoring clinical development efforts targeting liver diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03069508	Unknown status	Hepatocellular Carcinoma	Eiger Group International Inc.	2017-02-13	Phase 2
NCT00945880	Completed	Hepatitis C	Eiger BioPharmaceuticals	2009-07	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clemizole acts as an antagonist of histamine H1 receptors and an inhibitor of TRPC5 ion channels, blocking intracellular cation influx and downstream biochemical cascades to suppress aberrant cellular activation. By inhibiting these signaling pathways and viral replication processes, the compound provides therapeutic relevance in targeting hepatocellular carcinoma and hepatitis C infection.

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>).