Mibefradil dihydrochloride Clinical Trials

Size	Price	Qty
1mg	USD 197

Clinical Trials

Multiple Phase 1 clinical trials have evaluated Mibefradil dihydrochloride to assess its safety, tolerability, pharmacokinetic profile, and optimal dosing in healthy volunteers and patients with advanced malignancies, including glioblastoma multiforme and other central nervous system tumors. Sponsored by entities such as Cavion, Inc. and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, these protocols also investigated hypofractionated re-irradiation regimens and have all completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02202993	COMPLETED	Glioblastoma Multiforme (GBM)	Cavion, Inc.	2014-08	PHASE1
NCT01480050	COMPLETED	Brain and Central Nervous System Tumors	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2012-05-31	PHASE1
NCT01550458	COMPLETED	Healthy	Cavion, Inc.	2012-02	PHASE1

(data from https://clinicaltrials.gov, updated on 2019-07-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mibefradil dihydrochloride acts as a nondihydropyridine calcium channel antagonist that reversibly inhibits T-type and L-type calcium currents, thereby blocking intracellular calcium influx and downstream biochemical cascades essential for cell proliferation. This inhibition disrupts calcium-dependent cell survival mechanisms, providing the therapeutic rationale for its clinical investigation in suppressing growth in brain and central nervous system tumors such as glioblastoma multiforme.

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>).