Liarozole dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 299
25mg	USD 897

Clinical Trials

A completed, industry-sponsored Phase II/III clinical trial evaluated oral liarozole dihydrochloride for the treatment of lamellar ichthyosis. Sponsored by Stiefel (a GSK company), this randomized, double-blind, placebo-controlled study assessed two dosage regimens to evaluate safety, efficacy, and therapeutic outcomes on skin scaling and hyperkeratosis. Ultimately, this late-stage evaluation provides valuable evidence regarding the utility of cytochrome P450 inhibition in managing rare keratinization disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00282724	COMPLETED	Ichthyosis, Lamellar	Stiefel, a GSK Company	2006-01	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2011-09-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Liarozole dihydrochloride acts as an orally active inhibitor of cytochrome P450 enzymes, specifically targeting CYP26 to block the metabolic degradation of endogenous retinoic acid. By elevating tissue retinoic acid concentrations, it modulates epidermal cell differentiation and suppresses hyperkeratosis, offering therapeutic efficacy in severe dermatological conditions such as lamellar ichthyosis.

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>).