Demethyleneberberine Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

A Phase 3 comparative clinical trial evaluated the efficacy, safety, immunogenicity, and therapeutic equivalence of this subcutaneously administered compound for dermatological inflammatory indications. Sponsored by commercial pharmaceutical entities Dong-A ST Co. Ltd. and Meiji Seika Pharma Co. Ltd., the completed study targeted patients with moderate to severe chronic plaque psoriasis. This research represents the entire late-stage clinical landscape currently documented for the candidate.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04785326	Completed	Moderate to Severe Chronic Plaque Psoriasis	Dong-A ST Co. Ltd.\|Meiji Seika Pharma Co. Ltd.	2021-04-28	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Demethyleneberberine activates AMP-activated protein kinase signaling while inhibiting nuclear factor kappa B pathway activation, which significantly suppresses the downstream production of pro-inflammatory cytokines including interleukin-6 and tumor necrosis factor-alpha alongside reduced myeloperoxidase activity. By attenuating these key inflammatory signaling cascades and cytokine networks, the compound mitigates systemic and localized inflammatory responses, providing a mechanistically targeted approach for treating moderate to severe chronic plaque psoriasis.

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>).