Pinocembrin Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

A clinical trial evaluating pinocembrin injection is currently documented, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. This randomized, double-blind, placebo-controlled Phase 2 multicenter study was designed to assess the safety and efficacy of the treatment in patients with acute ischemic stroke, but its recruitment is currently suspended. Consequently, clinical evaluation of pinocembrin remains in an early stage, with no active or completed Phase 3 trials on record.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02059785	SUSPENDED	Ischemic Stroke	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	2013-06	PHASE2

(data from https://clinicaltrials.gov, updated on 2016-06-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a natural flavanone derivative, pinocembrin attenuates neuroinflammatory signaling cascades and suppresses reactive oxygen species generation, thereby preserving mitochondrial integrity and preventing apoptotic cell death in neural tissue. By mitigating ischemia-induced neuronal injury and cerebral microvascular damage, this neuroprotective mechanism provides a clear rationale for evaluating pinocembrin as a potential therapeutic intervention for ischemic stroke.

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>).