Daidzin Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 297

Clinical Trials

The clinical trial landscape for Daidzin currently consists of a clinical trial evaluating its safety and pharmacological profile in healthy volunteers. Sponsored by Parc de Salut Mar, this completed Phase 1 trial investigated human pharmacology and the interaction between this natural aldehyde dehydrogenase inhibitor and alcohol administration. With no active, recruiting, or completed higher-phase trials on record, overall clinical development remains in the early Phase 1 stage focused on safety and preliminary human pharmacology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02309801	COMPLETED	Healthy	Parc de Salut Mar	2012-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2014-12-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daidzin selectively binds to human mitochondrial aldehyde dehydrogenase with high affinity, suppressing the enzymatic oxidation of acetaldehyde and disrupting cellular alcohol metabolic cascades. This targeted inhibition prevents the metabolism of reactive aldehyde intermediates, providing the biological rationale for evaluating its pharmacological interaction with alcohol in healthy volunteer clinical assessments.

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>).