Demethoxycurcumin Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Multiple clinical trials are currently evaluating curcuminoid preparations, focusing primarily on ulcerative oral mucositis, formulation safety, and pharmacokinetics. Completed Phase 1 studies sponsored by the University of Hohenheim and the German Federal Ministry of Education and Research evaluated the safety profiles and enhanced bioavailability of novel delivery systems. Furthermore, clinical research led by the Tata Memorial Centre encompasses Phase 2 and Phase 3 trials—currently designated as completed or recruiting—to assess the capacity of these formulations to suppress inflammatory cytokines and reduce oral mucositis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04896164	Recruiting	Oral Mucositis (Ulcerative)	Tata Memorial Centre	2018-12-16	Phase 3
NCT01982734	Completed	Pharmacokinetics of New Curcumin Formulations\|Safety of New Curcumin Formulations	University of Hohenheim\|German Federal Ministry of Education and Research	2012-11	Early Phase 1
NCT01925287	Completed	Pharmacokinetics of Novel Curcumin Formulations\|Safety of Novel Curcumin Formulations	University of Hohenheim\|German Federal Ministry of Education and Research	2011-10	Early Phase 1
NCT04870060	Completed	Oral Mucositis (Ulcerative)	Tata Memorial Centre	2010-10-06	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Demethoxycurcumin suppresses pro-inflammatory signaling cascades by inhibiting nuclear factor kappa B activation and downregulating downstream inflammatory cytokine production. This molecular suppression reduces cellular oxidative stress and localized tissue inflammation, thereby providing a biological rationale for mitigating conditions such as ulcerative oral mucositis.

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>).