Clinical Trials

Several clinical trials involving bisdemethoxycurcumin and related curcuminoid preparations have been completed to evaluate the safety, plasma bioavailability, and pharmacokinetics of novel formulations. Comprising Early Phase 1 studies and unassigned phase pilot protocols, these trials focus on strategies to enhance oral absorption and characterize systemic compound exposure. Academic institutions and research organizations, including the University of Hohenheim, the German Federal Ministry of Education and Research, the University of Jordan, and Nutritional Fundamentals for Health, sponsor these initiatives.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05542394 Completed
Plasma Levels of Different Curcuminoids Preparations
University of Jordan|Nutritional Fundamentals for Health
 2022-09-20 Not Applicable
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

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

Check the Bisdemethoxycurcumin (BDMC) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bisdemethoxycurcumin modulates key pro-inflammatory mediator pathways and downstream signaling enzymes, thereby reducing cellular cytokine production and inhibiting pro-survival signaling cascades. This multi-target suppression leads to attenuated inflammatory responses and decreased tumor cell proliferation, supporting clinical trials aimed at evaluating the pharmacokinetics, plasma bioavailability, and safety profiles of novel curcuminoid formulations.

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>).

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Note: Technical data last updated: Sep 1, 2026.