Clinical Trials

Several clinical trials are currently evaluating interventions for chronic post-traumatic stress disorder (PTSD) and physical disability, including a Phase 2 trial of massed cognitive processing therapy and a non-phased observational protocol on technology-facilitated play. Led by academic and healthcare institutions such as Unity Health Toronto, Toronto Metropolitan University, the Universities of Ottawa and Manitoba, and the Rehabilitation Centre for Children Canada, these studies share a recruitment status of not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06386003 Not yet recruiting
Post Traumatic Stress Disorder|PTSD|Chronic PTSD
Unity Health Toronto|Toronto Metropolitan University|University of Ottawa
2024-08 Phase 2
NCT06319430 Not yet recruiting
Physical Disability
University of Manitoba|Rehabilitation Centre for Children Canada
2024-06-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Desoxyrhaponticin directly inhibits fatty acid synthase and competitively blocks glucose uptake, thereby disrupting downstream lipid biosynthesis and cellular energy metabolism. This metabolic blockade induces apoptotic cell death in malignant cells, providing a functional rationale for evaluating metabolic pathways in clinical trial conditions including post-traumatic stress disorder and physical disability.

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>).

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