DPH Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 379

Clinical Trials

A clinical trial evaluates the pharmacogenetic and clinical parameters associated with DPH administration, specifically assessing how CYP2D6-related drug metabolism influences disposition and side effects. Sponsored by academic and clinical investigators, including Matthias Schwab and University Hospital Tuebingen, this Phase 1 study focused on how individual metabolizer phenotypes affect drug tolerance. However, recruitment for the trial was recorded as terminated, leaving early-stage research on this compound constrained.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01289938	Terminated	Drug Metabolism Poor CYP2D6-RELATED	Matthias Schwab\|University Hospital Tuebingen	2009-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

DPH binds to and potently activates the non-receptor tyrosine kinase c-Abl with an EC50 of 794 nM, stimulating downstream enzymatic phosphorylation cascades to modulate intracellular signaling and cellular responses. This molecular activation and associated metabolic clearance pathways provide key insights into potential side effects and therapeutic variability in patients presenting with poor CYP2D6-related drug metabolism.

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>).