Dibenzazepine (YO-01027) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

A clinical trial sponsored by an academic institution, the University of Padova, is evaluating nutrient and microbiota modulation protocols to prevent and manage antibiotic-associated diarrhea. Currently in an unassigned phase and enrolling by invitation, this research focuses on non-invasive preventative strategies to improve gastrointestinal health. Overall, clinical evaluation remains highly specialized, with ongoing efforts centered on targeted therapeutic protocols in patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06982703	ENROLLING_BY_INVITATION	Antibiotic-associated Diarrhea	University of Padova	2024-06-15

(data from https://clinicaltrials.gov, updated on 2025-05-21)

Check the Dibenzazepine (YO-01027) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dibenzazepine (YO-01027) directly binds to the N-terminal Presenilin fragment of the gamma-secretase complex, effectively inhibiting the enzymatic proteolysis of key substrates including APPL and Notch. By blocking downstream Notch signaling, this agent modulates cell fate determination and intestinal epithelial differentiation, offering mechanistic relevance for clinical studies investigating gut health and antibiotic-associated diarrhea.

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>).