APD597 Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

A clinical trial has evaluated the therapeutic application of APD597 in individuals diagnosed with Type 2 Diabetes Mellitus. This completed Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development L.L.C., utilized a single ascending dose protocol to characterize the compound's safety, tolerability, and pharmacokinetic profile. Overall, early-stage clinical evaluation of APD597 has focused entirely on metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00910923	Completed	Diabetes Mellitus Type 2	Johnson & Johnson Pharmaceutical Research & Development L.L.C.	2008-11	Phase 1

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

Check the APD597 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

APD597 functions as a selective G protein-coupled receptor 119 (GPR119) agonist that stimulates receptor-mediated intracellular cyclic AMP production and downstream signaling cascades in pancreatic beta cells and enteroendocrine cells. This signaling cascade promotes glucose-dependent insulin secretion and gut peptide release, thereby facilitating glycemic control and metabolic homeostasis in Type 2 Diabetes Mellitus.

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>).