Novaluron Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial sponsored by the pharmaceutical company Sanofi has completed recruitment for a Phase 3 study investigating Diabetes Mellitus Type 2. The primary objective was to evaluate changes in glycated hemoglobin (HbA1c) among overweight or obese patients whose disease was inadequately controlled on oral antidiabetic agents.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00546325	Completed	Diabetes Mellitus Type 2	Sanofi	2007-10	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Novaluron targets and inhibits insect chitin biosynthesis, blocking epidermal polymer assembly and preventing normal cuticle formation during larval development. This cellular disruption leads to abortive insect molting and relates to clinical investigations evaluating therapeutic management in overweight or obese patients with Diabetes Mellitus Type 2.

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>).