Fleroxacin Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A clinical trial sponsored by industry sponsor Novo Nordisk A/S completed Phase 1 evaluation of the safety, tolerability, and pharmacokinetic properties of single subcutaneous doses in male Japanese and Caucasian cohorts categorized with obesity or overweight. Currently, no Phase 2 or Phase 3 clinical trials are documented in public trial registries.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03787225	Completed	Obesity\|Overweight	Novo Nordisk A/S	2019-01-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fleroxacin is a broad-spectrum fluoroquinolone that selectively targets bacterial DNA gyrase and topoisomerase IV, thereby inhibiting essential DNA replication and transcription machinery. This enzyme inhibition induces double-stranded DNA breakage and halts cellular proliferation, providing an essential pharmacodynamic basis for evaluating compound safety and pharmacokinetics in clinical populations, including cohorts studied for obesity and overweight.

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>).