Balofloxacin Clinical Trials

Size	Price	Qty
25mg	USD 107

Clinical Trials

Multiple completed clinical trials sponsored by industry entities, including HALEON and Ipsen, have evaluated this compound across Phase 3 investigations and studies classified as phase not applicable. These trials assessed clinical conditions such as dentin sensitivity and carcinoid syndrome. Completed protocols include real-world observational assessments on oral health-related quality of life associated with anti-sensitivity toothpaste usage, as well as a randomized, double-blind, placebo-controlled trial evaluating Lanreotide Autogel.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06045026	Completed	Dentin Sensitivity	HALEON	2023-09-21	Not Applicable
NCT04964063	Completed	Dentin Sensitivity	HALEON	2021-08-31	Not Applicable
NCT00774930	Completed	Carcinoid Syndrome	Ipsen	2009-05	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Balofloxacin is a quinolone antibiotic that directly binds to and inhibits bacterial DNA gyrase, thereby blocking the topological rearrangement and supercoiling of double-stranded DNA required for replication. This inhibition halts bacterial DNA synthesis and leads to cell death, providing antimicrobial efficacy relevant to bacterial infectious diseases as well as trial conditions such as dentin sensitivity and carcinoid syndrome.

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>).