Enoxacin Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of the broad-spectrum antibacterial agent enoxacin for the treatment of Amyotrophic Lateral Sclerosis. Sponsored by academic and institutional collaborators—including McGill University, the Weizmann Institute of Science, and Apotex Inc.—these completed Phase 1/2 studies assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in human subjects. Consequently, clinical exploration of enoxacin encompasses early-phase evaluations aimed at neurodegenerative indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04840823	COMPLETED	Amyotrophic Lateral Sclerosis	McGill University	2021-03-26	PHASE1; PHASE2
NCT04840823	Completed	Amyotrophic Lateral Sclerosis	McGill University\|Weizmann Institute of Science\|Apotex Inc.	2021-03-26	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-01-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enoxacin selectively binds to bacterial DNA gyrase and topoisomerase IV, blocking essential DNA replication and transcription pathways to compromise bacterial cell survival. This target inhibition accounts for its antimicrobial activity in urinary tract infections and gonorrhea, while its broader biochemical actions underpin clinical trials investigating its application in Amyotrophic Lateral Sclerosis.

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>).