Ofloxacin Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials are currently evaluating the therapeutic applications of this fluoroquinolone antimicrobial agent, primarily focusing on acute ischemic stroke and cataracts. These studies comprise Phase 1 evaluations alongside trials without formal phase classification, sponsored by both commercial entities like PolyActiva Pty Ltd and academic institutions such as The First Hospital of Jilin University. Across these evaluations, recruitment statuses encompass actively recruiting, not yet recruiting, and withdrawn studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05743101	Not yet recruiting	Acute Ischemic Stroke	Yi Yang\|The First Hospital of Jilin University	2024-04-01	Not Applicable
NCT05799326	Recruiting	Acute Ischemic Stroke	Yi Yang\|The First Hospital of Jilin University	2023-06-30	Not Applicable
NCT05741905	Recruiting	Acute Ischemic Stroke	Yi Yang\|The First Hospital of Jilin University	2023-06-01	Not Applicable
NCT05441930	Withdrawn	Cataract	PolyActiva Pty Ltd	2023-06-23	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ofloxacin selectively binds to bacterial DNA gyrase and topoisomerase IV enzymes, blocking DNA strand uncoiling and halting genomic replication. This enzymatic inhibition leads to bacterial cell division arrest and rapid cell death, providing the therapeutic basis for its clinical evaluation in conditions such as cataracts and acute ischemic stroke.

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>).