Kanamycin sulfate Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

Several completed clinical trials across Phases 1, 2, and 3 have evaluated kanamycin sulfate in various therapeutic settings. Research primarily focuses on multidrug-resistant and extensively drug-resistant tuberculosis, HIV co-infections, colorectal neoplasm surgical prophylaxis, and pharmacokinetic studies in healthy participants. These studies were sponsored by academic medical centers, non-profit organizations, and government institutions, including the National Institute of Allergy and Infectious Diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02409290	COMPLETED	MDR-TB	IUATLD, Inc	2016-03	PHASE3
NCT02454205	COMPLETED	Tuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis	University of Cape Town	2015-11-12	PHASE2; PHASE3
NCT00816426	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2008-12-29	PHASE1
NCT02128308	COMPLETED	Healthy	Seoul National University Hospital	2013-11	PHASE1
NCT00508690	COMPLETED	Colorectal Neoplasms	Japan Multinational Trial Organization	2007-09	PHASE3

(data from https://clinicaltrials.gov, updated on 2023-09-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Kanamycin sulfate selectively binds to the 30S subunit of prokaryotic ribosomes, inducing translation misreading and inhibiting translocation during bacterial protein synthesis. This disruption of essential polypeptide elongation causes bacterial cell death, providing therapeutic efficacy in clinical applications such as multidrug-resistant tuberculosis regimens and perioperative infection prophylaxis.

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>).