Chitosan oligosaccharide Clinical Trials

Size	Price	Qty
100mg	USD 70

Clinical Trials

Multiple clinical trials are currently recruiting to evaluate targeted interventions across distinct therapeutic areas. Among these, an active Phase 2 trial sponsored by the Spanish Oncology Genito-Urinary Group and Bristol-Myers Squibb is evaluating therapeutic regimens for patients with urothelial cancer. Additionally, a recruiting study sponsored by the University of Coimbra addresses adolescent behavioral and emotional problems under a non-applicable phase design.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06219057	Recruiting	Adolescent Behavior\|Adolescent - Emotional Problem	University of Coimbra	2023-06-01	Not Applicable
NCT05219435	Recruiting	Urothelial Cancer	Spanish Oncology Genito-Urinary Group\|Bristol-Myers Squibb	2022-07-06	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chitosan oligosaccharide suppresses nuclear factor kappa B (NF-κB) and mitogen-activated protein kinase (MAPK) cascades while activating AMP-activated protein kinase (AMPK), thereby downregulating pro-inflammatory gene expression and modulating key cellular metabolic pathways. This coordinated biochemical modulation reduces cellular proliferation and inflammatory responses, providing a mechanistic basis for investigating its therapeutic utility in conditions such as urothelial cancer.

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>).