N-Acetylglucosamine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 490

Clinical Trials

Multiple clinical trials evaluate N-acetylglucosamine from Early Phase 1 through Phase 3 across metabolic, gastrointestinal, and rare genetic conditions, including NGLY1 deficiency, congenital disorders of glycosylation, Crohn's disease, irritable bowel syndrome, and severe acute malnutrition. Sponsored by academic medical centers, clinical research hospitals, and government institutes—such as Johns Hopkins University, Mayo Clinic, Grace Science LLC, and the National Institute of Allergy and Infectious Diseases—these studies encompass actively recruiting, completed, terminated, and not yet recruiting protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07225998	NOT_YET_RECRUITING	Crohns Disease	Johns Hopkins University	2026-06-30	PHASE2
NCT05402345	Not yet recruiting	NGLY1 Deficiency	Eva Morava-Kozicz\|Children''s Hospital of Philadelphia\|Seattle Children''s Hospital\|Icahn School of Medicine at Mount Sinai	2024-05	Phase 2
NCT06199531	Recruiting	NGLY1 Deficiency	Grace Science LLC	2024-02-13	Phase 1\|Phase 2
NCT06268483	COMPLETED	Urinary Tract Infections, Recurrent	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	2022-03-01
NCT03716115	COMPLETED	Severe Acute Malnutrition	Queen Mary University of London	2020-05-04	PHASE2
NCT04706416	COMPLETED	Coronavirus; Covid19	Quantinosis.ai LLC	2020-11-14	PHASE1
NCT04201067	Enrolling by invitation	Congenital Disorders of Glycosylation	Mayo Clinic\|National Institute of Neurological Disorders and Stroke (NINDS)	2019-10-08	--
NCT02196909	COMPLETED	HIBM	Institut de Myologie, France	2014-07
NCT02511041	TERMINATED	PGM3	National Institute of Allergy and Infectious Diseases (NIAID)	2015-06-30	PHASE1
NCT01893606	UNKNOWN	Irritable Bowel Syndrome	Third Military Medical University	2013-04	PHASE2; PHASE3
NCT02504060	UNKNOWN	Irritable Bowel Syndrome	Third Military Medical University	2015-06	PHASE3
NCT01794884	Completed	Rheumatic Heart Disease\|Coronary Heart Disease	Yuejiang Liu\|Southeast University China	2013-01	Phase 2
NCT00720239	COMPLETED	Venous Stasis Ulcers; Venous Insufficiency	Medical University of South Carolina	2008-02	EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

N-Acetylglucosamine serves as a key substrate within the hexosamine biosynthetic pathway, directly driving protein N- and O-glycosylation to modulate cell-surface receptor signaling and glycan branching. This glycan modification suppresses pro-inflammatory mediator release and promotes cellular epithelial barrier integrity, providing a clear mechanistic rationale for its therapeutic evaluation in clinical trials targeting congenital disorders of glycosylation and inflammatory bowel diseases.

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>).