Levoglucosan Clinical Trials

Size	Price	Qty
5mg	USD 107

Clinical Trials

Multiple clinical trials evaluate this compound across diverse therapeutic areas, including transthyretin amyloid cardiomyopathy, aortic stenosis, familial hypercholesterolemia, chronic myeloid leukemia, oral dysbiosis in prediabetes and type 2 diabetes, and disability-related lifestyle habits. Sponsored by academic institutes, healthcare regions, and university medical centers—such as the Karolinska Institutet and Vanderbilt University Medical Center—these studies range from Phase 2 trials to unclassified protocols. Current operational statuses across these initiatives include both recruiting and not yet recruiting phases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06404632	Recruiting	Life Style\|Health-Related Behavior\|Disabilities Mental\|Disability Physical\|Acceptability of Health Care	Region Stockholm\|Karolinska Institutet\|Promobilia Foundation	2024-04-12	Not Applicable
NCT06372301	Recruiting	Transthyretin Amyloid Cardiomyopathy\|Aortic Stenosis	Steen Hvitfeldt Poulsen\|Aarhus University Hospital Skejby	2024-04-02	Not Applicable
NCT04941599	Recruiting	Familial Hypercholesterolemia	Vanderbilt University Medical Center\|National Heart Lung and Blood Institute (NHLBI)	2024-02-14	Phase 2
NCT06130787	Recruiting	LeukemiaMyeloid Chronic	University Hospital Clermont-Ferrand	2023-11-17	Not Applicable
NCT06040164	Not yet recruiting	PreDiabetes\|Diabetes Mellitus Type 2\|Obesity\|Oral Dysbiosis\|Mouth Disease	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	2023-10-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levoglucosan, an endogenous glucose-derived metabolite, interacts with cellular carbohydrate processing machinery to alter downstream intracellular glycolytic pathways and energy substrate availability. This regulation of glucose metabolite flux shifts cellular metabolic dynamics, offering mechanistic relevance to understanding altered carbohydrate utilization in clinical conditions such as prediabetes and type 2 diabetes.

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>).