D-Fructose Clinical Trials

Size	Price	Qty
25mg	USD 70

Clinical Trials

Multiple clinical trials currently evaluate therapeutic dietary interventions and conditions associated with D-Fructose metabolism, ranging from pediatric obesity and Type 2 Diabetes Mellitus to hereditary fructose intolerance. Encompassing Phase 1 and Phase 2 interventional studies alongside observational evaluations, these active and completed trials are supported by both academic and pharmaceutical sponsors. Specific research focus areas include assessing hepatic complications in obese adolescents and evaluating targeted ketohexokinase inhibition.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06365567	Recruiting	Pediatric Obesity	Azienda Ospedaliero Universitaria Maggiore della Carita\|Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	2024-03-04	--
NCT06089265	Completed	HFI	Maastricht University Medical Center\|Pfizer	2023-06-15	Phase 2
NCT06403241	Completed	Endothelial Dysfunction	Poznan University of Physical Education	2023-05-01	--
NCT05326646	Recruiting	Irritable Bowel Syndrome	University Hospital Rouen	2023-04-19	Not Applicable
NCT05761301	Recruiting	Type 2 Diabetes Mellitus (T2DM)	Alnylam Pharmaceuticals	2023-03-10	Phase 1\|Phase 2
NCT05717595	Recruiting	Insulin Resistance	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	2023-02-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Fructose selectively engages hepatic transporters and undergoes rapid phosphorylation by ketohexokinase, bypassing the major rate-limiting control points of glycolysis to fuel unregulated downstream lipogenesis and gluconeogenesis. This unchecked metabolic influx drives hepatocellular lipid accumulation, oxidative stress, and impaired insulin signaling, directly contributing to the pathogenesis of metabolic disorders such as Type 2 Diabetes Mellitus, insulin resistance, and pediatric obesity evaluated in clinical trials.

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>).