Clinical Trials

Several clinical trials evaluate conditions associated with dulcitol, primarily classic galactosemia and dietary biomarker identification for a healthy lifestyle. Industrial sponsor Applied Therapeutics Inc. has conducted a completed Phase 1/Phase 2 trial and an active, non-recruiting Phase 3 trial investigating the safety, pharmacokinetics, and pharmacodynamics of targeted therapies. Additionally, an academic study sponsored by the University of Jena has been completed under a non-applicable phase classification to validate nutritional biomarkers in defined dietary patterns.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05418829 Active not recruiting
Classic Galactosemia
Applied Therapeutics Inc.
 2021-10-01 Phase 3
NCT05067465 Completed
Healthy Lifestyle
University of Jena
 2021-10-14 Not Applicable
NCT04117711 Completed
Classic Galactosemia
Applied Therapeutics Inc.
 2019-06-21 Phase 1|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a polyol metabolite produced via aldose reductase reduction of galactose, dulcitol intracellularly accumulates to generate hyperosmotic stress and disrupt membrane transport biochemistry. This hyperosmotic accumulation induces cell swelling and localized toxicity, providing mechanical relevance to the pathogenesis and clinical management of classic galactosemia.

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>).

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Note: Technical data last updated: Sep 1, 2026.