Clinical Trials

Multiple Phase 1, Phase 2, and non-phased clinical trials evaluate D-galactose across metabolic, renal, and neurological conditions, including congenital disorders of glycosylation, focal segmental glomerulosclerosis, glycogen storage disease, refractory epilepsy, and sleep-induced metabolic disturbances. Conducted by academic institutions such as Tulane University and Children's National Research Institute alongside pharmaceutical sponsors like Orpha Labs, these global investigations encompass recruitment statuses ranging from completed studies to actively recruiting and upcoming trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05402384 NOT_YET_RECRUITING
SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
Eva Morava-Kozicz
 2027-01 PHASE2
NCT06852612 RECRUITING
Glycogen Storage Disease Type I
Insel Gruppe AG, University Hospital Bern
 2025-04-24
NCT05319262 Completed
Noise Exposure|Sleep Disturbance|Sleep Hygiene|Metabolic Disturbance|Cognitive Change
Göteborg University|University of Pennsylvania|University of Manitoba
 2022-04-24 Not Applicable
NCT04833322 UNKNOWN
Refractory Epilepsy; SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
Hospital Ruber Internacional
 2021-01-15
NCT03903861 COMPLETED
Exercise
University of Birmingham
 2019-07-01
NCT03404856 UNKNOWN
Glycogen Storage Disease, Type 14
Orpha Labs
 2017-10-31 PHASE1; PHASE2
NCT02955264 COMPLETED
Congenital Disorders of Glycosylation
Tulane University
 2014-07
NCT01113385 COMPLETED
Focal Segmental Glomerulosclerosis; Steroid Resistant Nephrotic Syndrome
Children's National Research Institute
 2009-10

(data from https://clinicaltrials.gov, updated on 2026-06-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Galactose functions as a fundamental hexose sugar that undergoes enzymatic phosphorylation by galactokinase to enter the Leloir pathway, generating UDP-galactose required for macromolecular glycosylation. By replenishing essential galactosyl precursors and cellular energy stores, it counteracts metabolic deficiencies and provides therapeutic benefit in clinical conditions such as congenital disorders of glycosylation, glycogen storage disease, and nephrotic syndrome.

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.