Sorbitol Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials are currently evaluating therapeutic approaches for conditions linked to sorbitol metabolism and neurodegenerative pathways, including Charcot-Marie-Tooth disease, phosphomannomutase 2 deficiency, and hereditary neuropathy caused by SORD deficiency. Representing Phase 2, Phase 3, and combined Phase 2/Phase 3 protocols, these studies are sponsored by academic and industry entities such as The Third Xiangya Hospital of Central South University, Maggie's Pearl LLC, and Applied Therapeutics Inc. Featuring recruitment statuses ranging from active, not recruiting to not yet recruiting, the trials aim to assess safety, pharmacodynamics, and clinical efficacy in affected patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05777226	Not yet recruiting	Charcot-Marie-Tooth Disease (CMT)	The Third Xiangya Hospital of Central South University	2023-04	Phase 2
NCT04925960	Active not recruiting	Pmm2-CDG\|Phosphomannomutase 2 Deficiency\|Phosphomannomutase 2 Congenital Disorder of Glycosylation\|Phosphomannomutase II Congenital Disorder of Glycosylation\|Phosphomannomutase II Deficiency	Maggie''s Pearl LLC	2022-11-10	Phase 3
NCT05397665	Active not recruiting	Hereditary Neuropathy Caused by SORD Deficiency	Applied Therapeutics Inc.	2022-01-01	Phase 2\|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sorbitol serves as an intracellular sugar alcohol substrate within the polyol metabolic pathway, where its accumulation drives hyperosmotic stress, liquid retention, and cellular dysfunction in neural and lens tissues. This osmotic and biochemical stress promotes tissue damage and cellular degeneration, providing direct mechanistic relevance to metabolic peripheral neuropathies including Charcot-Marie-Tooth disease and hereditary neuropathy caused by sorbitol dehydrogenase deficiency.

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>).