Epalrestat Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Multiple clinical trials are evaluating epalrestat across metabolic, neurological, congenital, and oncological indications, such as diabetes, diabetic peripheral neuropathy, Charcot-Marie-Tooth disease, phosphomannomutase 2 deficiency, hepatocellular carcinoma, and triple-negative breast cancer. These Phase II, Phase III, and Phase IV studies are sponsored by academic medical institutions, research institutes, and biopharmaceutical organizations. The trials exhibit varying recruitment statuses, including recruiting, not yet recruiting, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07557914	NOT_YET_RECRUITING	HCC - Hepatocellular Carcinoma; Diabetes	Haibo Shao	2026-06	PHASE2
NCT05777226	UNKNOWN	Charcot-Marie-Tooth Disease (CMT)	The Third Xiangya Hospital of Central South University	2023-04	PHASE2
NCT06201611	RECRUITING	Diabetic Neuropathy Peripheral	St. John's Research Institute	2024-11-15	PHASE2; PHASE3
NCT04925960	TERMINATED	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	PHASE3
NCT05184049	UNKNOWN	Diabetes	Xiangya Hospital of Central South University	2022-01	PHASE4
NCT03244358	TERMINATED	Triple Negative Breast Cancer	Sun Yat-sen University	2017-03-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Epalrestat selectively binds to and inhibits aldose reductase with an IC50 of 72 nM, blocking the polyol pathway's conversion of glucose into sorbitol. This inhibition reduces intracellular sorbitol accumulation, osmotic stress, and downstream tissue toxicity, providing therapeutic benefit in clinical trial conditions such as diabetic peripheral neuropathy and oncology indications.

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>).