epalrestat

Small moleculeexperimental

Epalrestat is a carboxylic acid derivative and a noncompetitive and reversible aldose reductase inhibitor used for the treatment of diabetic neuropathy, which is one of the most common long-term complications in patients with diabetes mellitus. It reduces the accumulation of intracellular sorbitol which is believed to be the cause of diabetic neuropathy, retinopathy and nephropathy It is well tolerated, with the most commonly reported adverse effects being gastrointestinal issues such as nausea and vomiting, as well as increases in certain liver enzymes. Chemically, epalrestat is unusual in that it is a drug that contains a rhodanine group. Aldose reductase is the key enzyme in the polyol pathway whose enhanced activity is the basis of diabetic neuropathy. Aldose reductase inhibitors (ARI) target this enzyme. Out of the many ARIs developed, ranirestat and fidarestat are in the trial stage. Others have been discarded due to unacceptable adverse effects or weak efficacy. Epalrestat is the only ARI commercially available. It is easily absorbed into the neural tissue and inhibits the enzyme with minimum side effects. — Wikipedia

Clinical trial activity

5 trials · 5 clinical orgs · 0 marketing orgs

Phase 1
0
Phase 2
3
Phase 3
1
Phase 4
1

Earliest trial started Mar 1, 2017 (NCT03244358)

Timeline

2010s

  1. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06201611Phase 2/Phase 3 (Phase 3)Jul 1, 2024St. John's Research Institute
NCT05777226Phase 2Apr 30, 2023Central South University
NCT05184049Phase 4Jan 31, 2022Central South University
NCT04925960Phase 2Jan 1, 2022Maggie's Pearl, LLC, Mayo Clinic
NCT03244358Phase 2Mar 1, 2017Sun Yat-Sen University
Showing 5 of 5 trials
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Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Central South UniversityAcademic/Hospital2222022
Maggie's Pearl, LLCAcademic/Hospital1012022
Mayo ClinicAcademic/Hospital1112022
St. John's Research InstituteAcademic/Hospital1112024
Sun Yat-Sen UniversityAcademic/Hospital1112017
5 organizations
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