epalrestat
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
Earliest trial started Mar 1, 2017 (NCT03244358)
Timeline
2010s
- Jan 1, 2017
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Aldose reductaseINHIBITOR
AKR1B1 inhibitor
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaEpalrestat ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06201611 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2024 | St. John's Research Institute |
| NCT05777226 | Phase 2 | Apr 30, 2023 | Central South University |
| NCT05184049 | Phase 4 | Jan 31, 2022 | Central South University |
| NCT04925960 | Phase 2 | Jan 1, 2022 | Maggie's Pearl, LLC, Mayo Clinic |
| NCT03244358 | Phase 2 | Mar 1, 2017 | Sun Yat-Sen University |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Central South University | Academic/Hospital | 2 | 2 | 2 | 2022 |
| Maggie's Pearl, LLC | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2022 |
| St. John's Research Institute | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Sun Yat-Sen University | Academic/Hospital | 1 | 1 | 1 | 2017 |