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Eabeth (EPALRESTAT)
Epalrestat (Eabeth) is a marketed drug primarily indicated for diabetic neuropathy, with a key composition patent expiring in 2028. Its key strength lies in its specific mechanism of action targeting diabetic neuropathy, a condition with limited therapeutic options. The primary risk is competition from off-patent drugs like valproic acid, which has been available since 1978 and has 14 generics on the market.
At a glance
| Generic name | EPALRESTAT |
|---|---|
| Drug class | epalrestat |
| Target | Aldose reductase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1992 |
Approved indications
- Diabetic neuropathy
Common side effects
Key clinical trials
- Oral Epalrestat Therapy in Pediatric Subjects With PMM2-CDG (PHASE3)
- Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study (NA)
- Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy. (PHASE2,PHASE3)
- Research of SORD-CMT Natural History and Epalrestat Treatment (PHASE2)
- Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patients (PHASE4)
- Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |