Summary
Tolrestat has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Neuropathy (Diabetic Peripheral Neuropathy) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Neuropathy (Diabetic Peripheral Neuropathy). No registered clinical trial in this database tests Tolrestat specifically in Peripheral Neuropathy (Diabetic Peripheral Neuropathy). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 1995 to 1996. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Diabetic Neuropathy ranks 186 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive with worsening glycaemic control; reversal essentially not possible with current treatments once established; spontaneous improvement only in cases of rapid glycaemic normalisation early in course.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 30.0 (trials 0.0, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 5 (5 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor; inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | AKR1B1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Tolrestat to Peripheral Neuropathy (Diabetic Peripheral Neuropathy) in the current OSMF trial extract.
Published literature
- Clinical trial publication Frequency of median mononeuropathy in patients with mild diabetic neuropathy in the early diabetes intervention trial (EDIT). Tolrestat Study Group For Edit (Early Diabetes Intervention Trial)Albers JW, Brown MB, Sima AA et al. · Muscle & nerve · 1996 · PMID 8559161
- Clinical trial publication Nerve conduction measures in mild diabetic neuropathy in the Early Diabetes Intervention Trial: the effects of age, sex, type of diabetes, disease duration, and anthropometric factors. Tolrestat Study Group for the Early Diabetes Intervention TrialAlbers JW, Brown MB, Sima AA et al. · Neurology · 1996 · PMID 8559426
- Clinical trial publication [Tolrestat in the therapy of diabetic peripheral neuropathy: is this drug really useful?]Daniele E, Coco MP · La Clinica terapeutica · 1995 · PMID 8681499
- Clinical trial publication Effect of Tolrestat on oesophageal transit time and cholecystic motility in type 2 diabetic patients with asymptomatic diabetic neuropathyFabiani F, De Vincentis N, Staffilano A · Diabete & metabolisme · 1995 · PMID 8586153
- Clinical trial publication Tolrestat in the primary prevention of diabetic neuropathyGiugliano D, Acampora R, Marfella R et al. · Diabetes care · 1995 · PMID 7497865
Mechanism and notes
Recorded mechanism or class: inhibitor; inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AKR1B1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Tolrestat approved for Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
Tolrestat has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Neuropathy (Diabetic Peripheral Neuropathy) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Neuropathy (Diabetic Peripheral Neuropathy). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tolrestat in clinical trials for Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
No registered clinical trial in this database tests Tolrestat specifically in Peripheral Neuropathy (Diabetic Peripheral Neuropathy). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Tolrestat in Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
The record for Tolrestat in Peripheral Neuropathy (Diabetic Peripheral Neuropathy) rests on 5 publications without a registered trial. This is a lead for hypothesis generation, not evidence of efficacy. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AKR1B1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.