Summary
Gabapentin Enacarbil 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). ClinicalTrials.gov lists 8 registered trials linking Gabapentin Enacarbil to Peripheral Neuropathy (Diabetic Peripheral Neuropathy): 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00634543). The largest enrolment is 421 participants (NCT00643760). Registration activity spans 2003 to 2024. No published literature item is linked to Gabapentin Enacarbil and Peripheral Neuropathy (Diabetic Peripheral Neuropathy) in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | 46.0 (trials 26.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | modulator |
| Data sources | DGIdb |
| Linked via biomarker / target | CACNA1C |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00644748 | A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy 2003 | completed | Phase 4 | 95 |
| NCT00634543 | A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy 2006 | completed | Phase 4 | 162 |
| NCT00619983 | Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy 2008 | terminated | Phase 4 | 22 |
| NCT00712439 | Safety and Efficacy of Gabapentin in Diabetic Peripheral Neuropathy 2006 | completed | Phase 2 | 147 |
| NCT00643760 | A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN) 2008 | completed | Phase 2 | 421 |
| NCT03202979 | Trazodone in Painful Diabetic Neuropathy 2017 | completed | Phase 2 | 142 |
| NCT07509671 | The Treatment of Painful Diabetic Neuropathy With Diet 2024 | recruiting | Not applicable | 40 |
| NCT04689958 | The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 2020 | status unknown | PHASE2, PHASE3 | 60 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: modulator.
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 CACNA1C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Gabapentin Enacarbil approved for Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
Gabapentin Enacarbil 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 Gabapentin Enacarbil in clinical trials for Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
ClinicalTrials.gov lists 8 registered trials linking Gabapentin Enacarbil to Peripheral Neuropathy (Diabetic Peripheral Neuropathy): 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00634543). The largest enrolment is 421 participants (NCT00643760). Registration activity spans 2003 to 2024.
What does the evidence show for Gabapentin Enacarbil in Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
Gabapentin Enacarbil has 5 completed registered trials for Peripheral Neuropathy (Diabetic Peripheral Neuropathy) but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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 CACNA1C. 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.