Summary
Gabapentin 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 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Peripheral Neuropathy (Diabetic Peripheral Neuropathy): 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status.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. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2011 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 2 systematic reviews) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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
- Cochrane review Efficacy and safety of gabapentinoid combination therapy versus monotherapy for the treatment of neuropathic painLi D, He Y, Fan Z et al. · Frontiers in physiology · 2026 · PMID 42051748
- Cochrane review Gabapentinoids and Neuropathic Pain: Evaluation of the Quality of Randomised Controlled Trials: An Umbrella Reviewde Freminville H, Lucatelli L, Chanelière M et al. · Fundamental & clinical pharmacology · 2026 · PMID 41385395
- Clinical trial publication Topical chamomile oil as a novel therapeutic intervention for diabetic neuropathy: A randomized double-blind controlled clinical trialAmiri M, Imani MH, Imani AH et al. · Explore (New York, N.Y.) · 2025 · PMID 40440968
- Cochrane review Evaluating the efficacy and safety of duloxetine and gabapentin in managing diabetic neuropathy: A systematic review and meta-analysisAttar AA, Halabi MH, Barnawi ET et al. · British journal of pain · 2025 · PMID 40786125
- Clinical trial publication A randomized, double-blind, placebo controlled study to evaluate the effect of alpha-lipoic acid on inhibition of ADP-and collagen-induced platelet aggregation ex vivo in diabetic neuropathy patients on gabapentin or pregabalinPingali U, Sravanasandya P, Mekala P et al. · Journal of postgraduate medicine · 2024 · PMID 39641383
- Clinical trial publication Topical Nigella sativa L. product: a new candidate for the management of diabetic peripheral neuropathyKhodaie SA, Nikkhah H, Namiranian N et al. · Inflammopharmacology · 2024 · PMID 37957516
- Clinical trial publication Effect of topical Zingiber cassumunar on painful diabetic neuropathy: a double-blind randomized-controlled trialJatuten N, Piyakunmala P, Budkaew J et al. · F1000Research · 2023 · PMID 39220605
- Clinical trial publication Management of diabetic neuropathy with memantine: A randomized clinical trialJafarzadeh E, Beheshtirouy S, Aghamohammadzadeh N et al. · Diabetes & vascular disease research · 2023 · PMID 37495223
- Cochrane review Pharmacological Management of Neuropathic Pain after Radiotherapy in Head and Neck Cancer Patients: A Systematic ReviewKouri M, Rekatsina M, Vadalouca A et al. · Journal of clinical medicine · 2022 · PMID 36013118
- Systematic review Evidence-Based Treatment of Painful Diabetic Neuropathy: a Systematic ReviewD'Souza RS, Barman R, Joseph A et al. · Current pain and headache reports · 2022 · PMID 35716275
- Cochrane review Comparison of efficacy and safety of gabapentin and duloxetine in painful diabetic peripheral neuropathy: A systematic review and meta-analysis of randomised controlled trialsKo YC, Lee CH, Wu CS et al. · International journal of clinical practice · 2021 · PMID 34171158
- Systematic review Gabapentin for chronic neuropathic pain in adultsWiffen PJ, Derry S, Bell RF et al. · The Cochrane database of systematic reviews · 2017 · PMID 28597471
- Meta-analysis Gabapentin for chronic neuropathic pain and fibromyalgia in adultsMoore RA, Wiffen PJ, Derry S et al. · The Cochrane database of systematic reviews · 2014 · PMID 24771480
- Meta-analysis Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysisRudroju N, Bansal D, Talakokkula ST et al. · Pain physician · 2013 · PMID 24284851
- Meta-analysis Antiepileptic drugs for neuropathic pain and fibromyalgia - an overview of Cochrane reviewsWiffen PJ, Derry S, Moore RA et al. · The Cochrane database of systematic reviews · 2013 · PMID 24217986
- Meta-analysis Gabapentin for chronic neuropathic pain and fibromyalgia in adultsMoore RA, Wiffen PJ, Derry S et al. · The Cochrane database of systematic reviews · 2011 · PMID 21412914
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 approved for Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
Gabapentin 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 in clinical trials for Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
ClinicalTrials.gov lists 8 registered trials linking Gabapentin 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 in Peripheral Neuropathy (Diabetic Peripheral Neuropathy)?
Gabapentin has both completed registered trials and synthesis-level publications linked to Peripheral Neuropathy (Diabetic Peripheral Neuropathy). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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.