Summary
Gabapentin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Irritable Bowel Syndrome (IBS) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Irritable Bowel Syndrome (IBS). ClinicalTrials.gov lists 1 registered trial linking Gabapentin to Irritable Bowel Syndrome (IBS): 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01678911). It plans or enrolled 11 participants. Registered activity dates to 2012. The literature layer holds 9 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 1 systematic review and 2 clinical trial publications. Publication years run from 2000 to 2025. 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 Irritable Bowel Syndrome ranks 228 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: IBS is chronic and remitting; spontaneous 'remission' (symptom resolution without treatment) in ~30-40% at 2 years but symptom recurrence common; 10-20% develop persistent daily symptoms; <10% achieve permanent remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 52.5 (trials 2.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 1 other |
| Linked publications | 9 (5 Cochrane reviews, 2 clinical trial publications, 1 meta-analysis, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | modulator |
| Data sources | DGIdb |
| Linked via biomarker / target | CACNA1G |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01678911 | Efficacy of Gralise® for Chronic Pelvic Pain 2012 | terminated | Phase 4 | 11 |
Published literature
- Clinical trial publication Clinical Trial: Study to Investigate the Efficacy and Safety of the Alpha-2-Delta Ligand PD-217,014 in Patients With Irritable Bowel SyndromeHoughton LA, Gao S, Gilbert SA et al. · Alimentary pharmacology & therapeutics · 2025 · PMID 39812493
- Meta-analysis Oral and parenteral anti-neuropathic agents for the management of pain and discomfort in irritable bowel syndrome: A systematic review and meta-analysisLambarth A, Zarate-Lopez N, Fayaz A · Neurogastroenterology and motility · 2022 · PMID 34755926
- Cochrane review Antidepressants for chronic non-cancer pain in children and adolescentsCooper TE, Heathcote LC, Clinch J et al. · The Cochrane database of systematic reviews · 2017 · PMID 28779487
- Cochrane review Non-surgical interventions for the management of chronic pelvic painCheong YC, Smotra G, Williams AC · The Cochrane database of systematic reviews · 2014 · PMID 24595586
- Systematic review Metabolic and toxicological considerations for the latest drugs used to treat irritable bowel syndromeMozaffari S, Nikfar S, Abdollahi M · Expert opinion on drug metabolism & toxicology · 2013 · PMID 23330973
- Cochrane review WITHDRAWN. Anticonvulsant drugs for acute and chronic painWiffen PJ, Collins S, McQuay HJ et al. · The Cochrane database of systematic reviews · 2010 · PMID 20091515
- Clinical trial publication Gabapentin reduces rectal mechanosensitivity and increases rectal compliance in patients with diarrhoea-predominant irritable bowel syndromeLee KJ, Kim JH, Cho SW · Alimentary pharmacology & therapeutics · 2005 · PMID 16268973
- Cochrane review Anticonvulsant drugs for acute and chronic painWiffen P, Collins S, McQuay H et al. · The Cochrane database of systematic reviews · 2005 · PMID 16034857
- Cochrane review Anticonvulsant drugs for acute and chronic painWiffen P, Collins S, McQuay H et al. · The Cochrane database of systematic reviews · 2000 · PMID 10908487
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 CACNA1G. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Gabapentin approved for Irritable Bowel Syndrome (IBS)?
Gabapentin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Irritable Bowel Syndrome (IBS) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Irritable Bowel Syndrome (IBS). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Gabapentin in clinical trials for Irritable Bowel Syndrome (IBS)?
ClinicalTrials.gov lists 1 registered trial linking Gabapentin to Irritable Bowel Syndrome (IBS): 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01678911). It plans or enrolled 11 participants. Registered activity dates to 2012.
What does the evidence show for Gabapentin in Irritable Bowel Syndrome (IBS)?
Trials of Gabapentin in Irritable Bowel Syndrome (IBS) are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. 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 CACNA1G. 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.