Summary
Pregabalin 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 3 registered trials linking Pregabalin to Irritable Bowel Syndrome (IBS): 1 is currently recruiting; 2 have completed. The most advanced is Phase 4 (NCT01331213). The largest enrolment is 258 participants (NCT07635394). Registration activity spans 2010 to 2026. The literature layer holds 8 publications for this pair: 1 Cochrane review, 1 meta-analysis, 1 systematic review and 5 clinical trial publications. Publication years run from 2007 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 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 | 53.0 (trials 11.0, literature 22.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 1 recruiting, 0 active / not yet recruiting, 2 completed, 0 other |
| Linked publications | 8 (5 clinical trial publications, 1 Cochrane review, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01331213 | Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome 2011 | completed | Phase 4 | 18 |
| NCT00977197 | A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome 2010 | completed | Phase 2 | 85 |
| NCT07635394 | Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome 2026 | recruiting | Not applicable | 258 |
Published literature
- Cochrane review Efficacy and safety of interventions for Fibromyalgia syndrome comorbid with Irritable bowel syndrome: systematic reviewElkalla MA, Ali YG, Ewais MM et al. · Clinical rheumatology · 2026 · PMID 41423615
- 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
- Clinical trial publication Randomised clinical trial: pregabalin vs placebo for irritable bowel syndromeSaito YA, Almazar AE, Tilkes KE et al. · Alimentary pharmacology & therapeutics · 2019 · PMID 30663077
- Clinical trial publication Effect of Baseline Characteristics on the Pain Response to Pregabalin in Fibromyalgia Patients with Comorbid DepressionSilverman SL, Backonja M, Pauer L et al. · Pain medicine (Malden, Mass.) · 2018 · PMID 28525632
- Clinical trial publication Pilot trial: pregabalin on colonic sensorimotor functions in irritable bowel syndromeIturrino J, Camilleri M, Busciglio I et al. · Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2014 · PMID 24095618
- 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
- Clinical trial publication Effect of a second-generation alpha2delta ligand (pregabalin) on visceral sensation in hypersensitive patients with irritable bowel syndromeHoughton LA, Fell C, Whorwell PJ et al. · Gut · 2007 · PMID 17446306
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 Pregabalin approved for Irritable Bowel Syndrome (IBS)?
Pregabalin 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 Pregabalin in clinical trials for Irritable Bowel Syndrome (IBS)?
ClinicalTrials.gov lists 3 registered trials linking Pregabalin to Irritable Bowel Syndrome (IBS): 1 is currently recruiting; 2 have completed. The most advanced is Phase 4 (NCT01331213). The largest enrolment is 258 participants (NCT07635394). Registration activity spans 2010 to 2026.
What does the evidence show for Pregabalin in Irritable Bowel Syndrome (IBS)?
Pregabalin has both completed registered trials and synthesis-level publications linked to Irritable Bowel Syndrome (IBS). 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 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.