Summary
Pentoxifylline 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 2 registered trials linking Pentoxifylline to Irritable Bowel Syndrome (IBS): 1 is currently recruiting; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01542268). The largest enrolment is 60 participants (NCT04217733). Registration activity spans 2012 to 2019. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2022. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 30.0 (trials 8.0, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 1 recruiting, 0 active / not yet recruiting, 0 completed, 1 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | ADORA2A |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01542268 | Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS) 2012 | status unknown | Phase 4 | 59 |
| NCT04217733 | Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome 2019 | recruiting | Phase 3 | 60 |
Published literature
- Clinical trial publication Pentoxifylline, a nonselective phosphodiesterase inhibitor, in adjunctive therapy in patients with irritable bowel syndrome treated with mebeverineEl-Haggar SM, Hegazy SK, Abd-Elsalam SM et al. · Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022 · PMID 34775240
Mechanism and notes
Recorded mechanism or class: 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 ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Pentoxifylline approved for Irritable Bowel Syndrome (IBS)?
Pentoxifylline 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 Pentoxifylline in clinical trials for Irritable Bowel Syndrome (IBS)?
ClinicalTrials.gov lists 2 registered trials linking Pentoxifylline to Irritable Bowel Syndrome (IBS): 1 is currently recruiting; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01542268). The largest enrolment is 60 participants (NCT04217733). Registration activity spans 2012 to 2019.
What does the evidence show for Pentoxifylline in Irritable Bowel Syndrome (IBS)?
Trials of Pentoxifylline 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 ADORA2A. 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.