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Acute inflammation in the intestinal mucosa of the continent ileal reservoir (or pouch) in patients who have undergone ileostomy and restorative proctocolectomy (proctocolectomy, restorative).
Biomarker and diagnostic research for pouchitis has been reported in the published literature.
No approved treatments are currently available for pouchitis. An additional 7 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for pouchitis, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for pouchitis. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: 1-5 in 10,000 (Uncommon).
13 clinical trials registered, 6 recruiting. Interventions under study include drug therapy, other interventions, and medical devices. Pipeline includes 5 PHASE4, 2 PHASE3, 3 PHASE2. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06443502](https://clinicaltrials.gov/study/NCT06443502) |
Data assembled from 5 of 12 sources · Last updated Sep 20, 2026, 8:40 AM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Exclusivity End |
|---|
Designation Status |
|---|
(-)-Epigallocatechin 3-gallate | (-)-Epigallocatechin 3-gallate | PharmassetX LLC | 2024 | — | Designated |
recombinant human interleukin-10 fusion protein | recombinant human interleukin-10 fusion protein | Applied Molecular Transport, Inc. | 2022 | — | Designated |
Rifamycin | Rifamycin | Cosmo Technologies, Ltd. | 2022 | — | Designated |
vedolizumab | vedolizumab | Takeda Development Center Americas, Inc. | 2021 | — | Designated |
EXE-346, a Live Biotherapeutic Product (LBP), contains eight strains of probiotic bacteria. | EXE-346, a Live Biotherapeutic Product (LBP), contains eight strains of probiotic bacteria. | ExeGi Pharma, LLC. | 2020 | — | Designated |
metronidazole | metronidazole | S.L.A. Pharma Limited (UK) | 2011 | — | Designated |
alicaforsen | alicaforsen | Bensen Therapeutics Limited | 2008 | — | Withdrawn |
vedolizumab is referenced in active clinical trials for pouchitis (designated 2021).
Gene therapy approaches for pouchitis have been reported in the published literature.
13 trials found
A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis |
PHASE3 |
Takeda |
RECRUITING |
[NCT06916390](https://clinicaltrials.gov/study/NCT06916390) | GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis | PHASE4 | Universitaire Ziekenhuizen KU Leuven | RECRUITING |
[NCT06864403](https://clinicaltrials.gov/study/NCT06864403) | Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch | PHASE4 | University of North Carolina, Chapel Hill | RECRUITING |
[NCT06312683](https://clinicaltrials.gov/study/NCT06312683) | Rifaximin for the Secondary Prevention of Recurrent Pouchitis | PHASE4 | University of North Carolina, Chapel Hill | RECRUITING |
[NCT05829109](https://clinicaltrials.gov/study/NCT05829109) | Fecal Microbiota Transplant for Patients With Chronic Pouchitis | EARLY_PHASE1 | Maia Kayal | RECRUITING |
172 publications have been identified in PubMed for pouchitis. Kisho has analyzed 131 by research type. Research spans Review / Meta-Analysis (37%), Epidemiology / Natural History (22%), and Clinical Trial Publication (14%).
Research Type | Count | % of Total |
|---|---|---|
Research summaries | 49 | 37% |
Disease patterns and progression | 29 | 22% |
Clinical study results | 18 | 14% |
Other research | 9 | 7% |
Patient case studies | 9 | 7% |
Laboratory research | 7 | 5% |
Testing and diagnosis research | 6 | 5% |
New treatment approaches | 4 | 3% |
Rhodes JM (2026). [PMID: 42027119](https://pubmed.ncbi.nlm.nih.gov/42027119/). *Br J Nutr*. [Review / Meta-Analysis]
Alsakarneh S (2026). [PMID: 41074561](https://pubmed.ncbi.nlm.nih.gov/41074561/). *Aliment Pharmacol Ther*. [Epidemiology / Natural History]
Laforce-van Lierop L (2026). [PMID: 42081060](https://pubmed.ncbi.nlm.nih.gov/42081060/). *Dig Dis Sci*. [Other]
Tanaka T (2026). [PMID: 41499034](https://pubmed.ncbi.nlm.nih.gov/41499034/). *Clin J Gastroenterol*. [Case Report / Case Series]
Desai A (2026). [PMID: 41365321](https://pubmed.ncbi.nlm.nih.gov/41365321/). *Inflamm Bowel Dis*. [Epidemiology / Natural History]
Gisbert JP (2026). [PMID: 41428330](https://pubmed.ncbi.nlm.nih.gov/41428330/). *Inflamm Bowel Dis*. [Review / Meta-Analysis]
To H (2026). [PMID: 41630572](https://pubmed.ncbi.nlm.nih.gov/41630572/). *Pediatr Int*. [Diagnostic / Biomarker]
Bronze S (2026). [PMID: 41884160](https://pubmed.ncbi.nlm.nih.gov/41884160/). *J Inflamm Res*. [Review / Meta-Analysis]
Yanagida T (2026). [PMID: 40300750](https://pubmed.ncbi.nlm.nih.gov/40300750/). *Intest Res*. [Diagnostic / Biomarker]
Sedano R (2026). [PMID: 40675404](https://pubmed.ncbi.nlm.nih.gov/40675404/). *Clin Gastroenterol Hepatol*. [Diagnostic / Biomarker]