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Disease

Pouchitis

Late-stage therapeutic developmentEmerging research
MeSHPouchitis
2
Publications
18
Clinical trials
1
Related conditions
2017
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 4 clinical trials expected to report results, the earliest in Q2 2027.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
Guselkumab Intervention and Diet Evaluation for Pouchitis
Results expected Q2 20282026-05-05
Major clinical milestoneHigh impact
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Primary completion2026-07-01
Clinical Milestones5View
Results expected 4
Recently completed 1
Activity timeline5

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Vedolizumabapproved

Approval — Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderate… (2014)

Clinical trials

12 sponsors · 3 new · 0 completed in the last 12 months (net +3)

The current development programme across all trial phases.

Clinical programme
18
All trials
6
Active
8
Late-stage
6
Completed
Late-stage studies

An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis

Phase 3 · Recruiting · Takeda

Guselkumab Intervention and Diet Evaluation for Pouchitis

Phase 4 · Recruiting · Universitaire Ziekenhuizen KU Leuven

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Phase 4 · Recruiting · University of North Carolina, Chapel Hill

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Phase 4 · Recruiting · University of North Carolina, Chapel Hill

Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Phase 3 · Completed · Odense University Hospital

Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian Open Label Multicenter Pilot-study

Phase 3 · Completed · Universitaire Ziekenhuizen KU Leuven
Recruiting

An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis

Phase 3 · Recruiting · Takeda

Guselkumab Intervention and Diet Evaluation for Pouchitis

Phase 4 · Recruiting · Universitaire Ziekenhuizen KU Leuven

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation

Early Phase 1 · Recruiting · Maia Kayal

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

Phase 4 · Recruiting · University of North Carolina, Chapel Hill

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Phase 4 · Recruiting · University of North Carolina, Chapel Hill

Etrasimod as Primary and Secondary Prevention of Pouchitis (ESPIRIT)

Phase 2 · Recruiting · Maia Kayal
Recently completed

Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian Open Label Multicenter Pilot-study

Phase 3 · Completed · Universitaire Ziekenhuizen KU Leuven

A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis

Phase 2 · Completed · Applied Molecular Transport

A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

Phase 4 · Completed · Takeda

A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects With Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

Phase 3 · Completed · Atlantic Pharmaceuticals Ltd

The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis

Phase 2 · Completed · Virginia O. Shaffer

Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Phase 3 · Completed · Odense University Hospital

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2014emaApproval — Vedolizumab· Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

2 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20162017
Major themes3
  • Health Status1
  • Population Surveillance1
  • Proctocolectomy, Restorative1
Leading journals2
  • Gut1
  • Journal of Crohn's & colitis1
Leading researchers8
  • Adams DH1
  • Ardizzone S1
  • Armuzzi A1
  • Barreiro-de Acosta M1
  • Burisch J1
  • Eliakim R1
  • Fava F1
  • Gecse KB1
Affiliations (unnormalised)6
  • Centre for Liver Research1
  • Chaim Sheba Medical Center1
  • Fondazione Policlinico Universitario Gemelli Universita' Cattolica del Sacro Cuore1
  • Gastrointestinal Unit ASST Fatebenefratelli Sacco-University of Milan-Milan1
  • Imperial College London1
  • Imperial College London; Chelsea and Westminster Hospital1

Related conditions

1 match

Diseases frequently studied alongside this one. Number shows shared papers.

Colitis, Ulcerative2

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Acute INFLAMMATION in the INTESTINAL MUCOSA of the continent ileal reservoir (or pouch) in patients who have undergone ILEOSTOMY and restorative proctocolectomy (PROCTOCOLECTOMY, RESTORATIVE).

Identifiers
MeSHPouchitis
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.