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Condition (MeSH)

Colitis, Ulcerative

ClinicalTrials.gov lists 1,785 trials for Colitis, Ulcerative or a narrower condition beneath it. Takeda has the most among industry and government lead sponsors, with 48.

MeSH D003093 Digestive System Diseases C06 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 157 Phase 1/2 Phase 1/2 41 Phase 2 Phase 2 267 Phase 2/3 Phase 2/3 34 Phase 3 Phase 3 188 Phase 4 Phase 4 127 Not applicable Not applicable 414 Observational Observational 553 Phase 1 Phase 1 157 Phase 1/2 Phase 1/2 41 Phase 2 Phase 2 267 Phase 2/3 Phase 2/3 34 Phase 3 Phase 3 188 Phase 4 Phase 4 127 Not applicable Not applicable 414 Observational Observational 553

Trials per phase

1 more section with rows

1,785 of the 1,785 trials are tagged with Colitis, Ulcerative itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Colitis, Ulcerative trials start? (31)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 9 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 136

1995: 1 trials (Observational 1) 1996: 2 trials (Observational 1, Phase 2 1) 1998: 1 trials (Observational 1) 1999: 1 trials (Observational 1) 2000: 4 trials (Observational 2, Not applicable 1, Phase 3 1) 2001: 3 trials (Phase 3 1, Phase 2/3 1, Phase 2 1) 2002: 11 trials (Observational 2, Phase 3 2, Phase 2/3 2, Phase 2 4, Phase 1/2 1) 2003: 19 trials (Observational 5, Not applicable 1, Phase 4 1, Phase 3 6, Phase 2 6) 2004: 15 trials (Observational 2, Not applicable 4, Phase 3 5, Phase 2/3 1, Phase 2 1, Phase 1/2 1, Phase 1 1) 2005: 21 trials (Observational 3, Not applicable 4, Phase 4 3, Phase 3 7, Phase 2 1, Phase 1/2 1, Phase 1 2) 2006: 33 trials (Observational 3, Not applicable 9, Phase 3 12, Phase 2/3 2, Phase 2 5, Phase 1 2) 2007: 38 trials (Observational 9, Not applicable 7, Phase 4 2, Phase 3 8, Phase 2/3 2, Phase 2 8, Phase 1 2) 2008: 37 trials (Observational 5, Not applicable 10, Phase 4 2, Phase 3 9, Phase 2 8, Phase 1/2 2, Phase 1 1) 2009: 40 trials (Observational 17, Not applicable 3, Phase 4 1, Phase 3 8, Phase 2 6, Phase 1/2 2, Phase 1 3) 2010: 37 trials (Observational 13, Not applicable 7, Phase 4 4, Phase 3 1, Phase 2/3 1, Phase 2 4, Phase 1/2 3, Phase 1 4) 2011: 43 trials (Observational 16, Not applicable 4, Phase 4 7, Phase 3 4, Phase 2/3 1, Phase 2 7, Phase 1/2 1, Phase 1 3) 2012: 62 trials (Observational 15, Not applicable 8, Phase 4 4, Phase 3 12, Phase 2 15, Phase 1 8) 2013: 65 trials (Observational 19, Not applicable 13, Phase 4 2, Phase 3 3, Phase 2/3 2, Phase 2 13, Phase 1/2 2, Phase 1 11) 2014: 70 trials (Observational 15, Not applicable 22, Phase 4 7, Phase 3 13, Phase 2 6, Phase 1/2 2, Phase 1 5) 2015: 80 trials (Observational 25, Not applicable 17, Phase 4 9, Phase 3 9, Phase 2/3 2, Phase 2 9, Phase 1/2 3, Phase 1 6) 2016: 91 trials (Observational 27, Not applicable 21, Phase 4 10, Phase 3 9, Phase 2/3 1, Phase 2 12, Phase 1/2 1, Phase 1 10) 2017: 85 trials (Observational 25, Not applicable 26, Phase 4 8, Phase 3 5, Phase 2 12, Phase 1/2 2, Phase 1 7) 2018: 102 trials (Observational 33, Not applicable 21, Phase 4 6, Phase 3 13, Phase 2/3 2, Phase 2 17, Phase 1/2 2, Phase 1 8) 2019: 104 trials (Observational 31, Not applicable 29, Phase 4 7, Phase 3 4, Phase 2/3 5, Phase 2 15, Phase 1/2 2, Phase 1 11) 2020: 87 trials (Observational 31, Not applicable 18, Phase 4 3, Phase 3 7, Phase 2/3 3, Phase 2 14, Phase 1/2 1, Phase 1 10) 2021: 103 trials (Observational 33, Not applicable 21, Phase 4 9, Phase 3 11, Phase 2 16, Phase 1 13) 2022: 109 trials (Observational 46, Not applicable 22, Phase 4 7, Phase 3 5, Phase 2/3 3, Phase 2 15, Phase 1/2 3, Phase 1 8) 2023: 101 trials (Observational 31, Not applicable 30, Phase 4 4, Phase 3 9, Phase 2/3 1, Phase 2 15, Phase 1/2 2, Phase 1 9) 2024: 127 trials (Observational 44, Not applicable 39, Phase 4 8, Phase 3 8, Phase 2/3 2, Phase 2 11, Phase 1/2 4, Phase 1 11) 2025: 136 trials (Observational 50, Not applicable 38, Phase 4 9, Phase 3 11, Phase 2 22, Phase 1/2 1, Phase 1 5)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 138
2025 136
2024 127
2023 101
2022 109
2021 103
2020 87
2019 104
2018 102
2017 85

Showing 10 of 31 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 150 trials starting in 2026 and about 140 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 174 trials still running at the 2026-10-09 snapshot; registered median of 27 months across 1,030 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Colitis, Ulcerative trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 157
Phase 1/2 41
Phase 2 267
Phase 2/3 34
Phase 3 188
Phase 4 127
Not applicable 414
Observational 553
Expanded access 4

How many Colitis, Ulcerative trials are recruiting? (11)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 118
Recruiting 249
Enrolling by invitation 27
Active, not recruiting 86
Available 3

Showing 5 of 11 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Colitis, Ulcerative trials? (11)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Takeda 48
AbbVie 40
Pfizer 37
Janssen Research & Development, LLC 23
Bausch Health Americas, Inc. 18

Showing 5 of 11 sponsors.

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Which drugs are being tested for Colitis, Ulcerative? (4)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
INFLIXIMAB 43
(CP-6890,550) Tofacitinib 16
Etrasimod 16
Ozanimod 14

Interventions as named in the registry (11)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
MMX Mesalamine 55
Vedolizumab IV 54
Fecal Microbiota Transplantation 32
Adalimumab-US 31
SC golimumab 19

Showing 5 of 11 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Colitis, Ulcerative trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Colitis ulcerative 1,534 120
Colitis Ulcerative 740 18
COLITIS ULCERATIVE 445 17
Crohn's disease 390 22
Anaemia 211 74

Showing 5 of 10 adverse events.

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Which publications cover Colitis, Ulcerative? (1,804)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease. Journal of Crohn's & colitis 2026 Yes
Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2026 Yes
Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid. Inflammatory bowel diseases 2026 Yes
A Phase 2 Study of MORF-057, an Oral α4β7 Integrin Inhibitor in Moderately to Severely Active Ulcerative Colitis. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2026 Yes
Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. The lancet. Gastroenterology & hepatology 2026 Yes

Showing 5 of 1,804 publications.

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Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.

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