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Colitis, Ulcerative

40
Pipeline Programs
29
Companies
50
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
9
1
18
0
6
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
12100%
+ 54 programs with unclassified modality

On Market (1)

Approved therapies currently available

Takeda
ENTYVIOApproved
vedolizumab
Takeda
Integrin Receptor Antagonist [EPC]intravenous2023

Competitive Landscape

28 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
5 programs
1
Anti-TNF TherapyN/A1 trial
Inflammatory Bowel Disease in South Eastern NorwayN/A1 trial
ENTYVIO(Vedolizumab)PHASE_3Monoclonal Antibody1 trial
Treatment Algorithm APHASE_41 trial
Vedolizumab 300 mgPHASE_41 trial
Active Trials
NCT03090139Completed1,731Est. Jun 2018
NCT02727959Completed2,286Est. Dec 2019
NCT02497469Completed771Est. Jan 2019
+2 more trials
Pfizer
PfizerNEW YORK, NY
5 programs
1
2
1
InfliximabPhase 4Monoclonal Antibody1 trial
AnrukinzumabPhase 2Monoclonal Antibody1 trial
PF-06480605Phase 21 trial
Single dose-group APhase 11 trial
Tofacitinib Registry of Patients With Ulcerative Colitis in GermanyN/A1 trial
Active Trials
NCT04032756Terminated50Est. Nov 2020
NCT00928681Completed80Est. Oct 2008
NCT01284062Completed84Est. Apr 2013
+2 more trials
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
4 programs
1
1
2
GolimumabPhase 4Monoclonal Antibody
Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kgPhase 4
InfliximabPhase 3Monoclonal Antibody
TulisokibartPhase 1
MSD
MSDIreland - Ballydine
4 programs
1
1
2
GolimumabPhase 4Monoclonal Antibody1 trial
Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kgPhase 41 trial
InfliximabPhase 3Monoclonal Antibody1 trial
TulisokibartPhase 11 trial
Active Trials
NCT06829225Completed48Est. Nov 2024
NCT00984568Terminated28Est. Mar 2012
NCT02318667Completed38Est. Sep 2017
+1 more trials
Dr. Falk Pharma
Dr. Falk PharmaGermany - Freiburg
4 programs
2
2
budesonidePhase 31 trial
mesalamine granulesPhase 31 trial
BudesonidePhase 21 trial
ST-0529Phase 21 trial
Active Trials
NCT02550418Completed60Est. Mar 2017
NCT03844932Terminated235Est. Apr 2021
NCT00747110Completed343Est. Aug 2010
+1 more trials
Kissei Pharmaceutical
Kissei PharmaceuticalJapan - Matsumoto City
2 programs
1
1
AJM300Phase 31 trial
KSP-0243Phase 21 trial
Active Trials
NCT05831670Completed108Est. Oct 2024
NCT03531892Completed198Est. Mar 2023
EA Pharma
EA PharmaJapan - Tokyo
1 program
1
AJM300Phase 3
ViiV Healthcare
ViiV HealthcareNC - Durham
10 programs
5
5
GSK1399686Phase 2
GSK1605786Phase 2
GSK2831781 - Double Blind PhasePhase 2
GSK2982772Phase 2
SB-656933Phase 2
+5 more programs
Prevail Therapeutics
2 programs
2
LY3471851Phase 21 trial
Mirikizumab - IntravenousPhase 21 trial
Active Trials
NCT04677179Terminated81Est. Aug 2022
NCT07483073Not Yet Recruiting60Est. Mar 2028
Otsuka
OtsukaJapan - Tokushima
2 programs
2
OPC-6535Phase 21 trial
rebamipidePhase 21 trial
Active Trials
NCT00317356Terminated43Est. Aug 2007
NCT00463151Completed124Est. Aug 2008
Holy Stone Healthcare
Holy Stone HealthcareTaiwan - Taipei
1 program
1
High dosePhase 21 trial
Active Trials
NCT02493712Completed51Est. Apr 2019
Sandoz
SandozAustria - Kundl
1 program
1
LYS006Phase 21 trial
Active Trials
NCT04074590Terminated23Est. Nov 2022
MRM Health
MRM HealthBelgium - Ghent
1 program
1
Low-dose MH002Phase 21 trial
Active Trials
NCT07296315Recruiting204Est. May 2028
Bayer
BayerLEVERKUSEN, Germany
1 program
1
STW5-IIPhase 21 trial
Active Trials
NCT02246686Terminated3Est. Apr 2016
Sterna Biologicals & KG
Sterna Biologicals & KGGermany - Marburg
1 program
1
SB012Phase 1/21 trial
Active Trials
NCT02129439Completed20Est. Jun 2017
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
Creatine monohydratePhase 11 trial
Active Trials
NCT02463305Withdrawn0Est. Mar 2023
GSK
GSKLONDON, United Kingdom
4 programs
GSK2586184 400mgPHASE_11 trial
SRT2104PHASE_15 trials
GSK1399686PHASE_21 trial
SB-656933PHASE_21 trial
Active Trials
NCT02000453Terminated2Est. Aug 2014
NCT01453491Completed17Est. Mar 2013
NCT01039909Withdrawn0Est. Feb 2011
+5 more trials
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
4 programs
SpesolimabPHASE_2Monoclonal Antibody1 trial
SpesolimabPHASE_2Monoclonal Antibody1 trial
SpesolimabPHASE_2Monoclonal Antibody1 trial
SpesolimabPHASE_2_3Monoclonal Antibody1 trial
Active Trials
NCT03123120Completed22Est. Sep 2020
NCT03648541Completed79Est. May 2023
NCT03100864Completed8Est. Oct 2019
+1 more trials
Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
2 programs
Inflammatory Bowel Disease in South Eastern NorwayN/A
BudesonidePHASE_31 trial
Active Trials
NCT03412682Completed274Est. May 2020
Eisai
EisaiChina - Liaoning
2 programs
GSK3050002PHASE_11 trial
AJM300PHASE_3
Active Trials
NCT01984047Completed49Est. Feb 2015
Merck & Co.
Merck & Co.RAHWAY, NJ
2 programs
TulisokibartPHASE_1
GolimumabPHASE_4Monoclonal Antibody
Galapagos
Galapagos2800 MECHELEN, Belgium
1 program
JAK inhibitor treatmentN/A1 trial
Active Trials
NCT05456412Recruiting60Est. Sep 2026
Bristol Myers Squibb
1 program
GED-0301PHASE_25 trials
Active Trials
NCT02974322Withdrawn0Est. Dec 2018
NCT02641392Terminated310Est. Jan 2018
NCT02601300Completed41Est. Aug 2017
+2 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
LY3471851PHASE_2
Nektar Therapeutics
Nektar TherapeuticsSAN FRANCISCO, CA
1 program
LY3471851PHASE_2
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Trichuris suis ovaPHASE_22 trials
Active Trials
NCT01953354Terminated16Est. Nov 2015
NCT01070498Completed18Est. Dec 2011
Cosmo Pharmaceuticals
Cosmo PharmaceuticalsIreland - Dublin
1 program
BudesonidePHASE_3
Faes Farma
Faes FarmaSpain - Leioa
1 program
MesalazinePHASE_31 trial
Active Trials
NCT06176560Unknown376Est. Aug 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
TakedaTreatment Algorithm A
PfizerInfliximab
MSDGolimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
TakedaVedolizumab 300 mg
MSDGolimumab
Faes FarmaMesalazine
Kissei PharmaceuticalAJM300
Ferring PharmaceuticalsBudesonide
Bristol Myers SquibbGED-0301
Bristol Myers SquibbGED-0301
Bristol Myers SquibbGED-0301
TakedaVedolizumab
MSDInfliximab
Dr. Falk Pharmabudesonide
Dr. Falk Pharmamesalamine granules

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 6,491 patients across 50 trials

NCT04259138TakedaTreatment Algorithm A

Determination of the Optimal Treatment Target in Ulcerative Colitis

Start: Feb 2020Est. completion: Mar 2026672 patients
Phase 4Active Not Recruiting

TITRATE (inducTIon for acuTe ulceRATivE Colitis)

Start: Sep 2019Est. completion: Dec 202450 patients
Phase 4Terminated
NCT03669029MSDGolimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg

Optimization of Golimumab Treatment in Ulcerative Colitis

Start: Oct 2018Est. completion: Dec 201950 patients
Phase 4Unknown
NCT02646657TakedaVedolizumab 300 mg

An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis

Start: Jul 2015Est. completion: Aug 2020120 patients
Phase 4Completed

Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).

Start: Feb 2015Est. completion: Sep 201738 patients
Phase 4Completed

Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.

Start: Mar 2024Est. completion: Aug 2025376 patients
Phase 3Unknown

A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

Start: Jun 2018Est. completion: Mar 2023198 patients
Phase 3Completed

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Start: Mar 2018Est. completion: May 2020274 patients
Phase 3Completed

A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

Start: Dec 2017Est. completion: Dec 20180
Phase 3Withdrawn

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Start: Jul 2016Est. completion: Jan 2018310 patients
Phase 3Terminated

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Start: Dec 2015Est. completion: Jan 2018701 patients
Phase 3Terminated

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Start: Jun 2015Est. completion: Jan 2019771 patients
Phase 3Completed
NCT00984568MSDInfliximab

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Start: Nov 2009Est. completion: Mar 201228 patients
Phase 3Terminated

Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

Start: Oct 2007Est. completion: Aug 2010343 patients
Phase 3Completed
NCT00746447Dr. Falk Pharmamesalamine granules

Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

Start: May 2005Est. completion: Mar 2008648 patients
Phase 3Completed

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Start: Mar 2018Est. completion: May 202098 patients
Phase 2/3Completed
NCT07296315MRM HealthLow-dose MH002

Confirmatory Clinical Study in Active Ulcerative Colitis

Start: Apr 2026Est. completion: May 2028204 patients
Phase 2Recruiting
NCT07483073Prevail TherapeuticsMirikizumab - Intravenous

A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

Start: Apr 2026Est. completion: Mar 202860 patients
Phase 2Not Yet Recruiting

An Early Phase 2 Clinical Study of KSP-0243

Start: Apr 2023Est. completion: Oct 2024108 patients
Phase 2Completed

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Start: Mar 2021Est. completion: Aug 202281 patients
Phase 2Terminated

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis

Start: Feb 2020Est. completion: Nov 202223 patients
Phase 2Terminated

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

Start: Jan 2019Est. completion: Apr 2021235 patients
Phase 2Terminated

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Start: Oct 2018Est. completion: May 202379 patients
Phase 2Completed

A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Start: Jun 2017Est. completion: Sep 202022 patients
Phase 2Completed

This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients

Start: May 2017Est. completion: Oct 20198 patients
Phase 2Completed

Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.

Start: Oct 2016Est. completion: Aug 201850 patients
Phase 2Completed

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M

Start: Jan 2016Est. completion: Apr 201951 patients
Phase 2Completed

An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis

Start: Dec 2015Est. completion: Aug 201741 patients
Phase 2Completed

Budesonide 9 mg Capsules in Active UC

Start: Oct 2015Est. completion: Mar 201760 patients
Phase 2Completed

Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

Start: Nov 2014Est. completion: Apr 20163 patients
Phase 2Terminated

Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Start: Nov 2013Est. completion: Nov 201516 patients
Phase 2Terminated
NCT01284062PfizerAnrukinzumab

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Start: Mar 2011Est. completion: Apr 201384 patients
Phase 2Completed

A Clinical Study to Assess the Safety, Tolerability, and Activity of Oral SRT2104 Capsules Administered for 28 Days to Subjects With Type 2 Diabetes Mellitus

Start: Mar 2010Est. completion: Dec 201086 patients
Phase 2Completed
NCT01036022GSKGSK1399686

Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis

Start: Sep 2009Est. completion: Jan 2013120 patients
Phase 2Completed

Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis

Start: Jan 2009Est. completion: Dec 20093 patients
Phase 2Terminated

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Start: Jun 2007Est. completion: Aug 2008124 patients
Phase 2Completed

A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Start: May 2006Est. completion: Aug 200743 patients
Phase 2Terminated

Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients

Start: Apr 2014Est. completion: Jun 201720 patients
Phase 1/2Completed
NCT06829225MSDTulisokibart

Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)

Start: Jun 2024Est. completion: Nov 202448 patients
Phase 1Completed

Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)

Start: Aug 2022Est. completion: Mar 20230
Phase 1Withdrawn

A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

Start: Apr 2015Est. completion: Dec 201764 patients
Phase 1Completed

Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002

Start: Jan 2014Est. completion: Feb 201549 patients
Phase 1Completed
NCT02000453GSKGSK2586184 400mg

Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

Start: Dec 2013Est. completion: Aug 20142 patients
Phase 1Terminated

A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis

Start: Feb 2012Est. completion: Mar 201317 patients
Phase 1Completed

A Clinical Study to Assess the Effects of SRT2104 Upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers

Start: Jan 2011Est. completion: Feb 20110
Phase 1Withdrawn

Trichuris Suis Ova in Peanut and Tree Nut Allergy

Start: Feb 2010Est. completion: Dec 201118 patients
Phase 1Completed

Effect of SRT2104 on Endotoxin-induced Inflammation

Start: Dec 2009Est. completion: May 201041 patients
Phase 1Completed

A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days

Start: Oct 2009Est. completion: Apr 201024 patients
Phase 1Completed

Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers

Start: Apr 2009Est. completion: Jun 200920 patients
Phase 1Completed

Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers

Start: Mar 2009Est. completion: May 200910 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 6,491 patients
29 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.