Ulcerative Colitis

Immunology
122
Pipeline Programs
30
Companies
50
Clinical Trials
5 recruiting
7
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
21
1
42
2
38
18
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2279%
Small Molecule
414%
RNA Therapeutic
27%
+ 105 programs with unclassified modality

On Market (7)

Approved therapies currently available

U
ASACOLApproved
mesalamine
Unknown Company
oral1992
U
AZASANApproved
azathioprine
Unknown Company
Purine Antimetabolite [EPC]oral1999
U
AZATHIOPRINEApproved
azathioprine
Unknown Company
Purine Antimetabolite [EPC]oral1999
AbbVie
HUMIRAApproved
adalimumab
AbbVie
2002
U
MESALAMINEApproved
mesalamine
Unknown Company
Aminosalicylate [EPC]oral2024
Astellas
PROGRAFApproved
tacrolimus
Astellas
oral1994
U
SIMPONIApproved
golimumab
Unknown Company
Tumor Necrosis Factor Blocker [EPC]injection2009

Competitive Landscape

49 companies ranked by most advanced pipeline stage

Ferring Pharmaceuticals
1
5
2
5-ASAPhase 41 trial
Observe patients with inactive ulcerative colitisPhase 41 trial
MesalaminePhase 31 trial
MesalaminePhase 31 trial
Mesalazine EnemaPhase 31 trial
+9 more programs
Active Trials
NCT01517607Completed506Est. Dec 2013
NCT04499495Completed11,385Est. Jul 2022
NCT01517594Completed568Est. Jun 2013
+11 more trials
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
10 programs
1
1
6
2
High dose budesonide rectal foamPhase 41 trial
Low Dose BudesonidePhase 41 trial
5 ASA, enemas, suppositories, corticosteroidsPhase 31 trial
Budesonide MMX 6 mg TabletPhase 31 trial
Budesonide MMX®Phase 31 trial
+5 more programs
Active Trials
NCT03327558CompletedEst. Aug 2017
NCT04857112CompletedEst. Nov 2024
NCT00269438CompletedEst. Jun 2007
+7 more trials
GS
Gilead SciencesFOSTER CITY, CA
9 programs
3
3
1
1
1
Filgotinib MaleatePhase 41 trial
FilgotinibPhase 3Small Molecule1 trial
AndecaliximabPhase 2/3Monoclonal Antibody1 trial
GS-1427Phase 21 trial
TilpisertibPhase 2Small Molecule1 trial
+4 more programs
Active Trials
NCT01831427Completed74Est. Feb 2015
NCT02209987Completed28Est. Oct 2014
NCT06290934Active Not Recruiting228Est. Apr 2028
+5 more trials
Takeda
TakedaTOKYO, Japan
8 programs
1
1
4
2
MMX MesalaminePhase 41 trial
MMX mesalamine/ mesalazinePhase 41 trial
OntamalimabPhase 3Monoclonal Antibody2 trials
OntamalimabPhase 3Monoclonal Antibody1 trial
SPD476Phase 33 trials
+3 more programs
Active Trials
NCT02093663Completed107Est. Nov 2018
NCT01130844Completed52Est. Jun 2013
NCT01771809Completed330Est. Dec 2017
+9 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
6 programs
2
2
1
RisankizumabPhase 3Monoclonal Antibody1 trial
adalimumabPhase 3Monoclonal Antibody
ABBV-668Phase 22 trials
LutikizumabPhase 2Monoclonal Antibody1 trial
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative ColitisN/A1 trial
+1 more programs
Active Trials
NCT02506179Completed100Est. Feb 2020
NCT01947816Completed1,621Est. Feb 2018
NCT06477926Completed25Est. Sep 2024
+3 more trials
M&
5 programs
1
2
GolimumabPhase 4Monoclonal Antibody1 trial
Prefilled Syringe delivery of GolimumabPhase 4Monoclonal Antibody1 trial
MK-6194Phase 11 trial
Exposure to golimumabN/AMonoclonal Antibody1 trial
Golimumab trough levelsN/A1 trial
Active Trials
NCT05405465Completed103Est. Jun 2021
NCT03773445Completed52Est. Sep 2021
NCT04924114Completed57Est. Jul 2024
+2 more trials
Celltrion
2 programs
1
1
AzathioprinePhase 41 trial
CT-P13 SCPhase 31 trial
Active Trials
NCT04205643Completed548Est. Jul 2023
NCT02579733TerminatedEst. Dec 2018
Astellas
2 programs
2
1
TacrolimusPhase 31 trial
tacrolimusPhase 31 trial
Active Trials
NCT00643071Completed32Est. May 2008
NCT00347048Completed62Est. Apr 2008
E
2 programs
1
1
Filgotinib MaleatePhase 4
adalimumabPhase 3Monoclonal Antibody
Abbott
AbbottABBOTT PARK, IL
6 programs
1
5
AdalimumabPhase 3Monoclonal Antibody1 trial
adalimumabPhase 3Monoclonal Antibody1 trial
adalimumabPhase 3Monoclonal Antibody1 trial
adalimumabPhase 3Monoclonal Antibody1 trial
adalimumabPhase 3Monoclonal Antibody1 trial
+1 more programs
Active Trials
NCT00307827Terminated38Est. Nov 2007
NCT01550965Completed463Est. Apr 2015
NCT00385736Completed576Est. Mar 2010
+3 more trials
Pfizer
PfizerNEW YORK, NY
5 programs
1
1
1
CP-690,550Phase 31 trial
EtrasimodPhase 25 trials
rhIL-11Phase 11 trial
Non-Interventional StudyN/A1 trial
Xeljanz Special Investigation for Long-term Use in UC PatientsN/A1 trial
Active Trials
NCT07177209Not Yet Recruiting4,000Est. May 2026
NCT03643211Completed2,016Est. Nov 2022
NCT00038922Terminated
+6 more trials
Galapagos
Galapagos2800 MECHELEN, Belgium
5 programs
3
2
FilgotinibPhase 3Small Molecule1 trial
FilgotinibPhase 3Small Molecule
GLPG0974Phase 21 trial
GLPG1205Phase 21 trial
GLPG3970Phase 21 trial
Active Trials
NCT01829321Completed45Est. Apr 2014
NCT02337608Completed64Est. Nov 2015
NCT04577794Completed31Est. May 2021
+1 more trials
Tillotts Pharma
4 programs
3
1
MesalaminPhase 31 trial
TP05Phase 11 trial
TP05 Coating APhase 11 trial
TP05 Coating DPhase 11 trial
Active Trials
NCT02306798CompletedEst. Dec 2013
NCT02306772CompletedEst. Mar 2012
NCT02306785CompletedEst. Jun 2013
+1 more trials
H
3 programs
1
2
HMPL-004Phase 31 trial
HMPL-004 1800 mg/dayPhase 31 trial
HMPL-004 low dosePhase 21 trial
Active Trials
NCT00659802Completed224Est. Oct 2009
NCT01882764Terminated66Est. Oct 2014
NCT01805791Terminated201Est. Oct 2014
Roche
RocheSTAVANGER NORWAY, Norway
2 programs
2
AdalimumabPhase 3Monoclonal Antibody1 trial
EtrolizumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT02171429Completed358Est. May 2020
NCT02118584Terminated1,822Est. Oct 2023
Teva
TevaIsrael - Petach Tikva
2 programs
2
DuvakitugPhase 31 trial
DuvakitugPhase 31 trial
Active Trials
NCT07184996Recruiting980Est. May 2028
NCT07185009Recruiting671Est. Apr 2033
Alvotech
1 program
1
AVT16Phase 31 trial
Active Trials
NCT06570772Terminated301Est. Nov 2025
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
4 programs
2
1
retarded release phosphatidylcholinePhase 2/31 trial
Retarded Release PhosphatidylcholinePhase 21 trial
retarded release phosphatidylcholinePhase 21 trial
Retarded release phosphatidylcholineN/A1 trial
Active Trials
NCT00463619Completed132Est. Apr 2010
NCT00259545Completed60Est. Feb 2006
NCT00259558Completed60Est. Mar 2006
+1 more trials
Bristol Myers Squibb
2
1
sterile saline for injectionPhase 21 trial
BMS-986166Phase 14 trials
MDX-1100Phase 11 trial
OzanimodN/A5 trials
Active Trials
NCT07271069Recruiting150Est. Dec 2027
NCT05953402Not Yet Recruiting1,182Est. Jun 2033
NCT06126835Active Not Recruiting2,828Est. Jun 2032
+8 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
MirikizumabPhase 2Monoclonal Antibody1 trial
Mirikizumab Real World ProtocolN/A1 trial
Active Trials
NCT06696014Recruiting100Est. Jan 2030
NCT04004611Completed26Est. Mar 2023
Gossamer Bio
Gossamer BioCA - San Diego
2 programs
1
1
GB004Phase 21 trial
GB004Phase 11 trial
Active Trials
NCT03860896Completed34Est. Dec 2019
NCT04556383TerminatedEst. Jun 2022
AM-Pharma
AM-PharmaNetherlands - Utrecht
2 programs
1
1
bovine intestinal alkaline phosphatasePhase 21 trial
HM201Phase 11 trial
Active Trials
NCT05088369CompletedEst. Dec 2022
NCT00727324CompletedEst. Dec 2006
Seres Therapeutics
Seres TherapeuticsCAMBRIDGE, MA
2 programs
1
1
Vancomycin Pre-TreatmentPhase 21 trial
SER-287Phase 11 trial
Active Trials
NCT02618187CompletedEst. Jan 2018
NCT03759041TerminatedEst. Oct 2021
A
AltruBioCA - San Francisco
2 programs
2
ALTB-168Phase 21 trial
ALTB-268Phase 21 trial
Active Trials
NCT03298022TerminatedEst. Jun 2020
NCT06109441Active Not RecruitingEst. Mar 2027
Ionis Pharmaceuticals
2 programs
2
AlicaforsenPhase 2RNA Therapeutic1 trial
AlicaforsenPhase 2RNA Therapeutic1 trial
Active Trials
NCT00063414CompletedEst. Mar 2005
NCT00063830CompletedEst. Oct 2004
Genentech
2 programs
2
RO7837195Phase 21 trial
UTTR1147APhase 21 trial
Active Trials
NCT06979336Recruiting224Est. Oct 2028
NCT03650413Terminated143Est. Jul 2022
Cosmo Pharmaceuticals
Cosmo PharmaceuticalsIreland - Dublin
2 programs
2
SigmoidoscopyPhase 21 trial
oral delivery mucosal stainPhase 21 trial
Active Trials
NCT00867438CompletedEst. Nov 2007
NCT01520324CompletedEst. Jul 2012
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
BI 3032950 intravenousPhase 21 trial
Active Trials
NCT06636656Active Not Recruiting45Est. Feb 2028
BioLineRx
1 program
1
BL-7040Phase 21 trial
Active Trials
NCT01506362CompletedEst. May 2013
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
Brazikumab Maintenance DosePhase 21 trial
Active Trials
NCT04277546Terminated57Est. Oct 2023

+19 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Bausch HealthHigh dose budesonide rectal foam
Gilead SciencesFilgotinib Maleate
Bristol Myers SquibbOzanimod
Bristol Myers SquibbOzanimod
Bausch HealthLow Dose Budesonide
Ferring Pharmaceuticals5-ASA
Bristol Myers SquibbOzanimod
Merck & Co.Golimumab
CelltrionAzathioprine
Merck & Co.Prefilled Syringe delivery of Golimumab
TakedaMMX mesalamine/ mesalazine
TakedaMMX Mesalamine
Ferring PharmaceuticalsObserve patients with inactive ulcerative colitis
TevaDuvakitug
TevaDuvakitug

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 15,103 patients across 50 trials

NCT05976802Bausch HealthHigh dose budesonide rectal foam

Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Start: Jun 2027Est. completion: Jan 2030
Phase 4Not Yet Recruiting
NCT06964113Gilead SciencesFilgotinib Maleate

A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

Start: Jun 2025Est. completion: Nov 202794 patients
Phase 4Recruiting

Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study

Start: Aug 2024Est. completion: Mar 20270
Phase 4Withdrawn

A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis

Start: May 2024Est. completion: Mar 202984 patients
Phase 4Active Not Recruiting
NCT04314375Bausch HealthLow Dose Budesonide

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Start: Sep 2023Est. completion: Jun 2027
Phase 4Recruiting

ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

Start: Jan 2023Est. completion: Feb 2024200 patients
Phase 4Completed

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

Start: Dec 2022Est. completion: Apr 2025139 patients
Phase 4Terminated

Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

Start: Sep 2017Est. completion: Sep 2019112 patients
Phase 4Completed

Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

Start: Feb 2016Est. completion: Dec 2018
Phase 4Terminated
NCT02155335Merck & Co.Prefilled Syringe delivery of Golimumab

Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)

Start: Jul 2014Est. completion: Oct 2015100 patients
Phase 4Completed
NCT01124149TakedaMMX mesalamine/ mesalazine

Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

Start: Jun 2010Est. completion: Dec 2012759 patients
Phase 4Completed
NCT00446849TakedaMMX Mesalamine

Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)

Start: May 2007Est. completion: Aug 2009290 patients
Phase 4Completed
NCT00209287Ferring PharmaceuticalsObserve patients with inactive ulcerative colitis

Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis

Start: Jun 2005Est. completion: Sep 20076 patients
Phase 4Terminated

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Start: Jan 2026Est. completion: Apr 2033671 patients
Phase 3Recruiting

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Start: Oct 2025Est. completion: May 2028980 patients
Phase 3Recruiting
NCT07071519AbbVieRisankizumab

A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

Start: Jul 2025Est. completion: Jul 2034120 patients
Phase 3Recruiting

Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

Start: Sep 2024Est. completion: Nov 2025301 patients
Phase 3Terminated

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

Start: Jul 2022Est. completion: Oct 202322 patients
Phase 3Terminated

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)

Start: Sep 2020Est. completion: Jul 2023548 patients
Phase 3Completed

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

Start: Apr 2018Est. completion: Jul 2021366 patients
Phase 3Completed

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Start: Feb 2018Est. completion: Dec 2023557 patients
Phase 3Completed

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

Start: Feb 2018Est. completion: Oct 2020380 patients
Phase 3Terminated

Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC

Start: May 2017Est. completion: Jan 20194 patients
Phase 3Terminated

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

Start: Feb 2017Est. completion: Sep 20261,173 patients
Phase 3Active Not Recruiting

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Start: Feb 2016Est. completion: Sep 2018276 patients
Phase 3Completed

Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Start: Oct 2015Est. completion: Apr 2018228 patients
Phase 3Completed

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

Start: Mar 2015Est. completion: Jul 2017281 patients
Phase 3Completed
NCT02093663TakedaMMX Mesalamine

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

Start: Dec 2014Est. completion: Nov 2018107 patients
Phase 3Completed

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

Start: Nov 2014Est. completion: May 2020358 patients
Phase 3Completed
NCT02118584RocheEtrolizumab

Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

Start: Sep 2014Est. completion: Oct 20231,822 patients
Phase 3Terminated

HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis

Start: Jun 2013Est. completion: Oct 201466 patients
Phase 3Terminated
NCT01805791HutchmedHMPL-004 1800 mg/day

A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

Start: Mar 2013Est. completion: Oct 2014201 patients
Phase 3Terminated

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

Start: Oct 2012Est. completion: Aug 2020944 patients
Phase 3Completed

A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting

Start: May 2012Est. completion: Apr 2015463 patients
Phase 3Completed
NCT01532648Bausch HealthBudesonide MMX®

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Start: Jan 2012Est. completion: Oct 2013
Phase 3Completed

Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

Start: Nov 2009Est. completion: Aug 2011
Phase 3Completed

A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Start: Feb 2009Est. completion: Aug 2013274 patients
Phase 3Completed
NCT00801723Bausch HealthBudesonide MMX 6 mg Tablet

(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

Start: Dec 2008Est. completion: Jun 2011
Phase 3Completed
NCT00737789Ferring PharmaceuticalsMesalazine slow-release granules

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.

Start: Nov 2008Est. completion: Jun 2010206 patients
Phase 3Completed

Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

Start: Nov 2007Est. completion: Dec 2016592 patients
Phase 3Completed

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

Start: Nov 2006Est. completion: Mar 2010576 patients
Phase 3Completed

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Start: Nov 2006Est. completion: Mar 2010518 patients
Phase 3Completed

Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Start: Sep 2006Est. completion: May 200832 patients
Phase 3Completed

Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Start: Sep 2006Est. completion: Apr 200862 patients
Phase 3Completed
NCT00326209Bausch HealthEncapsulated Mesalamine Granules

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

Start: Dec 2005Est. completion: May 2008
Phase 3Completed
NCT00269438Bausch Health5 ASA, enemas, suppositories, corticosteroids

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

Start: Dec 2005Est. completion: Jun 2007
Phase 3Completed

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Start: May 2005Est. completion: Jun 2007362 patients
Phase 3Completed

Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Start: Apr 2005Est. completion: Sep 2009829 patients
Phase 3Completed
NCT00767728Bausch HealthGranulated mesalamine

Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

Start: Dec 2004Est. completion: Oct 2007
Phase 3Completed
NCT00744016Bausch HealthGranulated mesalamine

Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis

Start: Dec 2004Est. completion: Oct 2007
Phase 3Completed

Related Jobs in Immunology

Phase Legend

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

Key Insights

38 late-stage (Phase 3) programs — potential near-term approvals
5 actively recruiting trials targeting 15,103 patients
30 companies competing in this space