Colitis, Ulcerative

27
Pipeline Programs
14
Companies
31
Clinical Trials
1 recruiting
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
7
1
6
10
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
7100%
+ 19 programs with unclassified modality

On Market (6)

Approved therapies currently available

Takeda
ENTYVIOApproved
vedolizumab
Takeda
Integrin Receptor Antagonist [EPC]injection2014
U
PULMICORT FLEXHALERApproved
budesonide
Unknown Company
Corticosteroid [EPC]inhalation2006
U
REMICADEApproved
infliximab
Unknown Company
Tumor Necrosis Factor Blocker [EPC]intravenous1998
U
RHINOCORTApproved
budesonide
Unknown Company
nasal1999
U
RHINOCORT ALLERGYApproved
budesonide
Unknown Company
nasal1999
U
SIMPONIApproved
golimumab
Unknown Company
Tumor Necrosis Factor Blocker [EPC]injection2009

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
5 programs
1
2
Treatment Algorithm APhase 41 trial
Vedolizumab 300 mgPhase 41 trial
ENTYVIO(Vedolizumab)Phase 3Monoclonal Antibody1 trial
Anti-TNF TherapyN/A1 trial
Inflammatory Bowel Disease in South Eastern NorwayN/A
Active Trials
NCT03090139Completed1,731Est. Jun 2018
NCT02497469Completed771Est. Jan 2019
NCT04259138Active Not Recruiting672Est. Mar 2026
+1 more trials
Pfizer
PfizerNEW YORK, NY
3 programs
1
1
InfliximabPhase 4Monoclonal Antibody1 trial
PF-06480605Phase 21 trial
EtrasimodN/A1 trial
Active Trials
NCT06025227Available
NCT02840721Completed50Est. Aug 2018
NCT03937609Terminated50Est. Dec 2024
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
GolimumabPhase 4Monoclonal Antibody1 trial
TulisokibartPhase 13 trials
Active Trials
NCT07405177Not Yet Recruiting330Est. Sep 2026
NCT06575595Completed60Est. Jan 2025
NCT06829225Completed48Est. Nov 2024
+1 more trials
Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
2 programs
1
BudesonidePhase 31 trial
Inflammatory Bowel Disease in South Eastern NorwayN/A1 trial
Active Trials
NCT02727959Completed2,286Est. Dec 2019
NCT03412682Completed274Est. May 2020
E
EisaiChina - Liaoning
2 programs
1
1
AJM300Phase 31 trial
GSK3050002Phase 11 trial
Active Trials
NCT01984047Completed49Est. Feb 2015
NCT03531892Completed198Est. Mar 2023
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
1
BudesonidePhase 3
Cosmo Pharmaceuticals
Cosmo PharmaceuticalsIreland - Dublin
1 program
1
BudesonidePhase 31 trial
Active Trials
NCT01100112CompletedEst. Aug 2010
Faes Farma
Faes FarmaSpain - Leioa
1 program
1
MesalazinePhase 31 trial
Active Trials
NCT06176560Unknown376Est. Aug 2025
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
4 programs
3
1
SpesolimabPhase 2/3Monoclonal Antibody1 trial
SpesolimabPhase 2Monoclonal Antibody1 trial
SpesolimabPhase 2Monoclonal Antibody1 trial
SpesolimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03648541Completed79Est. May 2023
NCT03100864Completed8Est. Oct 2019
NCT03123120Completed22Est. Sep 2020
+1 more trials
Nektar Therapeutics
Nektar TherapeuticsSAN FRANCISCO, CA
1 program
1
LY3471851Phase 2
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
LY3471851Phase 25 trials
Active Trials
NCT05565729Completed41Est. Feb 2023
NCT04998487Completed71Est. Jul 2022
NCT04677179Terminated81Est. Aug 2022
+2 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
Trichuris suis ovaPhase 21 trial
Active Trials
NCT01953354TerminatedEst. Nov 2015
GSK
GSKLONDON, United Kingdom
1 program
1
SRT2104Phase 11 trial
Active Trials
NCT01453491Completed17Est. Mar 2013
Galapagos
Galapagos2800 MECHELEN, Belgium
1 program
JAK inhibitor treatmentN/A1 trial
Active Trials
NCT05456412Recruiting60Est. Sep 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TakedaTreatment Algorithm A
PfizerInfliximab
TakedaVedolizumab 300 mg
Merck & Co.Golimumab
Faes FarmaMesalazine
EisaiAJM300
Ferring PharmaceuticalsBudesonide
TakedaVedolizumab
Cosmo PharmaceuticalsBudesonide
Boehringer IngelheimSpesolimab
Eli Lilly and CompanyLY3471851
Eli Lilly and CompanyLY3471851
Boehringer IngelheimSpesolimab
Boehringer IngelheimSpesolimab
Boehringer IngelheimSpesolimab

Showing 15 of 30 trials with date data

Clinical Trials (31)

Total enrollment: 8,005 patients across 31 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
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

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

(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets

Start: Feb 2010Est. completion: Aug 2010
Phase 3Completed

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

Start: Mar 2018Est. completion: May 202098 patients
Phase 2/3Completed

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

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

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

Start: Aug 2020Est. completion: Feb 2023291 patients
Phase 2Completed

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

Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Start: Nov 2013Est. completion: Nov 2015
Phase 2Terminated

A Study of MK-7240 in Healthy Participants

Start: Mar 2026Est. completion: Sep 2026330 patients
Phase 1Not Yet Recruiting

Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)

Start: Sep 2024Est. completion: Jan 202560 patients
Phase 1Completed

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

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

A Phase I Study of LY3471851 in Healthy Participants

Start: Oct 2022Est. completion: Feb 202341 patients
Phase 1Completed

A Single-Dose Study of LY3471851 in Healthy Participants

Start: Aug 2021Est. completion: Jul 202271 patients
Phase 1Completed

A Study of LY3471851 in Participants With Eczema

Start: Dec 2019Est. completion: Jun 202248 patients
Phase 1Completed

A Study of LY3471851 in Healthy Participants

Start: Oct 2019Est. completion: Mar 202036 patients
Phase 1Completed

A Study of NKTR-358 (LY3471851) in Healthy Participants

Start: Mar 2017Est. completion: Jan 2019100 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

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

Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.

N/AAvailable
NCT05456412GalapagosJAK inhibitor treatment

JAK Inhibition in Ulcerative Colitis

Start: Dec 2022Est. completion: Sep 202660 patients
N/ARecruiting
NCT03090139TakedaAnti-TNF Therapy

Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets

Start: Mar 2017Est. completion: Jun 20181,731 patients
N/ACompleted
NCT02727959Ferring PharmaceuticalsInflammatory Bowel Disease in South Eastern Norway

Inflammatory Bowel Disease in South Eastern Norway

Start: Jan 2017Est. completion: Dec 20192,286 patients
N/ACompleted

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 8,005 patients
14 companies competing in this space