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Ulcerative Colitis

Immunology 8 original drugs

Novel Drugs

Reformulations

Drug Targets

Immunology indication. Ulcerative Colitis has 8 FDA-approved novel treatments, led by Johnson & Johnson, with 147 active industry clinical trials across 15 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Ulcerative Colitis Market Leaders

Companies with the most FDA-approved novel Ulcerative Colitis drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q3 2026

IV Tulisokibart

Merck

Estimated · fresh NCT06052059

Q3 2026

Filgotinib

Alfasigma S.p.A.

Estimated · stale NCT02914535

Q1 2027

Afimkibart

Roche

Estimated · fresh NCT06588855

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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Ulcerative Colitis Treatments by Mechanism

Top 11 mechanisms across 30 industry trials with a known mechanism of action.

See full pipeline →

Integrin Receptor Antagonist

7 trials 2 active 2 sponsors

Janus Kinase Inhibitor

3 trials 1 active 1 sponsor

Interleukin-23 Antagonist

1 trials 1 active 1 sponsor

TNF

7 trials 3 sponsors

Aminosalicylate

5 trials 4 sponsors

Tumor Necrosis Factor Blocker

2 trials 2 sponsors

Tyrosine Kinase 2 Inhibitor

1 trials 1 sponsor

Phosphodiesterase 4 Inhibitor

1 trials 1 sponsor

Tryptophan Hydroxylase

1 trials 1 sponsor

Interleukin-13 Antagonist

1 trials 1 sponsor

Kinase Inhibitor

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Ulcerative Colitis Clinical Pipeline by Phase

320 industry-sponsored trials across 137 sponsors

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Showing 13 of 13 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Bausch Health Americas, Inc.	Low Dose Budesonide	—	RECRUITING	2026-12	NCT04314375
Takeda	Vedolizumab	Integrin Receptor Antagonist [EPC]	RECRUITING	2027-07-09	NCT06095128
Takeda	Vedolizumab IV	—	RECRUITING	2027-10-01	NCT06581328
Eisai Korea Inc.	Filgotinib Maleate	—	RECRUITING	2027-11-30	NCT06964113
Bausch Health Americas, Inc.	High dose budesonide rectal foam	—	NOT YET RECRUITING	2029-06	NCT05976802
Rubix LS	Mirikizumab	—	NOT YET RECRUITING	2026-01-01	NCT07059130
Takeda	Vedolizumab IV	—	COMPLETED	2024-02-02	NCT04804540
Merck	Golimumab	Tumor Necrosis Factor Blocker [EPC]	COMPLETED	2016-05-25	NCT02092285
Merck	Prefilled Syringe delivery of Golimumab	—	COMPLETED	2015-10-05	NCT02155335
Otsuka Pharmaceutical Europe Ltd	—	—	COMPLETED	2015-05	NCT01481142
Takeda	MMX mesalamine/ mesalazine	—	COMPLETED	2012-12-07	NCT01124149
Pfizer	CP-690,500 5 mg	—	TERMINATED	2020-02-14	NCT03281304
Asahi Kasei Medical Co., Ltd.	—	—	TERMINATED	2012-01	NCT00947674

Showing 100 of 102 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Roche	Afimkibart	—	RECRUITING	2027-01-30	NCT06588855
Takeda	Vedolizumab IV	—	RECRUITING	2027-11-15	NCT06100289
Eli Lilly	Mirikizumab	—	RECRUITING	2028-04	NCT06937086
Sanofi	Duvakitug	—	RECRUITING	2028-05-09	NCT07184996
Alfasigma S.p.A.	Filgotinib	—	RECRUITING	2028-06	NCT06865417
Sanofi	Duvakitug	—	RECRUITING	2028-09-21	NCT07185009
Roche	Afimkibart	—	RECRUITING	2030-03-31	NCT07158242
Takeda	Vedolizumab SC	—	RECRUITING	2030-08-12	NCT06405087
Eli Lilly	Mirikizumab	—	RECRUITING	2030-12	NCT04844606
Takeda	Vedolizumab IV	—	RECRUITING	2033-02-07	NCT05442567
AbbVie	Risankizumab	—	RECRUITING	2034-07	NCT07071519
Merck	IV Tulisokibart	—	ACTIVE NOT RECRUITING	2026-08-01	NCT06052059
Alfasigma S.p.A.	Filgotinib	—	ACTIVE NOT RECRUITING	2026-09	NCT02914535
Roche	Afimkibart	—	ACTIVE NOT RECRUITING	2027-01-30	NCT06589986
Pfizer	tofacitinib	—	ACTIVE NOT RECRUITING	2027-04-14	NCT04624230
AbbVie	Upadacitinib (ABT-494)	—	ACTIVE NOT RECRUITING	2027-07	NCT03006068
AbbVie	Risankizumab	—	ACTIVE NOT RECRUITING	2027-08	NCT06880744
Takeda	Vedolizumab IV	—	ACTIVE NOT RECRUITING	2027-09-24	NCT03221036
AbbVie	Upadacitinib	Janus Kinase Inhibitor [EPC]	ACTIVE NOT RECRUITING	2028-08	NCT05782907
AbbVie	risankizumab	—	ACTIVE NOT RECRUITING	2028-09	NCT03398135
Pfizer	Etrasimod	—	ACTIVE NOT RECRUITING	2029-06-19	NCT03950232
Abivax S.A.	ABX464	—	ACTIVE NOT RECRUITING	2026-04	NCT05535946
Eli Lilly	Mirikizumab	—	ACTIVE NOT RECRUITING	2026-03-04	NCT03519945
Polpharma Biologics S.A.	Intravenous (IV) infusions	—	ACTIVE NOT RECRUITING	2025-09	NCT05771155
Takeda	Vedolizumab	Integrin Receptor Antagonist [EPC]	ACTIVE NOT RECRUITING	2025-05-30	NCT04738942
Johnson & Johnson	Guselkumab	Interleukin-23 Antagonist [EPC]	ACTIVE NOT RECRUITING	2023-09-19	NCT04033445
Ganzhou Hemay Pharmaceutical Co., Ltd	Hemay005 tablet	—	NOT YET RECRUITING	2028-05	NCT07650942
Eli Lilly	Mirikizumab IV	—	COMPLETED	2026-05-01	NCT05784246
Abivax S.A.	ABX464	—	COMPLETED	2025-06-24	NCT05507203
Abivax S.A.	ABX464	—	COMPLETED	2025-06-24	NCT05507216
AbbVie	Adalimumab	TNF	COMPLETED	2025-04-08	NCT02632175
Bristol-Myers Squibb	RPC1063	—	COMPLETED	2024-12-19	NCT02531126
Eli Lilly	Mirikizumab	—	COMPLETED	2024-08-09	NCT05767021
Takeda	25 mg Ontamalimab	—	COMPLETED	2023-12-13	NCT03283085
AbbVie	risankizumab IV	—	COMPLETED	2022-11-09	NCT03398148
Pfizer	Etrasimod	—	COMPLETED	2022-08-03	NCT04706793
Celltrion	CT-P13 SC (Infliximab)	—	COMPLETED	2022-07-07	NCT04205643
Arena Pharmaceuticals	Etrasimod	—	COMPLETED	2022-02-08	NCT03945188
AbbVie	Upadacitinib	Janus Kinase Inhibitor [EPC]	COMPLETED	2021-12-13	NCT02819635
Arena Pharmaceuticals	Etrasimod	—	COMPLETED	2021-12-07	NCT03996369
Eli Lilly	Mirikizumab SC	—	COMPLETED	2021-11-03	NCT03524092
Takeda	Ontamalimab	—	COMPLETED	2021-07-01	NCT03290781
Eli Lilly	Mirikizumab	—	COMPLETED	2021-01-21	NCT03518086
AbbVie	Upadacitinib	Janus Kinase Inhibitor [EPC]	COMPLETED	2021-01-14	NCT03653026
Pfizer	CP-690,550	—	COMPLETED	2020-08-06	NCT01470612
Roche	Etrolizumab	—	COMPLETED	2020-06-23	NCT02136069
Roche	Etrozulimab	—	COMPLETED	2020-04-16	NCT02100696
Gilead	Filgotinib	—	COMPLETED	2020-03-31	NCT02914522
Bristol-Myers Squibb	RPC1063	—	COMPLETED	2020-03-27	NCT02435992
Roche	Adalimumab	TNF	COMPLETED	2020-03-02	NCT02171429
Roche	Adalimumab	TNF	COMPLETED	2020-02-19	NCT02163759
AbbVie	Adalimumab	TNF	COMPLETED	2020-02-07	NCT02065557
AbbVie	Adalimumab	TNF	COMPLETED	2019-09-05	NCT02065622
Takeda	MMX Mesalamine/Mesalazine (Low Dose)	—	COMPLETED	2018-11-28	NCT02093663
Dr. Falk Pharma GmbH	LT-02	—	COMPLETED	2018-10-05	NCT02280629
Ferring Pharmaceuticals	Mesalamine	Aminosalicylate [EPC]	COMPLETED	2018-09-19	NCT02522780
Takeda	Vedolizumab	Integrin Receptor Antagonist [EPC]	COMPLETED	2018-02-27	NCT02039505
Ferring Pharmaceuticals	Mesalamine	Aminosalicylate [EPC]	COMPLETED	2018-02-06	NCT02522767
Takeda	Vedolizumab	Integrin Receptor Antagonist [EPC]	COMPLETED	2017-10-31	NCT00790933
Ferring Pharmaceuticals	Mesalazine Enema	—	COMPLETED	2017-01-05	NCT02368717
Pfizer	CP690,550	—	COMPLETED	2016-05-27	NCT01458574
Tillotts Pharma AG	TP05	—	COMPLETED	2016-05	NCT01903252
Pfizer	tofacitinib	—	COMPLETED	2015-05	NCT01465763
Pfizer	tofacitinib	—	COMPLETED	2015-05	NCT01458951
AbbVie (prior sponsor, Abbott)	Adalimumab	TNF	COMPLETED	2015-04	NCT01550965
Dr. Falk Pharma GmbH	Mesalazine - TID 1000 mg	—	COMPLETED	2015-03	NCT01745770
Tanabe Pharma Corporation	TA-650	—	COMPLETED	2014-09	NCT01585155
Xian-Janssen Pharmaceutical Ltd.	Infliximab	Tumor Necrosis Factor Blocker [EPC]	COMPLETED	2014-03	NCT01551290
Bausch Health Americas, Inc.	Budesonide MMX®	—	COMPLETED	2013-10-02	NCT01532648
Shield Therapeutics	ST10-021	—	COMPLETED	2013-10	NCT01340872
Tillotts Pharma AG	Asacol®	—	COMPLETED	2013-01	NCT01257399
Nordisk Rebalance A/S	—	—	COMPLETED	2012-09	NCT01193894
Tillotts Pharma AG	Asacol®	—	COMPLETED	2012-08	NCT01257386
Millennium Pharmaceuticals, Inc.	vedolizumab	Integrin Receptor Antagonist [EPC]	COMPLETED	2011-12	NCT00783718
Tillotts Pharma AG	Mesalamin	—	COMPLETED	2011-07	NCT01059344
Bausch Health Americas, Inc.	Budesonide MMX 6 mg Tablet	—	COMPLETED	2011-05	NCT00801723
AbbVie (prior sponsor, Abbott)	adalimumab	TNF	COMPLETED	2011-05	NCT00853099
Warner Chilcott	Asacol 400 mg	—	COMPLETED	2011-03	NCT00713310
Ferring Pharmaceuticals	Mesalazine slow-release granules	—	COMPLETED	2010-06	NCT00737789
Bausch Health Americas, Inc.	budesonide-MMX® 6 mg	—	COMPLETED	2010-05	NCT00679432
Bausch Health Americas, Inc.	Budesonide MMX® 6 mg	—	COMPLETED	2010-02	NCT00679380
Vifor Pharma	Ferric carboxymaltose	—	COMPLETED	2009-12	NCT00810030
EMET Pharmaceuticals, LLC	Mesalamine	Aminosalicylate [EPC]	COMPLETED	2009-06	NCT01045018
Alvotech Swiss AG	AVT16	—	TERMINATED	2025-11-25	NCT06570772
Bristol-Myers Squibb	Ozanimod	—	TERMINATED	2025-03-07	NCT05644665
InDex Pharmaceuticals	Cobitolimod 250 mg	—	TERMINATED	2023-12-20	NCT04985968
Galapagos NV	Filgotinib	—	TERMINATED	2023-10-09	NCT05479058
Roche	Etrolizumab	—	TERMINATED	2023-10-05	NCT02118584
Theravance Biopharma	TD-1473 Dose A	—	TERMINATED	2021-10-27	NCT03920254
Theravance Biopharma	TD-1473 Dose A	—	TERMINATED	2021-10-20	NCT03758443
Takeda	Ontamalimab	—	TERMINATED	2020-07-22	NCT03259334
Takeda	Ontamalimab	—	TERMINATED	2020-07-15	NCT03259308
Prometheus Laboratories	LT-02	—	TERMINATED	2019-03	NCT02849951
Dr. Falk Pharma GmbH	LT-02	—	TERMINATED	2016-11-11	NCT02142725
Gilead	Andecaliximab	—	TERMINATED	2016-09	NCT02520284
Hutchison Medipharma Limited	HMPL-004	—	TERMINATED	2014-10	NCT01882764
Hutchison Medipharma Limited	HMPL-004 1800 mg/day	—	TERMINATED	2014-10	NCT01805791
sigma-tau i.f.r. S.p.A.	Propionyl-L-Carnitine	—	TERMINATED	2013-10	NCT01567956
sigma-tau i.f.r. S.p.A.	Propionyl-L-Carnitine	—	TERMINATED	2013-10	NCT01538251
Warner Chilcott	Asacol 400 mg	—	TERMINATED	2011-03	NCT01004185

Showing 100 of 137 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Roche	Vixarelimab	—	RECRUITING	2026-07-09	NCT06693908
InventisBio Co., Ltd	D-2570	—	RECRUITING	2026-07-30	NCT07035041
Accro Bioscience (Suzhou) Limited	AC-101	—	RECRUITING	2026-09-30	NCT07083193
Shandong Suncadia Medicine Co., Ltd.	HRS-7085	—	RECRUITING	2026-12	NCT07229950
Sanofi	SAR442970	—	RECRUITING	2026-12-17	NCT06975722
Gilead	Tilpisertib Fosmecarbil	—	RECRUITING	2027-01	NCT06029972
Biocad	anti-TL1A monoclonal antibody, low dose	—	RECRUITING	2027-01	NCT07080034
Mirador Therapeutics, Inc.	MT-501	—	RECRUITING	2027-04-30	NCT07113522
Eli Lilly	LY4268989	—	RECRUITING	2027-05	NCT07186101
Boehringer Ingelheim	BI 3032950 intravenous (Part A)	—	RECRUITING	2027-07-30	NCT06636656
InSilico Medicine Hong Kong Limited	ISM5411 tablets	—	RECRUITING	2027-08-15	NCT07265570
Roche	RO7837195	—	RECRUITING	2027-08-25	NCT06979336
Haisco Pharmaceutical Group Co., Ltd.	HSK47388	—	RECRUITING	2027-10-15	NCT07335055
Merck	MK-8690	—	RECRUITING	2027-10-28	NCT07463183
Eli Lilly	Eltrekibart	—	RECRUITING	2027-12	NCT06598943
Xencor, Inc.	XmAb942	—	RECRUITING	2028-04	NCT06619990
Mage Biologics	MB-001	—	RECRUITING	2028-07	NCT07374471
Pfizer	Etrasimod	—	RECRUITING	2029-06-16	NCT05287126
Takeda	Zasocitinib	—	RECRUITING	2029-12-30	NCT06764615
Eli Lilly	LY4268989	—	RECRUITING	2030-06	NCT07415044
Spyre Therapeutics, Inc.	SPY001	—	RECRUITING	2026-06	NCT07012395
Odyssey Therapeutics	OD-07656	—	RECRUITING	2026-04	NCT06850727
Takeda	TAK-279	—	ACTIVE NOT RECRUITING	2026-09-30	NCT06254950
Ganzhou Hemay Pharmaceutical Co., Ltd	Hemay005 tablets	—	ACTIVE NOT RECRUITING	2026-12-30	NCT05486104
Guangdong Hengrui Pharmaceutical Co., Ltd	SHR-1139 intravenous injection.	—	ACTIVE NOT RECRUITING	2027-08	NCT07232576
AbbVie	Lutikizumab	—	ACTIVE NOT RECRUITING	2027-09	NCT06257875
Abivax S.A.	ABX464	—	ACTIVE NOT RECRUITING	2028-03	NCT05177835
AltruBio Inc.	ALTB-268	—	ACTIVE NOT RECRUITING	2026-03-05	NCT06109441
Gilead	emvistegrast	—	ACTIVE NOT RECRUITING	2026-03-04	NCT06290934
AnaptysBio, Inc.	Rosnilimab	—	ACTIVE NOT RECRUITING	2026-01	NCT06127043
Palatin Technologies, Inc	PL8177	—	ACTIVE NOT RECRUITING	2025-02-10	NCT05466890
Nanjing Immunophage Biotech Co., Ltd	IPG11406	—	NOT YET RECRUITING	2028-12-01	NCT07535489
Athos Therapeutics Inc	ATH-063	—	NOT YET RECRUITING	2028-12-14	NCT07513181
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	627	—	NOT YET RECRUITING	2029-02-28	NCT07507513
Jina Pharmaceuticals Inc.	Tacrolimus Lipid Suspension for enema	—	NOT YET RECRUITING	2025-12	NCT06867042
Takeda	Vedolizumab	Integrin Receptor Antagonist [EPC]	COMPLETED	2025-04-03	NCT03196427
BioGaia Pharma AB	BGP-014	—	COMPLETED	2024-12-31	NCT05118919
AbbVie	ABBV-668	—	COMPLETED	2024-12-23	NCT05570006
Zydus Lifesciences Limited	Arm1	—	COMPLETED	2024-11-22	NCT06398808
Shanghai Pharmaceuticals Holding Co., Ltd	SPH3127 Tablets with Dose A	—	COMPLETED	2024-09-13	NCT05770609
Bausch Health Americas, Inc.	Low Dose MT-1303	—	COMPLETED	2024-09-03	NCT04857112
Innovent Biologics (Suzhou) Co. Ltd.	Period 2 IBI112 dose 3	—	COMPLETED	2024-06-21	NCT05377580
Pfizer	Etrasimod	—	COMPLETED	2024-06-19	NCT04607837
OSE Immunotherapeutics	OSE-127	—	COMPLETED	2024-04-30	NCT04882007
Pfizer	Etrasimod	—	COMPLETED	2023-10-06	NCT05061446
Bristol-Myers Squibb	Deucravacitinib	Tyrosine Kinase 2 Inhibitor [EPC]	COMPLETED	2023-08-29	NCT04877990
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Tulisokibart	—	COMPLETED	2023-06-06	NCT04996797
Eli Lilly	Mirikizumab	—	COMPLETED	2023-03-15	NCT04004611
Abivax S.A.	ABX464	—	COMPLETED	2023-02-23	NCT04023396
Protagonist Therapeutics, Inc.	PN-943	—	COMPLETED	2023-02-16	NCT04504383
Oncostellae S.L	OST-122	—	COMPLETED	2022-12-27	NCT04353791
Roche	Induction- PF-06480605 50 mg SC Q4W	—	COMPLETED	2022-10-25	NCT04090411
Abivax S.A.	ABX464	—	COMPLETED	2022-07-12	NCT03368118
Applied Molecular Transport	AMT-101 (oral)	—	COMPLETED	2022-06-01	NCT05372939
Bridge Biotherapeutics, Inc.	BBT-401-1S or Placebo	—	COMPLETED	2022-05-17	NCT04596293
Connect Biopharm LLC	Double-Blind 0.2mg CBP-307	—	COMPLETED	2022-02-23	NCT04700449
ParaTech A/S	Trichuris suis ova	—	COMPLETED	2022-01-10	NCT03565939
Roche	UTTR1147A	—	COMPLETED	2021-12-15	NCT03558152
Bristol-Myers Squibb	BMS-986165	—	COMPLETED	2021-06-13	NCT03934216
Palobiofarma SL	PBF-677	—	COMPLETED	2021-05-27	NCT03773952
Galapagos NV	GLPG3970	—	COMPLETED	2021-05-17	NCT04577794
Pfizer	PF-06700841	—	COMPLETED	2021-05-10	NCT02958865
AbbVie	Ravagalimab 600 mg	—	COMPLETED	2021-04-05	NCT03695185
Abivax S.A.	ABX464 100 mg	—	COMPLETED	2021-04-01	NCT03760003
I-Mab Biopharma HongKong Limited	TJ301 300mg	—	COMPLETED	2020-12-21	NCT03235752
NImmune Biopharma	BT-11 (440 mg)	—	COMPLETED	2020-12-10	NCT03861143
Reistone Biopharma Company Limited	SHR0302	—	COMPLETED	2020-11-30	NCT03675477
Takeda	Vedolizumab	Integrin Receptor Antagonist [EPC]	COMPLETED	2020-03-31	NCT03138655
InDex Pharmaceuticals	cobitolimod	—	COMPLETED	2019-08-30	NCT03178669
EA Pharma Co., Ltd.	E6007	—	COMPLETED	2019-04-17	NCT03018054
Arena Pharmaceuticals	Etrasimod	—	COMPLETED	2018-11-01	NCT02536404
Kyowa Kirin, Inc.	KHK4083	—	COMPLETED	2018-09	NCT02647866
Abivax S.A.	ABX464	—	COMPLETED	2018-07-25	NCT03093259
Arena Pharmaceuticals	Etrasimod	—	COMPLETED	2018-02-14	NCT02447302
Eli Lilly	Mirikizumab	—	COMPLETED	2017-12-19	NCT02589665
Takeda	75mg SHP647 (PF-00547659)	—	COMPLETED	2017-12-13	NCT01771809
Amgen	Apremilast	Phosphodiesterase 4 Inhibitor [EPC]	COMPLETED	2017-09-25	NCT02289417
Topivert Pharma Ltd	TOP1288	—	COMPLETED	2017-06-28	NCT02888379
Qu Biologics Inc.	QBECO SSI	—	COMPLETED	2016-12	NCT02426372
Roche	Etrolizumab	—	COMPLETED	2016-08-07	NCT01461317
Galapagos NV	GLPG1205	—	COMPLETED	2015-09	NCT02337608
AstraZeneca	MEDI7183 low dose	—	COMPLETED	2015-08-11	NCT01959165
Amgen	Abrilumab	—	COMPLETED	2015-07-13	NCT01694485
Bristol-Myers Squibb	Ozanimod	—	COMPLETED	2015-03-10	NCT01647516
Vascular Biogenics Ltd. operating as VBL Therapeutics	VB-201 160mg	—	COMPLETED	2014-11	NCT01839214
PurGenesis Technologies Inc.	PUR 0110 Rectal Enema 250 mg	—	COMPLETED	2014-10-01	NCT01149707
Takeda	PF-00547659 SC Injection	—	COMPLETED	2014-09-22	NCT01620255
GW Research Ltd	GWP42003	—	COMPLETED	2014-08-05	NCT01562314
Telsar Pharma Inc.	ASP3291	—	COMPLETED	2014-04	NCT01612039
Galapagos NV	GLPG0974	—	COMPLETED	2014-04	NCT01829321
Lexicon Pharmaceuticals	Telotristat Etiprate	Tryptophan Hydroxylase	COMPLETED	2013-09-03	NCT01456052
BioLineRx, Ltd.	BL-7040	—	COMPLETED	2013-05	NCT01506362
AstraZeneca	tralokinumab	Interleukin-13 Antagonist [EPC]	COMPLETED	2013-03	NCT01482884
Roche	rhuMAb Beta7	—	COMPLETED	2012-09	NCT01336465
Cosmo Technologies Ltd	—	—	COMPLETED	2012-07	NCT01520324
Novartis	AEB071	—	COMPLETED	2012-04	NCT00572585
Sigmoid Pharma	CyCol™	—	COMPLETED	2011-08	NCT01033305
Pfizer	CP- 690 550	—	COMPLETED	2010-09	NCT00787202
Palau Pharma S.L.U.	Dersalazine sodium	—	COMPLETED	2010-06	NCT00808977
Biogen	BG9418 (Interferon beta-1a)	—	COMPLETED	2010-03	NCT00616434

Showing 68 of 68 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Rise Therapeutics LLC	R-3750	—	RECRUITING	2026-07	NCT05666960
Benethera (Shaoxing) Biotechnology Co., Ltd.	BDHK-2009 Tablets	—	RECRUITING	2026-12-31	NCT07632573
Jiangsu Carephar Pharmaceutical Co., Ltd.	H021	—	RECRUITING	2025-02-27	NCT06627556
AltruBio Inc.	ALTB-268	—	ACTIVE NOT RECRUITING	2026-09-26	NCT07350577
LyncBio Therapeutics Co., Ltd.	LYNC-101	—	NOT YET RECRUITING	2027-03-19	NCT07505030
Liveome Inc.	LIV001	—	NOT YET RECRUITING	2026-01-17	NCT06749795
Microbiotica Ltd	MB310	—	COMPLETED	2026-01-08	NCT06582264
NIBEC Co., Ltd.	NP-201 acetate injection (Part A)	—	COMPLETED	2025-07-18	NCT06681389
Palisade Bio	PALI-2108	—	COMPLETED	2025-07-07	NCT06663605
Mage Biologics	MB-001	—	COMPLETED	2025-07-04	NCT06363383
Odyssey Therapeutics	OD-07656	—	COMPLETED	2024-11-25	NCT06206811
Sorriso Pharmaceuticals, Inc.	SOR102	—	COMPLETED	2024-10-16	NCT06080048
Liveome Inc.	LIV001	—	COMPLETED	2024-03-05	NCT05975047
Athos Therapeutics Inc	ATH-063	—	COMPLETED	2024-02-08	NCT05807971
Merck	MK-6194	—	COMPLETED	2024-01-08	NCT04924114
Adiso Therapeutics	BT051 200 mg	—	COMPLETED	2022-11-30	NCT05084261
AbbVie	Risankizumab	—	COMPLETED	2022-10-14	NCT04254783
Innovo Therapeutics, Inc.	INV-101	—	COMPLETED	2022-07-16	NCT05844592
Landos Biopharma Inc.	NX-13 250mg IR	—	COMPLETED	2022-06-17	NCT04862741
Akeso	AK101 IV	—	COMPLETED	2022-05-17	NCT06281704
Landos Biopharma Inc.	NX-13 250 mg	—	COMPLETED	2020-10-21	NCT04458805
LG Chem	Film-coated tablet	—	COMPLETED	2020-10-01	NCT04360343
Applied Molecular Transport	AMT-101	—	COMPLETED	2020-04-30	NCT04224857
Fresenius Kabi SwissBioSim GmbH	40 mg MSB11022	—	COMPLETED	2020-03-17	NCT04018599
Roche	UTTR1147A	—	COMPLETED	2020-02-19	NCT02749630
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.	GB004	—	COMPLETED	2019-12-17	NCT03860896
Provention Bio, Inc.	PRV-300	—	COMPLETED	2019-03-01	NCT03849599
Celltrion	CT-P13	—	COMPLETED	2019-02-04	NCT02883452
Bridge Biotherapeutics, Inc.	BBT-401-1S, Single dose	—	COMPLETED	2018-09-26	NCT03482648
Theravance Biopharma	TD-1473	—	COMPLETED	2018-03-29	NCT02818686
Kyowa Kirin Co., Ltd.	KHK4083	—	COMPLETED	2017-12-26	NCT02985593
Seres Therapeutics, Inc.	SER-287	—	COMPLETED	2017-12-06	NCT02618187
Theravance Biopharma	TD-3504	—	COMPLETED	2017-11-08	NCT03103412
VHsquared Ltd.	V565	—	COMPLETED	2017-10-24	NCT03705117
Bristol-Myers Squibb	BMS-986166	—	COMPLETED	2017-08-10	NCT03038711
Bausch Health Americas, Inc.	Apriso 0.375G ER CAP	—	COMPLETED	2017-06-23	NCT03327558
Topivert Pharma Ltd	TOP1288	—	COMPLETED	2017-06-02	NCT03071081
Topivert Pharma Ltd	TOP1288	—	COMPLETED	2016-07	NCT02463045
Lycera Corp.	LYC-30937	—	COMPLETED	2016-06	NCT02818543
Gilead	Andecaliximab	—	COMPLETED	2015-01-05	NCT01831427
Gilead	GS-5745 SC	—	COMPLETED	2014-10	NCT02209987
Amgen	AMG 181	—	COMPLETED	2014-04	NCT01290042
Takeda	lumbar puncture	—	COMPLETED	2014-03-31	NCT01387594
Avaxia Biologics, Incorporated	AVX 470	—	COMPLETED	2013-12	NCT01759056
Tillotts Pharma AG	TP05	—	COMPLETED	2013-11	NCT02306798
Takeda	MMX Mesalamine	—	COMPLETED	2013-06-27	NCT01130844
Tillotts Pharma AG	TP05 Coating D	—	COMPLETED	2013-02	NCT02306785
Tillotts Pharma AG	TP05 Coating A	—	COMPLETED	2012-02	NCT02306772
IBD Column Therapies International AB	—	—	COMPLETED	2011-10	NCT01097590
Roche	rhuMAb Beta7	—	COMPLETED	2011-09	NCT00694980
Telsar Pharma Inc.	ASP3291	—	COMPLETED	2011-08	NCT01320332
Altheus Therapeutics, Inc.	mesalamine	Aminosalicylate [EPC]	COMPLETED	2010-09	NCT01020708
PurGenesis Technologies Inc.	PUR 0110 Rectal Enema or Placebo Enema	—	COMPLETED	2009-08	NCT01149694
Vial Australia Pty Ltd	BB-TL1A-VIAL-HLE	—	TERMINATED	2025-12-23	NCT07029971
Pfizer	PF-07054894	—	TERMINATED	2025-11-11	NCT05549323
Direct Biologics, LLC	ExoFlo	—	TERMINATED	2024-12-01	NCT05176366
Johnson & Johnson	Ustekinumab IV Infusion	—	TERMINATED	2021-11-22	NCT03358706
Avalo Therapeutics, Inc.	MDGN-002	—	TERMINATED	2021-09-14	NCT03169894
Bridge Biotherapeutics, Inc.	BBT-401-1S	—	TERMINATED	2021-08-04	NCT04478825
Roche	RO7049665	—	TERMINATED	2021-07-22	NCT03943550
Assembly Biosciences	ABI-M201	—	TERMINATED	2021-01-20	NCT03923478
Aptevo Therapeutics	APVO210	—	TERMINATED	2020-06-30	NCT03768219
Roche	Etrolizumab	—	TERMINATED	2019-12-02	NCT03478956
Nutrition Science Partners Limited	HMPL004-6599	—	TERMINATED	2018-11-19	NCT03597971
Bristol-Myers Squibb	BMS-986184	—	TERMINATED	2017-09-27	NCT02864264
Amgen	Amg 181	—	TERMINATED	2013-01	NCT01164904
Ferring Pharmaceuticals	Microbiota suspension	—	WITHDRAWN	2026-01-15	NCT06260267
Human Genome Sciences Inc.	HGS1025	—	WITHDRAWN	2012-12	NCT01434576

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Ulcerative Colitis

TNF-alpha (20)

Novel Ulcerative Colitis Drugs by Company (New molecular entities)

6 companies have an FDA-approved novel drug for Ulcerative Colitis.

Johnson & Johnson 3 drugs

AbbVie 1 drug

Takeda 1 drug

Pfizer 1 drug

Eli Lilly 1 drug

Viatris 1 drug

Reformulations (12 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Ulcerative Colitis Drug Targets

Molecular targets of approved and investigational Ulcerative Colitis drugs — 15 targets tracked.

TNF 16 Cyclooxygenase 8 IL-23 8 IL-12 7 Lipoxygenase 2 JAK1 2 JAK2 2 Integrin alpha4beta7 1 Vitamin K 1 JAK3 1 TYK2 1 S1P1 1 S1P4 1 S1P5 1 TNFα 1

Biosimilars (20 BLA approved) Click to expand

Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.

Generic Drugs (4 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

Related Indications

Other Immunology indications

View all Immunology

Drug Categories:

Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
Biosimilars: BLA-approved biologics highly similar to reference products
Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology