Ulcerative Colitis Drug Landscape 2026

Approved therapies, pipeline drugs, and clinical trial intelligence

Data updated: Mar 29, 2026

Approved Drugs

141

Pipeline Trials

141

Active Trials

101

Companies

900,000+ US patients

Patient Population

Market: $9.2B (2025)

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New in 2025-2026

STARJEMZA (2025)

Overview

Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting the colon and rectum. Unlike Crohn's disease, UC inflammation is continuous (not patchy) and limited to the innermost lining of the colon. Affecting nearly 1 million Americans, UC causes symptoms including bloody diarrhea, urgency, and abdominal pain. Treatment has evolved from aminosalicylates and corticosteroids to targeted biologics and oral small molecules. The landscape includes TNF inhibitors, integrin antagonists, IL-23 blockers, JAK inhibitors, and S1P receptor modulators. Many therapies overlap with Crohn's, but UC has additional approved options like ozanimod (Zeposia) and etrasimod (Velsipity). Emerging targets include TL1A and novel S1P modulators.

Historical Context

First formally described in 1859 by Sir Samuel Wilks at Guy's Hospital in London, who distinguished it from bacterial dysentery. Wilks performed autopsies on patients who died from chronic bloody diarrhea and noted inflammation limited to the colon's mucosal layer. The term 'ulcerative colitis' was later coined in 1888 by William Hale White. For decades, UC was treated only with supportive care until sulfasalazine was introduced in the 1940s, revolutionizing medical management.

1859

Samuel Wilks

Guy's Hospital, London

Originally: "Idiopathic Colitis"

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Pro Intelligence — Coming Soon

Deeper insights for pharma professionals, investors, and analysts.

● Treatment Evolution Timeline — Mechanism shifts over 25 years

● Full Drug Dataset — FDA links, trial data, biosimilars

● Full Pipeline Dataset — All trials with NCT IDs

● Efficacy Comparison — Remission rates from FDA labels

● PDUFA Calendar — Upcoming FDA decision dates

● Company Analysis — Originators, biosimilars, pipeline by phase

● Head-to-Head Trials — Direct comparisons

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Mechanism Landscape

Current Crohn's disease treatments target several key inflammatory pathways. TNF inhibitors like Remicade and Humira remain widely used, while newer IL-23 blockers and JAK inhibitors offer alternatives for patients who don't respond to anti-TNF therapy.

JAK

RINVOQ LQ, RINVOQ

TNF

ZYMFENTRA, SIMPONI

IL-23

OMVOH, SKYRIZI

S1P

VELSIPITY, ZEPOSIA

Integrin

ENTYVIO

IL-12/23

STELARA

Note: Counts include originator drugs only. Biosimilars are tracked separately.

FDA-Approved Drugs Free

15 approved

FDA-approved biologics and small molecules for Crohn's disease, including TNF inhibitors, IL-23 blockers, integrin antagonists, and JAK inhibitors.

Drug	Company	Mechanism	Approved
RINVOQ LQ UPADACITINIB	AbbVie	JAK	2024
VELSIPITY ETRASIMOD ARGININE	Pfizer	S1P	2023
OMVOH MIRIKIZUMAB-MRKZ	Eli Lilly	IL-23	2023
ZYMFENTRA INFLIXIMAB-DYYB	CELLTRION	TNF	2023
ZEPOSIA OZANIMOD HYDROCHLORIDE	Bristol-Myers Squibb	S1P	2020
RINVOQ UPADACITINIB	AbbVie	JAK	2019
SKYRIZI RISANKIZUMAB-RZAA	AbbVie	IL-23	2019
TREMFYA GUSELKUMAB	Johnson & Johnson	IL-23	2017
XELJANZ XR TOFACITINIB CITRATE	Pfizer	JAK	2016
ENTYVIO VEDOLIZUMAB	Takeda	Integrin	2014
XELJANZ TOFACITINIB CITRATE	PF PRISM CV	JAK	2012
SIMPONI GOLIMUMAB	Johnson & Johnson	TNF	2009
STELARA USTEKINUMAB	Johnson & Johnson	IL-12/23	2009
HUMIRA ADALIMUMAB	AbbVie	TNF	2002
REMICADE INFLIXIMAB	Johnson & Johnson	TNF	1998

+ 20 biosimilars with FDA links and trial data available in Pro

Pipeline Snapshot Free

Active clinical trials for Crohn's disease drugs across all development phases. Includes novel mechanisms like TL1A inhibitors, next-generation IL-23 blockers, and S1P modulators currently in Phase 2 and Phase 3 studies.

Phase 3 Trials

18 recruiting

Phase 2 Trials

40 recruiting

Phase 1 Trials

7 recruiting

Full pipeline dataset coming soon in Pro

Key Companies Free

Major pharmaceutical companies active in Crohn's disease drug development.

AbbVie Takeda Eli Lilly Pfizer Johnson & Johnson Roche Samsung Bioepis Amgen Celltrion Sanofi ALVOTECH USA Fresenius Kabi

Detailed competitive analysis (originators, biosimilars, pipeline breakdown) available in Pro.

Patent & Exclusivity Cliff Free

Patent and exclusivity expirations for Crohn's disease biologics. Humira lost exclusivity in 2023, opening the market to multiple biosimilars. Stelara and Entyvio face upcoming patent cliffs, creating opportunities for biosimilar competition and potential cost savings.

REMICADE

Johnson & Johnson

2018

HUMIRA

AbbVie

2028

Upcoming Catalysts Free

Event	Drug/Company	Timeline
Phase 3	Risankizumab AbbVie	TBD
Phase 3	Afimkibart Hoffmann-La Roche	TBD
Phase 3	IV Tulisokibart Merck Sharp & Dohme LLC	TBD
Phase 3	Guselkumab Janssen Research & Development, LLC	TBD
Phase 3	Mirikizumab Eli Lilly and Company	TBD

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Frequently Asked Questions

What are the FDA-approved drugs for ulcerative colitis?

FDA-approved biologics for UC include infliximab (Remicade), adalimumab (Humira), golimumab (Simponi), vedolizumab (Entyvio), ustekinumab (Stelara), and mirikizumab (Omvoh). Small molecules include tofacitinib (Xeljanz), upadacitinib (Rinvoq), ozanimod (Zeposia), and etrasimod (Velsipity).

What is the ulcerative colitis drug pipeline?

The UC pipeline includes over 25 drugs in Phase 2 and Phase 3 development, targeting TL1A, novel JAK inhibitors, S1P modulators, and combination approaches. Key programs from Sanofi, Merck, Roche, and AbbVie are advancing.

How is ulcerative colitis different from Crohn's disease?

UC affects only the colon with continuous inflammation of the inner lining, while Crohn's can affect any part of the GI tract with patchy, transmural inflammation. Many treatments work for both, but some (like S1P modulators) were first approved for UC.