TheraRadar

Crohn's Disease Drug Landscape 2026

Approved therapies, pipeline drugs, and clinical trial intelligence

Data updated: Mar 29, 2026
32
Approved Drugs
140
Pipeline Trials
140
Active Trials
93
Companies
500,000+ US patients
Patient Population
Market: $8.5B (2025)

New in 2025-2026

Overview

Crohn's disease is a chronic autoimmune condition and one of two major forms of inflammatory bowel disease (IBD), alongside ulcerative colitis (UC). Affecting over 500,000 Americans, Crohn's can cause inflammation anywhere in the GI tract but most often affects the small intestine. The inflammation penetrates deep through all layers of the bowel wall and typically occurs in scattered patches separated by normal tissue. Treatment has evolved dramatically from corticosteroids to targeted biologics and small molecules. The landscape is now dominated by TNF inhibitors, IL-23 blockers, integrin antagonists, and JAK inhibitors, with emerging targets like TL1A showing promise. Many therapies are approved for both Crohn's and UC, making the IBD market highly interconnected.

Historical Context

First formally described in 1932 by Dr. Burrill Bernard Crohn and colleagues at Mount Sinai Hospital, who characterized 14 patients with granulomatous inflammation of the terminal ileum. Initially called 'terminal ileitis,' the name was changed to 'regional ileitis' to avoid the impression that the disease was always fatal. Though similar conditions were noted as early as 1769 by Giovanni Morgagni, Crohn's meticulous documentation established it as a distinct clinical entity, correcting the long-held belief that it was a form of intestinal tuberculosis.

1932
Burrill Bernard Crohn
Mount Sinai Hospital, New York
Originally: "Regional Ileitis"
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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.

4
3
2
1
1

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

FDA-Approved Drugs Free

11 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
OMVOH MIRIKIZUMAB-MRKZ Eli Lilly IL-23 2023
ZYMFENTRA INFLIXIMAB-DYYB CELLTRION TNF 2023
RINVOQ UPADACITINIB AbbVie JAK 2019
SKYRIZI RISANKIZUMAB-RZAA AbbVie IL-23 2019
TREMFYA GUSELKUMAB Johnson & Johnson IL-23 2017
ENTYVIO VEDOLIZUMAB Takeda Integrin 2014
STELARA USTEKINUMAB Johnson & Johnson IL-12/23 2009
CIMZIA CERTOLIZUMAB PEGOL UCB INC TNF 2008
TYSABRI NATALIZUMAB Biogen Integrin 2004
HUMIRA ADALIMUMAB AbbVie TNF 2002
REMICADE INFLIXIMAB Johnson & Johnson TNF 1998

+ 21 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.

46
Phase 3 Trials
28 recruiting
50
Phase 2 Trials
32 recruiting
12
Phase 1 Trials
5 recruiting

Full pipeline dataset coming soon in Pro

Key Companies Free

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

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
Guselkumab Dose 1
Janssen Research & Development, LLC
TBD
Phase 3
Afimkibart
Hoffmann-La Roche
TBD
Phase 3
Guselkumab
Janssen-Cilag Ltd.
TBD
Phase 3
IV Tulisokibart
Merck Sharp & Dohme LLC
TBD
Phase 3
Guselkumab
Janssen-Cilag Ltd.
TBD

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Frequently Asked Questions

What are the FDA-approved drugs for Crohn's disease?
FDA-approved biologics for Crohn's include infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), vedolizumab (Entyvio), ustekinumab (Stelara), and risankizumab (Skyrizi). Small molecules like upadacitinib (Rinvoq) are also approved.
What is the Crohn's disease drug pipeline?
The Crohn's pipeline includes over 20 drugs in Phase 2 and Phase 3 development, targeting mechanisms like TL1A, IL-23, S1P, and novel pathways. Multiple companies including AbbVie, J&J, Takeda, and Pfizer have active programs.
Which companies are developing Crohn's disease treatments?
Major pharmaceutical companies with Crohn's programs include AbbVie, Johnson & Johnson/Janssen, Takeda, Pfizer, Eli Lilly, Roche, and several biotechs focused on novel targets.

Related Intelligence

Data Sources: FDA Drugs@FDA, ClinicalTrials.gov, FDA Orange Book

Pipeline data refreshed weekly. Approved drugs from FDA database.