Ulcerative Colitis Drug Landscape 2026
Approved therapies, pipeline drugs, and clinical trial intelligence
New in 2025-2026
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.
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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.
Note: Counts include originator drugs only. Biosimilars are tracked separately.
FDA-Approved Drugs Free
35 approvedFDA-approved biologics and small molecules for Crohn's disease, including TNF inhibitors, IL-23 blockers, integrin antagonists, and JAK inhibitors.
| Drug | Company | Mechanism | Approved |
|---|---|---|---|
| STARJEMZA ustekinumab-hmny | BIO-THERA SOLUTIONS LTD | IL-12/23 | 2025 |
| SELARSDI USTEKINUMAB-AEKN | ALVOTECH USA INC | IL-12/23 | 2024 |
| PYZCHIVA USTEKINUMAB-TTWE | SAMSUNG BIOEPIS CO LTD | Unknown | 2024 |
| OTULFI USTEKINUMAB-AAUZ | Fresenius Kabi | IL-12/23 | 2024 |
| RINVOQ LQ UPADACITINIB | AbbVie | JAK | 2024 |
| IMULDOSA USTEKINUMAB-SRLF | ACCORD BIOPHARMA INC. | IL-12/23 | 2024 |
| SIMLANDI ADALIMUMAB-RYVK | ALVOTECH USA INC | TNF | 2024 |
| YESINTEK USTEKINUMAB-KFCE | BIOCON BIOLOGICS INC | IL-12/23 | 2024 |
| WEZLANA USTEKINUMAB-AUUB | Amgen | IL-12/23 | 2023 |
| YUFLYMA ADALIMUMAB-AATY | CELLTRION | TNF | 2023 |
| VELSIPITY ETRASIMOD ARGININE | Pfizer | S1P | 2023 |
| OMVOH MIRIKIZUMAB-MRKZ | Eli Lilly | IL-23 | 2023 |
| ZYMFENTRA INFLIXIMAB-DYYB | CELLTRION | TNF | 2023 |
| IDACIO ADALIMUMAB-AACF | Fresenius Kabi | TNF | 2022 |
| YUSIMRY ADALIMUMAB-AQVH | COHERUS BIOSCIENCES INC | TNF | 2021 |
| ZEPOSIA OZANIMOD HYDROCHLORIDE | Bristol-Myers Squibb | S1P | 2020 |
| HULIO ADALIMUMAB-FKJP | Viatris | TNF | 2020 |
| RINVOQ UPADACITINIB | AbbVie | JAK | 2019 |
| AVSOLA INFLIXIMAB-AXXQ | Amgen | TNF | 2019 |
| SKYRIZI RISANKIZUMAB-RZAA | AbbVie | IL-23 | 2019 |
| HADLIMA ADALIMUMAB-BWWD | SAMSUNG BIOEPIS CO LTD | TNF | 2019 |
| ABRILADA ADALIMUMAB-AFZB | Pfizer | TNF | 2019 |
| HYRIMOZ ADALIMUMAB-ADAZ | Novartis | TNF | 2018 |
| TREMFYA GUSELKUMAB | Johnson & Johnson | IL-23 | 2017 |
| RENFLEXIS INFLIXIMAB-ABDA | SAMSUNG BIOEPIS CO LTD | TNF | 2017 |
| CYLTEZO ADALIMUMAB-ADBM | Boehringer Ingelheim | TNF | 2017 |
| INFLECTRA INFLIXIMAB-DYYB | CELLTRION INC | TNF | 2016 |
| XELJANZ XR TOFACITINIB CITRATE | Pfizer | JAK | 2016 |
| AMJEVITA ADALIMUMAB-ATTO | Amgen | TNF | 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 |
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.
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.
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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