Press release
Ulcerative Colitis Clinical Trials and Drugs 2025: EMA, PDMA, FDA Approvals, Medication, NDA, Treatment market, IND, ROA, MOA and Companies by DelveInsight | Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuti
Ulcerative Colitis Drugs
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Key Takeaways from the Ulcerative Colitis Pipeline Report
- Over 75+ Ulcerative Colitis pipeline therapies are in various stages of development, and their anticipated acceptance in the Ulcerative Colitis market would significantly increase market revenue.
- Leading Ulcerative Colitis companies developing novel drug candidates to improve the Ulcerative Colitis treatment landscape include Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, GlaxoSmithKline, Galapagos, Celgene, Gossamer Bio, Eisai, UCB, Suzhou Connect Biopharmaceuticals, Landos Biopharma, Seres Therapeutics, Abivax, Genentech, ParaTech A/S, I-Mab Biopharma, Sublimity Therapeutics Holdco, Reistone Biopharma, Qu Biologics, PurGenesis Technologies, Protagonist Therapeutics, Pfizer, Palobiofarma, Novartis Pharmaceuticals, Bristol-Myers Squibb, Bridge Biotherapeutics, Amgen, Allergan, Applied Molecular Transport, AbGenomics International, Protalix BioTherapeutics, LTT Bio-Pharma Co Ltd, Dongwha pharma, Seres Therapeutics, Innovation Pharmaceuticals, Holy Stone Healthcare, SLA Pharma, OSE Immunotherapeutics, Bridge Biotherapeutics, Mitsubishi Tanabe Pharma, Sterna Biologicals, Mesoblast, Oncostellae, First Wave Bio, Oppilan Pharma, NeuClone, Morphic Therapeutic, Metacrine, LG Chem, Koutif Therapeutics, Kiniksa Pharmaceuticals, Avaxia Biologics, Algernon Pharmaceuticals, Akeso Biopharma, Kaleido Biosciences, Rebiotix, Prometheus Biosciences, PNB Vesper Life Science, Pandion Therapeutics, Palatin Technologies, Theravance Biopharma, VHsquared, Seres Therapeutics, Hoffmann-La Roche, Provention Bio, Bacainn Therapeutics, Landos Biopharma, Bristol-Myers Squibb, Janssen Research & Development, GlaxoSmithKline, Assembly Biosciences, NuBiyota, Tarus Therapeutics, Servatus, Athos Therapeutics, Aclaris Therapeutics, Exeliom Biosciences SAS, Voronoi Group, Ventria Bioscience, TheraSource LLC, Synlogic Inc, Synedgen, Surrozen Inc, StemRIM Inc, Shaperon Inc, Sareum Holdings, Saniona, RhemaStem, Regentys, Progenity, Pharmaxis, Pharmabiome, PanTheryx, Oncodesign, Nyrada, Microbiotica, MAKScientific, KoBioLabs, Istesso, Intract Pharma, Innovimmune Biotherapeutics, Impetis Biosciences, Finch Therapeutics Group, Vivreon Biosciences, NuMedii, Intact Therapeutics, Giiant Pharma, among others.
- Promising Ulcerative Colitis pipeline therapies in various stages of development include Mirikizumab, Risankizumab, Etrasimod, and others.
- A few FDA-approved drugs for ulcerative colitis treatment include SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), OMVOH (Eli Lilly) VELSIPITY (Arena Pharmaceuticals/Pfizer), and SKYRIZI (AbbVie).
- Recently, on 18 June 2024, the FDA approved SKYRIZI for treating adult patients with moderately to severely active ulcerative colitis. This approval extends the drug's reach to approximately 1 million US patients and makes SKYRIZI the first IL-23 inhibitor approved for both UC and Crohn's disease, the two types of inflammatory bowel disease (IBD).
Ulcerative Colitis Overview
Ulcerative colitis is an idiopathic inflammatory condition of the colon, characterized by diffuse friability and superficial erosions on the colonic wall, often associated with bleeding. It is the most common form of inflammatory bowel disease worldwide. The inflammation is typically restricted to the mucosa and submucosa of the colon, extending proximally in a continuous manner. In the United States, ulcerative colitis accounts for a quarter-million provider visits annually, with medical costs directly related to the disease estimated to exceed four billion dollars annually.
The specific cause of inflammatory bowel disease is not known, but there appears to be a primary genetic component, as the most important independent risk factor is a family history of the disease, affecting 8% to 14% of patients. A first-degree relative of a patient with ulcerative colitis has a four times higher risk of developing the disease. Additionally, ulcerative colitis has a higher incidence in Jewish populations compared to other ethnicities.
The pathophysiology of ulcerative colitis involves defects in the epithelial barrier, immune response, leukocyte recruitment, and microflora of the colon. The epithelial barrier defect includes abnormalities in colonic mucin and possibly tight junctions, leading to increased uptake of luminal antigens. The lamina propria of the mucosa also has an increased number of activated and mature dendritic cells, which include a large number of toll-like receptors (TLR), specifically TLR2 and TLR4. There is also an atypical T-helper (Th) cell response in patients with ulcerative colitis, particularly Th2, which exerts a cytotoxic response against epithelial cells.
Leukocyte recruitment is affected on two fronts. There is an upregulated release of the chemoattractant CXCL8 in ulcerative colitis, leading to the recruitment of leukocytes to the mucosa from systemic circulation. Additionally, there is an upregulation of mucosal cellular adhesion molecule-1 (Mad-CAM1) on the endothelium of mucosal blood vessels, promoting leukocyte adhesion and extravasation into mucosal tissue.
Studies have shown that enteric microflora plays a significant role in the pathogenesis and severity of inflammation and disease phenotype. Ulcerative colitis seems to result, in part, from a homeostatic imbalance between enteric microflora and the host's mucosal immunity, leading to an aberrant response to non-pathogenic bacteria.
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Ulcerative Colitis Emerging Drugs
Obefazimod: Abivax
Obefazimod is an oral small-molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase IIa and Phase IIb clinical trials. Currently, the drug is in Phase III stage of its clinical trial for the treatment of ulcerative colitis.
ABBV-668: AbbVie
ABBV-668 is under development for the treatment of crohn's disease, unspecified immunological disorders and ulcerative colitis. The drug candidate acts by targeting receptor interacting serine/threonine protein kinase 1 (RIPK1). It is administered through oral route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.
TEV-48574: Teva Pharmaceutical
Anti-TL1A (TEV-'574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-'574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-'574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-'574) have not been reviewed by any regulatory authority. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.
SOR102: Sorriso Pharmaceuticals
SOR102 combines anti-TNF and anti-IL-23 vorabodies into a single dual-acting molecule a trypsin cleavable linker releases the monomers to independently engage their targets throughout intestinal tissue. SOR102 provides combination therapy locally within inflamed tissue with minimal risk of systemic immunosuppression. Overall benefits of dual targeting approach increased efficacy through blockade of different inflammatory mechanisms of IBD. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ulcerative colitis.
Discover more about the emerging Ulcerative Colitis drugs @ https://www.delveinsight.com/sample-request/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Ulcerative Colitis Key Companies
• Eli Lilly and Company
• Lipid Therapeutics
• Hoffmann-La Roche
• Arena Pharmaceuticals
• InDex Pharmaceuticals
• EA Pharma
• Theravance Biopharma
• Boehringer Ingelheim
• Janssen Research & Development
• Lycera
• LG Chem
• Iltoo Pharma
• Immunic
• Hutchison Medipharma
• Tianjin Hemay Pharmaceutical
• GlaxoSmithKline
• Galapagos
• Celgene
• Gossamer Bio
• Eisai
• UCB
• Suzhou Connect Biopharmaceuticals
• Landos Biopharma
• Seres Therapeutics
• Abivax
• Genentech
• ParaTech A/S
• I-Mab Biopharma
• Sublimity Therapeutics Holdco
• Reistone Biopharma
• Qu Biologics
• PurGenesis Technologies
• Protagonist Therapeutics
• Pfizer
• Palobiofarma
• Novartis Pharmaceuticals
• Bristol-Myers Squibb
• Bridge Biotherapeutics
• Amgen
• Allergan
• Applied Molecular Transport
• AbGenomics International
• Protalix BioTherapeutics
• LTT Bio-Pharma Co Ltd
• Dongwha Pharma
• Seres Therapeutics
• Innovation Pharmaceuticals
• Holy Stone Healthcare
• SLA Pharma
• OSE Immunotherapeutics
• Bridge Biotherapeutics
• Mitsubishi Tanabe Pharma
• Sterna Biologicals
• Mesoblast
• Oncostellae
• First Wave Bio
• Oppilan Pharma
• NeuClone
• Morphic Therapeutic
• Metacrine
• LG Chem
• Koutif Therapeutics
• Kiniksa Pharmaceuticals
• Avaxia Biologics
• Algernon Pharmaceuticals
• Akeso Biopharma
• Kaleido Biosciences
• Rebiotix
• Prometheus Biosciences
• PNB Vesper Life Science
• Pandion Therapeutics
• Palatin Technologies
• Theravance Biopharma
• VHsquared
• Seres Therapeutics
• Hoffmann-La Roche
• Provention Bio
• Bacainn Therapeutics
• Landos Biopharma
• Bristol-Myers Squibb
• Janssen Research & Development
• GlaxoSmithKline
• Assembly Biosciences
• NuBiyota
• Tarus Therapeutics
• Servatus
• Athos Therapeutics
• Aclaris Therapeutics
• Exeliom Biosciences SAS
• Voronoi Group
• Ventria Bioscience
• TheraSource LLC
• Synlogic Inc
• Synedgen
• Surrozen Inc
• StemRIM Inc
• Shaperon Inc
• Sareum Holdings
• Saniona
• RhemaStem
• Regentys
• Progenity
• Pharmaxis
• Pharmabiome
• PanTheryx
• Oncodesign
• Nyrada
• Microbiotica
• MAKScientific
• KoBioLabs
• Istesso
• Intract Pharma
• Innovimmune Biotherapeutics
• Impetis Biosciences
• Finch Therapeutics Group
• Vivreon Biosciences
• NuMedii
• Intact Therapeutics
• Giiant Pharma
Ulcerative Colitis Pipeline Therapies
- Mirikizumab
- Risankizumab
- Etrasimod
Ulcerative Colitis Pipeline Therapeutics Assessment
- By development stage
- By product type
- By route of administration
- By molecule type
- By MOA type
Scope of the Ulcerative Colitis Pipeline Report
- Coverage: Global
- Key Ulcerative Colitis Companies: Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, GlaxoSmithKline, Galapagos, Celgene, Gossamer Bio, Eisai, UCB, Suzhou Connect Biopharmaceuticals, Landos Biopharma, Seres Therapeutics, Abivax, Genentech, ParaTech A/S, I-Mab Biopharma, Sublimity Therapeutics Holdco, Reistone Biopharma, Qu Biologics, PurGenesis Technologies, Protagonist Therapeutics, Pfizer, Palobiofarma, Novartis Pharmaceuticals, Bristol-Myers Squibb, Bridge Biotherapeutics, Amgen, Allergan, Applied Molecular Transport, AbGenomics International, Protalix BioTherapeutics, LTT Bio-Pharma Co Ltd, Dongwha pharma, Seres Therapeutics, Innovation Pharmaceuticals, Holy Stone Healthcare, SLA Pharma, OSE Immunotherapeutics, Bridge Biotherapeutics, Mitsubishi Tanabe Pharma, Sterna Biologicals, Mesoblast, Oncostellae, First Wave Bio, Oppilan Pharma, NeuClone, Morphic Therapeutic, Metacrine, LG Chem, Koutif Therapeutics, Kiniksa Pharmaceuticals, Avaxia Biologics, Algernon Pharmaceuticals, Akeso Biopharma, Kaleido Biosciences, Rebiotix, Prometheus Biosciences, PNB Vesper Life Science, Pandion Therapeutics, Palatin Technologies, Theravance Biopharma, VHsquared, Seres Therapeutics, Hoffmann-La Roche, Provention Bio, Bacainn Therapeutics, Landos Biopharma, Bristol-Myers Squibb, Janssen Research & Development, GlaxoSmithKline, Assembly Biosciences, NuBiyota, Tarus Therapeutics, Servatus, Athos Therapeutics, Aclaris Therapeutics, Exeliom Biosciences SAS, Voronoi Group, Ventria Bioscience, TheraSource LLC, Synlogic Inc, Synedgen, Surrozen Inc, StemRIM Inc, Shaperon Inc, Sareum Holdings, Saniona, RhemaStem, Regentys, Progenity, Pharmaxis, Pharmabiome, PanTheryx, Oncodesign, Nyrada, Microbiotica, MAKScientific, KoBioLabs, Istesso, Intract Pharma, Innovimmune Biotherapeutics, Impetis Biosciences, Finch Therapeutics Group, Vivreon Biosciences, NuMedii, Intact Therapeutics, Giiant Pharma, among others.
- Key Ulcerative Colitis Pipeline Therapies: Mirikizumab, Risankizumab, Etrasimod, and others
Find out more about the Ulcerative Colitis treatment options in development @ https://www.delveinsight.com/sample-request/ulcerative-colitis-uc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Table of Contents
1. Introduction
2. Executive Summary
3. Overview
4. Pipeline Therapeutics
5. Late-Stage Products (Phase III)
6. Mid-Stage Products (Phase II)
7. Early Stage Products (Phase I/II)
8. Preclinical Stage Products
9. Discovery Stage Products
10. Therapeutic Assessment
11. Inactive Products
12. Collaborations Assessment- Licensing / Partnering / Funding
13. Unmet Needs
14. Market Drivers and Barriers
15. Appendix
16. About DelveInsight
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About DelveInsight
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