Crohn's Disease Pipeline Insights, FDA Approvals, Drugs, Companies Report | DelveInsight

DelveInsight's, "Crohn's Disease Pipeline Insight" report provides comprehensive insights about 70+ companies and 80+ pipeline drugs in Crohn's Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Crohn's Disease Pipeline Report

* In January 2025:- Janssen-Cilag Ltd.:- A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease. The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
* In January 2025:- Tr1X Inc.:- A Phase 1/2a, Open Label, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX103 in Subjects with Moderate to Severe Treatment-Refractory Crohn's Disease. This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
* In Janssen Pharmaceutical K.K.: - A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease. The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
* In January 2025:- AbbVie:- Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
* DelveInsight's Crohn's Disease pipeline report depicts a robust space with 70+ active players working to develop 80+ pipeline therapies for Crohn's Disease treatment.
* The leading Crohn's Disease companies such as Janssen, RedHill Biopharma, Amgen, Pfizer, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Abbvie, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, Priothera , and others.
* Promising Crohn's Disease Pipeline Therapies such as Etrasimod, Infliximab, MEDI2070, Filgotinib, Risankizumab 600 mg IV, CT-P13 , and others.

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Crohn's Disease Emerging Drugs Profile

* Ozanimod: Bristol-Myers Squibb

Ozanimod (Zeposia) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood. The company is currently investigating the drug for the treatment of moderately to severely active Crohn's disease in the ongoing Phase III YELLOWSTONE clinical trial program.

* Etrasimod: Pfizer

Etrasimod is an investigational oral drug being studied for the treatment of Crohn's disease. It is a selective sphingosine 1-phosphate receptor modulator designed to treat immune-mediated inflammatory disorders. Clinical trials, such as the CULTIVATE trial, are evaluating the efficacy, safety, and tolerability of etrasimod in subjects with moderately to severely active Crohn's disease. Etrasimod has shown promising results in inducing and maintaining remission in patients with Crohn's disease, demonstrating significant improvements compared to a placebo in clinical trials. Currently, the drug is in the Phase III stage of its development for the treatment of Crohn's Disease.

* CBP-307: Suzhou Connect Biopharmaceuticals

CBP-307 is an orally available, next generation small molecule modulator of the sphingosine-1-phosphate 1 receptor (S1P1), a G-protein coupled receptor (GPCR) that plays a central role in regulating T cell movement and is a validated therapeutic target. S1P1 mediates the transit of T cells from lymph nodes into circulation and, as a result, the migration of T cells to tissues to release inflammatory mediators.6-10 CBP-307 causes T cells to internalize S1P1, trapping T cells inside the lymph nodes and preventing them from migrating to sites of inflammation.CBP-307 has high potency and selectivity11 and is designed to be the most potent modulator of the S1P1 drug class, if approved. CBP-307 has no significant activity for S1P3, a receptor subtype with known safety concerns, and significantly lower potency for S1P4 and S1P5 than S1P1. Currently, the drug is in the Phase II stage of its development for the treatment of Crohn's Disease.

* IMU-856: Immunic

IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound appears to represent a new and potentially disruptive approach for the treatment of intestinal diseases by potentially restoring the intestinal barrier function while maintaining immunocompetency. Currently, the drug is in the Phase I stage of its development for the treatment of Crohn's Disease.

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Crohn's Disease Companies

Janssen, RedHill Biopharma, Amgen, Pfizer, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Abbvie, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, Priothera, and others.

Crohn's Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Crohn's Disease Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the Crohn's Disease Pipeline Report

* Coverage- Global
* Crohn's Disease Companies- Janssen, RedHill Biopharma, Amgen, Pfizer, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Abbvie, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, Priothera, and others.
* Crohn's Disease Pipeline Therapies- Etrasimod, Infliximab, MEDI2070, Filgotinib, Risankizumab 600 mg IV, CT-P13, and others.
* Crohn's Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Crohn's Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Crohn's Disease: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Crohn's Disease- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Ozanimod: Bristol-Myers Squibb
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* CBP-307: Suzhou Connect Biopharmaceuticals
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* IMU-856: Immunic
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Crohn's Disease Key Companies
* Crohn's Disease Key Products
* Crohn's Disease- Unmet Needs
* Crohn's Disease- Market Drivers and Barriers
* Crohn's Disease- Future Perspectives and Conclusion
* Crohn's Disease Analyst Views
* Crohn's Disease Key Companies
* Appendix

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