Crohn's disease - Pipeline Insight, 2025

DelveInsight's, "Crohn's disease - Pipeline Insight, 2025" report provides comprehensive insights about 40+ companies and 50+ 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.

Geography Covered:

• Global coverage

Crohn's disease: Understanding

Crohn's disease: Overview

Crohn disease (CD) and ulcerative colitis (UC) are two conditions commonly referred to as inflammatory bowel disease (IBD). They are immunologically mediated inflammatory diseases of the gastrointestinal tract. In CD, the inflammation extends through the entire thickness of the bowel wall from the mucosa to the serosa. The disease runs a relapsing and remitting course. With multiple relapses, the CD can progress from initially mild to moderate inflammatory conditions to severe penetrating (fistulization) or stricturing disease. Crohn disease can affect any part of the gastrointestinal tract. About one-third of patients have small bowel involvement, especially the terminal ileum, another 20% have only colon involvement and about 50% have involvement of both the colon and small bowel. There is no cure and most patients experience bouts of remissions and relapse at unpredictable times. This disease leads to very poor quality of life. The most common symptoms include diarrhea, abdominal cramping and pain, and weight loss. Other possible symptoms are anemia, eye redness or pain, fatigue, fever, joint pain or soreness, nausea, loss of appetite, and skin changes that involve red, tender bumps under the skin. Crohn's disease can also cause complications such as intestinal obstruction, fistulas, abscesses, anal fissures, ulcers, and malnutrition. Additionally, it can lead to symptoms outside of the digestive tract, including sores or swelling in the eyes and skin changes. The level of pain and the specific symptoms can vary depending on the location and severity of the inflammation. It's important to note that the symptoms of Crohn's disease can vary from person to person and may change over time.

The pathophysiology is multifactorial and involves genetic predisposition, infectious, immunological, environmental, and dietary. The characteristic transmural inflammation can include the entire GI tract from mouth to the perianal area; although most frequently involve terminal ileum and right colon. The initial lesion starts out as an infiltrate around an intestinal crypt. This goes on to develop ulceration first in the superficial mucosa and involves deeper layers. As the inflammation progresses, non-caseating granulomas form involving all layers of the intestinal wall. It can develop into the classic cobblestone mucosal appearances and skip lesions along the length of the intestine sparing areas with normal mucosa. As the flare of Crohn settles, scarring replaces the inflamed areas of the intestines. There is no single test to diagnose Crohn's disease, but a combination of tests, including blood tests, stool studies, colonoscopy, and diagnostic imaging tests, can help confirm a diagnosis. A computed tomography scan/magnetic resonance enterography (MRE) of the abdomen and pelvis can detect abscesses and fistulization. The choice between CT or MRE is largely directed at minimizing radiation exposure in younger populations. Both give a higher definition of the diseased intestine. Treatment for Crohn's disease may involve medication, surgery, and nutritional supplements. Anti-inflammatory drugs are often the first step in treatment, and surgery may be necessary if other treatments do not relieve symptoms. Nutritional changes, stress reduction, and other approaches can also help manage symptoms. An interprofessional team, including a nurse practitioner or internist, hematologists, gastroenterologists, general surgeons, dietitians, stoma nurses, and a pharmacist, is necessary to manage Crohn's disease effectively. The goal of medical treatment is to reduce inflammation, relieve symptoms, and limit complications. Regular screening for skin cancers, bone density, and colon cancer is also necessary. Crohn disease is a chronic inflammatory disorder with no cure. Despite optimal therapy, most patients have a poor quality of life. The life expectancy is slightly reduced to the development of malignancies, genitourinary disease, liver, and biliary tract complications. The majority of Crohn patients who develop complications need surgery and as the disease progresses, some need multiple procedures. Overall, patients with the proximal disease have higher mortality than those with the distal disease.

"Crohn's disease - Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. A detailed picture of the Crohn's disease pipeline landscape is provided which includes the disease overview and Crohn's disease treatment guidelines. The assessment part of the report embraces, in depth Crohn's disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Crohn's disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Crohn's disease R&D. The therapies under development are focused on novel approaches to treat/improve Crohn's disease.

Crohn's disease Emerging Drugs Chapters

This segment of the Crohn's disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Crohn's disease Emerging Drugs

• RO7790121: Roche

RO7790121 is an investigational monoclonal antibody developed by Roche for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). Its mechanism of action targets TL1A, a cytokine involved in regulating gut mucosal immunity and inflammation, which plays a key role in the pathogenesis of inflammatory bowel diseases. By inhibiting TL1A, RO7790121 aims to reduce abnormal immune responses in the gut, thereby controlling inflammation and improving symptoms in patients who have not responded adequately to standard treatments. RO7790121 is currently being evaluated in Phase III clinical trials and is not yet approved by regulatory authorities.

• AGMB-129: AgomAb Therapeutics

AGMB-129 is an oral, small molecule GI-restricted inhibitor of ALK5 (or TGF-B RI) currently in clinical development for the treatment of Fibrostenosing Crohn's Disease (FSCD). TGF-B is a major driver of fibrosis. AGMB-129 is specifically designed to inhibit ALK5/TGF-B in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. In a Phase I trial in healthy subjects, single- and multiple-dose AGMB-129 was generally well-tolerated at all doses tested. In addition, the trial showed high local exposure to AGMB-129 in the ileum but no clinically relevant systemic exposure, demonstrating that the GI restricted mechanism may operate efficiently in humans. Fibrostenosing complications occur in nearly 50% of Crohn's disease patients and are the leading cause of bowel resection surgery, however there are no approved specific therapies for FSCD. AGMB-129 has received US FDA Fast Track Designation. Currently the drug is in Phase II stage of its clinical trial for the treatment of Crohn's Disease.

• GSK4528287: GSK

GSK4528287 is an investigational drug developed by GSK for the treatment of inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. It is currently in Phase I clinical trials, where its safety, tolerability, pharmacokinetics, and target engagement are being evaluated in healthy participants. While the exact mechanism of action has not been publicly disclosed, the drug is designed to modulate immune pathways implicated in gut inflammation, aiming to provide therapeutic benefit in immune-mediated digestive disorders.

Crohn's disease: Therapeutic Assessment

This segment of the report provides insights about the different Crohn's disease drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Crohn's disease

There are approx. 45+ key companies which are developing the therapies for Crohn's disease. The companies which have their Crohn's disease drug candidates in the most advanced stage, i.e. Phase III include Roche.

Phases

DelveInsight's report covers around 50+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Crohn's disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Crohn's disease therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Crohn's disease drugs.

Crohn's disease Report Insights

• Crohn's disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Crohn's disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Crohn's disease drugs?
• How many Crohn's disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Crohn's disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Crohn's disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Crohn's disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Ventyx Biosciences
• Teva Branded Pharmaceutical
• Boehringer Ingelheim
• Reistone Biopharma Company Limited
• Celgene
• RedHill Biopharma Limited
• Provention Bio
• Prometheus Biosciences
• Morphic Therapeutic
• Pfizer
• Medibiofarma
• Exeliom Biosciences
• Bristol-Myers Squibb
• AstraZeneca
• AgomAb Therapeutics
• Orchard Therapeutics

Key Products

• VTX958
• TEV-48574
• Spesolimab
• SHR0302
• RPC1063
• RHB-104
• PRV-6527
• PRA023
• MORF-057
• PF-06651600
• MBF-018
• EXL01
• Deucravacitinib
• AZD7798
• AGMB-129
• OTL-104