Crohn’s disease Pipeline Summary

DelveInsight’s, “Crohn’s disease - Pipeline Insight, 2026” report provides comprehensive insights about 40+ companies and 55+ 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's disease (CD) is a chronic, relapsing inflammatory bowel disease (IBD) characterized by transmural inflammation that can affect any part of the gastrointestinal tract from the mouth to the anus, although the terminal ileum and colon are most commonly involved. The disease is marked by discontinuous "skip lesions" and may present with inflammatory, stricturing, or penetrating phenotypes. Crohn's disease results from a complex interaction between genetic susceptibility, immune dysregulation, environmental factors, and alterations in the intestinal microbiome, leading to chronic intestinal inflammation.

Common symptoms include persistent diarrhea, abdominal pain, weight loss, fatigue, fever, anorexia, and rectal bleeding, while complications such as fistulas, abscesses, strictures, and perianal disease frequently occur. Extraintestinal manifestations involving the joints, skin, eyes, hepatobiliary system, and other organs are also common and contribute to disease burden.

The pathophysiology of Crohn's disease involves loss of intestinal immune homeostasis in genetically predisposed individuals, resulting in an exaggerated immune response to commensal gut microbiota. Genetic variants affecting genes such as NOD2, ATG16L1, IRGM, and IL23R impair epithelial barrier integrity, autophagy, and innate immune function, while activation of TNF-?, IL-12/23, IL-17, interferon-?, and other pro-inflammatory pathways drives persistent transmural inflammation and tissue injury. Chronic inflammation leads to ulceration, fibrosis, bowel wall thickening, fistula formation, and intestinal strictures.

Diagnosis is established through a combination of ileocolonoscopy with biopsy, histopathological evaluation, cross-sectional imaging using magnetic resonance enterography (MRE) or CT enterography, capsule endoscopy in selected patients, and laboratory assessment including inflammatory biomarkers such as C-reactive protein (CRP) and fecal calprotectin. Differential diagnosis includes ulcerative colitis, infectious enterocolitis, intestinal tuberculosis, ischemic colitis, and other causes of chronic intestinal inflammation.

Management of Crohn's disease aims to induce and maintain clinical and endoscopic remission, prevent disease progression, and improve quality of life through individualized, treat-to-target strategies. Corticosteroids are used for induction of remission but are not recommended for long-term maintenance, while immunomodulators such as azathioprine, 6-mercaptopurine, and methotrexate are used in selected patients. Biologic therapies, including anti-TNF agents (infliximab, adalimumab), anti-integrin therapy (vedolizumab), and IL-12/23 or IL-23 inhibitors (ustekinumab, risankizumab, mirikizumab), together with Janus kinase (JAK) inhibitors and S1P receptor modulators under investigation, have significantly expanded treatment options for moderate-to-severe disease. Nutritional support, smoking cessation, vaccination, and regular monitoring are essential components of care, while surgery is reserved for complications such as strictures, fistulas, abscesses, or medically refractory disease, recognizing that surgery is not curative and recurrence remains common.

“Crohn’s disease - Pipeline Insight, 2026" 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 (afimkibart; previously PF-06480605/RVT-3101) is an investigational anti-TL1A monoclonal antibody being developed by Roche for the treatment of moderately to severely active Crohn's disease. In the Phase III SIBERITE-2 trial, afimkibart is administered as an intravenous induction therapy followed by subcutaneous maintenance dosing and is being compared with placebo in patients who have had an inadequate response or intolerance to conventional or advanced therapies. The randomized, double-blind, placebo-controlled study is evaluating clinical remission (CDAI <150) and endoscopic response at Week 12, while also assessing safety, patient-reported outcomes, and quality of life. The trial plans to enroll approximately 425 participants, with primary completion expected in December 2028.

Duvakitug: Sanofi/ Teva Pharmaceuticals

Duvakitug (SAR447189) is an investigational anti-TL1A monoclonal antibody being co-developed by Sanofi and Teva for the treatment of moderately to severely active Crohn's disease. In the Phase III STARSCAPE-1 trial, subcutaneous duvakitug is being evaluated against placebo in adults with an inadequate response, loss of response, or intolerance to conventional or advanced therapies. The randomized, double-blind, placebo-controlled study will enroll approximately 980 participants and assess clinical remission, endoscopic response, and safety over a 12-week induction period, followed by an optional maintenance study.

AGMB-129: AgomAb Therapeutics

AGMB-129 is an investigational oral, gastrointestinal-restricted small-molecule inhibitor of activin receptor-like kinase 5 (ALK5/TGF-? receptor I) being developed by Agomab Therapeutics for fibrostenosing Crohn's disease, a form characterized by intestinal fibrosis and strictures. In the Phase II STENOVA-2 trial, AGMB-129 is being evaluated against placebo in patients with symptomatic fibrostenotic Crohn's disease to assess its safety, efficacy, and ability to reduce fibrotic bowel narrowing while patients continue standard therapy. The gut-restricted design aims to inhibit pro-fibrotic TGF-? signaling locally while minimizing systemic exposure and associated toxicities. The study will also assess improvements in obstructive symptoms, imaging and endoscopic outcomes, and overall safety, following encouraging results from earlier Phase IIa studies.

AZD7798: AstraZeneca

AZD7798 is an investigational biologic therapy being developed by AstraZeneca for the treatment of moderate-to-severe Crohn's disease. In the Phase IIa AMALTHEA trial, AZD7798 is being evaluated in a randomized, double-blind, placebo-controlled study to assess its efficacy and safety in adults with an inadequate response or intolerance to conventional or advanced therapies. The study enrolled 120 participants, with the primary endpoint evaluating Crohn's Disease Activity Index (CDAI) remission at Week 12, alongside endoscopic response, remission, pharmacokinetics, and immunogenicity assessments. The trial is active and aims to determine whether AZD7798 can provide meaningful clinical and endoscopic improvements while maintaining an acceptable safety profile.

TRX103: Tr1X, Inc.

TRX103 is an investigational autologous engineered regulatory T-cell (Treg) therapy being developed by Tr1X for patients with moderate-to-severe, treatment-refractory Crohn's disease. In the Phase I/IIa RESTORE study, a single intravenous infusion of TRX103 is being evaluated in an open-label, dose-escalation trial, with selected cohorts receiving low-dose cyclophosphamide conditioning before treatment. The study is assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of TRX103, including improvements in clinical remission, endoscopic healing, inflammatory biomarkers, and quality of life in patients who have failed at least two advanced therapies. TRX103 is designed to restore immune tolerance by enhancing antigen-specific Treg activity, offering the potential for durable disease control through targeted immune modulation rather than broad immunosuppression.

Further product details are provided in the report……..

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. 40+ 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 55+ 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?

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Key Players

• Teva Branded Pharmaceutical
• Sanofi
• Roche
• AgomAb Therapeutics
• RedHill Biopharma Limited
• Merck & Co
• AstraZeneca
• Orchard Therapeutics
• Direct Biologics
• Jiangsu Carephar Pharmaceutical Co., Ltd.
• Takeda
• Tr1X, Inc.
• Eli Lilly and Company
• Hope Medicine
• Mirador Therapeutics, Inc.
• Benethera (Shaoxing) Biotechnology Co., Ltd.
• Rise Therapeutics
• Seres Therapeutics
• Flightpath Biosciences
• Abbvie
• Redx Pharma

Key Products

• Duvakitug
• Brivekimig
• RO7790121
• AGMB-129
• RHB-204
• Tulisokibart
• AZD7798
• OTL-104
• DB-3Q
• H021
• Zasocitinib
• TRX103
• Zotemtegrast
• HB-adMSCs
• MT-501
• BDHK-2009
• R 3750
• SER 603
• FP 385
• ABBV-8736
• RXC008