2025 was a transformative year in gastroenterology, driven by rapid therapeutic innovation, evolving clinical guidelines, and a growing emphasis on long-term disease control and patient-centered care. Across inflammatory bowel disease, functional GI disorders, and colorectal cancer prevention, the field saw both an expansion of treatment options and greater clarity around how best to deploy them in clinical practice.

Inflammatory bowel disease (IBD) dominated the year’s headlines, particularly with multiple US Food and Drug Administration (FDA) approvals that reshaped the Crohn’s disease (CD) and ulcerative colitis (UC) landscapes. New and expanded indications for IL-23 inhibitors reflected a shift toward high-efficacy, durable therapies, supported by increasingly robust long-term data and more flexible dosing strategies. At the same time, late-stage trial results for agents such as obefazimod and icotrokinra reinforced the depth of the IBD pipeline, while updated American Gastroenterological Association (AGA) guidelines emphasized earlier use of advanced therapies to improve outcomes.

Beyond IBD, 2025 delivered meaningful progress in broader gastroenterology care. The FDA approval of linaclotide for pediatric irritable bowel syndrome with constipation (IBS-C) addressed a long-standing unmet need, while new AGA guidance on gastroparesis and US Multi-Society Task Force on Colorectal Cancer (USMSTF) recommendations on bowel preparation highlighted continued efforts to standardize and optimize care. Together, these developments define 2025 as a year of consolidation and forward momentum that strengthened evidence-based practice while setting the stage for the next generation of GI innovation.

FDA News

FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

On January 15, 2025, the FDA approved Lilly’s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active CD, the therapy’s second approval in IBD since 2023 when it was approved as a first-in-class treatment for moderately to severely active UC. The approval made mirikizumab the first biologic treatment in more than 15 years to have disclosed 2-year phase 3 efficacy data in CD at the time of approval.

FDA Approves Guselkumab (Tremfya) For Crohn Disease

On March 20, 2025, the FDA approved guselkumab (Tremfya) for the treatment of adults with moderately to severely active CD based on data from multiple phase 3 trials, including the GALAXI trials, which found guselkumab outperformed ustekinumab (Stelara) for multiple endoscopic endpoints. With the approval, the agent boasts indications for both moderately to severely active CD and moderately to severely active UC.

FDA Approves Guselkumab (Tremfya) Subcutaneous Induction Regimen for Ulcerative Colitis

On September 19, 2025, the FDA approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya) for the treatment of adults with moderately to severely active UC, making guselkumab the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and CD. The UC SC induction approval was based on results from the phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of guselkumab SC induction therapy in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy and advanced therapies.

FDA Approves Single-Dose Formulation of Mirikizumab-mrkz for Ulcerative Colitis

On October 27, 2025, the FDA approved mirikizumab-mrkz (Omvoh) as a single-injection once-monthly maintenance regimen for adult patients with UC based on results from a phase 1 study comparing a single 200 mg/2 mL subcutaneous injection to a pair of 100 mg/1 mL injections and confirming the bioequivalence of the new 1-dose treatment to the previously approved 2-dose regimen.

FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C

On November 5, 2025, the FDA approved linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population. The approval was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C.

Trial Updates and New Guidelines

ANTHEM-UC: Icotrokinra (JNJ-2113) Shows Promise for Ulcerative Colitis

On March 10, 2025, Johnson & Johnson announced positive topline results from the phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113) in adults with moderately to severely active UC showing the study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at week 12.

Obefazimod Meets Primary Endpoint in Phase 3 ABTECT Program for Ulcerative Colitis

On July 23, 2025, Abivax SA announced positive topline results from its phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials evaluating obefazimod (ABX464) in adult patients with moderately to severely active UC. Results from both trials showed obefazimod met its FDA primary endpoint of clinical remission at week 8 in the 50 mg once-daily dose regimens.

LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit in Ulcerative Colitis Through 4 Years

On October 7, 2025, Eli Lilly and Company announced data from the phase 3 LUCENT-3 open-label extension study establishing mirikizumab-mrkz (Omvoh) as the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active UC achieve sustained, long-term outcomes through 4 years. Results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%).

AGA Releases Gastroparesis Clinical Practice Guideline, Highlights Unmet Needs

On September 19, 2025, the AGA released its clinical practice guideline on the management of gastroparesis, offering 12 conditional recommendations for the diagnosis and management of the complex gastric motility disorder. The document provides recommendations for ensuring an accurate diagnosis and identifying evidence-based, effective treatments among the available pharmacologic and procedural interventions for patients with idiopathic gastroparesis or gastroparesis related to diabetes.

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active CD, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

Feature Content/Podcasts

USMSTF Guidance on Optimizing Bowel Preparation for Colonoscopy

The USMSTF, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy, released new guidance providing clinical recommendations to address challenges related to bowel preparation for colonoscopy, focusing specifically on outpatients at low risk for inadequate bowel preparation.

In a 6-part HCPLive RX Review, Brian Jacobson, MD, MPH, and Joseph Anderson, MD, discuss their work as co-authors on the recent USMSTF consensus statements and explain why adequate bowel preparation is so important in the context of colonoscopy.

Bridging Gut and Skin Care: A Call for Collaboration in Inflammatory Disease Management

In this 3-part HCPLive Special Report, advisory board members Adelina Hung, MD, and Raj Chovatiya, MD, PhD, discuss the connection between immune-mediated inflammatory diseases in GI and dermatology, unmet needs in management, and what the future may hold for patient care and drug development.