6 Gastroenterology Headlines You Missed in October 2025

October was a milestone month in gastroenterology, marked by multiple US Food and Drug Administration (FDA) decisions that continue to expand treatment flexibility and improve patient experience across inflammatory bowel disease (IBD). In addition to upadacitinib (Rinvoq)’s updated indication allowing use earlier in the treatment sequence when TNF blockers are considered clinically inadvisable, the Agency also approved a single-dose monthly formulation of mirikizumab (Omvoh), simplifying maintenance therapy for eligible patients. New long-term data from the LUCENT-3 extension study further reinforced mirikizumab’s staying power, demonstrating sustained clinical, symptomatic, endoscopic, and histologic benefit through 4 years, even among patients previously failing biologics or other advanced therapies.

Beyond therapeutics, October also delivered key developments in colorectal cancer screening and continued momentum in emerging areas like eosinophilic esophagitis and metabolic disease. The American College of Physicians weighed in with a position paper analyzing performance measures in colorectal cancer surveillance, aiming to guide policymakers and optimize screening practices. Meanwhile, research presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting highlighted persistent disparities in GLP-1 RA clinical trial enrollment and strengthened dupilumab’s growing role as a cornerstone in eosinophilic esophagitis care.

Check out this October 2025 gastroenterology month in review for a recap of HCPLive’s coverage of the top GI news and research from the past few weeks:

GI FDA Updates From October

FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD

On October 13, 2025, the FDA approved a supplemental new drug application (sNDA) updating the indication statement for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active UC and moderately to severely active CD, now allowing for use of upadacitinib after patients have received ≥ 1 approved systemic therapy in the event tumor necrosis factor (TNF) blockers are clinically inadvisable. Previously, upadacitinib was only indicated for adults who had an inadequate response or intolerance to ≥ 1 blockers.

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

On October 27, 2025, the FDA approved a single-injection, once-monthly maintenance regimen of mirikizumab-mrkz (Omvoh) 200 mg/2 mL for subcutaneous use in adults with moderately to severely active UC. The decision was based on results from a phase 1 study comparing a single 200 mg/2 mL subcutaneous injection to 2 100 mg/1 mL injections in participants, ultimately confirming mirikizumab single-injection is bioequivalent to the previously approved 2-injection regimen.

Trial Readouts in IBD

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%).

Colorectal Screening

ACP Releases Position Paper on Colorectal Cancer Screening, Surveillance

On October 21, 2025, the American College of Physicians (ACP) released a position paper reviewing current performance measures for colorectal cancer screening and surveillance, ultimately supporting 1 of 5 reviewed measures. Published in Annals of Internal Medicine, the paper seeks to inform physicians, payers, and policymakers in their selection and use of performance measures and make recommendations for measures that could be developed.

HCPLive at ACG 2025

Demographic Disparities in GLP-1 RA Trial Enrollment Raise Inclusivity, Validity Concerns

Research presented at ACG 2025 sheds light on notable demographic and regional disparities in access to GLP-1 RA clinical trials for weight loss, raising concerns about the external validity of such trials. Specifically, results showed substantial underrepresentation of Black, Hispanic, and American Indians/Natives in GLP-1 RA RCTs, especially in the US, despite bearing a greater obesity burden.

Solidifying Dupilumab’s Role in Eosinophilic Esophagitis Care, With Evan Dellon, MD, MPH

Data from a post-hoc analysis of LIBERTY EoE TREET and a pooled analysis of LIBERTY EoE TREET and EoE KIDS presented at ACG 2025 solidify dupilumab (Dupixent)’s role in EoE care, spotlighting sustained reductions in dysphagia and odynophagia as well as endoscopic features of the disease. In this interview with HCPLive, Evan Dellon, MD, MPH, a professor of medicine and adjunct professor of epidemiology at the University of North Carolina School of Medicine in Chapel Hill, breaks down the findings and what they mean for dupilumab in the context of EoE.