Q1 2025 Recap: Gastroenterology News and Updates

The first quarter of 2025 saw several notable developments in gastroenterology, ranging from key regulatory approvals to promising clinical trial data and advancements in colorectal cancer screening.

In US Food and Drug Administration (FDA) news, the agency expanded treatment options for Crohn’s disease (CD) with the approvals of mirikizumab and guselkumab, while a rolling New Drug Application (NDA) submission for apraglutide signaled potential progress on the horizon for patients with short bowel syndrome (SBS). Meanwhile, clinical trial data highlighted new possibilities in inflammatory bowel disease (IBD) and beyond, including fecal microbiota transplantation for type 1 diabetes-related gastroenteropathy and promising results for icotrokinra in ulcerative colitis (UC).

In colorectal cancer screening, new research reinforced the value of annual stool-based testing for low-adherence populations. Updated US Multi-Society Task Force on Colorectal Cancer (USMSTF) guidance aimed to optimize bowel preparation for colonoscopy, as spotlighted in a 6-part HCPLive RX Review with co-first authors Brian Jacobson, MD, MPH, and Joseph Anderson, MD.

The recap offers a look back at the top developments in gastroenterology from the first 3 months of 2025:

GI Regulatory Updates

FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

Starting Q1 off strong, on January 15, 2025, the FDA approved Lilly’s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active CD, marking the interleukin-23p19 antagonist’s second approval in IBD since 2023, when it was approved as a first-in-class treatment for moderately to severely active UC.

Related: Marla Dubinsky, MD: Ushering In a New Era of Crohn’s Disease Treatment with Mirikizumab

FDA Approves Guselkumab (Tremfya) For Crohn Disease

In the second CD approval of Q1, the FDA approved Johnson & Johnson’s guselkumab (Tremfya) based on data from multiple phase 3 trials, including the GALAXI trials, which found guselkumab outperformed ustekinumab (Stelara) for multiple endoscopic endpoints. Like mirikizumab, the approval of guselkumab for CD marked the agent’s second approval for IBD, building upon a previous indication for UC.

Ironwood Announces Rolling Apraglutide NDA Submission for Short Bowel Syndrome

Ironwood Pharmaceuticals announced the initiation of a rolling NDA submission for apraglutide for the treatment of patients with SBS who are dependent on parenteral support. Along with efficacy and tolerability data from STARS, the NDA will also include data from the open-label extension study, STARS Extend, demonstrating an increased number of patients on apraglutide achieving enteral autonomy over time.

Clinical Trial Updates in Gastroenterology

Long-Term VIVID-2 Data for Mirikizumab in Crohn’s Disease, with Edward Barnes, MD, MPH

Just weeks after the FDA approved mirikizumab for moderately to severely active CD, findings from the VIVID-2 open-label extension study were presented at the 2025 Crohn’s and Colitis Congress, highlighting the IL-23p19 antagonist’s impact on long-term clinical and endoscopic outcomes.

FMT Shows Promise for Type 1 Diabetes, Gastroenteropathy Treatment in Pilot Trial

Findings from a first-of-its-kind randomized clinical pilot trial suggest fecal microbiota transplantation (FMT) may offer a safe and effective treatment option for patients with type 1 diabetes and gastroenteropathy. Results of the trial, coined “Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy” (FADIGAS), showed FMT was safe, reduced gastrointestinal symptoms, and improved quality of life.

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. 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.

What’s New in Colorectal Cancer Screening

Annual Stool-Based CRC Screening Shows Greatest Benefit for Low Adherence Populations

While colonoscopy is widely regarded as the “gold standard” for colorectal cancer screening, noninvasive tests have gained traction in recent years to help improve screening rates among patients who are unable to or do not wish to receive a colonoscopy.

Using the validated Colorectal Cancer Simulated Population model for Incidence and Natural history (CRC-SPIN) microsimulation model, this study found annual colorectal cancer screening with fecal immunochemical testing is the most effective and least costly strategy in patient populations where screening adherence is low. In contrast, triennial blood-based screening was the least effective and most costly strategy.

USMSTF Guidance on Optimizing Bowel Preparation for Colonoscopy

Even with the advent of several new noninvasive testing options, 3 of which were approved by the FDA in 2024 alone, colonoscopy remains the preferred approach for colorectal cancer screening and prevention. However, its effectiveness relies heavily on adequate bowel preparation, with inadequate preparation potentially leading to missed lesions, prolonged procedures, and the need for repeat exams.

New guidance from the USMSTF provides clinical recommendations to address challenges related to bowel preparation for colonoscopy, focusing specifically on outpatients at low risk for inadequate bowel preparation. In this HCPLive RX Review, Brian Jacobson, MD, MPH, and Joseph Anderson, MD, discuss the nuances of the guidance, potential barriers to its implementation, and areas for future research.