Gastroenterology Month in Review: January 2025

The field of gastroenterology kicked off 2025 with a wave of significant developments, setting the stage for what could be a transformative year in research, treatment advancements, and disease management.

January saw major regulatory milestones, including the US Food and Drug Administration’s approvals of mirikizumab (Omvoh) for Crohn’s disease (CD) and generic rifaximin for irritable bowel syndrome with diarrhea (IBS-D) as well as a rolling New Drug Application (NDA) submission for apraglutide for short bowel syndrome (SBS). Beyond pipeline news, the month was also characterized by new GI research about fecal microbiota transplantation (FMT) for treating type 1 diabetes and gastroenteropathy; the association between metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction and alcohol-related liver disease (MetALD) cardiometabolic risk factors with inflammatory bowel disease (IBD) risk; and the best colorectal cancer (CRC) screening strategies for low adherence populations.

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

GI Pipeline News

FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

On January 15, 2025, the US Food and Drug Administration approved Lilly’s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active CD based on positive results from the phase 3 VIVID-1 study. The decision marked 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 ulcerative colitis (UC).

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

FDA Grants Tentative Approval to Generic Version of Rifaximin for IBS-D

Just days later on January 23, 2025, the FDA granted tentative approval to Amneal Pharmaceuticals’ rifaximin 550 mg oral tablets, which references Bausch Health’s Xifaxan, for the treatment of adults with IBS-D. The tentative nature of the approval was due to the product’s involvement in litigation.

Ironwood Announces Rolling Apraglutide NDA Submission for Short Bowel Syndrome

Rounding out the month in the GI pipeline was Ironwood Pharmaceuticals’ announcement of the initiation of a rolling NDA submission for apraglutide for the treatment of patients with SBS who are dependent on parenteral support. The company additionally detailed plans to announce new data from its open-label extension study, STARS Extend, demonstrating an increased number of patients on apraglutide achieving enteral autonomy over time, which will be included in the NDA along with efficacy and tolerability data from STARS.

Gastroenterology and Neurology in the Spotlight

The Paralyzed Stomach During Migraine Attacks: How to Treat Migraine with Gastroparesis

January also saw the launch of a feature project about the overlap between migraine and gastroparesis, highlighting the impact the GI condition can have on the absorption of oral medication and what drug developers are doing to address the issue.

New Gastro Research

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

Findings from this clinical pilot trial shed light on the potential safety and efficacy of FMT for patients with type 1 diabetes and gastroenteropathy, demonstrating its impact on gastrointestinal symptoms and quality of life.

“The patients experienced a significant improvement in their quality of life and symptoms, far beyond what we observed with placebo,” said lead investigator Katrine Lundby Høyer, MD, of the department of hepatology and gastroenterology at Aarhus University Hospital. “This is the first time FMT has been tested specifically in this patient group with placebo as a control. The results are very promising.”

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

Using the validated Colorectal Cancer Simulated Population model for Incidence and Natural history (CRC-SPIN) microsimulation model, this study demonstrates that annual CRC screening with fecal immunochemical testing (FIT) 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.

MASLD, MetALD Cardiometabolic Risk Factors Linked to Increased Long-Term Risk of IBD

Leveraging data from the UK Biobank, this study found patients with MASLD and MetALD were at an increased risk of developing incident IBD compared with those without these hepatic diseases. Findings also point to a greater risk of IBD as the number of cardiometabolic risk factors increases, including overweight/obesity, dysglycemia, hypertension, and dyslipidemia.