FDA Approves Two IL-23 Inhibitors for Crohn's Disease as Gastroenterology Advances in 2025
核心洞察
The FDA approved mirikizumab (Omvoh) and guselkumab (Tremfya) for moderately to severely active Crohn's disease (搜索) in early 2025, expanding IL-23 (搜索)-targeted therapy options for inflammatory bowel disease (搜索) patients.
Guselkumab demonstrated superiority over ustekinumab in multiple endoscopic endpoints in phase 3 GALAXI trials, while also receiving approval for a subcutaneous induction regimen for ulcerative colitis (搜索).
Fecal microbiota transplantation showed promise as a first-line treatment for primary C. difficile infection (搜索), achieving clinical cure rates of 66.7% compared to 61.2% with standard vancomycin therapy.
The first half of 2025 marked a significant milestone for inflammatory bowel disease (搜索) (IBD) treatment with the FDA approval of two IL-23 (搜索) inhibitors for Crohn's disease (搜索), while the third quarter brought additional regulatory updates and promising clinical trial data across multiple gastroenterology conditions.
Dual IL-23 Inhibitor Approvals Transform Crohn's Disease Treatment
On January 15, 2025, the FDA approved Lilly (搜索)'s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active Crohn's disease (搜索). This IL-23p19 antagonist marked its second approval in IBD, building on its 2023 first-in-class approval for moderately to severely active ulcerative colitis (搜索).
Following closely, the FDA approved Johnson & Johnson's guselkumab (Tremfya) for Crohn's disease (搜索) based on data from multiple phase 3 trials, including the GALAXI trials. The studies demonstrated that guselkumab outperformed ustekinumab (Stelara) for multiple endoscopic endpoints, representing the agent's second IBD indication after its previous ulcerative colitis (搜索) approval.
The regulatory momentum continued in the third quarter when the FDA approved a subcutaneous induction regimen of guselkumab for ulcerative colitis (搜索) on September 19, 2025. This approval made guselkumab the first and only IL-23 (搜索) inhibitor to offer both subcutaneous and intravenous induction options for treating both UC and Crohn's disease (搜索).
Microbiome Therapies Show Clinical Promise
Fecal microbiota transplantation emerged as a potential game-changer for C. difficile infection (搜索) treatment. A randomized, open-label, noninferiority phase 3 trial conducted at 20 hospitals in Norway demonstrated that FMT may serve as a viable first-line treatment for primary CDI. The study found clinical cure and no disease recurrence within 60 days without additional treatment occurred in 66.7% of patients receiving FMT versus 61.2% with standard-of-care vancomycin.
In the microbiome innovation space, EBX-102-02, a next-generation oral full-spectrum microbiome drug, showed promise for irritable bowel syndrome with constipation (搜索) in phase 2a data from the Treating IBS with an Intestinal Microbiota Product for Health (TrIuMPH) trial presented at Digestive Disease Week 2025. The treatment demonstrated safety, tolerability, and improvements in IBS-Symptom Severity Scale, abdominal pain, and stool consistency.
Pipeline Developments in Ulcerative Colitis
Johnson & Johnson announced positive topline results from the phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113) in adults with moderately to severely active ulcerative colitis (搜索) on March 10, 2025. 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 including clinical remission, symptomatic remission, and endoscopic improvement at week 12.
Additionally, Abivax SA announced positive topline results from its phase 3 ABTECT-1 and ABTECT-2 8-week induction trials evaluating obefazimod (ABX464) on July 22, 2025. Results showed obefazimod met its FDA primary endpoint of clinical remission at week 8 in the 50 mg once-daily dose regimens for both trials in adult patients with moderately to severely active ulcerative colitis (搜索).
Addressing Unmet Needs in Gastroparesis and IBS
The American Gastroenterological Association released its clinical practice guideline on gastroparesis (搜索) management on September 19, 2025, offering 12 conditional recommendations for accurate diagnosis and evidence-based treatments for patients with idiopathic gastroparesis or diabetes-related gastroparesis.
Research into irritable bowel syndrome revealed both therapeutic advances and persistent challenges. A proof-of-concept trial explored Well-being in IBS: Strengths and Happiness (WISH), a novel 9-week, manualized, phone-delivered, IBS-specific positive psychological intervention. The positive psychological-based gut-brain behavior therapy demonstrated feasibility, acceptability, and early benefits for IBS symptom severity, quality of life, depression, GI symptom-specific anxiety, pain catastrophizing, avoidant/restrictive eating behaviors, physical activity engagement, and resilience.
However, findings from the IBS in America survey conducted by the AGA and The Harris Poll revealed that despite recent advancements in public awareness and treatment options, IBS symptoms continue to significantly impact patients' daily lives and productivity, highlighting persistent challenges in the treatment landscape.
Colonoscopy Quality Remains Priority
Even with the advent of several new noninvasive testing options, including three FDA-approved options in 2024 alone, colonoscopy remains the preferred approach for colorectal cancer screening and prevention. The US Multi-Society Task Force on Colorectal Cancer released new 2025 guidance providing clinical recommendations to address challenges related to bowel preparation for colonoscopy, focusing specifically on outpatients at low risk for inadequate bowel preparation.