First Half 2026 Recap: Gastroenterology

The first half of 2026 delivered meaningful progress across gastroenterology, highlighted by important regulatory milestones, encouraging late-stage clinical trial results, and continued innovation in inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), and pediatric gastrointestinal care.

From new US Food and Drug Administration (FDA) approvals and application submissions to long-term efficacy data and promising investigational therapies, the field continued to expand treatment options while addressing persistent challenges related to access and disease management.

Innovation remained especially strong in IBD, where new clinical evidence supported novel mechanisms of action, including anti-TL1A and miR-124 enhancement, alongside durable long-term data for established IL-23 therapies. At the same time, advances in Crohn's disease treatment sequencing and expanded pediatric indications reflected a growing emphasis on individualized care across the GI spectrum.

In this first-half 2026 review, the editorial team of HCPLive Gastroenterology recaps the most significant regulatory developments, clinical milestones, and research updates shaping the future of gastroenterology.

EBX-102-02 Shows Benefit for IBS-C and IBS-D in Phase 2a TrIuMPH Trial

On January 8, 2026, EnteroBiotix Limited announced positive final results from the phase 2a TrIuMPH trial evaluating EBX-102-02, an investigational oral full-spectrum microbiome therapeutic, in patients with IBS-C and IBS-D. The study demonstrated clinically meaningful improvements in IBS symptom severity compared with placebo, with benefits emerging as early as week 1 and maintained throughout six weeks of follow-up.

Young Adults With IBD Face Greater Healthcare Access Challenges, Financial Burdens

Research from the Crohn's & Colitis Foundation highlighted the disproportionate healthcare access barriers and financial burdens experienced by young adults living with IBD. The findings underscored ongoing disparities in care and reinforced the need for improved insurance coverage, transition support, and access to specialty care for younger patients.

LUCENT: Durable UC Control With Mirikizumab Through 4 Years, With Fernando Magro, MD, PhD

Long-term data presented at the 21st Congress of ECCO demonstrated sustained efficacy and safety for mirikizumab through 212 weeks across the LUCENT clinical program. The findings strengthened evidence supporting the IL-23 inhibitor as a durable treatment option for patients with moderate-to-severe ulcerative colitis.

How Head-to-Head SEQUENCE Data Shape Crohn’s Disease Treatment Decisions, With Raja Atreya, MD

Extended follow-up from the landmark SEQUENCE trial continued to support risankizumab as an effective option for patients with Crohn's disease who previously failed anti-TNF therapy. Investigators emphasized that the head-to-head data are helping guide real-world treatment sequencing decisions.

FDA Accepts NDA For Next-Generation Hydrocortisone Acetate in Ulcerative Colitis of the Rectum

On April 21, 2026, the FDA accepted Cristcot's new drug application for its next-generation hydrocortisone acetate suppository for ulcerative colitis of the rectum. Supported by positive phase 3 data demonstrating clinical remission at Day 29, the application received an October 2026 PDUFA target date. If approved, the therapy would become the first FDA-approved hydrocortisone acetate suppository.

Risankizumab (Skyrizi) SC Induction Application Submitted to FDA for Crohn's Disease

AbbVie submitted a supplemental application to the FDA seeking approval of subcutaneous induction with risankizumab for adults with moderately to severely active Crohn's disease. Supported by positive findings from the phase 3 AFFIRM trial, the submission could offer patients an alternative to the currently approved intravenous induction regimen.

FDA Approves Linaclotide (Linzess) for Functional Constipation in Patients 2 Years And Older

On May 27, 2026, the FDA expanded approval of linaclotide to include children aged 2 to 5 years with functional constipation. The decision made linaclotide the only FDA-approved prescription treatment for pediatric functional constipation beginning at 2 years of age.

Tulisokibart Meets Phase 3 Endpoints in Ulcerative Colitis, First for Anti-TL1A

Merck announced positive topline results from the phase 3 ATLAS-UC induction study evaluating tulisokibart in moderately to severely active ulcerative colitis. The investigational anti-TL1A therapy met its primary endpoint of clinical remission at week 12 along with key secondary endpoints, becoming the first therapy targeting TL1A to achieve positive phase 3 results in ulcerative colitis.

Obefazimod Delivers Week 44 Remission in Refractory UC Patients

Late June brought additional encouraging news for the ulcerative colitis pipeline, as topline results from the ABTECT Maintenance Part 2 study showed obefazimod produced meaningful clinical benefit in a highly refractory patient population. More than one-third of induction nonresponders achieved clinical and endoscopic remission following continued treatment through week 44, further supporting the investigational oral miR-124 enhancer as a potential future treatment option.