Inflammatory bowel disease (IBD) is an umbrella term for chronic inflammatory conditions of the digestive tract, with ulcerative colitis and Crohn's disease as the main types. It can involve recurrent active disease and remission, and severity ranges from mild illness to disabling complications.
Abivax aligned with FDA on obefazimod NDA strategy for ulcerative colitis, targeting filing by end‑2026. Phase 3 ABTECT data at ECCO 2026 showed early symptom relief and positive DSMB safety review. Leadership appointments support potential commercialization.
Engineered extracellular vesicles deliver IL-2 and therapeutic antibodies with precision, reducing systemic toxicity and targeting inflamed tissues in autoimmune disease, cancer, and inflammatory bowel disease. Microfluidic electroporation enables efficient IL-2 loading, while exosome nanovesicles show efficacy in preclinical colitis models.
Recent Rethinking Clinical Trials Grand Rounds sessions covered the COMPARE-Pediatric IBD study, a hypertension self-management texting intervention for Black Veterans, and the upcoming Pediatric Trials Network presentation.
Two new studies in IBD genetics show that polygenic risk scores can predict disease severity in Danish patients, and that ancestry-specific variants in Hispanic populations reveal novel risk loci and differential effects of known genes. These findings advance precision medicine by improving risk prediction and highlighting the need for diverse genetic research.
Sanofi announces leadership transition with CEO departure and interim appointment, while reporting key regulatory milestones including FDA Breakthrough Therapy designation for venglustat and expanded Dupixent approvals. The company advances an observational RSV study in Australia and outlines strategic initiatives in AI drug discovery and potential consumer healthcare spin-off.
Duvakitug showed durable clinical and endoscopic efficacy over 44 weeks in UC and Crohn's patients in a phase 2b LTE study. The results reinforce duvakitug's potential as a best-in-class TL1A therapy. Both doses were well tolerated.
Teva Pharmaceuticals and Sanofi reported positive Phase 2b long-term extension results for duvakitug, a TL1A-targeting monoclonal antibody, showing durable efficacy over 44 weeks in ulcerative colitis and Crohn's disease patients. UC patients achieved up to 58% clinical remission and CD patients up to 55% endoscopic response at the higher dose.
Spyre will present SPY001 topline results in ulcerative colitis on April 13, 2026. Six Phase 2 readouts are expected in 2026; Q1 net loss was $69 million.
AbbVie posted record full-year 2025 revenue of $61.2B and raised its 2026 outlook after strong Q1 Skyrizi and Rinvoq sales. Phase 3 AFFIRM data and new FDA submissions highlight pipeline progress, while full-year revenue guidance was lifted to $67.3B.
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07619547 |
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease |
NOT_YET_RECRUITING | |
| NCT07612267 |
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication |
RECRUITING | PHASE4 |
| NCT07532213 |
A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab |
RECRUITING | |
| NCT07475052 |
Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD |
ENROLLING_BY_INVITATION | |
| NCT07466940 |
A Clinical Study to Evaluate SM17 in Healthy Participants |
COMPLETED | PHASE1 |
| NCT07391046 |
Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients |
NOT_YET_RECRUITING | |
| NCT07252427 |
Gut Microbiota in IBD With Comorbid Depressive Disorder |
RECRUITING | |
| NCT07242248 |
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK) |
RECRUITING | |
| NCT07210580 |
Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease |
RECRUITING | NA |
| NCT07207200 |
Impact of Morning Light Therapy in IBD |
RECRUITING | NA |
