Zeposia (ozanimod) / BMS - LARVOL DELTA

IL-11-induced NLRP3 inflammasome activation mediates pyroptotic cell death in human neurons (IMMUNOLOGY 2026) - "IL-11 within the CSF induces neuronal cell death, which is mediated via NLRP3 inflammasome-induced pyroptosis. Anti-IL11 mAb, MCC950, and Ozanimod demonstrated a neuroprotective effect."

CNS Disorders • Multiple Sclerosis • IL1B • IL6 • NLRP3 • S1PR1

Multiple Sclerosis Relapse Activity After Ozanimod Discontinuation in DAYBREAK Trial Participants. (PubMed, Ann Clin Transl Neurol) - P3 | "Most participants did not relapse within 90 days following ozanimod discontinuation. Post-treatment relapse cases suggestive of a rebound effect were not observed."

Journal • CNS Disorders • Multiple Sclerosis

Neutropenia after ocrelizumab treatment in patients with multiple sclerosis: A single-centre case series and systematic review of literature. (PubMed, Mult Scler Relat Disord) - "Neutropenia occurred early in treatment. Most patients presented with high-grade neutropenia but experienced a mild clinical course. Ocrelizumab resumption was possible. Recurrence may happen in the same or following cycles."

Journal • Review • CNS Disorders • Hematological Disorders • Multiple Sclerosis • Neutropenia

Sequencing Patterns and Efficacy of Biological Therapies and Small Molecules in Patients with Ulcerative Colitis: A Single-Center Retrospective Study (ECCO-IBD 2026) - "Patients underwent 78 courses of advanced therapy (Infliximab 30, Adalimumab 11, Golimumab 8, Vedolizumab 22, Ustekinumab 1, Tofacitinib 2, Filgotinib 2, Ozanimod 2). Conclusion Advanced biologic and small-molecule therapies were effective and generally well-tolerated in patients with refractory UC. Infliximab showed the most durable first-line treatment response, whereas Adalimumab was associated with a shorter treatment duration."

Retrospective data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

TREATMENT PERSISTENCE OF FIRST-LINE ADVANCED THERAPIES IN OLDER ADULTS WITH ULCERATIVE COLITIS USING US CLAIMS DATA (ISPOR 2026) - "The most frequently prescribed 1L AT was vedolizumab (n = 445, 48.1%), followed by infliximab (n = 241, 26.0%), adalimumab (n = 111, 12.0%), ustekinumab (n = 105, 11.3%), and tofacitinib (n = 11, 1.2%). Upadacitinib, ozanimod, and golimumab were infrequently prescribed (each n < 10). Real-world treatment persistence of vedolizumab as a 1L AT is longer than or similar to other ATs in older adults with UC."

Clinical • Metastases • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Comparative effectiveness of second-line therapies in ulcerative colitis after initial failure of vedolizumab: a retrospective multicentre Greek study (ECCO-IBD 2026) - "Second-line therapies included infliximab (IFX, n=55), ustekinumab (UST, n=16), tofacitinib (TOFA, n=7), upadacitinib (UPA, n=4), ozanimod (OZA, n=3), and Risankizumab (RIZ, n=1); Comparisons were performed only between the IFX and UST groups, given the limited sample size of the other groups. TOFA and UPA demonstrated similar efficacy, although the analysis was limited by small sample sizes. Nearly all patients with clinical response in week 12 remained on the same treatment for one year."

HEOR • Retrospective data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of concomitant mesalazine administration on the efficacy and safety of advanced therapies in ulcerative colitis: a meta-analysis over the induction and maintenance phases (ECCO-IBD 2026) - "Methods A meta-analysis of RCTs including approved biological agents (Adalimumab,Infliximab,Golimumab,Mirikizumab,Guselkumab,Ozanimod,Etrasimod,Ustekinumab) and small molecules (Tofacitinib,Upadacitinib) in UC patients reporting concomitant msz use was conducted through a search of four databases. Conclusion The concomitant use of msz and advanced therapies is associated with improved mucosal healing during maintenance therapy for UC, suggesting a potential synergistic effect in the long term. Future prospective studies incorporating histologic outcomes are warranted to elucidate the mechanistic contribution of msz in combination regimens."

Metastases • Retrospective data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Deep Learning Model Utilizing Stool Images to Predict Clinical Outcomes of Advanced Therapies in Patients with Moderate to Severe Ulcerative Colitis (ECCO-IBD 2026) - "Infliximab was the most commonly initiated therapy, followed by JAK inhibitors, vedolizumab, ustekinumab, and ozanimod. Conclusion A deep learning model applied to smartphone stool images may provide a practical, noninvasive tool to predict early clinical outcomes in UC patients initiating advanced therapies. This approach could complement established biomarkers and enhance personalized treatment monitoring."

Clinical • Clinical data • Metastases • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Real-world Experience With Ozanimod at Two Academic Multiple Sclerosis Centers With Expanded 24-month Data (AAN 2026) - "This real-world ozanimod-treated cohort included individuals who were older, had longer disease duration, and had more comorbidities than in the clinical trials. Ozanimod was effective with no new safety or tolerability signals."

Clinical • Real-world • Real-world evidence • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Hypertension • Infectious Disease • Metabolic Disorders • Multiple Sclerosis • Respiratory Diseases • Type 2 Diabetes Mellitus

Global and Cell-Type-Specific Gene Expression With Ozanimod, a S1P1 Modulator, in Multiple Sclerosis (MS) (AAN 2026) - "These findings suggest ozanimod exerts broad immunomodulatory effects beyond lymphocyte sequestration, promoting a cell-intrinsic downregulation of ribosomal and mitochondrial pathways. This transcriptional reprogramming may contribute to immune deactivation and therapeutic efficacy in MS immune and brain cells."

Clinical • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=1200 | Active, not recruiting | Sponsor: Celgene | Recruiting ➔ Active, not recruiting

Enrollment closed • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P3 | N=869 | Active, not recruiting | Sponsor: Celgene | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=535 | Recruiting | Sponsor: Celgene | Trial completion date: May 2021 ➔ Aug 2021

Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Inflammatory Bowel Disease

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=1040 | Recruiting | Sponsor: Celgene | Trial completion date: Jun 2024 ➔ Jun 2026 | Trial primary completion date: Mar 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

ABM/PROTECT-MS/2025: PRObiotic Therapy Examining Combinatorial Therapeutics in Multiple Sclerosis - phase II, multicenter, randomised, open-label clinical trial. (clinicaltrialsregister.eu) - P1/2 | N=210 | Sponsor: Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

New P1/2 trial • CNS Disorders • Multiple Sclerosis

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Celgene | Initiation date: Aug 2015 ➔ Dec 2015

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Celgene | Trial completion date: Dec 2020 ➔ Mar 2022 | Trial primary completion date: Dec 2020 ➔ Mar 2022

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: Receptos, Inc.

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

LC-MS/MS assay for etrasimod plasma concentration using phreephospholipid removal technology: Supporting pharmacokinetic variability and individualized dosing in hospital practice (ECCO-IBD 2026) - "The LC-MS/MS analysis, operated in positive electrospray ionization mode, was carried out in multiple-reaction monitoring mode, monitoring the characteristic mass transitions: m/z 485 → 159 for etrasimod and m/z 405 → 146 for the internal standard, ozanimod. Conclusion The developed LC-MS/MS method and the PhreePhospholipid sample cleanup, demonstrated exceptional performance and robustness, fully meeting all regulatory requirements for bioanalytical validation. This method provides a reliable foundation for the pharmacokinetic variability and safety monitoring of etrasimod as well as patients adherence within our hospital."

Clinical • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=485 | Recruiting | Sponsor: Celgene | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Sphingosine-1-phosphate (S1P) signaling as a novel therapeutic target for alcohol abuse. (PubMed, Res Sq) - "Specifically, we observed that two S1P receptor agonists FDA-approved for multiple sclerosis, fingolimod and ozanimod, and the more brain penetrant S1P 1 receptor agonist CYM5442, reduced binge alcohol drinking in the drinking in the dark (DID) paradigm in mice...Notably, CYM5442 was less aversive than naltrexone, an FDA-approved medication for the treatment of alcohol use disorder that shares a similar broad reducing action on alcohol intake and non-drug reinforcers...Lastly, gene expression analysis by RNA-Seq revealed that S1P regulates a complex set of genes in the transition to alcohol dependence. Overall, our results establish S1P signaling as a novel therapeutic target for alcohol use disorder."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Multiple Sclerosis

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=485 | Not yet recruiting | Sponsor: Celgene

New P3 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Inflammatory Bowel Disease

PREGNANCY OUTCOMES IN WOMEN WITH INFLAMMATORY BOWEL DISEASE EXPOSED TO TOFACITINIB, OZANIMOD, OR UPADACITINIB: A MULTICENTER REAL-WORLD COHORT ANALYSIS USING A FEDERATED ELECTRONIC HEALTH RECORD NETWORK (DDW 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P3 | N=878 | Active, not recruiting | Sponsor: Celgene | Trial primary completion date: Feb 2022 ➔ Dec 2022

Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis