Zeposia (ozanimod)
/ BMS
- LARVOL DELTA
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February 04, 2026
Neuroprotective and Promyelinating Effects of Ozanimod in Human Models of Inflammation and Remyelination
(ACTRIMS Forum 2026)
- "Ozanimod exhibited neuroprotective effects in human MS-derived neurons and promyelinating activity in OPCs under inflammatory stress, supporting a dual mechanism of action via S1PR1 and S1PR5. Although its impact on ex vivo remyelination was limited, enhanced S1PR5-specific activation promoted more robust myelination of human brain slices, highlighting a promising target for future remyelinating therapies in MS."
CNS Disorders • Inflammation • Multiple Sclerosis • Solid Tumor • S1PR1 • S1PR5
February 04, 2026
Retrospective Case Series of Pediatric-Onset Multiple Sclerosis in Central Texas
(ACTRIMS Forum 2026)
- "Initial DMT choices included B-cell therapies (15/24 - ocrelizumab, ublituximab, and rituximab), S1P modulators (5/24 all fingolimod), Interferon therapy (2/24), and dimethyl fumarate (2/24)...2 patients were switched off B-cell therapy due to side effects (infections and infusion reaction) to fingolimod and natalizumab...Over this time frame, there were 2 clinical relapses on DMT (1 on interferon and 1 on dimethyl fumarate); both patients were switched to a S1P modulator (1 of fingolimod and 1 on ozanimod)... In our population of patients, most of the EDA occurred prior to DMT initiation, further enforcing the ideal of early and aggressive treatment for POMS. After DMT initiation, EDA only occurred in patients on moderate-efficacy therapies (interferon therapy, fingolimod, and dimethyl fumarate). Patients on HE DMT had less EDA compared to patients on ME DMT."
Retrospective data • CNS Disorders • Infectious Disease • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pediatrics
February 04, 2026
Retrospective Analysis of the Efficacy, Safety, and Tolerability Outcomes AfterCD20-directed Cytolytic Antibody Treatment Switches to Ozanimod in Racial or Ethnic Minority Patients with Relapsing Multiple Sclerosis
(ACTRIMS Forum 2026)
- "Patients were female (65%), male (35%); black (51%), Hispanic or Latino (32%), Asian (7%) and middle eastern (8%), multi-racial (2%) who transitioned from ofatumumab (42%), ocrelizumab (41%), rituximab (5%) and ublituxumab (12%). Switching from a CD20-directed cytolytic antibody to ozanimod was largely driven by patient and provider preference. The majority of racial and ethnic minority populations patients on ozanimod experienced no disease activity and infrequent adverse events."
Retrospective data • CNS Disorders • Multiple Sclerosis • CD20
February 04, 2026
Brain Volume Changes Over Time in Ozanimod-Treated Patients With Early Relapsing Multiple Sclerosis in the Phase 3b ENLIGHTEN Trial: 3-Year Results
(ACTRIMS Forum 2026)
- P3 | "These findings suggest preservation of BV over 3 years of ozanimod treatment in patients with early RMS with yearly decline similar to that expected in otherwise heathy individuals and less than would be expected in patients with untreated RMS."
Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Multiple Sclerosis
February 04, 2026
Preliminary Baseline Characteristics and Early Follow-up in the COAST Study: Anti-CD20 to Ozanimod Sequencing Trial
(ACTRIMS Forum 2026)
- "For the 23 subjects starting ozanimod, the mean age at enrollment was 55 (range: 38-68) years, and most were women (60.9%), Caucasian (100%), and previously on ocrelizumab (69.6%, 21.7% on rituximab, and 8.7% on ofatumumab)... The COAST study is 23% enrolled with sequencing from B-cell depleting therapies to S1PR ozanimod appearing to maintain efficacy early in this transition. This is a three-year study that is ongoing to better evaluate efficacy and safety of this treatment switch."
CNS Disorders • Infectious Disease • Multiple Sclerosis • Nephrology
February 04, 2026
Efficacy and Safety of Ozanimod in Patients with Early Relapsing Multiple Sclerosis in the Phase 3b ENLIGHTEN Study: 3-Year Results
(ACTRIMS Forum 2026)
- P3 | "Improvements in SDMT scores as well as clinical and radiologic outcomes were observed after 3 y of ozanimod treatment. Rates of serious TEAEs and TEAEs leading to discontinuation were low. The safety profile of ozanimod was consistent with the overall clinical development program."
Clinical • P3 data • CNS Disorders • Infectious Disease • Multiple Sclerosis • Nephrology • Novel Coronavirus Disease • Respiratory Diseases
February 04, 2026
Changes in Cognitive Functioning in Ozanimod-treated Patients With Early Relapsing Multiple Sclerosis: Year 3 Analysis of the ENLIGHTEN study
(ACTRIMS Forum 2026)
- P3 | "Ozanimod treatment prevented cognitive decline over 3 years in this early, mostly treatment naive, RMS patient population."
Clinical • CNS Disorders • Multiple Sclerosis
February 04, 2026
Relationship Between Neurofilament Light Chain Levels and Cognitive Outcomes in Patients With Early Relapsing Multiple Sclerosis in the Phase 3b ENLIGHTEN Trial of Ozanimod: 3-Year Results
(ACTRIMS Forum 2026)
- P3 | "Lower baseline NfL concentrations were associated with greater cognitive improvements on the SDMT, CVLT-II, and BVTM-R. This analysis highlights the potential for plasma NfL, an indicator of neuronal damage, to serve as a marker of cognitive outcomes in patients with early RMS. These results suggest ozanimod acts peripherally and potentially centrally to reduce NfL levels; early NfL reduction with ozanimod may reduce the risk of new or worsening cognitive impairment in patients with RMS."
Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Multiple Sclerosis • NEFL • Plasma NfL
February 04, 2026
Relationship Between Neurofilament Light Chain Levels and Radiologic Outcomes in Patients With Early Relapsing Multiple Sclerosis in the Phase 3b ENLIGHTEN Trial of Ozanimod: 3-Year Results
(ACTRIMS Forum 2026)
- P3 | "Higher baseline and longitudinal NfL levels were consistently associated with markers of greater disease burden and neurodegeneration. These findings support the central effects of ozanimod and add to the growing body of literature that NfL is a robust biomarker of inflammatory activity and neurodegeneration, reinforcing its potential utility in disease monitoring and prognostication. These results also suggest that early intervention with ozanimod reduces NfL levels and may reduce the risk of brain volume loss in RMS."
Clinical • P3 data • CNS Disorders • Multiple Sclerosis • NEFL
February 04, 2026
Relationship Between Baseline Glial Fibrillary Acidic Protein Levels and Radiologic Outcomes in Patients With Early Relapsing Multiple Sclerosis in the Phase 3b ENLIGHTEN Trial of Ozanimod: 3-Year Results
(ACTRIMS Forum 2026)
- P3 | "These findings suggest that elevated baseline GFAP may be a prognostic biomarker for greater lesion burden and accelerated neurodegeneration in MS. Ozanimod treatment in this early MS patient population has resulted in a reduction of radiological activity and slowing of brain volume loss. Potential future analyses will explore the impact of ozanimod on GFAP levels over time."
Clinical • P3 data • CNS Disorders • Multiple Sclerosis • GFAP
January 20, 2026
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
January 06, 2026
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
December 20, 2025
Ozanimod in Korean ulcerative colitis: a real-world prospective multicenter study
(ECCO-IBD 2026)
- "Conclusion In this prospective real-world multicenter cohort, ozanimod demonstrated meaningful clinical, endoscopic, and biochemical improvement in Korean patients with moderate-to-severe ulcerative colitis, with a favorable safety profile and no serious adverse events. These findings support the effectiveness and tolerability of ozanimod in routine clinical practice within an East Asian population."
Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP
December 20, 2025
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
December 16, 2025
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
December 16, 2025
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
January 27, 2026
OUTCOMES OF ACUTE SEVERE ULCERATIVE COLITIS IN ELDERLY PATIENTS: A MULTICENTER EXPERIENCE
(CCCongress 2026)
- "Medication use prior to admission included steroids 73 patients (61 %), Mesalamine in 83 patients (70 %A), Anti TNF 35 patients (30%), prior Vedolizumab 31 (26%), prior Ustekinumab 4 patients (3%), prior JAK inhibitor 4 patients (3%) prior Ozanimod in 2 patients (1.7%)...In hospital treatment included IV steroids in 91% patients and IV Infliximab in 20%... We reviewed 120 records. The median age at diagnosis of ulcerative colitis was 64 years, and median age at admission was 71 years, with a median disease duration of 5 years prior to presentation. There were 66 males (56%)."
Clinical • Cognitive Disorders • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis
January 27, 2026
SYSTEMATIC REVIEW OF MALIGNANCY RISK WITH BIOLOGIC THERAPY FOR INFLAMMATORY BOWEL DISEASE
(CCCongress 2026)
- "While some IBD therapies, particularly thiopurines, have been associated with increased risk of lymphoproliferative disorders, data suggest that anti-TNF monotherapy, Ustekinumab, and Vedolizumab carry low malignancy risk, even in patients with a history of previous malignancies. So far, clinical trial evidence does not show a meaningful increase in overall cancer risk with S1P receptor modulators (ozanimod, etrasimod) in IBD patients. Kaposi sarcoma has been reported in one case linked to ozanimod."
Review • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Kaposi Sarcoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Sarcoma • Skin Cancer • Solid Tumor • IL12A • IL23A
January 30, 2026
Real-world experience of ozanimod in adults with multiple sclerosis.
(PubMed, Neurodegener Dis Manag)
- "When comparing pre-ozanimod baseline to 12-month data, the annualized relapse rate was reduced by 56% (p = 0.034), and fewer pwMS had new/enlarging brain MRI T2 lesions (6.6% versus 40%, p < 0.001) and gadolinium-enhancing lesions (3.9% versus 27%, p = 0.027). Ozanimod was well-tolerated with good treatment persistence, a favorable safety profile, and reductions in clinical and radiographic disease."
Journal • Real-world evidence • CNS Disorders • Multiple Sclerosis
January 05, 2026
Pharmacological properties and clinical efficacy of sphingosine 1-phosphate (S1P) receptor modulator, Ozanimod (ZEPOSIA®)
(PubMed, Nihon Yakurigaku Zasshi)
- "It has a favorable safety profile, high medication compliance, and is a convenient oral treatment for long-term use. Thus, providing Ozanimod as a new UC treatment option is of high clinical significance."
Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis
January 03, 2026
Effect of Sphingosine-1-Phosphate Receptor Modulators on Insulin Resistance: A Review.
(PubMed, Ann Pharmacother)
- "S1PR modulators are effective disease-modifying therapies in multiple sclerosis, but emerging evidence suggests a possible impact on insulin signaling and glucose metabolism. Vigilance in metabolic monitoring is recommended, particularly in patients with diabetes or other risk factors for insulin resistance."
Journal • Review • CNS Disorders • Diabetes • Metabolic Disorders • Multiple Sclerosis • Type 1 Diabetes Mellitus • IR
December 25, 2025
Sphingosine-1-phosphate receptor modulators in ulcerative colitis - a narrative review of current evidence and practical considerations.
(PubMed, Drugs Context)
- "S1PRMs offer distinct advantages, including oral administration and a lack of immunogenicity, positioning them as valuable additions to the UC treatment landscape. However, future research will be required to understand their position in the evolving UC treatment paradigms."
Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis
December 15, 2025
Cellular and humoral vaccination response under immunotherapies-German consensus on vaccination strategies in neurological autoimmune diseases.
(PubMed, Ther Adv Neurol Disord)
- "The specific humoral and cellular response to vaccination can be compromised under alemtuzumab, azathioprine, cladribine, cyclophosphamide, CD19/CD20 antibodies (inebilizumab, ocrelizumab, ofatumumab, rituximab, ublituximab), dimethyl fumarate/diroximel fumarate, FcRn inhibitors (efgartigimod, rozanolixizumab), complement C5 inhibitors (eculizumab, ravulizumab, zilucoplan), interleukin-6 receptor antibodies (tocilizumab, satralizumab), intravenous immunoglobulins, long-term steroid administration, methotrexate, mitoxantrone, mycophenolate mofetil, tacrolimus, teriflunomide, tumor necrosis factor-α blockers, and sphingosine-1-phosphate receptor modulators (fingolimod, ozanimod, ponesimod, siponimod), as well as after autologous stem cell transplantation...However, the humoral and cellular vaccination response may be impaired under immunotherapy necessitating close monitoring. Here, we provide applicable recommendations to optimize immunization for individuals receiving..."
Journal • CNS Disorders • Immunology • Infectious Disease • Oncology • Transplantation • IL6R
November 04, 2025
Therapeutic targeting of sphingosine-1-phosphate receptor 1 (S1PR1) in angioimmunoblastic T-cell lymphoma.
(ASH 2025)
- "The molecular landscape of AITL is characterized by frequent genomic alterationsin epigenetic regulators, including TET2, DNMT3A, and IDH2, as well as components of the T-cell receptor(TCR) signaling pathway...This, together with our observation of increased S1PR1 expression in humanRHOA G17V⁺ AITL tumor samples, identifies S1PR1 deregulation as a potentially relevant effector of theoncogenic effects of RHOA G17V in TFH cells.S1P receptor inhibitors, such as fingolimod (FTY720) and next-generation, more selective modulatorssuch as ozanimod, siponimod, and ponesimod, are FDA-approved for the treatment of multiple sclerosisand other autoimmune diseases...These findings definean S1PR1–STAT3 inflammatory loop that promotes survival and dissemination in RHOA G17V-driven AITLand identify this axis as a therapeutically actionable vulnerability.In summary, our preliminary data establish a mechanistic link between oncogenic RHOA signaling andS1PR1-mediated membrane receptor..."
IO biomarker • CNS Disorders • Hematological Malignancies • Immunology • Lymphoma • Multiple Sclerosis • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • DNMT3A • IDH2 • IL6 • RHOA • S1PR1 • S1PR5 • TET2 • TNFA
December 10, 2025
Cerebellar Subregional Atrophy in Relapsing-Remitting Multiple Sclerosis: Stage-dependent Dynamics and Pharmacological Modulation.
(PubMed, Brain Res Bull)
- "This study demonstrated stage-specific patterns of cerebellar atrophy in RRMS and the heterogeneous, stage-dependent effects of DMTs on posterior cerebellar subregions. Lobules IX and VIIIb emerged as critical loci linking pharmacological modulation with cognitive outcomes. These findings suggest that these regions may serve as potential imaging biomarkers of therapeutic response and prognosis in MS."
Journal • CNS Disorders • Multiple Sclerosis
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