Zeposia (ozanimod) / BMS - LARVOL DELTA

Brain atrophy and associations with long-term disability and cognitive function in participants with relapsing multiple sclerosis treated with ozanimod: Results from phase 3 and open-label extension trials. (PubMed, Mult Scler) - P3 | "This study confirms the sustained efficacy of ozanimod in reducing brain atrophy rates for up to 7 years. Brain volume preservation was associated with faster cognitive processing speed and slower physical disability progression."

Journal • P3 data • CNS Disorders • Multiple Sclerosis • IFNB1

A Review of the Current State of Off-Label Therapies for Pediatric Inflammatory Bowel Disease. (PubMed, Pediatr Discov) - "Real-world use of ustekinumab (UST), vedolizumab (VDZ), upadacitinib (UPA), tofacitinib, and ozanimod in the adult population could prove positive outcomes in the pediatric population. Outcomes and use of newer biologic therapies in patients with pediatric IBD have improved with increased rates of steroid-free clinical remission (SFCR). Novel therapies, including Janus kinase (JAK) inhibitors and sphingosine-1-phosphate receptor (S1Pr) modulators, require further studies but could also prove effective."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Switch from fingolimod to ozanimod for safety or intolerance reasons. (PubMed, Ther Adv Neurol Disord) - "Overall, patients with complete control of disease (NEDA) in the absence of adverse events (NADE) were 83.7% (NEDA3/NADE). Our findings suggest that switching from fingolimod to ozanimod may mitigate lymphopenia or hypertransaminasemia and ameliorate effectiveness on disease activity."

Journal • CNS Disorders • Multiple Sclerosis

Ozanimod: real world outcomes from three UK centres (BSG 2025) - "44 (59%) had previously received at least one advanced therapy, 26 (35%) had exposure to vedolizumab. No patients developed bradycardia or atrioventricular block.Download figure Open in new tab Download powerpoint Abstract FP24 Figure 1 Median SCCAI at each timepoint (as observed)Conclusions In a real-world cohort, ozanimod was effective at disease control by week 10 with a greater probability of treatment response in bio-naïve patients. There were no new safety signals."

Clinical • Real-world • Real-world evidence • Cardiovascular • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Macular Edema • Metabolic Disorders • Ocular Inflammation • Ophthalmology • Type 2 Diabetes Mellitus • Ulcerative Colitis • Uveitis • CRP

Nurse-led clinic (NLC) to expedite pathway for ophthalmology screening of IBD patients prior to treatment with sphingosine-1-phosphate receptor (S1PR) modulators (BSG 2025) - "The two approved drugs, etrasimod and ozanimod, have been associated with an increased risk of macular oedema. This direct access pathway is an effective use of resources to provide a timely and valuable service, as well as reducing consultant time. To the best of our knowledge, this represents the first nurse-led initiative in the country aimed at enabling ophthalmological screening for IBD patients starting S1PR modulators"

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Macular Edema • Ophthalmology • Ulcerative Colitis

A REAL-WORLD DATA ANALYSIS OF OZANIMOD IN FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) DATABASE (UEGW 2025) - No abstract available

Adverse events • Clinical • Real-world • Real-world evidence • Inflammatory Bowel Disease

EFFICACY AND SAFETY OF OZANIMOD AS FIRST-LINE ADVANCED TREATMENT FOR CROHN'S COLITIS IN A PATIENT WITH MULTIPLE SCLEROSIS (UEGW 2025) - No abstract available

Clinical • Metastases • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Multiple Sclerosis

Novel Autologous Regulatory T-Cell Therapy Ameliorates DSS-Induced Colitis in Humanized Mice. (PubMed, Inflamm Bowel Dis) - "Autologous Treg therapy ameliorated the symptoms of DSS-induced colitis in a humanized mouse model. The autologous PBMC-humanized DSS-induced colitis model may serve as a robust preclinical platform for evaluating the efficacy of personalized Treg cell therapy for IBD."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • FOXP3 • IL2RA • ISG20 • PTPRC

The Comparative Effectiveness and Tolerability of Sphingosine-1-Phosphate Receptor Modulators in Patients With Multiple Sclerosis: A Network Meta-Analysis of Randomized Controlled Trials. (PubMed, Ann Clin Transl Neurol) - "Fingolimod (1.25 mg) and ozanimod (1 mg) had the best efficacy, and siponimod (1.25 mg and 0.25 mg) had the best safety profile among the S1PRM. Further longitudinal studies should be conducted to assess the long-term effects of these drugs on patient-reported outcomes."

HEOR • Journal • Retrospective data • CNS Disorders • Multiple Sclerosis

COLIBRI: A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis (clinicaltrials.gov) - P=N/A | N=175 | Terminated | Sponsor: Bristol-Myers Squibb | N=380 ➔ 175 | Trial completion date: Nov 2026 ➔ May 2025 | Recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ May 2025; Business objectives have changed

Enrollment change • HEOR • Trial completion date • Trial primary completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AppreZiate: A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants (clinicaltrials.gov) - P=N/A | N=200 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Sep 2025 | Trial primary completion date: Mar 2026 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

ORION: A Post-Authorization, Long-term Study of Ozanimod Real-world Safety (clinicaltrials.gov) - P=N/A | N=9000 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2032 ➔ Jul 2033 | Trial primary completion date: Dec 2032 ➔ Jul 2033

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

The Role of Novel Small Molecule Drugs in the Management of Inflammatory Bowel Disease. (PubMed, Br J Hosp Med (Lond)) - "Novel small molecule drugs (SMDs) for IBD include the Janus Kinase (JAK) inhibitors Tofacitinib, Filgotinib and Upadactinib and the sphingosine-1 phosphate (S1P) inhibitors Ozanimod and Etrasimod. S1P inhibitors require pre-treatment electrocardiograms to reduce the risk of bradycardia and retinal exams at least in high-risk patients to avoid macular oedema. In this review we highlight the key evidence on efficacy and safety for general hospital physicians."

Journal • Review • Cardiovascular • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Macular Edema • Ophthalmology • Ulcerative Colitis

Targeting the sphingosine-1-phosphate receptor 1 (S1PR1) pathway in preclinical models of migraine-like periorbital hypersensitivity (AHS 2025) - " In both male and female mice, fingolimod (0.3–3.0 mg/kg, IP, n = 10) and ozanimod (0.1–1.0 mg/kg, IP, n = 10) dose-dependently prevented the development of NTG-mediated periorbital hypersensitivity, with the highest doses most effective (p < 0.001)...Ozanimod (1 mg/kg, n = 8) and TASP0277308 (3 mg/kg, n = 8) also prevented (p < 0.001) and reversed (p < 0.001) sumatriptan overuse-mediated periorbital hypersensitivity... Together, these data support that signaling at S1PR1, via S1P, is potentially involved in migraine-like mechanisms, and therefore, selectively targeting S1PR1 represents a novel and promising approach for the treatment and prevention of migraine and related headache disorders, including MOH. This is based on using two independent preclinical approaches, with selective and functional S1PR1 antagonists and selective S1PR1 agonists. These data are significant as functional S1PR1 antagonists are already FDA-approved for the treatment of MS, with a..."

Preclinical • CNS Disorders • Migraine • Pain • S1PR1

Treatment Options for the Comorbidity of Multiple Sclerosis With Other Chronic Inflammatory Diseases. (PubMed, Dtsch Arztebl Int) - "The treatment of patients who have both MS and another chronic inflammatory disease should be interdisciplinary and personalized, and treatments must be planned with due attention to potential adverse effects. Further studies of treatment for this group of patients are needed."

Journal • Review • CNS Disorders • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Multiple Sclerosis • Psoriasis • Rheumatoid Arthritis • Rheumatology • Ulcerative Colitis

Comparative Effectiveness of Fumarates Versus Sphingosine-1-Phosphate Receptor Modulators in Black Patients with Multiple Sclerosis. (PubMed, Neurol Ther) - "This real-world, claims-based analysis demonstrates that fumarates and S1P receptor modulators have similar effectiveness in reducing relapses among Black PwMS, with > 72% of patients in both treatment groups remaining relapse-free at 24 months. Given the underrepresentation of Black patients in MS clinical trials, these results provide valuable real-world evidence to guide treatment decisions for this population."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

ENLIGHTEN: Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) (clinicaltrials.gov) - P3 | N=188 | Terminated | Sponsor: Celgene | Trial completion date: Apr 2026 ➔ May 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ May 2025; Business objective has changed

Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Multiple Sclerosis

Sphingosine-1-Phosphate Receptor Modulators for the Treatment of Ulcerative Colitis: A Narrative Review Focusing on Safety. (PubMed, United European Gastroenterol J) - "Safety data from the field of multiple sclerosis (MS) will be discussed because the first S1PR modulator to reach the market, fingolimod, was used extensively for relapsing-remitting MS. Indications for the safe use of ozanimod and etrasimod in ulcerative colitis patients will be provided."

Journal • Review • CNS Disorders • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Oncology • Solid Tumor • Ulcerative Colitis

Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Beth Israel Deaconess Medical Center | N=20 ➔ 0 | Trial completion date: Apr 2024 ➔ Dec 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Apr 2024 ➔ Dec 2024

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials. (PubMed, Eur J Neurol) - P3 | "These data suggest that plasma GFAP is a relapse-independent metric of baseline disease severity and a predictor of treatment response in participants with RMS."

Biomarker • Clinical • Journal • P3 data • Retrospective data • CNS Disorders • Multiple Sclerosis • GFAP • IFNB1 • NEFL

A Lactation Study in Women Receiving Treatment With Ozanimod (clinicaltrials.gov) - P4 | N=16 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date

The Role of Patient-Reported Outcomes in US FDA Novel Drug Approvals and Reimbursement Decisions (2020-2024) (ISPOR 2025) - "Rinvoq (AbbVie) - PRO data showed improved quality of life in rheumatoid arthritis, contributing to $2.3 billion...Zeposia (Bristol-Myers Squibb) - PROs on fatigue reduction generated $500 million. Imcivree (Rhythm Pharmaceuticals) - PRO data supported FDA approval 2022: FDA : 37 drugs, with 30% (11 drugs) Reimbursement : 85 total approvals, with 35% (30 approvals) Adbry (LEO Pharma) - PROs on itch reduction generated $90 million . Camzyos (Bristol-Myers Squibb) - Symptom relief PROs were key 2023: FDA : 49 drugs, with 33% (16 drugs) Reimbursement 95 total approvals, with 45% (43 approvals. Leqembi (Eisai/Biogen) - FDA approval and Medicare conditional reimbursement for Alzheimer's disease leveraged PROs on cognitive function improvements, generating $200 million/ Jaypirca (Eli Lilly) - Patient-reported symptom relief supported FDA and payer decisions for mantle cell lymphoma... The inclusion of PROs in FDA novel drug approvals increased from 18% in 2020 to 40% in..."

Clinical • Patient reported outcomes • Reimbursement • US reimbursement • Alzheimer's Disease • CNS Disorders • Fatigue • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Mantle Cell Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis. (PubMed, J Clin Med) - "This narrative review aims to distil the key trial data on the efficacy and safety of ozanimod and etrasimod, the two S1PR modulators currently licensed for use in UC. We summarise their safety profiles, taking into consideration open label extension data. Finally, we consider where this class of drugs may be best placed in the treatment landscape and also provide a practical guide for their use in clinical practice."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

PREVALENCE OF EXTRAINTESTINAL CUTANEOUS MANIFESTATIONS OF INFLAMMATORY BOWEL DISEASE IN NON-WHITE PATIENTS: A RETROSPECTIVE COHORT ANALYSIS (DDW 2025) - " In this retrospective cohort study, we used TriNetX, a healthcare database comprising over 119 million patients, to identify both White and non-White patients with a diagnosis of IBD who were prescribed at least one IBD-specific medication or advanced therapy including: Mesalamine, sulfasalazine, balsalazide, budesonide, azathioprine, methotrexate, 6-mercatopurine, infliximab, certolizumab, golimumab, adalimumab, vedolizumab, ustekinumab, tofacitinib, upadacitinib, risankizumab, mirikizumab, guselkumab, etrasimod, and ozanimod. With the rise of IBD in non-White populations, the representation of CM of IBD in this population is significantly limited, underrecognized, and thus undertreated. Our results reveal increased prevalence of several CM in the non-White IBD patient population. Notably, hidradenitis suppurativa has been shown to be associated with IBD, however our study is one of the first to highlight that it is significantly increased in IBD patients who are..."

Retrospective data • Cognitive Disorders • Dermatology • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Varicella Zoster • Vasculitis • Vitiligo

RISK FOR RECURRENT VTE IN IBD PATIENTS ON ANTICOAGULATION FOR JAK INHIBITORS COMPARED TO OTHER THERAPIES (DDW 2025) - "This population was then divided into patients who were prescribed a JAKi (tofacitinib for ulcerative colitis (UC) or upadacitinib for either UC or Crohn's disease) or other IBD-specific medications including: Mesalamine, sulfasalazine, balsalazide, budesonide, azathioprine, methotrexate, 6-mercatopurine, infliximab, certolizumab, golimumab, adalimumab, vedolizumab, ustekinumab, and risankizumab, mirikizumab, guselkumab, etrasimod, and ozanimod. IBD is associated with an increased risk of VTE. The evidence of recurrent VTE for patients with JAKi use is limited. Current disclaimers for JAKi emphasize risks of use in patients with history of VTE."

Clinical • Cardiovascular • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Inflammatory Bowel Disease • Respiratory Diseases • Ulcerative Colitis • Venous Thromboembolism