Velsipity (etrasimod) / Everest Medicines, Pfizer - LARVOL DELTA

Safety Outcomes in Patients With Ulcerative Colitis Using a Healthcare Administrative Database in the United States. (PubMed, Inflamm Bowel Dis) - "These findings assist in understanding the background risks of safety events in patients with UC and suggest that the incidence of select safety outcomes is comparable between the ELEVATE UC trials and RWD."

Journal • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Skin Cancer • Solid Tumor • Ulcerative Colitis

Small Molecules in the Treatment of Acute Severe Ulcerative Colitis: A Review of Current Evidence. (PubMed, Pharmaceuticals (Basel)) - "Conversely, it is necessary to investigate whether infliximab can be effectively replaced or surpassed by other approved biological agents and small molecules as first-line therapy after steroid resistance. This review aims to summarise the available evidence on small molecules, specifically Janus kinase inhibitors and sphingosine-1-phosphate receptor modulators."

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

Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program. (PubMed, Inflamm Bowel Dis) - P3 | "The safety profile of etrasimod 2 mg QD in the ELEVATE UC population was consistent across age groups, with no change in the incidence of AEs. Patients receiving etrasimod vs placebo showed significant clinical benefit, regardless of age."

Journal • Retrospective data • Cardiovascular • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Inflammatory Bowel Disease • Musculoskeletal Pain • Ulcerative Colitis

Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. (PubMed, J Eur Acad Dermatol Venereol) - P2 | "Etrasimod did not meet the primary and secondary efficacy endpoints, but efficacy was numerically higher with etrasimod than with placebo. The etrasimod clinical programme for AA has been discontinued. Etrasimod was well tolerated, and its safety profile was consistent with other etrasimod studies to date."

Clinical • Journal • P2 data • Alopecia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Everest Medicines kicks off construction of VELSIPITY production project at Jiashan plant [Google translation] (Eastmoney.com) - "Shanghai Securities News China...On March 19, Genting Everest announced the launch of the VELSIPITY production and construction project at its Jiashan plant to provide support for the localized production of VELSIPITY. The total investment in the project is 70 million yuan....It is reported that VELSIPITY is used to treat patients with moderate to severe active ulcerative colitis (UC)."

Launch non-US • Ulcerative Colitis

Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies. (PubMed, J Clin Med) - "Recent approvals of etrasimod, upadacitinib, mirikizumab, and risankizumab have introduced novel mechanisms of action, offering renewed hope for IBD patients. Emerging therapies, precision medicine, and ongoing research into novel targets promise to reshape the IBD treatment landscape. As these advances continue to unfold, IBD patients can anticipate a brighter future, one marked by more effective, personalized, and accessible treatments."

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

Guselkumab (Tremfya) for ulcerative colitis. (PubMed, Med Lett Drugs Ther) - No abstract available

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

SYNERGISTIC REDUCTION OF INFLAMMATORY CYTOKINES WITH OBEFAZIMOD AND ETRASIMOD IN COMBINATION TREATMENT VS. EITHER MONOTHERAPY IN A MOUSE MODEL OF INFLAMMATORY BOWEL DISEASE (DDW 2025) - No abstract available

Monotherapy • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

4435: IMIBD_DAP: Immunology, Microbiology & Inflammatory Bowel Diseases (IMIBD) Section Distinguished Abstract Plenary (DDW 2025) - "Description: This session highlights the best of the best in basic and clinical science inflammatory bowel diseases research submitted to DDW 2025 and will cover novel genetic variants and gene expression patterns linked with disease, recent findings on the role of the gut microbiota on disease pathogenesis and the latest clinical trials controlled clinical trials in the field.Learning Objectives:• Examine the effect of a low-emulsifer diet on disease activity in Crohn's disease• Examine the efficacy of etrasimod for treatment of mild to moderately active UC• Learn about novel genetic variants and gene expression signatures in Inflammatory Bowel Disease; Understand host microbe interactions in Inflammatory Bowel Disease"

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

THE EFFICACY AND SAFETY OF ETRASIMOD IN MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL (DDW 2025) - No abstract available

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

ETRASIMOD FOR THE TREATMENT OF ULCERATIVE COLITIS: UP TO 4 YEARS OF SAFETY DATA FROM THE GLOBAL CLINICAL PROGRAM (DDW 2025) - No abstract available

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

THE IMPACT OF ETRASIMOD ON NEUTROPHILS IN THE ELEVATE UC CLINICAL PROGRAM (DDW 2025) - No abstract available

Clinical • Inflammatory Bowel Disease

ETRASIMOD EFFICACY IN PATIENTS WITH MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS (MODIFIED MAYO SCORE 4–6) IN THE PHASE 3 ELEVATE UC CLINICAL PROGRAM (DDW 2025) - No abstract available

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY OF ETRASIMOD AT WEEK 52 AMONG BIOLOGIC/JANUS KINASE INHIBITOR-NAÏVE PATIENTS WITH ULCERATIVE COLITIS WHO REACHED CLINICAL RESPONSE AT WEEK 12: POST HOC ANALYSIS OF THE PHASE 3 ELEVATE UC 52 RANDOMIZED TRIAL (DDW 2025) - No abstract available

Clinical • P3 data • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

The Ministry of Health publishes the first reports that will justify the financing of drugs [Google translation] (Infobae) - "The Ministry of Health began publishing reports on Friday justifying the criteria used to decide to fund a drug in order to improve transparency regarding the process of including medicines in the public system...The first three drugs that already have their respective reports posted on the website are etranacogene dezaparvovec (Hemgenix, by its commercial name, used for hemophilia B); mavacamten (Camzyos, indicated for hypertrophic obstructive cardiomyopathy) and etrasimod (Velsipity, for ulcerative colitis)...Thus, from now on, each new medicine that is incorporated into the National Health System will have its own file detailing information about its financing conditions or comparative evaluation with similar medicines, the Ministry explained in a note....It also includes information on the decision of the CIPM, the conditions of inclusion, detailing the specific criteria by which the drug was included in the SNS, from the target population to possible restrictions, among others."

Reimbursement • Hemophilia B • Obstructive Hypertrophic Cardiomyopathy • Ulcerative Colitis

Etrasimod for moderate to severe ulcerative colitis. (PubMed, Aust Prescr) - No abstract available

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

Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program. (PubMed, Inflamm Bowel Dis) - P3 | "At week 12, etrasimod showed greater reductions in disease activity and higher rates of clinical response vs placebo in patients with either moderately or severely active disease at baseline. The safety profile of etrasimod was consistent with the overall trial population and was unimpacted by baseline disease activity."

Journal • P3 data • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Clinical response trajectories identify distinct subpopulations of ulcerative colitis patients and are linked to disease outcome across different therapy classes. Patient level analysis of 2378 participants from 6 randomized controlled trials in moderate-severe UC representing 8 different mechanisms of action. (ECCO-IBD 2025) - "Post hoc analysis of the SELECTION trial (filgotinib) demonstrated that treating daily PRO2 scores (stool frequency, rectal bleeding) as time-series data reveals discrete subpopulations.Patients with in the faster response trajectory groups achieve wk52 endpoints at higher rates including disease control. Methods In a cross-industry/academic collaboration, data from 2,378 UC responders from RCTs of adalimumab, brepocitinib, etrasimod, etrolizumab, ozanimod, ritlecitinib, ustekinumab, and vedolizumab in UC were analyzed for PRO2-based treatment response trajectories using Group-based trajectory modeling (GBTM)...Response trajectories likely reflect underlying heterogeneity in disease biology in the interaction with the different MOA (i.e. endotypes). RNASeq analysis of transcriptome regulation in these patients aims to further explore this hypothesis."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Ozanimod Does Not Directly Impact B Cell Activation, Proliferation, and Memory Recall in Human ex vivo Functional Assays (ACTRIMS Forum 2025) - "A recent retrospective analysis of the DAYBREAK study has demonstrated that all MS patients on ozanimod treatment effectively generate a vaccine-induced antibody response against SARS-CoV-2, though heterogeneity in the magnitude of serologic response was observed, with some patients developing lower antibody levels.Objectives: Our objective was to evaluate whether ozanimod, or other S1P receptor modulators (fingolimod, etrasimod, ponesimod and, siponimod), had a direct impact on primary human B cell function when assessing activation, proliferation, differentiation, and antibody memory recall. We utilized human peripheral blood mononuclear cells (PBMC) or isolated B cells from healthy donors. Results from this work suggest that ozanimod does not directly impact primary human B cell activation, proliferation, differentiation, or memory recall. Findings reinforce the observation that MS patients treated with ozanimod mount an effective immune response with 100%..."

Preclinical • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases • Tetanus • CCL3 • CD40LG • CD69 • CSF2 • CXCL8 • IL2 • IL21 • IL2RA • IL6 • TNFA

Everest Medicines Announces Acceptance of VELSIPITY New Drug Application in Macau (PRNewswire) - "Everest Medicines...announced the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, has accepted Everest's New Drug Application (NDA) for VELSIPITY (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis....'The company now awaits the 52-week data from our Phase 3 Asia clinical trial and plans to submit the NDA for NMPA approval in mainland China this year'...Everest is conducting a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries and regions, including mainland China, China Taiwan and South Korea....The data for maintenance period is expected for readout in 2H 2024."

Non-US regulatory • P3 data • Ulcerative Colitis

Everest Medicines Presents Complete Maintenance Period Data for Etrasimod at ECCO 2025 (PRNewswire) - P3 | N=341 | NCT04176588 | Sponsor: Everstar Therapeutics Limited | "The results demonstrate that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints at the end of maintenance period. A statistically significant greater proportion of etrasimod-treated patients achieved clinical remission at Week 40 compared with placebo (etrasimod: 48.1%; placebo: 12.5%; difference = 35.9%; 95% CI: [22.5%, 49.2%]; 2-sided p value < 0.0001). A statistically significant greater proportion of etrasimod-treated patients achieved endoscopic improvement (etrasimod: 61.0%; placebo: 15.0%, difference = 46.6% [95% CI : 33.2%，60.1%], 2-sided p value < 0.0001) and clinical response (etrasimod: 79.2%; placebo: 35.0%, difference = 45.6% [ 95% CI :31.9%，59.3%], 2-sided p value < 0.0001) at week 40 compared with placebo."

P3 data • Ulcerative Colitis

Recent advances in epidemiology, pathogenesis, diagnosis, and treatment of inflammatory bowel disease: Insights from the past two years. (PubMed, Chin Med J (Engl)) - "A wide range of novel drugs for IBD, including interleukin-23 inhibitors (mirikizumab, risankizumab, and guselkumab) and small-molecule drugs (etrasimod and upadacitinib), have been introduced in the past few years. Despite these advancements, approximately one-third of patients remain primary non-responders to the initial treatment, and half eventually lose response over time. Precision medicine integrating multi-omics data, advanced combination therapy, and complementary approaches, including stem cell transplantation, psychological therapies, neuromodulation, and gut microbiome modulation therapy, may offer solutions to break through the therapeutic ceiling."

Journal • Bone Marrow Transplantation • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Transplantation • Ulcerative Colitis

Matching-adjusted indirect comparisons of efficacy outcomes between etrasimod and ozanimod for moderately to severely active ulcerative colitis. (PubMed, J Comp Eff Res) - " MAIC results suggest that patients receiving etrasimod have similar induction results but are more likely to have clinical response and clinical remission at the end of the maintenance phase compared with patients receiving ozanimod. Despite the approach to ensure similarity between the trials by weighting, residual imbalance is possible, and results should be interpreted in the context of the assumptions."

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

Impact of pharmacological therapies for moderate to severe Ulcerative Colitis on health-related quality of life: a systematic review and network meta-analysis (ECCO-IBD 2025) - "Results Twenty-six randomized, double-blind, placebo-controlled trials with 14 interventions (adalimumab, etrasimod, filgotinib, golimumab, guselkumab, guselkumab/golimumab, infliximab, mirikizumab, risankizumab, tofacitinib, upadacitinib, ustekinumab, vedolizumab and placebo) assessed HRQL using the IBDQ score. Among the treatments evaluated, upadacitinib and filgotinib showed the most substantial benefits in improving IBDQ scores and were highly ranked for both IBDQ response and remission. Head-to-head trials are warranted to validate these comparative benefits and inform optimal treatment strategies."

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

Comparative efficacy on steroid-free remission of pharmacological therapies for moderate-to-severe Ulcerative Colitis: A systematic review and network meta-analysis (ECCO-IBD 2025) - "Results We included 22 studies (5 infliximab, 2 adalimumab, 2 golimumab, 3 vedolizumab, 1 ustekinumab, 1 ozanimod, 2 filgotinib, 1 upadacitinib, 1 etrasimod, 1 mirikizumab, 1 tofacitinib, 1 risankizumab, 1 guselkumab). Conclusion Very low-quality evidence supports the efficacy of all interventions except golimumab, vedolizumab, and filgotinib 100mg for steroid-free remission. Upadacitinib 30 mg/day and etrasimod 2 mg/day were ranked highest for efficacy in re-randomized and treat-through patients, respectively."

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