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

ESPIRIT: Etrasimod as Prevention of Pouchitis (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Maia Kayal

New P2 trial • Gastrointestinal Disorder • Inflammation

The efficacy of biologics and small molecules in the induction of remission in ulcerative proctitis: an international multicentre study (ECCO-IBD 2026) - "TNFα inhibitors were the most commonly initiated therapies (41.2%; n=47: 38 infliximab, 7 adalimumab, 2 golimumab), followed by JAK inhibitors (21.9%; n=25: 11 filgotinib, 9 upadacitinib, and 5 tofacitinib), ustekinumab (21.1%; n=24), vedolizumab (6.1%; n=7), etrasimod (6.1%; n=7), and mirikizumab (3.5%; n=4). Overall, six treatment discontinuations were recorded (four for lack of efficacy, one for disease progression, one for an allergic reaction), with no additional safety signals observed. Conclusion This multicentre international study demonstrates the effectiveness and safety of advanced therapy in inducing clinical remission in patients with ulcerative proctitis in a real-life setting."

Clinical • Inflammatory Bowel Disease • Ulcerative proctitis • CRP

Etrasimod Treatment Modulates Circulating and Lymph Node-Derived Lymphocytes in Crohn's Disease. (PubMed, Int J Mol Sci) - "Our data indicate that etrasimod's pharmacodynamic effect is related primarily with the attenuation of the T-cell mediated inflammation with minor changes in B-cells. However, additional follow-up studies are needed for the validation of these observations in the context of Crohn's disease."

Clinical • Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CD4 • CD8

ELEVATE-UCkids: A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Pfizer

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • 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

THE FALSE CONFIDENCE OF UNANCHORED MAIC: LESSONS IN ULCERATIVE COLITIS (ISPOR 2026) - "The objective of this study is to compare statistical uncertainty between unanchored and anchored MAICs using data from patients with ulcerative colitis. Using data from the Phase III UNIFI trial of ustekinumab in moderate-to-severe ulcerative colitis, obtained through the YODA Project, we compared its efficacy with published trial results for vedolizumab, upadacitinib, mirikizumab, guselkumab, etrasimod, and adalimumab. Unanchored and anchored MAICs can yield substantially different inferences, which may lead to contradictory decisions in comparative effectiveness assessments. Confidence intervals from unanchored MAICs are narrower compared to those from anchored MAICs despite leveraging less information. While anchored MAICs are always preferable when feasible, this research highlights differences between the two approaches and stresses the need for caution when interpreting results from unanchored MAICs in situations where anchoring is not possible."

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

An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis (clinicaltrials.gov) - P=N/A | N=553 | Not yet recruiting | Sponsor: Pfizer

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

Everest Medicines...announced the commercial launch of VELSIPITY (etrasimod arginine tablets) in Mainland China, highlighted by the issuance of the first prescription at The First Affiliated Hospital of Sun Yat-sen University, marking a milestone in patient access in the region. (The Manila Times)

Launch non-US • Ulcerative Colitis

C5041018: A Study of how the Medicine Called "Etrasimod" Works in Children With the gut Disease Called Ulcerative Colitis (clinicaltrialsregister.eu) - P1/2 | N=10 | Not yet recruiting | Sponsor: Pfizer Inc.

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Early disease activity informs real-world response to etrasimod in ulcerative colitis. (BWG 2026) - "Etrasimod induced rapid symptomatic and endoscopic improvements with meaningful w8 remission and sustained steroid-free symptomatic remission to month 6. Early on, treatment disease activity, particularly w4 partial modified Mayo and WBC count, was prognostic. Discontinuation was more frequent in patients with moderate-severe UC."

Clinical • Real-world • Real-world evidence • 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

C5041018: A Study of how the Medicine Called "Etrasimod" Works in Children With the gut Disease Called Ulcerative Colitis (clinicaltrialsregister.eu) - P1/2 | N=1 | Not yet recruiting | Sponsor: Pfizer Inc.

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

EFFICACY OF ETRASIMOD IN BIOLOGIC/JANUS KINASE INHIBITOR-NAÏVE PATIENTS WITH MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL (DDW 2026) - No abstract available

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

Real-world effectiveness and safety of etrasimod in Ulcerative Colitis: interim analysis of the EFFECT-UC study (ECCO-IBD 2026) - P | "No new safety signals were identified. These findings and future analyses provide important real-world evidence supporting the use of etrasimod in routine clinical practice."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Effectiveness and Safety of Etrasimod in Moderate to Severe Ulcerative Colitis: A Real-World Multicenter Study (ECCO-IBD 2026) - "Conclusion This is the first real-world multicentre study confirming the effectiveness and reassuring safety profile of etrasimod at week 12 in moderately to severely active UC. Further studies with larger sample size and longer follow-up are warranted."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Efficacy of Etrasimod in Ulcerative Colitis Patients Previously Treated with 5-Aminosalicylates and/or Thiopurines: Post Hoc Results from the Phase 3 ENLIGHT UC Study (ECCO-IBD 2026) - P3 | "Similar trends were observed for endoscopic improvement (37.2% vs 5.9% at week 12; 61.3% vs 17.5% at week 40), mucosal healing (26.6% vs 3.5% at week 12; 53.2% vs 9.5% at week 40), and symptomatic remission (39.9% vs 15.3% at week 12; 61.3% vs 31.7% at week 40), all with p < 0.0001. Conclusion Etrasimod was effective as an oral induction and maintenance treatment in moderately to severely active UC patients treated with prior 5-aminosalicylates and/or thiopurines, supporting its effectiveness when used early in the UC treatment algorithm."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Disease Clearance with Etrasimod in Asian Patients with Moderately to Severely Active Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 ENLIGHT UC Trial (ECCO-IBD 2026) - P3 | "Conclusion Etrasimod was effective in resolving colonic inflammation, as assessed by the stringent histologic and composite outcomes, including disease clearance. These findings further support Etrasimod as a promising treatment option for patients with moderately to severely active UC to achieve long-term treat goal."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Early disease activity informs real-world response to etrasimod in ulcerative colitis (ECCO-IBD 2026) - "Discontinuation was more frequent in patients with moderate–severe UC. These real-world findings support etrasimod as an effective and well-tolerated therapy in routine clinical practice."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Etrasimod Real-World Experience in Ulcerative Colitis: A multicentre cohort study (ECCO-IBD 2026) - "Conclusion This real-world study of etrasimod demonstrated a safety and efficacy profile consistent with data from the registration studies of etrasimod in UC, supporting its role in clinical practice. Ongoing, well curated real world datasets will enhance our understanding of this novel mechanism of action further."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Etrasimod for the treatment of Ulcerative Colitis: up to 5 years of safety data from the global clinical programme (ECCO-IBD 2026) - "Malignancies were uncommon (0.5%; IR/100PY: 0.27) and five patients had NMSC events (0.4%). Conclusion In this integrated safety analysis, including nine clinical trials in patients with moderately to severely active UC with etrasimod treatment exposure for up to 5 years, etrasimod was well tolerated and continues to have a favourable and stable safety profile."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term etrasimod efficacy in patients with Ulcerative Colitis stratified by prior biologic/JAKi experience: 2-year outcomes from ELEVATE UC OLE (ECCO-IBD 2026) - P3 | "Conclusion Etrasimod demonstrated durable efficacy through 2 years of treatment in the OLE across clinical, endoscopic and symptomatic outcomes in patients with UC with and without prior bio/JAKi exposure. This study is ongoing with future data readouts expected."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of up to 3 years of continuous etrasimod treatment: Long-term efficacy results from the ELEVATE UC open-label extension (ECCO-IBD 2026) - P3 | "Conclusion Etrasimod demonstrated maintenance of efficacy across clinical, endoscopic, symptomatic and histological endpoints for up to 3 years of continuous treatment, supporting durable efficacy. Future data readouts will continue to provide information on the long-term efficacy of etrasimod."

Clinical • Inflammatory Bowel Disease • Ulcerative Colitis

Etrasimod efficacy in patients with mildly to moderately active Ulcerative Colitis: pooled results from the ELEVATE UC and GLADIATOR trials (ECCO-IBD 2026) - "Safety in the GLADIATOR trial and the subpopulation of patients from the ELEVATE UC clinical programme with mildly to moderately active UC was consistent with the known safety profile of etrasimod. Conclusion In this pooled analysis, etrasimod demonstrated efficacy in the treatment of patients with mildly to moderately active UC, adding evidence to support the efficacy of etrasimod across the spectrum of active UC."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy of etrasimod in biologic/Janus kinase inhibitor-naïve patients with mildly to moderately active Ulcerative Colitis: results from the GLADIATOR trial (ECCO-IBD 2026) - P2 | "Safety in GLADIATOR was consistent with the known safety profile of etrasimod. Conclusion Etrasimod demonstrated efficacy in patients with mildly to moderately active UC and no prior bio/JAKi exposure, supporting the favourable benefit–risk profile and early use in the UC treatment algorithm."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Advances in the Management of Pediatric Inflammatory Bowel Disease: From Biologics to Small Molecules. (PubMed, Pharmaceuticals (Basel)) - " Anti-tumor necrosis factor (TNF) agents such as infliximab and adalimumab remain first-line biologics with proven efficacy in remission induction and maintenance. Newer biologics-vedolizumab, ustekinumab, risankizumab, and mirikizumab-offer alternatives for anti-TNF-refractory cases, showing encouraging short-term results and favorable safety profiles. Although many are approved only for adults with limited pediatric evidence, emerging small molecules-including Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) modulators (etrasimod)-provide oral, rapidly acting, and non-immunogenic treatment options for refractory disease... While biologics and small molecules have transformed PIBD management, challenges remain, including high treatment costs, limited pediatric trial data, and variable access worldwide. Future directions include multicenter pediatric studies, integration of pharmacogenomics, and biomarker-guided precision..."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Pediatrics