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

Drug-Induced Pancreatitis Across UC Therapeutics: A Real-World Pharmacovigilance Study (ACG 2026) - " FAERS was queried for reports of pancreatitis associated with UC treatments including immunomodulators (azathioprine, mercaptopurine, methotrexate, tacrolimus), 5-aminosalicylates (mesalamine, balsalazide, olsalazine, sulfasalazine), anti-TNF agents (adalimumab, infliximab, golimumab, certolizumab pegol), integrin inhibitors (vedolizumab, natalizumab), IL-12/23 inhibitors (ustekinumab, risankizumab, guselkumab), JAK inhibitors (tofacitinib, upadacitinib), and S1P modulators (ozanimod, etrasimod). 83,046 reports with 612 pancreatitis cases were analyzed. Significantly elevated risk was observed with azathioprine (ROR 4.38, 95% CI 3.56-5.38), mesalamine (ROR 2.32, 95% CI 1.87-2.89), and infliximab (ROR 1.47, 95% CI 1.21-1.80; all p< 0.0001). Reduced risk was identified with adalimumab (ROR 0.60, 95% CI 0.49-0.74), vedolizumab (ROR 0.69, 95% CI 0.51-0.93), and ustekinumab (ROR 0.13, 95% CI 0.02-0.94)."

Adverse events • Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pancreatitis • Ulcerative Colitis • IL12A • ROR1

Herpes Zoster Infection as an Adverse Reaction to Treatments for Ulcerative Colitis: A Review of Reports to the FDA Adverse Events Reporting System (FAERS) (ACG 2026) - "Reports of ADRs of all FDA approved UC therapies including mesalamine, sulfasalazine, balsalazide, olsalazine, methotrexate, azathioprine, 6-mercaptopurine, infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab, mirikizumab, risankizumab, guselkumab, ozanimod, etrasimod, tofacitinib, and upadacitinib along with combination infliximab with methotrexate, infliximab with azathioprine, adalimumab with azathioprine, and golimumab with azathioprine were reviewed. Table 1 displays the total FAERS reports of ADRs and reported HZ infection in patients treated for UC. The JAK inhibitor tofacitinib showed increased risk of HZ with 58 total reports (ROR 2.79). In addition, methotrexate (ROR 1.83), azathioprine (ROR 1.74), 6-mercaptopurine (ROR 2.4), infliximab (ROR 2.49), and combination therapies of infliximab with methotrexate (ROR 2.61) and infliximab with azathioprine (ROR 2.91) demonstrated increased risk."

Adverse events • Review • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster • ROR1

Prevalence and Outcomes of Hormone Therapy Use Among Menopausal Women With Inflammatory Bowel Disease (ACG 2026) - "However, patients with CD prescribed systemic HT had higher oral prednisone use, while osteoporosis/fracture outcomes were lower among patients receiving systemic HT. Figure: 1-Systemic non-transdermal HRT included oral estradiol, conjugated estrogens, esterified estrogens, synthetic conjugated estrogens A and B, oral progesterone, oral medroxyprogesterone, conjugated estrogens/bazedoxifene (Duavee), estradiol acetate vaginal ring (Femring), and norethindrone acetate/ethinyl estradiol (Femhrt). 2-Systemic transdermal HRT included estradiol/norethindrone acetate transdermal patch (CombiPatch), estradiol/levonorgestrel transdermal patch (Climara Pro), estradiol transdermal patches (Alora, Climara, Dotti, Estraderm, Lyllana, Minivelle, Vivelle-Dot), estradiol transdermal gel (EstroGel, Divigel), and estradiol transdermal spray (Evamist). 3-Local estrogen therapy included low-dose vaginal estradiol formulations (Estring, Imvexxy, Vagifem, and Yuvafem) and vaginal conjugated..."

Clinical • Cardiovascular • Coronary Artery Disease • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pulmonary Embolism • Respiratory Diseases • Ulcerative Colitis

Impact of Continued Etrasimod Treatment in Patients Without Clinical Response at the End of the Induction Period: Results From the ELEVATE UC Open-Label Extension (ACG 2026) - P3 | "A total of 129 etrasimod-treated pts were included. At induction study baseline, 32.6% had prior biologic/Janus kinase inhibitor failure, 55.8% had a modified Mayo score ⥠7, and 69.8% had an endoscopic subscore of 3 (Table). By OLE Weekâ¯12, symptomatic response was observed in 57.4% of pts (NRI: 45.0%; Figure)."

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

Long-Term Maintenance of Efficacy With Etrasimod After up to 3 Years of Continuous Treatment in the ELEVATE UC Program (ACG 2026) - P3 | "Overall, 185 patients were included in this analysis; total exposure to etrasimod across parent studies and the OLE ranged from 64 to 156 weeks. At Week 52 and Week 104 of the OLE, respectively, 71.5% (NRI: 60.0%) and 70.0% (NRI: 51.3%) of patients maintained clinical remission, while 87.6% (NRI: 72.9%) and 86.9% (NRI: 62.0%) of patients were in symptomatic remission (Table). At the same time points, endoscopic improvement was observed in 79.4% (NRI: 64.5%) and 76.4% (NRI: 54.0%) of patients, respectively, and histologic improvement was observed in 78.1% (NRI: 64.5%) and 82.1% (NRI: 58.0%) of patients, respectively."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Risk of Herpes Zoster in Patients With Inflammatory Bowel Disease Treated With Janus Kinase Inhibitors Compared With Anti-TNF Therapy: A Retrospective Cohort Study (ACG 2026) - "2 Advanced therapy was defined infliximab, adalimumab, certolizumab pegol, golimumab, vedolizumab, ustekinumab, tofacitinib, upadacitinib, risankizumab, etrasimod, ozanimod, guselkumab, and mirikizumab. Among 8,293 patients with IBD, 3,164 received JAKi and 5,129 received anti-TNF therapy (Table 1). JAKi-treated patients had higher HZ incidence rates than anti-TNF patients (32.81 vs. 14.58 per 1,000 person-years; p< 0.001)."

Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster

Comparative Efficacy and Safety of Etrasimod Versus Ozanimod, JAK Inhibitors, and Placebo in Adults With Moderate to Severe Ulcerative Colitis (ACG 2026) - "Regarding safety, filgotinib 100 mg was the only treatment significantly reducing any-TEAE risk versus placebo (OR 0.82; 95% CrI 0.68-0.98), while ozanimod 1 mg was the only treatment significantly increasing TEAE risk (OR 1.71; 95% CrI 1.22-2.40). Up to 28 RCTs enrolling 8,377 participants were included. For induction clinical remission (18 RCTs; N=6,562), upadacitinib 45 mg ranked highest (OR 9.92, 95% CrI 5.81-18.11; SUCRA 90%), followed by ozanimod 1 mg (OR 4.37; SUCRA 63%), tofacitinib 10 mg induction (OR 4.23; SUCRA 60%), and etrasimod 2 mg (OR 3.61; SUCRA 52%). For induction clinical response, upadacitinib 45 mg again ranked first (OR 7.84; SUCRA 94%), with etrasimod 2 mg (OR 3.01; SUCRA 59%) and tofacitinib 10 mg (OR 2.96; SUCRA 58%) performing comparably."

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

Corticosteroid-Free Remission and Patient-Reported Outcomes With Etrasimod in Ulcerative Colitis: Interim Data From the Real-World EFFECT-UC Study (ACG 2026) - P | "As of June 16, 2025, 121 patients received etrasimod (mean age 40.2 years; mean modified Mayo score 4.9; 60.3% advanced therapy naïve; 27.0% baseline CS use). CS-free symptomatic remission was achieved by 23/63 (36.5%) and 18/38 (47.4%) patients at Week 12 and Week 24, respectively. Mean change from baseline (standard error of mean [SEM]) for SIBDQ was 7.6 (1.6) and 10.0 (2.0), and for FACIT-F was 3.8 (1.2) and 4.8 (1.8) at Week 12 and Week 24, respectively."

Clinical • Patient reported outcomes • Real-world • Real-world effectiveness • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Early Experience With Etrasimod in Ulcerative Colitis Patients: A Claims Database Study in the United States (ACG 2026) - "(e)Advanced treatments: adalimumab, golimumab, infliximab, vedolizumab, ustekinumab, mirikizumab, risankizumab, guselkumab, tofacitinib, upadacitinib, and ozanimod. A total of 297 patients were included (mean age, 47.3 years [SD, 17.5]; 52.2% male), and 127 comprised the follow-up population. In the follow-up population, most patients were AT-naïve (67.7%), and 48.0% had used steroids within 24 weeks prior to index date (Table 1). Through week 24, median adherence was 89.8% (quartile 1: 53.9%; quartile 3: 98.8%), and 59.1% of patients had PDC â¥0.80."

Claims database • Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy of Risankizumab Versus Other Advanced Therapies for Moderate to Severe Ulcerative Colitis in Advanced Therapy Naïve Populations: A Bayesian Network Meta-Analysis (ACG 2026) - " This NMA utilized published data from phase 3 randomized controlled trials of the following FDA-approved first-line ATs for moderate to severe UC: RZB, guselkumab (GUS), mirikizumab (MIR), ustekinumab (UST), vedolizumab (VDZ), golimumab (GOL), infliximab (IFX), adalimumab (ADA), etrasimod (ETR), and ozanimod (OZA). ITT efficacy rates of clinical remission and endoscopic improvement were highest for RZB (1200 mg x 360 mg) ( Figure ). GUS, MIR, and RZB (1200 mg x 180 mg) had the highest ITT rates for clinical response. In the Induction NMA, RZB demonstrated the highest odds ratio (OR [95% credible interval]) vs PBO for clinical response (5.12 [3.29-7.94]) and endoscopic improvement (5.32 [3.03-9.68])."

Metastases • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis

Pregnancy Outcomes After Maternal or Paternal Exposure to Etrasimod: An Updated Analysis From the Clinical Development Program (ACG 2026) - "[c]One patient had an anembryonic gestation where umifenovir (received for a respiratory tract infection) was a co-suspected drug. Of 2,665 unique patients exposed to etrasimod in the clinical program, 753 (28.3%) were women of childbearing age (16â44 years). A total of 24 pregnancies with etrasimod exposure were reported (13 maternal, 11 paternal). Women with maternal exposure were aged 18â37 years."

Clinical • Alopecia • Atopic Dermatitis • Crohn's disease • Dermatitis • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Long-acting Reversible Contraceptives • Respiratory Diseases • Ulcerative Colitis

Beyond the Label? Real-World Dosing Strategies for Newer Biologic Therapies in Ulcerative Colitis (ACG 2026) - "The following are considered unique advanced therapies: adalimumab, etrasimod, golimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab (includes biosimilars), upadacitinib, vedolizumab, tofacitinib, ozanimod assessed 12-months prior to index date...on-label refers to FDA label maintenance dosing: Q2W (vedolizumab [subcutaneous]), Q4W (mirikizumab) and Q8W (ustekinumab, risankizumab, vedolizumab [intravenous])... The maintenance cohorts comprised patients receiving USTE (n=7641), MIRI (n=322), RISA (n=707), and VEDO (n=15167) ( Table 1 ). Patients with â¥2 unique advanced therapies within 12 mo prior to index drug were 13.4% in MIRI, 10.9% in RISA, 7.1% in USTE and 1.7% in VEDO cohorts. During the maintenance period, most fills occurred at the on-label dosing interval for each therapy."

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

Real-World Effectiveness and Safety of Etrasimod in Patients With Ulcerative Colitis in the United States: Interim Analysis of the ENDEAVOUR-UC Study (ACG 2026) - P | "As of March 6, 2026, 72 patients had received etrasimod and 69 were included in the full analysis set (mean age 38.5 years; 40.6% female; 82.1% advanced therapy-naïve; Table). At baseline, mean patient-reported outcome scores were 0.5 for Mayo stool frequency subscore, 0.8 for Mayo rectal bleeding subscore, 5.1 for BU NRS, 2.9 for AP NRS, and 34.7 for FACIT-F. At Week 12 and Week 24, respectively, 50.0% (95% confidence intervals 33.8, 66.2) and 54.5% (32.2, 75.6) of patients were in symptomatic remission, and 23.3% (11.8, 38.6) and 30.0% (11.9, 54.3) were in BU remission (Figure)."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Epilepsy • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease • Leukopenia • Ulcerative Colitis • CRP

Comparative Post-Marketing Safety Signals of Etrasimod Versus Ozanimod: A Head-to-Head Disproportionality Analysis of the FDA Adverse Event Reporting System (FAERS) (ACG 2026) - "After these interpretive exclusions, 42 clinically relevant PTs were identified with etrasimod and 16 with ozanimod. Etrasimod-preferred signals included bradycardia (ROR 4.90, 95% CI 2.58â9.31), macular edema ( 2.36, 95% CI 1.17â4.76), blurry vision( 2.23, 95% CI 1.49â3.33), LFTs increased (6.01, 2.11â17.17), rash (1.80, 1.22â2.67), and dizziness (1.62, 1.27â2.07). Ozanimod PTs included fatigue (0.51, 0.39â0.66), lymphopenia (0.22, 0.07â0.70), back pain (0.32, 0.17â0.58), and urinary tract infection (0.36, 0.17â0.78)."

Adverse events • Clinical • Head-to-Head • P4 data • Back Pain • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Macular Edema • Multiple Sclerosis • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Ophthalmology • Ulcerative Colitis

Exhibitor Product Theater - Identifying Appropriate Patients for VELSIPITY� (etrasimod) (ACG 2026) - "These programs are independent of the ACG 2026 Annual Scientific Meeting and Postgraduate Course programs. No CME is provided for Exhibitor Product Theater presentations."

Clinical

Advanced Therapies in IBD: Biologics and Beyond (IASGO 2026) - "Ulcerative colitis: For moderate-to-severe UC, biologic options include anti-TNF agents (infliximab, adalimumab,and golimumab), vedolizumab, ustekinumab, and selective IL-23 inhibitors (mirikizumab,risankizumab, and guselkumab). Small-molecule therapies, including JAK inhibitors (tofacitiniband upadacitinib) and S1P receptor modulators (ozanimod and etrasimod), further expandtherapeutic options...Recent AGA guidance further incorporates newer IL-23inhibitors, including mirikizumab and guselkumab, and upadacitinib into the expandingtherapeutic armamentarium. Overall, contemporary IBD management is shifting from rigid treatment algorithms toward early,individualized selection of advanced therapies, integrating efficacy, safety, disease phenotype, priortreatment exposure, and patient preference."

Metastases • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries. (PubMed, Paediatr Drugs) - "Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD."

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

Application of Vitamin B6 in Diabetic Cardiomyopathy through Modulation of Endoplasmic Reticulum Stress. (PubMed, J Nutr Biochem) - "Vitamin B6 mitigates DCM-associated injury and is accompanied by restoration of S1P1 expression, ERK/CREB phosphorylation, and SIRT1 expression, together with attenuation of ER stress. These findings suggest the involvement of an S1P1-related ERK/CREB-SIRT1 regulatory network, while the precise causal hierarchy and direct molecular links remain to be established."

Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Diabetes • Fibrosis • Heart Failure • Immunology • Metabolic Disorders • ATF4

Comparative Cost-Effectiveness of Advanced Treatment Sequences for Moderately to Severely Active Ulcerative Colitis in Japan. (PubMed, Adv Ther) - "Under the assumptions of this model, a treatment sequence with first-line etrasimod followed by second-line upadacitinib was identified as the most cost-effective strategy for advanced therapy-naïve patients with moderately to severely active UC in Japan."

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

Influence of Ageing on the Pharmacology, Efficacy and Safety of Oral Targeted Therapies for Inflammatory Bowel Disease: Focus on Janus Kinase (JAK) Inhibitors and Sphingosine-1-Phosphate (S1P) Receptor Modulators. (PubMed, Drugs Aging) - "This review synthesises the available evidence on the influence of ageing on the pharmacology, efficacy and safety of orally administered targeted inflammatory bowel disease therapies, focusing on registered Janus kinase inhibitors (tofacitinib, upadacitinib, filgotinib) and sphingosine-1-phosphate receptor modulators (ozanimod, etrasimod). There is, however, no clear consensus on how ageing-related vulnerability, including frailty and comorbidity burden, should be defined, measured, and reported across studies, which complicates the interpretation and comparison of outcomes. In the absence of robust outcome data for older adults with inflammatory bowel disease, treatment selection should be guided by biological vulnerability (frailty, organ function, comorbidity burden) and structured risk-mitigation strategies, while future research should prioritise age- and frailty-enriched prospective studies with geriatric-relevant outcomes and long-term pharmacovigilance."

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

An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=553 ➔ 1

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

Pharmacological properties and clinical efficacy of sphingosine 1-phosphate (S1P) receptor modulator, Etrasimod (Velsipity® 2 mg tablets) (PubMed, Nihon Yakurigaku Zasshi) - "Based on these results, etrasimod was approved in Japan in June 2025 for moderate to severe UC with inadequate response to existing therapies. With once-daily oral dosing without titration and a favorable safety profile, etrasimod represents a new therapeutic option for UC."

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

Autoimmune Disease Portfolio (Everest Medicines Press Release) - "In May 2026, Everest announced that South Korea’s Ministry of Food and Drug Safety (MFDS) approved VELSIPITY (etrasimod) for the treatment of adults with moderately to severely active UC. The approval marked the fifth market approval for VELSIPITY in Everest’s licensed territories, following approvals in Macao SAR, Singapore, Hong Kong SAR and Chinese Mainland....We expect to receive NDA approval in China Taiwan in the second half of 2026; We plan to participate in NRDL negotiations for VELSIPITY in the second half of 2026."

China approval • Commercial • Korea approval • Ulcerative Colitis

CORTICOSTEROID-FREE REMISSION AND PATIENT-REPORTED OUTCOMES WITH ETRASIMOD IN ULCERATIVE COLITIS: INTERIM DATA FROM THE REAL-WORLD EFFECT-UC STUDY (UEGW 2026) - No abstract available

Clinical • Patient reported outcomes • Real-world • Real-world effectiveness • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • 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 THE ELEVATE UC OLE (UEGW 2026) - No abstract available

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