Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis
Eli Lilly (NYSE: LLY) reported Phase 3b LUCENT-URGE results showing early, sustained improvement in bowel urgency for adults with moderately to severely active ulcerative colitis treated with Omvoh (mirikizumab‑mrkz).
Key outcomes: 55% reduction in daily bowel urgency episodes by Week 12 (maintained at Week 28), 52% reduction in urgency severity by Week 28, and increase in patients able to delay a bowel movement ≥15 minutes from 4.1% at baseline to 29.7% at Week 28. Safety was consistent with prior LUCENT data: 5.2% serious adverse events and 4.7% discontinuations due to adverse events. Results will be presented at ACG Oct 24–29, 2025.
Eli Lilly (NYSE: LLY) ha riportato i risultati della fase 3b LUCENT-URGE che mostrano un miglioramento precoce e sostenuto nell'urgenza intestinale negli adulti con colite ulcerosa attiva da moderata a grave trattata con Omvoh (mirikizumab‑mrkz).
Risultati chiave: 55% riduzione degli episodi quotidiani di urgenza intestinale entro la settimana 12 (mantenuta fino alla settimana 28), 52% riduzione della gravità dell'urgenza entro la settimana 28, e aumento dei pazienti in grado di posticipare lo stimolo a evacuare di ≥15 minuti da 4,1% al basale a 29,7% alla settimana 28. La sicurezza è risultata coerente con i dati LUCENT precedenti: 5,2% eventi avversi gravi e 4,7% interruzioni dovute a eventi avversi. I risultati saranno presentati all'ACG dal 24 al 29 ottobre 2025.
Eli Lilly (NYSE: LLY) informó resultados de la fase 3b LUCENT-URGE que muestran una mejora inicial y sostenida en la urgencia intestinal en adultos con colitis ulcerosa activa de moderada a grave tratados con Omvoh (mirikizumab‑mrkz).
Resultados clave: 55% reducción de los episodios diarios de urgencia intestinal para la semana 12 (mantenida para la semana 28), 52% reducción de la severidad de la urgencia para la semana 28, y aumento en pacientes capaces de retrasar la defecación ≥15 minutos desde 4,1% en la línea de base a 29,7% en la semana 28. La seguridad fue consistente con los datos previos de LUCENT: 5,2% eventos adversos graves y 4,7% interrupciones por eventos adversos. Los resultados se presentarán en ACG del 24 al 29 de octubre de 2025.
엘리 릴리(Eli Lilly, NYSE: LLY)가 모더레이트에서 중등도~심하게 활성화된 궤양성 대장염을 가진 성인을 대상으로 Omvoh( mirikizumab‑mrkz )로 치료했을 때 초기적이고 지속적인 항문 급박 개선을 보인 3b상 LUCENT-URGE 결과를 발표했습니다.
핵심 결과: 12주 차까지 매일 항문 급박 발작이 55% 감소(28주 차까지 유지), 28주 차까지 급박의 심각도 52% 감소, 기저선에서 4.1%에서 주차 28에 29.7%로 대변 배출을 ≥15분까지 지연할 수 있는 환자 비율 증가. 안전성은 이전 LUCENT 데이터와 일치: 5.2%의 중대한 이상사건과 4.7%의 이상반응으로 인한 중단. 결과는 2025년 10월 24–29일 ACG에서 발표될 예정입니다.
Eli Lilly (NYSE: LLY) a communiqué les résultats de la phase 3b LUCENT-URGE montrant une amélioration précoce et durable de l’urgence intestinale chez les adultes atteints de colite ulcéreuse active modérée à sévère traités par Omvoh (mirikizumab‑mrkz).
Résultats clés : 55% réduction des épisodes quotidiens d’urgence intestinale d’ici la semaine 12 (maintenue jusqu’à la semaine 28), 52% réduction de la gravité de l’urgence d’ici la semaine 28, et augmentation du nombre de patients capables de retarder l’envie d’aller à la selle ≥15 minutes, passant de 4,1% à la ligne de base à 29,7% à la semaine 28. La sécurité était cohérente avec les données LUCENT précédentes : 5,2% d’événements indésirables graves et 4,7% d’arrêts dus à des événements indésirables. Les résultats seront présentés à l’ACG du 24 au 29 octobre 2025.
Eli Lilly (NYSE: LLY) berichtete über die Phase-3b-LUCENT-URGE-Ergebnisse, die eine frühe, anhaltende Verbesserung der Darmentzugsdringlichkeit bei Erwachsenen mit moderat bis stark aktiver Colitis ulcerosa zeigen, die mit Omvoh (mirikizumab‑mrkz) behandelt wurden.
Zentrale Ergebnisse: 55% Reduktion der täglichen Darmentzugs-Episoden bis Woche 12 (bis Woche 28 beibehalten), 52% Reduktion der Dringlichkeits-Schwere bis Woche 28 und eine Zunahme der Patienten, die eine Stuhldrang >=15 Minuten verzögern können, von 4,1% zu Basislinie auf 29,7% in Woche 28. Die Sicherheit entsprach den bisherigen LUCENT-Daten: 5,2% schwere unerwünschte Ereignisse und 4,7% Abbrüche aufgrund von unerwünschten Ereignissen. Die Ergebnisse werden auf der ACG vom 24. bis 29. Oktober 2025 vorgestellt.
إيلي ليلي (NYSE: LLY) أبلغت عن نتائج المرحلة 3b LUCENT-URGE التي أظهرت تحسنًا مبكرًا ومستمرًا في الاستعجال البطني لدى البالغين المصابين بالتهاب القولون التقرحي النشط من الدرجة المتوسطة إلى الشديدة الذين يعالجون بـ Omvoh (mirikizumab‑mrkz).
النتائج الرئيسية: تقليل 55% في نوبات الاستعجال البطني اليومية حتى الأسبوع 12 (والحفاظ عليها حتى الأسبوع 28)، وتقليل 52% في شدة الاستعجال حتى الأسبوع 28، وزيادة عدد المرضى القادرين على تأجيل حركة الأمعاء بمقدار ≥15 دقيقة من 4.1% في خط الأساس إلى 29.7% في الأسبوع 28. والسلامة كانت متسقة مع بيانات LUCENT السابقة: 5.2% وفيات جانبية خطيرة و4.7% انسحابات بسبب أحداث جانبية. سيتم عرض النتائج في اجتماع ACG من 24 إلى 29 أكتوبر 2025.
辉瑞/礼来（NYSE: LLY）公布了第3b期LUCENT-URGE的结果，显示在用< b>Omvoh (mirikizumab‑mrkz)治疗的中度至重度活动性溃疡性结肠炎成人患者中，肠道急迫性有早期且持续的改善。
关键结果：在第12周前每日肠道急迫发作减少55%（到第28周维持），在第28周急迫程度减少< b>52%，并且能够将排便延迟≥15分钟的患者比例从基线的4.1%增加到第28周的29.7%。安全性与此前LUCENT数据一致：5.2%严重不良事件和4.7%因不良事件而终止治疗。结果将于2025年10月24–29日在ACG会议上公布。
- Bowel urgency frequency −55% by Week 12
- Urgency severity −52% at Week 28
- Stool deferral ≥15 minutes rose to 29.7% at Week 28
- Efficacy maintained from Week 12 through Week 28
- Regulatory approvals in 45 countries for UC and Crohn's
- Serious adverse events reported in 5.2% of patients
- Treatment discontinuations due to adverse events 4.7%
Insights
Omvoh showed early, sustained improvements in bowel urgency frequency, severity, and stool deferral by Week 28 in a Phase 3b study.
Omvoh produced measurable symptom changes: daily urgency fell from 6.9 to 3.1 by
These endpoints target patient-facing function rather than only endoscopy scores, so they capture different dimensions of benefit. Safety signals reported were consistent with prior data:
Watch the presentation at the American College of Gastroenterology meeting and subsequent peer-reviewed detail for subgroup data and responder definitions; short-term (
Phase 3b LUCENT-URGE is the first study in inflammatory bowel disease to assess bowel urgency across three measures — severity, frequency and stool deferral time — reflecting the spectrum of its burden on patients
By Week 12, patients experienced a
At Week 28, nearly one-third of patients were able to delay using the restroom for at least 15 minutes after feeling urgency, up from
"For many people with ulcerative colitis, the unpredictable and immediate need to find a restroom can be stressful and disrupt everyday activities, often forcing them to map restroom locations or to avoid important events," said David Rubin, M.D., Professor of Medicine and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine. "These data build on prior Phase 3 and long-term results demonstrating Omvoh can reduce bowel urgency and help people regain control over a symptom that has often dictated their daily life."
In LUCENT-URGE, the following results were observed:1
-
Bowel urgency severity: Bowel urgency severity was reduced by
52% at Week 28, with the average Urgency Numeric Rating Scale (UNRS) score dropping from 6.9 at baseline to 3.7 at Week 12 and 3.3 at Week 28. -
Bowel urgency frequency: Patients reported a
55% reduction from baseline in the number of times they experienced bowel urgency per day, from 6.9 times per day at baseline to 3.1 at Week 12, which was maintained at Week 28. -
Stool deferral time: The proportion of patients who were able to delay a bowel movement for at least 15 minutes or experienced no urgency in the previous 24 hours increased from
4.1% at baseline to15.7% at Week 12 and29.7% at Week 28, allowing them more time to reach a restroom.
Clinical, endoscopic and histologic improvements were consistent with previously disclosed LUCENT Phase 3 trial data. The safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. In LUCENT-URGE,
"Lilly is continuing to drive novel science in the study and treatment of bowel urgency because comprehensive control of ulcerative colitis must reflect the daily realities patients face, including the constant calculations and compromises they often make to navigate bowel urgency and its challenges," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "With Omvoh, we are delivering on our commitment to provide better patient outcomes."
The results from LUCENT-URGE build on the learnings from Lilly's CONFIDE study, which highlighted the often-overlooked burden of bowel urgency and other daily challenges faced by people living with UC. Lilly also recently disclosed four-year final data from LUCENT-3 in UC, including long-term outcomes in bowel urgency severity.
Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057) (NCT07186101), an oral α4β7 integrin inhibitor. Lilly is also advancing novel science to uncover the potential of incretins in immunology and has initiated the COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials evaluating the efficacy and safety of treating adults with UC or Crohn's disease and obesity with the concomitant use of mirikizumab with an incretin-based therapy. In addition, a trial of mirikizumab in pediatric patients is ongoing in UC (NCT05784246).
Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 45 countries around the world.
About the LUCENT Clinical Trial Program
Omvoh was studied in two, Phase 3 clinical trials which evaluated the efficacy and safety of mirikizumab in adults with moderately to severely active ulcerative colitis (UC), in both biologic-naïve patients and those who had previously failed biologic or Janus kinase inhibitors (JAKi). The randomized, double-blind, placebo-controlled LUCENT-1 (induction) and LUCENT-2 (maintenance) studies included patients with inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy or JAKi.2
LUCENT-URGE, a Phase 3b, single arm, open-label study, evaluated the impact of Omvoh on bowel urgency in adults with moderately to severely active UC and bowel urgency at baseline. Participants enrolled in LUCENT-URGE received Omvoh intravenously (300mg) at Weeks 0, 4 and 8, followed by subcutaneous dosing (200mg) every four weeks through Week 28. The study used baseline observation carried forward for continuous endpoints and non-responder imputation for binary endpoints. Participants were evaluated on bowel urgency severity, bowel urgency frequency, stool deferral time, clinical remission, endoscopic remission and histological-endoscopic mucosal improvement through Week 28, with the primary endpoint evaluating improvement in bowel urgency severity.1
Indications and Usage for Omvoh
®
(mirikizumab-mrkz) (in
Omvoh is an interleukin-23 antagonist indicated for adults with:
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn's disease
Important Safety Information for Omvoh (mirikizumab-mrkz)
CONTRAINDICATIONS
Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.
Infections
Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.
Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Immunizations
Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.
ADVERSE REACTIONS
Most common adverse reactions associated with Omvoh (≥
Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.
MR HCP ISI CD APP
Click to access provided Prescribing Information and Medication Guide . See Instructions for Use provided with the device.
About Omvoh
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.3
Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References
1 Danese S, et al. Mirikizumab demonstrates rapid and sustained improvements in bowel urgency measures and clinical measures in patients with moderately-to-severely active ulcerative colitis: 28-week results from the Phase 3b LUCENT-URGE trial. 2025 American College of Gastroenterology Meeting. October 24–29, 2025.
2 Sands, B, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflammatory Bowel Diseases, 2024;, izae253, https://doi.org/10.1093/ibd/izae253
3 Omvoh. Prescribing Information. Lilly
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Refer to: |
Kelly Hoffman; kelly.hoffman@lilly.com; 765-736-2555 (Lilly media) |
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Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors) |
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FAQ
What did Eli Lilly announce on Oct 27, 2025 about Omvoh (LLY) and bowel urgency?
How much did bowel urgency severity improve with Omvoh (LLY) in LUCENT-URGE?
What change in stool deferral time did Omvoh (LLY) produce in the study?
Were there safety concerns reported for Omvoh (mirikizumab) in LUCENT-URGE?
When and where will Lilly present the LUCENT-URGE results for Omvoh (LLY)?
Is Omvoh (LLY) approved for ulcerative colitis and Crohn's disease?
