Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial

The choice of drug therapy for Crohn's disease depends on several factors, such as the severity of the condition, the sections of the bowel affected, or the patient's previous treatment history. Conventional therapy consists of a short course of corticosteroid treatment followed by azathioprine therapy. Alternatively, there are so-called advanced therapies using biologics (biotechnologically produced protein substances such as antibodies), for example mirikizumab. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the standard therapy of azathioprine in combination with corticosteroids. Following an inclusion phase, patients will be randomly assigned to either treatment with mirikizumab or azathioprine + corticosteroids. Patients in the azathioprine arm may switch to mirikizumab therapy at three time points from week 24 onwards if they do not respond adequately to azathioprine therapy. The study consists of an initial treatment period of 12 weeks (induction therapy) and a maintenance therapy period of 40 weeks. Patients in the mirikizumab arm receive 13 doses of mirikizumab. This includes initially 900 mg intravenously every 4 weeks followed by 300 mg subcutaneously. In the azathioprine arm patients receive daily administration of azathioprine tablets in combination with a steroid. Assignment to one of the two treatment options is randomised with equal probability for each of the treatment options.

Start Date01 Aug 2026

Sponsor / Collaborator-

NCT07686757

/ Not yet recruitingPhase 4IIT

INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab

The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
The main questions it aims to answer are:
* Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
* Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
* Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
* Receive either mirikizumab or standard biologic therapy as part of routine clinical care
* Attend follow-up visits at approximately 3, 6, 12, and 18 months
* Have clinical data collected from electronic health records and healthcare utilization sources
* Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
* Undergo routine laboratory tests and clinical assessments as part of standard care

Start Date01 Jun 2026

Sponsor / Collaborator

Eli Lilly & Co.

NCT07612267

/ Not yet recruitingPhase 4

A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
Participation in this study could last up to 94 days, including screening and follow-up period.

Start Date01 Jun 2026

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Mirikizumab

100 Translational Medicine associated with Mirikizumab

100 Patents (Medical) associated with Mirikizumab

341

Literatures (Medical) associated with Mirikizumab

31 Dec 2026·Gut Microbes

An oral–gut microbial metabolite links Fusobacterium nucleatum to aggravated myocardial ischemia–reperfusion injury

Article

Author: Liu, Yanfei ; Yang, Hongjun ; Li, Yiwen ; Zhu, Mengmeng ; Liu, Yue ; Wang, Wenting ; Xu, Qian

BACKGROUND:

Myocardial ischemia-reperfusion injury (MIRI) remains a major complication. Fusobacterium nucleatum (F. nucleatum), an oral pathobiont associated with cardiometabolic disease, may influence host physiology by reshaping gut microbial function through an oral-gut axis. Whether such microbial interactions contribute to MIRI remains unclear.

METHODS:

An oral F. nucleatum gavage mouse model and cohorts were established to investigate the effect of oral F. nucleatum on MIRI, gut microbial histidine metabolism including imidazole propionate (ImP) production, the association of ImP with coronary heart disease (CHD), and its microbial sources. MIRI was induced with or without antibiotic-mediated microbiota depletion and/or ImP administration, and p62 dependence was examined by knockdown approaches in vitro and in vivo. Plasma metabolites, cardiac injury, ultrastructure, and p62/mTOR signaling were assessed.

RESULTS:

F. nucleatum aggravated MIRI despite the absence of persistent colonic colonization. Instead, F. nucleatum altered gut microbial composition, including Lactobacillus abundance, and was associated with elevated circulating ImP. Antibiotic-mediated microbiota depletion reduced ImP and attenuated myocardial injury. Plasma ImP was elevated in patients with CHD, and ImP-producing capacity was supported primarily by gut microbiota urocanate reductase (UAR)-associated functions. In H9c2 cells, ImP exacerbated hypoxia/reoxygenation injury, and increased the autophagy adaptor p62 together with downstream mTOR/S6K1 signaling. p62 knockdown attenuated the mTOR/S6K1 response and injury-associated changes, whereas IRS1 suppression persisted.

CONCLUSIONS:

F. nucleatum reshapes gut microbial metabolism, thereby amplifying MIRI via ImP. ImP emerges as a functional mediator linking oral dysbiosis to MIRI, and reducing microbiota-derived ImP may represent a more mechanistically grounded strategy to mitigate MIRI.

01 Jul 2026·BIODRUGS

Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials

Article

Author: Wang, Yufang ; Tang, Dan ; Ran, Zhihua ; Chen, Yan ; Shen, Jun ; Miao, Yinglei ; Zhang, Xiaolan ; Hu, Naizhong ; Wang, Chengdang ; Yu, Jiao ; Qian, Chenxi ; Zhong, Jie ; Ding, Yijuan ; Gao, Xiang ; Ding, Xueli

BACKGROUND:

Mirikizumab, a p19-directed anti-interleukin-23 antibody, demonstrated efficacy in patients with moderately-to-severely active ulcerative colitis in the global phase 3 LUCENT-1 induction (NCT03518086) and LUCENT-2 maintenance (NCT03524092) trials.

OBJECTIVE:

The aim was to conduct a pre-specified Chinese subpopulation analysis of LUCENT-1 and LUCENT-2.

METHODS:

In LUCENT-1, patients were randomized 3:1 to mirikizumab 300 mg or placebo intravenously every 4 weeks (Q4W) for 12 weeks. In LUCENT-2, patients with a clinical response to mirikizumab at week 12 of LUCENT-1 were re-randomized 2:1 to mirikizumab 200 mg or placebo via subcutaneous injection Q4W for 40 weeks. The primary endpoint in both trials was clinical remission at study end, defined as a Mayo stool frequency subscore of 0, or 1 with a ≥ 1-point decrease from baseline, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1 (excluding friability).

RESULTS:

Among 183 Chinese patients included in the LUCENT-1 induction trial, clinical remission rates at week 12 were higher with mirikizumab 300 mg (n = 140) versus placebo (n = 43) (18.6% vs. 7.0%; common risk difference 11.5%). Among 80 patients who responded to mirikizumab and underwent randomization again in the LUCENT-2 maintenance trial, clinical remission rates at week 40 were higher with mirikizumab 200 mg (n = 56) versus placebo (n = 24) (50.0% vs. 12.5%; common risk difference 40.4%). During induction and maintenance, the incidence of adverse events was comparable between the mirikizumab and placebo groups.

CONCLUSIONS:

Mirikizumab was effective and well tolerated in the subpopulation of Chinese patients with moderately-to-severely active ulcerative colitis, consistent with the overall trial population.

TRIAL REGISTRATIONS:

Clinicaltrials.gov (NCT03518086 and NCT03524092).

01 Jul 2026·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

A multicenter, randomized, double-blinded, placebo-controlled phase III trial to evaluate efficacy and safety of picankibart in moderate-to-severe plaque psoriasis

Article

Author: Feng, Yanyan ; Li, Shanshan ; Zhang, Shifa ; Liu, Lunfei ; Shi, Yuling ; Qian, Lei ; Chen, Mingxia ; Li, Yue ; Han-Zhang, Han ; Li, Yumei ; Lu, Jianyun ; Gao, Yunlu ; Qin, Lanying ; Wang, Lihua ; Cui, Yong ; Cai, Chenghang ; Ci, Chao ; Chen, Rixin

BACKGROUND:

The development of interleukin-23 inhibitors that offer sustained complete skin clearance with reduced-frequency dosing addresses a significant unmet clinical need in managing moderate-to-severe plaque psoriasis.

OBJECTIVE:

To evaluate the efficacy and safety of picankibart, an interleukin-23p19 inhibitor, in Chinese patients.

METHODS:

CLEAR-1 enrolled participants aged 18-75 years to randomly receive picankibart subcutaneously 200 mg at weeks 0/4/8/20/32/44, picankibart 200 mg at weeks 0/4/8 then 100 mg at weeks 20/32/44; or placebo at weeks 0/4/8 then picankibart 200 mg at weeks 16/20/24/32/44. The co-primary endpoints were ≥90% improvement in psoriasis area and severity index and static physician's global assessment clear/almost clear status (0/1) at week 16.

RESULTS:

In picankibart 200 mg group, 80.3% achieved ≥90% improvement in psoriasis area and severity index and 93.5% achieved static physician's global assessment 0/1 at week 16 vs 2.0% and 13.1%, respectively with placebo. All key secondary endpoints were significantly improved (all two-sided P < .0001 vs placebo). Efficacy was maintained through week 52 for both 100 mg and 200 mg doses, with no new safety signal observed.

LIMITATIONS:

Chinese only; no active comparator.

CONCLUSION:

Picankibart provided effective skin clearance in Chinese participants by week 16. A dosing regimen of every 12 weeks with either 100 mg or 200 mg maintained these clinical improvements through week 52.

170

News (Medical) associated with Mirikizumab

28 May 2026

·www.prnewswire.com

FDA approves label expansion, cementing TREMFYA® as the only IL‑23 inhibitor proven to help stop further joint damage

TREMFYA® showed significant inhibition of structural joint damage in adults with active psoriatic arthritis HORSHAM, Pa., May 28, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA® (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA). The inclusion of this key outcome reflects that TREMFYA is the only IL-23 inhibitor proven to help stop further structural damage, offering patients with active PsA a first-line treatment option that provides effective symptom control and no new safety signals, while significantly inhibiting irreversible joint damage. "Joint damage associated with active psoriatic arthritis can happen as soon as six months after onset of disease, so it's important to have treatment solutions that can help provide daily symptom relief while also protecting joints from long-term structural damage," said Philip J. Mease,a M.D., Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA. "With the inclusion of these findings in the label, we now have stronger clinical evidence that sets TREMFYA apart as a treatment option for patients with active psoriatic arthritis at risk for joint damage." The label update is supported by 24-week results from the Phase 3b APEX study. The study met its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibiting progression of structural damage, as measured by change in the PsA-modified van der Heijde-Sharp (vdH-S) scoreb, compared to placebo in bio-naïve patients.1,2,3 Additionally, for patients in the study's placebo group who switched to TREMFYA at Week 24, the rate of radiographic progression was reduced by 57% from Week 24 through Week 48, demonstrating benefit even after initial disease progression. Data from the APEX study were consistent with the well-established safety profile of TREMFYA, with no new safety signals identified.4 "Up to half of all patients living with active psoriatic arthritis can develop early irreversible joint damage, leaving them unable to perform simple daily tasks or go to work," said Brandee Pappalardo, Ph.D., M.P.H., Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. "This label update reinforces our commitment to advancing innovation for these patients by offering the only IL-23 inhibitor with structural inhibition in its label, making TREMFYA a differentiated treatment option for symptom relief and joint preservation that helps address the progressive nature of active psoriatic arthritis." TREMFYA is the only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocytes, macrophages, and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA, moderate to severe plaque psoriasis (PsO), moderate to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Findings are based on in vitro.5,6,7,8,9 Editor's notes: a. Dr. Philip Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. b. VdH-S scores are from the Week 48 x-ray read. ABOUT APEX (NCT04882098) APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment is scheduled prior to the final safety follow-up.10 ABOUT PSORIATIC ARTHRITIS Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).11,12,13 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.14 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.15 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.16 Studies show up to 30% of people with plaque PsO also develop PsA.10 ABOUT TREMFYA (guselkumab) Developed by Johnson & Johnson, TREMFYA is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA is a prescription medicine approved in the U.S. to treat: adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease. TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. The legal manufacturer for TREMFYA is Janssen Biotech, Inc. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit: . TREMFYA ® IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA ® ? TREMFYA ® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: Do not use TREMFYA ® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA ® , tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA ® ?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. Children should be brought up to date with all vaccines before starting TREMFYA® are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting , by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA ® ? TREMFYA ® may cause serious side effects. See "What is the most important information I should know about TREMFYA ® ?" The most common side effects of TREMFYA ® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, bronchitis, feeling very tired (fatigue), fever (pyrexia), and skin rash. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information , including Medication Guide , for TREMFYA ® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088 . Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2026. All rights reserved. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Abstract presented at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. Late-Breaking Abstracts Session II. 2 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Oral presentation at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. 3 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. 2025;84(12):1983-1994. 4 Ritchlin CT, et al. Durable Inhibition of Structural Damage Progression and Improvements in Joint Disease Activity With the Selective Interleukin-23 Inhibitor Guselkumab in Active and Erosive Psoriatic Arthritis: Week 48 Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Presented at ISDS 2025. November 12-15. Poster 331. 5 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 6 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 7 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 8 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 9 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 10 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: . Accessed May 2026. 11 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: . Accessed May 2026. 12 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: . Accessed May 2026. 13 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: . Accessed May 2026. 14 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: . Accessed May 2026. 15 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: . Accessed May 2026. 16 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: . Accessed May 2026. SOURCE Johnson & Johnson 21% more press release views with Request a Demo

Clinical ResultPhase 3Drug Approval

26 May 2026

·www.biospace.com

Lilly is pharma’s top dog, placing first in innovation and invention: IDEA

iStock, subin thanuma Eli Lilly is the first pharma company to take first place in both categories in the eight years that intelligence firm IDEA Pharma has put out its analysis. Skyrocketing sales and multiple FDA approvals helped the company shoot to the top. Eli Lilly is this year’s undisputed pharma R&D leader, emerging as the industry’s best inventor and innovator. That’s according to industry intelligence firm IDEA Pharma, which for eight years now has been rating drugmakers based on how well they can take a theoretical small molecule drug through early and clinical development and successfully execute a commercial strategy for the product. IDEA defines invention as a company’s ability to combine novel ideas and technologies “to create something that did not exist before,” according to the firm’s 2026 Global Pharmaceutical Innovation & Invention Index , published May 12. The invention index also assesses the “breadth and depth” of drugmakers’ pipeline, looking at “who is developing medicines that matter.” Innovation, on the other hand, is how well a company can create meaningful value returns from its invention. This year, Lilly is the clear winner on both fronts. This is the pharma’s second year as the innovation leader, a distinction supported by a 45% year-on-year (YoY) surge in its annual earnings, which hit nearly $65.2 billion in 2025. The pharma’s incretin products are “central” to its performance, according to IDEA, pointing to a 99% YoY growth in Mounjaro sales to $23 billion and a 175% YoY increase in Zepbound revenue to $13.5 billion. Lilly reinvested the financial gains from its incretin franchise into its development pipeline, giving the pharma a big boost to its 2026 invention rating. Last year, Lilly was sixth on IDEA’s leaderboard. “Building on its core metabolic franchise, Lilly continues to expand across oncology, neuroscience and immunology,” IDEA said earlier this month. “The rise on the Invention Index is underpinned by continued early pipeline investment and strategic transactions.” Key pipeline wins for Lilly include the approval of its weight-loss pill Foundayo, the label expansion of Omvoh into Crohn’s disease and the approval of Inluriyo in breast cancer, according to IDEA. The firm also pointed to Lilly’s acquisition of Verve Therapeutics and SiteOne Therapeutics as contributors to the pharma’s improved invention rating. Trailing Lilly is Merck, which kept its second-place innovation rank from last year, driven by the continued strong performance of cornerstone cancer therapy Keytruda and bolstered by the growth of its pulmonary hypertension drug Winrevair and chronic obstructive pulmonary disease medicine Ohtuvayre, according to IDEA. Meanwhile, Merck jumped two places to fifth on the invention ranking, driven by its cholesterol-lowering pill enlicitide, along with improvements in its infectious disease pipeline, anchored by the $9.2 billion acquisition of Cidara Therapeutics. Another standout company on IDEA’s ranking is Sanofi, which skyrocketed 19 spots to third place on the innovation index, while dropping five notches to 17th on the invention ranking. GSK ranked fourth on innovation, followed by Regeneron. Weight loss Lilly Redefines the Pharma Mega-Blockbuster Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in. November 25, 2025 · 2 min read · Annalee Armstrong Read more

Acquisition

05 May 2026

·www.prnewswire.com

Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years

In LUCENT-3, more than 60% of patients who achieved disease clearance at one year maintained it after four years of continuous Omvoh treatment Disease clearance is a high clinical bar in UC requiring simultaneous symptomatic, endoscopic and histologic remission INDIANAPOLIS, May 5, 2026 /PRNewswire/ -- New long-term data from Eli Lilly and Company (NYSE: LLY) show patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment. In the LUCENT-3 open-label extension study, 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years. These results will be presented at Digestive Disease Week® (DDW) and represent the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through four years in people with UC.1 Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission. In real-world studies, achieving disease clearance has been associated with reduced rates of hospitalizations and surgery.2-3 While previously reported four-year Omvoh data showed durable individual outcomes, this new analysis goes further by evaluating those outcomes together as a composite endpoint, reflecting a higher clinical bar. "Ulcerative colitis is a lifelong disease, and every person living with the condition deserves a treatment that can deliver strong and durable disease control, not just symptom relief," said Adrienne Brown, executive vice president and president of Lilly Immunology. "Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing." Durable Disease Clearance in Ulcerative Colitis Disease clearance was evaluated among patients who achieved clinical remission with Omvoh at one year in the LUCENT-2 maintenance study and continued treatment in LUCENT-3, an open-label extension study. This analysis, which was not pre-specified, showed 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years.* Even at the most stringent measure — requiring endoscopic normalization in addition to symptomatic and histologic remission — 61.3% of patients who achieved it at one year maintained it through four years.† "What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years," said Jean-Frédéric Colombel, M.D., director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. "Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in ulcerative colitis. For a progressive disease like ulcerative colitis, that level of durable remission has the potential to change the long-term course of the disease for patients." These findings expand the growing body of long-term data on Omvoh in inflammatory bowel disease (IBD), building on previously disclosed four-year results in UC and three-year results in Crohn's disease, including reduction of serious disease-related complications. In LUCENT-3, one UC-related hospitalization and zero UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension.4 The long-term 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. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.5 The most common adverse reactions (reported in at least 2% of subjects at a higher frequency than placebo) associated with Omvoh treatment in LUCENT-1 and -2 were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.6 Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. In UC, Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (NCT05784246) and Crohn's disease (NCT05509777). 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 47 countries around the world. In the U.S., Omvoh is also approved for a single-injection maintenance regimen in UC. About the LUCENT Clinical Trial Program Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi). The randomized, double‑blind, placebo‑controlled LUCENT‑1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT‑2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT‑1.5 LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total). Using a modified non-responder imputation analysis to handle discontinuation and missing data, 49.7% and 42.8% of patients who achieved disease clearance and stringent disease clearance at one year, respectively, sustained it at four years.1 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.6 Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company. Endnotes and References *Observed cases, post hoc. Symptomatic remission [Mayo stool frequency (SF)=0, or SF=1 with a ≥1-point decrease from baseline, and rectal bleeding=0], and histologic-endoscopic mucosal remission [Histologic remission (Geboes score ≤2B.0) and endoscopic remission (endoscopic subscore [ES] of 0 or 1, excluding friability)]. †Observed cases, post hoc. Symptomatic + histologic remission + endoscopic normalization (ES=0). 1Magro F, et al. Mirikizumab demonstrates consistent and sustained disease clearance at four years of treatment in patients with moderately to severely active ulcerative colitis. Digestive Disease Week 2026. May 2-5, 2026. 2Andronic AM, et al. J Crohn's Colitis. 2023;17(Supplement_1):i529. 3Pai RK, et al. Expert Rev Gastroenterol Hepatol. 2024;18(1-3):73–87. 4Magro F, et al. J Crohn's Colitis. 2026;20(Suppl 1):jjaf231.1300. 5Sands, B, et al. Mirikizumab provides sustained long-term efficacy up to 4 years of treatment for ulcerative colitis: final results from the LUCENT-3 open-label extension study. 2025 United European Gastroenterology Week. October 4-7, 2025. 6Omvoh. Prescribing Information. Lilly USA, LLC. Indications and Usage for Omvoh® (mirikizumab-mrkz) (in the United States) 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 (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests. 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 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. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Clinical ResultPhase 3Drug ApprovalImmunotherapy

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D11123	Mirikizumab	-	DB14910

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Crohn Disease	Canada	Eli Lilly & Co.	15 Jul 2025
Crohn's disease, active moderate	United States	Eli Lilly & Co.	15 Jan 2025
Crohn's disease, active severe	United States	Eli Lilly & Co.	15 Jan 2025
Ulcerative colitis, active moderate	European Union	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active moderate	Iceland	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active moderate	Liechtenstein	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active moderate	Norway	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	European Union	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	Iceland	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	Liechtenstein	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	Norway	Eli Lilly & Co.	26 May 2023
Colitis, Ulcerative	Japan	Eli Lilly Japan KK	27 Mar 2023

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	United States	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Austria	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Belgium	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Brazil	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Bulgaria	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Canada	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Czechia	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Denmark	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	France	Eli Lilly & Co.	26 Jun 2025
Obesity	Phase 3	Germany	Eli Lilly & Co.	26 Jun 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03518086 \| NCT03524092 (LUCENT-2, Pubmed \| BioDrugs)	Phase 3	Colitis, Ulcerative	263	Mirikizumab 300 mg	hcwblcwugm(pemgequyub) = the incidence of adverse events was comparable between the mirikizumab and placebo groups. yvttyufikr (itlfqlkjxt )	Positive	12 May 2026
NCT03518086 \| NCT03524092 (LUCENT-2, Pubmed \| BioDrugs)	Phase 3	Colitis, Ulcerative	263	Placebo		Positive	12 May 2026
NCT05767021 (LUCENT-URGE, Pubmed \| J Crohns Colitis)	Phase 3	Colitis, Ulcerative	175	Mirikizumab	pleyxcrhlj(oqradmgerz) = utwoqnojfs vpbmsigudg (fdyetxvyqq ) View more	Positive	08 May 2026
NCT03518086 \| NCT03524092 (LUCENT-2, Pubmed \| United European Gastroenterol J)	Phase 3	Ulcerative colitis, active severe	1,162	Mirikizumab	nlzdgwihas(cxjhuphbtk) = qzacljzhiz emmumbpsej (inbpbyjfee ) View more	Positive	01 May 2026
	Phase 3	Ulcerative colitis, active severe	1,162	Mirikizumab (1-PATF)	nlzdgwihas(cxjhuphbtk) = hqgnvrggpt emmumbpsej (inbpbyjfee ) View more	Positive	01 May 2026
NCT05767021 (LUCENT-URGE, ECCO2026)	Phase 3	Colitis, Ulcerative	172	Mirikizumab	wluaoceixg(fyxintobvi) = ilfnwsupgr tkcwysexzc (hsuclnkfzz ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	21	Mirikizumab	bfkzuvpkgw(czmrdfpyiq) = uwdftlhifn poeblzmcan (jywutqepju ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	269	Mirikizumab	iwuegldfqf(sadsxusodr) = yahgqnpirw eyocrntvfi (hthwadipms ) View more	Positive	18 Feb 2026
MIRACLE-UC (ECCO2026)	Not Applicable	Colitis, Ulcerative	407	Mirikizumab	wqnenwdfcs(aztgmtdkzq) = pabgfqvtde omofxuogyd (dfqbleulms, 162.0) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	105	Mirikizumab	omylxqhtym(dxmjvmypet) = ewcagjrtzg oiyavrkoku (isothsfmue ) View more	Positive	18 Feb 2026
SHELTER (ECCO2026)	Not Applicable	Crohn Disease \| Colitis, Ulcerative	33	Risankizumab	osizbwflrj(apzyswinvf) = One year after switching to a p19 inhibitor (all mirikizumab, four patients with extended intravenous induction), the median (IQR) EMS score dropped significantly from 2 (2-3) to 1 (0–2) (p = 0.034). zxibrebdki (fwzgloxfvo ) View more	Positive	18 Feb 2026
SHELTER (ECCO2026)	Not Applicable	Crohn Disease \| Colitis, Ulcerative	33	Mirikizumab		Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	236	Mirikizumab	wcmctghacd(xiotzqryhu) = significant at both w12 (p = 4.31 × 10−11; r = 0.57; n = 182) and w24 (p = 5.34 × 10−8; r = 0.52; n = 147) ukqxyttrms (ajjifxilkh ) View more	Positive	18 Feb 2026

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