This is an open-label, single-arm, phase 3b/4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.

Start Date01 Sep 2025

Sponsor / Collaborator

Alimentiv, Inc.

NCT07059130

/ Not yet recruitingPhase 4

Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis: A Phase IV Multicenter Interventional Study

This research study looks at how safe and effective a medicine called Mirikizumab is for treating older adults (aged 60 and above) who have moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). These two conditions, known as inflammatory bowel diseases (IBD), cause inflammation (swelling and irritation) in the digestive tract. Older adults with these conditions often have other health issues and face increased risks and complications, making it challenging for them to use certain treatments.
Mirikizumab is already approved by the FDA for adults with IBD, but there's limited information about how well it works specifically for older adults. This study aims to fill that gap by seeing if Mirikizumab can help these patients safely manage their condition.
The study plans to enroll around 150 people from various locations across the United States. Everyone participating will receive Mirikizumab according to the standard, FDA-approved guidelines.
The main goal is to see how many participants achieve clinical remission, meaning their symptoms significantly improve or disappear, after 24 weeks of treatment. Researchers will also look at whether this remission lasts up to 48 weeks, how well symptoms are controlled without steroids, how treatment affects indicators of inflammation (such as blood tests), and how the participants feel overall based on their own reports.
The safety of Mirikizumab will also be closely monitored throughout the study by regularly checking for any side effects.
This study hopes to provide clearer information to help older adults with IBD and their doctors make better treatment decisions, ultimately improving health outcomes and quality of life.

Start Date16 Jul 2025

Sponsor / Collaborator

Eli Lilly & Co.

NCT06937099

/ RecruitingPhase 3

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 weeks.

Start Date26 Jun 2025

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Mirikizumab

100 Translational Medicine associated with Mirikizumab

100 Patents (Medical) associated with Mirikizumab

261

Literatures (Medical) associated with Mirikizumab

31 Dec 2025·REDOX REPORT

M6a demethylase FTO regulates the oxidative stress, mitochondrial biogenesis of cardiomyocytes and PGC-1a stability in myocardial ischemia-reperfusion injury

Article

Author: Zhang, Feilong ; Chen, Lianglong ; Jiang, Qiong ; Gong, Kezeng ; Chen, Xuehai ; Xu, Zhe

OBJECTIVE:

Myocardial ischemia-reperfusion injury (MIRI) is a highly complex disease with high morbidity and mortality. Studying the molecular mechanism of MIRI and discovering new targets are crucial for the future treatment of MIRI.

METHODS:

We constructed the MIRI rat model and hypoxia/reoxygenation (H/R) injury cardiomyocytes model. RT-PCR and Western blot were used to investigate the expression of the fat mass and obesity-associated (FTO) gene. Electrocardiogram, echocardiography, triphenyltetrazolium chloride (TTC) staining and hematoxylin-eosin (HE) staining were used to assess the model and the effect of FTO overexpression. The generation of reactive oxygen species (ROS) and the levels of superoxide dismutase (SOD2), mitochondrial transcription factor (TFAM) and cytochrome c oxidase I (COXI) were detected to assess the oxidative stress and mitochondrial biogenesis. RNA immunoprecipitation (RIP) and RNA pulldown assays were used to identify the interaction of FTO and PGC-1a. The m6A dot blot, methylated RNA immunoprecipitation PCR (MeRIP-PCR) and RNA stability analysis were used to analyze the regulation of methylation of PGC-1a by FTO.

RESULTS:

FTO was downregulated in MIRI rats and H/R induced cardiomyocytes. Overexpression of FTO inhibited ROS level and increased the expression of SOD2, TFAM and COXI in vitro and in vivo. In addition, PGC-1a was identified as a downstream target of FTO. FTO enhanced the stability of PGC-1a mRNA through removing the m6A modification.

CONCLUSION:

Our study revealed the role of FTO regulates the oxidative stress and mitochondrial biogenesis via PGC-1a in MIRI, which may provide a new approach to mitigating MIRI.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost per remission for mirikizumab versus ustekinumab for moderately to severely active ulcerative colitis treatment from the United States commercial payer perspective

Article

Author: Upadhyay, Navneet ; Creveling, Thomas ; Fisher, Deborah A. ; Mittal, Neha ; Chanan, Neha ; Bires, Nicholas ; Kane, Sunanda ; Gulati, Ankit ; Koushik, Amit Kumar

INTRODUCTION:

Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.

METHODS:

An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.

RESULTS:

The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).

CONCLUSION:

Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.

01 Sep 2025·BIOMATERIALS

Superoxide anion-responsive persulfide and all-trans retinoic acid co-donating peptide assemblies attenuate myocardial ischemia-reperfusion injury

Article

Author: Shao, Yiyang ; Zhang, Yanwen ; Zhao, Xueshan ; Ge, Yuxuan ; Wang, Yin ; Wu, Shiqi ; Lu, Yujia ; Gu, Jun

Myocardial ischemia-reperfusion injury (MIRI) has become a severe threat to human health due to its high mortality rate and poor prognosis. Mutually entangled issues including ROS over-production, excessive inflammatory responses, and myocardial apoptosis are involved during MIRI. Effective inhibition of ROS burst at the beginning of reperfusion has been proved as the key for MIRI treatment. In this work, we report a superoxide anion-responsive peptide co-assembly (S/A-P) capable of delivering the H₂S donor (i.e., superoxide-responsive persulfide donor) and all-trans retinoic acid (ATRA) simultaneously for the treatment. Our results suggest that compared with its single peptidic counterparts, the as-prepared system can significantly lower ROS production and repair myocardial mitochondrial dysfunction due to the synergy effect from the persulfides/H₂S and ATRA. Moreover, S/A-P can reduce excessive inflammatory response through regulating macrophage polarization, which is further mapped by RNA sequencing. In vivo assessment of the co-assembly also displays an excellent therapeutic effect of MIRI on rats. In terms of good biocompatibility and outstanding efficacy, we believe that S/A-P will have a bright future for the treatment of cardiovascular diseases or other related diseases.

146

News (Medical) associated with Mirikizumab

21 Jul 2025

·www.globenewswire.com

Oruka Therapeutics Announces IND Clearance for EVERLAST-A Phase 2a Trial of ORKA-001 in Psoriasis with Phase 1 Data to be Presented at EADV in September

IND cleared for the EVERLAST-A Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis, with initial data expected 2H 2026 Interim Phase 1 data and further details on EVERLAST-A study design to be shared in an oral presentation at EADV in September MENLO PARK, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that the U.S. FDA cleared its investigational new drug (IND) application for its Phase 2a trial of ORKA-001 (the Company’s long-acting anti-IL-23p19 antibody) in moderate-to-severe psoriasis, called EVERLAST-A. “We’re thrilled by this rapid progress into Phase 2 development, and very excited to start our first psoriasis study,” said Lawrence Klein, PhD, CEO of Oruka. “We think that ORKA-001 can redefine the standard of care in this important disease with potential for once per year dosing, off-treatment remissions and higher rates of disease clearance.” The U.S. FDA cleared the Company’s IND submission to initiate EVERLAST-A. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI 100 at Week 28 will receive ORKA-001 every six months. Additional details on the EVERLAST-A design, as well as interim data from the ORKA-001 Phase 1 study, will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September. The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. "We have made great strides in our ability to treat psoriatic disease, but many patients are still seeking improved treatment options. I’m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications. There is evidence now that these improvements could be within reach, and they would be a significant step forward for both patients and the field,” commented Bruce Strober, MD, PhD, the lead Principal Investigator on the EVERLAST-A study on behalf of Oruka’s Scientific Advisory Board. Oruka’s Scientific Advisory Board played a key role in designing the EVERLAST clinical program. Other SAB members include Drs. Andy Blauvelt, Joel Gelfand, Johann Gudjonsson, Mark Lebwohl, James Kreuger, and Joe Merola, all leading physicians whose work has underpinned advances in the psoriasis treatment landscape over the last 25 years. About ORKA-001 ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Financial Disclosures Oruka’s SAB members receive compensation as scientific advisors. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including timelines to clinical and data release milestones, the details of its clinical studies, the potential half-life and exposures of ORKA-001 and its potential dosing interval as well as the potential of ORKA-001 treatment to lead to off-treatment remissions and/or higher rates of disease clearance than other treatments. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 alan.lada@orukatx.com

Phase 2Phase 1IND

02 Jun 2025

·pmlive.com

Eli Lilly’s Omvoh recommended by NICE to treat Crohn's disease in adults

Eli Lilly’s Omvoh (mirikizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat moderately to severely active Crohn’s disease in adults on the NHS in England and Wales. The health technology assessment agency has recommended in final draft guidance that the drug be used in patients whose disease has not responded well enough or stopped responding to a previous biological treatment, not tolerated a previous biological treatment, or been unsuitable for tumour necrosis factor-alpha inhibitors. NICE’s decision comes less than two months after the Medicines and Healthcare products Regulatory Agency approved Omvoh for use in the UK and was based on positive data from the late-stage VIVID-1 study. Results showed that 45% of Omvoh-treated patients achieved clinical remission at one year, compared to 20% of those receiving placebo. Visible healing of the intestinal lining at one year was seen in 38% of patients receiving Lilly’s drug versus 9% on placebo. Additionally, 33% of patients in the Omvoh cohort achieved early improvement in endoscopic response, compared to 13% in the placebo group at three months. Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), which affects more than 500,000 people in the UK. The condition causes symptoms such as persistent diarrhoea and abdominal pain and, if not adequately controlled, can lead to complications that require hospitalisation and surgical intervention. Lilly’s Omvoh is already recommended by NICE to treat certain cases of ulcerative colitis, another of the two main forms of IBD, and is designed to reduce inflammation within the gastrointestinal tract by targeting the interleukin-23p19 protein. James Neville, associate vice president of specialty care, Lilly UK and Ireland, said: “People living with Crohn’s disease have shared with us how truly disruptive symptoms such as abdominal pain, frequent bowel movements and bowel urgency can be. “With [Omvoh] now authorised in both Crohn’s disease and ulcerative colitis, more patients will have access to a treatment option that may provide long-term disease control and address key symptoms that matter most to them…”

Clinical ResultDrug Approval

05 May 2025

·www.prnewswire.com

TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks

TREMFYA® subcutaneous induction demonstrates significant rates of clinical remission and endoscopic improvement at Week 24 in ulcerative colitis Findings build on recent FDA-approval of both routes of administration for induction therapy with TREMFYA® in Crohn's disease SAN DIEGO, May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). The ASTRO Week 24 data build on the Week 12 SC induction data that showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the U.S. Food and Drug Administration (FDA)-approved intravenous (IV) induction regimen evaluated in this population, in the Phase 3 QUASAR study.1,2 TREMFYA® is the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. These findings are among 24 abstracts highlighting the Company's research being presented at Digestive Disease Week (DDW) 2025. Data at Week 24 show patients treated with TREMFYA® 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.1 "Data from the ASTRO study demonstrate that subcutaneous induction treatment with TREMFYA provides clinically meaningful remission in patients with ulcerative colitis, similar to the effects seen with intravenous induction," said Millie Long, M.D., MPH, Professor of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and study investigator.e "The availability of both subcutaneous and intravenous induction options would offer physicians and patients greater flexibility in their treatment approach." Furthermore, at Week 24, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA® demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients. Safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA®.1 "These results highlight the potential of TREMFYA to redefine ulcerative colitis care with a fully subcutaneous induction and maintenance regimen that offers a convenient option with meaningful clinical and endoscopic improvements," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "Our goal is to reshape UC care and empower prescribers with a differentiated and effective treatment that offers the option of patient self-administration from day one." TREMFYA® is the first and only approved, dual-acting monoclonal antibody 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 monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.3,4,5,6,7 TREMFYA® received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. In November 2024, a supplemental Biologics License Application (sBLA) was submitted to the FDA seeking approval of a SC induction regimen of TREMFYA® for the treatment of adults with moderately to severely active UC. TREMFYA® was also approved by the FDA in March 2025 for SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease (CD). For a full list of all data being presented at DDW visit: Editor's Notes: a. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0, or 1 with no friability present on the endoscopy. b. Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). c. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy. d. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. e. Dr. Long is a paid consultant for Johnson & Johnson. She has not been compensated for any media work. ABOUT THE ASTRO STUDY (NCT05528510) ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study designed to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients (n = 418) were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC every 4 weeks (q4w); or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC every 8 weeks (q8w); or placebo. The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.8 ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.9 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 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 with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.5 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. In addition, TREMFYA ® is approved in Europe, Japan and Brazil for the treatment of adult patients with moderately to severely active UC and in Brazil and China for the treatment of adults with moderately to severely active CD. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . 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®. 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®. 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, and bronchitis. 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. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.  Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding 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: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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. References: 1 Peyrin-Biroulet, et al. Efficacy and safety of subcutaneous guselkumab induction therapy in patients with Ulcerative Colitis: Results through week 12 from the phase 3 ASTRO study. Results from the Phase 3 ASTRO study. Oral presentation (#OP10) at the 20th Congress of the European Crohn's and Colitis Organization (ECCO). February 2025. 2 Long M, et al. Efficacy And Safety Of Subcutaneous Guselkumab Induction Therapy In Patients With Ulcerative Colitis: Results Through Week 24 From The Phase 3 Astro Study. Oral presentation (#4241895) at Digestive Disease Week 2025. May 2025. 3 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. 4 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. 5 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 6 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 7 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 8 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. . Accessed March 2025. 9 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed March 2025 SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

100 Deals associated with Mirikizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11123	Mirikizumab	-	DB14910

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn Disease	Canada	Eli Lilly & Co.	15 Jul 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
Crohn's disease, active moderate	Japan	Eli Lilly Japan KK	27 Mar 2023
Crohn's disease, active severe	Japan	Eli Lilly Japan KK	27 Mar 2023

Developing

10 top R&D records.

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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	Croatia	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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05644353 (CTgov)	Phase 1	-	450	Mirikizumab (Mirikizumab)	cyptniytos(xcyimmwifi) = nskartdywm wyduudtchq (qedmgysroa, 43) View more	-	28 Mar 2025
				Mirikizumab (Citrate-Free Mirikizumab)	cyptniytos(xcyimmwifi) = fzgcbjmuah wyduudtchq (qedmgysroa, 39) View more
LUCENT-1, LUCENT-2, LUCENT-3 (Pubmed \| Am J Gastroenterol)	Phase 3	Ulcerative colitis, active severe	-	Mirikizumab	lhqnyafxqa(bbhqobjjai) = bfznxcaaps tustmuinrh (ynzojvwdwl ) View more	Positive	12 Mar 2025
NCT05069896 (CTgov)	Phase 1	-	237	Mirikizumab (Mirikizumab PFS)	uqinytlsji(ghpcountva) = patfsabajy czulxlurnt (wwheflyizk, 44) View more	-	04 Mar 2025
				Mirikizumab (Mirikizumab AI)	uqinytlsji(ghpcountva) = vvqgxbzynp czulxlurnt (wwheflyizk, 40) View more
NCT04232553 (VIVID-2, PRNewswire) Manual	Phase 3	Crohn Disease	-	Omvoh® (mirikizumab-mrkz) (clinical remission at one year in VIVID-1)	qjdjapkbxx(tqebirpmdr) = arbwgbzhvr jybnioqqdn (amwcsphckc ) View more	Positive	07 Feb 2025
				Omvoh® (mirikizumab-mrkz) (not in clinical remission by CDAI at one year)	qjdjapkbxx(tqebirpmdr) = patyeypcpn jybnioqqdn (amwcsphckc ) View more
NCT03926130 (VIVID-1, CTgov)	Phase 3	Crohn Disease	1,158	Placebo	geunvlnudx(xmxowbtuef) = cxtavytnjn kradbbqwrs (nmylnhoxuf, liofbxmbrb - ycxtaxibbv) View more	-	27 Dec 2024
NCT04232553 (VIVID-2, Company_Website) Manual	Phase 3	Crohn Disease	-	Mirikizumab	ujixuqqnhr(jgvzgwlkzc) = ssqpixadso fpwclpnpfa (lzbookhnkx ) View more	Positive	28 Oct 2024
NCT03519945 \| NCT03518086 \| NCT03524092 (Literature) Manual	Phase 3	Colitis, Ulcerative	868	Mirikizumab (week 52 responders)	ooiyywetuq(wyewwkrbzb) = obwjunzdgs dqmfdxrmjq (tckpjhfdet ) View more	Positive	25 Oct 2024
				Mirikizumab (week 52 remitters)	ooiyywetuq(wyewwkrbzb) = muzzqpzeho dqmfdxrmjq (tckpjhfdet ) View more
NCT03519945 \| NCT03518086 \| NCT03524092 (LUCENT-3, Pubmed \| Inflamm Bowel Dis)	Phase 3	Colitis, Ulcerative Maintenance	868	Mirikizumab	innnihwbkj(wmtcttkqya) = opportunistic infection (1.8%), hepatic disorders (3.2%), cerebrocardiovascular events (1.5%), and malignancy (0.3%) ntqdxfgask (ngpubsdznh ) View more	Positive	25 Oct 2024
NCT03926130 (VIVID-1, NEWS) Manual	Phase 3	Crohn Disease	-	Mirikizumab	tysgqtvipj(crppblkmcx) = jghepcqnyp bmadnnstnk (aokjdvlnoe ) View more	Positive	15 Oct 2024
				Stelara (ustekinumab)	tysgqtvipj(crppblkmcx) = pzxvxxdpcj bmadnnstnk (aokjdvlnoe ) View more
UEGW2024	Not Applicable	Ulcerative colitis, active moderate	-	Mirikizumab 300mg IV	ywtxrwfzlh(sgpbzeouxl) = pzlntcybtr htpcpfzkks (ahgowkduvt ) View more	-	13 Oct 2024
				Placebo	ywtxrwfzlh(sgpbzeouxl) = hrvhlzmhwj htpcpfzkks (ahgowkduvt ) View more

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