A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Start Date01 Apr 2026

Sponsor / Collaborator

Eli Lilly & Co.

NCT07446101

/ RecruitingPhase 1

An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants

The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.

Start Date24 Mar 2026

Sponsor / Collaborator

Eli Lilly & Co.

CTIS2025-522362-78-00

/ 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

Start Date01 Mar 2026

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Mirikizumab

100 Translational Medicine associated with Mirikizumab

100 Patents (Medical) associated with Mirikizumab

320

Literatures (Medical) associated with Mirikizumab

01 May 2026·LIFE SCIENCES

p38MAPK protects against myocardial ischemia-reperfusion injury by regulating GLUT4 expression and translocation through MEF2A/MEF2C in isolated rat heart

Article

Author: Chen, Hongjin ; Zhang, Benfa ; Song, Yingnan ; Zhang, Dan ; Gao, Weilong ; Yang, Siyuan ; Cao, Ying ; Sun, Peng

AIMS:

Myocardial ischemia-reperfusion injury (MIRI) remains a critical complication associated with cardiopulmonary bypass (CPB). This study investigated whether p38 mitogen-activated protein kinase (p38MAPK) sustains myocardial glucose uptake by controlling glucose transporter-4 (GLUT4) expression and membrane translocation through distinct myocyte enhancer factor-2 (MEF2) isoforms.

MATERIALS AND METHODS:

MIRI was induced in Langendorff-perfused isolated rat hearts and oxygen-glucose deprivation/reoxygenation (OGD/R)-treated neonatal rat ventricular myocytes (NRVMs) and H9C2 cells. p38MAPK was inhibited with SB203580, MEF2 isoforms were overexpressed via lentiviral transduction. and GLUT4 translocation was assessed by subcellular fractionation, Wheat Germ Agglutinin (WGA) co-staining. Akt substrate of 160 kDa (AS160) phosphorylation and Rab8a-GLUT4 interaction were also examined.

KEY FINDINGS:

MIRI significantly suppressed both total and phosphorylated p38MAPK, concomitant with dual-specificity phosphatase 1 (DUSP1/MKP1) upregulation. This was associated with reduced GLUT4 expression, impaired membrane translocation, and diminished glucose uptake, while GLUT1 expression remained unchanged. SB203580 further aggravated these deficits. MEF2A and MEF2C were significantly downregulated during MIRI, whereas MEF2D was unaffected, and MEF2B was undetectable in adult cardiac tissue. Overexpression of MEF2A or MEF2C restored GLUT4 expression and promoted membrane translocation by enhancing AS160 phosphorylation at isoform-specific sites (MEF2A: Thr642/Ser588; MEF2C: Ser318/Ser341/Ser570/Ser588). This phosphorylation pattern promoted Rab8a-GLUT4 vesicle association independently of AKT activation. In contrast, MEF2D overexpression increased GLUT4 expression without facilitating membrane translocation.

SIGNIFICANCE:

These findings identify a p38MAPK-MEF2A/C-AS160-Rab8a signaling axis that drives GLUT4 expression and membrane translocation to sustain myocardial glucose uptake during MIRI. This study provides mechanistic insight into the metabolic role of p38MAPK in MIRI.

01 Apr 2026·INFLAMMATORY BOWEL DISEASES

Serum and Histologic Eosinophilia as a Predictive Biomarker of Response to Mirikizumab in Ulcerative Colitis

Article

Author: Narula, Neeraj ; Wong, Emily C L ; Jairath, Vipul ; Marshall, John K ; Reinisch, Walter ; Dulai, Parambir S

Abstract:

Introduction:

Eosinophils may contribute to ulcerative colitis (UC) pathogenesis through inflammation and epithelial injury. Mirikizumab, a selective IL-23 inhibitor, has shown efficacy in moderate-to-severe UC. However, the relationship between eosinophils and treatment outcomes with IL-23 inhibition remains unclear.

Objective:

This post-hoc analysis of the LUCENT-1 trial evaluated trends in serum and histologic eosinophils as biomarkers for early response to mirikizumab induction therapy in UC.

Design:

Data from LUCENT-1 (NCT03518086) were analyzed to assess serum eosinophil counts and histologic eosinophil presence at baseline and week 12. Clinical response, remission, and endoscopic improvement were defined by modified Mayo score criteria. Logistic regression models, adjusted for factors including steroid use, prior biologic failure, disease severity, and albumin levels, assessed associations between baseline eosinophil levels and treatment outcomes.

Results:

Among 928 participants, 66.6% achieved clinical response. Responders had higher baseline serum eosinophils (0.23 × 109/L vs 0.19 × 109/L, P = .001) and showed greater reductions at week 12. Elevated baseline eosinophils (≥0.57 × 109/L) were associated with higher rates of clinical response (80% vs 65.7%, aOR: 2.31, P = .013), remission (33.3% vs 25.1%, aOR: 1.91, P = .044), and endoscopic improvement (46.7% vs 33.8%, aOR: 2.33, P = .003). Reductions in histologic eosinophils were also linked to improved outcomes, especially in those with moderate/marked baseline presence.

Conclusions and Relevance:

Baseline eosinophil levels may predict response to mirikizumab and guide early treatment decisions. These findings support a potential role for eosinophils as biomarkers in UC management.

01 Apr 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.

168

News (Medical) associated with Mirikizumab

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

05 May 2026

·allsci.com

J&J’s guselkumab demonstrates efficacy in Phase III perianal fistulizing Crohn’s disease trial

Johnson & Johnson (NYSE: JNJ) reported that guselkumab (Tremfya) met the primary endpoint of combined fistula remission in the Phase III FUZION study in adults with active perianal fistulizing Crohn’s disease, positioning it as the first IL-23 inhibitor to demonstrate efficacy in an indication where the only approved systemic options have, for more than two decades, been anti-TNF agents. The FUZION study (NCT05347095) is a randomized, double-blind, placebo-controlled, multicenter Phase III trial evaluating guselkumab in adults with one or more active draining perianal fistulas confirmed by blinded central MRI review. At Week 24, combined fistula remission — defined as complete closure of all external fistula openings with no drainage, no new fistulas, and no evidence of underlying fluid collections on MRI — was achieved by 28.3% of patients receiving guselkumab 100 mg every 8 weeks and 27.0% of those receiving 200 mg every 4 weeks, compared with 10.3% for placebo. Both dosing regimens reached statistical significance versus placebo (p\=0.007 and p\=0.013, respectively). Adverse events through Week 24 were consistent with guselkumab’s established safety profile in Crohn’s disease; no numerical breakdown was disclosed in the announcement. The magnitude of the treatment effect — roughly a 17–18 percentage point absolute difference over placebo — is notable given the stringency of the endpoint, which required both clinical and radiographic confirmation of remission. That MRI-confirmed component matters: earlier fistula trials in Crohn’s disease have used clinical closure alone as the primary measure, which can overestimate true healing by missing residual subcutaneous collections. The FUZION endpoint design therefore sets a higher evidentiary bar than some historical comparators, though cross-trial comparisons are limited by differences in population, endpoint definitions, and background therapy. Perianal fistulizing Crohn’s disease affects approximately 25% of patients with Crohn’s disease and carries a substantial burden of pain, recurrent abscess formation, and repeated surgical intervention. Despite that prevalence, the condition has been largely absent from dedicated randomized trial programs. The last major controlled study of an approved therapy in this population was conducted more than 20 years ago — the ACCENT II trial of Johnson & Johnson’s Remicade (infliximab), which established infliximab as the first biologic approved specifically for fistulizing Crohn’s disease in 1999. AbbVie’s Humira (adalimumab) subsequently became a clinical standard based on fistula closure data from the CHARM trial, though its label language for the fistulizing subtype is less explicit than infliximab’s. Both approved systemic options act through TNF-α inhibition, leaving patients who fail or cannot tolerate anti-TNF therapy without an approved systemic alternative in the US for this specific manifestation. Guselkumab works through a distinct mechanism. It is a fully human monoclonal antibody targeting the p19 subunit of interleukin-23, blocking IL-23 signaling and the downstream Th17-driven inflammatory cascade implicated in both luminal and perianal Crohn’s disease pathology. The company also describes a secondary binding interaction with CD64, a receptor expressed on IL-23-producing inflammatory monocytes, though the clinical relevance of that interaction remains uncharacterized beyond in vitro data. The IL-23 pathway has reshaped the treatment of luminal Crohn’s disease over the past several years. AbbVie’s Skyrizi (risankizumab), another IL-23 p19 inhibitor, received FDA approval for Crohn’s disease in 2022 and ulcerative colitis in 2024, while Eli Lilly’s Omvoh (mirikizumab) was approved for ulcerative colitis in 2023. Neither risankizumab nor mirikizumab has reported controlled efficacy data in perianal fistulizing Crohn’s disease, and the FUZION readout is the first Phase III evidence for any IL-23 inhibitor in this population. The competitive picture within fistulizing Crohn’s disease also includes Takeda’s Alofisel (darvadstrocel), an allogeneic adipose-derived mesenchymal stem cell therapy approved by the European Medicines Agency in 2018 for complex perianal fistulas in adults with non-active or mildly active luminal Crohn’s disease following inadequate response to at least one conventional or biologic therapy. Darvadstrocel is not FDA-approved and requires intralesional surgical administration, limiting its reach and positioning it as a second-line rescue option rather than a broadly accessible systemic therapy. Guselkumab, if approved for this indication, would represent the first non-anti-TNF systemic biologic available in the US for perianal fistulizing Crohn’s disease — a mechanistically distinct option for the anti-TNF-refractory or anti-TNF-intolerant population. Johnson & Johnson also announced the initiation of the CHARGE study, described as the first head-to-head trial of IL-23 inhibitors in inflammatory bowel disease, which will compare guselkumab against risankizumab in Crohn’s disease; trial sites are open for enrollment. The company is expected to pursue a regulatory submission for guselkumab in perianal fistulizing Crohn’s disease based on the FUZION data, though no filing timeline has been disclosed. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

27 Apr 2026

·firstwordpharma.com

Oruka's long-acting IL-23 for psoriasis may turn up heat on Skyrizi, Bimzelx

Oruka Therapeutics unveiled mid-stage results for its experimental psoriasis therapy that it says point to a key advantage – less frequent dosing than current blockbuster treatments.Data from the Phase IIa EVERLAST-A trial, which sent Oruka shares up about 19% on Monday, could set up ORKA-001 as a potential challenger to drugs such as AbbVie's IL-23 blocker Skyrizi (risankizumab) and UCB's Bimzelx (bimekizumab), a dual inhibitor of IL-17A and IL-17F.The EVERLAST-A study randomised 84 patients with moderate-to-severe psoriasis to receive Oruka's half-life extended IL-23p19 antibody or a placebo at week 0 and then again four weeks later.Once-yearly dosing?According to Oruka, 63.5% of patients achieved the primary endpoint of 100% improvement on the Psoriasis Area and Severity Index (PASI 100) score at the 16-week mark, compared to 4.8% for placebo. Other key secondary endpoints over the same period included PASI 90 and Investigator's Global Assessment (IGA) of "clear" (0) or "almost clear" (1) skin, which was achieved by 82.5% and 84.1% of ORKA-001 recipients, compared to about 4.8% for placebo on both those measures.Additionally, the company pointed to updated Phase I data on pharmacokinetics and pharmacodynamics that it said continue to support the possibility of once-yearly dosing.Meanwhile, the drug's safety profile appeared consistent with the IL-23 class, according to Oruka, with no serious treatment-emergent adverse events (TEAEs) and most side effects considered mild. The only TEAE that occurred in 5% or more of patients in either group was upper respiratory tract infection, at rates of 19% for ORKA-001 and 14% for placebo.'Top end' of expectations"These data reached the top end of what we could have expected from ORKA-001 across efficacy, tolerability, and potential for long-lasting response," said Joana Goncalves, chief medical officer at Oruka. Longer-term EVERLAST-A data are due in the second half.The focus now is likely to be on whether ORKA-001 can improve on entrenched biologics.Skyrizi, which had sales of $17.6 billion last year, is administered every 12 weeks after induction, while Bimzelx, whose sales reached €2.2 billion ($2.6 billion) in 2025, is typically given every eight weeks.Lawrence Klein, CEO at Oruka, recently told Investor's Business Daily that he even sees a scenario where treatment with ORKA-001 for some patients could involve "a couple of starter doses," followed by "multiple years with absence of disease."If ORKA-001 can match Skyrizi's efficacy while reducing dosing frequency by two- to four-fold, Jefferies analysts suggested in a recent note that Oruka's drug could "capture decent share." However, they said demonstrating superior efficacy with a delta of about 10% could "materially change [the] magnitude of market adoption…partially validated by recent strong launch of Bimzelx, which showed ~10% efficacy delta despite less clean safety/ tolerability."A FirstWord survey of US dermatologists last year had found that more than three-quarters would strongly recommend Skyrizi for moderate-to-severe psoriasis, though Bimzelx was gaining ground as a physician-backed alternative (see – Spotlight On: UCB's Bimzelx makes in-roads on AbbVie's Skyrizi as a physician-recommended therapy for psoriasis).

Clinical ResultPhase 1Phase 2Drug 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
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

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	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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECCO2026	Not Applicable	Colitis, Ulcerative First line	360	Infliximab	jakvoyjifc(amdvbyjkzc) = chghbiukhv qhesyficyz (tozzzdirmh ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative First line	360	Adalimumab	jakvoyjifc(amdvbyjkzc) = iywzflbkyv qhesyficyz (tozzzdirmh ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	105	Mirikizumab	naaopqxvbk(amjpzkglqd) = paceeqxoyl zabjhnegne (jylqndeftg ) View more	Positive	18 Feb 2026
MIRACLE-UC (ECCO2026)	Not Applicable	Colitis, Ulcerative	407	Mirikizumab	qwosavdetc(iciwuslhby) = qcdurlpkwq wcnbmrzcmj (jkqkthfukd, 162.0) View more	Positive	18 Feb 2026
NCT04232553 (VIVID-2, ECCO2026)	Phase 3	Perianal fistula due to Crohn's disease Maintenance	251	Mirikizumab (Week 52 Endoscopic Responders)	wwqwjodwbw(lvglfwouay) = telobozbef uskmzacizf (efuuketvzi ) View more	Positive	18 Feb 2026
NCT03518086 (LEUCT-1, ECCO2026)	Phase 3	Colitis, Ulcerative	1,457	Mirikizumab 300mg	uqrcsoebni(pukisqhxwv) = yvnyemwkzl tnhtshlkso (uguxzjyfwz ) View more	Positive	18 Feb 2026
NCT05767021 (LUCENT-URGE, ECCO2026)	Phase 3	Colitis, Ulcerative	172	Mirikizumab	dxxrqstkou(nscmhrblso) = xeviybtewd sywxsbgrfl (cucchfqoaw ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	21	Mirikizumab	wcdqzhcqeu(yududhygds) = tavpbfrhfm vtwapnqwqt (pfqvskorrx ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	236	Mirikizumab	pdodriyyjk(ufuzbkvrcr) = 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) otsluexwsv (kdinwvhhhk ) View more	Positive	18 Feb 2026
NCT03519945 (LUCENT-3, ECCO2026)	Phase 3	Colitis, Ulcerative	179	Mirikizumab	fnfbvaetay(gsqiikjgsn) = jjnnzptwve excgknkvdi (zozfhderzt ) View more	Positive	18 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	33	Mirikizumab	vxbubihrir(emptvioosg) = tkrbbehnol cabccwnnqv (dzeleeetmk ) View more	Positive	18 Feb 2026

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