The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab.
Patients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year.
Guselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care.
Researchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy.
The goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.

Start Date29 Jan 2026

Sponsor / Collaborator

Janssen, Inc.

NCT07310095

/ Not yet recruitingPhase 4

Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab

The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.

Start Date16 Jan 2026

Sponsor / Collaborator

Xian-Janssen Pharmaceutical Ltd.

KCT0010930

/ RecruitingPhase 2IIT

Proof-of-concept study to explore efficacy and safety of guselkumab on recalcitrant oral ulcers in patients with Behçet’s disease

Start Date09 Jan 2026

Sponsor / Collaborator

Yonsei University Severance Hospital

100 Clinical Results associated with Guselkumab

100 Translational Medicine associated with Guselkumab

100 Patents (Medical) associated with Guselkumab

872

Literatures (Medical) associated with Guselkumab

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Real-world effectiveness and safety of guselkumab in adult patients with facial and/or genital psoriasis: a 52-week analysis from the Italian multicentric GULLIVER study

Article

Author: Pallotta, Sabatino ; Galluzzo, Marco ; Stingeni, Luca ; Megna, Matteo ; Corazza, Monica ; Lasagni, Claudia ; Argenziano, Giuseppe ; Piaserico, Stefano ; Costanzo, Antonio ; Fargnoli, Maria Concetta ; Bardazzi, Federico ; Offidani, Annamaria ; Bonifati, Claudio ; Richetta, Antonio Giovanni ; Potenza, Concetta ; Saibene, Federico ; Atzori, Laura ; Gramiccia, Talia ; Papini, Manuela ; Giofrè, Claudia ; Bongiorno, Maria Rita ; Di Lernia, Vito Giuseppe ; Dapavo, Paolo ; Prignano, Francesca ; Lembo, Serena ; Savoia, Paola ; Satolli, Francesca ; Burlando, Martina ; Guarneri, Claudio ; Zichichi, Leonardo ; Rongioletti, Franco ; Loconsole, Francesco ; Micali, Giuseppe ; Peris, Ketty ; Donini, Massimo ; Romanelli, Marco ; Stinco, Giuseppe ; Carrera, Carlo Giovanni

OBJECTIVES:

Facial and genital plaques are common manifestations of psoriasis, are challenging to treat, and significantly impact patients' quality of life (QoL).

METHODS:

GULLIVER is a prospective, non-interventional study conducted in 2020-2023 in Italy, aimed at examining the effectiveness, safety and QoL impact of guselkumab through 52 weeks of treatment in patients with facial and/or genital psoriasis. The primary endpoint was the percentage of patients achieving a static Physician Global Assessment (sPGA) score of ≤1 and a minimum 2-grade improvement in sPGA score at Week 52.

RESULTS:

Of 351 enrolled patients, 88.6% remained on guselkumab treatment at Week 52. The proportions of patients achieving the sPGA targets in the facial and genital groups, respectively, were 83.3% and 76.5% at week 12, increasing to 93.8% and 97.9% at Week 52. Mean Dermatology Life Quality Index score improved from 12.0 ± 7.5 at baseline to 1.1 ± 2.0 at Week 52 for patients with facial psoriasis (p-value <0.001) and from 12.0 ± 6.9 to 1.6 ± 3.5 for those with genital psoriasis (p-value <0.001). Guselkumab was well-tolerated and no new safety signals were identified.

CONCLUSIONS:

This Italian real-world study demonstrated the high effectiveness and a good safety profile of guselkumab in treating facial and genital psoriasis.

01 Mar 2026·JID innovations : skin science from molecules to population health

Assessing T-Cell Profile Shifts through IL-23 Inhibition by Guselkumab on Psoriasis

Article

Author: Morita, Akimichi ; Enomoto, Yuki ; Miyashiro, Masahiko ; Kanayama, Yoshifumi ; Masuda, Junya ; Watanabe, Oki ; Sugiura, Yukako ; Yamamoto, Aya ; Sakurai, Mai ; Mashiko, Shunya

Anti-IL-23 antibody therapies improve the underlying immunopathology of psoriasis. Immune profile dynamics after anti-IL-23 treatment and their association with the treatment response are unclear. Focusing on guselkumab, an anti-IL-23p19 antibody, we comprehensively analyzed immune cells, serum inflammatory molecules, and CD4⁺ T-cell transcriptomics to identify drug effects in psoriasis. Peripheral and lesional skin blood samples were collected from 24 biologic-naïve patients at baseline and after treatment with guselkumab. We conducted FACS analysis of regulatory T cells, resident memory T cells, and dendritic cells; measured serum cytokine and chemokine levels; and analyzed RNA-sequencing data for gene expression changes in peripheral CD4⁺ T cells. Guselkumab administration increased regulatory T cells and decreased resident memory T cells. Gene expression differences at baseline defined 2 groups on the basis of the treatment response: transcriptomic profile-based high responders and transcriptomic profile-based moderate responders. Expression of certain chemokines, such as CXCL1 and CXCL5, was higher in the moderate responders, suggesting their association with a lower treatment response. RNA-sequencing analysis revealed gene expression changes related to T helper 17 cells and regulatory T cell activity. We observed alterations in regulatory T cells and resident memory T cells in response to guselkumab treatment that may contribute to the long-term suppression of the IL-23-driven inflammatory pathology in psoriasis. Furthermore, baseline peripheral blood transcriptomic immune findings may predict therapeutic outcomes. The G-Grope trial was registered as jRCTs041200070 with the Japan Registry of Clinical Trials on December 8, 2020.

01 Feb 2026·Rheumatology and Therapy

Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials

Article

Author: Pina Vegas, Laura ; Mease, Philip J ; Eder, Lihi ; Ogdie, Alexis ; Rampakakis, Emmanouil ; Selmi, Carlo ; Adamson, Elizabeth ; Gladman, Dafna D ; Sharaf, Mohamed ; Coates, Laura C ; Lozenski, Karissa

INTRODUCTION:

Psoriatic arthritis (PsA) is a heterogeneous disease, and clinical manifestations can differ between sexes. Sex-disaggregated baseline characteristics, guselkumab efficacy, and radiographic progression were assessed in a pooled cohort of randomized controlled trial (RCT) participants with active PsA.

METHODS:

Post hoc analyses of DISCOVER-1 (N = 381), DISCOVER-2 (N = 739), and COSMOS (N = 285) assessed sex-related baseline characteristics differences. Week (W) 24 clinical response rates with guselkumab 100 mg at W0/W4/every 8W (Q8W) were compared between sexes using multivariate logistic regression. In DISCOVER-2, multivariate repeated-measures mixed models evaluated associations between sex and radiographic progression with guselkumab Q4W + Q8W through W100, and between early (W8) response in joint disease activity with guselkumab Q4W + Q8W and radiographic progression, stratifying by sex.

RESULTS:

Females were older; had higher body mass index; longer PsA duration; less severe psoriasis; more prevalent enthesitis; and reported more fatigue, pain, and functional impairment. Analyses adjusting for sex-specific differences in baseline characteristics showed no significant sex impact on guselkumab clinical response. Through W100, males exhibited significantly greater radiographic progression than females in unadjusted and adjusted models. Early clinical improvement in joint disease activity with guselkumab afforded significantly less radiographic progression through W100 in males (p = 0.0288) and numerically less in females.

CONCLUSIONS:

Despite being associated with significant differences in characteristics at baseline, sex had no independent effect on guselkumab clinical efficacy in this RCT cohort. The known independent association between male sex and radiographic progression was confirmed; males exhibited a stronger relationship between early improvement in joint disease activity and lower long-term rates of radiographic progression.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT03162796, NCT03158285, NCT03796858.

291

News (Medical) associated with Guselkumab

21 Feb 2026

·www.prnewswire.com

TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement) STOCKHOLM, Feb. 21, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new long-term data from the QUASAR long-term extension (LTE) study showing that TREMFYA® (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis (UC). These data are among the 30 company-sponsored abstracts being presented at the European Crohn's and Colitis Organisation (ECCO) 2026 conference. At Week 140, 80.8% of patients taking TREMFYA® were in clinical remissiona. Additionally, 78.6% of patients achieved histo-endoscopic mucosal improvement (HEMI)b, and 53.6% of patients were in endoscopic remissionc, respectively.d Approximately 89% of eligible study participants combined completed treatment through Week 140. Nearly all participants who achieved clinical remission at Week 140 were corticosteroid-free for at least eight weeks.1 The study also showed that of those in clinical remission at Week 44, 87.5% maintained clinical remission through Week 140. Efficacy was sustained regardless of prior biologic and/or JAK inhibitor treatment history, and no new safety concerns were observed.1 "Ulcerative colitis is a lifelong condition that can significantly impact patients' overall health and they need treatment options that remain effective and well-tolerated over time," said Laurent Peyrin-Biroulet, MD, PhD, study investigator.e "The QUASAR long-term study shows the sustained ability of TREMFYA to deliver durable results, with consistent outcomes regardless of previous biologic or JAK inhibitor treatment. With high study retention and no new safety concerns over this extended time period, the data strengthen confidence in the long-term use of TREMFYA in ulcerative colitis." "These findings highlight the endoscopic outcomes that can be achieved with TREMFYA, raising expectations for what is possible for patients with ulcerative colitis," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "Patients who achieve endoscopic remission experience fewer flare-ups and are less likely to need steroids or require surgery over time. We are energized by these findings and remain focused on delivering treatments that help more patients achieve meaningful, lasting disease control." 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. Findings are based on in vitro studies. 2 3 4 5 6 TREMFYA® has received U.S. Food and Drug Administration (FDA) and European Commission (EC) approval for both SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease and U.S. FDA approval for both SC and IV induction options for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA® is approved by the EC for the treatment of adult patients with moderately to severely active ulcerative colitis and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. Two other Johnson & Johnson-sponsored abstracts were selected as Top 10 oral abstracts by ECCO, highlighting continued commitment to providing treatment options to those with inflammatory bowel disease: Results from the Phase 2b ANTHEM-UC study of icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, demonstrating its impact on systemic and tissue biomarkers of inflammatory burden in UC.7 Primary safety results from the UNITI Jr study of STELARA® (ustekinumab) showing that it was effective and well-tolerated, with no new safety signals, in treating pediatric patients with Crohn's disease.8 For a full list of all Johnson & Johnson data being presented at ECCO visit: . Editor's Notes: a. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore (MES) of 0 or 1. b. Histo-endoscopic mucosal improvement was defined as a combination of endoscopic improvement and histologic improvement (neutrophil infiltration in <5% of crypts, no crypts destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. c. Endoscopic remission (normalization) was defined as a MES of 0. d. As observed. Data were analyzed using 2 methods: 'nonresponder imputation' (NRI) accounting for patients with treatment failure or missing data, and 'as observed'. NRI results were consistent with as observed. e. Dr. Laurent Peyrin-Biroulet is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. About the QUASAR Program ( NCT04033445 ) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® 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 JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the Phase 3 induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the Phase 3 maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo. The ongoing long-term extension study provides an additional 4 years of treatment. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.9 About ANTHEM-UC (NCT06049017) ANTHEM-UC is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients 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. The study is evaluating three once-daily dosages of icotrokinra taken orally. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.10 About UNITI JR (NCT04673357) UNITI-Jr is a randomized, double-blind Phase 3 study evaluating the efficacy, safety, and pharmacokinetics of ustekinumab in 48 pediatric patients (aged 2-17) with moderately to severely active Crohn's disease (defined by a Pediatric Crohn's Disease Activity Index [PCDAI] score >30) through 52 weeks of treatment (8 weeks of induction and 44 weeks of maintenance treatment).1,3 The study included an open-label induction treatment with a single ustekinumab intravenous dose of approximately 6mg/kg followed by a randomized double-blind subcutaneous maintenance regimen of 90mg administered either every 8 weeks or every 12 weeks. 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.11 About Crohn's Disease Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.12 13 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.14 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn's disease.15 About TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first 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 the dual-acting mechanism 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 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, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis. The legal manufacturer for TREMFYA® is Janssen Biotech, Inc. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor16, which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.17 18 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.19 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.20 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.21 22 23 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. 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®. 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. WHAT IS STELARA® (ustekinumab)? STELARA® is a prescription medicine used to treat: adults and children 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). adults and children 6 years of age and older with active psoriatic arthritis. adults with moderately to severely active Crohn's disease. adults with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATION STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects, including: Serious Infections STELARA® may lower your ability to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA®, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Your healthcare provider should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment Before starting STELARA®, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: are being treated for an infection or have any open cuts. get a lot of infections or have infections that keep coming back. have TB or have been in close contact with someone with TB. After starting STELARA®, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections. Cancers STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your healthcare provider if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your healthcare provider if you have any new skin growths. Serious Allergic Reactions Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you get any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash. Posterior Reversible Encephalopathy Syndrome (PRES) PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with STELARA®, including: headache, seizures, confusion, and vision problems. Lung Inflammation Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA®. Before you use or receive STELARA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed above for serious infections or cancers. ever had an allergic reaction to STELARA® or any of its ingredients. Ask your healthcare provider if you are not sure. are allergic to latex. The needle cover on the prefilled syringe contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with STELARA® should avoid receiving live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should avoid receiving the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®. have any new or changing lesions within psoriasis areas or on normal skin. are receiving or have received allergy shots, especially for serious allergic reactions. receive or have received phototherapy for your psoriasis. are pregnant or plan to become pregnant. It is not known if STELARA® can harm your unborn baby. You and your healthcare provider should decide if you will receive STELARA®. are breastfeeding or plan to breastfeed. STELARA® can pass into your breast milk. talk to your healthcare provider about the best way to feed your baby if you receive STELARA®. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. When prescribed STELARA®: Use STELARA® exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of STELARA®, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments. STELARA® is intended for use under the guidance and supervision of your healthcare provider. In children, it is recommended that STELARA® be administered by a healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of STELARA® at home, you or a caregiver should receive training on the right way to prepare and inject STELARA®. Do not try to inject STELARA® until you have been shown how to inject STELARA® by a healthcare provider. Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, influenza, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information. Please read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor. 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. 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. SOURCE Johnson & Johnson 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 2License out/inDrug Approval

19 Feb 2026

·www.fiercepharma.com

FDA untitled letter lambastes efficacy claims in ad for J&J's Tremfya

Unlike most entries in the FDA’s recent spate of untitled letters, this one doesn’t take issue with “attention-grabbing visuals” that could potentially distract from important drug facts. Instead, it focuses on the ad’s claims about Tremfya’s benefits. In recent months, Johnson & Johnson has massively upped its spending on television advertisements for immunology heavyweight Tremfya, with the brand topping the list of the biggest TV drug ad spenders for the last two months running. One of its many on-screen promos, however, now finds itself in the FDA’s crosshairs.An untitled letter (PDF) shared to the agency’s public database this month homes in on certain details of a commercial touting Tremfya’s use in ulcerative colitis.Unlike most entries in the FDA’s recent spate of untitled letters, this one doesn’t take issue with “attention-grabbing visuals” that could potentially distract from important drug facts. Instead, it focuses on the ad’s claims about Tremfya’s benefits.For one, the FDA singled out the ad’s claim in voiceover and on-screen text that “many people” or “~1 out of 2 patients” experienced clinical remission “at 1 and even 2 years.” That’s “misleading,” according to the regulator, because the one-year claims appear to be based on data from a maintenance trial comprising only the subset of patients who demonstrated a clinical response to Tremfya after 12 weeks in a pair of original trials. The two-year claim, meanwhile, is based on results from an extension trial that enrolled “a subset of that subset,” the letter said.The agency used the same reasoning to call out another of the ad’s claims. On-screen text notes that about a third of Tremfya patients achieved endoscopic remission after a year of treatment, which the FDA said “misleadingly overstates the efficacy of Tremfya,” as it too is based on data from the maintenance trial. The FDA called out another alleged overstatement in the ad’s claims throughout that “healing is possible” with the drug and that some patients saw “100% visible healing of their intestinal lining.”“There is uncertainty about whether the drug effects on endoscopic endpoints will reliably predict the drug effects on long-term clinical outcomes; neither endoscopic response nor endoscopic remission guarantee a long-term curative effect or ‘healing’ for these patients,” the FDA wrote.Though the regulator acknowledged the ad’s inclusion of the disclaimer that “visually assessed areas may not represent remission of the entire colon lining,” it dismissed that statement as insufficient for correcting or mitigating the “healing” claims.Finally, the letter took issue with the ad’s omission of one piece of Tremfya’s risk information that warns that the drug “may lower the ability of your immune system to fight infections”—though the commercial does include the other half of that statement, about an “increased risk of infections” linked to Tremfya.As with its other untitled letters, the FDA gave J&J 15 working days to respond to its concerns in writing. J&J did not immediately respond to a Fierce Pharma Marketing request for comment.

Clinical Result

18 Feb 2026

·www.prnewswire.com

Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with psoriasis and obesity or overweight

At 36 weeks in the TOGETHER-PsO study, concomitant Taltz and Zepbound met primary endpoint of superiority vs. Taltz monotherapy in achieving complete skin clearance (PASI 100) and ≥10% weight loss In a key secondary endpoint, patients taking Taltz and Zepbound were 40% more likely to achieve PASI 100 compared to those taking Taltz alone (40.6% of patients vs. 29.0%, p<0.05) Taltz is the first and only psoriatic disease biologic with data from two trials supporting a potential comprehensive treatment approach alongside an incretin therapy for obesity INDIANAPOLIS, Feb. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the landmark TOGETHER-PsO open-label Phase 3b clinical trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared to Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight with at least one additional weight-related comorbid condition. At 36 weeks, treatment with Taltz and Zepbound met the primary and all key secondary endpoints, delivering superior skin clearance and weight loss versus Taltz monotherapy. In the U.S., approximately 61% of people with psoriasis also have obesity or overweight with at least one weight-related comorbidity,1 highlighting a need for comprehensive treatment approaches that address the full burden of their diseases. In the first-of-its-kind TOGETHER-PsO study, 27.1% of participants receiving Taltz and Zepbound reached complete skin clearance (Psoriasis Area Severity Index (PASI) 100) and at least 10% weight loss, compared to 5.8% of patients treated with Taltz alone, meeting the primary endpoint (p<0.001). In a key secondary endpoint, Taltz plus Zepbound delivered a 40% relative increase over Taltz monotherapy in the proportion of patients who achieved PASI 100 (40.6% of patients vs. 29.0%, respectively, p<0.05), demonstrating that treatment of obesity or overweight with Zepbound reduced the burden of psoriasis.2 The study enrolled a population with a very high burden of disease that is often associated with poorer treatment outcomes,3 with an average BMI of more than 39 kg/m2 across both treatment arms. This reflects a mean BMI of approximately 9-10 kg/m2 higher than any population studied to date in Phase 3 pivotal trials of a psoriasis biologic.4-9 An increase in BMI has been shown to reduce the odds of reaching skin clearance across multiple psoriasis studies.10 Most patients in the TOGETHER-PsO trial had extensive skin involvement, with approximately 25% of their body surface area affected, and nearly all (97%) had psoriasis affecting high-impact body areas linked to significant morbidity, itch, and skin pain, such as the face, scalp or genitals.11,12 "Psoriasis and obesity can profoundly impact how people feel, how they are seen, and how they live," said Adrienne Brown, executive vice president and president, Lilly Immunology. "For people living at the intersection of these chronic inflammatory diseases, these PASI 100 results represent far more than a clinical milestone—they demonstrate what becomes possible when we address both simultaneously. Taltz has a decade of proven efficacy in psoriasis, and the superior outcomes achieved when Zepbound was used concomitantly for obesity signal a potential advance in treatment for patients who deserve nothing less." Adverse events in participants treated with concomitant administration of Taltz and Zepbound were generally mild to moderate, and the types of adverse events were generally consistent with the known safety profile of each medicine. The most common adverse events occurring in ≥5% of participants were nausea, diarrhea, constipation, injection site reaction, dosing error, vomiting, and dizziness in the Taltz and Zepbound concomitant treatment arm, and injection site reaction, dosing error, and nasopharyngitis in the Taltz monotherapy arm. "Psoriasis and obesity share underlying inflammatory pathways, yet they are too often treated in silos despite psoriasis treatment guidelines calling for obesity management," said Mark Lebwohl, M.D., Dean for Clinical Therapeutics, and Professor and Chairman Emeritus of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, and TOGETHER-PsO principal investigator. "This study involved patients with particularly high BMI and difficult-to-treat psoriasis, making the PASI 100 results with Taltz plus Zepbound especially remarkable. The findings show that treating psoriasis and obesity or overweight at the same time significantly improved outcomes, reinforcing psoriasis as an obesity-related condition and supporting a potential comprehensive approach to care." Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. Building on positive topline data from the TOGETHER-PsA study, it is now the only biologic with data supporting a comprehensive treatment approach alongside an incretin therapy for people with psoriasis or psoriatic arthritis who also have obesity or overweight. Zepbound is the only FDA-approved dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity management medication. Detailed 36-week results from TOGETHER-PsO will be published in a peer-reviewed journal and discussed with regulators. About the TOGETHER-PsO Trial TOGETHER-PsO (NCT06588283) is a 52-week Phase 3b, randomized, multicenter, assessor-blinded, open-label study assessing the efficacy and safety of concomitant administration of Taltz and Zepbound compared with Taltz alone in adult participants with moderate-to-severe plaque psoriasis and obesity or overweight with at least one additional weight-related comorbid condition. A total of 274 participants were randomized 1:1 to receive either Taltz alone or concomitantly with Zepbound, both administered subcutaneously. Patients in both arms received counseling on a reduced-calorie diet and increased physical activity. The primary objective of the study is to assess the proportion of participants achieving both Psoriasis Area and Severity Index (PASI) 100 and ≥10% weight reduction at Week 36. Participants must have a BMI ≥30 kg/m², or ≥27 to <30 kg/m² with at least one weight-related comorbidity. About Taltz (ixekizumab)13 Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines. Taltz is approved to treat adults and children 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Additionally, Taltz is approved for adults with active psoriatic arthritis, adults with active ankylosing spondylitis, and adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. About Zepbound (tirzepatide) injection14 Zepbound is a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound lowers body weight by decreasing calorie intake and appetite. Zepbound is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction in adults with obesity, or adults with overweight in the presence of at least one weight-related comorbid condition. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity in combination with a reduced-calorie diet and increased physical activity. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Endnotes and References 1 Armstrong et al, Addressing the Obesity-Psoriasis Connection: Prevalence, Incidence, and Comorbidity Insights from a Large US Population of 19.9 Million (2018-2024). Presented at Maui Derm, 2026. 2 Hypothetical estimand in the modified intent-to-treat (mITT) population is used. The hypothetical estimand represents efficacy in all mITT participants who remained on study intervention without initiating prohibited medication. 3 Enos, Clinton W. et al. Comorbid obesity and history of diabetes are independently associated with poorer treatment response to biologics at 6 months: A prospective analysis in Corrona Psoriasis Registry. Journal of the American Academy of Dermatology, Volume 86, Issue 1, 68 - 76. 4 Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-1328. 5 Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis — results of two phase 3 trials. N Engl J Med. 2014;371(4):326-338. 6 Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. 7 Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. 8 Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839. 9 Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. 10 Hjort G, Schwarz CW, Skov L, Loft N. Clinical characteristics associated with response to biologics in the treatment of psoriasis: a meta-analysis. JAMA Dermatol. 2024;160(8):830-837. DOI: 10.1001/jamadermatol.2024.1677 11 Weight-related comorbidities in study participants included cardiovascular disease, type 2 diabetes mellitus (T2DM), dyslipidemia, hypertension, obstructive sleep apnea (OSA). Participants had an average of 14.6 years since their psoriasis diagnosis. High-impact body areas impacted by psoriasis included the face, genitalia, scalp, palm, sole, axilla, inframammary fold, abdominal skin fold and inguinal region. 12 Merola JF, Qureshi A, Husni ME. Underdiagnosed and undertreated psoriasis: Nuances of treating psoriasis affecting the scalp, face, intertriginous areas, genitals, hands, feet, and nails. Dermatol Ther. 2018 May;31(3):e12589. doi: 10.1111/dth.12589. Epub 2018 Mar 6. PMID: 29512290; PMCID: PMC6901032. 13 Taltz. Prescribing Information. Lilly USA, LLC. 14 Zepbound. Prescribing Information. Lilly USA, LLC. TALTZ INDICATIONS AND SAFETY SUMMARY Taltz® (tȯl-ts) is an injectable medicine used to treat: People 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). Adults with active psoriatic arthritis. Adults with active ankylosing spondylitis. Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. It is not known if Taltz is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age. Warnings - Taltz affects the immune system. It may increase your risk of infections, some people have had serious infections, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized from these infections. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away. Your doctor should check you for TB before you start Taltz, and watch you closely for signs of TB during and after treatment with Taltz. If you have TB, or had it in the past, your doctor may treat you for it before you start Taltz. Do not use Taltz if you have had a serious allergic reaction to ixekizumab or any other ingredient in Taltz, such as: swelling of your eyelids, lips, mouth, tongue or throat, trouble breathing, feeling faint, throat or chest tightness, or skin rash. Get emergency help right away if you have any of these reactions. See the Medication Guide that comes with Taltz for a list of ingredients. Severe skin reactions that look like eczema can happen during treatment with Taltz from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with Taltz if you develop severe skin reactions. Tell your doctor if you have any of the following: redness or rash, itching, patches, your skin is dry or feels like leather, blisters or abrasions that ooze or become crusty, small bumps or plaques with scale or crusting. Crohn's disease or ulcerative colitis (inflammatory bowel disease) can start or get worse with Taltz use. Tell your doctor if you have any of these symptoms or if they get worse: stomach pain, diarrhea, and weight loss. You should not get live vaccines while taking Taltz. You should get the vaccines you need before you start Taltz. Common side effects The most common side effects of Taltz include: Injection site reactions Nausea Upper respiratory infections Fungal skin infections Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Before you use Taltz, review these questions with your doctor: Are you being treated for an infection? Do you have an infection that does not go away or keeps coming back? Do you have TB or have you been in close contact with someone with TB? Do you have possible symptoms of an infection such as fever, cough, sores, diarrhea, or other symptoms? Ask your doctor about other possible symptoms. Do you have Crohn's disease or ulcerative colitis? Tell your doctor if: You need any vaccines or have had one recently. You take prescription or over-the-counter medicines, vitamins, or herbal supplements. You are pregnant or planning to become pregnant. It is not known if Taltz can harm an unborn baby. Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to Taltz during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking Taltz, you are encouraged to enroll in the pregnancy registry by calling 1-800-284-1695 or by visiting online at . You are breastfeeding or planning to breastfeed. It is not known if Taltz passes into breastmilk. How to take See the instructions for use that come with Taltz. There you will find information about how to store, prepare, and inject Taltz. Adults may self-inject after receiving training from a healthcare provider. For children 6 to 17 years of age: If your child's healthcare provider decides that you may give Taltz injections at home, you should receive training on the right way to prepare and inject Taltz. Do not try to give Taltz to your child until you have been shown how to inject Taltz. Children should not inject themselves with Taltz. You or an adult caregiver should prepare and give Taltz injections to your child. Learn more Taltz is a prescription medicine available as a 80 mg/mL, 40 mg/0.5mL, 20 mg/0.25mL injection. For more information, call 1-800-545-5979 or go to taltz.lilly.com. This summary provides basic information about Taltz but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Taltz and how to take it. Your doctor is the best person to help you decide if Taltz is right for you. IX CON BS 20AUG2024 ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound® (ZEHP-bownd) is an injectable prescription medicine that may help adults with: obesity, or some adults with overweight who also have weight-related medical problems to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. It should be used with a reduced-calorie diet and increased physical activity. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider: Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? Do you take other diabetes medicines, such as insulin or sulfonylureas? Do you have a history of diabetic retinopathy? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979). How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound injection is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial. Learn more Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to . This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 25SEP2025 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 Taltz (ixekizumab) as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis and Zepbound (tirzepatide) as a treatment for adults with obesity or overweight, potential comprehensive treatment strategies for patients with moderate to severe plaque psoriasis and obesity, and the timeline for future readouts, 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 future study results will be consistent with the results to date, or that Lilly will execute its strategies as planned. 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 Approval

100 Deals associated with Guselkumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10438	Guselkumab	L04AC16	DB11834

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	China	Janssen-Cilag International NV	20 Feb 2025
Crohn's disease, active severe	China	Janssen-Cilag International NV	20 Feb 2025
Ulcerative colitis, active moderate	United States	Janssen Biotech, Inc.	11 Sep 2024
Ulcerative colitis, active severe	United States	Janssen Biotech, Inc.	11 Sep 2024
Pustulosis of Palms and Soles	Japan	Janssen Pharmaceutical KK	21 Nov 2018
Colitis, Ulcerative	South Korea	Janssen Korea Ltd.	12 Apr 2018
Crohn Disease	South Korea	Janssen Korea Ltd.	12 Apr 2018
Keratoderma, Palmoplantar	South Korea	Janssen Korea Ltd.	12 Apr 2018
Erythrodermic psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Pustular psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Arthritis, Psoriatic	European Union	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Iceland	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Liechtenstein	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Norway	Janssen-Cilag International NV	10 Nov 2017
Plaque psoriasis	United States	Janssen Biotech, Inc.	13 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	NDA/BLA	United States	Johnson & Johnson	02 Dec 2024
Pediatric Crohn's Disease	Phase 3	Netherlands	Janssen Research & Development LLC	10 Jan 2023
Psoriasis of scalp	Phase 3	United States	Janssen Research & Development LLC	13 Jul 2022
Psoriasis of scalp	Phase 3	Canada	Janssen Research & Development LLC	13 Jul 2022
Inflammatory Bowel Diseases	Phase 3	Netherlands	Janssen Research & Development LLC	01 Jun 2022
Perianal fistula due to Crohn's disease	Phase 3	Spain	Janssen Research & Development LLC	19 Apr 2022
Neoplasms	Phase 3	United States	Janssen Research & Development LLC	24 Aug 2017
Neoplasms	Phase 3	Australia	Janssen Research & Development LLC	24 Aug 2017
Neoplasms	Phase 3	Canada	Janssen Research & Development LLC	24 Aug 2017
Neoplasms	Phase 3	Czechia	Janssen Research & Development LLC	24 Aug 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04882098 (APEX, CTgov)	Phase 3	Arthritis, Psoriatic	1,054	Placebo+Guselkumab	zhwlkczkbu = yitozpigph uusfcobfuy (txemftkkuo, prydfvqhqk - afgygrakbg) View more	-	04 Feb 2026
NCT03796858 (COSMOS, Pubmed \| Rheumatol Ther)	Phase 3	Arthritis, Psoriatic	285	Guselkumab	jqqaudcfqs(yroobkrmml): HR = 1.29 (95.0% CI, 0.93 - 1.81) View more	Positive	23 Jan 2026
				Placebo
NCT05528510 (ASTRO, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 3	Colitis, Ulcerative	418	Guselkumab 400/100 mg	htebncyqxw(sdfkadjjeg) = fsxrkwxceh zinbpaijlx (lgzitlvsfi ) View more	Positive	01 Jan 2026
				Guselkumab 400/200 mg	htebncyqxw(thkmyspvka) = yrjozwloqp wiibqlcneh (ccxbbgxabl ) View more
NCT05528510 (ASTRO, CTgov)	Phase 3	Colitis, Ulcerative	418	placebo+guselkumab (Placebo)	qcohkaluou = ovhlyeyyjl iabwkmuxpv (osecmdoxqg, samuifakvg - gryfxxzhla) View more	-	09 Dec 2025
				Guselkumab (Combined Guselkumab 400 mg)	qcohkaluou = nmutnkhkmk iabwkmuxpv (osecmdoxqg, eptgufieyb - cbpzjfrrca) View more
NCT04936308 (SOLSTICE, CTgov)	Phase 3	Salivary Gland Adenoma, Pleomorphic \| Neoplasms \| Arthritis, Psoriatic	453	Placebo+Guselkumab (Placebo Followed by Guselkumab 100 mg)	mdcmfedssq = vsspxefdho thyivtpqzr (qssisxdend, jkxdjleclw - phjpcrdmxl) View more	-	08 Dec 2025
				Guselkumab (Guselkumab 100 mg q8w)	mdcmfedssq = xlyebobdxf thyivtpqzr (qssisxdend, utmqaepooj - uevdzruoiv) View more
NCT03158285 \| NCT03451851 (DISCOVER-1/-2, Pubmed \| Paediatr Drugs)	Phase 3	Psoriasis \| Arthritis, Psoriatic \| Juvenile Idiopathic Arthritis	1,589	Guselkumab (pediatric PsO)	tbfjnfiumy(ubksrwixge) = ufmijtnlxf tukiwtthys (ewbyufxstc ) View more	Positive	28 Oct 2025
				Guselkumab (adult PsO)	tbfjnfiumy(ubksrwixge) = tlexaaliqh tukiwtthys (ewbyufxstc ) View more
NCT05197049 (GALAXI 3, PRNewswire) Manual	Phase 3	Crohn Disease	-	TREMFYA® 100 mg q8w	oycehmmblm(ewlcqjxtrc) = hplrnehapy mvnxjpstvo (gnwfpgbkke ) View more	Positive	27 Oct 2025
				TREMFYA® 200 mg q4w	oycehmmblm(ewlcqjxtrc) = fuaqqjnjvt mvnxjpstvo (gnwfpgbkke ) View more
SPECTREM (ACR2025)	Phase 3	Psoriasis	338	Guselkumab 100 mg	vwmtwfzaoe(mnwsoojcbe) = famwannlyt fnrjbpdkdr (dvzwgbyiby ) View more	Positive	24 Oct 2025
				Placebo	vwmtwfzaoe(mnwsoojcbe) = otfrqmtjge fnrjbpdkdr (dvzwgbyiby ) View more
CNTO1959PSA4009 (ACR2025)	Not Applicable	Arthritis, Psoriatic Second line	175	Guselkumab	vpxqkioztb(qaxbuqokjb) = gzqrzpgieb lqdzxaaequ (apdnyezgte ) View more	Positive	24 Oct 2025
				TNF inhibitors	vpxqkioztb(qaxbuqokjb) = isojnmvvtx lqdzxaaequ (apdnyezgte ) View more
ACR2025	Not Applicable	Arthritis, Psoriatic	2,754	Guselkumab (biologic-naïve)	udwrpbwmcz(nkdmofxfaa) = iwnwazpvqy eflwifflxn (cyvofigtsl ) View more	Positive	24 Oct 2025
				SC Interleukin-17A Inhibitors (biologic-naïve)	udwrpbwmcz(nkdmofxfaa) = cyspcdjmba eflwifflxn (cyvofigtsl ) View more

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