A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Start Date01 Mar 2025

Sponsor / Collaborator

Sun Pharmaceutical Industries Ltd.

NCT06488170

/ RecruitingNot Applicable

Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version

The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

Start Date04 Apr 2024

Sponsor / Collaborator

Almirall SA

NCT06029257

/ RecruitingNot Applicable

Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic

The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.

Start Date14 Nov 2023

Sponsor / Collaborator

Almirall SA

100 Clinical Results associated with Tildrakizumab-ASMN

100 Translational Medicine associated with Tildrakizumab-ASMN

100 Patents (Medical) associated with Tildrakizumab-ASMN

315

Literatures (Medical) associated with Tildrakizumab-ASMN

01 Mar 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Persistence of advanced systemic pharmacological treatment of moderate‐to‐severe psoriasis among bio‐naïve patients—A retrospective register‐based cohort study in Finland and Sweden

Article

Author: Passey, A. ; Wennerström, C. ; Johnsson, I. ; Hoti, F. ; Mälkönen, T. ; Katus, U. ; Hermanrud, C. ; Westerlund, A. ; Sveide, I. ; Hassan, F. ; Polesie, S. ; Tskhvarashvili, G. ; Saarelainen, L. ; Aher, K. ; Lee, J. ; Nissinen, R.

Abstract:

Background:

Plaque psoriasis (PsO) requires long‐term treatment for symptom control and remission; thus, a long‐term pharmacological intervention is necessary. Treatment persistence reflects long‐term therapeutic effectiveness and tolerance.

Objectives:

This study investigates drug persistence and compares treatment discontinuation rates across biologic agents and apremilast used by PsO patients in Finland and Sweden.

Methods:

This retrospective register‐based cohort study included bio‐naïve patients (≥18 years) with moderate‐to‐severe PsO, who initiated treatment with abatacept, adalimumab, brodalumab, certolizumab pegol, etanercept, golimumab, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab or apremilast during 2008–2020 in Finland or Sweden. The main analysis evaluated persistence (based on duration of continuous treatment) and compared rates of treatment discontinuation using guselkumab as reference drug, during 2018–2020 in Finland. Treatment discontinuation was assessed by survival analysis of the time to first drug discontinuation, including switching to other study drugs. Due to limited sample size (n < 20), certain biologics (abatacept, brodalumab, certolizumab pegol, etanercept, golimumab, risankizumab and tildrakizumab) were excluded from the persistence analysis.

Results:

In Finland, 709 patients fulfilled the inclusion criteria during 2018–2020 for the main analysis. The highest persistence was observed for guselkumab and ustekinumab with 90 and 85% of treated patients, respectively, continuing treatment for ≥1 year. Comparable results were observed in the expanded cohort analysis (index starting in 2008; 2745 bio‐naïve patients in Finland and 10,970 in Sweden). Furthermore, patients treated with guselkumab in Finland showed lower treatment discontinuation rates compared to other study drugs.

Conclusion:

Guselkumab and ustekinumab demonstrated high persistence as measured by continued treatment for at least 1 year. Furthermore, these treatments demonstrated lower rates of discontinuation compared to other study drugs included in the analysis. Understanding the balance between efficacy and feasibility in treatment decisions is crucial, as feasibility may impact persistency outcomes and potentially increase persistency rates.

01 Mar 2025·Italian Journal of Dermatology and Venereology

Facial psoriasis treated with tildrakizumab

Article

Author: Dragotto, Martina ; Rubegni, Pietro ; Capalbo, Eugenio ; Trovato, Emanuele ; Lamberti, Arianna

24 Feb 2025·CLINICAL AND EXPERIMENTAL DERMATOLOGY

Impact of tildrakizumab on the quality of life of patients with moderate-to-severe psoriasis: a 36-week prospective monocentric real-life observational study

Article

Author: Ruggiero, Angelo ; Megna, Matteo ; Scalvenzi, Massimiliano ; Battista, Teresa ; Potestio, Luca ; Cacciapuoti, Sara

Abstract:

Background:

Psoriasis may significantly affect the health-related quality of life (HRQoL) of patients. Clinical assessment has been combined with HRQoL scores to evaluate the ways in which cutaneous disease affects patients. Tildrakizumab is a humanized IgG1 monoclonal antibody that targets the p19 subunit of interleukin-23 and is approved for the management of moderate-to-severe plaque psoriasis.

Objectives:

To evaluate the impact of tildrakizumab treatment on the psychological symptoms experienced by patients with moderate-to-severe plaque psoriasis.

Methods:

A 36-week observational study that enrolled patients with psoriasis who initiated treatment with tildrakizumab 100 mg was carried out. The Dermatology Life Quality Index (DLQI) and Skindex-16 questionnaires were administered at baseline and at weeks 12, 24 and 36. Psoriasis Area Severity Index (PASI), body surface area (BSA) involvement (%) and a visual analogue scale for pruritus (p-VAS) were also assessed at baseline and at each follow-up visit.

Results:

Thirty-four patients were enrolled. Baseline mean (SD) PASI score and BSA involvement were 28.4 (5.6) and 38.8 (21.4), respectively. The mean (SD) DLQI, Skindex-16 and p-VAS scores at baseline were 26.4 (3.2), 68 (5.8) and 8.2 (SD not available for p-VAS). Clinical improvement was assessed at weeks 12 [PASI: 12.4 (4.2); BSA involvement: 16.5 (7.3)], 24 [PASI: 4.2 (2.8); BSA involvement: 6.1 (3.1)] and 36 [PASI: 3.6 (3.2); BSA involvement: 4.2 (1.37)]. Clinical improvement was accompanied by an improvement in quality of life at weeks 16 [DLQI: 15.5 (2.9); Skindex-16: 28.2 (4.2); p-VAS: 3.8], 24 [DLQI: 8.2 (1.4); Skindex-16: 16.2 (3.6); p-VAS: 2.6] and 36 [DLQI: 3.1 (2.4); Skindex-16: 9.3 (2.8); p-VAS: 2.8]. Our study also confirmed the safety of tildrakizumab in real-life settings, with no treatment discontinuation due to inefficacy or adverse events.

Conclusions:

Our results confirm tildrakizumab as an effective treatment option for improving the HRQoL of patients with psoriasis.

News (Medical) associated with Tildrakizumab-ASMN

12 Mar 2025

·www.prnewswire.com

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultPhase 2

07 Mar 2025

·www.prnewswire.com

ILUMYA® (tildrakizumab-asmn) Found Effective for Treatment of Moderate-to-Severe Plaque Psoriasis Affecting Nails in Study Presented at 2025 AAD Conference

Data Presented at American Academy of Dermatology Shows Significant Improvement in Moderate-to-Severe Nail Psoriasis with No New Safety Signals PRINCETON, N.J., March 7, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries, Inc., USA, a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (Sun Pharma), today presented the results of a Phase 3b, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of ILUMYA® (tildrakizumab-asmn) for the treatment of moderate-to-severe psoriasis affecting the nails. The study, which included 99 patients with moderate-to-severe plaque psoriasis, found that ILUMYA significantly improved nail psoriasis severity compared to placebo, marking forward progress in addressing this difficult-to-treat condition. This trial showed that: Patients treated with ILUMYA demonstrated a significantly higher rate of 75% improvement from baseline in the Nail Psoriasis Severity Index (mNAPSI 75) at Week 28 (25.5% mNAPSI 75 response rate vs. 4.5% in the placebo group; P=0.003). 29.4% of patients treated with ILUMYA achieved normal nails or nails with minimal psoriasis (ViSENPsO® score of 0 or 1), compared to 4.2% in the placebo group (P = 0.0008). ViSENPsO is a clinical tool used for detecting and assessing psoriasis including a visual medical scale to evaluate nail psoriasis severity and Patient Global Assessment (PGA) questionnaires. The safety profile was consistent with the known safety profile of ILUMYA, and no serious adverse events related to ILUMYA treatment occurred in this clinical trial. "Nail psoriasis is understood as a difficult to treat population, and many current therapies fall short of providing lasting relief or are slow to produce results," said Dr. Paul Yamauchi, MD, lead investigator of the ILUMYA study. "While other IL-23 inhibitors do not have a dedicated study to evaluate efficacy in nail psoriasis, these trial results clearly demonstrate the promise for ILUMYA to ease discomfort and improve patient outcomes." Nail psoriasis impacts approximately 50% of patients living with plaque psoriasis and can have an increased negative impact on quality of life.1 Effective, long-term treatments for nail psoriasis have been limited due to the complicated nature of the treatment area, making the condition difficult to manage. "Psoriasis affecting the nails can have a profound impact on a patient's daily life, causing both physical discomfort and emotional distress. Although highly prevalent in people with plaque psoriasis, nail psoriasis has been challenging to treat," said Marek Honczarenko, M.D., PhD, Senior Vice President, Head of Development, Sun Pharma, North America. "As a company dedicated to developing innovative therapies which help improve quality of life for patients, these data, along with our existing data in scalp psoriasis, reinforces the benefits of ILUMYA in difficult to treat populations." The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. The results of this study contribute to the growing body of evidence supporting ILUMYA as a promising treatment for patients living with moderate-to-severe plaque psoriasis, including those with scalp and nail involvement. About ILUMYA (tildrakizumab-asmn) ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and Japan, and under the brand name ILUMETRI® in Europe, where it is marketed by Almirall. INDICATIONS AND USAGE ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. Please see Full Prescribing Information. About Sun Pharmaceutical Industries Limited Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit & follow us on Twitter @SunPharma_ Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References SOURCE Sun Pharmaceutical Industries Inc., USA (Sun Pharma) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

15 Jan 2025

·endpts.com

Eli Lilly's Omvoh earns FDA approval for Crohn's disease

The FDA approved Eli Lilly’s Omvoh in Crohn’s disease, the company announced Wednesday, handing the drug its second indication after giving it a green light for ulcerative colitis in late 2023. While Lilly is largely known for its diabetes and obesity medications, the company has slowly expanded a small suite of drugs like Omvoh targeting immunological diseases. In addition to Omvoh, Lilly also has Ebglyss, which was approved last September for eczema, and two older drugs in Taltz and Olumiant. Omvoh is a monoclonal antibody that inhibits a subunit of the IL-23 pathway called p19. Though other approved drugs like Skyrizi, Tremfya and Ilumya target IL-23, Omvoh was the first medication approved for UC specifically going after the p19 subunit. Omvoh’s approval came after Phase 3 studies showed 53% of patients achieved clinical remission of their Crohn’s disease after one year, compared to 36% on placebo. And 46% saw “visible healing” of the intestinal lining, as confirmed by endoscopy, compared to 23% on placebo. Patients in the placebo arm switched to Omvoh after 12 weeks. The news comes a day after Lilly lowered its revenue guidance, which has varied widely this year. Wall Street was disappointed by the revised estimate: Lilly’s stock price $LLY fell 7% on Tuesday.

Clinical ResultDrug ApprovalPhase 3Biosimilar

100 Deals associated with Tildrakizumab-ASMN

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tildrakizumab-ASMN	L04AC	DB14004

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Plaque psoriasis	United States	Sun Pharmaceutical Industries Ltd.	20 Mar 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis of nail	Phase 3	United States	Sun Pharmaceutical Industries Ltd.	13 May 2021
Psoriasis of nail	Phase 3	Australia	Sun Pharmaceutical Industries Ltd.	13 May 2021
Scalp Dermatoses	Phase 3	United States	Sun Pharmaceutical Industries Ltd.	29 Mar 2019
Scalp Dermatoses	Phase 3	Australia	Sun Pharmaceutical Industries Ltd.	29 Mar 2019
Arthritis, Psoriatic	Phase 3	Argentina	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Hungary	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Mexico	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Russia	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Ukraine	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Metastatic castration-resistant prostate cancer	Phase 2	Switzerland	Sun Pharmaceutical Industries Ltd.	01 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03552276 (CTgov)	Phase 2/3	Arthritis, Psoriatic	281	Tildrakizumab (Tildrakizumab 200 mg q4 Weeks)	zosllqnbzb = mqwywuiojb iwfcowfqcm (pfngihplma, hufdacmbaq - hytytdjvyx)	-	21 Nov 2024
NCT03552276 (CTgov)	Phase 2/3	Arthritis, Psoriatic	281	Tildrakizumab (Tildrakizumab 200 mg q12 Weeks)	zosllqnbzb = udeooumkzs iwfcowfqcm (pfngihplma, nduvrahbkq - svcagevwqe)	-	21 Nov 2024
Pubmed Manual	Not Applicable	Psoriasis	-	Tildrakizumab 200 mg	mhjdqjoftj(cxaidjtzhh) = owwijpxmxe iqvpdufcal (anuizywevg ) View more	Positive	27 Oct 2024
NCT04541329 (CTgov)	Phase 4	inflammatory dermatosis \| Psoriasis vulgaris	7	Tildrakizumab	uxuscpeohd(bwhsimbugb) = qoghngnlgc ayrxciwzrf (extrkrmguc, 4.1) View more	-	30 Apr 2024
NCT05108766 (Pubmed) Manual	Phase 3	Plaque psoriasis	220	Tildrakizumab 100 mg	tqzjjcncpu(rckfumbcrz) = elzbvbsmca ekzufrzdjn (xfrmxqtctf ) View more	Positive	09 Jan 2024
EADV2023	Not Applicable	-	51	Tildrakizumab 100 mg	nbhavucdzo(fgcztugitk) = no adverse event was reported by our patients during the whole 12-week follow-up period gldkjwvnsc (lsejmgkpqy )	Positive	11 Oct 2023
EADV2023	Phase 4	Plaque psoriasis	177	Tildrakizumab 100 mg	xtxvowaqhs(jbdkzcvchs) = 6.2% ndawixjxeh (wrhcflrklf ) View more	Positive	11 Oct 2023
NCT04229836 (TRIBUTE, EADV2023)	Phase 4	Plaque psoriasis	177	Tildrakizumab 100 mg	vywuotjawq(mhivhhxqpt) = a greater BSA affected at baseline could be argued clqypuymdu (iumxunmqcz ) View more	Positive	11 Oct 2023
EADV2023	Not Applicable	-	1,078	Tildrakizumab 100 mg	uggcawoshj(rrjskzfdjl) = vpeeasoltm gzointwzjq (jprunvtcyj, 82.1 - 86.9)	Positive	11 Oct 2023
EADV2023	Not Applicable	-	1,078	Tildrakizumab 200 mg	uggcawoshj(rrjskzfdjl) = xsndyquxft gzointwzjq (jprunvtcyj, 88.4 - 92.5)	Positive	11 Oct 2023
EADV2023	Not Applicable	SNPs	81	Tildrakizumab	erdhiaythq(jalwmyndha) = gwfzevhfwq sgilxfefdk (ivtjwwzijo ) View more	-	11 Oct 2023
TILOT (EADV2023)	Not Applicable	Plaque psoriasis	503	Tildrakizumab 100 mg (s.c.)	nlrrbjdjrm(gwgxeyvbit) = lttryzdkvy zwcauzvxqe (zhkzhkuvun ) View more	Positive	11 Oct 2023
TILOT (EADV2023)	Not Applicable	Plaque psoriasis	503	Placebo	nlrrbjdjrm(gwgxeyvbit) = qvhzwdupes zwcauzvxqe (zhkzhkuvun ) View more	Positive	11 Oct 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis