A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants With Nonsegmental Vitiligo

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches).
The main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo.
The participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months.
During the study, participants will visit their study clinic 11 times.

Start Date14 Nov 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06973291

/ RecruitingPhase 3

A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis

The main aim of this study is to assess whether zasocitinib works better than deucravacitinib in treating participants with moderate-to-severe plaque psoriasis.
Participants will take one tablet daily of either zasocitinib or a matching placebo, along with one capsule daily of either over-encapsulated deucravacitinib or a matching placebo, for a duration of 16 weeks.
Participants will be in the study for up to 25 weeks, which includes screening period of up to 35 days, a 16-week treatment period, and a 4-week safety follow-up period.

Start Date09 Jul 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06764615

/ RecruitingPhase 2

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation.
This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461) and TAK-279-UC-2001 (NCT06254950). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study.
The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD.
The participants will be treated with TAK-279 for up to 2 years (108 weeks).
During the study, participants will visit their study clinic 11 times.

Start Date28 May 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zasocitinib

100 Translational Medicine associated with Zasocitinib

100 Patents (Medical) associated with Zasocitinib

Literatures (Medical) associated with Zasocitinib

01 Oct 2025·ANNALS OF THE RHEUMATIC DISEASES

Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study

Article

Author: Zhang, Xinyan ; Hong, Ting ; Trivedi, Mona ; Kivitz, Alan ; Dokoupilova, Eva ; Srivastava, Bhaskar ; Muensterman, Elena Tomaselli ; Kavanaugh, Arthur ; Weng, Haoling Holly ; van der Heijde, Désirée ; Poirier, Gabrielle ; Valenzuela, Guillermo ; Lertratanakul, Apinya ; Klimiuk, Piotr A ; Baraliakos, Xenofon ; Dasen, Sue ; Pothula, Peter ; Chen, Jingjing

OBJECTIVES:

To assess the efficacy, safety, and tolerability of the investigational, oral, allosteric, highly selective, and potent tyrosine kinase 2 inhibitor zasocitinib (TAK-279) in patients with active psoriatic arthritis (PsA).

METHODS:

In this phase 2b, randomised, multicentre, double-blind, placebo-controlled, multiple-dose study, patients (≥18 years, with PsA symptoms for ≥6 months) received 30 mg, 15 mg, or 5 mg zasocitinib or placebo (1:1:1:1) once daily for 12 weeks, with a 4-week safety follow-up. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12. Secondary efficacy endpoints included ACR50 response, ACR70 response, Psoriasis Area and Severity Index (PASI) 75 response among those with ≥3% body surface area at baseline and minimal disease activity (MDA) at week 12.

RESULTS:

Overall, 290 patients (mean [SD] age, 49.9 [11.6] years; 57.2% female) received treatment. At week 12, 30 mg or 15 mg zasocitinib treatment resulted in significantly higher ACR20 responses (54.2%; P = .002 and 53.3%; P = .002, respectively) than placebo (29.2%). A numerically higher number of ACR50 responses were achieved at week 12 with 30 mg (26.4%; nominal P = .009) or 15 mg (26.7%; nominal P = .005) zasocitinib than placebo (9.7%). In addition, 30 mg zasocitinib demonstrated a numerically higher number of ACR70 responses (13.9% versus 5.6%, respectively; nominal P = .158), PASI 75 responses (45.7% versus 15.4%, respectively; nominal P = .002), and MDA (29.2% versus 12.5%, respectively; nominal P = .014) at week 12 versus placebo. In this small study of limited duration, most adverse events were mild/moderate and were more frequently observed in the higher dose group. In this small sample size, no new safety signals or clear dose-dependent laboratory parameter changes were identified.

CONCLUSIONS:

Here, 30 mg and 15 mg zasocitinib demonstrated efficacy across core domains in patients with active PsA with no new safety signals. These findings will be confirmed in ongoing larger studies of longer duration.

01 May 2025·JOURNAL OF INVESTIGATIVE DERMATOLOGY

Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective, and Potent Allosteric TYK2 Inhibitor

Article

Author: Bunick, Christopher G ; Dunbar, Faith ; McInnes, Iain B ; Kong, Kok-Fai ; Sano, Yasuyo ; Xia, Guliang ; Heap, Graham A ; Halkowycz, Petro ; Wilson, Elizabeth ; Mehrotra, Shailly ; Spector, Taylor ; Durairaj, Chandra

Zasocitinib (TAK-279) is an investigational, oral, highly selective, and potent allosteric TYK2 inhibitor. This study assessed the TYK2 inhibitory selectivity and potency of zasocitinib versus those of licensed TYK2 and Jak inhibitors. Binding affinities were determined using homogenous time-resolved fluorescence. In vitro concentration-percentage inhibition curves for IL-23-phosphorylated signal transducer and activator of transcription (pSTAT)3, type I IFN-pSTAT3, IL-12-pSTAT4, IL-2-pSTAT5, and thrombopoietin-pSTAT3 pathways were established using human whole-blood assays. Relationships between concentration and percentage inhibition were determined to estimate half-maximal inhibitory concentration. Times above half-maximal inhibitory concentration and percentage daily inhibition were modeled from simulated clinical concentrations. Zasocitinib bound the TYK2 Janus homology 2 domain with an inhibitory constant of 0.0087 nM, demonstrating more than 1 millionfold selectivity over Jak1. Zasocitinib potently inhibited TYK2 signaling, with half-maximal inhibitory concentrations of 48.2 nM (95% confidence interval = 36.8-63.1 nM), 21.6 nM (95% confidence interval = 17.3-26.9 nM), and 57.0 nM (95% confidence interval = 44.2-73.4 nM) for IL-23-pSTAT3, type I IFN-pSTAT3, and IL-12-pSTAT4 pathways, respectively; zasocitinib showed no inhibition of Jak1/2/3. Simulated clinical concentrations of 30 mg zasocitinib once daily exceeded the TYK2 half-maximal inhibitory concentration for 24 hours, maintaining >90% daily inhibition, with no Jak1/2/3 inhibition. The distinct potent and selective inhibition profile of zasocitinib defines it as a next-generation TYK2 inhibitor.

28 Mar 2025·Recent Advances in Inflammation & Allergy Drug Discovery

Pharmacological Management of Psoriasis: Current Landscape and Future Perspectives

Article

Author: Tomar, Anush ; Bawari, Sweta ; Pedwar, Roopal

Abstract::

Psoriasis is a relapsing, chronic, and inflammatory disease of the skin. However, its impact goes beyond just pathophysiology and takes a toll on the physical and psychological aspects of the health of the afflicted, lowering the quality of life significantly. It is also a mechanistically complex disease with a substantial immune component. Therefore, ongoing treatment strategies focus on targeting at least one immune component associated with the disease development and progression by employing biological agents like IL-1 inhibitors, IL-23 inhibitors, IL-36 inhibitors, and TNF-α inhibitors. Psoriasis-induced disruptions in cellular signalling pathways have drawn significant attention as novel drug targets. Numerous novel synthetic agents, such as JAK/STAT inhibitors [ruxolitinib, peficitinib], TYK2 inhibitors [zasocitinib, ropsacitinib], RORꝩT inhibitors [cedirogant], A3AR agonists [piclodenoson], and CXCR2 antagonists [vimnerixin] are undergoing extensive clinical trials and have demonstrated beneficial outcomes in multiple phases of these trials. Deucravacitinib, an orally administered TYK2 inhibitor, has recently received FDA approval for the treatment of moderate to severe plaque psoriasis. These synthetic agents hold promise to change the outlook of psoriasis management by modulating specific molecular targets associated with the dysregulated immune response observed in psoriasis. Moreover, these pathways can be exploited to personalize anti-psoriatic therapy, minimize side effects, and maximize therapeutic outcomes. Altogether, the integration of biological agents and synthetic agents can overcome the challenges associated with the management of the repertoire of psoriatic pathophysiology and symptoms.

News (Medical) associated with Zasocitinib

25 Aug 2025

·www.prnewswire.com

Crohn's Disease Market Projected to Grow at 4.3% CAGR (2020-2034), Driven by Improved Diagnosis, Pediatric Label Expansion, and New Second-line Therapies | DelveInsight

The Crohn's disease pipeline includes several drugs in mid- and late-stage development, poised for approval in the near future in both adults and pediatrics. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including RHB-104, Tulisokibart, LITFULO (ritlecitinib), AGMB-129, Duvakitug, and others. The expected launch of these therapies shall further create a positive impact on the Crohn's disease market. LAS VEGAS, Aug. 25, 2025 /PRNewswire/ -- DelveInsight's Crohn's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Crohn's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Crohn's Disease Market Report According to DelveInsight's analysis, the market size for Crohn's disease was found to be USD 10.8 billion in the 7MM, with roughly 8-10% of it being the pediatric market in 2024. The United States accounted for the highest market size of Crohn's disease, approximately 78% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Adalimumab (HUMIRA and its generics) accounted for the highest market share of ~ USD 4 billion in 2024 for the treatment of Crohn's disease in the 7MM. Based on DelveInsight's assessment in 2024, the 7MM had 2.1 million diagnosed prevalent cases of Crohn's disease, out of which almost 200,000 cases are pediatric. In 2024, it was estimated that almost 60% of the cases were within the moderate-to-severe category as compared to mild severity in the US. Leading Crohn's disease companies developing emerging therapies, such as RedHill Biopharma, Merck, Teva Pharmaceutical, Pfizer, Agomab Therapeutics, Sanofi, Medibiofarma, Eli Lilly, NImmune, Avobis Bio, Abivax, Roche, Telavant, Mesoblast, Takeda, AstraZeneca, and others, are developing novel Crohn's disease drugs that can be available in the Crohn's disease market in the coming years. The promising Crohn's disease therapies in the pipeline include RHB-104, Tulisokibart (MK-7240, PRA023), Duvakitug (TEV-574), LITFULO (Ritlecitinib/PF-06651600), AGMB-129, Balinatunfib (SAR441566), MBF-118, MORF-057, Omilancor (BT-11), AVB-114, Obefazimod (ABX464), Afimkibart (RVT-3101 or RG6631), RYONCIL (Remestemcel-L), Zasocitinib (TAK-279), AZD7798, and others. Discover what is the best medicine for Crohn's disease @ Crohn's Disease Medication List Crohn's Disease Market Dynamics Crohn's disease can be managed through nutritional support, medication, and surgery in more severe cases. Treatment typically begins with glucocorticosteroids such as budesonide, although 5-Aminosalicylates (5-ASA) are considered when steroids are not suitable. For moderate disease, immunomodulators like azathioprine, methotrexate, and 6-mercaptopurine are commonly used. However, long-term steroid use is generally avoided due to potential side effects. Over time, biologic and small-molecule therapies for Crohn's disease have seen considerable advancements, varying in approval timelines, mechanisms of action, dosing schedules, and clinical effectiveness. REMICADE, the first TNF inhibitor approved in 1998, later gained approval for pediatric use in 2006. HUMIRA, introduced in 2007, provided an alternative for patients not responding to traditional treatments or REMICADE. In 2008, CIMZIA became the first PEGylated TNF inhibitor, offering extended half-life and reduced immune response. These therapies differ in administration routes; REMICADE is given via IV infusion every eight weeks, whereas HUMIRA and CIMZIA are administered subcutaneously, allowing for at-home treatment. In addition to TNF inhibitors, newer biologics and small molecules have broadened therapeutic options with unique mechanisms. ENTYVIO, approved in 2014, is a gut-specific α4β7 integrin blocker, initially given intravenously with maintenance every eight weeks; a subcutaneous version was introduced in 2024. STELARA, launched in 2016, targets IL-12 and IL-23 by blocking the p40 subunit, with an IV induction followed by SC dosing every eight weeks. SKYRIZI, approved in 2022, inhibits IL-23 and follows an IV induction schedule at Weeks 0, 4, and 8, then shifts to subcutaneous maintenance. It demonstrated 61% clinical remission at Week 52 in trials. RINVOQ, a JAK1 inhibitor approved in 2023, represents a small-molecule alternative targeting the JAK/STAT pathway and is taken orally, 45 mg daily for induction, followed by 15 mg or 30 mg maintenance. OMVOH, a selective IL-23 p19 subunit blocker, received approval in 2025, with IV induction and subcutaneous maintenance every four weeks. While currently small molecules and biologics are ruling the Crohn's disease treatment space, in 2018, a cell therapy was also introduced in the market. ALOFISEL (darvadstrocel), an allogeneic stem cell therapy, was approved in the EU (2018) and Japan (2021) for complex perianal fistulas in Crohn's disease patients. However, despite initial promise, Takeda discontinued its marketing authorization in the EU (December 2024), withdrawing the product as the clinical benefit of ALOFISEL was no longer sufficient to justify its continued use in the EU. Additionally, the company has removed the planned pediatric trial for refractory complex perianal fistulas from its pipeline, limiting future expansion into younger patient populations. The discontinuation of ALOFISEL highlights the ongoing challenges in developing and commercializing advanced regenerative therapies for Crohn's disease, particularly in niche indications. Regarding the challenges for biologics, the rise of biosimilars has lowered treatment costs and increased accessibility to biologic therapies. The first REMICADE biosimilar was introduced in 2016; as of now several biosimilars of REMICADE are approved, including INFLECTRA, RENFLEXIS, AVSOLA, and others. In 2023, biosimilars for HUMIRA, including AMJEVITA and CYLTEZO, entered the market, further enhancing affordability. TYRUKO, the first biosimilar for TYSABRI, was approved in Germany in 2024, indicating continued growth in the biosimilars landscape. With STELARA experiencing a 4% sales decline, now amplified by the entry of biosimilars in the US, Johnson & Johnson has now TREMFYA. TREMFYA's FDA approval in March 2025—offering both IV and SC induction and a dual-acting mechanism is expected to solidify Johnson & Johnson's IBD leadership. Despite these advances, challenges such as physician resistance, patient hesitation, and payer-related issues persist. In the pediatric segment, treatment-related challenges are even more pronounced due to limited approved options. HUMIRA and REMICADE remain the primary TNF inhibitors, but early disease onset, aggressive progression, and long-term immunosuppression risks create significant unmet needs. Recently, in April 2025, the European Commission approved STELARA for the treatment of moderately to severely active Crohn's disease in paediatric patients. While biologics have improved management, immunogenicity and secondary loss of response remain key concerns. To address these gaps, pharmaceutical companies are advancing novel mechanisms of action, including integrin blockers, IL-12/IL-23 inhibitors, and JAK inhibitors, aiming for improved efficacy, safety, and durability in pediatric patients. The anticipated approvals of ENTYVIO in the near future, followed by RINVOQ and OMVOH for pediatric Crohn's disease patients, will diversify the therapeutic landscape, offering more personalized treatment options based on disease severity and individual patient response. The Crohn's disease market dynamics are expected to change in the coming years. Biologics continue to dominate Crohn's disease treatment, with TNF inhibitors (HUMIRA, REMICADE), IL-12/23 inhibitors (STELARA), and IL-23 inhibitors (SKYRIZI) offering strong efficacy and long-term disease control. In contrast, the development of new treatments such as JAK inhibitors, immunomodulators, and first-in-class therapies like Tulisokibart (TL1A inhibitor) and AGMB-129 (ALK5/TGFβR1 inhibitor) reflects a promising shift toward more targeted options with improved clinical profiles, subcutaneous formulations, and greater convenience, driving higher penetration in the moderate-to-severe patient population and paving the way for Crohn's disease market innovation. Overall, the Crohn's disease market is undergoing a transformative shift. With continued investment in next-generation biologics, oral small molecules, and novel combinations, the Crohn's disease treatment landscape is set to evolve significantly, reshaping the standard of care for both adult and pediatric patients. To know more about FDA-approved drugs for Crohn's disease, visit @ Crohn's Disease Treatment Crohn's Disease Pipeline Therapies and Key Companies The promising late- and mid-stage emerging pipeline assets for Crohn's disease include RHB-104 (RedHill Biopharma), Tulisokibart (Merck), LITFULO (Pfizer), AGMB-129 (Agomab Therapeutics), Duvakitug (Teva Pharmaceuticals and Sanofi), and others. RHB-104, developed by RedHill Biopharma, is an investigational oral capsule with strong intracellular, antimycobacterial, and anti-inflammatory properties. It has the potential to be a groundbreaking therapy. RedHill has completed two Phase III clinical trials (NCT03009396 and NCT01951326). The MAP US study, a randomized, double-blind, placebo-controlled Phase III trial in Crohn's disease, achieved both its primary and key secondary endpoints. Further clinical trials are needed to support a New Drug Application (NDA), with a new study expected to launch in mid-2025. No recent updates are available, and the drug is not visible in the company's pipeline. RedHill Biopharma is also developing RHB-204, a next-generation formulation of RHB-104 with an optimized formulation for the treatment of Crohn's disease. RHB-204 is patent-protected until at least 2041, and has an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104). Tulisokibart is a humanized monoclonal antibody targeting the novel protein TL1A, which is linked to intestinal inflammation and fibrosis. The antibody is believed to bind both soluble and membrane-bound forms of TL1A, potentially blocking inflammatory pathways and reducing fibrosis in inflammatory bowel disease (IBD). This could be significant in modifying disease progression. Following Merck's acquisition of Prometheus Biosciences in June 2023, Tulisokibart is now part of Merck's portfolio. The drug is protected by US patents extending into the 2040s and is currently in two Phase III trials for Crohn's disease. AGMB-129 is an orally administered, gastrointestinal-restricted small molecule that inhibits ALK5 (TGFβR1), a key mediator in fibrotic processes. It is specifically developed for treating Fibrostenosing Crohn's Disease (FSCD). TGFβ is a central regulator of fibrosis, and early clinical data support its potential as a therapeutic target. In October 2024, the company raised USD 89 million in a Series D round, with participation from new investors including Sanofi and Invus, along with support from existing backers. In May 2025, Agomab Therapeutics presented interim data from the Phase IIa STENOVA trial at Digestive Disease Week 2025. The primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses. The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients. The other therapies in the pipeline for Crohn's disease treatment include Omilancor (BT-11): NImmune AVB-114: Avobis Bio/Alimentiv Obefazimod (ABX464): Abivax RVT-3101 (RG6631): Roche RYONCIL (Remestemcel-L): Mesoblast Zasocitinib (TAK-279): Takeda AZD7798: AstraZeneca Balinatunfib (SAR441566): Sanofi MBF-118: Medibiofarma MORF-057: Eli Lilly/Morphic Therapeutic And others As potential therapies are being investigated for the treatment of Crohn's disease, it is safe to predict that the treatment space will significantly impact the Crohn's disease market during the forecast period. Moreover, the anticipated launch of emerging therapies are poised to transform the Crohn's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Crohn's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. However, several factors may impede the growth of the Crohn's disease market. Despite the emergence of novel treatments, a significant portion of Crohn's disease patients remains refractory to multiple therapies, underscoring the need for breakthrough innovations beyond current biologic and small-molecule options; however, biological therapies remain expensive and face accessibility challenges, JAK inhibitors like RINVOQ are limited by serious safety concerns, and brand erosion following the patent expiry of market leaders such as REMICADE, HUMIRA, ENTYVIO, and STELARA is expected to lead to sales decline. Moreover, Crohn's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Crohn's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Crohn's disease market growth. Discover more about Crohn's disease drugs in development @ Crohn's Disease Clinical Trials Recent Developments in the Crohn's Disease Market In July 2025, the Phase III trial evaluating VELSIPITY (Etrasimod) a product of Arena (a wholly owned subsidiary of Pfizer), for the treatment of adult participants with moderately to severely active Crohn's disease, was terminated due to lack of efficacy in sub-study 1. In June 2025, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand approval of STELARA for the treatment of children two years and older with moderately to severely active Crohn's disease. In March 2025, the FDA approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease. In March 2025, Celltrion announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following FDA approval in December 2024. STEQEYMA is approved for the same indications as STELARA, offering consistent treatment for patients and healthcare providers. In February 2025, Eli Lilly and Company announced the results from the VIVID-2 open-label extension study, which showed the majority of patients with moderate-to-severely active Crohn's disease receiving 2 years of continuous treatment with OMVOH achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure at the Crohn's and Colitis Congress (CCC). In January 2025, the FDA approved OMVOH (mirikizumab) for Crohn's disease, further solidifying the IL-23 inhibitor class. With strong long-term efficacy, OMVOH is also being investigated for pediatric patients, potentially addressing a significant unmet need in this population. Crohn's Disease Overview Crohn's disease is a long-term inflammatory disorder of the gastrointestinal (GI) tract and is classified under inflammatory bowel disease (IBD). Although it can impact any part of the digestive tract, from the mouth to the anus, it most frequently affects the small intestine and colon. Its exact cause is still unknown, but it's thought to arise from a mix of genetic predisposition, environmental triggers, and immune system irregularities. Crohn's disease symptoms can differ in intensity and may include abdominal discomfort, persistent diarrhea, weight loss, fatigue, and nutrient deficiencies. While a cure has yet to be found, treatment aims to control inflammation, relieve symptoms, and prevent complications through the use of medications, biologic therapies, lifestyle adjustments, and sometimes surgical intervention. Continuous research and innovation in targeted treatments are expanding the options available, offering renewed hope for better management and improved quality of life for those affected. Diagnosing Crohn's disease can be complex due to symptom overlap with other GI disorders, such as ulcerative colitis and irritable bowel syndrome (IBS). Physicians use a comprehensive diagnostic approach that includes a clinical assessment, lab work, imaging, and endoscopic evaluations. Blood tests can reveal signs of inflammation, anemia, or nutritional imbalances, while stool tests help exclude infections. Imaging methods like CT scans, MRIs, and intestinal ultrasounds provide detailed insights into areas of inflammation, narrowing, or abnormal connections. Endoscopic procedures, such as colonoscopy and upper endoscopy, offer a direct look at the intestinal lining and allow for tissue biopsies to confirm the diagnosis. Because no single test can definitively confirm Crohn's, a combination of diagnostic tools is used to establish an accurate diagnosis and guide effective treatment planning. Crohn's Disease Epidemiology Segmentation The Crohn's disease epidemiology section provides insights into the historical and current Crohn's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Crohn's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Crohn's Disease Prevalence Age-specific Diagnosed Crohn's Disease Prevalence Severity-specific Diagnosed Crohn's Disease Prevalence Scope of the Crohn's Disease Market Report Therapeutic Assessment: Crohn's Disease current marketed and emerging therapies Crohn's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Crohn's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Crohn's Disease Market Access and Reimbursement Download the report to understand which factors are driving Crohn's disease market trends @ Crohn's Disease Market Forecast Table of Contents Related Reports Inflammatory Bowel Disease Market Inflammatory Bowel Disease 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 IBD companies including Takeda Pharmaceutical, Janssen Pharmaceuticals, Hoffmann-La Roche, Genentech, AbbVie, Boehringer Ingelheim, Gilead Sciences, Arena Pharmaceuticals, Eli Lilly, AstraZeneca, among others. Ulcerative Colitis Market Ulcerative Colitis 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 ulcerative colitis companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including TiumBio Co., Jiangsu Gensciences Inc., Pfizer, Novo Nordisk, Genzyme, AbbVie, Bayer, Spark Therapeutics, G & P Bioscience, Gritgen Therapeutics, Biocad, Belief Biomed, Chugai Pharmaceutical, Staidson Beijing BioPharmaceuticals, Jiangsu Gensciences, Poseida Therapeutics, Chia Tai Tianqing Pharmaceutical Group, Takeda, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, 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 3Clinical ResultDrug ApprovalPhase 2Orphan Drug

09 May 2025

·www.fiercepharma.com

Fierce Pharma Asia—Enhertu's neoadjuvant win; Takeda eyes inflection point; Trump targets foreign plants

Enhertu's positive early-stage breast cancer readout, Takeda's LOE plan and Trump's drug manufacturing executive order made our news this week. Enhertu delivered a phase 3 trial win in early-stage breast cancer. Takeda spotlighted three late-stage readouts as a potential "inflection point" for the company. President Donald Trump is directing the FDA to go hard on foreign manufacturing facilities. And more.1. AstraZeneca, Daiichi Sankyo's Enhertu rings up success in another breast cancer trialAstraZeneca and Daiichi Sankyo reported a positive readout for Enhertu as a neoadjuvant therapy in early-stage breast cancer. When added to the THP regimen of paclitaxel, Herceptin and Perjeta before surgery, the antibody-drug conjugate mounted a statistically and clinically meaningful improvement in pathologic complete response (pCR) versus THP alone. Although the secondary endpoint of event-free survival is not mature yet, pCR is an approvable endpoint for neoadjuvant breast cancer treatment at the FDA.2. Takeda looks toward 'inflection point' as it eyes new launches to shake off Vyvanse generic impactsTakeda is looking to phase 3 readouts from three key drugs that Chief Financial Officer Milano Furuta called could form an “inflection point” for the company as it tackles the loss-of-exclusivity impact from Vyvanse and Entyvio. These are blood disorder candidate rusfertide, narcolepsy drug oveporexton and TYK2 inhibitor zasocitinib in psoriasis.3. Takeda shoots down bispecifics bagged in Maverick buyout amid pipeline clearoutTakeda has terminated two T-cell engagers separately targeting EGFR and B7-H3, which the company got from its acquisition of Maverick Therapeutics. Separately, the company has axed the STING agonist dazostinag in solid tumors. The three removals halved the size of Takeda’s phase 1 and 2 oncology pipeline.4. Trump signs executive order to boost US drug manufacturing amid threat of tariffsPresident Donald Trump has signed an executive order asking the FDA to reduce regulatory hurdles for domestic drug manufacturers but to “increase fees for an inspections of foreign manufacturing plants.” FDA Commissioner Marty Makary, M.D., also said that the agency will switch from announced to surprise visits for overseas drug facility inspections.5. Vivo Capital secures $740M to invest in preclinical- and clinical-stage biotechsCalifornia-headquartered investment firm Vivo Capital, which has a major presence in Asia, has secured $740 million in commitments to fund preclinical- and clinical-stage life science companies. The so-called Vivo Opportunity Fund is now in its third three-year investment cycle. Some of the biotechs Vivo has backed include Chinook Therapeutics, Gracell Therapeutics and RayzeBio.

Phase 3Clinical ResultAcquisitionPhase 1

08 May 2025

·www.fiercepharma.com

Takeda looks toward 'inflection point' as it eyes new launches to shake off Vyvanse generic impacts

The Japanese drugmaker is looking to embark on a new path for growth as it leaves generics-ridden ADHD med Vyvanse behind. This time last year, Takeda was scrambling to accommodate for rapidly sinking profits from the hasty decline of ADHD mainstay Vyvanse with a 140 billion Japanese yen ($899 million) restructuring campaign. Now, things are looking up for the Japanese drugmaker with several key products keeping it afloat as it looks to unlock a new path to growth with upcoming launches.While six new launches are expected to help weather the storm ahead of biosimilar competition to lead sales driver Entyvio at the end of the decade, three “potentially life-transforming” new treatment options are on track for phase 3 readouts this year, the company said in its 2024 full-year earnings release. Takeda’s fiscal year just wrapped up in March 2025 and began in April 2024.2025’s fiscal year, meanwhile, will be “pivotal” as it invests in launch readiness, which is key for the company’s long-term growth potential despite a flat 2025 outlook, CEO Christophe Weber commented. Rusfertide, a treatment for chronic blood disorder polycythemia vera that Takeda bought from Protagonist Therapeutics for $300 million last year, already delivered a phase 3 win in March. The company expects that the buy will be well worth it with $1 billion to $2 billion in potential peak revenue and previously noted that FDA submissions are expected in 2025. Elsewhere, the first half of the year should see a phase 3 readout for narcolepsy type 1 treatment oveporexton, which is looking at $2 billion to $3 billion in peak sales, while the latter half of the year should have phase 3 data from zasocitinib, a TYK2 inhibitor that could “redefine what is possible” as an oral therapy for psoriasis. That one has the greatest potential revenues with $3 billion to $6 billion.Together, the three make an “inflection point” for the company, said Chief Financial Officer Milano Furuta, who is “excited about our growth trajectory." Takeda is hoping that the boosts to come will help it shake off the ghost of its Vyvanse past, its longtime top-selling ADHD med that succumbed to generic competition in late 2023 after 16 years of market exclusivity. The company described its 2025 outlook (PDF) as the final year of “significant” generic headwind to the med, although it may be worth noting that it said the same last year about its 2024 expectations. Nonetheless, the new launch preparations and an expected 30% sales slide for Vyvanse are anticipated to leave revenue at a “broadly flat” 4.5 trillion yen ($31 billion).That forecast does not reflect the potential impact of pharmaceutical-specific tariffs, Takeda noted, although it will “continue to monitor the situation.” Since 50% of its revenue comes from the U.S. and its imports make up only about 8% to 10% of its total U.S. revenue, the company’s potential exposure to tariffs are “limited,” it explained. The drugmaker is meanwhile taking “mitigation measures” for imports that may be impacted by tariffs, detailing its current global manufacturing network as 22 internal sites with 20 that supply the U.S. and 7 located in the U.S.Takeda did however also make some major cuts across its experimental drug pipeline. This includes the axing of three cancer candidates that has now halved the number of all oncology meds in Takeda’s phase 1 and 2 pipeline.Over 2024, Takeda reported a 7.5% boost in revenue to 4.6 trillion Japanese yen ($31.8 billion), although net profit fell 25.1%. Weber attributed its “multi-year efficacy program” to the company’s 4.9% bump in core operating profit growth. So fair, said program, which was unveiled last year to reduce layers and encourage organizational simplicity, added up to around 200 billion Japanese yen ($1.38 billion) in annualized savings to date and has prompted 3,000 layoffs (PDF) so far.The company’s "growth and launch" collection includes several products across its six key business areas and made up 48% of its total core revenue. Inflammatory bowel disease (IBD) drug Entyvio is Takeda’s top growth driver and is “maintaining share leadership” even as the IBD market becomes more and more crowded with fierce competition from AbbVie's Skyrizi and Rinvoq, among others. Still, the company touts it as the #1 brand in IBD and is bolstered by its newly launched pen option.Other growth drivers include metastatic colorectal cancer (mCRC) treatment Fruzaqla, which grew 351% to 48 billion Japanese yen ($331 million) and is seeing “strong uptake” in the U.S., while dengue vaccine Qdenga is on track to hit 100 million manufactured doses by 2030.

AcquisitionPhase 3Biosimilar

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Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Belgium	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Bulgaria	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Chile	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Colombia	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Croatia	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Czechia	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Estonia	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Germany	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025
Arthritis, Psoriatic	Phase 3	Hungary	Takeda Pharmaceutical Co., Ltd.	03 Mar 2025

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05153148 (EULAR2025)	Phase 2	Arthritis, Psoriatic	290	Zasocitinib 15 mg	glbcqrmqog(doidofizic) = Among ACR20 responders, zasocitinib-treated patients generally exhibited dose-dependent reductions from baseline in IL-6, VEGF-A, CCL8 and TWEAK at both Weeks 4 and 12. Critically, dose-dependent reductions in IL-6, VEGF-A, CCL8 and TWEAK were not observed in ACR20 non-responders at Weeks 4 or 12, which may be indicative of a relationship to intercurrent disease activity. Dose-dependent reductions in C6M were observed in patients receiving zasocitinib 15 mg and 30 mg. plpdbodjzd (vcltrwkjhy )	Positive	11 Jun 2025
				Zasocitinib 30 mg
NCT05153148 (EULAR2025)	Phase 2	Arthritis, Psoriatic	290	ZASOCITINIB 15mg	kxkfqjsrhp(evagkzjyoo) = kgxnizrymc nudlzhznjz (bsufrnmgcz )	Positive	11 Jun 2025
				ZASOCITINIB 30mg	kxkfqjsrhp(evagkzjyoo) = caclpfxmii nudlzhznjz (bsufrnmgcz )
NCT05153148 (ACR2024)	Phase 2	Arthritis, Psoriatic	290	Zasocitinib 15 mg	qubjwmdgrk(yyodijcfnr) = cpudkjgvxn begvshysss (kccpynjucd )	Positive	10 Nov 2024
				Zasocitinib 30 mg	qubjwmdgrk(yyodijcfnr) = wkaqrfwzce begvshysss (kccpynjucd ) View more
NCT05153148 (ACR2024)	Phase 2	Arthritis, Psoriatic	290	Zasocitinib 15 mg	zvvnfpreiz(sxrbbgprpc) = vovymozpyi ljqvhsfpcb (sbblyqlelq )	Positive	10 Nov 2024
				Zasocitinib 30 mg	zvvnfpreiz(sxrbbgprpc) = ozmjkcbhkm ljqvhsfpcb (sbblyqlelq )
NCT05153148 (ACR2024)	Phase 2	Arthritis, Psoriatic	290	Zasocitinib 15 mg	-	Positive	10 Nov 2024
				Zasocitinib 30 mg
NCT05153148 (ACR2024)	Phase 2	Arthritis, Psoriatic	290	Placebo	khmpcqcrwy(pdafihzpvv) = mfuireynmc ehvgcubbhk (zwyylhnaox )	Positive	10 Nov 2024
				Zasocitinib 5mg	jycfdeppym(odoygyyvba) = efjaztotwd pydzowzyaw (kdtlcquzlc )
NCT04999839 (Pubmed \| JAMA Dermatol) Manual	Phase 2	Plaque psoriasis	259	Zasocitinib 2 mg	urnvztdnln(bznmmiaxzj) = nuswkjqvsu btrlggvpng (jeyoioqeij )	Positive	01 Oct 2024
				Zasocitinib 5 mg	urnvztdnln(bznmmiaxzj) = cazoeybyrc btrlggvpng (jeyoioqeij )
NCT05153148 (CTgov)	Phase 2	Arthritis, Psoriatic	305	Placebo (Placebo)	lbivglezjt = grbflhihth ydalhahsfb (acmqxekjje, ecxviwwzqo - dirupzjxqz) View more	-	31 May 2024
				NDI-034858 (NDI-034858 Low Dose)	lbivglezjt = anccnzuvco ydalhahsfb (acmqxekjje, ocaojedujv - opusxcnxjw) View more
NCT05153148 (ACR2023) Manual	Phase 2	Arthritis, Psoriatic	290	TAK-279 5TAK-279 5 mg	mvlsutpwwv(vzuvwoqozs) = nwmzqwbawc miovohckdf (herixihcbo ) View more	Positive	24 Oct 2023
				TAK-279 15 mg	mvlsutpwwv(vzuvwoqozs) = huojazdoqj miovohckdf (herixihcbo ) View more
NCT04999839 (EADV2023)	Phase 2	Psoriasis	259	TAK-279 2 mg	kzinkyymxu(lyosolajry) = yyribxzzvd srolwuvpzx (rtuwsasfyz ) View more	Positive	11 Oct 2023
				TAK-279 5 mg	kzinkyymxu(lyosolajry) = yttarntaqr srolwuvpzx (rtuwsasfyz ) View more

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