An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease

Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is.
The participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy.
During the study, participants will visit the study clinic several times.

开始日期2026-07-15

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT07286058

/ Recruiting临床3期

A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.
The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.
Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).
Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

开始日期2026-03-11

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT07244263

/ Recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) is a skin condition that causes deep, painful bumps on the skin. These bumps usually appear in an area where the skin rubs together. They start as small bumps but may become swollen and red over time. If they fill with pus, these lumps are called abscesses; these can also burst. Over time, the area can get scars and tunnels on or under the skin. Recent studies suggest that the condition may start when hair follicles become damaged and blocked. This impacts the skin and may activate the body's germ-fighting (immune) system. This allows bacteria to grow on the skin which worsens the condition and can cause abscesses.
The main aims of this study are to learn how safe zasocitinib is, how well it works and how well adults with HS tolerate it compared with a placebo.
The participants will receive the study treatment (either zasocitinib or placebo) for up to 4 months (16 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. After the first 4 months, all participants (also those who initially received placebo) will then receive zasocitinib for up to 8 months (36 weeks).
During the study, participants will visit their study clinic 12 times.

开始日期2026-01-26

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与扎索替尼相关的临床结果

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100 项与扎索替尼相关的转化医学

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100 项与扎索替尼相关的专利（医药）

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项与扎索替尼相关的文献（医药）

2026-06-01·Dermatology and Therapy

Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial

Article

作者: Green, Lawrence ; Laquer, Vivian ; Vender, Ronald ; Weisman, Jamie ; Zhang, Wenwen ; Gooderham, Melinda J ; Winkelman, Warren ; Armstrong, April W ; Elbuluk, Nada ; Bhutani, Tina ; Moore, Angela ; Ferris, Laura K

INTRODUCTION:

Zasocitinib (TAK-279) is an investigational, once daily, oral, allosteric, highly selective, and potent tyrosine kinase 2 inhibitor. Post hoc analyses of a 12-week phase IIb trial in patients with moderate-to-severe plaque psoriasis evaluated zasocitinib 15 mg or 30 mg efficacy versus placebo by baseline characteristic subgroups, Psoriasis Area and Severity Index (PASI) improvements by body region and component scores, and patient-reported and other clinical outcomes.

METHODS:

Disease severity assessments included PASI, Physician's Global Assessment (PGA), body surface area (BSA), Dermatology Life Quality Index (DLQI) 0/1, and PGA × BSA. Subgroups included weight, sex, age, race, disease duration, prior biologic use, and PASI score. Body regions included head, trunk, and upper and lower extremities. Scoring components included erythema, induration, and desquamation. DLQI 0/1 attainment was assessed by PASI.

RESULTS:

At week 12, zasocitinib 15 mg or 30 mg demonstrated greater response rates in PASI 75/90/100 and PGA 0/1 in nearly all patient subgroups versus placebo. A greater proportion of patients receiving zasocitinib achieved PASI 75/90/100 across all PASI body regions and scoring components versus placebo. Reductions in BSA or PASI were greater in zasocitinib groups as early as week 2 and through week 12 versus placebo; most patients attaining PASI ≤ 1 or ≤ 2 or PASI 75/90/100 also achieved DLQI 0/1. Absolute PASI and PGA × BSA improvements were strongly positively correlated (ρ = 0.95), with PGA × BSA 75 and PASI 75 showing high agreement.

CONCLUSION:

Zasocitinib demonstrated consistent improvements in skin clearance, irrespective of baseline disease characteristics, PASI body region, and scoring component, with meaningful quality of life improvements. Graphical abstract available for this article.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04999839.

2026-05-01·Skin therapy letter

Zasocitinib: New Frontier in Tyrosine Kinase 2 Inhibition.

Review

作者: Sauder, Maxwell ; Adam, Samantha R

Zasocitinib is a novel highly selective tyrosine kinase 2 (TYK2) inhibitor that is in late phase development for the treatment of psoriasis and psoriatic arthritis. This article will review its efficacy, safety and tolerability. Currently, deucravacitinib is the only TYK2 inhibitor with regulatory approval from most major authorities. Zasocitinib offers potential benefits, as it has higher target selectivity and affinity of the Janus homology 2 (JH2) domain of TYK2 as compared to deucravacitinib. This selectivity leads to minimal inhibition of Janus kinase (JAK) 1, JAK2 and JAK3 (JAK1-3), and therefore may result in less off-target effects that have been associated with other molecules.

2026-05-01·JOURNAL OF INVESTIGATIVE DERMATOLOGY

Molecular, histological, and clinical effects of selective TYK2 inhibition with zasocitinib (TAK-279) in patients with moderate-to-severe plaque psoriasis

Article

作者: Rambhia, Darshna ; Krueger, James G ; Blau, Jessamyn ; Hong, Feng ; Kumar, Sachin ; Tang, Jay ; Wennbo, Håkan ; Cheng, Jie ; Saha, Banishree ; Arunachalam, Vinayagam ; Kunjravia, Norma ; Choudhury, Amit ; Thakker, Paresh ; Li, Xuan ; Garcet, Sandra ; Zhang, Wenwen ; Cueto, Inna

713

项与扎索替尼相关的新闻（医药）

2026-08-06

·FiercePharma

Takeda gains FDA nod for first-in-class narcolepsy treatment Orzeyful

After coming up short in trials with two orexin type 2 receptor (OX2R) selective agonists, Takeda has scored with oveporexton, gaining FDA approval for the first-in-class, twice-daily tablet as a treatment for adults with narcolepsy type 1 (NT1). Rather than addressing the symptoms of narcolepsy, Orzeyful—as it will be known commercially—becomes the first medicine to address its root cause, doing so by mimicking the body’s orexin cycle. Orexin is a neuropeptide lacking in patients with narcolepsy that helps regulate waking, wakefulness, appetite and energy. “The FDA approval of Orzeyful marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and how people feel on treatment,” Takeda CEO Julie Kim said in a statement. Takeda has a lot riding on Orzeyful, pegging its peak sales at between $2 billion and $3 billion. It is one of three potential blockbusters the Japanese company is counting on as it faces biosimilar competition for its top-selling product Entyvio. NT1 is a neurological condition driven by the loss of orexin, affecting roughly 120,000 people in the U.S., many of whom remain undiagnosed. NT1 causes daytime sleepiness, cataplexy (sudden loss of muscle tone), cognitive symptoms, disrupted nighttime sleep and hallucinations. Julie Flygare, who is the CEO of Project Sleep and an NT1 patient, called the approval “a historic moment,” as it “expands our treatment choices.” The approval is backed by two phase 3 studies which showed that Orzeyful, compared to placebo, provides statistically significant improvements in daytime sleepiness, cataplexy and health-related quality of life measures. No serious treatment-related adverse events were reported in the trials. The most common side effects were insomnia and urinary urgency and frequency. Takeda will launch Orzeyful after the Drug Enforcement Administration (DEA) completes its controlled substance classification review, which is expected within the next 90 days. The company added that it does not expect Orzeyful sales to significantly affect its revenue forecast for the fiscal year, ending March 31, 2027. The success of Orzeyful comes after the company’s first attempt in the indication with an OX2R agonist, TAK-994, was halted five years ago in two phase 2 trials because of liver toxicity issues. Then, two years ago, Takeda grounded OX2R agonist danavorexton (TAK-925) because of slow enrollment in a phase 2 trial testing the intravenous treatment in post-surgical patients with obstructive sleep apnea. "Orzeyful is just the beginning. With orexin emerging as a powerful therapeutic pathway, Takeda is unlocking the potential of this new class of medicine for patients across a range of disorders," Andy Plump, M.D., Ph.D., Takeda's R&D chief, said in the release. Takeda hopes to gain FDA approval for another first-in-class treatment later in this quarter as rusfertide is under review for the blood disorder polycythemia vera. The injected hepcidin-mimetic peptide, which was acquired in a $300 million licensing deal with Protagonist Therapeutics in 2024, scored in a phase 3 trial last year. Takeda expects that rusfertide has the potential to bring between $1 billion and $2 billion in peak sales. Takeda’s highest hopes in its pipeline are for Entyvio follow-on zasocitinib. The TYK2 inhibitor, which was secured in a $4 billion upfront deal with Nimbus Therapeutics four years ago, has the potential to become the top oral drug in psoriasis and psoriatic arthritis, according to Takeda, drawing a peak sales forecast of between $3 billion and $6 billion. Last month, the company unveiled additional data from a successful phase 3 study of zasocitinib.

临床3期上市批准引进/卖出临床2期加速审批

2026-08-06

·拓麦Derm

银屑病口服前沿 | 第2期：从PDE4到TYK2，从经典小分子到创新口服肽

点击蓝字关注“拓麦Derm” 银屑病是一种免疫介导的慢性炎症性皮肤病，其治疗方案经历了从传统系统用药到生物制剂的革命性跨越。然而，生物制剂存在注射给药不便、患者依从性不佳以及疗效不充分等问题，在临床实践中，口服靶向药物始终是未被满足的重要需求。近年来，随着对银屑病发病机制认识的不断深入，多种新型口服药物相继问世，涵盖了磷酸二酯酶4（PDE4）、酪氨酸激酶2（TYK2）以及白介素（IL）-23受体等多个作用靶点。本文系统梳理了其中四款代表性口服药物——阿普米司特（Apremilast）、氘可来昔替尼（Deucravacitinib）、Zasocitinib和Icotrokinra的作用机制与药代动力学/药理学特征，这些药物通过特异性作用于炎症信号通路中的关键分子，在维持安全性的同时显著提升了疗效，为银屑病口服治疗开辟了新的时代。一、阿普米司特：PDE4抑制剂阿普米司特是全球首个口服PDE4抑制剂，用于治疗符合光疗或系统治疗指征的中度至重度斑块状银屑病成人患者。作用机制阿普米司特是一种对环磷酸腺苷（cAMP）有特异性的PDE4口服小分子抑制剂。抑制PDE4可导致cAMP水平升高，阻止促炎性分子（如TNF-α、IFN-γ、IL-23、IL-12和趋化因子CXCL9、CXCL10和CCL4）的合成；还可促进抗炎标志物（如IL-10）的增加。因此，阻断PDE4具有抗炎作用。药代动力学特征口服给药后，阿普米司特在中位约2.5小时内达到峰值血浆浓度（Cmax），并且具有约73%的绝对生物利用度；可以与食物一起服用或单独服用。阿普米司特表现出线性药代动力学，在10-100 mg/天的剂量范围内，全身暴露剂量按比例增加。约60%的剂量通过尿液排出；其余的剂量则通过胃肠道排出。同机制其他药物 PDE4抑制剂家族还包括克立硼罗（外用，已获批用于特应性皮炎）和罗氟司特（外用，已获批用于银屑病）等，但目前仅阿普米司特为口服制剂。此外，多种新型PDE4抑制剂的口服制剂和外用制剂正处于不同阶段的临床研发中。二、氘可来昔替尼和Zasocitinib： TYK2变构抑制剂氘可来昔替尼氘可来昔替尼是全球首个获批的口服选择性TYK2变构抑制剂，用于适合系统治疗或光疗的成年中重度斑块状银屑病患者。作用机制氘可来昔替尼可抑制IL-23、IL-12以及I型干扰素（IFN）等细胞因子的信号传导，对TYK2细胞的选择性比JAK-1和JAK-3高≥100倍，比JAK2高≥2000倍。它特异性地结合于TYK2的调节结构域，而非JAK-1、JAK-2和JAK-3抑制剂所结合的催化结构域，因此更不易产生与JAK抑制剂相关的脱靶效应。由于其独特的作用机制，氘可来昔替尼是首个新型免疫调节剂类药物。药代动力学特征氘可来昔替尼的临床推荐剂量为6 mg，每日一次，口服。它的首次人体研究（NCT02534636）结果显示：氘可来昔替尼吸收迅速，半衰期为8-15 h，多次给药后蓄积1.4-1.9倍。氘可来昔替尼在体外以剂量和浓度依赖性方式抑制IL-12/IL-18诱导的IFNγ生成。IFNα-2a体内激发后，氘可来昔替尼对淋巴细胞计数降低和53个IFN调节基因表达表现出剂量依赖性抑制。未发生严重不良事件（AE）。 Zasocitinib Zasocitinib是一款口服、变构选择性TYK2抑制剂，目前处于后期临床开发阶段，用于治疗中重度斑块状银屑病成人患者。作用机制 Zasocitinib作为TYK2的变构抑制剂，其作用机制与氘可来昔替尼相似——通过结合TYK2的Janus同源2（JH2）假激酶结构域，抑制激酶活性和随后的下游信号转导；不同的是，zasocitinib对TYK2的JH2结构域的选择性高于氘可来昔替尼。药理学特征 Zasocitinib可强效抑制TYK2信号转导：IL-23-pSTAT3、Ⅰ型干扰素-pSTAT3、IL-12-pSTAT4通路对应的半数抑制浓度依次为48.2  nM（95% CI：36.8-63.1 nM）、21.6  nM（95% CI：17.3-26.9 nM）、57.0 nM（95% CI：44.2-73.4 nM）；每日一次口服30 mg zasocitinib的模拟临床浓度在24小时内均超过TYK2最大半数抑制浓度，维持每日抑制率大于90%，且不存在对JAK1/2/3的抑制作用。同机制其他药物除氘可来昔替尼和zasocitinib外，brepocitinib、ropsacitinib等多种TYK2抑制剂正处于临床研发阶段。其中，brepocitinib（PF-06700841）是JAK1/TYK2双重抑制剂，可与TYK2和JAK1催化结构域中的活性位点结合。三、Icotrokinra：IL-23受体靶向肽 Icotrokinra是首个也是唯一一个靶向IL-23的口服肽，能阻断IL-23受体并抑制IL-23通路信号传导及下游细胞因子产生；有效结合了生物制剂的免疫特异性、高效性，以及口服给药的便利性。该药已获美国FDA批准用于治疗成人及青少年（≥12岁，≥40kg）中重度斑块状银屑病。作用机制 Icotrokinra是一种环状肽，通过与IL-23R结合抑制IL-23激活这一炎症级联反应。IL-23/Th17通路是一种促炎通路，在斑块状银屑病的发病机制和进展中起着重要作用。树突状细胞释放IL-23，该因子与Th17细胞上的IL-23R结合，激活磷酸化级联反应，从而促进IL-17、IL-22及其他炎症性细胞因子的产生。这些细胞因子不仅促进角质形成细胞增殖，还会增强树突状细胞中IL-23的释放，推动斑块状银屑病中持续的炎症循环。药代动力学特征在动物实验中，Icotrokinra在不同物种体内的蛋白结合率较低（在人血浆中约为50%），并能自由地分布到皮肤、关节和胃肠道等组织中。Icotrokinra既不是典型药物转运蛋白的底物，也不是其抑制剂；同时，它也不抑制细胞色素P450酶的活性。在首次人体试验中，当剂量从25 mg增加到1000 mg时，Icotrokinra的药代动力学特征仍呈剂量比例关系。在单次及多次给药后，均未出现严重的不良事件。未发生变化的Icotrokinra是人血浆中唯一与药物相关的成分。总结与展望银屑病的口服治疗正在经历一场深刻的变革。从阿普米司特到氘可来昔替尼、zasocitinib，再到icotrokinra，这四款药物代表了银屑病口服治疗从"泛靶点"到"高选择性"、从"小分子酶抑制"到"肽类受体拮抗"的演进路径。这些新型药物的作用机制精准，安全性良好，且均为口服给药，极大地提高了患者的治疗便利性和依从性。当然，口服靶向治疗仍面临一些挑战：如何进一步提升疗效？长期的安全性数据如何？特殊人群（如儿童、孕妇、老年患者）的注意事项？这些问题都需要更多的临床研究和真实世界数据来回答。可以预见的是，随着药物研发技术的不断进步和对银屑病发病机制认识的持续深化，未来将会有更多高效、安全、便捷的口服治疗方案问世，推动银屑病治疗向着"精准、个体、便利"的方向不断迈进。 1 END 1 供稿：Serine 校对：Joy 排版：Vanessa 声明：编辑部对刊载内容进行仔细审阅以尽力保持其准确性，但对稿件的使用或其中的任何错误、遗漏或不准确之处等均不承担任何责任。文中所表达的任何观点不代表编辑部的观点，文中提及或排除任何方法或药物并不构成对其使用的提倡、建议或拒绝，因此在为本文中提及的任何产品开处方前，请查阅生产商的最新处方信息。内容仅限医疗卫生专业人士学习交流使用，非医疗卫生专业人士请主动退出浏览与阅读，否则由此产生的相关风险与后果应自行承担。在未获得正式授权前，所有转载及使用文中内容均为侵权。参考文献： 1.Vangipuram R, Alikhan A. Apremilast for the management of moderate to severe plaque psoriasis. Expert Rev Clin Pharmacol. 2017;10(4):349-360. doi:10.1080/17512433.2017.1293519 2.Zhang J, Ding Y, Wang P, et al. Deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, in patients from China mainland, Taiwan and South Korea with moderate-to-severe plaque psoriasis: a phase III randomized clinical trial. Br J Dermatol. 2025;192(3):402-409. doi:10.1093/bjd/ljae406 3.氘可来昔替尼片说明书 4.Catlett IM, Aras U, Hansen L, et al. First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Clin Transl Sci. 2023;16(1):151-164. doi:10.1111/cts.13435 5.Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024;160(10):1066-1074. doi:10.1001/jamadermatol.2024.2701 6.Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective, and Potent Allosteric TYK2 Inhibitor. J Invest Dermatol. 2026;146(1):214-222.e7. doi:10.1016/j.jid.2025.05.014 7.Stein Gold L, Armstrong AW, Soung J, et al. Durability of Response to Icotrokinra in Adults With Moderate-to-Severe Plaque Psoriasis: One-Year Results From the Phase 3, Placebo- and Active Comparator-Controlled ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 Trials. Br J Dermatol. Published online July 3, 2026. doi:10.1093/bjd/ljag264 8.Okundia F, Shakhashiro M, Tyring SK. Icotrokinra: A Promising Oral IL-23 Receptor Inhibitor for Moderate-to-Severe Plaque Psoriasis. Skin Therapy Lett. 2026;31(1):4-7. 9.Knight B, Tammara B, Modi NB, et al. Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling. Dermatol Ther (Heidelb). 2025;15(9):2495-2520. doi:10.1007/s13555-025-01454-7

2026-08-06

·PRNewswire

cAMPfield Strengthens Leadership Team with Key Executive Appointments, Including Graham Heap, MD, PhD as President, R&D, to Advance Prifemilast into Global Phase 2 Development for Inflammatory Bowel Disease

Graham Heap, MD, PhD, formerly Vice President and Program Leader for Takeda's global TYK2 immunology franchise, appointed President, Research and Development Also appointed: Ezequiel Neimark, MD, Head of Clinical Development; Taylor Spector, PhD, Head of Medical Affairs; Scott Stirn, DSc, Head of CMC cAMPfield Therapeutics is advancing prifemilast, a once-daily oral PDE4 inhibitor, for the treatment of inflammatory bowel disease (IBD) into global Phase 2 trials in moderate-to-severe ulcerative colitis and Crohn's disease SAN DIEGO, Aug. 3, 2026 /PRNewswire/ -- cAMPfield Therapeutics, Inc. (cAMPfield), a clinical-stage biopharmaceutical company formed to develop well-tolerated and highly effective oral medicines for immune-mediated inflammatory diseases, today announced key executive appointments to its senior leadership team. Continue Reading Graham Heap Graham Heap, MD, PhD joins as President, Research and Development (R&D), with responsibility for leading all the Company's research and development activities. Ezequiel Neimark, MD joins as Head of Clinical Development and will lead clinical execution for the prifemilast program in ulcerative colitis (UC) and Crohn's disease (CD). Taylor Spector, PhD joins as Head of Medical Affairs and will lead medical strategy, evidence generation, scientific communications, and external engagement. Scott Stirn, DSc joins as Head of Chemistry, Manufacturing, and Controls (CMC) and will lead drug substance and drug product development, manufacturing scale-up, analytical development, and clinical supply of prifemilast. These appointments deepen cAMPfield's leadership bench as the company advances prifemilast, a potentially best-in-class once-daily oral PDE4 inhibitor, into global Phase 2 trials in moderate-to-severe UC and CD. "Building a world-class leadership team with a proven track record of developing therapies for immune-mediated diseases is critical to our success," said Bill Gerhart, Chief Executive Officer of cAMPfield. "Graham, Ezequiel, Taylor, and Scott each bring deep expertise in inflammatory disease drug development and share our passionate belief that patients with IBD need better oral treatment options. Their considerable experience and leadership will be instrumental as we advance prifemilast through global Phase 2 development and position cAMPfield as a leader in IBD." "The treatment landscape for IBD continues to evolve, yet many patients still do not achieve durable disease control with existing therapies," said Dr. Heap. "I've long believed the potential of the PDE4 pathway has been underappreciated in IBD. Prifemilast combines a differentiated mechanism with encouraging clinical data, and I believe it can become an important new oral treatment option for patients with IBD. I look forward to working with the team to advance its development and to help build a broader pipeline beyond it." In addition to these appointments, cAMPfield's leadership team includes other accomplished executives building the company's technical, operational, clinical, and regulatory foundation. Patricia Turney, MBA, Chief Technical Officer, leads technical operations and manufacturing, bringing prior experience from Acelyrin, Arcutis, and Amgen. John Kempen, MS, Senior Vice President of Clinical Development Operations, oversees clinical execution for the prifemilast program, drawing on prior experience from Gossamer Bio, Receptos/Celgene, Ardea Biosciences/AstraZeneca, Allergan, PPD, and ICON. Rita Shah, PharmD, Vice President of Regulatory Affairs, directs the company's global regulatory strategy, leveraging prior experience from Vertex Pharmaceuticals, MBX Biosciences, AstraZeneca, and Johnson & Johnson. Biographies Graham Heap, MD, PhD – President, R&D A physician-scientist with an academic foundation in IBD and extensive development experience across gastroenterology, dermatology and rheumatology, Dr. Heap brings broad leadership expertise advancing therapies for immune-mediated diseases. Most recently, he served as Vice President and Program Leader for Takeda's global TYK2 immunology franchise, leading a large global cross-functional organization responsible for the strategy and execution of a late-stage development portfolio spanning six immune-mediated disease indications. He led zasocitinib from program integration through Phase 2 and Phase 3 readouts, including head-to-head trials against multiple comparators, while expanding the portfolio into five additional indications in Phase 2 or Phase 3 development. Prior to Takeda, Dr. Heap advanced multiple immunology and UC development programs at AbbVie, including risankizumab and ravagalimab. He earned his MBBS from St. George's, University of London and his PhD from Barts and The London School of Medicine and Dentistry. Ezequiel Neimark, MD – Vice President, Head of Clinical Development During more than a decade at AbbVie, Dr. Neimark held senior development leadership roles across gastroenterology, dermatology, and rheumatology and contributed to multiple pivotal IBD programs with adalimumab and risankizumab. He most recently served as Head of Asset/Indication for Skyrizi®, Humira®, ABBV-547, and ABBV-423, and is a physician-scientist trained in gastroenterology and hepatology. Taylor Spector, PhD – Executive Director, Head of Medical Affairs Dr. Spector brings nearly 15 years of Medical Affairs experience across all stages of the product lifecycle advancing programs in immune-mediated inflammatory diseases. Most recently she served as Global Medical Lead for Takeda's TYK2 program in Dermatology. Previously, she held Medical Affairs and Commercial leadership roles at Sobi, Alexion Pharmaceuticals, Sage Therapeutics, Amarin, and AstraZeneca. Scott Stirn, DSc – Executive Director, Head of CMC Dr. Stirn brings over two decades of experience advancing the product development and manufacturing of small molecules, peptides, and biologics from discovery through clinical development. Most recently, as Director and Head of Early Phase Product Development at Neurocrine Biosciences, he served as a global program and CMC lead across multiple small-molecule, peptide, and gene therapy programs, and contributed to the CMC regulatory filings supporting approved therapies including Ingrezza® (valbenazine) and Crenessity® (crinecerfont). Earlier in his career, he led formulation and product development efforts at Pharmatek, Celgene, and Arena Pharmaceuticals, spanning oral and injectable programs—including the development of lorcaserin (Belviq®) and S1P receptor modulator assets. About Inflammatory Bowel Disease Inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, is a chronic immune-mediated inflammatory disease that affects more than 2.4 million people in the United States and remains an area of substantial unmet medical need. Despite significant advances in treatment, many patients fail to achieve durable remission or lose response over time, resulting in frequent treatment switching. While biologic therapies have transformed outcomes for many patients, there remains a need for additional effective, well-tolerated treatment options. Convenient oral therapies are an important part of the treatment landscape, yet currently approved oral agents for IBD are limited by tolerability, safety concerns and/or modest efficacy. About Prifemilast Prifemilast is an investigational, once-daily, PDE4B-selective inhibitor that has been studied in more than 700 participants to date, including more than 250 participants treated for up to 52 weeks. Prifemilast preferentially inhibits PDE4B, the isoform most closely associated with anti-inflammatory activity, while minimizing inhibition of PDE4D, an isoform associated with dose-limiting adverse effects. Across clinical studies, prifemilast has been well tolerated, with treatment discontinuation rates comparable to placebo, and with demonstrated efficacy thus far in Phase 3 clinical trials in plaque psoriasis. About cAMPfield Therapeutics cAMPfield Therapeutics is a clinical-stage biopharmaceutical company focused on developing well-tolerated and highly effective oral medicines for immune-mediated inflammatory diseases, including inflammatory bowel disease. cAMPfield was founded by Mountainfield Venture Partners in partnership with executives who played key roles in the development and/or commercialization of Entyvio®, Humira®, Otezla®, and Zeposia®. cAMPfield holds exclusive global development and commercialization rights to prifemilast outside Greater China through a license agreement with Newsoara Biopharma Co., Ltd. The company is headquartered in San Diego, California. For more information, visit . Media and Investor Contact Rayne Rodgers [email protected] cAMPfield Therapeutics All third-party product names, company names, and logos are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them. 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临床3期临床2期高管变更引进/卖出

100 项与扎索替尼相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
手掌和足底脓疱病	临床3期	-	Takeda Pharmaceutical Co., Ltd.	2026-09-01
银屑病关节炎	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	智利	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	克罗地亚	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	爱沙尼亚	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	德国	Takeda Pharmaceutical Co., Ltd.	2025-03-03
银屑病关节炎	临床3期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2025-03-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04999839 (Pubmed \| Dermatol Ther (Heidelb))	临床2期	斑块状银屑病	151	Zasocitinib 30 mg	鑰觸網獵憲衊築蓋積鬱(襯鬱選繭壓廠壓齋築範) = 積膚憲糧壓蓋範膚窪鹹衊觸糧窪鹹積壓簾選蓋 (餘鬱鹹鹽簾範願夢觸膚 )	积极	2026-05-16
				Placebo	淵願廠夢簾夢憲醖遞襯(艱鏇膚蓋淵選壓襯艱鑰) = 夢襯遞願糧鏇製構淵積鹹願構衊齋鬱餘選積衊 (窪憲蓋簾願簾觸壓鬱簾 )
NCT04999839 (AAD2026)	临床2期	斑块状银屑病 IL-23 \| type I IFN pathway signaling	62	Zasocitinib 15mg QD	顧憲構鹽淵鏇觸鹹膚蓋(壓鬱壓襯衊艱製衊窪積) = 繭簾衊觸繭壓窪構鹹憲顧鬱鹽壓繭憲膚膚衊顧 (顧網鹽築築顧憲衊膚蓋 )	积极	2026-03-27
NCT05153148 (EULAR2025)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	鏇願鬱築積製鑰顧網鹽(鬱壓鏇獵繭簾觸壓廠遞) = 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. 築齋齋遞願積鬱廠窪夢 (選醖積遞鹹鬱構糧鑰窪 )	积极	2025-06-11
				Zasocitinib 30 mg
NCT05153148 (EULAR2025)	临床2期	银屑病关节炎	290	ZASOCITINIB 15mg	鏇構餘繭襯糧網鹽網蓋(顧構齋鏇選餘遞遞襯遞) = 顧築網簾鹹選齋窪顧糧鑰膚鑰衊齋鏇願願蓋鹹 (鏇鹹顧觸艱顧積衊蓋獵 )	积极	2025-06-11
				ZASOCITINIB 30mg	鏇構餘繭襯糧網鹽網蓋(顧構齋鏇選餘遞遞襯遞) = 鬱鏇構範衊廠艱鹽膚範鑰膚鑰衊齋鏇願願蓋鹹 (鏇鹹顧觸艱顧積衊蓋獵 )
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	淵襯窪餘範積遞醖顧鑰(鹽鹹餘廠願觸繭選選獵) = 鏇膚遞選壓鏇構膚窪顧鏇製蓋鹹窪壓鬱鹽窪鹽 (齋築鹽蓋選鹹衊鏇觸鑰 )	积极	2024-11-10
				Zasocitinib 30 mg	淵襯窪餘範積遞醖顧鑰(鹽鹹餘廠願觸繭選選獵) = 鏇願壓遞夢壓製餘壓醖鏇製蓋鹹窪壓鬱鹽窪鹽 (齋築鹽蓋選鹹衊鏇觸鑰 ) 更多
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Placebo	製鹽艱糧鑰壓鹹觸選蓋(餘夢願鑰蓋繭鏇廠齋鏇) = 廠繭餘顧鏇醖製衊鏇繭網淵餘構衊鹽繭糧繭範 (糧膚網衊積網網夢鏇襯 )	积极	2024-11-10
				Zasocitinib 5mg	鹽觸築繭觸簾襯簾鹹蓋(餘網衊蓋獵選壓願鏇鏇) = 鑰膚膚網醖衊遞積鬱網窪壓艱獵齋構淵觸遞選 (網獵遞醖鹽夢齋襯壓廠 )
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	-	积极	2024-11-10
				Zasocitinib 30 mg
NCT05153148 (ACR2024)	临床2期	银屑病关节炎	290	Zasocitinib 15 mg	壓鑰鑰淵積膚廠構顧鹹(願艱壓蓋鏇選廠顧蓋鹽) = 窪繭鹹衊襯鏇齋鑰構願艱積鬱蓋齋鏇壓窪簾壓 (鏇夢壓餘鬱衊衊築構蓋 )	积极	2024-11-10
				Zasocitinib 30 mg	壓鑰鑰淵積膚廠構顧鹹(願艱壓蓋鏇選廠顧蓋鹽) = 夢衊範餘獵鹽淵簾壓簾艱積鬱蓋齋鏇壓窪簾壓 (鏇夢壓餘鬱衊衊築構蓋 )
NCT04999839 (Pubmed \| JAMA Dermatol) 人工标引	临床2期	斑块状银屑病	259	Zasocitinib 2 mg	壓餘範醖願艱衊鑰廠選(艱窪膚鬱糧鏇鏇積膚壓) = 淵製顧遞窪艱膚襯淵憲鏇願鑰廠襯膚構積鬱憲 (簾製憲願廠膚鏇遞衊簾 )	积极	2024-10-01
				Zasocitinib 5 mg	壓餘範醖願艱衊鑰廠選(艱窪膚鬱糧鏇鏇積膚壓) = 衊築壓遞鬱襯蓋鹹鑰遞鏇願鑰廠襯膚構積鬱憲 (簾製憲願廠膚鏇遞衊簾 )
NCT05153148 (CTgov)	临床2期	银屑病关节炎	305	Placebo (Placebo)	顧壓網選衊淵範鑰衊獵 = 醖選鏇鬱窪鬱糧窪築鏇範憲選壓憲簾願襯鬱鑰 (齋餘憲糧壓網廠選觸構, 壓構醖鹽夢積範壓餘願 ~ 顧衊遞淵鏇糧憲壓齋膚) 更多	-	2024-05-31
				NDI-034858 (NDI-034858 Low Dose)	顧壓網選衊淵範鑰衊獵 = 築鏇鹹顧網鏇淵衊鹹獵範憲選壓憲簾願襯鬱鑰 (齋餘憲糧壓網廠選觸構, 鬱顧鑰鑰襯製窪鏇醖鑰 ~ 構構夢獵醖醖憲廠壓顧) 更多