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.

开始日期2025-04-29

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06671496

/ Recruiting临床3期

A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.
The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.

开始日期2025-03-10

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06671483

/ Recruiting临床3期

A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.
The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.

开始日期2025-03-03

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 Zasocitinib 相关的临床结果

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100 项与 Zasocitinib 相关的转化医学

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100 项与 Zasocitinib 相关的专利（医药）

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项与 Zasocitinib 相关的文献（医药）

2024-10-01·JAMA Dermatology

Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis

Article

作者: Lynde, Charles ; Maari, Catherine ; Srivastava, Bhaskar ; Green, Lawrence ; Heap, Graham ; Zhao, Yiwei ; Blau, Jessamyn ; Armstrong, April W. ; Papp, Kim ; Franchimont, Nathalie ; Zhang, Wenwen ; Laquer, Vivian ; Gangolli, Esha A. ; Zhang, Xinyan ; Gooderham, Melinda ; Forman, Seth

Importance:

New, effective, and well-tolerated oral therapies are needed for treating psoriasis. Zasocitinib, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, is a potential new oral treatment for this disease.

Objective:

To assess the efficacy, safety, and tolerability of zasocitinib in patients with moderate to severe plaque psoriasis.

Design, Setting, and Participants:

This phase 2b, randomized, double-blind, placebo-controlled, multiple-dose randomized clinical trial was conducted from August 11, 2021, to September 12, 2022, at 47 centers in the US and 8 in Canada. The study included a 12-week treatment period and a 4-week follow-up period. Key eligibility criteria for participants included age 18 to 70 years; a Psoriasis Area and Severity Index (PASI) score of 12 or greater; a Physician’s Global Assessment score of 3 or greater; and a body surface area covered by plaque psoriasis of 10% or greater. Of 287 patients randomized, 259 (90.2%) received at least 1 dose of study treatment.

Intervention:

Patients were randomly assigned (1:1:1:1:1) to receive zasocitinib at 2, 5, 15, or 30 mg or placebo orally, once daily, for 12 weeks.

Main Outcomes and Measures:

The primary efficacy end point was the proportion of patients achieving 75% or greater improvement in PASI score (PASI 75) at week 12. Secondary efficacy end points included PASI 90 and 100 responses. Safety was also assessed.

Results:

In total, 259 patients were randomized and received treatment (mean [SD] age, 47 [13] years; 82 women [32%]). At week 12, PASI 75 was achieved for 9 (18%), 23 (44%), 36 (68%), and 35 (67%) patients receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and 3 patients (6%) receiving placebo. PASI 90 responses were consistent with PASI 75. PASI 100 demonstrated a dose response at all doses, with 17 patients (33%) achieving PASI 100 with zasocitinib, 30 mg. Treatment-emergent adverse events occurred for 23 patients (44%) receiving placebo and 28 (53%) to 31 (62%) patients receiving the 4 different doses of zasocitinib, with no dose dependency and no clinically meaningful longitudinal differences in laboratory parameters.

Conclusions and Relevance:

This randomized clinical trial found that potent and selective inhibition of TYK2 with zasocitinib at oral doses of 5 mg or more once daily resulted in greater skin clearance than placebo over 12 weeks.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04999839

2023-08-10·Journal of medicinal chemistry1区 · 医学

Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279.

1区 · 医学

Article

作者: Carriero, Samantha ; Hosagrahara, Vinayak ; Ashwell, Mark ; Miao, Wenyan ; Ghanakota, Phani ; Romero, Donna L ; Leit, Silvana ; Kaila, Neelu ; McElwee, Joshua J ; Tummino, Peter ; Kapeller, Rosanna ; Abel, Robert ; Tarantino, Paul M ; Blanchette, Heather ; Feng, Shulu ; Mondal, Sayan ; Toms, Angela V ; Timaniya, Jignesh ; Srivastava, Bhaskar ; Wester, Ronald T ; Westlin, William ; Greenwood, Jeremy ; Cartwright, Mark ; Collis, Alan ; Edmondson, Scott D ; Boyles, Nicholas A ; Masse, Craig E ; Harriman, Geraldine C ; Rafi, Salma B

TYK2 is a key mediator of IL12, IL23, and type I interferon signaling, and these cytokines have been implicated in the pathogenesis of multiple inflammatory and autoimmune diseases such as psoriasis, rheumatoid arthritis, lupus, and inflammatory bowel diseases. Supported by compelling data from human genome-wide association studies and clinical results, TYK2 inhibition through small molecules is an attractive therapeutic strategy to treat these diseases. Herein, we report the discovery of a series of highly selective pseudokinase (Janus homology 2, JH2) domain inhibitors of TYK2 enzymatic activity. A computationally enabled design strategy, including the use of FEP+, was instrumental in identifying a pyrazolo-pyrimidine core. We highlight the utility of computational physics-based predictions used to optimize this series of molecules to identify the development candidate 30, a potent, exquisitely selective cellular TYK2 inhibitor that is currently in Phase 2 clinical trials for the treatment of psoriasis and psoriatic arthritis.

2023-08-01·International immunopharmacology

Recent progress on tyrosine kinase 2 JH2 inhibitors

Review

作者: Liao, Tingting ; Wang, Jie ; Wu, Xianbo ; Deng, Lidan ; Wang, Lin ; Wan, Li ; Shi, Jianyou

Tyrosine kinase 2 (TYK2) is a member of the Janus kinase (JAK) family, which can regulate the signaling of multiple pro-inflammatory cytokines, including IL12, IL23 and type I interferon (IFNα/β), and its inhibitors can treat autoimmune diseases caused by the abnormal expression of IL12 and IL23. Interest in TYK2 JH2 inhibitors has increased as a result of safety concerns with JAK inhibitors. This overview introduces TYK2 JH2 inhibitors that are already on the market, including Deucravactinib (BMS-986165), as well as those currently in clinical trials, such as BMS-986202, NDI-034858, and ESK-001.

147

项与 Zasocitinib 相关的新闻（医药）

2025-03-10

·FiercePharma

Trial results enhance Bristol Myers' bid for Sotyktu in psoriatic arthritis

Two successful phase 3 trials have strengthened Bristol Myers Squibb’s bid for Sotyktu in psoriatic arthritis. The company revealed promising data from one of the trials at the American Academy of Dermatology's annual meeting in Orlando. Three months after Bristol Myers Squibb revealed the success of two phase 3 trials of its oral targeted therapy Sotyktu in psoriatic arthritis (PsA), the company has presented detailed data from one of the studies.In the POETYK PsA-2 trial, a significantly greater proportion of those on Sotyktu experienced at least a 20% improvement in their disease than those on placebo. At Week 16, 54% of those on Sotuktu reached the ACR20 response standard compared to 39% on placebo.Additionally, there were no new safety signals as the profile with Sotyktu through week 16 was consistent with previous studies for the tyrosine kinase 2 (TYK2) inhibitor, including a phase 2 trial in PsA and a phase 3 study in plaque psoriasis, which set up Sotyktu for its 2022 approval in the indication. The drug also succeeded on secondary endpoints, with significantly more Sotyktu patients compared to placebo achieving a 75% reduction in symptoms as measured by the Psoriasis Area and Severity Index (PASI). Those on Sotyktu also experienced better outcomes in the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) measure compared with those on placebo, BMS reported.“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” Philip Mease, M.D., a clinical professor at the University of Washington, said in a March 8 press release. “These results are particularly encouraging because they support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes.”The data were presented Saturday at the American Academy of Dermatology (AAD) Annual Meeting in Orlando.POETYK PsA-2 enrolled 730 patients who had not used a biologic disease modifying anti-rheumatic drug (bDMARD) or who had previously used a TNF blocker such as AbbVie's Humira. The study also included an arm who received Amgen’s oral PDE4 inhibitor Otezla for a safety reference with no efficacy comparison.BMS said it will present additional data from the POETYK trial program later this year. The company also recently touted the success of the POETYK PsA-1 study in 670 patients who were bDMARD-naive.The drugmaker did not offer a timeline of when it might file for regulatory approval to treat PsA.While there are a multitude of products on the market to treat PsA, in recent years oral therapies have gained the most focus, starting with Otezla, which was brought to the market by Celgene in 2014 before that company sold to BMS for $74 billion in 2019. To clear competition hurdles surrounding the merger, Celgene sold the Otezla franchise to Amgen for $13.4 billion. The plaque psoriasis approval of Sotyktu—which came with BMS estimating its peak sales potential in multiple indications at $4 billion—was based on it outperforming Otezla in skin clearance and safety measures in a head-to-head trial.So far, the uptake of Sotyktu hasn’t quite matched up to the lofty projection, with sales increasing 45% to $246 million in 2024. Meanwhile, Otezla generated $2.1 billion last year, a 3% drop from 2023.Another potential candidate from the same TYK2 class is Takeda’s TAK-279, which the company gained in a $4 billion acquisition of Nimbus Lakshmi.While it’s difficult to make assumptions from cross-trial comparisons, Takeda’s phase 2b study of TAK-279 in PsA showed a marked difference in efficacy when compared to placebo. TAK-279 produced ARC20 response rates of 53% (15 mg) and 54% (30 mg) at Week 12 versus 29% for placebo. Johnson & Johnson also has an oral peptide candidate making noise in JNJ-2113, an IL-23 antagonist. In fact, at the same AAD meeting this weekend, J&J and its partner Protagonist Therapeutics touted topline results for head-to-head trials of the investigational drug against Sotyktu in plaque psoriasis. In a note to clients, Leerink Partners analysts said the outcome "was fully expected based upon historical trial results."J&J's drug, also known as icotrokinra, also met the mark in a separate study in ulcerative colitis.For its part, BMS is also investigating Sotyktu as a treatment for other autoimmune diseases including discoid lupus erythematosus (DLE), systemic lupus erythematosus (SLE) and Sjögren’s syndrome. BMS has advanced its DLE study to phase 2, while the others are in phase 3.

临床结果临床3期并购临床2期上市批准

2025-03-02

·研发客

创新合作、新技术应用，为加速武田研发带来巨大潜力 | 遇见艾伦科

// “无论是寻找合作伙伴还是授权引进新药，我们的目的都是在武田聚焦的三大核心治疗领域，即肿瘤、神经科学和消化及炎性疾病，解决目前未尽的治疗需求。”艾伦科博士说。对于全球医药行业而言，2024年充满挑战，而武田却交出了一份漂亮的成绩。这要归功于公司在研发管线突破、战略合作拓展等方面取得的系列成果，包括其自研罕见病药物Adzynma在欧盟获批，以及用于治疗经治的转移性结直肠癌的新药呋喹替尼在日本商业上市；2023年，武田与和黄医药达成合作，获得该药在中国内地、中国香港及中国澳门以外进一步开发、商业化和生产的全球独家许可；此外，针对发作性睡病I型，武田自研药物oveporexton（TAK-861）在临床IIb期阶段取得了令人鼓舞的数据，也彰显着武田研发的强劲潜力。这些成果也从侧面印证了武田所坚持的策略，即以自主研发与外部合作来驱动创新。最近，研发客有幸邀请到武田全球研发首席科学官兼研究负责人艾伦科（Christopher Arendt）博士，和我们深入分享武田如何构建多样化的研发体系，以及其在推动全球医药行业格局中发挥的作用。艾伦科博士合作创新，以满足患者未尽需求 “无论是寻找合作伙伴还是授权引进新药，我们的目的都是在武田聚焦的三大核心治疗领域，即肿瘤、神经科学和消化及炎性疾病，解决目前未尽的治疗需求。”艾伦科说。这个策略，从武田过去一年里与两家生物制药公司达成的协议中就能窥见一斑。一家是美国公司Keros。其创新的激活素抑制剂elritercept（现为TAK226）可治疗包括骨髓异常增生在内的一些血液肿瘤所引发的贫血。武田在2024年12月初与Keros 签订授权合同，获得进一步开发、生产和商业化elritercept的全球独家许可，并预计在2029年向美国FDA递交新药上市申请。另一家公司是中国的亚盛医药。武田看中该公司第三代BCR-ABL酪氨酸激酶抑制剂奥雷巴替尼（olverembatinib）。该药已于2021年在中国内地获批治疗慢性髓细胞白血病（CML），目前正在美国开展临床研究。针对该药物，武田于2024年6月与亚盛签署了一份选择权协议，以开发和商业化奥雷巴替尼。值得一提的是，武田虽然已于2017年通过收购Ariad，获得全球首个上市的第三代BCR-ABL抑制剂Iclusig（ponatinib，普纳替尼），但仍然认为奥雷巴替尼作为更新一代的药物，具备同类最优的潜力。 “武田在血液系统疾病方面拥有极为丰富的专业知识。与亚盛医药的合作能帮助我们更好地为那些受慢性髓细胞白血病等癌症困扰的更广泛的患者群体提供治疗。”艾伦科说。以上两个案例中的药物在临床上都属于成熟产品。同时，武田也在积极寻找更早期的合作机会。比如在2024年5月，武田携手上海达歌生物共同开发针对肿瘤、神经科学和炎症领域的多个靶点的新型分子胶降解剂。达歌生物的总部位于中国，并在中国和美国均有业务。 “我们与达歌的合作聚焦在临床前阶段。针对已验证的生物学靶点，我们旨在通过前沿的新型模式策略，拓宽创新边界。”艾伦科说。此外，他补充道，武田对此领域感兴趣，也是因为分子胶和PROTACs分子一样能诱导蛋白质降解，且相较于PROTACs分子更小。“在神经科学领域，我们正在寻找小分子药物，因为其体积较小，可开发成口服药物，能够穿过血脑屏障。”他说。在消化及炎性疾病领域，武田于2023年从美国生物药公司Nimbus收购了酪氨酸激酶2 (TYK2)抑制剂zasocitinib（TAK-279），目前正处于开发阶段。武田计划2024财年末启动该药针对银屑病关节炎的三期临床研究，预计将在2025年获得该药针对银屑病三期试验结果。加强通用型细胞治疗的研发武田的早期临床项目也聚焦于细胞治疗等前沿领域。2024年2月，武田将三个早期自体CAR-T疗法的优先级下调，转而专注于同种异体、通用型细胞治疗。2024年11月，武田与Alloy Therapeutics公司达成合作，基于武田的诱导多能干细胞（iPSC）衍生的CAR-T细胞平台和CAR-NK平台，开发同种异体细胞治疗，用于治疗各种实体和血液肿瘤。 “我们决定专注于类似固有免疫细胞的自然杀伤细胞和γδ T细胞，因为这些细胞可以应用于同种异体细胞治疗。”艾伦科说。早在2021年，武田就加速了在该领域的布局，并于当年收购了总部位于伦敦的GammaDelta Therapeutics，加快开发基于γδ T细胞的创新疗法。2022年武田又买下从GammaDelta分拆出来的Adaptate Biotherapeutics，以获得Adaptate基于抗体的γδ T细胞衔接器平台。 “这两笔收购使武田在同种异体细胞治疗领域占据了领先地位，并大大增强了我们的实力。除了当下已经获批的细胞治疗领域，我们也希望将这些差异化的细胞治疗应用于更广泛的疾病。”艾伦科说。在承认早期项目研发风险更高的同时，艾伦科也表示，他的团队将通过与内部各科学团队的紧密合作以及基于成果的里程碑来最小化风险。 “我们有能力在早期阶段进行大量的建模和评估工作，以确保能够选择最优的靶点和治疗方案。当我们发现值得探索的方向，我们就会全力以赴。”他表示。速度质量双卓越的中国创新武田自1994年进入中国以来，见证了中国制药行业，尤其是研发领域的显著进步。三十多年过去，艾伦科对中国创新的速度和质量印象尤为深刻。 “我认为，中国最令人惊叹的一点就是创新的推进速度，这是无可比拟的，”他说，“基础设施的建设、人才的聚集以及研发项目的进展速度都非常令人瞩目。” “质量和速度是行业成功的两大关键，而中国在这两方面都具备优势。所以我可以说，放弃中国市场，就等同于放弃机遇。”他接着说，“中国再也不是以前大家认为的只会做me-too或者me-better的那个中国了。” 艾伦科并没有夸大中国公司的研发实力。麦肯锡的数据显示，中国本土制药公司在2023年初到2024年末共授权了70多个管线项目给海外合作伙伴，这要比2019年初到2020末的总量增加超过一倍。其中，肿瘤领域的资产目前在海外授权上依然占主流，比如近期，在2025年1月13日的摩根大通医疗健康年会上，艾伯维与先声再明宣布，双方就先声再明的在研候选药物SIM0500达成许可选择协议，以推进这种新型的三特异性抗体的研发，帮助解决多发性骨髓瘤患者尚未满足的重大临床需求。SIM0500目前正在中美两国开展针对复发或难治性多发性骨髓瘤（MM）的临床一期研究。为了更好地协同中国创新，武田的研发部门不仅积极寻找像达歌生物这样拥有创新资产和创新能力的合作伙伴，同时也与中国本土创新孵化器达成了合作。2024年11月，武田与ATLATL飞镖创新中心（以下简称“ATLATL”）宣布签署合作备忘录，计划在早期开发、新技术应用、创新企业赋能、人才培养及国际交流等领域展开深入合作。作为知名的创新孵化器，ATLATL还为礼来、诺和诺德等跨国药企提供服务。 “我们与ATLATL的合作非常有趣，我把它看作是通向早期创新生态系统的一个入口，”艾伦科说，“这项合作使武田能够接触到灵活的实验室、早期阶段的中国创新者，并支持实验室基础的科学研究。” “这将帮助武田更好地了解中国的早期创新，也让我们能够参与到中国前沿科学研究的进程当中。”他补充说。 AI助力决策制定像许多大型制药公司一样，武田在各个业务部门都应用了人工智能。在数据密集型的研究领域，AI往往能发挥其最大的潜力，以辅助决策的制定。艾伦科指出这些庞大的数据不仅产生于武田内部，也来自武田全球的外部合作伙伴。在将内部的数据与外部数据结合，并将高质量的数据融入决策中的过程中，蕴藏着巨大的机遇。 “选择靶点、设计分子、发现生物标志物……在将新药成功交付患者的过程中，我们需要做出成千上万的决策。如果人工智能能帮助我们更高效、更严谨地做出这些决策，就能大大加快这一过程，及时将有效治疗带给有需要的患者。”他说道。尽管艾伦科承认当下关于人工智能未来应用的讨论并不完全现实，但他依然对数字化在加速研发中的潜力充满信心。他表示，在TAK-279的开发中，数字化技术就发挥了重要作用。 “AI和其他各种辅助加速研发的工具正被更广泛地应用于我们的药物研发过程中，我们看到了它们在研发领域中的巨大潜力。”他说。编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2348期访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

并购申请上市临床2期引进/卖出医药出海

2025-03-02

·信狐药迅

3个品规新药上市申请、8个品规国产仿制药上市申请发通知书| 新获批(2.24-3.2）

每周药品注册获批数据，分门别类呈现，一目了然。(2.24-3.2）新药上市申请药品名称企业注册分类受理号锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液佛山瑞迪奥医药有限公司1CXHS2400086注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽佛山瑞迪奥医药有限公司1CXHS2400087葡萄糖口服液国仁健康制药(北京)有限公司2.2CXHS2300109菲诺利单抗注射液神州细胞工程有限公司1CXSS2400009贝伐珠单抗注射液神州细胞工程有限公司2.2CXSS2400010 新药临床申请药品名称企业注册分类受理号WJ01024片苏州君境生物医药科技有限公司1CXHL2401407TT-00420片药捷安康(南京)科技股份有限公司1CXHL2401402TT-00420片药捷安康(南京)科技股份有限公司1CXHL2401401TT-00420片药捷安康(南京)科技股份有限公司1CXHL2401400CXJM-66注射液宜昌人福药业有限责任公司1CXHL2401378QY201片启元生物(杭州)有限公司1CXHL2401377QY201片启元生物(杭州)有限公司1CXHL2401376LT-002-158片领泰生物医药(绍兴)有限公司1CXHL2401375LT-002-158片领泰生物医药(绍兴)有限公司1CXHL2401374XS-03片江苏星盛新辉医药有限公司1CXHL2401371XS-03片江苏星盛新辉医药有限公司1CXHL2401370XS-03片江苏星盛新辉医药有限公司1CXHL2401369HS-10501-2江苏豪森药业集团有限公司1CXHL2401362HS-10501-2江苏豪森药业集团有限公司1CXHL2401359HS-10501-2江苏豪森药业集团有限公司1CXHL2401357JK0001片深圳嘉科生物科技有限公司1CXHL2401346JK0001片深圳嘉科生物科技有限公司1CXHL2401345HS-10561胶囊江苏豪森药业集团有限公司1CXHL2401351HS-10561胶囊江苏豪森药业集团有限公司1CXHL2401350HS-10561胶囊江苏豪森药业集团有限公司1CXHL2401349AP306片上海礼邦医药科技有限公司1CXHL2401355AP306片上海礼邦医药科技有限公司1CXHL2401354AP306片上海礼邦医药科技有限公司1CXHL2401353AP306片上海礼邦医药科技有限公司1CXHL2401352ADC189颗粒嘉兴安帝康生物科技有限公司1CXHL2401340CS12088片成都微芯药业有限公司1CXHL2401337CS12088片成都微芯药业有限公司1CXHL2401335HDM1005注射液杭州中美华东制药有限公司1CXHL2401330HDM1005注射液杭州中美华东制药有限公司1CXHL2401329HRS-1301片山东盛迪医药有限公司1CXHL2401318HRS-1301片山东盛迪医药有限公司1CXHL2401317HRS-1301片山东盛迪医药有限公司1CXHL2401316QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401308QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401307RFUS-301注射剂宜昌人福药业有限责任公司2.1;2.2;2.4CXHL2401333ADLS1026注射液真奥金银花药业有限公司2.1;2.2;2.4CXHL2401341BN021208H山东百诺医药股份有限公司2.2CXHL2401356天麻素注射液昆药集团股份有限公司2.4CXHL2401294注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2400871重组人源化抗表皮生长因子受体单抗注射液上海津曼特生物科技有限公司1CXSL2400876SYS6002石药集团巨石生物制药有限公司1CXSL2400873注射用DXC008杭州多禧生物科技有限公司1CXSL2400868注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2400866IMM01宜明昂科生物医药技术(上海)股份有限公司1CXSL2400862HC006注射液上海宏成药业有限公司1CXSL2400853注射用Tye1001深圳市泰尔康生物医药科技有限公司1CXSL2400852IBI3002信达生物制药(苏州)有限公司1CXSL2400833IBI3002信达生物制药(苏州)有限公司1CXSL2400832注射用SLN12140领诺(上海)医药科技有限公司1CXSL2400831阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400872SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2400869贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2400870 仿制药申请药品名称企业注册分类受理号吸入用盐酸氨溴索溶液四川普锐特药业有限公司3CYHS2401222吸入用盐酸氨溴索溶液四川普锐特药业有限公司3CYHS2401221吸入用盐酸氨溴索溶液四川普锐特药业有限公司3CYHS2401220复方聚乙二醇电解质散(II)广东科泓药业有限公司3CYHS2401130复方聚乙二醇电解质散(II)广东科泓药业有限公司3CYHS2401129盐酸胍法辛缓释片四川百利药业有限责任公司3CYHS2400473盐酸胍法辛缓释片四川百利药业有限责任公司3CYHS2400472吗替麦考酚酯干混悬剂杭州中美华东制药有限公司3CYHS2303280氯化钾注射液北京布霖生物科技有限公司3CYHS2303251氨溴特罗口服溶液安盛药业有限公司3CYHS2303179吸入用盐酸氨溴索溶液瑞阳制药股份有限公司3CYHS2302805吸入用盐酸氨溴索溶液瑞阳制药股份有限公司3CYHS2302804盐酸他喷他多片宜昌人福药业有限责任公司3CYHS2302569盐酸他喷他多片宜昌人福药业有限责任公司3CYHS2302568盐酸他喷他多片宜昌人福药业有限责任公司3CYHS2302567己酮可可碱注射液山西惠达林曦医药科技有限公司3CYHS2302369注射用尼可地尔合肥盛秦医药科技有限公司3CYHS2302325氨氯地平贝那普利胶囊杭州沐源生物医药科技有限公司3CYHS2302279法莫替丁注射液成都米子生物医药科技有限公司3CYHS2302251注射用尼可地尔常州四药制药有限公司3CYHS2302173注射用尼可地尔常州四药制药有限公司3CYHS2302172复合磷酸氢钾注射液湖北科伦药业有限公司3CYHS2302126聚普瑞锌颗粒江苏正大丰海制药有限公司3CYHS2301999吲哚布芬片福安药业集团湖北人民制药有限公司3CYHS2301929吲哚布芬片福安药业集团湖北人民制药有限公司3CYHS2301928法莫替丁注射液云南先施药业有限公司3CYHS2301883腺苷钴胺胶囊北京柏雅联合药物研究所有限公司3CYHS2301823艾司奥美拉唑镁肠溶胶囊广州新济药业科技有限公司3CYHS2301835艾司奥美拉唑镁肠溶胶囊广州新济药业科技有限公司3CYHS2301834倍他米松磷酸钠注射液陕西丽彩药业有限公司3CYHS2301809米诺地尔搽剂福元药业有限公司3CYHS2301775米诺地尔搽剂福元药业有限公司3CYHS2301774缩宫素注射液裕松源药业有限公司3CYHS2301747艾司奥美拉唑镁肠溶胶囊湖南银泽华浩生物科技有限公司3CYHS2301644艾司奥美拉唑镁肠溶胶囊湖南银泽华浩生物科技有限公司3CYHS2301643西咪替丁注射液山西诺成制药有限公司3CYHS2301528艾司奥美拉唑镁肠溶胶囊江苏中邦制药有限公司3CYHS2301499艾司奥美拉唑镁肠溶胶囊江苏中邦制药有限公司3CYHS2301498地氯雷他定口服溶液南京创迪生物技术有限公司3CYHS2301371恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301338氨溴特罗口服溶液山东朗诺制药有限公司3CYHS2301242氨溴特罗口服溶液海南全星制药有限公司3CYHS2301203盐酸丙美卡因滴眼液合肥立方制药股份有限公司3CYHS2301065氨溴特罗口服溶液山西同达药业有限公司3CYHS2300730盐酸氨溴索口服溶液安徽四环科宝制药有限公司3CYHS2300663盐酸氨溴索口服溶液安徽四环科宝制药有限公司3CYHS2300662复方醋酸钠林格注射液浙江医药股份有限公司新昌制药厂3CYHS2300622复方匹可硫酸钠颗粒苏州二叶制药有限公司3CYHS2300519恩格列净二甲双胍缓释片乐普药业股份有限公司3CYHS2300066盐酸去氧肾上腺素注射液远大医药(中国)有限公司3CYHS2202105国;CYHS2202105马立巴韦片齐鲁制药(海南)有限公司4CYHS2500156妥布霉素地塞米松滴眼液湖南明瑞制药股份有限公司4CYHS2500148氧(液态)侨源(金堂)气体有限公司4CYHS2401403马来酸氟伏沙明片石家庄四药有限公司4CYHS2401286阿昔莫司胶囊石家庄四药有限公司4CYHS2400073非布司他片广州汇元医药科技有限公司4CYHS2400062氨甲环酸片石家庄四药有限公司4CYHS2400007左卡尼汀注射液浙江昂利康制药股份有限公司4CYHS2303573枸橼酸氢钾钠颗粒浙江众延医药科技有限公司4CYHS2303580左氧氟沙星氯化钠注射液广东大翔制药有限公司4CYHS2303579左氧氟沙星氯化钠注射液广东大翔制药有限公司4CYHS2303578硫酸氨基葡萄糖胶囊合肥国高药业有限公司4CYHS2303517沙库巴曲缬沙坦钠片江苏万高药业股份有限公司4CYHS2303500沙库巴曲缬沙坦钠片江苏万高药业股份有限公司4CYHS2303499氧慈利县和气气体厂4CYHS2303452米拉贝隆缓释片江苏德源药业股份有限公司4CYHS2303421碘美普尔注射液成都倍特药业股份有限公司4CYHS2303352非诺贝特片(III)河北东圣科宇医药科技有限公司4CYHS2303347盐酸尼卡地平注射液陕西丽彩药业有限公司4CYHS2303327他达拉非片广东九明制药有限公司4CYHS2303275他达拉非片广东九明制药有限公司4CYHS2303274他达拉非片广东九明制药有限公司4CYHS2303273复方聚乙二醇电解质散(III)重庆药谷制药有限公司4CYHS2303243他达拉非片重庆朗天制药有限公司4CYHS2303188熊去氧胆酸胶囊福建省宝诺医药研发有限公司4CYHS2303153拉考沙胺注射液浙江华海药业股份有限公司4CYHS2303102普拉洛芬滴眼液山东百诺医药股份有限公司4CYHS2303009盐酸尼卡地平注射液成都地奥九泓制药厂4CYHS2302954拉考沙胺注射液浙江兄弟药业有限公司4CYHS2302957盐酸左布比卡因注射液山东新时代药业有限公司4CYHS2302953盐酸齐拉西酮胶囊湖南九典制药股份有限公司4CYHS2302874左乙拉西坦口服溶液湖南省湘中制药有限公司4CYHS2302859间苯三酚注射液国药集团国瑞药业有限公司4CYHS2302802骨化三醇软胶囊海南葫芦娃药业集团股份有限公司4CYHS2302755富马酸伏诺拉生片山东朗诺制药有限公司4CYHS2302610富马酸伏诺拉生片山东朗诺制药有限公司4CYHS2302609复方氨基酸注射液(18AA-VII)内蒙古白医制药股份有限公司4CYHS2302533苯磺顺阿曲库铵注射液海南斯达制药有限公司4CYHS2302502地诺孕素片亚宝药业四川制药有限公司4CYHS2302418间苯三酚注射液江苏东科康德药业有限公司4CYHS2302370间苯三酚注射液呋欧医药科技(湖州)有限公司4CYHS2302368间苯三酚注射液江苏明圣康源药业有限公司4CYHS2302343注射用利培酮微球浙江圣兆药物科技股份有限公司4CYHS2302328注射用利培酮微球浙江圣兆药物科技股份有限公司4CYHS2302327盐酸屈他维林注射液成都倍特药业股份有限公司4CYHS2302232洛索洛芬钠凝胶贴膏湖南金圃医药科技有限公司4CYHS2302174盐酸奥洛他定滴眼液浙江莎普爱思药业股份有限公司4CYHS2302146盐酸二甲双胍缓释片重庆药友制药有限责任公司4CYHS2302114布洛芬混悬液福建太平洋制药有限公司4CYHS2301656富马酸伏诺拉生片江苏万高药业股份有限公司4CYHS2301632富马酸伏诺拉生片江苏万高药业股份有限公司4CYHS2301631阿卡波糖片恒昌(广州)新药研究有限公司4CYHS2301628铝碳酸镁咀嚼片湖北唯森制药有限公司4CYHS2301514甲磺酸仑伐替尼胶囊江苏东科康德药业有限公司4CYHS2300534蛋白琥珀酸铁口服溶液河北一品制药股份有限公司4CYHS2300152罗库溴铵注射液南京健友生化制药股份有限公司4CYHS2201910国;CYHS2201910罗库溴铵注射液南京健友生化制药股份有限公司4CYHS2201909国;CYHS2201909复方硫酸钠片广东逸舒制药股份有限公司3CYHL2400255盐酸美金刚多奈哌齐缓释胶囊四川科瑞德制药股份有限公司3CYHL2400250盐酸美金刚多奈哌齐缓释胶囊四川科瑞德制药股份有限公司3CYHL2400249奥卡西平缓释片武汉人福利康药业有限公司3CYHL2400247奥卡西平缓释片武汉人福利康药业有限公司3CYHL2400246奥卡西平缓释片武汉人福利康药业有限公司3CYHL2400245吲哚美辛凝胶贴膏深圳珐玛易药品科技有限公司3CYHL2400238氟比洛芬凝胶贴膏福元药业有限公司4CYHL2400258 进口申请药品名称企业注册分类受理号盐酸替纳帕诺片Ardelyx, Inc.2.4JXHS2300064盐酸替纳帕诺片Ardelyx, Inc.2.4JXHS2300063盐酸替纳帕诺片Ardelyx, Inc.2.4JXHS2300062古塞奇尤单抗注射液Janssen-Cilag International NV2.1;2.2JXSS2400054古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2400053古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2400052注射用两性霉素B脂质体Taiwan Liposome Company, Ltd.5.2JYHS2300035Zasocitinib (TAK-279) 片Takeda Development Center Americas, Inc.1JXHL2500012Zasocitinib (TAK-279) 片Takeda Development Center Americas, Inc.1JXHL2500011Fosmanogepix注射液Basilea Pharmaceutica International Ltd, Allschwil1JXHL2400273Fosmanogepix片Basilea Pharmaceutica International Ltd, Allschwil1JXHL2400272Fosmanogepix片Basilea Pharmaceutica International Ltd, Allschwil1JXHL2400271Amycretin注射液Novo Nordisk A/S1JXSL2400237注射用M9140Merck Healthcare KGaA1JXSL2400236 中药相关申请药品名称企业注册分类受理号固本消疹颗粒江苏康缘药业股份有限公司1.1CXZL2400087小儿热平颗粒九华华源药业股份有限公司1.1CXZL2400083小儿热平颗粒九华华源药业股份有限公司1.1CXZL2400082淫羊藿总黄酮胶囊江苏康缘阳光药业有限公司2.3CXZL2400088比那甫西颗粒新疆银朵兰药业股份有限公司1.1CXZS2300019二冬颗粒贵州威门药业股份有限公司3.1CXZS2400016 注：橙色字体部分结论为不批准或收到通知件；

申请上市

100 项与 Zasocitinib 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
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	哥伦比亚	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 \| JAMA Dermatol) 人工标引	临床2期	斑块状银屑病	259	Zasocitinib 2 mg	網窪繭醖憲鹽築願夢膚(遞鬱淵築遞壓簾獵鹽齋) = 製範顧繭鑰積鹹糧襯餘範遞鑰願範獵襯鑰淵鹽 (憲構簾鑰憲構淵廠鑰膚 )	积极	2024-10-01
				Zasocitinib 5 mg	網窪繭醖憲鹽築願夢膚(遞鬱淵築遞壓簾獵鹽齋) = 簾鹽願壓艱鏇繭製糧網範遞鑰願範獵襯鑰淵鹽 (憲構簾鑰憲構淵廠鑰膚 )
NCT05153148 (CTgov)	临床2期	银屑病关节炎	305	Placebo (Placebo)	築鹹顧淵膚積衊襯襯網 = 構壓鬱觸壓願醖簾選鏇築構窪膚遞簾鹽積鑰醖 (鹽築範積獵齋選獵構蓋, 顧觸醖鏇淵鹽鑰網襯蓋 ~ 艱鹹簾蓋夢壓糧願窪積) 更多	-	2024-05-31
				NDI-034858 (NDI-034858 Low Dose)	築鹹顧淵膚積衊襯襯網 = 醖艱廠醖醖鬱鏇淵顧憲築構窪膚遞簾鹽積鑰醖 (鹽築範積獵齋選獵構蓋, 選蓋齋繭獵積襯鑰夢齋 ~ 淵鏇艱齋淵壓鹹衊夢憲) 更多
NCT05153148 (ACR2023) 人工标引	临床2期	银屑病关节炎	290	TAK-279 5TAK-279 5 mg	顧選願壓艱製蓋襯鹽壓(齋築艱築齋膚窪觸願選) = 壓餘簾繭顧憲淵壓鏇鏇窪積蓋觸餘鬱觸蓋網衊 (膚鹹願憲構鹹構壓襯遞 ) 更多	积极	2023-10-24
				TAK-279 15 mg	顧選願壓艱製蓋襯鹽壓(齋築艱築齋膚窪觸願選) = 繭願糧鹹網餘構憲鹹遞窪積蓋觸餘鬱觸蓋網衊 (膚鹹願憲構鹹構壓襯遞 ) 更多
NCT04999839 (EADV2023)	临床2期	银屑病	259	TAK-279 2 mg	衊繭蓋襯鹽窪鹹鹹齋顧(顧願壓餘廠構淵積艱鬱) = 積艱簾鬱繭獵廠壓醖蓋築糧襯繭衊憲選餘壓鹹 (築憲獵繭築蓋壓淵糧襯 ) 更多	积极	2023-10-11
				TAK-279 5 mg	衊繭蓋襯鹽窪鹹鹹齋顧(顧願壓餘廠構淵積艱鬱) = 簾簾築鹹鬱衊鬱夢顧鬱築糧襯繭衊憲選餘壓鹹 (築憲獵繭築蓋壓淵糧襯 ) 更多
NCT04999839 (phase 2b trial of the oral TYK2 inhibitor TAK-279, CTgov)	临床2期	斑块状银屑病	259	Placebo (Placebo)	顧淵觸襯齋壓衊壓襯廠 = 築餘鏇觸繭膚齋製壓構膚簾餘遞壓製齋獵鹹鏇 (繭醖蓋蓋遞壓壓膚構選, 衊鹹製觸壓觸觸淵襯糧 ~ 製鏇繭獵艱鏇範艱憲憲) 更多	-	2023-09-28
				NDI-034858 study drug (NDI-034858 5 mg)	顧淵觸襯齋壓衊壓襯廠 = 糧鏇餘艱壓鏇繭鑰糧網膚簾餘遞壓製齋獵鹹鏇 (繭醖蓋蓋遞壓壓膚構選, 壓鑰鑰範淵醖製獵鹽顧 ~ 構餘鏇淵觸窪襯鏇憲醖) 更多
NCT05153148 (Corporate Publications) 人工标引	临床2期	银屑病关节炎	290	TAK-279	選選膚襯淵醖選鏇積襯(網鏇鏇顧網遞鹽艱鹹鏇) = The study met its primary endpoint with a greater proportion of patients treated once-daily with TAK-279 achieving at least a 20 percent improvement in signs and symptoms of disease (American College of Rheumatology 20 response) at week 12 compared to placebo. 膚遞構窪衊製襯願醖獵 (膚鏇憲襯鹹淵選鹹簾獵 )	积极	2023-09-11
				placebo
NCT04999839 (Corporate Publications) 人工标引	临床2期	斑块状银屑病	259	TAK-279 (30mg)	艱積積範顧築艱淵醖範(觸範製鹽顧構觸鏇網顧) = 蓋鬱鹽積選壓廠襯齋繭艱膚廠壓憲衊積製範網 (製願築繭蓋醖糧簾鏇壓 ) 达到更多	积极	2023-03-18
NCT04999839 (Corporate Publications) 人工标引	临床2期	银屑病	259	NDI-034858	襯遞願夢夢憲鹽願餘鏇(廠壓蓋衊衊鹹廠鬱願網) = statistically significant greater proportion of patients reaching PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo at 12 weeks. 夢鹽憲蓋構窪廠築鬱鑰 (構襯淵夢製範淵構簾艱 ) 更多	积极	2022-11-30
				Placebo
NDI-034858 (Corporate Publications) 人工标引	临床1期	银屑病	39	NDI-034858 5mg	齋簾襯齋夢獵網鹽觸繭(觸鑰鏇憲鹽壓築壓窪蓋) = None 繭觸襯窪醖獵繭襯衊窪 (觸顧壓鏇鹽餘憲觸繭廠 ) 更多	积极	2022-03-25
				NDI-034858 10mg