A phase 2b/3 randomized, double-blind, placebo-controlled, parallel group, multicenter protocol to evaluate the efficacy and safety of Icotrokinra in participants with moderately to severely active Crohn's Disease

开始日期2025-11-01

申办/合作机构

Janssen-Cilag International NV

NCT07196722

/ Recruiting临床2/3期

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

开始日期2025-10-03

申办/合作机构

Janssen Research & Development LLC

NCT07196748

/ Recruiting临床3期

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

开始日期2025-10-01

申办/合作机构

Janssen Research & Development LLC

100 项与盐酸伊可白滞素相关的临床结果

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100 项与盐酸伊可白滞素相关的转化医学

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100 项与盐酸伊可白滞素相关的专利（医药）

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项与盐酸伊可白滞素相关的文献（医药）

2025-11-25·NEJM evidence

Targeted Oral Peptide Icotrokinra for Psoriasis Involving High-Impact Sites

Article

作者: Ceitlin, Raul Hernan Gabriel ; Weirich, Oliver ; Bissonnette, Robert ; Huang, Yu-Huei ; Hoffmann, Matthias ; DeKlotz, Cynthia M. C. ; Warren, Richard B. ; Lain, Edward ; Li, Shu ; Song, Eingun James ; Hsu, Ming-Chun ; Nunes, Fabio ; Lynde, Charles W. ; Rubens, Jessica H. ; Ota, Takayuki ; DeLozier, Amy M. ; Gooderham, Melinda

BACKGROUND:

Plaque psoriasis involving high-impact sites is difficult to treat. Icotrokinra, a targeted oral peptide that selectively binds interleukin-23 receptors, is a new treatment being investigated for this condition.

METHODS:

This phase 3, double-blind, placebo-controlled trial randomly assigned participants 12 years of age and over with plaque psoriasis {with a body surface area ≥1%; an Investigator's Global Assessment (IGA) score ≥2 [clear (0), minimal (1), mild (2), moderate (3), and severe (4)] for overall skin; and at least moderate psoriasis involving the scalp, genitalia, and/or hands and feet} to receive either icotrokinra 200 mg daily or placebo in a 2:1 ratio. The primary end point at week 16 was the proportion of participants achieving an overall IGA score of 0 or 1 and an improvement of 2 points or more from baseline (IGA score of 0 or 1), reported as the between-group difference adjusted for high-impact site involvement, geographic region, and body surface area category using Mantel-Haenszel weights. Absent/clear or minimal/almost clear scalp, genital, and/or hand and foot psoriasis at 16 weeks were secondary end points. Adverse events were recorded.

RESULTS:

The trial randomly assigned 311 participants (icotrokinra, n=208; placebo, n=103) with scalp (n=252: icotrokinra, n=167; placebo, n=85), genital (n=140: icotrokinra, n=98; placebo, n=42), and/or hand and foot (n=71: icotrokinra, n=48; placebo, n=23) psoriasis. The proportions of participants achieving an IGA score of 0 or 1 in the icotrokinra and placebo groups were 56.7% and 5.8%, respectively [adjusted difference, 51.1 percentage points; 95% confidence interval (CI), 42.1 to 58.8; P<0.001]. The proportions of icotrokinra-treated and placebo-treated participants achieving absence/clear or minimal/almost clear high-impact site psoriasis were as follows: scalp, 65.9% and 10.6% (difference, 55.5 percentage points; 95% CI, 44.8 to 64.4; P<0.001); genitalia, 76.5% and 21.4% (difference, 55.4 percentage points; 95% CI, 39.1 to 68.0; P<0.001); and hand and foot, 41.7% and 26.1% (difference, 16.7 percentage points; 95% CI, -6.2 to 36.8; P=0.144). Adverse events occurred among 50% and 42% of participants in the icotrokinra and placebo groups, respectively.

CONCLUSIONS:

At 16 weeks, significantly higher proportions of participants 12 years of age and over with at least moderate psoriasis involving high-impact sites treated with icotrokinra versus placebo achieved clearance or minimal psoriasis in their skin overall and in the scalp and genital areas, but not in their hands and feet. No safety signals were identified. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT06095102.).

2025-11-06·NEW ENGLAND JOURNAL OF MEDICINE

Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents

Article

作者: Soung, Jennifer ; Pink, Andrew E. ; Lebwohl, Mark G. ; Shi, Yuling ; DeKlotz, Cynthia M.C. ; Jiang, Jingzhi ; Bissonnette, Robert ; Miller-Kassamali, Megan ; Cafone, Joseph ; Wang, Wen-hui ; Hebert, Adelaide A. ; Moore, Angela Y. ; Li, Shu ; Nunes, Fabio ; Pinter, Andreas ; Toth, Darryl P.

BACKGROUND:

Icotrokinra, a targeted oral peptide that selectively binds the interleukin-23 receptor, is under investigation for the treatment of plaque psoriasis.

METHODS:

We conducted a phase 3, double-blind, randomized, placebo-controlled trial involving adults and adolescents (≥12 years of age) with moderate-to-severe plaque psoriasis, as defined by all the following: a total body-surface area of psoriasis involvement of at least 10%, a Psoriasis Area and Severity Index (PASI) score of at least 12 (range, 0 to 72, with higher scores indicating a greater extent or severity of psoriasis), and an Investigator's Global Assessment (IGA) score of at least 3 (range, 0 [clear skin] to 4 [severe disease]). Participants were assigned in a 2:1 ratio to receive icotrokinra at a dose of 200 mg once daily through week 24 or placebo through week 16 followed by transition to icotrokinra. The coprimary end points were an IGA 0/1 response (IGA score of 0 or 1 with ≥2-point reduction from baseline) and a PASI 90 response (≥90% reduction from baseline in the PASI score) at week 16.

RESULTS:

A total of 684 participants underwent randomization (456 to the icotrokinra group and 228 to the placebo group). At week 16, a total of 65% of the participants receiving icotrokinra and 8% of those receiving placebo had an IGA 0/1 response, and 50% and 4%, respectively, had a PASI 90 response (P<0.001 for both comparisons). Complete clearance of skin at week 16 was significantly more likely with icotrokinra than with placebo (IGA score of 0, 33% vs. 1%; PASI 100 response [100% reduction from baseline in the PASI score], 27% vs. <1%; P<0.001 for both comparisons). The percentage of participants with at least one adverse event through week 16 was 49% in each group; the most common adverse events in each group were nasopharyngitis and upper respiratory tract infection. The exposure-adjusted incidence of adverse events was consistent through week 24.

CONCLUSIONS:

Selective blockade of the interleukin-23 receptor with the targeted oral peptide icotrokinra resulted in a significantly higher incidence of skin clearance at week 16 than placebo among adults and adolescents with moderate-to-severe plaque psoriasis. Longer-term data will provide a more complete understanding of the benefit-risk profile of icotrokinra. (Funded by Johnson & Johnson; ICONIC-LEAD ClinicalTrials.gov number, NCT06095115.)See also in NEJM Evidence: Targeted Oral Peptide Icotrokinra for Psoriasis Involving High‑Impact Sites.

2025-09-01·Dermatology and Therapy

Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling

Article

作者: Patel, Shefali ; Shi, Yifan ; Baguet, Tristan ; Ndifor, Anthony ; Wang, Jianyao ; Somani, Sandeep ; Sensenhauser, Carlo ; Park, Seonghee ; Adriaenssen, Lieve ; Leclercq, Laurent ; Fourie, Anne ; Mardirosian, Saro ; Monshouwer, Mario ; Chaudhuri, Siladitya Ray ; Dallas, Shannon ; Knight, Beverly ; Sukumaran, Siddharth ; Polidori, David ; Patch, Raymond ; DiLoreto, Karen ; Sun, Chengzao ; Barros, Stephanie A ; Tammara, Brinda ; Geist, Brian ; Modi, Nishit B ; Moss, Darren ; Laenen, Aline

INTRODUCTION:

Icotrokinra (formerly JNJ-77242113 or PN-21235) is a targeted oral peptide that selectively inhibits interleukin-23 receptor signaling. The studies described here assessed its absorption, distribution, metabolism, and excretion (ADME), and potential for drug-drug interactions (DDI).

METHODS:

In vitro assays evaluated permeability, plasma protein binding, blood-to-plasma partitioning, metabolic stability, and interactions with drug transporters and metabolic enzymes. The nonclinical pharmacokinetic properties of icotrokinra were studied in vivo in rats and monkeys. Phase 1 studies evaluated the pharmacokinetic profile, metabolic profile and excretion in healthy volunteers.

RESULTS:

Icotrokinra demonstrated oral bioavailability of 0.1-0.3% in animals, with evidence of systemic pharmacodynamic activity, without the use of an absorption enhancer. The compound was stable across species in plasma, gastrointestinal matrices, and hepatocytes. Protein binding was low across species (~ 50% in human plasma), and icotrokinra distributed freely to tissues, including skin, joints, and gastrointestinal tissues. Following oral dosing in both rats and monkeys, fecal excretion of unabsorbed drug was the primary elimination route, and metabolite levels were low (each < 2% of dose) in plasma and excreta, with unchanged icotrokinra being the main circulating component. Icotrokinra was neither a substrate nor an inhibitor of prototypical drug transporters or cytochrome P450 enzymes. Icotrokinra exhibited dose-proportional pharmacokinetics from 25 mg to 1000 mg in a first-in-human study, and no serious adverse events were identified following single and multiple dose administrations. Unchanged icotrokinra was the only drug-related component in human plasma.

CONCLUSIONS:

Icotrokinra exhibited high stability and an ADME profile consistent with that of a small peptide, with no risk of DDI identified on the basis of in vitro studies. Clinical data demonstrated linear pharmacokinetics and no major metabolites.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov, NCT04621630. Euclinicaltrials.eu, EUCT: 2023-504720-26-00. A Graphical Abstract is available for this article.

350

项与盐酸伊可白滞素相关的新闻（医药）

2025-12-19

·医见微光

武田制药Zasocitinib：每日一次口服治疗斑块型银屑病在III期试验中全线告捷，FDA申请提上日程

在当前全球银屑病治疗领域不断追求疗效提升与患者依从性优化的背景下，日本制药巨头武田制药（Takeda Pharmaceutical Company Limited）宣布其口服TYK2抑制剂zasocitinib在两项关键性III期临床试验中成功达成所有主要与次要终点，标志着这一创新治疗方案有望在未来成为斑块型银屑病（PsO）治疗的新里程碑。公司计划于2026年向美国食品药品监督管理局（FDA）提交新药上市申请（NDA），同时也将向其他全球主要监管机构同步推进审批进程。银屑病治疗新纪元：TYK2抑制剂zasocitinib在III期试验中表现卓越在两项编号为NCT06088043和NCT06108544的多中心、随机、双盲、安慰剂和积极对照III期临床试验中，武田制药的zasocitinib在接受治疗的中重度斑块型银屑病成人患者群体中展现了显著的治疗优势与稳定的安全性表现。临床研究设计亮点随机、双盲设计：确保数据客观性与科学性；双重对照组设定：不仅设置安慰剂组，还设置与现有口服药物**阿普米司特（Apremilast）**的对照；治疗时长：观察周期涵盖第4周、第16周至第24周，以追踪疗效的持续性与峰值反应；主要终点：以静态医师总体评估（sPGA）0/1与银屑病面积与严重程度指数（PASI）75为主要衡量标准；次要终点：涵盖PASI 90、PASI 100、sPGA 0等高标准指标，累计44项次要终点全部达成。关键疗效数据第4周即显示反应趋势，PASI 75应答率明显优于对照组；第16周时，超过一半患者达到PASI 90（皮损清除或接近清除）；约30%的患者实现PASI 100（完全清除）；到第24周，临床反应仍呈上升趋势，显示持续疗效。这一数据组合在当前银屑病治疗研究中极具突破性意义，尤以“每日一次口服”这一高依从性设计，使其具备更广泛的市场适应性。安全性与耐受性验证令人满意 Zasocitinib在两项III期临床中展现出的安全性表现亦不容忽视：不良事件（AE）概况根据研究数据，zasocitinib的不良反应类型与先前研究结果一致，未观察到新型或严重不良信号：上呼吸道感染鼻咽炎痤疮这些副作用大多数为轻至中度，可管理性高，且并未对试验中止率产生显著影响。武田方面观点武田制药研发负责人Andy Plump博士对此表示： “我们在II期研究中所观察到的正面结果，在III期试验中得到了完整验证。超过一半患者在第16周时实现接近或完全皮损清除，这是我们对银屑病治疗方式改写的坚定步伐。”2026年启动NDA申请基于上述临床成果，武田计划在2026财年（截至3月）前后正式向FDA提交新药上市申请（NDA），并同步提交至其他国际主要市场监管机构，包括欧洲药品管理局（EMA）、日本PMDA等。此外，公司将于即将召开的国际皮肤病学大会上公开完整研究数据集与分析结果，以加强医学界与投资方的信心。Zasocitinib vs Sotyktu：TYK2靶点竞争愈演愈烈 Zasocitinib并非TYK2靶点领域的“独舞者”。其竞争对手、由百时美施贵宝（Bristol Myers Squibb）推出的Sotyktu（Deucravacitinib），早在2022年9月即获得FDA批准上市。相似机制，不同路径 Sotyktu与zasocitinib皆为选择性TYK2抑制剂；然而，两者在化学结构、口服频率、疗效曲线、起效时间及副作用谱方面存在细微差异；武田已启动zasocitinib与Sotyktu的头对头对比研究，力图在疗效与安全性上占据高地。药物 2025年预测销售额 2030年预测销售额Sotyktu 重磅药地位确立 $21.7 亿美元Zasocitinib 正在崛起中 $12.8 亿美元尽管Sotyktu在市场时间上占据先发优势，但Zasocitinib凭借其每日一次的高依从性口服剂型、广泛的适应症布局与更稳定的安全性表现，依然有望后发制人，瓜分高增长市场份额。从银屑病拓展至免疫炎症全领域武田并未将zasocitinib局限于斑块型银屑病这一单一适应症，而是构建了多疾病线并进的研发蓝图：正在进行的临床研究适应症银屑病关节炎（PsA）：III期临床试验推进中；克罗恩病（Crohn’s Disease）：II期研究中；溃疡性结肠炎（UC）：II期研究并行；头对头研究：与Sotyktu直接比较以评估临床优越性。这种适应症横向拓展策略意味着一旦Zasocitinib成功获批，其后续的扩展标签可迅速形成交叉市场覆盖，提升产品生命周期价值（Product Lifecycle Value, PLV）。根据GlobalData最新报告，预计至2030年，在七大主要市场（7MM：美国、法国、德国、意大利、西班牙、英国、日本）内，斑块型银屑病药物市场总销售额将达到115.6亿美元。行业内主要玩家强生（J&J）：其在研产品icotrokinra展现出潜在SoC（标准治疗）特质，目前也已向FDA提交NDA，处于待批阶段；诺华（Novartis）：其生物制剂Cosentyx依然在部分患者中占据领先地位；艾伯维（AbbVie）：Skyrizi表现强劲，在部分市场占有率快速提升。在此背景下，Zasocitinib要脱颖而出，需充分依靠其口服优势、快速起效、高清除率和耐受性好等多维因素。对于银屑病患者而言，治疗目标不仅是皮损清除，更是生活质量的提升。传统治疗方案如光疗、生物制剂注射等，虽然有效但不便捷。Zasocitinib作为每日一次口服药物，大大简化了治疗过程，提高了患者依从性与满意度。患者潜在获益避免频繁注射带来的心理负担；每日服药，疗效维持更稳定；高清除率，有望实现长期缓解；安全性良好，不良事件可控，适用于多种人群。随着III期临床数据的全面成功与FDA申请进入倒计时阶段，Zasocitinib正逐步确立其在全球斑块型银屑病治疗领域的战略地位。这款药物不仅具备打破当前治疗格局的潜力，更因其卓越的疗效、安全性、口服便利性和多适应症拓展能力，而可能成为武田在免疫炎症领域的又一旗舰产品。随着2026年NDA申请的推进，全球医疗界和投资者均将目光投向Zasocitinib —— 一款或将重塑银屑病治疗格局的“明日之星”。

2025-12-19

·腾讯网

和美药业二次递表港交所：主力产品战力不强、特色产品市场不大商业化价值或难兑现

来源：新浪证券　　近日，和美药业在首款新药Mufemilast获批后，再次向港交所递交招股书，国投证券国际为其独家保荐人。此前，公司曾于今年6月首次递表，但无果而终。招股书显示，和美药业成立于2002年，作为一家生物制药公司，致力于发现和开发针对自身免疫性疾病和肿瘤的自主研发小分子药物。　　成立以来，和美药业已经完成了数轮融资，主要投资者包括真灼医药、真灼新祺、上海千骥、泰格投资、泰鲲投资和倚锋资本等。E轮融资后，其投后估值为39亿元。然而，在光鲜的资本履历背后，对公司招股书等相关资料进行梳理后发现，公司核心管线临床数据弱于竞品或市场规模有限，未来的商业化之路仍面临挑战。　“独苗”产品竞品众多且疗效平平同类产品价格已降至地板价　　从财务数据看，由于尚未有产品实现商业化销售，公司始终处于亏损状态，现金持续失血。2023年、2024年以及2025年上半年，公司期内亏损分别为-1.56亿元、-1.23亿元、-0.73亿元，2025年上半年亏损额同比扩大26.93%。　　同期公司经营活动所用现金净额在报告期内均为净流出，分别为1.41亿元、9125.8万元、5162.8万元。截至2025年6月30日，公司现金储备约为0.73亿元，按照往年现金使用情况推算，现有资本储备已难以维持公司正常经营一年。　　产品方面，截至最后实际可行日期，和美药业已开发七个小分子候选药物，包括两种核心产品PDE4B蛋白表达阻断剂、PDE4抑制剂Mufemilast及EGFR/HER2双靶点小分子抑制剂Hemay022。其中Mufemilast已于今年9月获得国家药监局的新药上市申请批准，用于治疗中重度斑块状银屑病（Ps）。　　尽管已实现商业化产品0的突破，但需要关注的是，Mufemilast竞品众多，且临床数据并不拔尖，公司未来所要面临的市场竞争压力不小。截至目前，国内有18种获批治疗银屑病的靶向药物，其中13种为生物制剂，包括诺华的司库奇尤单抗、礼来的依奇珠单抗以及强生年销售额超百亿美元的乌司奴单抗等。　　国内企业智翔金泰、恒瑞医药、康方生物和信达生物针对银屑病的生物制剂也在近两年相继获批。此外，另有多款候选药物正处于临床开发阶段，如武田的TAK-279、翰森制药的HS-10374、先声药业的SIM 0335等。　　即便在小分子口服药细分领域，和美药业也面临激烈竞争。目前，国内市场已有艾伯维的JAK1抑制剂乌帕替尼和百时美施贵宝的TYK2抑制剂德卡伐替尼获批上市，翰森制药、益方生物、诺诚健华等国内企业也在追赶，加速推进TYK2类药物的临床。　　临床数据方面，大多数银屑病药物临床试验的基准是PASI（银屑病面积与严重程度指数）评分降低75%（PASI-75）。非头对头对比来看，Mufemilast的临床疗效数据显著低于可比竞品。根据III期关键临床试验的最终临床总结报告，Mufemilast于第16周的PASI-75和PASI-90分别为53.6%、32.5%。　　可比在研竞品中，信达生物的匹康奇拜单抗在16周的PASI-90为80%，PASI-75未统计；强生的JNJ-2113在16周的PASI-75和PASI-90分别为78.6%、59.5%；BMS的氘可来昔替尼在16周的PASI-75和PASI-90分别为58.4%、35.5%，数据表现均优于Mufemilast。　　价格方面，在国家医保谈判和集采常态化背景下，银屑病等慢性病药物的年治疗费用已被大幅压低，部分药物费用已降至数百元级别。作为后来者，Mufemilast面对诸多占据先发优势、已建立市场认知、价格更为低廉的成熟竞品，其定价空间及利润空间或将被压缩。　主力产品战力不强、特色产品市场不大商业化价值或难兑现　　Hemay022治疗晚期乳腺癌的情况与之类似。资料显示，乳腺癌患者可以细分为三个基因分型，分别为HR+/HER2-、HER2+以及三阴性乳腺癌。Hemay022目前处于三期临床的适应症为ER阳性、HER2阳性的晚期乳腺癌，该分型患者占比大概占乳腺癌患者总数的10%。　　尽管患者群体相对有限，但该亚型乳腺癌市场竞争仍十分激烈，目前已获批的药物种类包括单克隆抗体（mAb）、酪氨酸激酶抑制剂（TKI）和抗体-药物偶联物（ADC）。分疾病进展阶段看，一线至三线均已有成熟的标准治疗疗法，亦有多种未来潜在疗法。　　从临床数据看，Hemay022已完成的Ib期临床试验中，55名可评估参与者的客观缓解率为29.1%，mPFS为9.0个月。在接受Hemay022 400毫克或更高剂量联合治疗的44名参与者中，客观缓解率为31.8%，mPFS维持在9.0个月。非头对头对比来看，这样的数据不仅全面显著低于T-Dxd等HER2 ADC，甚至也远低于同类竞品——恒瑞医药的吡咯替尼，疗效数据难言竞争力。　　公司唯一在竞品中可能显出差异化的适应症——Mufemilast用于治疗白塞病，却因该病属于患者基数极小的罕见病，我国白塞病患病率约为1.4/10万，美国患病率约为1/30万，市场天花板很低，对公司整体营收的贡献预期有限。因此，凌科药业的管线呈现出主力产品战力不强，特色产品市场不大的尴尬局面，其未来商业化价值兑现仍存在较大不确定性。

财报上市批准申请上市引进/卖出

2025-12-19

·BioSpace

Takeda’s $4B Nimbus Bet Pays Off With ‘Best-in-Class’ Phase III Plaque Psoriasis Data

iStock, Veronique D With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to zasocitinib’s FDA approval next year. Takeda’s oral drug candidate zasocitinib significantly eased disease severity in two late-stage plaque psoriasis studies, setting the Japanese pharma up to challenge Bristol Myers Squibb in this indication. “The oral psoriasis segment is projected to exceed $5B by 2030,” analysts at Jefferies told investors in a Thursday note, explaining that patients are partial to pills over injectables. In this area, zasocitinib’s “strong efficacy and safety pro regulatory approval,” the firm continued. Takeda expects to new drug application for zasocitinib at the start of its 2026 fiscal year, which begins in April. Takeda acquired zasocitinib from Nimbus Therapeutics for $4 billion at the end of 2022, outcompeting “almost every biopharmaceutical company” to get it, according to Andy Plump, Takeda’s head of research and development. Across the two Phase III LATITUDE studies, Takeda enrolled more than 1,800 adults with moderate to severe plaque psoriasis. Both studies compared zasocitinib with placebo and Amgen’s Otezla. Data were sparse in the pharma’s Thursday release , in which it noted that “on average about 30 percent” of treated patients achieved completely clear skin, or a score of 100 on the Psoriasis Area and Severity Index (PASI). Meanwhile, “more than half” of patients hit PASI 90, indicating clear or almost clear skin. Despite the lack of details, Jefferies said that zasocitinib “demonstrated best-in-class Ph3 results,” which in turn point to its “potential to redefine the oral psoriasis market.” Zasocitinib is an AI-designed molecule, something which trial organizers said helped make its targeting “ 1.7 million times ” more selective than other drugs for psoriasis. After a reshuffle of pipeline priorities and dropping its entire cell therapy program this fall, Takeda re-upped a pact with AI-discovery firm Nabla Bio to refill its early pipeline. With zasocitinib, Takeda is stepping up to Bristol Myers Squibb and its oral tyrosine kinase inhibitor Sotyktu, which was approved in September 2022 for plaque psoriasis. Sotyktu made $246 million worldwide for BMS last year, a 45% year-on-year increase. Takeda is running a Phase III head-to-head study that compares zasocitinib against Sotyktu in moderate to severe plaque psoriasis. The trial is expected to be completed in July next year. Aside from Sotyktu, Takeda’s zasocitinib will also be going up against Johnson & Johnson’s icotrokinra, which in March this year hit a 50% PASI 90 response. Truist in its note said that zasocitinib appears “comparable” to icotrokinra, however noting that J&J’s molecule “has first mover advantage with PDUFA expected sometime in 2026.”

临床3期并购临床结果上市批准细胞疗法

100 项与盐酸伊可白滞素相关的药物交易

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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
斑块状银屑病	申请上市	美国	Johnson & Johnson	2025-07-21
克罗恩病	临床3期	美国	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	美国	Janssen Pharmaceutica NV	2025-10-03
克罗恩病	临床3期	中国	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	日本	Janssen Pharmaceutica NV	2025-10-03
克罗恩病	临床3期	日本	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	阿根廷	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	阿根廷	Janssen Pharmaceutica NV	2025-10-03
克罗恩病	临床3期	澳大利亚	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	澳大利亚	Janssen Pharmaceutica NV	2025-10-03

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临床结果

适应症

分期

评价

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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


NCT06095102 (ICONIC-TOTAL, Pubmed \| NEJM Evid) 人工标引	临床3期	银屑病	311	Icotrokinra 200 mg daily	膚糧廠艱鹽醖衊艱範糧(齋簾衊鑰構壓網網獵餘) = 鏇簾選製窪壓遞選糧顧鏇鑰觸築簾範觸範糧淵 (鑰繭衊襯廠範願積襯鹽 ) 更多	积极	2025-11-05
				Placebo	膚糧廠艱鹽醖衊艱範糧(齋簾衊鑰構壓網網獵餘) = 膚繭鬱築願窪蓋鹹願鏇鏇鑰觸築簾範觸範糧淵 (鑰繭衊襯廠範願積襯鹽 ) 更多
NCT06049017 (ANTHEM-UC, Company_Website) 人工标引	临床2期	溃疡性结肠炎	-	Icotrokinra 400 mg once daily	窪衊淵壓鏇願鑰鹹簾齋(鏇鏇構遞膚顧積網壓獵) = Similar proportions of pts reported AEs and SAEs through Week 28 across all icotrokinra dose groups and the placebo group. 遞構艱繭觸顧願壓鏇蓋 (簾醖膚廠憲衊憲淵鹹膚 )	积极	2025-10-27
				Placebo
NCT06095102 (ICONIC-TOTAL, ACR2025) 人工标引	临床3期	斑块状银屑病	311	Icotrokinra 200 mg	淵簾製糧選網築築齋簾(選構築鏇鏇繭糧觸遞鏇) = 鬱醖壓醖築餘鬱製窪鬱願餘壓鹽蓋願壓艱獵簾 (衊築蓋鏇遞餘窪獵構鹽 ) 达到更多	积极	2025-10-24
				Placebo	淵簾製糧選網築築齋簾(選構築鏇鏇繭糧觸遞鏇) = 膚鏇憲積鏇觸糧鏇餘夢願餘壓鹽蓋願壓艱獵簾 (衊築蓋鏇遞餘窪獵構鹽 ) 达到更多
NCT06095102 (ICONIC-TOTAL, Company_Website) 人工标引	临床3期	银屑病	-	Icotrokinra	選憲築衊襯鏇餘齋構觸(願壓齋醖觸鏇鬱選壓鹽) = 顧壓糧構鏇鹹鹽積觸壓餘網膚鏇餘憲蓋築簾選 (繭製遞淵夢襯廠製糧襯 ) 更多	积极	2025-10-24
NCT06095115 (ICONIC-LEAD, ACR2025)	临床3期	斑块状银屑病	684	Icotrokinra 200 mg	獵鬱簾糧憲繭築製壓積(構齋窪鹹繭蓋顧壓窪遞) = 鹽廠淵網壓繭齋蓋膚顧遞構憲鏇簾鹽衊鏇壓夢 (網壓鏇膚範艱獵淵遞選 ) 更多	积极	2025-10-24
				Placebo	獵鬱簾糧憲繭築製壓積(構齋窪鹹繭蓋顧壓窪遞) = 憲鹽艱積簾簾膚鏇顧築遞構憲鏇簾鹽衊鏇壓夢 (網壓鏇膚範艱獵淵遞選 ) 更多
FRONTIER 1 (ACR2025)	临床2期	银屑病关节炎 β-Defensin-2 (BD-2) \| IL-22 \| IL-17A ... 更多	23	Icotrokinra (ICO)	簾繭襯壓糧築夢廠夢醖(壓鑰蓋築壓製鏇壓廠遞) = 糧憲築淵築網積鬱鹽簾鬱廠衊鑰鑰襯夢觸糧鏇 (選廠淵構齋觸夢獵廠蓋 ) 更多	积极	2025-10-24
				Placebo	窪蓋醖構選廠廠獵鹽憲(憲醖憲網遞齋範襯選餘) = 廠獵鬱憲選餘醖鹽醖築繭鑰壓鹹簾糧齋繭蓋壓 (齋餘齋鬱衊顧憲夢顧繭 ) 更多
NCT06049017 (ANTHEM-UC, Company_Website) 人工标引	临床2期	溃疡性结肠炎	-	Icotrokinra 400 mg QD	簾選鑰遞餘範廠鹽網觸(製憲鬱遞積獵窪築鹽選) = 範積窪壓鬱廠築願廠築廠積廠願艱簾積鑰製網 (窪壓鑰繭衊繭築鹹淵醖 ) 达到更多	积极	2025-10-07
				Icotrokinra 200 mg QD	簾選鑰遞餘範廠鹽網觸(製憲鬱遞積獵窪築鹽選) = 醖憲糧積選衊繭遞齋艱廠積廠願艱簾積鑰製網 (窪壓鑰繭衊繭築鹹淵醖 ) 达到更多
NCT06220604 \| NCT06143878 (ICONIC-ADVANCE 2, PRNewswire) 人工标引	临床3期	斑块状银屑病	-	Icotrokinra	顧鹹鏇廠鏇繭齋製選艱(鏇廠膚鏇齋積餘築衊壓) = Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24). 鏇淵餘憲簾鏇齋齋築膚 (餘鹹窪壓衊窪觸糧糧憲 ) 达到更多	优效	2025-09-17
				Deucravacitinib
NCT06095115 (ICONIC-LEAD, PRNewswire) 人工标引	临床3期	斑块状银屑病	-	Icotrokinra (re-randomized at Week 24)	鏇選廠餘壓餘艱衊網願(憲願觸積衊顧糧鹹繭顧) = 窪壓獵鬱鬱選壓壓淵網鏇壓築網繭築鬱網獵網 (製糧鑰襯網淵鹽糧夢衊 )	积极	2025-09-17
				Placebo (re-randomized at Week 24)	鏇選廠餘壓餘艱衊網願(憲願觸積衊顧糧鹹繭顧) = 築糧網選艱壓願鏇襯鑰鏇壓築網繭築鬱網獵網 (製糧鑰襯網淵鹽糧夢衊 )
NCT06095115 (ICONIC-LEAD, NEWS) 人工标引	临床3期	斑块状银屑病	-	Icotrokinra	鏇範蓋蓋構鹽憲積夢鑰(積鏇範網壓膚餘選淵積) = 淵鏇壓憲憲積衊蓋醖壓壓膚選膚範壓繭齋觸範 (鬱糧積選鏇壓鹹鏇築網 ) 更多	积极	2025-08-04
				Placebo	積醖繭餘製廠積選襯糧(膚鹽窪糧齋廠憲膚艱衊) = 衊構構選窪築夢選選衊繭構窪繭鬱蓋顧鏇壓鹹 (艱積糧簾糧糧鑰構餘衊 )