A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

开始日期2025-04-08

申办/合作机构

Celgene Corp.

NCT06528665

/ RecruitingN/A

A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects

The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.

开始日期2025-02-10

申办/合作机构

Corium Innovations, Inc.

100 项与盐酸奥扎莫德相关的临床结果

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100 项与盐酸奥扎莫德相关的转化医学

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100 项与盐酸奥扎莫德相关的专利（医药）

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359

项与盐酸奥扎莫德相关的文献（医药）

2025-12-01·Lancet Regional Health-Europe

The effect of disease-modifying therapies on brain volume loss and disability accumulation in multiple sclerosis: a systematic review and network meta-analysis

Article

作者: Cagol, Alessandro ; Schaedelin, Sabine ; Sormani, Maria Pia ; Pretzsch, Roxanne ; Granziera, Cristina ; Kappos, Ludwig

Background:

Multiple treatments have demonstrated efficacy in preventing brain volume loss (BVL) in randomized controlled trials (RCTs) for multiple sclerosis (MS). However, assessing their relative effectiveness remains challenging due to limited head-to-head comparisons. Additionally, the relationship between treatment effects on BVL and disability accumulation is not established for newer therapies. This study aimed to compare the efficacy of approved disease-modifying therapies (DMTs) in reducing BVL in MS and to investigate the association between treatment effects on BVL and disability accumulation.

Methods:

In this systematic review and network meta-analysis, we included all RCTs enrolling adults with MS that evaluated FDA-approved DMTs and reported BVL outcomes over at least one year. We searched PubMed, Embase, and Cochrane from inception to September 2024. Following PRISMA guidelines, two reviewers independently extracted data on BVL, MRI lesion activity, and disability progression. We conducted a mixed-effects network meta-analysis with placebo as the reference group. Meta-regression analyses examined the association between treatment effects on BVL and disability progression, adjusting for MRI lesion activity.The primary outcome was BVL. Secondary outcomes included MRI lesion accumulation and risk of confirmed disability progression. Effect sizes were reported as the ratio of means (ROM) and hazard ratios (HRs), with 95% confidence intervals (CIs). This study is registered with PROSPERO (CRD420251034936).

Findings:

We included 33 RCTs evaluating 16 DMTs and 26,247 patients. Eight DMTs significantly reduced BVL compared to placebo, including ponesimod (ROM = 0.52; 95%-CI: 0.35-0.77), ofatumumab (ROM = 0.58; 95%-CI: 0.40-0.83), alemtuzumab (ROM = 0.63; 95%-CI: 0.49-0.83), teriflunomide (ROM = 0.71; 95%-CI: 0.52-0.97), ozanimod (ROM = 0.74; 95%-CI: 0.56-0.98), natalizumab (ROM = 0.77; 95%-CI: 0.61-0.96), siponimod (ROM = 0.77; 95%-CI: 0.60-0.98), and fingolimod (ROM = 0.83; 95%-CI: 0.71-0.96). The treatment effect on BVL was associated with the treatment effect on disability accumulation (β = 0.466; p = 0.008), and this association remained significant independently of the treatment effect on MRI activity (β = 0.422; p = 0.005).

Interpretation:

Several DMTs-including newer therapies-significantly reduce BVL, and this effect correlates with reduced disability accumulation. These findings support BVL as a meaningful treatment target in MS.

Funding:

None.

2025-11-01·PAIN

Ozanimod, a functional sphingosine-1-phosphate receptor 1 antagonist, restores brainstem descending pain pathways in murine models of neuropathic pain

Article

作者: Chen, Zhomou ; Squillace, Silvia ; Lauro, Filomena ; Giancotti, Luigino Antonio ; Li, Ying ; Salvemini, Daniela

Abstract:

Activation of sphingosine-1-phosphate (S1P) receptor 1 (S1PR1) in the spinal cord contributes to neuropathic pain; however, its role at supraspinal sites remains unexplored. Ozanimod is a new FDA-approved S1PR1 antagonist for multiple sclerosis. Here, we show that systemic ozanimod administration reverses behavioral hypersensitivities in male rodents induced by chronic sciatic nerve constriction and chemotherapy (oxaliplatin and paclitaxel). Moreover, bilateral ozanimod injection in the rostral ventral medulla (RVM) reversed behavioral hypersensitivities in a time-dependent manner, evincing a role for S1PR1 in the descending pain modulatory system. RNA-Seq analysis of the RVM revealed that traumatic nerve injury downregulated type I interferons (IFN-I) signaling. Intra-RVM ozanimod administration normalized IFN-I–associated gene expression levels, suggesting that S1PR1 activation mediated IFN-I signaling downregulation that, in turn, may regulate RVM descending pain pathways. In the RVM, engagement of noradrenergic and serotonergic inhibitory circuits suppressed spinal nociception. Intrathecal injection of an α2 antagonist (yohimbine) or a serotonin antagonist (methysergide) prevented the antinociceptive effects of ozanimod in both models of neuropathic pain implicating these descending inhibitory projections in S1PR1 antagonism. In contrast to the disease state, intra-RVM injection of the S1PR1 agonist SEW2871 to uninjured animals did not cause behavioral hypersensitivities, underscoring a state-dependent role of S1PR1 in nociception. Our results establish a role for S1PR1 in descending facilitation and suggest that this function may inhibit IFN-I signaling pathways. Our findings support repurposing FDA-approved functional S1PR1 antagonists as nonopioid treatments for neuropathic pain.

2025-10-01·AMERICAN JOURNAL OF GASTROENTEROLOGY

Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial

Article

作者: D'Haens, Geert ; Rubin, David T. ; Jain, Anjali ; Wolf, Douglas C. ; Regueiro, Miguel ; Vermeire, Severine ; Panaccione, Remo ; Lawlor, Garrett ; Dignass, Axel ; Sands, Bruce E. ; Afzali, Anita ; Osterman, Mark T. ; Ahmad, Harris A. ; Loftus, Edward V. ; Colombel, Jean-Frederic ; Wu, Hsiuanlin

INTRODUCTION::

Patients with ulcerative colitis (UC) and prior biologic failure may have reduced or delayed efficacy with subsequent advanced therapies. This analysis evaluated the efficacy and safety of ozanimod during the True North (TN) study and its open-label extension (OLE) in biologic-exposed patients with UC.

METHODS::

TN was a randomized, placebo-controlled 52-week trial (10-week induction, 42-week maintenance period). Eligible patients could enter the OLE. Clinical outcomes were assessed at TN week (W) 10 and W52 and OLE W46 and W94. Symptomatic efficacy was evaluated through induction and in the OLE until W94. Safety was assessed.

RESULTS::

This analysis included 376 biologic-exposed patients. In the placebo-controlled cohort, more ozanimod-treated patients achieved clinical response than placebo at W10 regardless of the number or type of prior biologics; patients who used 1 vs ≥2 prior biologics achieved higher efficacy rates. Efficacy rates were higher at W52 than W10 and were similar across subgroups regardless of the number or type of prior biologics. Significantly greater proportions of ozanimod vs placebo patients achieved symptomatic response by W5 (P = 0.0173) and symptomatic remission by W10 (P = 0.0207). Among biologic-exposed TN W10 ozanimod nonresponders who entered the OLE, 61% achieved symptomatic response with an extra 10 weeks of ozanimod treatment. Ozanimod efficacy was durable for ∼3 years of continuous treatment in biologic-exposed W52 clinical responders who entered the OLE. No new safety signals were observed.

DISCUSSION::

Ozanimod was effective and safe in biologic-exposed patients with UC, but these patients may require more time to respond to treatment. Clinical trial registry website and trial numbers: ClinicalTrials.gov, numbers NCT02435992 and NCT02531126.

241

项与盐酸奥扎莫德相关的新闻（医药）

2025-10-30

·有驾

硕迪生物的创新药物研发与市场布局

1月12日，全球生物制药公司硕迪生物（前身为ShouTi Inc.）向美国证券交易委员会递交了IPO上市的S-1文件，计划募资1亿美元，此金额仅供参考，实际募资金额以最终结果为准。硕迪生物是一家临床阶段的全球生物制药公司，专注于开发和提供创新口服疗法，以应对各类慢性疾病。凭借其独特的基于结构的药物发现和计算化学技术平台，该公司能够研发出针对代谢、心血管及肺系统等疾病的口服小分子疗法。由首席执行官Raymond Stevens博士与全球领先的药物发现公司Schrödinger共同创立，硕迪生物已成功吸引到包括BVF Partners、Deep Track Capital、Eight Roads Ventures、F-Prime Capital、启明创投和红杉资本中国在内的全球顶尖投资者财团的支持，累计筹集资金达1.98亿美元。公司的初期焦点集中在G蛋白偶联受体（GPCR）上，这是一种在多种生理和病理过程中发挥关键作用的靶点。目前，市场上每三种上市药物中就有一种与GPCR相关。借助世界顶尖的GPCR技术，硕迪生物致力于设计出能够克服生物制剂和肽疗法局限性的差异化小分子疗法。 ▲ 重点产品GSBR-1290 硕迪生物目前正处于研发阶段，其重点产品GSBR-1290是一款口服小分子GLP-1R激动剂，旨在治疗2型糖尿病和肥胖症。该产品已于2022年9月顺利完成1期单次递增剂量研究，显示出良好的耐受性，并具备剂量依赖性的药代动力学和药理学活性。硕迪生物已向FDA提交了一份IND申请，以支持启动T2DM和肥胖症的1b期概念验证研究，并于同年9月获得FDA批准。进入2023年1月，公司启动了1b期多次递增剂量（MAD）研究，并计划进一步向FDA提交方案修正案，以过渡到T2DM和肥胖症的2a期概念验证研究，预计将于2023年下半年启动。 ▲ 其他研发项目与合作除GSBR-1290外，公司还致力于开发下一代GLP-1R候选药物，这些药物均具备独特特性，旨在带来额外益处。最近，ANPA-073这款口服小分子APJR激动剂也备受瞩目，其1期SAD和MAD研究于2022年9月圆满完成，为特发性肺纤维化（IPF）和肺动脉高压（PAH）患者带来了新的治疗希望。APJR靶点不仅吸引了硕迪生物的关注，还吸引了安进、BMS、CohBar、Apie Therapeutics、FibroGen、Galapagos、Galecto、Pliant Therapeutics、Gilead、Roche和Boehringer Ingelheim等众多行业领军企业的竞相研发。同时，公司也在探索一种分化的溶血磷脂酸1受体（LPA1R）抑制剂，以期为IPF患者提供更多治疗选择。 ▲ GPCR药物研发的挑战 G蛋白偶联受体（GPCR）作为人类基因组中最大的膜蛋白家族，在人类健康中发挥着至关重要的作用。迄今为止，已有约475种上市药物针对100多个独特的GPCR进行治疗，然而，仍有220多种GPCR等待临床探索，这无疑为药物研发领域带来了广阔的发展空间。 ▲ 硕迪生物的技术突破许多GPCR特性使其成为重要的药物靶点，这些特性包括与多种信号分子的相互作用、参与众多生理和病理过程，以及其细胞表面表达，使得细胞外药物能够与其结合。为了应对这些挑战，硕迪生物已开发出一个独特的平台，该平台基于创始人25年的技术积累，旨在发现能够有效靶向GPCR的小分子药物。硕迪生物的平台在药物研发过程中实现了GPCR结构与结合位点的可视化，加速了药物研发进程。 Raymond Stevens博士在药物开发领域贡献卓越，特别是推动了基于结构的药物研发。他深度参与了多个治疗分子的研发历程，这些分子后来衍生出多种突破性药物，如BioMarin公司开发的Palnziq®。此外，Raymond Stevens博士创立的Receptos公司推出的Zeposia®是一种针对S1PR1受体的GPCR激动剂，于2020年获批多发性硬化症治疗，2021年又获批准用于溃疡性结肠炎的治疗。硕迪生物在2019年4月成功筹集到3200万美元的A轮融资，每股定价为1.6667美元。2020年3月，该生物技术公司又迎来了新的融资里程碑，成功筹集到2600万美元的A+轮融资，每股定价为2.0313美元。此次融资活动得到了斯道资本、F-Prime、红杉中国和启明创投等知名投资机构的鼎力支持。2021年7月，硕迪生物再次迎来融资佳绩，成功筹集到1亿美元的B轮融资，每股定价为4.0483美元，吸引了众多新投资机构的积极参与。2022年4月，硕迪生物再次取得融资突破，成功筹集到3300万美元的超额认购资金。 2022年2月，硕迪生物宣布成立全资子公司——倍勘生物（Basecamp Bio），旨在进一步拓展其研发领域并寻求与药物研发合作伙伴的携手共进。倍勘生物的成立，为C-suite成员提供了更多发展机会，并且股权架构显示现有投资者的持股比例。

临床1期临床申请财报IPO

2025-10-29

·广东食药审评认证协会

全球销售额前十的专利临期神经系统用药品种分析

引言本栏目旨在定期分享药品专利领域的最新资讯，涵盖创新药与仿制药的动态，以及药品临期专利信息等，将重点系统梳理全球重点品种的核心专利信息，帮助企业精准把握专利窗口期，在合规前提下提前启动仿制药研发与注册准备，助力广东省医药企业抢占市场先机，缩短专利到期与仿制药上市之间的时间差，加速高质量仿制药上市，惠及广大民众。 01 品种概况表一销售额前十的临期神经系统用药品种 ¹ 销售额来源：数据销售额为2024年，数据参考企业公开、行业推测 ² 仿制企业数据来源：国家药品监督管理局药品审评中心（CDE）、摩熵数据库以上是在神经系统领域销售额靠前的专利临期品种，核心专利在2030年12月31日前临期。在抗精神分裂症及双相障碍领域，布瑞哌唑通过5-HT1A/D2受体部分激动以及5-HT2A受体的拮抗剂活性控症；卢美哌隆多维调节5-HT2A/D2/谷氨酸改善精神分裂症患者阴阳性症状。在抗偏头痛领域，依瑞奈尤单抗长效阻断CGRP-R达到预防作用；瑞美吉泮小分子CGRP-R拮抗，阻断炎症和血管扩张反应，可同时用于偏头痛急性治疗及预防性治疗。在促觉醒领域，替洛利生选择性组胺H3受体反向激动，增强组胺能神经元活性，专攻嗜睡症日间嗜睡。在神经免疫疾病领域，奥扎莫德S1P-R抑淋巴细胞外溢治疗MS；萨特利珠单抗阻断IL-6R信号抑制T细胞向脊髓迁移，防止血脑屏障通透性增加，从而预防NMOSD的发作。在神经退行性疾病领域，奥吡卡朋是外周选择性和可逆性的第三代COMT抑制剂，可延缓左旋多巴和多巴胺的分解，用于辅助帕金森治疗；仑卡奈单抗人源化的IgG4单克隆抗体，可以选择性结合并清除大脑中的淀粉样β蛋白(Aβ)斑块，从而缓解阿尔茨海默进展。在神经性疼痛领域，苯磺酸美洛加巴林属于第三代钙离子通道调节剂类药物，与钙离子通道α2δ亚基亲和力高，精准缓解糖尿病周围神经痛。从药物类型看，神经系统用药呈“小分子主导、生物药精准补充”格局。小分子药物覆盖神经递质系统（如5-HT、D2受体调节剂布瑞哌唑）、离子通道（如钙通道调节剂美洛加巴林）及免疫通路（S1P调节剂奥扎莫德）；生物制剂则聚焦单克隆抗体，涵盖CGRP受体（依瑞奈尤单抗）、β-淀粉样蛋白（仑卡奈单抗）和IL-6受体（萨特利珠单抗）等精准靶点，实现对神经系统疾病的多维度干预。销售额靠前的临期神经系统用药品种主要来自大冢制药、诺华、辉瑞、百时美施贵宝、卫材及罗氏等国际巨头。国内布局方面，复星医药通过“独家许可+联合申报”引进奥吡卡朋，实现本土产业化；科伦、人福等已提交卢美哌隆仿制申请；正大天晴、齐鲁等抢仿苯磺酸美洛加巴林；布瑞哌唑更吸引超40家药企竞相布局，首仿竞争白热化。 02 专利布局表二 2030年前临期重点神经系统用药品种中国专利布局 ³ 专利数据来源：中国上市药品专利登记平台、壹专利表二展示了重点临期神经系统用药品种的专利布局情况。从中国专利到期时间看，各品种陆续到期，为仿制药企业分批切入提供了清晰时间轴。其中，布瑞哌唑、替洛利生与奥吡卡朋核心化合物专利同于2026年到期；仑卡奈单抗生物序列专利2027年届满；卢美哌隆与苯磺酸美洛加巴林2028年到期；依瑞奈尤单抗和奥扎莫德核心专利延至2029年；瑞美吉泮化合物专利则2030年失效。上述品种大部分在国内均受化合物或生物序列专利保护，卢美哌隆尚有数件申请处于实审阶段，企业需持续监控其法律状态并滚动调整立项目节奏。其中，布瑞哌唑的核心化合物专利（CN101155804B）最初保护范围涵盖一大类化合物。2024年2月，南京华讯知识产权顾问有限对该专利发起无效挑战，专利权人大冢制药对权利要求进行了限缩，删除了原权利要求1–6和8，仅保留原权利要求7中的第一个化合物——即布瑞哌唑（7-[4-(4-苯并[b]噻吩-4-基-哌嗪-1-基)丁氧基]-1H-喹啉-2-酮）作为新的权利要求1。经审理，该专利被维持部分有效，因此，布瑞哌唑的化合物专利目前仍处于保护期内。但目前该品种已吸引四十多家国内企业布局仿制。其中，石药欧意于2022年率先启动生物等效性（BE）试验，预计于2024年11月完成，并计划在2026年上半年获批上市，从而实现与专利到期日的“无缝衔接”。值得注意的是，多数仿制药企业已承诺在专利到期前不上市。另外，依瑞奈尤单抗的用途专利（CN108156814B）正被湖北某药企发起无效宣告请求，表明已有企业积极寻求专利壁垒突破。 03 仿制药开发建议（1）评估市场竞争格局，审慎选择研发品种布瑞哌唑等销售额高（20亿美元），但国内仿制申报企业已超40家的品种，市场竞争已呈“红海”态势。除非企业具备极强的原料药－制剂一体化成本优势或卓越的市场商业化能力，否则应谨慎介入。盲目跟进可能导致高昂的研发投入难以在激烈的价格战中收回成本。对于卢美哌隆、苯磺酸美洛加巴林等已有数家企业在布局的品种，需结合自身研发进度和市场渠道优势进行决策。若选择进入，应寻求差异化开发策略，例如开发复方制剂、新剂型（如长效注射剂、口溶膜等），或探索新的适应症，以形成独特的市场竞争力。（2）关注专利悬崖节奏，提前布局专利即将到期品种专利到期时间是仿制药上市的关键节点。应重点关注核心专利即将在2026-2027年集中到期的品种，如布瑞哌唑、替洛利生和奥吡卡朋，以及仑卡奈单抗（生物类似药）。对于这些品种，建议企业现在就启动研发，完成药学研究、BE试验（生物等效性试验）等准备工作，力争在专利到期后第一时间提交上市申请，实现“专利悬崖”下的无缝衔接，抢占市场先机。对于专利期稍长的品种（如瑞美吉泮核心专利2030年到期），可将其列为中长期研发规划，持续跟踪其专利法律状态的任何变化（如无效请求结果），并提前进行技术储备。（3）聚焦临床需求与市场潜力巨大的蓝海领域阿尔茨海默病领域存在巨大的未满足临床需求，患者基数庞大超1500万。仑卡奈单抗作为疾病修饰疗法的突破性药物，虽然生物类似药的研发技术门槛和资金投入更高，但其市场潜力和临床价值也极为可观。对于有技术实力和资金雄厚的企业，提前布局此类生物类似药是一个重要的战略方向，有望在未来占据领先地位。（4）规避严密的专利网，全面开展FTO分析许多原研药（如依瑞奈尤单抗、卢美哌隆）构筑了包括化合物、晶型、制剂、用途在内的严密专利网。在立项前，必须进行彻底的专利排查与自由实施（FTO）分析，不仅要关注核心化合物专利，还需警惕外围专利和仍在审中的专利申请可能带来的潜在侵权风险，如卢美哌隆的多件在审专利，必要时主动发起无效或挑战。总之，仿制药开发策略应是对于竞争过于激烈的品种保持谨慎；精准把握专利到期节奏，提前卡位；勇于投入技术门槛高但市场空间大的蓝海领域；始终将全面、深度的知识产权风险评估作为立项决策的前置条件。免责申明本文涉及的信息主要来源于官方平台，但需注意官方平台登记的专利可能存在不全的情况，部分外围专利（如晶型专利、制备工艺专利、用途专利等）可能未被完整收录，专利法律状态可能因诉讼、无效宣告等程序发生变化。实际研发立项等需进一步检索国家知识产权局专利数据库等权威渠道，开展全面的专利排查和FTO分析。本文内容仅供参考，不构成法律或商业建议，使用者应自行承担基于本文决策的全部风险。致谢感谢广东省食品药品审评认证技术协会专家罗志波、黄晓泉、曹大鹏、张孟迪对本期简报的专业指导与完善。感谢广州奥凯信息咨询有限公司对本专栏内容的支持。 END 编辑：梁沅晴一审：陈洁玲二审：张元纯三审：杨田协会介绍广东省食品药品审评认证技术协会成立于2013年，是由广东省药品监督管理局审评认证中心联合广东省多家优秀企业发起成立的省级专业技术协会，现业务工作受广东省药品监督管理局指导，专注于打造一流的医药大健康领域专业的技术服务平台，是广东省 AAAA 级协会，于2022年通过了质量管理体系ISO9001认证。协会自成立以来，一直致力于广泛团结相关领域各方力量积极参与到政府决策中；致力于行业关键人员能力提升；致力于审评检查专业技术服务，助推产业高质量发展。协会成立逾十年，已形成较为成熟的五大服务体系：政务服务体系、品牌会议（含高端交流）服务体系、职业化专业化能力培训体系、质量提升（含审评咨询）专业技术服务体系、团标指南制定推广服务体系。协会追求高质量会员服务，提出“初心、用心、贴心，为行业、为会员”的服务口号，协会最朴素的初心就是：干点实事——为行业、为会员做一点有价值的事情。期待您的加入，我们将竭诚为您提供各种优质服务！

专利到期

2025-10-27

·PRNewswire

Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis

Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo in the Phase 2b ANTHEM-UC study Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and Crohn's disease PHOENIX, Oct. 27, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). These results underscore the potential of icotrokinra to deliver a combination of therapeutic benefit and a favorable safety profile with once-daily oral dosing and will be featured among Johnson & Johnson's 23 accepted abstracts at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG). At Week 28, icotrokinra demonstrated sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical responsea, clinical remissionb, endoscopic improvementc and histologic-endoscopic mucosal improvement (HEMI)d at Week 28 compared to placebo.1 These outcomes build on Week 12 data recently presented at United European Gastroenterology (UEG) Week 2025 where all doses of icotrokinra demonstrated superiority to placebo for the primary endpoint of clinical response.2 "The ANTHEM-UC results show that targeting the IL-23 pathway with a once-daily oral therapy can provide meaningful, sustained benefit and a favorable safety profile, giving healthcare providers a potential new approach to managing this challenging disease," said Vipul Jairath, MBChB, DPhil, Professor of Medicine at Western University in Ontario, and study investigator.e "For those living with ulcerative colitis, icotrokinra could represent an important step forward in how their disease is managed." Similar proportions of participants reported adverse events and serious adverse events through Week 28 across all icotrokinra dose groups and the placebo group.1 "These exciting results show how we are harnessing our deep understanding of the IL-23 pathway to advance innovative treatments for inflammatory bowel disease that address the daily needs of patients," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With Phase 3 development now underway in both adult and adolescent patients, our aim is to establish icotrokinra as a promising therapy that could transform the treatment paradigm in ulcerative colitis and bring patients a potential new option." Based on results from the Phase 2b ANTHEM-UC study, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn's disease. Icotrokinra is also being studied in the pivotal Phase 3 ICONIC program in moderate-to-severe plaque psoriasis and the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in July 2025 seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis. Editor's notes: a. Clinical response was defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. b. Clinical remission was defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. c. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1. d. Histologic-endoscopic mucosal improvement (HEMI) was defined as histologic remission (absence of neutrophils from the mucosa in both lamina propria and epithelium, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1). e. Dr. Jairath is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. About ANTHEM-UC ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.3 About Ulcerative Colitis Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.4 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor,5 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.6,7 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signalling in human T cells.8 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.9 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.10,11,12 Icotrokinra is being studied in the Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. References: 1 Jairath V., et al. Efficacy and Safety of Icotrokinra, a Targeted Oral Peptide That Selectively Blocks IL-23 Receptor Activation, In Ulcerative Colitis: Results From Week 28 of ANTHEM-UC, a Phase 2b Dose-ranging Trial. Poster 1066 at ACG Annual Scientific Meeting 2025. October 2025. 2 Abreu M., et al. Icotrokinra, a targeted oral peptide that selectively blocks IL-23 receptor activation, in moderately to severely active ulcerative colitis: week 12 results from the phase 2b, randomized, double-blind, placebo-controlled, treat-through, dose-ranging ANTHEMUC trial. Oral presentation OP206 at United European Gastroenterology Week (UEGW) 2025. October 2025. 3 Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. . Accessed February 2025. 4 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 5 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 6 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. 7 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 8 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 9 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: . Accessed November 2024. 10 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: . Accessed November 2024. 11 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: . Accessed November 2024. 12 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: . Accessed November 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期临床3期引进/卖出申请上市

100 项与盐酸奥扎莫德相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10967	盐酸奥扎莫德	L04AA38	DB12612

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复发性多发性硬化	澳大利亚	Celgene Pty Ltd.	2020-07-17
复发-缓解型多发性硬化	欧盟	Bristol-Myers Squibb Pharma EEIG	2020-05-20
复发-缓解型多发性硬化	冰岛	Bristol-Myers Squibb Pharma EEIG	2020-05-20
复发-缓解型多发性硬化	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2020-05-20
复发-缓解型多发性硬化	挪威	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性中度溃疡性结肠炎	欧盟	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性中度溃疡性结肠炎	冰岛	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性中度溃疡性结肠炎	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性中度溃疡性结肠炎	挪威	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性重度溃疡性结肠炎	欧盟	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性重度溃疡性结肠炎	冰岛	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性重度溃疡性结肠炎	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2020-05-20
活动性重度溃疡性结肠炎	挪威	Bristol-Myers Squibb Pharma EEIG	2020-05-20
多发性硬化症	美国	Bristol Myers Squibb Co.	2020-03-25

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适应症	最高研发状态	国家/地区	公司	日期
克罗恩病	申请上市	中国	Bristol Myers Squibb Co.	2021-07-30
小儿克罗恩病	临床3期	美国	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	澳大利亚	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	比利时	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	加拿大	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	法国	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	德国	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	匈牙利	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	波兰	Bristol Myers Squibb Co.	2023-08-22
小儿克罗恩病	临床3期	西班牙	Bristol Myers Squibb Co.	2023-08-22

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临床结果

适应症

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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


NCT03440372 (CTgov)	临床3期	克罗恩病	625	ozanimod (Treatment 1)	鏇餘衊選蓋餘鑰艱夢醖 = 醖觸遞夢衊憲襯蓋遞鹹積積糧顧鑰築夢顧夢淵 (糧獵淵製願壓製構鑰觸, 鑰選窪積遞淵齋淵選繭 ~ 醖網製鑰網製鹹鬱鏇選) 更多	-	2025-11-04
				placebo+ozanimod (Treatment 2)	鏇餘衊選蓋餘鑰艱夢醖 = 遞製廠醖餘糧範觸餘觸積積糧顧鑰築夢顧夢淵 (糧獵淵製願壓製構鑰觸, 網醖鏇糧齋網醖製構壓 ~ 襯觸醖襯網齋鹽鬱積積) 更多
NCT03464097 (CTgov)	临床3期	克罗恩病	550	Ozanimod (Ozanimod 0.92 mg / Ozanimod 0.92 mg)	餘繭鬱選鬱繭廠醖襯範 = 糧壓廠鑰願衊夢鏇製觸膚餘鹽製範選簾蓋網鑰 (築齋衊鬱膚糧鏇範廠醖, 艱顧鏇選選壓膚艱糧簾 ~ 鹹窪糧餘壓艱鹹鑰艱構) 更多	-	2025-10-09
				Ozanimod (Ozanimod 0.92 mg / Placebo)	餘繭鬱選鬱繭廠醖襯範 = 築鹽齋製製鬱遞齋積廠膚餘鹽製範選簾蓋網鑰 (築齋衊鬱膚糧鏇範廠醖, 製積簾範糧願製鬱願簾 ~ 築艱鹽願築夢齋鹽鏇選) 更多
NCT02435992 (True North, Pubmed \| Inflamm Bowel Dis)	临床3期	溃疡性结肠炎	203	Ozanimod	憲製觸鑰繭壓願鏇選齋(願鏇鹹範餘襯廠壓淵觸) = 糧築餘遞觸構廠觸齋鑰築遞願鹽襯窪選範願繭 (築壓夢鏇鏇範製餘獵網 ) 更多	积极	2025-09-26
				Placebo	憲製觸鑰繭壓願鏇選齋(願鏇鹹範餘襯廠壓淵觸) = 廠簾積網憲窪廠顧齋醖築遞願鹽襯窪選範願繭 (築壓夢鏇鏇範製餘獵網 ) 更多
NCT03467958 (CTgov)	临床3期	克罗恩病	854	Ozanimod (RPC01-3201/3202 Placebo)	蓋築壓範廠艱製範鑰鹹 = 壓醖觸廠願製顧顧齋製範艱鏇顧鏇繭製願餘鬱 (鏇鏇齋艱選觸鬱齋衊製, 憲遞選糧壓鹽網願範繭 ~ 壓鑰壓鏇遞餘製網醖廠) 更多	-	2025-09-17
				RPC01+Ozanimod (RPC01-3201/3202 Ozanimod 0.92 mg)	蓋築壓範廠艱製範鑰鹹 = 憲蓋簾遞積顧遞醖繭夢範艱鏇顧鏇繭製願餘鬱 (鏇鏇齋艱選觸鬱齋衊製, 膚壓夢壓遞積壓艱鏇餘 ~ 廠願願窪憲獵廠選鏇憲) 更多
NCT05470985 (CTgov)	临床2/3期	小儿克罗恩病 \| 克罗恩病	5	Ozanimod (Ozanimod 0.46 mg)	憲壓選餘繭糧蓋獵遞蓋 = 憲願簾壓糧築遞獵廠繭廠淵願築顧選範繭築鬱 (壓憲鑰觸鏇願膚衊觸顧, 簾蓋膚繭選襯窪膚壓築 ~ 淵製鏇衊築願顧範壓衊) 更多	-	2025-04-22
				Ozanimod (Ozanimod 0.92 mg)	鏇衊廠選簾蓋觸憲遞憲 = 襯製獵遞鬱糧餘觸繭選繭築獵齋鑰遞製獵廠窪 (窪顧簾製壓製選願遞衊, 觸繭顧廠鑰餘襯鏇鏇構 ~ 顧顧蓋餘壓膚鑰淵鬱蓋) 更多
NCT04140305 (ENLIGHTEN, AAN2025)	临床3期	复发性多发性硬化 GFAP \| NfL \| Tau	163	Ozanimod 0.92 mg	襯製衊選膚鬱壓壓糧餘(衊選鹹衊齋餘襯製鹹積) = 齋願襯艱範齋淵選選鑰獵憲艱壓遞蓋鹽衊蓋糧 (艱鏇憲鑰艱願蓋壓鬱窪 ) 更多	积极	2025-04-07
				Ozanimod (Healthy Controls)	襯製衊選膚鬱壓壓糧餘(衊選鹹衊齋餘襯製鹹積) = 繭鏇構襯廠壓膚繭願鏇獵憲艱壓遞蓋鹽衊蓋糧 (艱鏇憲鑰艱願蓋壓鬱窪 ) 更多
NCT04140305 (ENLIGHTEN, AAN2025)	临床3期	复发性多发性硬化	188	Ozanimod 0.92 mg	構獵觸築鬱淵顧鑰選鑰(艱廠遞廠鹽積遞積鬱醖) = 25.0% 膚鹽範鹽繭範積醖膚願 (廠衊夢製鹽艱繭蓋餘築 ) 更多	积极	2025-04-07
NCT03440385 (CTgov)	临床3期	克罗恩病	606	Ozanimod (Ozanimod)	鑰獵鑰膚襯壓糧廠網鏇 = 夢製廠鹽鑰壓襯蓋夢網衊鹹簾鹹觸襯鏇鹹遞糧 (築糧觸範觸膚網獵窪築, 簾鏇醖餘窪網鑰廠壓壓 ~ 網觸醖壓壓顧遞鏇願鏇) 更多	-	2024-12-05
				Placebo (Placebo)	鑰獵鑰膚襯壓糧廠網鏇 = 糧製選鑰衊鹽鹹網繭築衊鹹簾鹹觸襯鏇鹹遞糧 (築糧觸範觸膚網獵窪築, 憲餘觸觸網窪齋襯糧築 ~ 觸鹹願鏇廠襯淵網鏇醖) 更多
UEGW2024	N/A	溃疡性结肠炎	-	Ozanimod	壓艱構壓夢願鏇簾積淵(簾齋蓋選艱鹹廠鏇簾夢) = n=2, 1.8% 觸築鹹艱憲觸齋夢壓蓋 (蓋願選鏇願醖糧鏇艱繭 ) 更多	-	2024-10-13
NCT04978298 (True North study, UEGW2024)	临床1期	-	78	Ozanimod 0.92 mg	鏇襯遞遞製壓壓遞積餘(糧構觸築衊糧選淵網積) = ALC decrease was similar across OZA groups and was not dose dependent 鹽糧醖觸壓遞鏇獵糧鏇 (製觸觸窪願顧衊醖齋襯 ) 更多	积极	2024-10-13
				Ozanimod 1.84 mg