A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

开始日期2026-08-29

申办/合作机构

Juno Therapeutics, Inc.

[+1]

NCT07679893

/ Recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension

This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.

开始日期2026-06-30

申办/合作机构

MannKind Corp.

JPRN-jRCT2033260131

/ Not yet recruiting临床3期

开始日期2026-05-14

申办/合作机构

Bristol Myers Squibb Co.

100 项与乙磺酸尼达尼布相关的临床结果

登录后查看更多信息

100 项与乙磺酸尼达尼布相关的转化医学

登录后查看更多信息

100 项与乙磺酸尼达尼布相关的专利（医药）

登录后查看更多信息

2,444

项与乙磺酸尼达尼布相关的文献（医药）

2026-11-01·Respiratory Medicine and Research

Should nintedanib be continued after acute exacerbation of idiopathic pulmonary fibrosis? A retrospective observational study using a nationwide database in Japan

Article

作者: Fushimi, Kiyohide ; Komiya, Kosaku ; Shuto, Hisayuki ; Omori, Shota ; Hagiwara, Akihiko ; Kudoh, Ryohei ; Matsumoto, Hiroyuki

BACKGROUND:

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) carries a high risk of short-term mortality, and optimal management strategies remain unclear. Although recent studies have suggested that antifibrotic therapy improves outcomes following acute exacerbation, whether antifibrotic therapy continuation confers prognostic benefit in patients already receiving treatment at the time of AE remains unclear. In real-world practice, continuation during the acute phase is usually difficult due to adverse events and impaired oral intake.

METHODS:

This retrospective observational cohort study used the Japanese nationwide Diagnosis Procedure Combination database. It included patients hospitalized for AE-IPF between April 2018 and March 2023 and receiving nintedanib before admission. Patients who received nintedanib within 3 days of admission and continued treatment until day 7 were classified as the nintedanib-continued group and the remaining patients as the nintedanib-discontinued group. Propensity score matching was employed for baseline difference adjustment. The primary outcome was in-hospital mortality, whereas the secondary outcomes included survival time from admission to death or discharge and adverse events during hospitalization.

RESULTS:

Of the 572 eligible patients, 181 continued and 391 discontinued nintedanib during hospitalization. After propensity score matching, 146 matched pairs were analyzed. In-hospital mortality did not significantly differ between the continued and discontinued groups. The median in-hospital survival time was identical in both groups (76 days). Adverse events were uncommon and did not significantly differ between the groups.

CONCLUSIONS:

In this nationwide cohort of patients hospitalized for AE-IPF, nintedanib continuation during the acute phase did not result in improved short-term outcomes compared with discontinuation.

2026-09-01·Biofabrication

Targeting the YAP-mediated stromal signaling unlocks chemoresistance in a human organoid fibrosis model

Article

作者: Xiong, Duoer ; Chen, Wei ; Zheng, Qihang ; Chen, You ; Li, Meiqi ; Liu, Jie ; Zhang, Changhua

Abstract:

The fibrotic stroma drives tumor progression and impairs therapy, but existing models fail to capture its dual barrier and signaling roles, limiting mechanistic understanding and therapeutic development. To address this, we established a patient-derived fibrotic tumor model that recapitulates key pathophysiological features: extracellular matrix remodeling, substantial tissue stiffening (12-fold increase), and pro-malignant transcriptomic reprogramming. This model demonstrated microenvironment-mediated chemoresistance, increasing the area under the dose‐response curve by 1.3-fold and suppressing oxaliplatin-induced apoptosis. Although stiffening delayed drug penetration, barrier disruption did not restore sensitivity. Instead, stiffness inactivated the Hippo pathway, activating YAP as the key chemoprotection driver. YAP inhibition restored drug sensitivity without altering stiffness, revealing a targetable biochemical mechanism independent of the physical barrier. Using this insight, we designed a sequential regimen in which nintedanib preconditioning precedes chemotherapy, achieving near-complete tumor eradication (<5% tumor viability). This work provides a physiological model of stromal biology and a mechanism-guided strategy to overcome microenvironment-mediated chemoresistance.

2026-09-01·EXPERIMENTAL EYE RESEARCH

Intravitreal nintedanib attenuates proliferative vitreoretinopathy in a mouse model: Efficacy, safety, and mechanistic insights

Article

作者: Aykut, Aslan ; Şahin, Özlem ; Midi, Ahmet ; Ertaş, Büşra ; Vurgun, Elif Bağatur ; Çetin, Burcu ; Sevik, Mehmet Orkun

BACKGROUND:

To evaluate the efficacy and safety of intravitreal injection of the multityrosine kinase inhibitor nintedanib (NTB) in a mouse model of proliferative vitreoretinopathy (PVR) induced by dispase.

METHODS:

Fifty-two male C57BL/6 mice received intravitreal injections in the right eye and were divided into four groups: PVR, PVR + NTB, NTB-only, and vehicle. Uninjected contralateral eyes served as a healthy-control group. The PVR and PVR + NTB groups were compared based on clinical and histopathological PVR grading. Immunohistochemistry, ELISA, RT-PCR, and Western blot analyses were used to evaluate and compare markers of inflammation, fibrogenesis, and epithelial-mesenchymal transition between PVR, PVR + NTB, and healthy-control groups. Potential retinal toxicity was assessed using electroretinography and histopathology in the NTB-only and vehicle groups.

RESULTS:

Clinical PVR grades were significantly lower in the PVR + NTB group (0.65 ± 0.93) than in the PVR group (2.70 ± 1.75) (p < 0.001). Histopathological grading was also significantly lower in the PVR + NTB group (1.62 ± 0.91) compared with the PVR group (3.87 ± 1.24) (p = 0.002). Compared with the PVR group, IL-6, PDGF, TGF-β, and TNF-α levels, as well as acta-2, col1a1, and fn-1 mRNA expression were significantly lower in the PVR + NTB group. Phosphorylated-PDGFR-α levels were also reduced, whereas PDGFR-α protein expression remained unchanged. No signs of retinal toxicity were observed in electroretinography or histopathology.

CONCLUSIONS:

In this mouse PVR model, intravitreal NTB reduced clinical, histopathological, and biochemical manifestations of PVR without detectable toxicity. Intravitreal NTB may represent a promising therapeutic option for the management of PVR.

1,190

项与乙磺酸尼达尼布相关的新闻（医药）

2026-07-13

·和泽医药

【药闻周选】医药行业重点资讯速览（07.06-07.12）

政策监管动态 1. 中医药振兴发展“十五五”规划获国务院批复 7月7日，国务院批复《中医药振兴发展“十五五”规划》（国函〔2026〕71号），7月10日正式公开发布。《规划》由三部门联合报送，明确要完善中医药传承创新发展机制，加快推进中医药现代化，推动中医药走向世界。国家中医药局与国家发改委将加强统筹协调，对《规划》实施情况进行动态监测和评估。作为“十五五”时期中医药发展的纲领性文件，该规划为未来五年中医药振兴发展明确了方向与路径。 2. CDE启动“先锋计划”，推动类器官等新方法替代动物试验 7月7日，CDE发布通知，就“推进新方法（NAMs）研究和应用试点计划（先锋计划）”的申报指南、申请表及实施框架公开征求意见，征求意见时限为自发布之日起1个月。该计划旨在搭建“产、学、研、监”协同平台，推动类器官、器官芯片等创新方法在药物非临床评价领域的研究与应用，为传统动物实验的逐步替代探索可行路径。全球范围内，FDA已于2022年通过现代化法案2.0取消创新药上市前强制动物实验的联邦要求，EMA和MHRA亦在推进相关监管改革。此次“先锋计划”的推出，标志着中国药监在NAMs监管领域进入政策试点与标准制定的关键阶段。 3. 2026年版国家基本药物目录发布，创新药首次批量入围 7月9日，国家卫生健康委、国家中医药局、国家疾控局三部门联合发布《国家基本药物目录（2026年版）》，自2026年9月1日起施行。新版目录共收录药品794种，新增药品品种116种，调出2种。创新药首次批量纳入新版目录，共计16种入选。国家卫健委药政司司长龚向光表示，此次调整尝试将创新药纳入遴选范围，为今后更多创新药进入基本药物目录探索可行路径。目录新增品种聚焦慢性病和常见病，新增糖尿病用药5种、高血压用药4种、慢性阻塞性肺疾病用药7种、常见消化道疾病用药8种等。此次目录更新将扩大基层药品种类，让更多创新药惠及基层患者。 4. 国家卫健委推动建立患者个体化用药信息库 7月10日，国家卫健委发布通知，提出实施居民连续用药信息联通的医疗卫生机构，应梳理患者诊断情况和用药方案，通过对患者用药指标监测和不同治疗阶段效果的分析，形成患者的个体化用药信息库。通知要求省级卫健部门拓展区域内居民连续用药管理功能，实现居民连续用药信息跨机构调阅和分析应用。此举是“十五五”开局之年推动合理用药、提升基层药学服务能力的重要举措，标志着用药管理从“通用规范”向“个体化精准”升级。行业新品动态 1. 翰宇药业利拉鲁肽化学原料药获NMPA批准 7月6日，翰宇药业（300199.SZ）公告，全资子公司翰宇药业（武汉）有限公司收到NMPA下发的《化学原料药上市申请批准通知书》，化学原料药利拉鲁肽（H）获批上市。公司是国内首家按化学合成途径获批利拉鲁肽的企业。 2. 恒瑞医药口服小分子GLP-1 HRS-7535减重III期研究达主要终点 7月7日，恒瑞医药宣布，口服小分子GLP-1受体激动剂HRS-7535在中国成人肥胖及超重人群中的III期临床试验取得积极顶线数据。该研究纳入556名肥胖成人患者。第44周时，基于治疗方案估计目标，180mg剂量组平均减重9.8%，120mg组平均减重9.5%，安慰剂组为2.5%；第50周时，180mg组平均减重可达11.1%。58.6%—68.2%的参与者体重减轻≥5%，26.0%的参与者体重减轻≥15%。安全性特征与口服GLP-1疗法一致，未观察到新的安全性信号，肝脏安全性良好。恒瑞医药计划今年在中国递交该药用于体重管理的上市申请。 3. 首个埃克替尼片剂仿制药获批上市 7月10日，NMPA官网显示，首个埃克替尼片剂仿制药获批上市，来自昆山龙灯瑞迪制药。原研埃克替尼是贝达药业自主研发的一款一代EGFR-TKI，也是中国第一个自主创新的小分子靶向抗癌新药。该品种是目前唯一一款递交上市申请的埃克替尼片剂仿制药。埃克替尼仿制药的获批将增加EGFR突变非小细胞肺癌患者的用药选择，有助于进一步降低患者用药负担。 4. 智飞生物利拉鲁肽注射液获批上市 7月10日，智飞生物控股子公司重庆宸安生物研发的利拉鲁肽注射液正式获得NMPA批准上市。该药属于GLP-1受体激动剂类药物，本次获批适应症包括成人2型糖尿病患者的血糖控制，以及降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件风险。这是智飞生物在代谢类疾病领域第一款获批上市的治疗用生物制品，标志着该业务板块从研发正式迈入商业化阶段，也是企业“预防+治疗”战略布局纵深推进的重要成果。。 5. 恒瑞“双艾组合”获FDA第三封完整回复函 7月10日，恒瑞医药公告，卡瑞利珠单抗联合rivoceranib（阿帕替尼）用于不可切除或转移性肝细胞癌一线治疗的上市申请，获FDA发出第三封完整回复函（CRL）。该联合疗法此前已多次遭遇审评障碍，此次再度受挫意味着该组合疗法在美国市场的上市进程进一步延后。本次CRL主要与阿帕替尼相关生产场地的CGMP检查观察项有关，未涉及产品临床研究数据、安全性及有效性方面的问题。 6. ST人福尼达尼布软胶囊获美国FDA批准文号 7月10日，ST人福（600079.SH）公告，全资子公司武汉普克收到美国FDA签发的尼达尼布软胶囊ANDA批准文号。该药为处方药，用于治疗成人特发性肺纤维化及具有进行性表型的慢性纤维化性间质性肺疾病-。尼达尼布是治疗特发性肺纤维化的重要药物，此次ANDA获批将丰富国内药企在美国仿制药市场的产品布局。市场与资本动态 1. 华夏英泰完成超2亿元C轮融资 7月6日，中关村生命科学园内企业华夏英泰宣布完成超2亿元人民币C轮融资，由正心谷资本领投，复旦科创跟投。本轮融资将重点用于推进通用型STAR-T核心产品YTS109注册临床开发、加速In vivo STAR-T技术平台建设，以及商业化体系搭建和全球知识产权布局。华夏英泰由清华大学长聘教授林欣于2018年领衔创立，专注于STAR-T技术及通用型定点整合技术平台的研发与转化，累计融资已超过5亿元人民币。 2. 建发致新拟收购建发致瑞100%股权 7月8日晚，建发致新（301584.SZ）公告，公司拟以自有资金收购控股股东建发医疗及弘园医疗持有的建发致瑞100%股权，交易对价3506.68万元。本次收购事项已于2026年7月6日经公司董事会审议通过。收购完成后，建发致瑞将纳入公司合并报表范围。建发致新专注于医疗器械流通行业，标的公司建发致瑞主要为生物制药企业及科研院所提供专业物资流通服务。此次收购旨在向医疗产业链上游相关领域的流通服务业务延伸布局。 3. 中国生物制药以最高19亿美元将TQC3721海外权益授权阿斯利康 7月8日，中国生物制药（01177.HK）公告，将自主研发的慢性阻塞性肺疾病（COPD）创新药TQC3721海外权益以总额最高19亿美元授权给阿斯利康。中国生物制药已获得2亿美元首付款，以及最高17亿美元的开发、监管及销售里程碑付款，外加最高双位数的阶梯式特许权使用费。TQC3721为吸入式PDE3/4双重抑制剂，目前雾化吸入混悬液在中国开展III期临床试验。该交易创下国内呼吸领域近三年单产品对外授权之最。 4. 丰原药业控制权拟变更，蚌埠国资约7亿元接盘 7月9日，丰原药业（000153.SZ）公告，控股股东丰原集团的一致行动人安徽省无为制药厂、马鞍山丰原、蚌埠涂山管理与蚌埠投资集团签署《股份转让意向协议》，拟转让1.09亿股。本次股份转让拟按照丰原药业总市值29.8亿元进行交易，对应交易金额约为7.01亿元。交易完成后，蚌埠市国资委将成为实际控制人。蚌埠投资集团承诺锁定期60个月。本次交易尚需经过国资全面尽职调查、资产评估及审批等程序。

申请上市引进/卖出上市批准

2026-07-13

·米内网

【市场】人福医药1类新药来袭，抢攻300亿市场

精彩内容日前，人福医药发布公告，其全资子公司湖北生物医药产业技术研究院的1类新药HW211026软膏进入II期临床试验研究。米内网数据显示，皮肤病用药（化+生）在2025年中国三大终端六大市场超过300亿元销售规模，同比增长2.31%。 HW211026软膏在2024年10月获得国家药监局核准签发的《药物临床试验批准通知书》（临床试验申请人原为公司全资子公司武汉人福创新药物研发中心，于2025年12月转让至湖北生物医药产业技术研究院），该产品为化药1类新药，获批临床的适应症为用于光化性角化病（AK）的治疗。近年中国三大终端六大市场皮肤病用药（化+生）销售情况（单位：万元）来源：米内网格局数据库米内网数据显示，皮肤病用药（化+生）在近年中国三大终端六大市场（统计范围详见本文末）销售规模持续扩容，2025年超过300亿元，同比增长2.31%。从剂型格局来看，软膏剂的市场份额位居第一，销售额稳步增长。 2025年中国三大终端六大市场皮肤病用药（化+生）剂型格局来源：米内网格局数据库人福医药表示，HW211026软膏作为短期外用创新药，患者依从性良好。截至目前，国内暂无同靶点同适应症药物上市，该项目累计研发投入约4300万元。在此之前，人福医药控股子公司宜昌人福药业的盐酸氢吗啡酮片以仿制3类获批临床，同意本品开展用于成人术后中重度疼痛镇痛的随机对照临床研究，目前该产品未在国内获批上市。药品基本情况 7月11日，人福医药再发公告，其全资子公司人福普克药业（武汉）的尼达尼布软胶囊获得美国FDA批准文号，用于治疗成人：特发性肺纤维化（IPF）；具有进行性表型的慢性纤维化性间质性肺疾病。此次尼达尼布软胶囊获得美国FDA的批准，标志着人福普克药业（武汉）具备在美国市场销售该产品的资格，将对公司拓展美国仿制药市场带来积极的影响，人福普克药业（武汉）后续将积极推进该产品在美国市场的上市准备工作。资料来源：公司公告、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com 稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

2026-07-13

·BioSpace

PureTech Founded Entity Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

SURPASS-IPF is the first industry-sponsored head-to-head Phase 3 trial in IPF and will evaluate the superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Topline data expected in the second half of 2029 BOSTON--(BUSINESS WIRE)-- PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, is pleased to note that its Founded Entity Celea Therapeutics (“Celea”) today announced that the first patient has been dosed in the global Phase 3 SURPASS-IPF trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) vs. pirfenidone 801 mg TID for the treatment of idiopathic pulmonary fibrosis (IPF). The commencement of the potentially registrational Phase 3 trial follows the recent completion of Celea’s $180 million financing , which enables the continued advancement of deupirfenidone as a potential new standard of care for people living with IPF. Robert Lyne, Chief Executive Officer of PureTech commented: "The initiation of SURPASS-IPF marks another important milestone for both PureTech and Celea. Just days after the completion of Celea's financing, the first patient has now been dosed in the first industry-sponsored head-to-head Phase 3 trial in IPF. This rapid progression reflects the strength of the clinical, regulatory, and operational foundation established for the program and the team’s ability to execute as deupirfenidone enters this important stage of development.” The full text of the announcement from Celea is as follows: Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) SURPASS-IPF is the first industry-sponsored head-to-head Phase 3 trial in IPF and will evaluate the superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Topline data expected in the second half of 2029 BOSTON, July 13, 2026 - Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the first patient has been dosed in the global Phase 3 SURPASS-IPF trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) vs. pirfenidone 801 mg TID for the treatment of idiopathic pulmonary fibrosis (IPF). The commencement of the potentially registrational Phase 3 trial follows Celea’s recently completed $180 million financing , enabling the Company to rapidly advance development of deupirfenidone as a potential new standard of care for the treatment of IPF. "The speed with which we have progressed from completing our financing to dosing the first patient in SURPASS-IPF reflects the extensive preparation that preceded this milestone, the strength of our organization, and our unwavering focus on execution," said Sven Dethlefs, PhD, Chief Executive Officer of Celea. “We designed SURPASS-IPF as the first industry-sponsored Phase 3 trial in IPF to evaluate superiority over an approved antifibrotic because we believe deupirfenidone has the potential to achieve a level of efficacy once thought attainable only through combination approaches, while maintaining a favorable tolerability profile. This milestone represents an important step toward delivering a truly differentiated treatment option for people living with this devastating disease." The pivotal Phase 3 SURPASS-IPF trial is a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID over 52 weeks in adults living with IPF who are not receiving background antifibrotic therapy. The trial is designed to evaluate the superiority of deupirfenidone 825 mg TID over pirfenidone 801 mg TID, using change from baseline in absolute forced vital capacity (FVC) as the primary endpoint, while also further characterizing the overall safety and tolerability pro deupirfenidone 825 mg TID. The trial is expected to enroll approximately 1,100 people living with IPF across more than 30 countries. "I’m proud that our site was able to dose the first patient in the SURPASS-IPF trial,” said Rafael Lupercio, M.D., Pulmonologist at Shasta Critical Care Specialists in Redding, CA, and an investigator in the SURPASS-IPF trial. “When discussing clinical trial participation with people living with IPF, study design matters. What stands out to me about SURPASS-IPF is that it directly compares deupirfenidone to an approved antifibrotic. Knowing that every participant will receive active treatment is an important consideration in a disease as serious and progressive as IPF. As both an investigator and a treating physician, I believe this trial has the potential to generate the type of evidence that will be highly meaningful to people living with IPF and the clinicians who care for them.” SURPASS-IPF builds upon the strong results from the global Phase 2b ELEVATE-IPF trial and open-label extension, which together demonstrated the potential for deupirfenidone to substantially reduce lung function decline toward the rate expected with normal physiological aging in healthy older adults over at least 52 weeks, while maintaining a favorable safety and tolerability profile. The Phase 3 trial employs the same active comparator and dosing regimen evaluated in Phase 2b, providing continuity across the clinical development program while expanding evaluation to a larger, global patient population. "We applaud Celea's commitment to advancing care for those impacted by IPF," said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation. "Celea’s Phase 3 SURPASS-IPF trial represents an important step forward for the IPF community and strengthens the path toward more effective treatment options while reflecting the priorities of people living with IPF." SURPASS-IPF was designed to generate robust, high-confidence data while ensuring the clinical trial experience prioritizes patient needs. The trial does not include a placebo arm and instead compares deupirfenidone 825 mg TID directly with an approved standard-of-care therapy, pirfenidone 801 mg TID. This approach ensures that all participants receive active treatment—an important consideration in a progressive and irreversible disease such as IPF. This patient-centric approach builds upon the design principles established in the Phase 2b ELEVATE-IPF trial, which minimized unnecessary placebo exposure duration while generating robust clinical evidence. "As a physician-scientist, I've seen firsthand how difficult treatment decisions can be for people living with IPF and the physicians who care for them," said Camilla Graham, MD, MPH, Senior Vice President of Medical Affairs at Celea. "SURPASS-IPF was designed to answer the question that matters most in clinical practice: can we meaningfully improve upon today's standard of care? Building on the encouraging efficacy and tolerability observed in Phase 2b, this trial has the potential to generate the robust evidence needed to inform future treatment decisions and, ultimately, improve outcomes for people living with IPF." Topline results from the Phase 3 SURPASS-IPF trial are expected in the second half of 2029. Based on feedback from the FDA, results from this single Phase 3 trial, supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone in the U.S. About SURPASS-IPF SURPASS-IPF ( NCT07284602 ) is a global, randomized, double-blind, head-to-head Phase 3 trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit . About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission. It is an investigational, next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019. 1 Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, 2 and currently there is no cure. About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” the name reflects the company’s mission to rise above the status quo and deliver therapies that change lives. Celea’s lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit . About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit or connect with us on LinkedIn and X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the planned development of deupirfenidone and our and Celea’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. 1 Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the American Thoracic Society, 18(7), 1121–1128. 2 Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23 (3-b Suppl), S17–S24. Contacts PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com U.S. Media Justin Chen jchen@tenbridgecommunications.com

临床2期临床3期临床结果孤儿药

100 项与乙磺酸尼达尼布相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10396 D10481	乙磺酸尼达尼布	L01XE31	DB09079

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
局部晚期非小细胞肺癌	澳大利亚	Boehringer Ingelheim Pty Ltd.	2015-09-01
转移性非小细胞肺癌	澳大利亚	Boehringer Ingelheim Pty Ltd.	2015-09-01
复发性非小细胞肺癌	澳大利亚	Boehringer Ingelheim Pty Ltd.	2015-09-01
系统性硬化相关的间质性肺病	欧盟	Boehringer Ingelheim International GmbH	2015-01-14
系统性硬化相关的间质性肺病	冰岛	Boehringer Ingelheim International GmbH	2015-01-14
系统性硬化相关的间质性肺病	列支敦士登	Boehringer Ingelheim International GmbH	2015-01-14
系统性硬化相关的间质性肺病	挪威	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	欧盟	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	冰岛	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	列支敦士登	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	挪威	Boehringer Ingelheim International GmbH	2015-01-14
肺腺癌	欧盟	Boehringer Ingelheim International GmbH	2014-11-21
肺腺癌	冰岛	Boehringer Ingelheim International GmbH	2014-11-21
肺腺癌	列支敦士登	Boehringer Ingelheim International GmbH	2014-11-21
肺腺癌	挪威	Boehringer Ingelheim International GmbH	2014-11-21
特发性肺纤维化	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2014-10-15

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性间质性肺病	申请上市	欧盟	Accord Healthcare SL	2024-02-22
间质性肺疾病	申请上市	美国	Boehringer Ingelheim GmbH	2023-07-25
翼状胬肉	临床3期	美国	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	中国	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	澳大利亚	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	印度	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	新西兰	Cloudbreak Therapeutics LLC	2022-06-30
硬皮病	临床3期	美国	Boehringer Ingelheim International GmbH	2017-12-05
硬皮病	临床3期	日本	Boehringer Ingelheim International GmbH	2017-12-05
硬皮病	临床3期	阿根廷	Boehringer Ingelheim International GmbH	2017-12-05

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2026	N/A	系统性硬化相关的间质性肺病	19	Nintedanib	壓獵顧糧膚繭夢夢網鑰(鏇淵蓋獵夢壓蓋艱艱構) = No statistically significant difference was detected between baseline and 12-month follow-up CT findings (p = 0.07). Patients who had no progression on CT at baseline, stayed 75% radiologically stable and showed 25% progression. Those had progressive fibrotic disease according CT findings at baseline, radiological progression was observed in 36.4% at the end of 12 months. 遞築鏇範網獵鏇齋膚觸 (網蓋醖觸鬱觸糧廠醖齋 )	积极	2026-06-11
EULAR2026	N/A	间质性肺疾病	94	Nintedanib + glucocorticoids + cDMARD + bDMARD +/- JAKi	糧網願糧壓壓網獵糧蓋(簾鬱糧觸觸蓋鹹餘艱簾) = 膚遞獵獵衊壓遞鏇鹽艱鑰膚鏇觸壓廠繭窪遞淵 (淵艱顧膚範遞醖醖積鹽, 20.9) 更多	积极	2026-06-11
				Nintedanib	糧網願糧壓壓網獵糧蓋(簾鬱糧觸觸蓋鹹餘艱簾) = 觸艱襯淵願齋願製願襯鑰膚鏇觸壓廠繭窪遞淵 (淵艱顧膚範遞醖醖積鹽, 20.9) 更多
EULAR2026	N/A	结缔组织病相关间质性肺疾病	72	NintedanibPirfenidone + NintedanibPirfenidone (Antifibrotic Therapy)	憲鏇鏇願膚襯艱鬱醖蓋(膚獵淵蓋憲窪糧窪遞遞) = significant improvements were observed in both FVC (p<0.001 at 6 and 12 months) and DLCO (p<0.001 at 6 and 12 months) for the overall cohort 窪觸網獵糧廠積壓淵鑰 (範鹽夢範餘淵襯繭鏇鑰 ) 更多	积极	2026-06-11
EULAR2026	N/A	风湿性疾病	135	Nintedanib + Nintedanibressants	願鹹夢範鏇製廠糧壓鬱(積願膚選製遞淵顧鹽積) = 獵醖繭網繭鹹製餘淵膚選繭獵鏇積衊鏇觸鏇淵 (壓獵築獵構製顧顧選網 ) 更多	积极	2026-06-11
EULAR2026	N/A	间质性肺疾病	107	Nintedanib	簾襯繭憲膚鬱淵淵衊憲(繭襯選網艱蓋襯觸醖衊) = 淵積積構觸襯築憲構遞齋淵網選醖選醖鏇蓋淵 (鑰襯夢遞簾膚膚選鬱簾 ) 更多	积极	2026-06-11
				Pirfenidone	簾襯繭憲膚鬱淵淵衊憲(繭襯選網艱蓋襯觸醖衊) = 夢膚觸蓋窪獵選遞遞淵齋淵網選醖選醖鏇蓋淵 (鑰襯夢遞簾膚膚選鬱簾 ) 更多
EULAR2026	N/A	间质性肺疾病	1,037	biologic-treated RA	餘齋廠構蓋觸餘鬱簾鑰(遞齋夢窪齋鏇觸鹹衊網) = When available, baseline PFTs showed a median FVC of 99% (60-157) predicted, FEV1 90% (41-145), DLCO 71% (40-98), and values declined at first follow-up to FVC 86% (52-193), FEV1 88% (53-182), DLCO 65% (44-94). 鏇窪窪築鑰衊艱鑰艱觸 (觸艱鹽鏇餘顧鹹遞窪淵 ) 更多	积极	2026-06-11
EULAR2026	N/A	间质性肺疾病	51	Mycophenolate mofetil + Rituximab	憲衊鹹廠鹽鑰繭獵繭製(築鑰積壓鑰鹽蓋鏇憲鹽) = 範衊餘醖膚蓋顧襯蓋齋範艱觸醖範鬱齋獵鬱蓋 (艱選獵窪衊積鹽糧鏇獵 ) 更多	积极	2026-06-11
				Mycophenolate mofetil + Rituximab + Nintedanib	憲衊鹹廠鹽鑰繭獵繭製(築鑰積壓鑰鹽蓋鏇憲鹽) = 醖築選夢糧蓋鑰糧膚憲範艱觸醖範鬱齋獵鬱蓋 (艱選獵窪衊積鹽糧鏇獵 ) 更多
EULAR2026	N/A	类风湿性关节炎伴有类风湿性肺病	526	Abatacept ± other drugs (Non-progressive ILD)	範衊網顧蓋簾壓醖簾簾(簾窪鑰範憲憲顧艱壓艱) = 膚鬱憲蓋膚夢憲選構蓋獵簾餘選範夢衊鹹築廠 (夢膚廠糧憲構襯糧鹽襯 )	积极	2026-06-11
EULAR2026	N/A	间质性肺疾病	64	Nintedanib + Mycophenolate mofetil + Rituximab	襯襯選繭構衊襯選繭獵(範製膚憲夢憲觸衊廠鏇) = 願觸夢醖餘範糧選蓋獵獵醖餘鑰觸壓築觸糧鏇 (醖齋築鹹鹽鏇鹽壓廠鹽 ) 更多	积极	2026-06-11
				Nintedanib + Mycophenolate mofetil + Rituximab	-
EULAR2026	N/A	特发性肺纤维化 \| 系统性硬化相关的间质性肺病	274	Nintedanib (IPF)	壓糧觸衊憲壓衊鬱繭糧(齋艱鹽願餘窪壓鑰憲夢) = 壓夢獵簾夢襯壓襯繭衊衊糧獵鑰鹽範膚窪窪壓 (顧鹹餘願鏇範鹹繭選鬱 ) 更多	积极	2026-06-11
				Nintedanib (SARD-ILD/PPF)	壓糧觸衊憲壓衊鬱繭糧(齋艱鹽願餘窪壓鑰憲夢) = 淵夢膚齋鹽製繭淵醖觸衊糧獵鑰鹽範膚窪窪壓 (顧鹹餘願鏇範鹹繭選鬱 ) 更多