This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another.
Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet.
Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2025-10-20

申办/合作机构

Boehringer Ingelheim GmbH

NCT07141810

/ Not yet recruiting临床4期IIT

Early Antifibrotic Therapy for f-ILD

Early antifibrotic therapy for f-ILD

开始日期2025-10-01

申办/合作机构

上海市肺科医院

NCT06912763

/ Not yet recruiting临床2期IIT

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.

开始日期2025-09-18

申办/合作机构-

100 项与吡非尼酮相关的临床结果

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100 项与吡非尼酮相关的转化医学

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100 项与吡非尼酮相关的专利（医药）

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2,503

项与吡非尼酮相关的文献（医药）

2025-12-01·Annals of Diagnostic Pathology

Relationship between fibroblastic foci and respiratory function: Does the abundance of fibroblastic foci reflect a recent decline in respiratory function?

Article

作者: Sakamoto, Ryo ; Nakajima, Daisuke ; Tanaka, Satona ; Handa, Tomohiro ; Date, Hiroshi ; Hamaji, Masatsugu ; Katsuragawa, Hiroyuki ; Haga, Hironori ; Ito, Hiroaki ; Yoshizawa, Akihiko

AIMS:

Fibroblastic foci (FF) are main findings in idiopathic pulmonary fibrosis (IPF) but are not specific to IPF. Pirfenidone and nintedanib are standard antifibrotic treatments for IPF and affect factors associated with fibroblasts. A proportion of interstitial lung diseases (ILDs) are progressive fibrosing ILDs (PF-ILDs). This progressive fibrosing phenotype includes various ILDs, including fibrotic hypersensitivity pneumonitis (FHP) and connective tissue disease-related ILD (CTD-ILD). We examined the relationship between FF and a relative decline in respiratory function.

METHODS AND RESULTS:

Among patients with lung transplantation (LT), those diagnosed with IPF, nonspecific interstitial pneumonia (NSIP), CTD-ILD, and FHP for whom respiratory function test results within 24 months before LT were retrospectively available were included (n = 67). Patients were classified as PF-ILD+ or PF-ILD- based on the criteria for the progression of a relative decline in the predicted value of forced vital capacity (FVC) within 24 months before LT. We classified FF into peripheral (pFF), alveolar (aFF), centrilobular (cFF), and distorted or dense fibrotic lesions (dFF). The number of FF/cm² at each location was counted, and its percentage was calculated. Spearman's rank correlation coefficient between a relative decline in %FVC and total FF/cm² in NSIP was 0.721. The dFF/cm² and dFF/total FF ratios were higher and the aFF/total FF ratio was lower in the PF-ILD+ group than in the PF-ILD- group.

CONCLUSION:

Total FF correlated with relative declines in %FVC in NSIP. Higher dFF/total FF ratios were associated with progressive status, and higher aFF/total FF ratios were associated with less progressive status.

2025-12-01·AUTOIMMUNITY REVIEWS

Updated systematic literature review and meta-analysis to inform the Italian Society of Rheumatology Recommendations on the treatment of rheumatoid arthritis-associated interstitial lung disease

Review

作者: Mancuso, S ; De Lorenzis, E ; Manfredi, A ; Cozzini, F ; Radin, M ; Pollastri, F ; Carrara, G ; Fassio, A ; Landolfi, G ; Sebastiani, M ; Ughi, N ; Rozza, D ; Crotti, C

BACKGROUND:

rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a severe extra-articular manifestation of rheumatoid arthritis (RA). Despite recent guideline initiatives, no treatment recommendations specifically tailored to RA-ILD have been developed in Italy. This systematic literature review (SLR) and meta-analysis was conducted to inform the Italian Society of Rheumatology (SIR) national recommendations for the management of RA-ILD.

METHODS:

we conducted a systematic review and meta-analysis of studies evaluating pharmacological interventions for RA-ILD from inception up to October 2023, followed by an update up to April 2025, with a pre-defined protocol. Eligible studies included randomized controlled trials, cohort studies, and case series reporting pulmonary function outcomes, radiological progression, adverse events, and mortality. Meta-analyses were performed, and heterogeneity and publication bias were thoroughly assessed.

RESULTS:

sixty-nine studies encompassing 7879 RA-ILD patients were included. Treatments with conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), rituximab (RTX), mycophenolate mofetil (MMF), abatacept (ABA), and Janus kinase inhibitors (JAKi) were associated with stabilization or improvement of forced vital capacity (FVC). Methotrexate (MTX) was associated with reduced risk of ILD progression and mortality. Antifibrotics, particularly nintedanib, demonstrated variable efficacy, while pirfenidone showed limited benefit. Safety profiles favored antifibrotics over csDMARDs/immunosuppressants regarding serious adverse events.

CONCLUSIONS:

this SLR provides an updated synthesis of evidence on RA-ILD treatments, supporting the forthcoming SIR recommendations. Despite inherent limitations of observational studies and heterogeneity, the data highlight the safety of MTX and particularly support ABA, RTX, and nintedanib as promising options, while underscoring the need for further high-quality trials specifically in RA-ILD.

2025-11-01·HEART & LUNG

Perioperative antifibrotic therapy for patients with idiopathic pulmonary fibrosis undergoing lung cancer surgery: A systematic review and meta-analysis

Review

作者: Moua, Teng ; De Giacomi, Federica ; Ryu, Jay H ; Srivali, Narat

BACKGROUND:

Patients with idiopathic pulmonary fibrosis (IPF) undergoing lung cancer surgery face a 4.4-20 % risk of acute exacerbation (AE-IPF) with mortality exceeding 50 %. The potential role of perioperative antifibrotic therapy in reducing surgical complications in this high-risk population remains unclear.

OBJECTIVES:

To evaluate whether perioperative antifibrotic therapy (pirfenidone/nintedanib) reduces complications, particularly acute exacerbations and mortality, in IPF patients undergoing lung cancer surgery through systematic review and meta-analysis.

METHODS:

Following PRISMA guidelines, we conducted a systematic review and meta-analysis of observational studies examining perioperative antifibrotic therapy in IPF patients undergoing lung cancer surgery. Four studies comprising 261 patients (124 treated, 137 controls) from Japan and Italy (2016-2024) were analyzed. Pooled risk ratios were calculated using Review Manager 5.4. The study protocol was registered with PROSPERO (ID: CRD42025649005).

RESULTS:

Perioperative antifibrotic therapy achieved a 69 % reduction in AE-IPF risk (RR 0.31, 95 % CI 0.13-0.70) and an 81 % reduction in 90-day mortality (RR 0.19, 95 % CI 0.07-0.52). Additional benefits included significantly shorter hospital stays (5 vs 7 days, p = 0.029) and reduced complications, including decreased prolonged air leak rates (3.4 % vs 26.9 %). Adverse events were minimal, consisting primarily of mild nausea and photosensitivity.

CONCLUSIONS:

Perioperative antifibrotic therapy significantly reduces acute exacerbations and mortality in IPF patients undergoing lung cancer surgery. However, findings are limited by small observational studies concentrated in specific geographic regions. Randomized controlled trials are needed to confirm efficacy and establish standardized treatment protocols.

318

项与吡非尼酮相关的新闻（医药）

2025-09-15

·GlobeNewswire-Health Care

Avalyn to Highlight AURA-IPF Phase 2 Clinical Trial Design for AP02, Inhaled Nintedanib, at the European Respiratory Society International Congress 2025

CAMBRIDGE, Mass., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced a poster presentation highlighting its AURA-IPF Phase 2 clinical trial design for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis, at the European Respiratory Society (ERS) International Congress 2025. The congress will be held September 27 - October 1, 2025, in Amsterdam, Netherlands. “We are excited to unveil the study design for AURA-IPF, our planned Phase 2 clinical trial of AP02 for the treatment of idiopathic pulmonary fibrosis, at this year’s ERS congress,” said Howard M. Lazarus, M.D., FCCP, Chief Medical Officer at Avalyn. "The AURA-IPF study design was informed by our successful Phase 1 studies of AP02, which demonstrated favorable tolerability, improved drug concentrations in the lungs and reduced systemic exposure compared to oral nintedanib, the current standard of care. These encouraging findings suggest that our inhaled delivery approach may provide enhanced therapeutic benefit with fewer side effects thus enabling long-term treatment. We look forward to advancing AP02 as rapidly as possible for patients who urgently need better treatment options." Avalyn’s abstract is available on the ERS International Congress 2025 online program. Poster Presentation Details: Title: Inhalation Innovation: Phase 2 Study Design of Inhaled Nintedanib in the Treatment of Idiopathic Pulmonary FibrosisAuthors: Michael Kreuter, Howard M. Lazarus, Debra Murwin, Elena Alhaja, Craig S. Conoscenti, Joyce LeeSession: PS-37, Poster #: PA5139 Date and Time: September 30, 2025, between 8:00 a.m. - 9:30 a.m. CEST About Avalyn PharmaAvalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Investor Contact:Alex Straus, THRUST alex@thrustsc.comir@avalynpharma.com Media Contact:Kat Lippincott, Deerfield Groupkat.lippincott@deerfieldgroup.commedia@avalynpharma.com

临床2期临床结果临床1期

2025-09-10

·科兴制药

强强联合拓新局！科兴制药引进人福普克乙磺酸尼达尼布共启呼吸领域全球征程

近日，公司与行业知名制药企业人福医药集团股份公司（以下简称“人福医药”，600079.SH）全资子公司人福普克药业（武汉）有限公司（以下简称“人福普克”）达成乙磺酸尼达尼布软胶囊的海外商业化合作。呼吸领域重磅药物全球商业价值持续攀升乙磺酸尼达尼布软胶囊全球唯二已获批且受指南推荐的特发性肺纤维化（IPF）治疗药物（另一款为吡非尼酮）。主要适应症为特发性肺纤维化（IPF）、具有进行性表型的慢性纤维化间质性肺疾病（ILDs）以及减缓系统性硬化症相关间质性肺疾病（SSc-ILD）患者的肺功能下降速度。作为多靶点酪氨酸激酶抑制剂，尼达尼布通过阻断血管内皮生长因子受体（VEGFR）、血小板衍生生长因子受体（PDGFR）和成纤维细胞生长因子受体（FGFR）的活性，抑制成纤维细胞增殖和炎症反应，从而减缓肺纤维化进程。凭借明确的临床疗效与安全性，该药物的原研药已在中国、美国、欧盟等全球数十个国家和地区成为呼吸领域临床治疗的核心选择。人福普克的乙磺酸尼达尼布软胶囊为中美双报项目，于2023年在国内获批，美国预计2026年可获批。商业价值方面，乙磺酸尼达尼布展现出强劲增长动力。原研药2023年销售额为35.1亿欧元，2024年销售额37.66亿欧元，同比增长7.3%。同时，数据显示，2015～2022年，全球IPF患病人数由140万人增长至170万人，复合年增长率为3.0%，预计2025年患病人数将达到180万人,尼达尼布作为呼吸领域抗纤维化重磅级产品，将持续发力保持有力增长。锚定跨国发展目标欧盟市场潜力巨大本次乙磺酸尼达尼布的海外商业化合作区域，包括除中国大陆（包括港澳台）、美国、沙特阿拉伯、厄瓜多尔、玻利维亚、巴拉圭、乌拉圭以外的全球其他国家和地区。凭借在生物药领域三十多年的深厚积累，科兴制药早已形成涵盖海外市场洞察、高效注册申报、精准营销推广的全链条国际化综合能力，也让“快速注册”逐步成为公司国际化竞争的核心优势。公司合作引进的核心产品白蛋白紫杉醇（下称 “白紫”）自2024年欧盟获批以来，已成功登陆全球30余个国家和地区，是公司海外商业化的拳头品种之一。白紫在欧盟的顺利推进同时也让科兴制药海外商业化迈进2.0时代，实现从新兴市场向欧盟市场的拓展，海外营销渠道进一步覆盖至70个国家和地区，以“全球选品，全球覆盖”的平台型出海模式，在海外重点市场建立子公司或办事处，强化本土化营销，深耕欧盟、拉美、东南亚、中东北非等医药市场。此次承接乙磺酸尼达尼布海外商业化亦包含了欧盟市场权益，将进一步扩充科兴制药在欧盟市场的产品布局。人福医药成立于1993年，1997年在上海证券交易所上市，是湖北省医药工业龙头企业、中国医药工业20强、国家企业技术中心、国家技术创新示范企业、中国医药企业制剂国际化先导企业，已在国内的神经系统用药、甾体激素类药物、维吾尔药等多个细分领域建立了领先地位。作为人福医药的全资子公司，人福普克的研发、生产实力强劲，与科兴制药的海外商业化能力将形成协同效应，叠加乙磺酸尼达尼布的全球临床认可度与“中美双报”优势，双方的合作值得期待！关于科兴制药科兴制药（股票代码：688136）是一家专注于重组蛋白、多功能抗体、细胞基因治疗等药物的研发、生产、销售一体化的创新型跨国生物制药企业。聚焦抗肿瘤、自身免疫、抗病毒等治疗领域，围绕未被满足的临床需求，打造新型蛋白、新型抗体、核酸药物等前沿生物技术平台，开发精准治疗及新型靶向递送药物，坚持“创新+国际化”双轮驱动的平台型发展模式，致力于成为高品质生物药领导者，服务全球患者。公司核心产品稳居国内同类品种前列，覆盖全国各省市地区约20000家终端，其中等级医院约8000家，已通过欧盟、巴西、菲律宾、印度尼西亚等全球70多个国家的市场准入并实现销售。推荐阅读 *药出海热点丨一文掌握2025年8月医药出海资讯 *CPHI（深圳）——中国医药产业出海新兴市场发展论坛顺利召开科兴制药携手合作伙伴共拓蓝海 *特应性皮炎药物，新兴市场的强烈需求

申请上市临床申请上市批准

2025-09-06

·动脉网

1亿美元D轮融资！Avalyn Pharma 以吸入疗法破局肺纤维化治疗

近日，专注于吸入式肺纤维化疗法开发的生物技术公司Avalyn Pharma宣布完成超额认购的1亿美元D轮融资。此次融资由Suvretta Capital Management和SR One共同领投，Norwest Venture Partners、Perceptive Advisors等现有投资者跟投。本轮融资将主要用于支持Avalyn在肺纤维化治疗领域的关键临床进展，包括推进核心候选药物AP01（吸入式吡非尼酮）在全球范围内开展的IIb期临床试验、AP02（吸入式尼达尼布）的后期开发，以及AP03（吡非尼酮/尼达尼布固定剂量组合）进入I期临床阶段。通过对三款产品的并行投入，Avalyn正逐步构建其在吸入式抗纤维化领域的多元化产品布局。 01 吸入递送+局部靶向，打造减毒保效新路径在罕见肺部疾病治疗领域，特发性肺纤维化（IPF）犹如一座难以攻克的堡垒。这种起病隐匿、进展迅猛的间质性肺病，病程堪比恶性肿瘤，患者中位生存期仅3-5年[1]，超过200种病理类型的间质性肺病（ILD）最终多发展为肺纤维化，严重威胁患者生命健康。尽管吡非尼酮与尼达尼布等抗纤维化药物已获批，但口服制剂带来的普遍副作用与有限依从性，成为患者治疗路上的巨大阻碍。 Avalyn Pharma正是在这一背景下切入，试图通过构建“吸入递送+局部靶向”的治疗路径，在疗效兑现与长期耐受之间寻找更优解。其核心技术策略是——将已被验证有效、但因全身暴露而毒副作用显著的现有药物重新开发为吸入配方。药物借助微粒径雾化装置，精准沉积于肺泡区域，绕开胃肠道吸收与肝脏首过代谢，大幅减少系统毒性，提升肺部局部浓度。这不仅实现了“减毒保效”，更为纤维化类慢性病患者提供了可长期坚持的治疗可能。 02 从单药优化到联合治疗，构建多元吸入疗法管线 Avalyn目前围绕吸入式抗纤维化平台，搭建了以AP01、AP02、AP03为核心的候选药物组合，致力于解决肺部纤维化治疗的两大关键难题：疗效不足与系统性不良反应频发。图1：Avalyn管线一览（信息来源：Avalyn官网） ■ AP01：首个核心产品，重塑吡非尼酮安全性与依从性吡非尼酮（Pirfenidone）作为经临床验证的抗纤维化药物，虽可通过调节细胞因子与生长因子发挥抗炎及抗纤维化作用，但口服剂型存在显著局限性：系统性暴露导致胃肠道不适、皮肤反应等副作用频发，临床中常需通过降低剂量控制毒性，却又不可避免地削弱疗效，形成“疗效-毒性”的治疗矛盾。 Avalyn将口服吡非尼酮重构为吸入剂型，通过FDA认证的eFlow雾化器实现软雾输送。该技术使药物以微粒径直接沉积于肺泡区域，相比口服制剂剂量降低的同时，精准靶向肺部病灶——既绕开胃肠道吸收与肝脏首过代谢，又避免全身循环导致的毒副作用，实现“肺部高浓度、全身低暴露”的递送优势。在完成的Ib期临床研究中，AP01显示出良好的安全性和耐受性。[2]目前，AP01正在招募患者参加全球多中心IIb期临床，旨在进一步评估其在目标患者群体中的有效性与安全性，并为后续关键性Ⅲ期研究提供依据。 ■ AP02：吸入式尼达尼布，拓展患者人群适用性尼达尼布（Nintedanib）作为多靶点酪氨酸激酶抑制剂，可有效阻断肺纤维化进程，但口服给药的系统性暴露导致腹泻、高胆红素血症、药物性肝损伤等不良反应发生率较高。通过吸入递送技术重构尼达尼布的给药路径，开发AP02吸入剂型。借助专用雾化装置，药物直接作用于肺部病灶，大幅减少全身暴露量。目前，AP02完成了单次递增剂量（SAD）和多次递增剂量（MAD）的Ⅰ期临床试验，该试验在所有剂量水平下都证明了安全性和耐受性以及良好的药代动力学特征。值得注意的是，临床数据显示，与150 mg口服剂量相比，单次4 mg AP02剂量的肺部暴露量高出20倍以上。 Avalyn将其定位为AP01的重要补充，用于覆盖对吡非尼酮疗效不足或不耐受的人群，尤其聚焦于进展性肺纤维化（PPF）和系统性硬化相关间质性肺病（SSc-ILD）等适应症。计划中AP02将被推进到IPF适应症Ⅱ期临床，后续将根据疗效与耐受性数据，与AP01形成差异化组合策略。 ■ AP03：多靶点组合开发中的早期项目临床研究表明，吡非尼酮与尼达尼布联合口服虽可能增强抗纤维化效果，但叠加的系统性毒性（如肝损伤风险升高）使联合疗法在临床中不可行。传统口服途径无法解决“联合增效”与“毒性累加”的矛盾，成为抗纤维化治疗的重要技术壁垒。 AP03采用“吸入固定剂量组合”策略，将两种药物通过气溶胶肺输送技术实现同步递送。该设计利用吸入疗法的局部靶向特性，在肺部病灶区形成药物协同效应，同时避免全身联合用药的毒性叠加。临床前数据显示，该组合在动物模型中展现出优于单药的抗纤维化效果，且未观察到新增毒副作用。目前，Avalyn正在推进AP03的IND支持研究，并计划进行Ⅰ期临床试验。尽管尚处于临床前阶段，但该项目体现了Avalyn在平台层面对“精准递送+多靶点协同”的持续创新路径，具备向更复杂疾病谱系拓展的潜力。整体来看，Avalyn正借助吸入式递送这一差异化平台，围绕肺部纤维化这一高度未满足领域构建多元产品组合，在提升疗效、优化安全性与扩大适应症范围之间形成良性协同，展现出较强的技术护城河与商业落地潜力。 03 四轮融资加持，临床、监管协同发力自2011年在西雅图成立以来，Avalyn从一家专注雾化递送技术的小型初创公司，迅速成长为具备完整候选药物管线与生态运作能力的临床阶段生物医药企业。 Avalyn Pharma自平台构建阶段起便获得资本高度认可，迄今累计完成四轮融资，总额超3亿美元，为其推进核心管线开发、临床试验扩展及平台生态搭建提供了坚实支撑。表1：Avalyn融资情况一览（信息来源：Avalyn官网）在融资的推动下，Avalyn同步构建了完整的生态体系。一方面，Avalyn与美国ILD Collaborative Research Network（间质性肺病研究网络）及多家大学附属医院合作开展临床研究，保证数据质量与临床效率。另一方面，其主力产品AP01已获得FDA快速通道资格，加速审批进程。Avalyn同步启动生产基地建设与供应链验证等商业化准备，为未来获批上市后迅速交付打下基础。融资、临床、监管与商业能力协同发力，Avalyn从平台孵化期稳步迈向临床产品驱动型企业，构建起具有竞争壁垒的肺部吸入治疗产品矩阵。尽管目前肺纤维化治疗手段有限，但随着像Avalyn这样的企业不断推进局部靶向药物开发，未来可能出现一批更安全、可长期使用、依从性更高的新疗法。参考文献： [1] Lederer DJ, Martinez FJ. Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 May 10;378(19):1811-1823. doi: 10.1056/NEJMra1705751. PMID: 29742380. [2] West A, Chaudhuri N, Barczyk A, et alInhaled pirfenidone solution (AP01) for IPF: a randomised, open-label, dose–response trialThorax 2023;78:882-889. 如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。动脉网，未来医疗服务平台

100 项与吡非尼酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01583	吡非尼酮	L04AX05	DB04951

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
特发性肺纤维化	日本	Shionogi & Co., Ltd.	2008-10-16

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
系统性硬化相关的间质性肺病	临床3期	中国	GNI Group Ltd.	2023-05-29
煤肺病	临床3期	-	北京康蒂尼药业股份有限公司	2022-04-15
尘肺病	临床3期	-	北京康蒂尼药业股份有限公司	2022-04-15
矽肺	临床3期	-	北京康蒂尼药业股份有限公司	2022-04-15
皮肌炎	临床3期	中国	北京康蒂尼药业股份有限公司	2018-06-01
间质性肺疾病	临床3期	中国	北京康蒂尼药业股份有限公司	2017-10-31
硬化肼胝症	临床3期	中国	北京康蒂尼药业股份有限公司	2017-10-31
进展性肺纤维化	临床2期	美国	Avalyn Pharma Inc.	2024-04-03
进展性肺纤维化	临床2期	阿根廷	Avalyn Pharma Inc.	2024-04-03
进展性肺纤维化	临床2期	澳大利亚	Avalyn Pharma Inc.	2024-04-03

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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


ASCO2025	N/A	特发性肺纤维化	4,529	Pirfenidone	獵構膚鏇夢艱構遞選夢(壓構壓積壓鑰膚鹹積鏇) = 夢遞網鏇選觸夢蓋醖壓觸獵衊襯艱鬱夢簾獵艱 (繭選網繭繭繭襯鹹簾壓 )	积极	2025-05-30
				Non-Pirfenidone	獵構膚鏇夢艱構遞選夢(壓構壓積壓鑰膚鹹積鏇) = 壓窪蓋夢鏇獵網繭鑰鹽觸獵衊襯艱鬱夢簾獵艱 (繭選網繭繭繭襯鹹簾壓 )
ATLAS Phase 1b Trial (ATS2025)	临床1期	特发性肺纤维化	64	Nebulised AP01 50mg QD	憲構壓網顧製淵鬱艱網(鏇鹽網廠築鏇願憲遞鑰) = 餘築鏇願遞願繭鑰憲構壓蓋築廠糧鏇鑰壓醖糧 (淵構遞衊簾廠獵範選選 ) 更多	积极	2025-05-16
				Nebulised AP01 100mg BID	憲構壓網顧製淵鬱艱網(鏇鹽網廠築鏇願憲遞鑰) = 廠餘膚鏇齋顧糧選鑰淵壓蓋築廠糧鏇鑰壓醖糧 (淵構遞衊簾廠獵範選選 ) 更多
AP01-002 (ATLAS) (ATS2025)	N/A	-	91	50 mg AP01 once daily	醖淵憲齋窪觸衊選衊壓(窪廠夢簾網齋網網齋構) = 範鏇憲淵蓋鬱衊鏇衊襯範鬱壓簾膚蓋網夢衊衊 (糧願艱夢遞膚網鏇鑰憲 )	积极	2025-05-16
				100 mg AP01 twice daily	醖淵憲齋窪觸衊選衊壓(窪廠夢簾網齋網網齋構) = 廠夢壓襯淵鏇顧築簾願範鬱壓簾膚蓋網夢衊衊 (糧願艱夢遞膚網鏇鑰憲 ) 更多
ASTRO2024	临床2期	辐射损伤	134	Pirfenidone plus standard therapy	淵鏇廠鏇範願醖憲網製(鹹鹹鏇積鹽淵選膚襯簾) = 壓鬱鏇遞製夢簾選憲觸艱壓鑰廠選襯構積壓選 (艱鏇鹽積廠顧壓觸糧觸 ) 更多	积极	2024-10-01
WCLC2024	临床2期	肺损伤 PD-1 inhibitors	14	Pirfenidone	顧蓋積齋夢範壓壓觸餘(艱選餘遞鑰襯鹹簾廠衊) = Pirfenidone-related adverse events (≤ grade 2) occurred in 7 patients, including six gastrointestinal reactions and one photosensitivity reaction 獵襯鑰壓製襯壓膚鹹遞 (窪廠鹹鏇遞遞構選構積 )	积极	2024-09-07
				Immune Checkpoint Inhibitors
ATLAS AP01 (ATS2024)	临床1期	特发性肺纤维化 WRVS \| e-Lung volume	63	Nebulised Pirfenidone 100mg BD	衊構衊遞醖鏇網簾獵襯(餘繭範選獵鹽簾餘衊糧) = 醖鑰願獵廠廠襯範醖鏇積築選廠鬱構鹽鏇獵簾 (艱鹹築膚構憲願衊網齋, -5.5% ~ +3.9) 更多	积极	2024-05-19
				Nebulised Pirfenidone 50mg OD	衊構衊遞醖鏇網簾獵襯(餘繭範選獵鹽簾餘衊糧) = 獵鑰簾鏇構鏇糧淵壓繭積築選廠鬱構鹽鏇獵簾 (艱鹹築膚構憲願衊網齋, 1.2% ~ 9.5%) 更多
ATS2024	N/A	特发性肺纤维化	-	Fybro® 400 mg	築願選選鏇願襯鬱襯選(衊鏇夢艱窪選製網繭齋) = 16.5% 夢鹽獵築簾遞範艱夢膚 (壓遞憲廠膚廠製繭醖鏇 ) 更多	-	2024-05-19
NCT02622477 (AERplus, Pubmed \| Pneumologie) 人工标引	N/A	特发性肺纤维化	34	Pirfenidone	鑰選網淵選襯網積顧網(艱獵鹽窪鑰餘壓積鏇糧) = 顧鑰憲襯廠膚餘觸襯範繭鑰積餘遞觸衊憲鹽繭 (鹹範構遞壓餘顧願築觸 ) 更多	积极	2024-04-01
NCT03221257 (SLSIII, CTgov)	临床2期	系统性硬皮病 \| 间质性肺疾病	51	Placebo (Plac)+Mycophenolate Mofetil (MMF) (Placebo (Plac) + Mycophenolate (MMF))	築築觸衊鹽網積襯鹽繭(顧艱選網簾鏇蓋鹽鑰餘) = 鑰鏇鏇網選夢窪鹹淵構齋憲獵餘糧憲廠鹹壓遞 (壓簾鹽鑰鏇壓醖簾觸遞, 1.351) 更多	-	2023-12-15
				Pirfenidone (PFD)+Mycophenolate Mofetil (MMF) (Pirfenidone (PFD) + Mycophenolate (MMF))	築築觸衊鹽網積襯鹽繭(顧艱選網簾鏇蓋鹽鑰餘) = 艱夢簾蓋餘淵觸糧襯憲齋憲獵餘糧憲廠鹹壓遞 (壓簾鹽鑰鏇壓醖簾觸遞, 1.278) 更多
AP01-002 (NEWS) 人工标引	临床1期	特发性肺纤维化	69	pirfenidone	糧簾製壓壓獵壓築齋憲(鑰觸餘築鑰鏇衊繭壓鹽) = 選糧夢蓋鹹範窪膚網網選範鏇範窪艱醖網顧觸 (壓襯鑰餘觸築範鑰構顧, 185.28) 更多	积极	2023-11-09
				pirfenidone	糧簾製壓壓獵壓築齋憲(鑰觸餘築鑰鏇衊繭壓鹽) = 繭顧積襯廠憲顧網蓋鏇選範鏇範窪艱醖網顧觸 (壓襯鑰餘觸築範鑰構顧, 271.17) 更多