肾上腺素(Adrenaline) - 药物靶点：adrenergic receptor_在研适应症：间歇性哮喘，瞳孔散大，超敏反应_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Adrenaline (JP17)、Adrenaline Hydrochlaride、Adrenaline Hydrochloride

+ [63]

靶点

adrenergic receptor

作用方式

激动剂

作用机制

adrenergic receptor激动剂(肾上腺素能受体家族激动剂)

治疗领域

免疫系统疾病神经系统疾病心血管疾病+ [5]

在研适应症

非在研适应症

原研机构

在研机构

Alfresa Pharma Corp.ARS Pharmaceuticals Operations, Inc.

+ [25]

非在研机构

Amphastar Pharmaceuticals, Inc.Wyeth Consumer Healthcare LLC

Shin Nippon Biomedical Laboratories, Ltd.

+ [3]

权益机构

Aptar France SAS

ARS Pharmaceuticals, Inc.

科园信海（北京）医疗用品贸易有限公司

+ [17]

最高研发阶段批准上市

首次获批日期

美国 (1967-11-08),

哮喘

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、优先审评 (美国)

登录后查看时间轴

结构/序列

分子式C9H13NO3

InChIKeyUCTWMZQNUQWSLP-VIFPVBQESA-N

CAS号51-43-4

关联

399

项与肾上腺素相关的临床试验

NCT07392580

/ Recruiting临床2期IIT

A Single-Arm, Open-Label Study of Intralesional Treatment of Laryngeal Squamous Cell Carcinoma With Cisplatin

The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.

开始日期2026-12-01

申办/合作机构

University of Miami

CTRI/2026/08/116724

/ Not yet recruitingN/AIIT

ANESTHETIC EFFICACY OF 3 VOLUMES OF LIDOCAINE WITH EPINEPHRINE IN INFERIOR ALVEOLAR NERVE BLOCK FOR THE EXTRACTION OF MANDIBULAR 1ST AND 2ND MOLARS. - NIL

开始日期2026-09-08

申办/合作机构-

CTRI/2026/06/113105

/ Not yet recruiting临床1/2期IIT

The Synergistic Effect of Adding Magnesium Sulphate to 4% Articaine With 1:100000 Adrenaline in Mandibular Third Molar Surgery:A Randomised Controlled Study - NIL

开始日期2026-07-27

申办/合作机构-

100 项与肾上腺素相关的临床结果

登录后查看更多信息

100 项与肾上腺素相关的转化医学

登录后查看更多信息

100 项与肾上腺素相关的专利（医药）

登录后查看更多信息

39,762

项与肾上腺素相关的文献（医药）

2027-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Yishen Tongluo formula regulates apoptosis and autophagy in testicular spermatogenic cells of oligoasthenozoospermic rats via the AMPK/mTOR pathway

Article

作者: Miao, Mingsan ; Bi, Fanggang ; Sun, Zixue ; Chen, Jianshe ; Hua, Zhong ; Li, Chenxi ; Chen, Yangdi

ETHNOPHARMACOLOGICAL RELEVANCE:

Yishen Tongluo Formula (YSTLF) is a modern compound formula derived from the traditional Chinese medicine (TCM) theory of "kidney deficiency and collateral obstruction", and consists of seven Chinese medicinal herbs. It has been used clinically to treat oligoasthenozoospermia (OAS) for more than two decades, with proven efficacy and a favorable safety profile. However, its precise molecular mechanism has yet to be fully elucidated.

AIM OF THE STUDY:

The aim was to investigate the therapeutic efficacy and the underlying mechanism of YSTLF in treating OAS associated with the kidney deficiency and collateral obstruction pattern.

MATERIALS AND METHODS:

The chemical constituents of YSTLF were identified by UHPLC-Q-Orbitrap HRMS, and molecular docking was performed between the ten most abundant compounds and AMPK/mTOR. Rat OAS models were established by combined GTW, adrenaline, and ice-water immersion. Pharmacodynamic effects were evaluated through general status, reproductive organ weights, sperm quality, coagulation parameters, and serum sex hormones. Testicular histopathology, ultrastructure, and autolysosomes were examined by HE staining and TEM. Apoptosis was detected by TUNEL staining, and autophagy/apoptosis-related protein expression by IHC. Integrated metabolomics and proteomics with KEGG enrichment were conducted. In GTW-injured GC-1spg cells treated with Compound C or rapamycin, CCK-8 assay assessed viability, flow cytometry evaluated apoptosis, immunofluorescence examined LC3B/cleaved caspase-3 expression and colocalization, and Western blotting/RT-qPCR validated AMPK/mTOR pathway key molecules.

RESULTS:

Among 307 identified compounds (mostly flavonoids), YSTLF improved general status, organ weights, and sperm quality in model rats. The ten most abundant compounds showed binding energies < -7.0 kcal/mol for AMPK/mTOR. Sperm concentration and motility increased dose-dependently. PT and TT were prolonged, FIB decreased, and FSH, LH, T, PRL, and Inh-B were restored. H&E, TEM, and TUNEL revealed alleviated testicular pathology, improved ultrastructure, reduced autolysosomes, and decreased apoptosis. IHC showed downregulated Beclin1 and Bax, and upregulated p62 and Bcl-2. Multi-omics revealed co-enrichment of differential proteins/metabolites in autophagy and mTOR pathways. Western blot/RT-qPCR validated downregulated p-AMPK/AMPK, AMPK mRNA, LC3II, Beclin1, Bax, cleaved caspase-3, and cleaved caspase-3/caspase-3 ratio, alongside upregulated p-mTOR/mTOR, mTOR mRNA, p62, and Bcl-2. In vitro, GTW reduced viability concentration-/time-dependently (stable model: 10%/24 h); YSTLF reversed this (optimal: 15%/24 h), restored viability, reduced apoptosis, and decreased LC3B/cleaved caspase-3 fluorescence/colocalization, while downregulating p-AMPK, LC3II, Bax and upregulating p-mTOR, p62, Bcl-2. Compound C alone mimicked YSTLF's effects without additivity, whereas rapamycin aggravated GTW-induced viability loss, apoptosis, and autophagy/apoptosis co-activation.

CONCLUSION:

YSTLF improved spermatogenic function in rats with OAS (kidney deficiency and collateral obstruction pattern). Its mechanism of action involves regulation of the AMPK/mTOR signaling pathway and restoration of the balance between autophagy and apoptosis.

2026-12-01·Journal of Cardiovascular Translational Research

Ventricle-Specific Biomechanical Responses to Inotropic and Vasoactive Drugs in Human Myocardial Slices

Article

作者: Meuwese, Christiaan L ; Bogers, Ad J J C ; Amesz, Jorik H ; Taverne, Yannick J H J ; Langmuur, Sanne J J ; Manintveld, Olivier C ; de Groot, Natasja M S ; Veen, Kevin M ; Alipour Symakani, Rahi S

Abstract:

This study aimed to compare baseline biomechanical contractile properties between right (RV) and left ventricular (LV) human living myocardial slices (LMS) and explore the effect of dobutamine, noradrenaline, adrenaline, levosimendan and enoximone in both ventricles. Sixty-three slices (33 RV, 30 LV) were produced from 5 explanted hearts. At baseline, RV LMS had a higher maximum contraction force, shorter contraction duration, time to peak and time to relaxation, steeper dF/dt and a larger peak area than LV LMS. Dobutamine administration had a larger effect in RV than LV LMS. Spontaneous, irregular contractions were observed after noradrenaline, adrenaline and dobutamine administration. In conclusion, RV LMS showed a stronger contraction with higher contraction velocity as compared to LV LMS and exhibited a greater response to dobutamine. These findings contribute to the understanding of the RV physiology as a separate entity, advocating for a different approach in treating RV or LV dysfunction.Graphical Abstract

2026-12-01·JOURNAL OF NUTRITIONAL BIOCHEMISTRY

Adrenaline induces oxidative stress-mediated perturbation in cardiac riboflavin metabolism through direct interaction with flavin coenzymes: Protection by melatonin-a mechanistic insight

Article

作者: Bandyopadhyay, Debasish ; Chakraborty, Souradipta ; Sarkar, Sarmistha ; Islam, Saiful ; Nath, Anupama ; Das, Asish Ranjan ; Chattopadhyay, Aindrila

Riboflavin metabolism governs a myriad of redox-driven biochemical processes fundamental to energy production, cellular signaling, and biosynthesis. Flavin adenine dinucleotide (FAD) and flavin mononucleotide (FMN) act as obligatory prosthetic groups for a plethora of regulatory enzymes of key metabolic pathways, correlating riboflavin status directly to cellular energy flux and redox balance. Oxidative stress may disturb physiological activities of riboflavin metabolizing machineries. Chronic stress induces surge in levels of circulatory catecholamines including adrenaline which subsequently undergo auto-oxidation generating free radicals. Cardio-protective efficacy of melatonin is well-documented against cardiovascular diseases. In this study, subcutaneous administration of adrenaline in rats for 10 consecutive days induces an oxidative stress milieu in heart, mimicking a chronic stress model. Adrenaline precipitates antioxidant imbalance, tissue-morphological alterations and disruption of mitochondrial membrane potential accompanied by alterations in tissue riboflavin, FMN and FAD levels and prominent reductions in the activities of riboflavin metabolizing enzymes. Altered levels of these co-factors also disrupt cardiac energy metabolism. However, melatonin protects against these deleterious repercussions of adrenaline. Melatonin safeguards cardiac tissue from inflammation by restraining the surge in interleukin-1 beta, tumor necrosis factor-alpha and interleukin-10 and also from apoptosis by suppression of Caspase-8 and Caspase-3 levels. Intriguingly, isothermal titration calorimetric study revealed spontaneous binding of adrenaline with FAD and FMN. Melatonin also exhibits strong binding affinity for adrenaline. ¹H-NMR spectroscopic studies unveiled fascinating findings concerning the site of interactions of adrenaline with FAD, FMN, and melatonin. Findings suggest that melatonin may impede binding of adrenaline with flavin co-enzymes plausibly by potential encounter and sequestration of adrenaline, FMN or FAD by melatonin.

926

项与肾上腺素相关的新闻（医药）

2026-10-07

·干粉吸入制剂

🫁吸闻乐见：经口鼻吸入制剂国内外技术市场动态(2026年第9期)

『国内动态』国内首仿，上海新黄河制药有限公司申报的布地奈德福莫特罗吸入粉雾剂（Ⅱ）获批上市，原研产品为阿斯利康信必可®都保®(英文商品名:Symbicort® Turbuhaler®)，2005年8月在中国上市。齐鲁制药糠酸氟替卡松鼻用喷雾剂（畅齐灵®）获得国家药品监督管理局批准上市，成为该品种国内首家获批产品，用于治疗2岁及以上患者的季节性和常年性过敏性鼻炎。海思科自主研发的PDE3/4双重抑制剂干粉吸入剂HSK39004（海外代号AN01）公布Ⅱb期顶线阳性结果，顺利达成主要研究终点，关键性Ⅲ期临床试验已经正式启动，有望为COPD维持治疗带来全新的治疗选择。国家药品监督管理局批准Milestone Pharmaceuticals Inc.申报的1类创新药艾曲帕米鼻喷雾剂（商品名称：星必妥）上市，该药用于治疗成人阵发性室上性心动过速（PSVT）急性症状发作，转复为窦性心律。该药品上市为患者提供了新的治疗选择。 CDE 发布关于公开征求《吸入用丙酸倍氯米松混悬液生物等效性研究技术指导原则（征求意见稿）》意见的通知；立生医药吸入制剂PAS转场获美国FDA免检查批准，金谷路智能化工厂首款美国市场产品落地；上药信谊旗下浙江信谊瑞爵制药自主研发的糠酸莫米松鼻喷雾剂完成首批美国市场商业化生产并正式发运，标志着上药信谊向国际高端制剂市场迈出关键一步。 Insilico Medicine正在将其通过AI发现的特发性肺纤维化治疗药物推进至III期人体临床试验。这一进展为计算药物发现领域提供了实证案例，使一款AI药物从早期安全性评估进入到晚期疗效验证阶段。易合医药成功中标温州医科大学“治疗肺纤维化吸入重组蛋白制剂处方及小试工艺开发”项目（项目编号：WMU-2026ZB945）。南昌弘益药业噻托溴铵吸入粉雾剂（弘明瑞®）顺利通过第三届“赣出精品”复核浙江致新医药科技有限公司申报的‌糠酸莫米松鼻喷雾剂‌（受理号CYHS2503621）被拒，签发日期为9月21日。长风药业股份有限公司其全球首创（First-in-Class）用于治疗间质性肺疾病（ILD）的吸入粉雾剂ICF004（化学药1类）的I期临床试验，已顺利完成首例健康志愿者的入组与给药工作。易合医药自主研发的2类改良新药F2008吸入粉雾剂获国家药品监督管理局（NMPA）临床试验批准，拟用于特发性肺纤维化（IPF）治疗。悦康药业YKYY018雾化吸入剂RSV适应症Ⅱ期临床研究启动，有望填补RSV临床治疗空白湖北美林药业有限公司提交的瑞维那新吸入溶液仿制申请（受理号CYHS2602318，化药4类）中，生产企业是‌湖北美林药业‌，受托生产方是‌南京海纳制药有限公司‌，2026年9月17日获CDE受理。利多卡因丙胺卡因气雾剂‌:受理号为CYHS2602321，申请企业为福元药业有限公司，承办日期2026年9月17日。‌‌ 鲑降钙素鼻用喷雾剂‌：受理号CYHS2602211，申请企业为四川普锐特药业，承办日期2026年9月7日。‌‌ 2026年9月4日Pfizer Inc.的Zavegepant鼻喷雾剂申请已获受理，受理号为JXHL2600396。 2026年9月9日，远大医药科技（武汉）有限公司的GPN01564雾化吸入剂申请已获受理，受理号为CXHL2601093。 2026年9月10日，山东京卫制药有限公司的茚达特罗格隆溴铵吸入粉雾剂申请已获受理，受理号为CYHS2602253。 2026年9月10日，西安丽彩医药研发有限公司的奥洛他定莫米松鼻喷雾剂申请已获受理，受理号为CYHL2600097。 2026年9月15日，四川普锐特药业有限公司的茚达特罗格隆溴铵吸入粉雾剂申请已获受理，受理号为CYHS2602284。 2026年9月23日，中曦（福建）药业有限公司的瑞维那新吸入溶液申请已获受理，受理号为CYHS2602392。盐酸氮䓬斯汀鼻喷雾剂‌云南圣科药业有限公司的仿制申请，受理号 CYHS2602390，承办日期2026年9月23日，注册分类4类，合作企业为贵州云峰药业有限公司；『国外动态』 FDA已对Aurobindo Pharma公司的ANDA给予最终批准，涉及40 mcg和80 mcg规格的Teva QVAR倍氯米松HFA定量吸入剂的仿制等效产品，用于治疗哮喘。 Hikma集团宣布其正开发用于过敏反应（过敏性休克）紧急治疗的肾上腺素鼻喷雾剂的监管申报，已获美国、欧洲及英国监管机构受理审评。欧盟委员会已批准该公司的Trixeo（Breztri）Aerosphere布地奈德/格隆溴铵/福莫特罗定量吸入剂，用于治疗12岁及以上、使用ICS/LABA复方制剂仍未充分控制哮喘的患者。在美国，FDA已于2026年4月批准Breztri Aerosphere用于哮喘适应症。 Chiesi其已通过集中审评程序向EMA提交了其两款采用Orbia公司HFA 152a二丙酸倍氯米松/富马酸福莫特罗/格隆溴铵定量吸入剂（Trimbow）的申请，并通过以德国为参考成员国的非集中审评程序提交了HFA 152a二丙酸倍氯米松/富马酸福莫特罗定量吸入剂（Fostair）的申请。美国FDA 授予 Insmed 公司 ARIKAYCE®（阿米卡星脂质体吸入混悬液）治疗 MAC 肺病的补充新药申请优先审评资格，PDUFA目标审评日期定为 2027 年 1 月 28 日； FDA已授予Liquidia公司的Yutrepia吸入用曲前列尼尔干粉剂快速通道资格，用于治疗与系统性硬化症相关的雷诺现象（SSc-RP）。Yutrepia目前在美国已获批用于治疗肺动脉高压（PAH）和间质性肺病相关肺高压（PH-ILD）。 Glenmark宣布Ryaltris奥洛他定/莫米松鼻喷雾剂已于今年早些时候获得ANVISA批准，用于治疗12岁及以上患者的过敏性鼻炎，该公司现已在巴西推出该产品。阿普塔携手Aceso Therapeutics推进囊性纤维化的吸入式反义寡核苷酸（ASO）候选药物ACT-101开发； FDA接受United Therapeutics的补充新药申请（sNDA），将Tyvaso曲前列尼尔吸入溶液的使用范围扩展至特发性肺纤维化（IPF）的治疗 MannKind授予Rose一项全球许可，利用MannKind的Technosphere干粉技术，将其快速起效的GLP-1药物ROSE-010开发为用于减重的吸入疗法。MannKind将提供制剂及其他服务，直至1b期开发阶段。作为回报，MannKind获得Rose的股权以及未来销售的特许权使用费。 Orexo AB宣布已于2026 年 9 月 29 日完成向美国FDA重新提交IZIPRY（纳洛酮鼻用干粉剂）的新药上市申请。IZIPRY是基于Orexo自有粉体给药平台 AmorphOX®开发的高剂量纳洛酮阿片类药物过量解救药物。 Pulmovant宣布其吸入用干粉剂mosliciguat在间质性肺病相关肺高压（PH-ILD）患者中开展的2期PHocus临床试验已达到主要终点，3期PHrontier试验已启动; Polyrizon宣布启动其首个临床试验，即研究其Nasarix（PL-14）水凝胶鼻喷雾剂用于季节性过敏性鼻炎患者的效果。 SpliSense启动SPL84吸入式反义寡核苷酸治疗囊性纤维化的2b期试验；药物递送专业公司Zeteo Biomedical宣布推出其新型用于肺部递送的器械——AriesMR干粉吸入器（DPI）；囊性纤维化基金会将向Ride Therapeutics进行最高730万美元的战略投资，以支持囊性纤维化吸入式基因疗法的开发 FDA已批准Nasus Pharma的NS002鼻内干粉肾上腺素用于治疗过敏性休克的研究性新药（IND）申请。Nasus表示，公司还计划在2026年底前启动NS002的关键性试验，预计顶线数据将于2027年初公布。郑重声明：内容摘自网络公开内容，仅供同行学习参考，不构成投资建议和用药依据，侵权联系删除

上市批准临床3期临床2期申请上市临床结果

2026-10-06

·药代动力学

辉瑞很头疼！

最近，宇宙大药厂辉瑞很头疼。全球制药巨头辉瑞（Pfizer）在美国面临多线诉讼压力，涉及新冠疫苗宣传、仿制药定价、医疗补助欺诈等多个领域。从各州总检察长的消费者保护诉讼到联邦反垄断指控，辉瑞的法律风险呈现出“历史纠纷逐步出清、新冠疫苗争议持续发酵”的格局。新冠疫苗是辉瑞近年来诉讼最为集中的领域。2026年10月1日，佛罗里达州总检察长James Uthmeier对辉瑞及其CEO阿尔伯特·布尔拉提起诉讼，指控其违反《佛罗里达州欺骗性和不公平贸易行为法》。长达49页的诉状指出，辉瑞在宣传中将疫苗描述为“安全”，却未充分披露心肌炎、心包炎等潜在风险，同时以“接种疫苗保护他人”为由推广疫苗，但从未测试疫苗是否能阻止病毒传播。佛罗里达州称辉瑞从新冠疫苗中获得了超过800亿美元的收入，并在2023年将疫苗价格从约30美元提高至110至130美元。该州寻求禁令、利润返还以及每项违规最高1万美元（涉及老年人或残障人士则最高1.5万美元）的民事罚款。辉瑞回应称指控“毫无根据”，并强调其关于疫苗的声明“准确且基于科学”。在此之前，得克萨斯州于2023年起诉辉瑞，指控其以相对危险降低率宣传疫苗有效性具有误导性，实际绝对危险降低率仅为0.85%。该案于2024年12月被联邦法官依据《PREP法案》驳回。但得克萨斯州总检察长已向第五巡回上诉法院提出上诉，2026年9月庭审中多位法官对一审法院管辖权提出质疑，案件存在被发回州法院重审的可能性。堪萨斯州于2024年提起诉讼，指控辉瑞在明知疫苗存在严重不良事件的情况下仍将其宣传为“安全有效”。该案经历管辖权拉锯后，2025年5月联邦法官裁定将案件发回堪萨斯州托马斯县法院审理。目前案件仍在州法院审理中。在药品定价领域，辉瑞面临的最重大诉讼之一是来自45个州及多个地区的仿制药定价共谋指控。各州指控辉瑞及其前子公司Greenstone在2010至2014年间与其他制药商合谋操纵六种仿制药的价格、分配市场和操纵投标。然而，2026年6月康涅狄格州联邦法官Michael Shea裁定各州未能提供充分证据证明辉瑞直接参与共谋或指使Greenstone实施反竞争行为，将辉瑞从被告名单中移除并撤销全部指控。这一裁决对辉瑞而言是重大利好。另一重大案件涉及肾上腺素自动注射器EpiPen的定价。辉瑞面临由保险公司、养老基金和消费者提起的多起集体诉讼，被指控通过专利和解等手段人为抬高EpiPen价格。辉瑞已同意支付3.45亿美元解决消费者集体诉讼，并另外支付5000万美元了结药品批发商的集体诉讼。辉瑞在和解中明确表示“否认任何不当行为”。在医疗补助欺诈方面，辉瑞面临多起指控。得克萨斯州司法部指控辉瑞及其供应商在2012至2018年间明知多动症药物Quillivant XR存在品控问题，仍操纵检测结果以骗取联邦医疗补助。2025年11月，辉瑞与Tris Pharma同意支付4150万美元达成和解，辉瑞同时否认任何不当行为和责任。在回扣和不当营销方面，辉瑞同样面临多起诉讼。2025年1月，辉瑞同意代表其子公司Biohaven支付约5975万美元，以解决Biohaven在2020至2022年间通过“讲课费”和高档宴请向医生支付回扣、诱导其开具偏头痛药物Nurtec ODT处方的指控。此外，辉瑞还曾就药品回扣和“超适应症”营销问题与联邦政府达成过涉及23亿美元的历史性和解，其子公司同意认罪并支付13亿美元刑事罚款，成为美国历史上医疗诈骗案中最高罚款之一。值得注意的是，辉瑞在反垄断领域不仅是被告，也在主动出击。2025年10月至11月，辉瑞对减肥药厂商Metsera及其竞争对手诺和诺德（Novo Nordisk）提起诉讼，指控诺和诺德以高于辉瑞的出价收购Metsera构成反竞争行为，试图通过“前所未有的结构”故意逃避反垄断审查。辉瑞向特拉华州衡平法院提起诉讼，并申请临时限制令阻止Metsera终止合并协议。尽管法院驳回了辉瑞的临时禁令请求，但辉瑞表示将继续通过诉讼程序推进相关主张。此外，辉瑞与Viatris（由Mylan与辉瑞Upjohn业务合并而成）在阿片类药物诉讼中也有关联。Viatris同意支付最高3.35亿美元以解决阿片类药物相关索赔，并同意向辉瑞支付实际损失的57%作为补偿。综合来看，辉瑞近年的法律风险呈现清晰的分层格局：在仿制药定价共谋、EpiPen反垄断以及回扣与超适应症营销等历史遗留问题上，辉瑞要么在法庭上赢得撤诉，要么通过支付和解金了结案件，相关风险已基本出清。然而，新冠疫苗相关的州级诉讼仍是最大不确定性来源——佛罗里达州案件刚刚立案，堪萨斯州案件在州法院审理中，得克萨斯州案件的上诉结果尚待第五巡回法院裁定。辉瑞在这些案件中始终坚持否认指控、强调行为合规的立场，但最终走向仍有待司法程序的进一步推进。

疫苗专利无效

2026-10-06

·BioSpace

Belhaven Biopharma Initiates Pivotal Study of BBP01, a Nasal Powder Formulation of Epinephrine to Treat Anaphylaxis

Randomized crossover trial will compare the pharmacokinetics and pharmacodynamics of intranasal epinephrine powder against intramuscular auto-injector and manual injection in healthy participants RALEIGH, NC / ACCESS Newswire / October 6, 2026 / Belhaven Biopharma, Inc. today announced the initiation of a pivotal clinical study evaluating BBP01, an investigational nasal powder formulation of epinephrine being developed as a needle-free alternative for the delivery of epinephrine to treat anaphylaxis. The randomized, open-label, three-treatment crossover study design will assess the comparative bioavailability of an intranasal dose of BBP01 against two established intramuscular reference products: a 0.3 mg epinephrine auto-injector and a 0.3 mg manual intramuscular injection of Adrenalin® in 60 adult participants. Secondary endpoints will assess the safety and tolerability of BBP01, including nasal examinations, and pharmacodynamic changes in blood pressure, heart rate and mean arterial pressure. "This study will generate the definitive data we need to conduct our pre-NDA meeting with FDA in 1Q27," said Scott Lyman, CEO of Belhaven Biopharma. "Confirming FDA alignment with our previous interactions on the work completed in the clinic, human factors, and manufacturing validates that we move into completing the remaining supportive work needed for filing our NDA in 2027." BBP01 is an investigational product and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Its safety and efficacy have not been established. For more information, please visit: About Belhaven Biopharma, Inc. Belhaven Biopharma is a clinical-stage pharmaceutical research company specializing in developing life-saving medications delivered quickly, effectively, and painlessly with a simple, dry powder, single-use nasal device. They are at the forefront of developing nasal dry powder epinephrine, which is revolutionizing emergency-use epinephrine delivery and expanding global access. Nasdepi ® , Belhaven's lead program, is the first dry powder nasal device for treating life-threatening allergic reactions. MEDIA CONTACT Janie Mackenzie Vice President, Public Relations Ascendant Group 856.473.2166 SOURCE: Belhaven Biopharma View the original press release on ACCESS Newswire

临床研究

100 项与肾上腺素相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00095	肾上腺素	C01CA24 B02BC09 S01EA01	DB00668

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
间歇性哮喘	美国	Armstrong Pharmaceuticals, Inc.	2018-11-07
瞳孔散大	美国	PH HEALTH	2012-12-07
瞳孔散大	美国	Ph Healthcare Services	2012-12-07
超敏反应	美国	Viatris Specialty LLC	1987-12-22
麻醉	日本	Daiichi Sankyo Co., Ltd.	1986-02-25
支气管痉挛	日本	Daiichi Sankyo Co., Ltd.	1986-02-25
出血	日本	Daiichi Sankyo Co., Ltd.	1986-02-25
低血压	日本	Daiichi Sankyo Co., Ltd.	1986-02-25
休克	日本	Daiichi Sankyo Co., Ltd.	1986-02-25
过敏反应	中国	远大医药集团	1981-01-01
心脏停搏	中国	远大医药集团	1981-01-01
哮喘	美国	Wyeth Consumer Healthcare LLC	1967-11-08

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
过敏性鼻炎	临床2期	加拿大	Nasus Pharma Ltd.	2025-11-03
季节性过敏性鼻炎	临床2期	加拿大	Nasus Pharma Ltd.	2025-11-03
持续性哮喘	临床2期	美国	ARS Pharmaceuticals, Inc.	2022-07-28
荨麻疹	临床2期	美国	ARS Pharmaceuticals, Inc.	2022-07-28
速发型超敏反应	临床2期	加拿大	Aquestive Therapeutics, Inc.	2022-07-12
药物过敏反应	临床1期	瑞典	Orexo AB	2024-04-22
呼吸道感染	临床1期	澳大利亚	ARS Pharmaceuticals, Inc.	2021-08-09

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


NCT04032119 (Pubmed \| Gastrointest Endosc)	临床3期	胃粘膜病变	774	1:100,000 diluted epinephrine-added injection solution	顧構艱齋選艱製願齋構(願廠鏇鑰製鏇衊積鹹積) = 餘鬱醖餘齋鬱艱蓋蓋憲憲鬱餘淵醖壓遞獵窪範 (鹹夢糧憲築餘醖衊築齋, 46.0)	积极	2026-09-01
				Normal injection solution	顧構艱齋選艱製願齋構(願廠鏇鑰製鏇衊積鹹積) = 簾淵鏇築鹹鏇範餘齋鏇憲鬱餘淵醖壓遞獵窪範 (鹹夢糧憲築餘醖衊築齋, 45.0)
NCT00678145 (CTgov)	临床2期	低血糖 \| 单纯自主神经功能衰竭 \| 糖尿病	39	Morphine Sulfate (Morphine Sulfate)	齋廠簾鑰糧獵襯糧遞鹹(獵顧齋醖齋壓鑰獵觸窪) = 膚鬱繭範選觸衊遞憲顧襯蓋鏇夢鏇範鏇願蓋鹹 (積範襯鏇淵顧憲構製鑰, 0.18) 更多	-	2026-05-19
				Morphine Sulfate (Matched Placebo (Saline for Morphine Sulfate))	齋廠簾鑰糧獵襯糧遞鹹(獵顧齋醖齋壓鑰獵觸窪) = 鏇壓築積遞醖餘積鑰鏇襯蓋鏇夢鏇範鏇願蓋鹹 (積範襯鏇淵顧憲構製鑰, 0.33) 更多
NCT03913845 (Retropubic Lidocaine vs Saline, CTgov)	临床4期	压力性尿失禁 \| 尿潴留	150	Epinephrine+Lidocaine (Lidocaine + Epinephrine)	醖範獵遞網醖糧網願網 = 衊願餘獵製觸齋糧範蓋範選鏇淵蓋網糧遞鏇壓 (願淵餘醖廠夢襯衊鬱蓋, 淵製範鏇觸糧築遞衊蓋 ~ 網獵鹹餘壓鹽衊夢鹹鹽) 更多	-	2026-04-30
				Epinephrine+Saline (Saline + Epinephrine)	醖範獵遞網醖糧網願網 = 淵淵繭構餘醖襯簾願遞範選鏇淵蓋網糧遞鏇壓 (願淵餘醖廠夢襯衊鬱蓋, 遞憲窪構蓋壓積願蓋糧 ~ 繭鹽網壓獵簾獵鏇顧鏇) 更多
Company_Website 人工标引	临床2期	过敏性鼻炎	50	NS002	顧鏇構餘壓選蓋網簾獵(遞觸築蓋淵壓醖夢壓醖) = 襯願糧簾願憲艱遞廠醖廠廠鹹夢淵網廠選醖築 (鏇範構遞餘觸構鑰鑰襯 ) 更多	积极	2026-03-16
				EpiPen	顧鏇構餘壓選蓋網簾獵(遞觸築蓋淵壓醖夢壓醖) = 簾壓膚構鑰窪遞糧壓蓋廠廠鹹夢淵網廠選醖築 (鏇範構遞餘觸構鑰鑰襯 ) 更多
NCT05488847 (CTgov)	临床4期	肩痛 \| 肩关节周围炎	83	pregabalin+epinephrine+ropivacaine+acetaminophen+magnesium+oxycodone extended-release+ketorolac+dexamethasone+ibuprofen+celecoxib+tizanidine (Non Opioid, Multimodal Protocol)	襯積願簾齋鏇鏇鹹廠壓(選願鏇鹽蓋獵窪鹹餘顧) = 窪艱襯廠鹽襯廠選糧遞憲蓋繭選獵壓餘醖範齋 (築壓夢獵構鏇選簾襯網, 1.7)	-	2026-02-10
				pregabalin+epinephrine+ropivacaine+acetaminophen+magnesium+oxycodone extended-release+ketorolac+dexamethasone+ibuprofen+celecoxib+tizanidine (Opioid Protocol)	襯積願簾齋鏇鏇鹹廠壓(選願鏇鹽蓋獵窪鹹餘顧) = 獵醖鬱廠構簾選簾獵淵憲蓋繭選獵壓餘醖範齋 (築壓夢獵構鏇選簾襯網, 1.6) 更多
NCT02722746 (Pilot epinephrine dose-finding study, CTgov)	临床1/2期	镇痛 \| 低血压	66	Ropivacaine (Ropivacaine Only Control Group)	衊鑰憲願顧壓願壓窪糧: percent difference = 20.8 (95% CI, -8.9 ~ 47.3), P-Value = 0.165	-	2025-06-18
				Ropivacaine+Epinephrine (Ropivacaine + 2 mcg/mL Epinephrine)
NCT04696822 (AAAAI2025)	临床1期	过敏反应	24	FMXIN002 4.0mg	網夢鹽窪鏇遞衊積衊醖(餘餘網網遞齋築廠蓋醖) = 鏇壓簾獵願鏇糧夢鏇觸願觸遞鏇壓鹽夢鬱淵鹹 (顧夢淵憲蓋鬱鏇鬱壓網 )	积极	2025-02-28
				0.3mg IM autoinjector	網夢鹽窪鏇遞衊積衊醖(餘餘網網遞齋築廠蓋醖) = 鹽繭簾遞構鹽醖製鏇夢願觸遞鏇壓鹽夢鬱淵鹹 (顧夢淵憲蓋鬱鏇鬱壓網 ) 更多
CTIS2024-514037-38-00 (OX640-002, Company_Website) 人工标引	N/A	过敏性鼻炎	30	OX640	鏇範製夢簾鹹糧膚鏇製(範鹽膚觸鏇鏇淵餘簾範) = Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. 積淵鹹積築製餘醖膚鑰 (衊繭窪鏇壓觸壓醖膚壓 ) 更多	积极	2025-01-10
				0.3 mg intramuscular epinephrine
GlobeNewswire 人工标引	N/A	口腔过敏综合征	-	Anaphylm (with allergen exposure)	遞鏇餘齋鹽窪醖夢鏇顧(製積遞觸襯鏇廠鹽衊壓) = no significant differences found between Anaphylm PK results in subjects with and without allergen exposure. 淵積鏇膚糧鏇糧蓋築襯 (餘齋繭壓鹹夢築鏇製鹽 ) 达到更多	积极	2024-10-24
				Anaphylm (without allergen exposure)
NCT04207840 (Pubmed \| J Aerosol Med Pulm Drug Deliv)	临床4期	哮喘 \| 过敏反应	28	Epinephrine MDI	壓窪襯網願觸網簾願顧(選鬱簾糧繭積夢選憲醖) = 構製製鬱蓋構築蓋網襯淵遞網窪糧餘選憲膚顧 (積蓋糧鏇製遞遞廠壓糧 )	积极	2024-08-29
				Epinephrine IM	壓窪襯網願觸網簾願顧(選鬱簾糧繭積夢選憲醖) = 鑰築蓋範繭壓齋鏇鹹壓淵遞網窪糧餘選憲膚顧 (積蓋糧鏇製遞遞廠壓糧 )