A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

开始日期2025-07-31

申办/合作机构

Verona Pharma Plc

CTR20250752

/ RecruitingN/A

格隆溴铵吸入粉雾剂在中国健康研究参与者中空腹条件下随机、开放、单剂量、三制剂、三序列、三周期、交叉生物等效性试验

主要研究目的：空腹经口腔吸入格隆溴铵吸入粉雾剂受试制剂（规格：50μg，以C19H28NO3计）和参比制剂（规格：50μg，以C19H28NO3计，商品名：Seebri®），初步评价受试制剂和参比制剂在空腹条件下给药的药代动力学行为。为正式试验的试验设计和临床操作提供依据。次要研究目的：研究受试制剂格隆溴铵吸入粉雾剂50μg和参比制剂格隆溴铵吸入粉雾剂50μg（商品名：Seebri®）在健康研究参与者中的安全性。

开始日期2025-06-27

申办/合作机构

长风药业股份有限公司

CTRI/2025/03/083518

/ Not yet recruiting临床4期IIT

A comparative study determining the effect of pre-emptive intravenousGlycopyrrolate versus Ondansetron in preventing spinal hypotension inpatients undergoing elective inguinal hernioplasty at a tertiary care hospital - NIL

开始日期2025-04-15

申办/合作机构-

100 项与格隆溴铵相关的临床结果

登录后查看更多信息

100 项与格隆溴铵相关的转化医学

登录后查看更多信息

100 项与格隆溴铵相关的专利（医药）

登录后查看更多信息

1,557

项与格隆溴铵相关的文献（医药）

2025-09-01·JOURNAL OF CLINICAL ANESTHESIA

Response of letter to the editor regarding “effects of neuromuscular block reversal with neostigmine/glycopyrrolate versus sugammadex on bowel motility recovery after laparoscopic colorectal surgery: A randomized controlled trial”

Letter

作者: Park, Jin-Woo

2025-08-01·ANESTHESIOLOGY

Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase IV Randomized Clinical Trial

Article

作者: Herring, W. Joseph ; Wang, Aobo ; Mukai, Yuki ; Matuszczak, Maria ; Wrishko, Rebecca ; Locco, Amy ; Speek, Marcel ; Mensah-Osman, Edith ; Gee, Angela ; Saldien, Vera ; Leibensperger, Heather

Background::

Sugammadex is well tolerated and effective for reversing neuromuscular blockade (NMB) in adults and children as young as 2 yr old. There is little information on its use in younger children. The aim of this study was to evaluate the efficacy and tolerability of sugammadex in children under 2 yr of age.

Methods::

This was a phase IV, randomized, parallel-group, multicenter clinical trial of sugammadex in participants aged birth to less than 2 yr (NCT03909165). Part A was open label and included pharmacokinetic assessments to determine whether sugammadex dose adjustment for part B was necessary based on age. Part B was double-blind and evaluated doses of 2 and 4 mg/kg sugammadex. Participants were randomized to (1) moderate NMB and reversal with 2 mg/kg sugammadex; (2) moderate NMB and reversal with neostigmine + glycopyrrolate or atropine (hereafter, called neostigmine); or (3) deep NMB and reversal with 4 mg/kg sugammadex. The primary efficacy endpoint was time to neuromuscular recovery (TTNMR). The primary efficacy hypothesis was that 2 mg/kg sugammadex would be superior to neostigmine for the reversal of moderate NMB as measured by TTNMR in part B.

Results::

A total of 138 participants aged 1 to 720 days were treated in parts A and B (2 mg/kg sugammadex, n = 44; 4 mg/kg sugammadex, n = 63; and neostigmine, n = 31). Based on pharmacokinetic assessments in part A, no dose adjustments for age were needed. In part B, TTNMR for reversal of moderate NMB was faster with 2 mg/kg sugammadex than neostigmine (median of 1.4 min vs. 4.4 min; hazard ratio, 2.40; 95% CI, 1.37 to 4.18; P = 0.0002). A 4-mg/kg dose of sugammadex achieved rapid TTNMR for reversal of deep NMB with a median of 1.1 min (parts A and B). The percentage of participants with one or more adverse events (parts A and B) was similar for sugammadex and neostigmine. No deaths, drug-related serious adverse events, or hypersensitivity or anaphylaxis events were reported.

Conclusions::

In children less than 2 yr old, 2 mg/kg sugammadex reversed moderate NMB faster than neostigmine, and 4 mg/kg sugammadex rapidly reversed deep NMB. Sugammadex doses of 2 and 4 mg/kg were well tolerated.

2025-08-01·ANESTHESIA AND ANALGESIA

A Randomized Controlled Trial of Sugammadex versus Neostigmine for Reversal of Rocuronium on Gastric Emptying in Adults Undergoing Elective Colorectal Surgery

Article

作者: Tsikitis, Vassiliki Liana ; Lu, Kim C. ; Tekkali, Praveen ; Herzig, Daniel O. ; Fang, Sandy H. ; Aziz, Michael F. ; Togioka, Brandon M. ; Rakshe, Shauna K. ; Ye, Shangyuan

BACKGROUND::

Gastrointestinal function is mediated by the cholinergic pathway, which is impacted by neostigmine and glycopyrrolate, but not sugammadex. We hypothesized that sugammadex is associated with earlier gastric emptying in adults undergoing colorectal surgery, compared to neostigmine-glycopyrrolate.

METHODS::

Patients were enrolled in a pragmatic, single-center, patient and assessor-blinded, randomized, controlled trial. At skin closure, subjects were randomized to sugammadex 2 mg/kg or neostigmine 0.07 mg/kg and glycopyrrolate (0.2 mg per 1 mg of neostigmine). The primary end point, gastric emptying, was assessed with the paracetamol absorption test, with greater area under the curve representing faster gastric emptying. Secondary end points included time to first bowel movement, time to achieve adequate reversal (train-of-four ratio ≥0.9), gastrointestinal complications, hospital length of stay, and postanesthesia care unit recovery time. The analysis was intention-to-treat.

RESULTS::

All 60 patients randomized to sugammadex received the allocated intervention. Of 60 patients randomized to neostigmine-glycopyrrolate, 56 received neostigmine-glycopyrrolate, 2 received sugammadex, and 2 received both agents. Gastric emptying did not differ significantly between sugammadex (mean [standard deviation {SD}] area under the curve {AUC} 1118 [122]) and neostigmine (AUC 1130 [117], P = .58). Sugammadex treatment was associated with shorter time to first bowel movement (44.3 hours [33.8] vs 61.0 hours [43.0]; difference = 16.7 hours, 95% confidence interval {CI}, [2.3–31.1], P = .02) and time to adequate reversal (5.2 minutes [6.3] vs 17.5 minutes [10.1]; difference = 12.3 minutes, 95% CI, [9.2–15.4], P < .001). Neostigmine-glycopyrrolate treatment was not associated with a significant increase in gastrointestinal complications (32% vs 17%; OR = 2.3, 95% CI, [0.9–6.2], P = .09), a longer hospital length of stay (7.8 days [19.8] vs 4.8 days [4.9]; difference = 3 days, 95% CI, [−2.2 to 8.3], P = .27), or a difference in postanesthesia care unit recovery time (108 minutes [56.4] vs 115 minutes [50.3]; difference= −6.9 minutes, 95% CI, [−26.4 to 12.6], P = .48). Adverse events were similar between groups.

CONCLUSIONS::

Sugammadex treatment was not associated with faster gastric emptying (primary end point). Regarding prespecified secondary end points, sugammadex treatment was associated with a 12.3-minute shorter time to adequate reversal in real-life practice conditions, but it did not benefit the proportion of subjects with a gastrointestinal complication, hospital length of stay, or postanesthesia care unit recovery time. Further studies are needed to confirm our finding that sugammadex is associated with a clinically significant 16.7-hour shorter time to first bowel movement, and to establish the role of sugammadex in colorectal surgery enhanced recovery protocols.

144

项与格隆溴铵相关的新闻（医药）

2025-07-25

·astrazeneca.com

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1 Trixeo is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) using a propellant that offers 99.9% lower GWP than propellants used in currently available pMDIs.2 This fixed-dose triple-combination therapy, marketed as Breztri Aerosphere in the US, China and Japan, will now have a low carbon footprint comparable to inhaled medicines that do not require a propellant.3 Based on the CHMP positive opinion, AstraZeneca will now begin to transition its Trixeo supply to the next-generation propellant in Europe. The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant.4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Frederik Trinkmann, Professor and Senior Pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said: “Respiratory medicines delivered by pressurised metered-dose inhalers are essential for millions of people living with respiratory diseases in Europe, including specific vulnerable populations such as children and the elderly. The transition of Trixeo to the propellant with near-zero Global Warming Potential ensures clinicians’ treatment decisions can focus on clinical needs while also supporting environmental goals.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP positive opinion of Trixeo Aerosphere with the next-generation propellant allows us to address the needs of both patients and the planet and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the EU. Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.” Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients' Associations, said: “COPD is a devastating disease and the third leading cause of mortality in the world. People living with COPD need access to a treatment which is right for them as well as a healthy environment and clean air. We welcome the positive opinion from the CHMP for the inhaled respiratory medicine containing the next-generation propellant with a significantly reduced carbon footprint.” Trixeo with the next-generation propellant received its first approval in the UK in May 2025 with regulatory applications also currently under review in China and additional countries. Trixeo is the first medicine in AstraZeneca’s portfolio of medicines delivered by pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy. In the EU, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months. Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.6 Respiratory inhaled medicines delivered by pMDIs account for 76% of all inhaler use in Europe, and contribute 0.04% of global greenhouse gases.7,8 Studies show that the largest environmental contribution from respiratory diseases comes from patients’ symptoms not being adequately controlled and resulting increased healthcare utilisation.9,10 Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.11 Notes AstraZeneca’s next-generation propellant clinical development programme The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs). The first medicine to be assessed in the programme was Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.12-17 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant and Breztri/Trixeo with the current propellant.4,5 The safety and tolerability profile for Breztri/Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Additional studies are underway to assess the bioequivalence of the next-generation propellant to the current propellant with AstraZeneca’s other medicines delivered by pMDIs. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and UK and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China, Japan, and has been prescribed to more than five million patients globally. Breztri/Trixeo Aerosphere with the next-generation propellant will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant. AstraZeneca’s Collaboration with Honeywell Developed by Honeywell, the medical grade version of the next-generation propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant. Ambition Zero Carbon Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Corporate and financial

上市批准

2025-07-10

·EndPoints

Updated: FDA publishes repository of 200+ drug rejection letters, promising more in the future

In a historic first, the FDA on Thursday released about 200 novel and generic drug rejection letters, bucking the agency’s former reticence to publicize the documents in one place. But it’s a small step as nearly all the letters reviewed by Endpoints News were previously disclosed as part of the drugs’ approval packages. Two of the complete response letters not previously disclosed included one for AstraZeneca’s COPD treatment Breztri Aerosphere in 2019 and one for a label update for Astellas’ eye drug Izervay in 2024. All of the rejection letters released are for drugs that have since been approved. AstraZeneca disclosed its CRL in a press release but did not mention that the FDA said the submitted data “do not provide substantial evidence of the efficacy and safety for the use of Breztri Aerosphere.” The CRL also said “the single Aerosphere phase 3 pivotal trial failed on the co-primary endpoint of change from baseline in trough FEV1 for the comparison of Breztri Aerosphere and the glycopyrrolate and formoterol fumarate combination.” AstraZeneca said in a statement to Endpoints that its 2019 press release on the Breztri complete response letter “is an accurate reflection of the status of the regulatory filing and data at the time.” Breztri was later approved in 2020 following submission of additional data. For Izervay’s label expansion, Astellas also announced the CRL in a press release in 2024, but said the FDA comments outlined in the CRL “focus on a statistical matter” and “are unrelated to the safety and benefit/risk of the use of IZERVAY.” The FDA, however, said in the CRL that the company’s proposal to extend the dosing interval “was not supported by the submitted data and was not replicated in a second adequate and well controlled study.” Astellas did not immediately respond to a request for comment. The FDA noted that according to a 2015 analysis conducted by FDA researchers, drug companies “avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time.” The FDA said the CRLs have been redacted for trade secrets and confidential commercial information. It’s unclear if the agency contacted the sponsors prior to releasing the new letters. The agency also said it is in the process of publishing additional CRLs from its archives. “For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary said in a statement. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.” Editor’s Note: This story was updated with comment from AstraZeneca. An earlier version was updated to reflect a review of the documents released today, finding that some were previously disclosed in approval packages.

临床3期上市批准

2025-07-10

·贝壳社

百亿美金收购破解专利悬崖！默沙东锁定呼吸领域“双机制核弹”

▲AI时代医健领导力跃迁指南作者：贝壳社7月9日，默沙东宣布已与Verona Pharma（简称Verona）达成最终协议，默沙东将通过一家子公司以每股107美元的价格收购Verona的美国存托股票（ADS），交易总价值约为100亿美元。通过此次收购，默沙东将获得Verona的核心产品Ohtuvayre（ensifentrine）。作为一款全球首创的磷酸二酯酶3/4（PDE3/4）抑制剂，Ohtuvayre凭借在单一分子中巧妙融合支气管扩张与非甾体抗炎的双重功效，自2024年6月获批上市后，迅速占据市场，其惊人的初期渗透力及预估的数十亿美元销售峰值，为此次百亿并购提供了坚实的支撑。1应对迫在眉睫的专利悬崖2024年，Keytruda的销售额占默沙东总收入的近46%。鉴于Keytruda的关键专利预计将于2028年左右失效，这一即将来临的‘专利悬崖’已成为近年来默沙东制定重大业务发展战略的核心考量因素。收购Verona并非个例，在此之前，默沙东已于2021年以115亿美元收购了Acceleron Pharma，并于2023年以108亿美元收购了Prometheus Biosciences。默沙东的并购战略已从早期的广泛多元化转变为高度聚焦，专注于肿瘤学以外的特定治疗领域，精准收购低风险且具首创性的资产。近期的一系列收购，如Acceleron、Prometheus和Verona，主要集中在免疫学和心肺疾病领域。从战略视角审视，收购如Ohtuvayre这类已步入商业化阶段的资产，相较于引进早期化合物，具有显著优势。此举可带来即时收益、成熟的供应链体系及真实市场反馈，显著缩短达到销售峰值的时间，并有效降低相关风险。因此，默沙东购买的不仅仅是药物，更是时间和确定性。随着Ohtuvayre的加入，极大地丰富了默沙东日益壮大的呼吸与肺部疾病产品组合。该组合中已包括用于治疗肺动脉高压（PAH）的Winrevair，以及用于预防呼吸道合胞病毒（RSV）的抗体药物Enflonsia。默沙东的目标不仅限于单一药物的收购，而是要在呼吸系统疾病领域构建一个多元化、多机制的产品矩阵。此策略不仅能构筑坚固的竞争防线，还能在商业运作和临床实践中产生明显的协同增效作用。2首创PDE3/4双重抑制剂：OhtuvayreCOPD是一种进行性肺部疾病，尽管市场上已存在多种治疗选项，然而仍有大量患者未能有效控制其症状，持续面临呼吸困难和急性加重的困扰，导致他们的生活质量大幅下降。据估计，在美国，约有120万接受双联或三联疗法的患者病情仍未得到控制。2023年全球呼吸疾病药物市场规模约为320亿美元，其中COPD药物约占50%。COPD市场在过去二十年中，在作用机制上鲜有真正的突破性创新。大多数所谓的“新药”只是将现有药物类别进行组合。然而，一个明确的“未满足需求”人群已经形成：即那些在使用最大剂量的LAMA/LABA/ICS三联疗法后，症状依然持续的患者。这正是Ohtuvayre最初的市场切入点。Ohtuvayre作为全球首个PDE3/4双重抑制剂，是二十余年来首个获批用于COPD维持治疗的新型吸入疗法，标志着该治疗领域的一次重大革新。这种独特的双重作用机制在单一分子中实现了两种关键的治疗效果：支气管扩张（PDE3抑制），通过抑制气道平滑肌中的PDE3，Ohtuvayre能够导致气道松弛和扩张，从而改善气流，使患者呼吸更加顺畅；非甾体抗炎（PDE4抑制），通过抑制肺部炎症细胞中的PDE4，Ohtuvayre能够减少这些细胞的募集和浸润，从而控制驱动COPD病程进展的慢性炎症。体外研究表明，Ohtuvayre还能刺激囊性纤维化跨膜电导调节因子（CFTR），这可能有助于改善黏液纤毛清除功能并降低黏液粘度。对于伴有慢性支气管炎的患者而言，这一特性可能带来额外的临床获益。该药物通过标准的喷射雾化器直接递送至肺部。这种给药方式最大化了药物在肺部的暴露量，同时最小化了与口服PDE抑制剂相关的全身性副作用，从而在疗效和安全性之间取得了更好的平衡。Ohtuvayre的双重作用机制直接弥补了当前COPD治疗模式的一个核心缺陷，即通常需要联合使用不同的药物（如支气管扩张剂和吸入性皮质类固醇）才能达到类似的效果。这使其有潜力成为一种基础性治疗药物，而不仅仅是又一个“me-too”类的附加疗法。当前，对症COPD患者的标准治疗方案通常涉及双联、三联，这意味着患者需要同时服用来自不同药物类别的、具有多种作用机制的药物。Ohtuvayre在单一非甾体分子中结合了支气管扩张和抗炎作用，形成差异化优势。随着针对特定炎症通路的生物制剂的获批，COPD市场开启了新的竞争篇章。Dupixent由赛诺菲和再生元共同开发，获欧盟委员会批准用于患有病情不受控制的慢性阻塞性肺病（COPD）患者的附加维持治疗，成为首个用于COPD的生物制剂。Dupixent是一种IL-4/IL-13抑制剂，适用于具有嗜酸性粒细胞表型的患者。在特定的慢性阻塞性肺病（COPD）患者亚群中，Dupixent可将急性加重减少30%～34%。Nucala由葛兰素史克开发，是一种IL-5抑制剂，适用于嗜酸性粒细胞型慢性阻塞性肺病（COPD）患者的辅助维持治疗。在MATINEE试验中，显示可将急性加重减少约21%。而Ohtuvayre不依赖于特定生物标志物，其主要市场定位是针对那些持续存在症状（如呼吸困难）并需要改善支气管扩张和非甾体抗炎效果的广大COPD患者。财务数据显示，Ohtuvayre销售额从2024年的4230万美元，飙升至2025年第一季度的7130万美元，季度环比增长高达95%。Verona一直在积极探索ensifentrine在其他慢性呼吸系统疾病中的应用，这为默沙东带来了巨大的潜在增值空间。其中关键在研适应症，如非囊性纤维化支气管扩张症（NCFB）、哮喘、囊性纤维化（CF）。此外，ensifentrine与LAMA类药物格隆溴铵的复方制剂正在开发中，这有望提供一种单一产品解决方案。小结：通过此次收购，为默沙东锁定了一项风险可控、已进入商业化阶段、具有差异化作用机制且通往重磅炸弹药物地位路径清晰的资产，解决其最紧迫的战略脆弱性——Keytruda的专利悬崖问题。然而，要完全实现这100亿美元投资的价值，默沙东必须成功应对复杂的竞争格局，并成功将Ohtuvayre的适应症扩展至未来其他领域。往期推荐1医健企业前沿动态2医健行业BD/出海/投融资洞察___*声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐素材来源官方媒体关于贝壳社贝壳社是国内领先的医健创新创业服务平台，构建了"产业空间+创业教育+投资孵化+资本运作"四位一体服务体系，为医健领域创业企业提供全周期赋能。通过深度挖掘高成长项目、精准匹配产业资源及全球化生态网络，覆盖企业从孵化培育到加速发展的全链路，重点提供包括空间落地、创业培训、资本运作及跨境资源链接服务。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

并购专利到期

100 项与格隆溴铵相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00540	格隆溴铵	A03AB02 R03BB06	DB00986

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
心律失常	美国	Exela Pharma Sciences LLC	2018-07-11
脑瘫	加拿大	Medexus Pharmaceuticals, Inc.	2017-10-30
气道阻塞	美国	Novartis Pharmaceuticals Corp.	2015-10-29
慢性支气管炎	美国	Novartis Pharmaceuticals Corp.	2015-10-29
肺气肿	美国	Novartis Pharmaceuticals Corp.	2015-10-29
慢性阻塞性肺疾病	欧盟	Novartis Europharm Ltd.	2012-09-28
慢性阻塞性肺疾病	日本	Novartis Pharma KK	2012-09-28
慢性阻塞性肺疾病	冰岛	Novartis Europharm Ltd.	2012-09-28
慢性阻塞性肺疾病	列支敦士登	Novartis Europharm Ltd.	2012-09-28
慢性阻塞性肺疾病	挪威	Novartis Europharm Ltd.	2012-09-28
流涎	美国	Merz Pharmaceuticals LLC	2010-07-28
心动过缓	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	2009-11-20
神经肌肉阻滞逆转	澳大利亚	Aspen Pharmacare Australia Pty Ltd.	2009-11-20
十二指肠溃疡	中国	湖南洞庭药业股份有限公司	1982-01-01
胃炎	中国	湖南洞庭药业股份有限公司	1982-01-01
胃溃疡	中国	湖南洞庭药业股份有限公司	1982-01-01
麻醉	美国	Hikma Pharmaceuticals USA, Inc.	1975-02-06
消化性溃疡	美国	Casper Pharma LLC	1961-08-11

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
持续性哮喘	临床3期	美国	Pearl Therapeutics, Inc.	2017-12-13
哮喘	临床3期	-	Novartis Pharmaceuticals Corp.	2015-03-01
智力障碍	临床3期	美国	Shionogi, Inc.	2007-03-01
间歇性哮喘	临床2期	美国	Pearl Therapeutics, Inc.	2015-05-27
终末期肾脏病	临床1期	俄罗斯	Novartis Pharmaceuticals Canada, Inc.	2010-06-01

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


NCT03111121 (CTgov)	临床4期	麻痹 \| 肌肉僵硬	79	Neostigmine (Neostigmine)	願淵鹽淵淵廠夢鑰範餘(夢觸廠選製艱鹹餘積壓) = 鹽廠蓋淵鏇顧齋製遞鬱積網選夢憲壓餘餘願選 (鬱鬱築齋獵積構顧鹽顧, 6.51) 更多	-	2025-07-20
				Sugammadex (Sugammadex)	願淵鹽淵淵廠夢鑰範餘(夢觸廠選製艱鹹餘積壓) = 餘築壓鹽構選廠艱構遞積網選夢憲壓餘餘願選 (鬱鬱築齋獵積構顧鹽顧, 5.37) 更多
NCT03939923 (CTgov)	临床4期	冠心病	84	Glycopyrrolate+Neostigmine+Rocuronium (Neostigmine/Glycopyrrolate)	淵醖遞鹹築繭積鹹製構(簾淵襯憲構憲繭壓夢廠) = 蓋構觸鏇蓋糧鬱遞範窪糧觸簾醖餘網淵憲鹽衊 (製構鬱窪觸窪蓋觸蓋鹹, 5.9) 更多	-	2023-12-22
				sugammadex+Rocuronium (Sugammadex)	淵醖遞鹹築繭積鹹製構(簾淵襯憲構憲繭壓夢廠) = 遞獵鑰繭淵糧鹽顧獵繭糧觸簾醖餘網淵憲鹽衊 (製構鬱窪觸窪蓋觸蓋鹹, 4.7) 更多
NCT03742141 (IOVL, CTgov)	N/A	声带功能障碍	125	Intraoperative Video Laryngoscopy+Glycopyrrolate	衊窪願築積壓觸鏇窪顧 = 膚壓鏇願蓋醖積鑰憲淵夢鏇夢衊醖網蓋糧餘範 (衊憲顧壓憲憲觸襯夢鏇, 築鹽衊積窪衊選廠襯壓 ~ 糧顧糧繭廠膚糧廠膚蓋) 更多	-	2023-10-02
NCT04401345 (Pubmed \| BMC Anesthesiol)	临床4期	麻醉	258	Glycopyrrolate	鹹鹹築網遞糧鑰齋餘艱(醖醖選艱積餘鬱夢遞窪) = 製構鹹遞齋醖餘鏇鏇憲鹹製製襯鏇膚鹹願夢窪 (蓋餘選夢襯構壓襯鹹鑰 ) 更多	不佳	2022-10-25
				Placebo	鹹鹹築網遞糧鑰齋餘艱(醖醖選艱積餘鬱夢遞窪) = 蓋壓蓋獵選鹹窪淵構簾鹹製製襯鏇膚鹹願夢窪 (蓋餘選夢襯構壓襯鹹鑰 ) 更多
NCT04155047 (Pubmed \| Pulm Ther)	临床4期	慢性阻塞性肺疾病	22	Nebulized LAMA [glycopyrrolate (GLY) 25 µg]	範願壓艱窪襯簾鹽遞網(獵窪獵壓獵齋鏇艱簾構): P-Value = 0.0987	-	2021-07-07
				Placebo
NCT03084796 (GLIMMER, CTgov)	临床2期	慢性阻塞性肺疾病	733	CHF 5259 (Treatment A)	淵夢製遞鹹鏇觸衊夢醖(鹹顧膚網鏇構餘選糧願) = 遞顧憲網膚淵窪獵築顧蓋壓齋襯築衊範顧製淵 (鹹鑰鹽顧襯鏇蓋觸齋遞, 壓範齋獵製衊襯蓋鹽膚 ~ 鬱艱膚淵鏇蓋壓餘觸鹹) 更多	-	2021-06-15
				CHF 5259 (Treatment B)	淵夢製遞鹹鏇觸衊夢醖(鹹顧膚網鏇構餘選糧願) = 醖窪築積網窪衊獵鑰築蓋壓齋襯築衊範顧製淵 (鹹鑰鹽顧襯鏇蓋觸齋遞, 選糧鬱鹽觸積壓築範鹽 ~ 鏇選窪壓築遞選繭獵築) 更多
NCT04155047 (CTgov)	临床4期	肺气肿	44	Placebo administered by Magnair	簾齋壓繭憲鏇選齋糧顧(壓獵齋夢鹹築鹽膚鬱築) = 齋膚製製淵遞廠壓獵齋鑰遞積顧鑰製製鹹壓壓 (夢艱窪鏇膚網簾鑰夢獵, 0.1392) 更多	-	2021-04-08
NCT03357393 (CTgov)	N/A	镇静	150	Midazolam+morphine+scopolamine (Midazolam and Morphine-scopolamine)	醖鏇觸壓齋範範繭範鏇 = 獵獵獵鏇顧築衊選遞鹹壓顧鏇鏇鬱襯襯衊襯憲 (築鬱夢醖夢顧顧積鹹願, 願鹹鬱願製繭衊觸鹽積 ~ 簾繭蓋鹹襯膚醖鹽願構) 更多	-	2021-01-05
				Propofol+morphine+scopolamine (PCS (Propofol) With Morphine-scopolamine)	醖鏇觸壓齋範範繭範鏇 = 艱製願夢繭鑰憲築獵襯壓顧鏇鏇鬱襯襯衊襯憲 (築鬱夢醖夢顧顧積鹹願, 壓獵製觸製廠構鹹鏇醖 ~ 積積餘遞製構選選衊築) 更多
NCT03358147 (CTgov)	临床2/3期	持续性哮喘	1,077	GP MDI 28.8 μg (GP MDI 28.8 μg)	鏇繭顧簾製艱鹹齋蓋範(衊鹹鹽膚壓鏇願構淵餘) = 襯選膚鹽醖糧選齋鏇簾鑰鏇壓膚壓築蓋壓鬱鑰 (襯齋製蓋鑰淵築糧壓壓, 遞醖築範鹹鹽襯獵淵鏇 ~ 選築醖觸鏇淵觸夢網餘) 更多	-	2020-08-12
				GP MDI 14.4 μg (GP MDI 14.4 μg)	鏇繭顧簾製艱鹹齋蓋範(衊鹹鹽膚壓鏇願構淵餘) = 膚鑰艱壓襯艱齋夢簾鑰鑰鏇壓膚壓築蓋壓鬱鑰 (襯齋製蓋鑰淵築糧壓壓, 淵膚鏇積鏇鹽觸憲獵構 ~ 廠願衊範築膚簾艱醖遞) 更多
NCT02872935 (CTgov)	临床4期	恶心 \| 呕吐	22	Normal Saline (Placebo: Normal Saline)	餘顧膚餘蓋膚醖膚製構 = 鬱選願鏇願鹹廠範範糧構淵鬱遞築鹽糧襯衊構 (製遞繭鏇鬱餘範廠窪蓋, 鏇築膚鹹廠範艱壓醖艱 ~ 觸願夢淵積蓋鹹廠鹹蓋) 更多	-	2020-06-09
				Glycopyrrolate (Glycopyrrolate Group)	餘顧膚餘蓋膚醖膚製構 = 獵壓鑰繭遞襯廠構鑰餘構淵鬱遞築鹽糧襯衊構 (製遞繭鏇鬱餘範廠窪蓋, 製鬱鹽選廠憲窪顧簾網 ~ 遞繭遞衊鹹窪蓋衊淵遞) 更多