Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.

开始日期2024-05-30

申办/合作机构

Rambam Health Care Campus

[+2]

NCT06086626 / Recruiting临床2期

A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.

开始日期2024-03-14

申办/合作机构

Shionogi, Inc.

JPRN-UMIN000053151 / SuspendedN/A

Fetroja for Intravenous Drip Infusion Regular Drug Use-results Survey - Fetroja for Intravenous Drip Infusion Regular Drug Use-results Survey

开始日期2023-12-20

申办/合作机构

Shionogi & Co., Ltd.

100 项与头孢地尔相关的临床结果

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100 项与头孢地尔相关的转化医学

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100 项与头孢地尔相关的专利（医药）

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项与头孢地尔相关的文献（医药）

2024-02-20·Antimicrobial agents and chemotherapy

A multi-species outbreak of VIM-producing carbapenem-resistant bacteria in a burn unit and subsequent investigation of rapid development of cefiderocol resistance.

Article

作者: Jeffrey A Freiberg ; Lili Tao ; Carmila Manuel ; Laura A Mike ; George E Nelson ; Bryan D Harris ; Amy J Mathers ; Thomas R Talbot ; Eric P Skaar ; Romney M Humphries

Carbapenem resistance due to metallo-β-lactamases (MBLs) such as the Verona integron-encoded metallo-β-lactamase (VIM) is particularly problematic due to the limited treatment options. We describe a case series of bacterial infections in a tertiary care hospital due to multi-species acquisition of a VIM gene along with our experience using novel β-lactam antibiotics and antibiotic combinations to treat these infections. Four patients were treated with the combination of ceftazidime-avibactam and aztreonam, with no resistance to the combination detected. However, cefiderocol-resistant Klebsiella pneumoniae isolates were detected in two out of the five patients who received cefiderocol within 3 weeks of having started the antibiotic. Strain pairs of sequential susceptible and resistant isolates from both patients were analyzed using whole-genome sequencing. This analysis revealed that the pairs of isolates independently acquired point mutations in both the cirA and fiu genes, which encode siderophore receptors. These point mutations were remade in a laboratory strain of K. pneumoniae and resulted in a significant increase in the MIC of cefiderocol, even in the absence of a beta-lactamase enzyme or a penicillin-binding protein 3 (PBP3) mutation. While newer β-lactam antibiotics remain an exciting addition to the antibiotic armamentarium, their use must be accompanied by diligent monitoring for the rapid development of resistance.

2024-02-07·Journal of global antimicrobial resistance

In vitro activity of Cefiderocol against Gram-negative pathogens isolated from people with cystic fibrosis and bronchiectasis.

Article

作者: C S McLaughlin ; J S Elborn ; C M Longshaw ; Tunney Mm

OBJECTIVES:

Gram-negative pathogens causing respiratory infection in people with cystic fibrosis and bronchiectasis are becoming progressively more resistant to conventional antibiotics. Although cefiderocol is licensed for the treatment of infections due to Gram-negative organisms, there is limited data on the activity of cefiderocol against pathogens associated with chronic respiratory diseases. The aim of this study was to determine the susceptibility of Gram-negative pathogens from cystic fibrosis and bronchiectasis to cefiderocol and comparator antibiotics.

METHODS:

Minimal inhibitory concentrations (MICs) of cefiderocol and 15 comparator antibiotics were determined by broth microdilution against 300 respiratory isolates: Burkholderia spp., Stenotrophomonas spp., Achromobacter spp., Ralstonia spp. and Pandoraea spp. and used to calculate the MIC of each antibiotic required to inhibit 50% (MIC₅₀) and 90% (MIC₉₀) of isolates.

RESULTS:

The MIC₅₀ and MIC₉₀ of cefiderocol for all 300 isolates tested was 0.25 and 32 mg/L with 232 (77.3%) isolates having an MIC value ≤2 mg/L. In addition, cefiderocol demonstrated excellent activity against Stenotrophomonas spp. and Achromobacter spp. isolates with 86.7% and 87.2%, respectively, exhibiting an MIC of 2 mg/L. Tigecycline also demonstrated good activity against all isolates with an MIC₅₀ of <0.5 mg/L.

CONCLUSIONS:

These in vitro data demonstrated that cefiderocol had greater activity than most comparator antibiotics and could be an alternative treatment option for respiratory infection caused by these pathogens that has not responded to first line therapy.

2024-02-06·Journal of global antimicrobial resistance

Evaluation of antibiofilm activity of cefiderocol alone and in combination with imipenem against Pseudomonas aeruginosa.

Article

作者: Caterina Ferretti ; Noemi Violeta Poma ; Mariano Bernardo ; Laura Rindi ; Novella Cesta ; Arianna Tavanti ; Carlo Tascini ; Mariagrazia Di Luca

OBJECTIVES;: The main aim of this study was to evaluate the antibiofilm activity of cefiderocol alone and in combination with imipenem versus sessile cells of Pseudomonas aeruginosa, assessing a potential synergistic bactericidal effect. METHODS;: Ten P. aeruginosa clinical isolates from infected implants and bloodstream were included in the study. Cefiderocol was tested alone and in combination with imipenem on 24 hour-old P. aeruginosa biofilm formed on porous glass beads. For each antibiotic formulation, minimum bactericidal biofilm concentration (MBBC), defined as the lowest concentration that determined a reduction of at least 3-log10 CFU/mL compared to the untreated control, was evaluated. Scanning electron microscopy (SEM) was used to investigate the biofilm of P. aeruginosa treated with cefiderocol, imipenem or their combination. RESULTS;: Cefiderocol and imipenem were tested alone on P. aeruginosa biofilm and a reasonable reduction in the number of viable cells was observed especially at high drugs concentrations tested. The synergistic effect of cefiderocol in combination with imipenem was evaluated for five selected isolates. Co-treatment with the two drugs led to a remarkable reduction of cell viability, by resulting in synergistic bactericidal activity in all tested strains and in synergistic eradicating activity in only one isolate. SEM analysis revealed that in cefiderocol-treated biofilm, bacterial cells became more elongated than those of the untreated control, forming filaments in which bacterial division seems to be inhibited. CONCLUSIONS;: Cefiderocol exhibited an encouraging antibiofilm activity against tested strains, representing a valid option for the treatment of P. aeruginosa biofilm-associated infections, especially when administered in combination with imipenem.

项与头孢地尔相关的新闻（医药）

2024-02-27

·Business Wire

Sepsis Drug Pipeline Research Report 2024: Insights from 30 Companies and 35 Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Sepsis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sepsis pipeline landscape is provided which includes the disease overview and Sepsis treatment guidelines. The assessment part of the report embraces, in depth Sepsis commercial assessment and clinical assessment of the pipeline products under development In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sepsis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D. The therapies under development are focused on novel approaches to treat/improve Sepsis. Sepsis Emerging Drugs Chapters This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Sepsis Emerging Drugs Thymosin alpha 1: SciClone Pharmaceuticals Thymosin alpha 1, referred to as thymalfasin, is a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement. SciClone developed and launched Thymosin alpha 1, under the trade name Zadaxin, for the treatment of hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infections. The drug is also being developed for the treatment of COVID 2019 infections. Scientific and clinical studies have shown that Thymosin alpha 1 helps to stimulate and direct the body's immune response to eradicate infectious diseases, such as HBV, HCV, bacterial, and fungal infections; to fight certain cancers such as melanoma and liver cancer; and to enhance response to vaccines. Clinical trials have shown that Thymosin alpha 1 improves survival in patients in intensive care units being treated for sepsis from severe bacterial infections. The therapy is being evaluated in Phase III stage to treat Sepsis. Currently, the drug is in Phase III stage of its development for the treatment of sepsis. Enibarcimab: AdrenoMed AG Enibarcimab (HAM8101; former name: Adrecizumab) a clinical-stage, first-in-class drug targeting loss of vascular integrity. The strong rationale for Enibarcimab is supported by the elegance of its mode of action, a monoclonal antibody that on binding to its target Adrenomedullin preserves its functionality as regulator of vascular integrity. Enibarcimab targets Adrenomedullin (ADM), a vasoprotective peptide hormone. ADM that remains in the bloodstream, however, has a different effect, one that helps mitigate sepsis: promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage. In health, levels of ADM in the bloodstream and extravascular space are in equilibrium so that endothelial barrier integrity is maintained and blood pressure remains normal. Currently, the drug is in Phase II stage of its development for the treatment of sepsis. M 6229: Matisse Pharmaceuticals Matisse's platform technology is based on the discovery that in many patients suffering from sepsis, proteins called histones are released by the innate immune system and dying cells into the blood stream, where they are toxic to other cells. Due to a self-enforcing cascade, people may die from organ failure within one or two days. Preclinical results have shown that by neutralizing the toxic histones with Matisse's product M6229, the negative cascade is terminated by neutralization of cationic histones by anionic M6229. Matisse claims to have identified an elegant solution for treating one of the major complications in sepsis by using a non-anticoagulant fraction of heparin called M6229 to neutralize toxic circulatory histones .Currently, the drug is in Phase I stage of its development for the treatment of sepsis. SNIPR 001: SNIPR Biome SNIPR001 is a novel, orally-administered antibiotic that is designed to precisely target difficult-to-treat bacterial infections. It is developed using SNIPR Biome's CRISPR-Guided VectorsT (CGVT Technology), which is designed to deliver CRISPR reagents into target bacterial cells. SNIPR001 is designed to target certain E. coli bacteria in the gut and thus prevent their translocation to the bloodstream, without affecting beneficial bacteria in the microbiome. It contains four CRISPR-armed phages that selectively target and eliminate E. coli strains that are resistant to fluoroquinolone, with demonstrated efficacy in animal disease models. Currently, the drug is in preclinical stage of its development for the treatment of sepsis. Sepsis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sepsis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sepsis drugs. Sepsis: Therapeutic Assessment Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Sepsis Report Insights Sepsis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Sepsis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players SciClone Pharmaceuticals AdrenoMed AG Matisse Pharmaceuticals SNIPR Biome Tianjin Chase Sun Pharmaceutical Beijing Scitech-Mq Pharmaceuticals Recce Pharmaceuticals Inotrem Octapharma Shaperon Shionogi Pharmazz Seres Therapeutics Key Products Thymosin alpha 1 Enibarcimab M 6229 SNIPR 001 Kukoamine B ST-1830 RECCE 327 Nangibotide OctaplasLG HY209 Cefiderocol Centhaquine SER 155 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ixi7k5 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

临床2期临床3期临床1期

2024-01-08

·CPHI制药在线

2023年日本批准新药简述

关注并星标CPHI制药在线2023年，日本共批准21款新药，其中化药10款，生物药及细胞疗法11款。从药物类型来看，化药研发越来越多样化。10款化药中包括5款小分子、3款合成多肽、1款抗生素和1款小干扰RNA。本文主要从基本信息、国际注册、涉及本药的医药交易、核心专利等情况，简述2023年日本批准的化药，为行业提供一些思考。注：本文所列新药是日本医药品医疗器械综合机构（PMDA）首次批准的新活性物质；不包含化学仿制药、疫苗、血液制品、生物类似药、新适应症、新剂型、新给药途径和改变适用人群等情形。参考来源：PMDA、FDA、EMA、NMPA等各大评审局，图片自制 1.1 Cefiderocol Sulfate Tosylate 简介：Cefiderocol Sulfate Tosylate是由盐野义制药株式会社研发的一种头孢菌素类抗生素，是一种PBPs抑制剂，用于治疗细菌感染、呼吸机相关性肺炎、细菌性肺炎、医院获得性肺炎、革兰氏阴性细菌感染和泌尿系统感染。国际注册：2019-11-14美国、2020-04-23 欧盟、2023-11-30日本；中国III期。相关交易：截止目前，该药已有三起披露的合作。 2022年06月15日, 盐野义制药和Global Antibiotic Research and Development Partnership Foundation与CHAI就cefiderocol达成合作； 2022年06月16日, 盐野义制药和Nhs England就FETCROJA? (CEFIDEROCOL)达成合作； 2023年09月12日, Orchid Pharma Ltd获得Global Antibiotic Research and Development Partnership Foundation关于cefiderocol的许可。核心专利：原研化合物专利WO2010050468A1于2009-10-27申请，已进入各大主流国家。其中，中国：CN102203100B预计2029-10-27到期。美国：US9238657B2橙皮书显示2033-11-14到期，已延长。 Cefiderocol Sulfate Tosylate结构式，图片来源：说明书 1.2 Zilucoplan 简介：Zilucoplan是由Ra Pharmaceuticals Inc和比利时联合化工集团研发的一种合成多肽，是一种C5抑制剂，用于治疗重症肌无力。国际注册：2023-09-25日本、2023-10-17美国；中国暂无进展。相关交易：暂未检索到公开交易。核心专利：原研化合物/序列专利WO2015191951A3于2015-06-12申请，已进入各大主流国家。其中，中国：CN106456701B预计2035-06-12到期。美国：橙皮书显示US10106579B2于2035-06-12到期。 Zilucoplan结构式，图片来源：说明书 1.3 Tenapanor hydrochloride 简介：Tenapanor hydrochloride（盐酸替纳帕诺）是由Ardelyx Inc研发的一种First-in-Class小分子药物，是一种NHE3抑制剂，用于治疗慢性肾功能不全、高磷血症、便秘和肠易激综合征。国际注册：2019-09-12美国、2023-09-25日本；中国：原研2.4类申请上市，2023-07-12承办（复星医药和Ardelyx共同申报）。相关交易：2017年12月11日, 复星医药获得Ardelyx关于Tenapanor的许可。核心专利：原研化合物专利WO2010078449A3于2009-12-30申请，已进入各大主流国家。其中，中国：CN103819403B预计2029-12-30到期；美国：US8541448B2橙皮书显示2033-08-01到期，已延长。 Tenapanor hydrochloride结构式，图片来源：说明书 1.4 Difelikefalin 简介：Difelikefalin（地非法林）是由Ferring Pharmaceuticals及Cara Therapeutics研发的一种First-in-Class合成多肽，是一种KOR1激动剂，用于治疗瘙痒症。国际注册：2021-08-23美国、2022-04-25欧盟、2023-09-25日本；中国：III期。相关交易：截止目前，本药涉及六项交易。 2012年05月03日, Chong Kun Dang Pharmaceutical获得Cara Therapeutics关于Difelikefalin的许可； 2012年05月03日, Chong Kun Dang Pharmaceutical获得Cara Therapeutics关于Difelikefalin的许可； 2018年05月23日, 维福公司获得Cara Therapeutics关于Difelikefalin的许可； 2019年08月21日, Cara Therapeutics获得Enteris BioPharma关于Difelikefalin的许可； 2020年10月20日, Cara Therapeutics和维福就Difelikefalin达成合作； 2023年09月25日, 丸石制药获得Cara Therapeutics Inc关于KORSUVA IV Injection的许可(里程碑付款)。核心专利：原研化合物/序列专利WO2008057608A8于2007-11-12申请，已进入各大评审局。其中，中国：CN101627049B预计2027-11-13到期；美国：US7402564B1橙皮书显示2027-11-12到期。 Difelikefalin结构式，图片来源：说明书 1.5 Inclisiran sodium 简介：Inclisiran sodium（英克司兰钠）是由Alnylam Pharmaceuticals Inc研发的一种First-in-Classs iRNA，是一种PCSK9抑制剂，用于治疗高胆固醇血症、血脂障碍、颈动脉疾病、杂合子家族性高胆固醇血症和动脉粥样硬化。国际注册：2020-12-09 欧盟、2021-12-22美国、2023-08-22中国、2023-09-25 日本相关交易：本药涉及两起交易。 2013年02月04日, Alnylam Pharmaceuticals和The Medicines Company就ALN-PCS02和Inclisiran sodium达成合作； 2021年09月06日, Novartis和英国国家医疗服务体系就Inclisiran sodium达成合作。核心专利：原研化合物/序列专利WO2014089313A1于2013-12-05申请，已进入各大主流国家。其中，中国：CN104854242B预计2033-12-05到期。美国：美国橙皮书显示US10125369B2 于2034-08-18到期，已延长。 Inclisiran sodium结构式，图片来源：说明书 1.6 Lenacapavir sodium 简介：Lenacapavir sodium（来那帕韦）是由Gilead Inc研发的一种First-in-Class小分子药物，是一种Capsid抑制剂，用于治疗HIV感染。国际注册：2022-08-17欧盟、2022-12-22美国、2023-08-0日本；中国：原研5.1类申请上市，涉及两个剂型，片剂及注射液。来那帕韦片（2023-09-23承办）、来那帕韦注射液（2023-09-28承办）。相关交易：暂未检索到公开交易。核心专利：原研化合物专利WO2018035359A1于2017-08-17申请，已进入各大主流国家。其中，中国：CN109890808B，预计2037-08-17到期；美国：橙皮书显示US10071985B2于2037-08-17到期。 Lenacapavir sodium结构式，图片来源：说明书 1.7 Ritlecitinib 简介： Ritlecitinib（利特昔替尼）是由辉瑞研发的一种小分子药物，是一种JAK3抑制剂和TEC抑制剂，用于治疗斑秃。国际注册：2023-06-23美国、2023-06-26 日本、2023-09-15 欧盟、2023-10-18 中国。相关交易：暂未检索到公开交易。核心专利：原研化合物专利WO2015083028A1于2014-11-20申请，已进入各大主流国家。其中，中国：CN106061973B，预计2034-11-20到期；美国：橙皮书显示US9617258B2于2034-12-03到期，已延长。 Ritlecitinib结构式，图片来源：说明书 1.8 Futibatinib 简介：Futibatinib（福巴替尼）是由大鹏药品工业株式会社和大冢制药株式会社研发的一种小分子药物，是一种FGFR1-4拮抗剂，用于治疗胆管上皮癌和胆管癌。国际注册：2022-09-30美国、2023-06-26日本、2023-07-04欧盟。中国：暂无进展。相关交易：暂未检索到公开交易。核心专利：原研化合物专利WO2013108809A1于2013-01-17申请，已进入各大主流国家。其中，中国：CN103958512B预计2033-01-17到期；美国：橙皮书显示US10434103B2于2033-02-23到期，已延长。 Futibatinib结构式，图片来源：说明书 1.9 Pegcetacoplan 简介：Pegcetacoplan是由Apellis Pharmaceuticals Inc研发的一种合成多肽，是一种C3抑制剂，用于治疗阵发性血红蛋白尿症和地图状萎缩。国际注册：2021-05-14美国、2021-12-13欧盟、2023-03-27日本；中国：暂无进展。相关交易：2020年10月27日, Apellis和Swedish Orphan Biovitrum就Pegcetacoplan达成合作。核心专利：原研化合物/序列专利WO2014078731A3于2013-11-15申请，已进入各大主流国家。其中，中国：CN105051057B预计2033-11-15到期。美国：橙皮书显示US11292815B2，于2033-11-15到期。 Pegcetacoplan结构式，图片来源：说明书 1.10 Avatrombopag Maleate 简介：Avatrombopag Maleate（马来酸阿伐曲泊帕）是由安斯泰来制药集团研发的一种小分子药物，是一种TpoR激动剂，用于治疗血小板减少和肝脏疾病。国际注册: 2018-05-21美国、2019-06-20欧盟、2020-04-14 中国、 2023-03-27 日本。相关交易：2018年03月19日, 复星医药获得Dova Pharmaceuticals（安斯泰来合作公司）关于阿伐曲泊帕的许可。核心专利：原研化合物专利WO2003062233A1于2003-01-15申请，已进入各大主流国家。其中，中国：CN1319967C于2023-01-15已经到期。美国：橙皮书显示US7638536B2于2025-05-05到期，已延长。 Avatrombopag Maleate结构式，图片来源：说明书参考资源： 1、药物信息：各大药物说明书 2、注册信息：PMDA、FDA、EMA、NMPA等国际评审局 3、专利信息：美国橙皮书、中国专利局、欧专局等作者简介：药丸，中国药科大学硕士毕业，具有法律及药学教育背景，拥有法律资格证和专利代理师资格证，致力研究药学和专利，做一颗有价值的药丸。智药研习社1月直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

专利到期疫苗临床3期生物类似药

2023-09-15

·FiercePharma

Fierce Pharma Asia—Otsuka's gene therapy deal; Astellas' $354M plant; Exelixis and Insilico's AI drug pact

Otsuka's gene therapy collab with Shape Therapeutics, Astellas' new manufacturing plant and an AI drug licensing deal between Exelixis and Insilico Medicine made our news this week. Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5 billion. Astellas will build its third Irish manufacturing facility. Insilico Medicine out-licensed an AI-discovered cancer drug candidate to Exelixis. And more. 1. Otsuka's eye disease strategy takes Shape with $1.5B biobucks deal In a deal potentially worth up to $1.5 billion, Otsuka has hired Shape Therapeutics to develop new gene therapies for serious eye diseases. Shape, a 2022 Fierce 15 winner, will apply its adeno-associated virus capsid discovery platform, while Otsuka will design the genetic payload. Shape will provide extra optimization with its transgene engineering technology as well. 2. Astellas lays out plans to build $354M manufacturing facility in Ireland Astellas plans to invest 330 million euros ($354 million) to build a new manufacturing facility in Tralee, Ireland. Pending planning permits, construction will begin in 2024, and operation is expected to commence in 2028. The plant, Astellas’ third in Ireland, will make aseptic products including antibody drugs. 3. Exelixis links up with AI drug finder Insilico, LIB offloads China rights for PCSK9 inhibitor Exelixis has in-licensed a phase 1 small molecule from artificial intelligence drug discovery firm Insilico Medicine. For $80 million upfront and undisclosed milestone payments, Exelixis gains worldwide rights to a cancer candidate targeting USP1, which may have value in BCMA-mutated tumors, according to Insilico. 4. Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients Eisai has established a first-of-its-kind “digital business.” Called Theoria, the platform aims to build an ecosystem for people living with dementia. Eisai, maker of Alzheimer’s disease drug Leqembi, will launch Theoria in Japan next April. The platform will tap various data and health records to help find people who may be at risk of developing dementia. 5. AstraZeneca, Daiichi Sankyo show off ADC portfolio with safety top of mind AstraZeneca and Daiichi Sankyo have unveiled additional early-stage data for their TROP2 antibody-drug conjugate, nicknamed Dato-DXd. Results from just 14 patients in the phase 1b TROPION-Lung04 study showed that the combination of Dato-DXd and AZ’s PD-L1 inhibitor Imfinzi triggered a 50% tumor response rate. In a cohort of 13 patients who also received chemotherapy, the response rate was 77%. 6. Sandoz, nearing Novartis split, signs up to commercialize Samsung Bioepis' Stelara biosimilar Sandoz continues to beef up its biosimilar portfolio as a separation from Novartis draws near. Sandoz signed a deal to commercialize Samsung Bioepis’ biosimilar to Johnson & Johnson’s immunology blockbuster Stelara in the U.S., Canada and several European countries. J&J has inked patent settlements with several companies to delay launches for their Stelara copycats until 2025. Other News of Note: 7. In global access push, Orchid Pharma gains license to manufacture the antibiotic cefiderocol 8. China approves BioRay’s homemade lymphoma rival to Roche’s Rituxan (release) 9. Takeda commits $30M in 5 humanatarian programs (release)

临床1期引进/卖出抗体药物偶联物临床结果基因疗法

100 项与头孢地尔相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11013	头孢地尔	J01D	DB14879

研发状态

适应症	最高研发状态	国家/地区	公司
呼吸机相关性肺炎	批准上市	美国更多	Shionogi, Inc. 更多
革兰氏阴性菌感染	批准上市	英国更多	Shionogi & Co., Ltd. 更多
沙雷菌感染	批准上市	美国更多	Shionogi, Inc. 更多
感染	批准上市	日本更多	Shionogi Pharma, Inc. 更多
医院获得性肺炎	批准上市	美国更多	Shionogi, Inc. 更多

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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


NCT02321800 (APEKS-cUTI, Pubmed)	临床2期	复杂下尿路感染	371	Cefiderocol	(醖鑰願網積構簾醖鏇艱) = 淵獵鹽觸遞顧積淵膚膚鏇鏇範鹽網壓艱積夢憲 (淵築選選淵鬱襯淵繭願 )	-	2021-01-01
				Imipenem-cilastatin	(醖鑰願網積構簾醖鏇艱) = 餘夢鬱蓋衊製顧醖餘願鏇鏇範鹽網壓艱積夢憲 (淵築選選淵鬱襯淵繭願 )
NCT03032380 (APEKS-NP, Pubmed) 人工标引	临床3期	医疗保健相关性肺炎	-	Linezolid+Cefiderocol	(夢鹹襯遞範繭窪壓鑰醖) = 積繭積鬱遞憲網淵網積鑰範獵糧顧糧顧壓鑰顧 (糧廠築衊觸選願簾顧壓 ) 更多	非劣	2022-01-13
				Linezolid+meropenem	(夢鹹襯遞範繭窪壓鑰醖) = 製膚糧顧顧壓憲襯窪願鑰範獵糧顧糧顧壓鑰顧 (糧廠築衊觸選願簾顧壓 ) 更多
NCT03032380 (CTgov)	临床3期	医院获得性细菌性肺炎 \| 医院获得性肺炎 \| 呼吸机相关性肺炎 \| 呼吸机相关细菌性肺炎	300	Cefiderocol+Linezolid (Cefiderocol)	壓遞淵遞繭鏇遞夢製顧(願艱遞顧築簾顧醖觸遞) = 觸繭積壓壓觸繭顧築醖壓選遞獵艱積簾齋積築 (遞齋餘壓廠繭選窪觸廠, 糧艱窪遞蓋餘鬱範淵艱 ~ 窪憲衊鹽壓壓築簾簾餘) 更多	-	2020-11-13
				Meropenem+Linezolid (Meropenem)	壓遞淵遞繭鏇遞夢製顧(願艱遞顧築簾顧醖觸遞) = 憲獵糧廠鬱網簾蓋齋構壓選遞獵艱積簾齋積築 (遞齋餘壓廠繭選窪觸廠, 鬱憲壓衊選積糧製積選 ~ 顧廠壓夢窪夢壓遞鬱艱) 更多
NCT02321800 (Pubmed) 人工标引	临床2期	泌尿道感染 Gram-negative	452	Cefiderocol	遞憲獵襯鏇襯淵鹽簾製(醖鹹繭鹹襯鹽築膚鬱遞) = 鬱窪製衊觸鏇膚鬱繭齋觸鹽鬱範繭簾膚鬱醖願 (膚鏇蓋鑰鬱顧簾襯廠繭 ) 更多	积极	2018-12-01
				imipenem-cilastatin	遞憲獵襯鏇襯淵鹽簾製(醖鹹繭鹹襯鹽築膚鬱遞) = 鑰壓願繭構觸網淵顧繭觸鹽鬱範繭簾膚鬱醖願 (膚鏇蓋鑰鬱顧簾襯廠繭 ) 更多
NCT03862040 (CTgov)	临床1期	细菌性肺炎	7	Standard of Care Antibiotic+Cefiderocol	艱憲鏇廠範襯觸範製範(襯憲鹽顧製壓遞觸鑰範) = 積鏇艱選觸範積選鑰憲顧蓋鏇憲築網鑰襯齋餘 (醖觸醖艱鏇窪製繭製齋, 蓋餘衊積鹹鬱壓積壓夢 ~ 鑰廠艱鏇觸築遞鹽餘憲) 更多	-	2020-11-05
NCT05395104 (CTgov)	临床1期	-	14	Cefiderocol+Midazolam	憲鹽膚鹹餘積膚鏇獵衊(鑰遞範鏇窪膚鏇鹹遞鏇) = 築餘遞鏇網獵夢選齋艱範顧鑰網壓構積鹹遞範 (醖繭鏇鹹衊鬱蓋衊壓艱, 糧選窪壓網構餘齋壓簾 ~ 鬱鬱獵蓋窪簾餘鹹餘鹹) 更多	-	2023-12-14
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) 人工标引	临床3期	感染	152	cefiderocol	(蓋鑰糧積範鑰選糧窪範) = 膚範獵簾膚醖觸簾選構網簾醖簾範蓋觸製顧簾 (糧鬱鏇鹽鏇衊構蓋淵壓, 23.2 ~ 65.5) 更多	相似	2021-02-01
				best available therapy	(蓋鑰糧積範鑰選糧窪範) = 繭構襯壓廠糧範願窪顧網簾醖簾範蓋觸製顧簾 (糧鬱鏇鹽鏇衊構蓋淵壓, 17.7 ~ 71.1) 更多