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更新于：2025-12-11

Alprazolam

阿普唑仑

更新于：2025-12-11

概要

基本信息

简介阿普唑仑是一种小分子药物，可作为 GABAA 受体的激动剂，GABAA 受体是一种对抑制性神经递质γ-氨基丁酸 (GABA) 有反应的神经递质受体。通过增强 GABA 在大脑中的作用，阿普唑仑具有抗焦虑、镇静和抗惊厥的特性。这种药物主要用于治疗焦虑症和恐慌症。然而，它也被发现对某些癫痫和哮喘相关焦虑症有效。阿普唑仑于1981年10月16日首次获得FDA批准，由日本制药公司武田制药公司研制。阿普唑仑有多种形式，包括速释片和缓释片，以及口服溶液。应谨慎使用，因为它可能会导致依赖性和戒断症状。

药物类型

小分子化药

别名

8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-a)(1,4)benzodiazepine、Alprazolcem、AP-1002

+ [19]

靶点

DOCK5 x GABAA receptor

作用方式

抑制剂、激动剂

作用机制

DOCK5抑制剂(dedicator of cytokinesis 5 inhibitors)、GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂)

治疗领域

神经系统疾病其他疾病

在研适应症

睡眠异常紧张症抑郁症+ [7]

非在研适应症

药物滥用Dravet综合征轻度哮喘+ [1]

原研机构

Takeda Pharmaceutical Co., Ltd.Upjohn Pharmaceuticals Ltd.

在研机构

Unimed Pharmaceutical, Inc.UCB Pharma SA

Teva Takeda Pharma Ltd.

+ [6]

非在研机构

Viatris, Inc.

Sandoz Group AGVIATRIS Pharmaceuticals Ltd.

+ [4]

权益机构

Alexza Pharmaceuticals, Inc.

李氏大药厂控股有限公司

Engage Therapeutics, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1981-10-16),

焦虑症惊恐障碍

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (中国)

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结构/序列

分子式C17H13ClN4

InChIKeyVREFGVBLTWBCJP-UHFFFAOYSA-N

CAS号28981-97-7

关联

127

项与阿普唑仑相关的临床试验

NCT07275710

/ Not yet recruitingN/AIIT

Role of Alprazolam in Management of Post Endodontic Pain After Single Visit Root Canal Treatment

To compare mean pain score between two group of participants undergoing post operative pain management after single visit root canal treatment: one group receiving NSAIDs alone and the other receiving a combination of NSAIDs and an anxiolytic medication i.e alprazolam.

开始日期2026-02-01

申办/合作机构-

NCT07154147

/ Recruiting临床4期IIT

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.

开始日期2025-08-12

申办/合作机构

The University of California, San Francisco

NCT07020988

/ Recruiting临床1期

An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam and of Staccato Alprazolam Versus Nasal Diazepam in Healthy Study Participants

The purpose of this study is to estimate the difference in the time to onset of action between Staccato alprazolam and intravenous (iv) midazolam using changes in power in the combined spindle and ?1 frequency bands in the qEEG (quantitative electroencephalogram).

开始日期2025-06-12

申办/合作机构

UCB Biopharma SRL

100 项与阿普唑仑相关的临床结果

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100 项与阿普唑仑相关的转化医学

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100 项与阿普唑仑相关的专利（医药）

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4,711

项与阿普唑仑相关的文献（医药）

2026-02-01·FORENSIC SCIENCE INTERNATIONAL

Drug use pattern of suspected drug-influenced drivers in Hungary (2019–2023)

Article

作者: Institóris, László ; Süvegh, Gábor ; Kereszty, Éva M ; Hidvégi, Előd ; Kovács, Katalin ; Rárosi, Ferenc ; Berkecz, Róbert ; Sija, Éva

Between 2019 and 2023, blood and urine samples of 6229 suspected impaired drivers were analysed, with a positivity rate of 91.5 %. Classical illicit drugs were detected in 4693 drivers, medicines in 850 drivers, stimulant new psychoactive substances (sNPS) in 928 drivers and synthetic cannabinoid receptor agonists (SCRAs) in 657 drivers. The consumption of cannabis, N-ethyl-norpentedron, and N-ethyl-hexedrone increased significantly over time, while the consumption of five SCRAs declined. These changes were concordant with the seizure data for the entire country. 74.2 % of drug-positive drivers were deemed impaired. Impairment was determined by fixed concentration limits in 3538 cases, multi-drug use in 507 cases, and clinical symptoms (when only one active substance with no impairment limit was present in the blood) in 217 cases. To evaluate clinical tests, the prevalence of positive and negative clinical findings was compared for amphetamine/methamphetamine, THC, MDMA, alprazolam, and clonazepam above and below their fixed concentration limits. Only alprazolam showed a significantly higher frequency of positive clinical signs above the limit. This finding suggests that the current protocol of medical examination in Hungary is inadequate for diagnosing impairment when only one active substance without a defined threshold is detected in the blood. Given that sNPS was detected in 24.1 % of drivers, the medical investigation system requires a major revision. The aim of this study was to investigate the illicit and licit drug consumption of suspected impaired drivers in Hungary and to present the disadvantages of the system currently used for diagnosing and proving impairment.

2025-12-01·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Attenuation of the discriminative stimulus and reinforcing effects of positive GABAA modulators after Shisa7 knockdown in rats

Article

作者: Winsauer, Peter J ; Abdurrahman, Aslan ; Henderson, Ashley S ; Melton, Sarah M ; Morris, Tamara M ; Aiyar, Ashok

γ-aminobutyric acid type-A receptors associate with auxiliary proteins such as Shisa7 and have allosteric binding sites for benzodiazepines, barbiturates, and alcohols. In this study, Shisa7 was knocked down to assess its involvement in the discriminative-stimulus effects of drugs from each class and in the positive reinforcing effects of alcohol. Twelve male Long-Evans rats were trained to respond in a drug-discrimination procedure with 6 trained to discriminate ethanol (1 g/kg) from saline and 6 trained to discriminate alprazolam (1.8 mg/kg) from cyclodextrin. Following training, cumulative dose-effect curves for ethanol, alprazolam, and pentobarbital were established before and after Shisa7 knockdown was achieved using an intravenous dicer substrate small-interfering ribonucleic acid. A separate group of 6 rats was also trained to consume ethanol orally to assess ethanol intake before and after Shisa7 knockdown. In general, before Shisa7 knockdown, alprazolam and pentobarbital partially substituted for ethanol in ethanol-trained subjects up to doses that decreased response rate, whereas pentobarbital, but not ethanol, partially substituted for alprazolam in alprazolam-trained subjects. After Shisa7 knockdown, the dose-effect curve for ethanol-lever responding in ethanol-trained subjects was shifted downward, the curve for alprazolam-lever responding in alprazolam-trained subjects was shifted rightward, and the curve for pentobarbital was shifted rightward in both ethanol- and alprazolam-trained subjects. Shisa7 knockdown did not affect response rates. In rats orally consuming ethanol, both ethanol intake and dose were significantly decreased after Shisa7 knockdown compared with the dicer substrate small-interfering ribonucleic acid control. These findings demonstrate that reducing Shisa7 levels attenuated the discriminative-stimulus effects of 3 positive allosteric modulators of γ-aminobutyric acid type-A receptors and decreased ethanol's reinforcing effects. SIGNIFICANCE STATEMENT: This study demonstrates that Shisa7, an auxiliary protein associated with γ-aminobutyric acid type-A receptor, plays a crucial role in mediating the discriminative-stimulus effects of ethanol, alprazolam, and pentobarbital, as well as the reinforcing effects of ethanol. By demonstrating that Shisa7 knockdown attenuates the behavioral effects of these drugs, the findings provide new insights into the molecular mechanisms underlying γ-aminobutyric acid type-A receptor-mediated drug effects and potentially identify Shisa7 as a key modulatory mechanism through which these drugs produce their effects.

2025-12-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development and validation of a LC–MS/MS method for the detection of 38 benzodiazepines and 2 Z-drugs in blood

Article

作者: Liu, Yu ; Liu, Xin-Ze ; Guo, Zhen-Shuo ; Yan, Hui ; Xiang, Ping

Benzodiazepines and Z-drugs are commonly used as prescription medications to treat anxiety, epilepsy, insomnia, and alcohol withdrawal syndrome, but their use can lead to tolerance, dependence, and withdrawal reactions if taken against official guidelines. Furthermore, designer benzodiazepines, most of which lack clinical and toxicological data, have entered the illicit drug market as new psychoactive substances and are used for recreational purposes. Their abuse can cause confusion, memory loss, respiratory depression, and even death, especially when combined with other sedative-hypnotics or alcohol. Therefore, new qualitative and quantitative methods for benzodiazepines and Z-drugs are needed for use in forensic and clinical toxicology. This study explored the sample preparation and liquid-liquid extraction using 0.5 mL blood samples and 2 mL of extraction solvent for analysis of these drugs by liquid chromatography-tandem mass spectrometry and multiple reaction monitoring. The benzodiazepines were separated on a pentafluorophenylpropyl (PFPP) column using a mobile phase gradient consisting of A (water, 0.1 % formic acid, 5 % acetonitrile, and 20 mmol/L ammonium acetate) and B (acetonitrile) for 9 min. Validation steps confirmed that the method demonstrated good selectivity, sensitivity (limit of detection: 0.2 ng/mL, lower limit of quantification: 0.5 ng/mL), linearity (R² ≥ 0.99), accuracy, and precision (<20 %). Matrix effects ranged from 35 to 126 %, and recoveries ranged from 17 to 99 %, with 35 compounds having recoveries of more than 50 %. The method was successfully applied for the identification and quantification of benzodiazepines and nonbenzodiazepines in blood samples from 15 authentic poisoning cases. Ten analytes were detected: alprazolam (130.2-575.3 ng/mL), hydroxyalprazolam (2.3-37.3 ng/mL), clonazepam (11.7-773.2 ng/mL), lorazepam (63.4-166.9 ng/mL), 7-aminoclonazepam (17.4-385.3 ng/mL), oxazepam (2.6-964.1 ng/mL), diazepam (227.2 ng/mL), nordazepam(22.4 ng/mL), zolpidem (11.8-64.0 ng/mL), midazolam (70.2 ng/mL), and hydroxymidazolam (162.8 ng/mL).

138

项与阿普唑仑相关的新闻（医药）

2025-12-11

·PRNewswire

Lee's Pharmaceutical Holdings Limited Acquires Staccato® One Breath Technology® Platform and Assets, Driving Pipeline Expansion and Advancing Global Partnership with UCB Through Acquired Rights

Acquisition of Staccato® One Breath Technology®, a proprietary platform technology with broad therapeutic potential Synergistic and complementary to Lee's Pharm's existing products pipeline, and Acquisition of rights as licensor and manufacturer of Staccato® alprazolam under a global partnership with UCB HONG KONG, Dec. 11, 2025 /PRNewswire/ -- Nova Pneuma Inc. ("NPI"), the Delaware incorporated and wholly owned subsidiary of Lee's Pharmaceutical Holdings Limited (0950.HK) ("Lee's Pharm" or the "Company"), announced today the assets acquisition from Alexza Pharmaceuticals, Inc. ("Alexza"). The transaction grants Lee's Pharm and NPI, the full ownership of the Staccato® One Breath Technology® ("Staccato® OBT®") platform and assets in relation to Staccato® OBT®, including intellectual property, know-how, trademarks, product pipeline, equipment, products and access to GMP facility, and Alexza's right as licensor and manufacturer of Staccato® alprazolam. This strategic move strengthens Lee's Pharm's aerosolized inhalation drug delivery capabilities, expands the Company's inhalation product pipeline, and aligns with the Company's global expansion strategy. Continue Reading GMP Facility, Fremont CA The transaction remains subject to certain closing conditions and is expected to close by the end of 2025. Proprietary And Well-Validated Staccato® One Breath Technology® The acquisition of the Staccato® OBT® platform represents a major step forward for the Company, granting full ownership of this technology platform which is a well-validated and proven platform supported by approved product, Adasuve®, and several Staccato® based late-stage development programs. This strategic move strengthens the Company's drug delivery capabilities and positions it to drive future innovation in inhalation therapeutics. Synergistic and Complementary to Lee's Pharm's Existing Products Pipeline The transaction also delivers significant synergies with the Company's existing pipeline. The Company has been advancing its clinical development of Staccato® based medicine for cancer-related breakthrough pain and started commercializing Adasuve® for acute agitation in adult schizophrenia or bipolar I disorder across Greater China. Upon completion of the acquisition, all licensing payment obligations payable thereafter by Lee's Pharm to Alexza for the development and commercialization of Staccato® based medicine and Adasuve®, will be eliminated, delivering immediate cost savings and enhancing overall deal economics. In addition, two promising CNS pipeline assets targeting Parkinson's disease and Cyclic Vomiting Syndrome (CVS), both at Phase 2 clinical stage, will be integrated into the Company's portfolio, unlocking new commercial opportunities. Acquisition of Rights as Licensor and Manufacturer of Staccato® alprazolam Under a Global Partnership With UCB Complementing these benefits, the Company acquires Alexza's rights and obligations under the existing worldwide licensing and manufacturing supply agreement with UCB, a biopharmaceutical with strong presence in epilepsy treatment. Under this agreement, UCB holds and will keep global development and commercialization rights for Staccato® alprazolam, which is currently in Phase 3 clinical trial (CinicalTrial.gov ID: NCT05077904), reinforcing the clinical maturity and commercial potential of the Staccato® OBT® platform. UCB acquired Engaged Therapeutics, Inc. for Staccato® alprazolam in June 2020 and entered into an updated license and related commercial supply agreement with Alexza.[1] Subject to achieving specified development, regulatory, and sales milestones, Lee's Pharm together with NPI may receive milestone payments totalling up to US$60.5 million, along with tiered royalties on global net sales of Staccato® alprazolam, in addition to manufacturing revenue from worldwide supply of Staccato® alprazolam. Note: [1] Source of reference: "Acquiring the Staccato® OBT® platform is a transformative step for Lee's Pharm, reinforcing our commitment to innovation in inhalation therapeutics targeting CNS and neurodegenerative disorders, and expanding our global footprint." said Dr. Benjamin Li, Founder and Director of Lee's Pharmaceutical Holdings Limited. "This transaction not only strengthens our pipeline and inhalation R&D capabilities but also creates new revenue streams through the strategic partnerships with UCB." " We are delighted to partner with UCB as it commits and advances solutions to address critical unmet needs in epileptic seizure therapy. This transaction not only delivers near-term financial benefits but also positions us for sustained growth in high-value therapeutic areas, marking a significant milestone in the Company's global expansion strategy." said Ms. Wanee Lee, Managing Director of Lee's Pharmaceutical Holdings Limited. "Under the new leadership, our team is energized to continue collaborating closely with UCB and to ensure the reliable manufacture of meaningful therapy for patients with significant unmet needs. We are equally excited about the opportunity to bring additional Staccato® based medicines to patients around the world, strengthening our shared commitment to improving lives through innovative science." said Dr. Wolfgang Schmidt, SVP Manufacturing and Operations at NPI. About Lee's Pharmaceutical Holdings Limited The Company is a research-driven and market-oriented biopharmaceutical company with more than over 30 years of operation' experience in the pharmaceutical industry in China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global perspectives. The Company has established extensive partnerships with around 30 international companies and currently markets over 25 proprietary, generic and licensed-in pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease therapeutic areas such as cardiovascular health, woman's health, paediatrics, rare diseases, oncology, dermatology and obstetrics. More information available at . About Staccato® One Breath Technology® The Staccato® One Breath Technology® is a unique and highly differentiated drug delivery technology that delivers excipient free drug as fast as intra-venous injection, but non-invasively, resulting in rapid onset of therapeutic effect. It is best positioned for treatment of acute conditions that require quick relief. The ability of the technology with the combination of different molecules to give response to unmet medical needs in an innovative manner has been well proven in large number of clinical studies with different compounds and across number of indications. The proprietary technology is well protected by large numbers of patents across different therapeutic areas. More information available at . 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引进/卖出并购临床3期

2025-12-10

·医药健闻

蔡司医疗与任职仅7个月的CEO解除合约；泰利福超20亿美元抛售多个业务；复星医药与辉瑞签订许可协议 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态卡尔蔡司医疗宣布，将与任职仅7个月的首席执行官Maximilian Foerst解除合约，相关决定将于2025年12月31日正式生效。据公司周一发布的公告，Foerst本人已承认曾违反公司内部《行为准则》，涉及多年前在蔡司内部工作环境中与某位人员存在利益冲突的不当行为。公司强调，该事件与蔡司医疗的业务运营无任何关联。双方经协商一致，同意提前终止其合同。蔡司集团CEO兼蔡司医疗监事会主席Andreas Pecher将暂时接管Foerst的CEO职责。礼来宣布，将投资60亿美元在美国阿拉巴马州亨茨维尔市建设一座生产工厂，以扩大其备受关注的实验性减肥药及其他药物的产能。这是该制药巨头计划在美国新增的一系列投资项目中的第三座工厂。今年2月，礼来曾宣布将投资至少270亿美元在美国新建四座生产工厂，而自2020年以来，该公司已累计完成230亿美元的相关投资。阿拉巴马州工厂的建设预计将于2026年启动，2032年竣工。西门子医疗与尼日利亚主权投资局（NSIA）达成一项为期十年的战略合作伙伴关系，旨在彻底改革尼日利亚的诊断基础设施。此次合作聚焦于两大核心方向。一方面，西门子医疗将提供尖端医学影像技术，为尼日利亚医疗诊断带来质的飞跃。另一方面，开展能力建设项目，从技术设备与专业人才两方面双管齐下，确保MedServe医疗扩展项目获得可持续支持。泰利福（Teleflex）宣布，已与两家独立买家签订最终协议，同意出售其急性护理、介入泌尿科和OEM业务，交易总额达20.3亿美元。英国医疗器械制造商Intersurgical Ltd收购了泰利福的Acute Care and Interventional Urology（急性护理和介入泌尿科）业务；私募股权公司蒙塔古（Montagu）和科尔伯格（Kohlberg）收购了OEM业务。根据协议条款，泰利福为其OEM业务获得约15亿美元，为急性护理和介入泌尿科业务获得5.3亿美元。公司预计税后净收益约为18亿美元。该交易预计在2026年下半年完成。德昇济医药（D3 Bio）宣布完成1.08亿美元B轮融资，以加速肿瘤创新疗法的全球开发。本轮融资由一批知名投资机构共同参与，包括IDG资本和松青资本。公司现有投资方，包括药明康德风险投资基金、淡马锡、红杉中国、经纬创投以及Medicxi持续追加投资。本轮融资资金将主要用于支持公司核心候选药物elisrasib（D3S001）的全球Ⅲ期关键性临床研究，并推进公司以靶向与肿瘤免疫为核心的创新药物管线。李氏大药厂全资子公司Nova Pneuma Inc.（NPI）宣布对Alexza Pharmaceuticals, Inc.的资产进行收购。该交易完成后，李氏大药厂及NPI将对Staccato One Breath Technology（Staccato OBT）平台技术及相关资产拥有完全所有权，包括知识产权、平台技术、商标、产品管线、设备、产品管线及GMP设施的使用权，以及获取Alexza作为Staccato阿普唑仑（Staccato alprazolam）许可方和制造供应方的权利。此战略举措强化了李氏大药厂在气雾吸入药物递送领域的能力，扩展公司吸入类产品管线，并契合公司全球扩张战略。该交易仍需满足特定交割条件，预计将在2025年底完成。外高桥集团旗下UDC Consulting与高博医疗集团宣布联合构建“创新药管线合作研发体系”。该体系由双方共同出资运作，首期合作总规模为人民币1亿元。该体系聚焦肿瘤及相关领域的创新药研发管线，重点支持已取得IND（新药研究申请）批件、即将进入I期临床的管线，以临床价值为核心进行合作。单个合作管线出资原则上不超过人民币500万元。产业动态复星医药控股子公司药友制药、复星医药产业与辉瑞共同签订《许可协议》，其中主要包括由药友制药就口服小分子胰高血糖素样肽-1受体（GLP-1R）激动剂（包括YP05002）及含有该活性成分的产品授予辉瑞于许可区域（即全球范围）及领域（人类、动物所有适应症的治疗、诊断及预防）独家开发、使用、生产及商业化权利；就本次许可，药友制药将有权依约获得（其中包括）不可退还的首付款1.5亿美元及基于许可产品临床、商业化进展获得开发里程碑付款至多3.5亿美元。基于许可产品的年度净销售额达成情况，由辉瑞向药友制药依约支付至多15.85亿美元的销售里程碑款项。诺华制药与英国生物技术公司Relation Therapeutics达成一项高达逾17亿美元的交易，以帮助寻找治疗过敏性疾病的药物靶点。该交易旨在将诺华制药在免疫皮肤病学方面的专业知识与Relation的药物发现人工智能平台相结合，后者借助包括人体组织在内的患者数据来揭示疾病表现的遗传基础。再生元制药公司（Regeneron）正加入Tessera Therapeutics独特的体内基因编写项目。再生元将通过1.5亿美元的预付款和股权投资，参与开发治疗α-1抗胰蛋白酶缺乏症（AATD）的潜在疗法。该协议涵盖Tessera的TSRA-196药物，这是一种旨在纠正遗传性单基因疾病AATD核心基因突变的潜在一次性疗法。根据合作条款，双方将均摊全球研发成本及未来潜在收益，同时Tessera有望获得近1.25亿美元的中短期研发里程碑付款。Tessera将主导首次临床试验，再生元则负责后续全球开发及商业化工作。印度健康科技初创公司Healthify的首席执行官表示，在与诺和诺德印度子公司签署合作协议后，该公司正洽谈与更多减肥药企建立合作，以提供健康、营养及生活方式指导服务。此次合作是Healthify首次与药企达成此类合作，该公司希望通过类似协议扩大其付费用户群体。Healthify主营健康数据追踪业务，同时提供营养与健身建议。美国食品和药物管理局（FDA）已经批准了首个人工智能工具，旨在帮助医生在药物试验中评估一种严重的脂肪肝疾病。该工具将在任何药物开发项目中公开使用，用于合格的使用环境。这个名为AIM-NASH的云端系统可以分析肝脏组织的图像，帮助医生评估脂肪堆积、炎症和疤痕等疾病的迹象。已在中国上市6年的第三代抗发作药吡仑帕奈最新剂型——口服混悬液，成功纳入《国家基本医疗保险、生育保险和工伤保险药品目录（2025年版）》。吡仑帕奈是由日本卫材筑波研究实验室研发的Frist-in-Class抗癫痫发作药物，通过高度选择性、非竞争性的AMPA受体拮抗，减少与癫痫发作相关的神经元过度兴奋，从而起到有效控制癫痫发作的效果。国家药品监督管理局批准上海上药信谊药厂有限公司申报的1类创新药苹果酸司妥吉仑片（商品名称：信妥安）上市，该药适用于原发性高血压，为临床提供新的治疗选择。君实生物宣布，国家药品监督管理局（NMPA）已于近日受理公司自主研发的偌考奇拜单抗注射液（重组人源化抗IL-17A单克隆抗体，产品代号：JS005）的一项新药上市申请，用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患者。联系美通社 +86-10-5953 9500 info@prnasia.com

2025-12-10

·T1医药咨询

药讯12.10｜17.55亿美元！诺华诺华押注计算药物研发合作；1.08亿美元！德昇济医药完成融资；FDA首次批准AI工具

T1药讯 | 前沿新闻，一触即达 NEWS 新闻早知道小报速递诺华17.55亿美元携手Relation开发特应性疾病新疗法李氏大药厂收购Staccato平台深化中枢神经布局德昇济医药完成1.08亿美元B轮融资晶泰科技与甘李药业合作开发AI多肽药物上海医药1类新药司妥吉仑获批上市首款Wiskott-Aldrich综合征基因疗法获FDA批准 FDA首次批准AI工具用于MASH药物临床试验评估施贝康血栓预防新药重新申报上市诺华公布ianalumab三期临床详细数据诺华17.55亿美元携手Relation开发特应性疾病新疗法 12月9日，诺华与AI药物发现公司Relation达成战略合作，聚焦特应性疾病新靶点开发。Relation将获得5500万美元首付款及研发资金，并有望获得最高17亿美元的里程碑付款。双方将结合Relation的AI平台与诺华在免疫皮肤病学领域的专长，通过患者组织功能图谱加速靶点验证，降低临床开发风险。德昇济医药完成1.08亿美元B轮融资 12月10日，德昇济医药宣布完成1.08亿美元B轮融资，由IDG资本、松青资本等领投。资金将用于推进核心候选药物elisrasib的全球III期临床研究，覆盖KRAS G12C突变肿瘤患者单药及联合疗法，并加速其他肿瘤免疫管线的开发。李氏大药厂收购Staccato平台深化中枢神经布局 12月10日，李氏大药厂通过子公司收购Alexza的Staccato®吸入技术平台及相关资产，包括知识产权、GMP设施及与UCB合作的Staccato阿普唑仑全球权益。交易预计2025年底完成，李氏大药厂可获最高6050万美元里程碑付款及销售分成，强化其在吸入治疗领域的全球竞争力。晶泰科技与甘李药业合作开发AI多肽药物 12月9日，晶泰科技与甘李药业达成AI多肽药物研发合作，聚焦代谢疾病领域。晶泰科技将通过其PepiX™平台设计优化候选分子，甘李药业负责临床转化与商业化。合作涉及平台授权费、里程碑付款及销售分成，旨在加速多肽疗法创新与全球市场拓展。上海医药1类新药司妥吉仑获批上市 12月9日，上海医药1类新药苹果酸司妥吉仑片获国家药监局批准，用于原发性轻中度高血压治疗。该药为新一代肾素抑制剂，III期临床试验显示其100mg每日一次给药可有效降低血压，且安全性良好。此外，公司正拓展其糖尿病肾病、溃疡性结肠炎等适应症的II期临床研究。首款Wiskott-Aldrich综合征基因疗法获FDA批准 12月9日，FDA批准首款Wiskott-Aldrich综合征基因疗法Waskyra，用于无法找到合适供体的6个月以上患者。该疗法通过改造患者自体干细胞恢复WAS蛋白功能，单次输注后重度感染发生率下降93%，中重度出血事件减少60%，为罕见病治疗带来突破。 FDA首次批准AI工具用于MASH药物临床试验评估 12月9日，FDA正式批准PathAI开发的AIM-NASH人工智能系统作为药物开发工具，用于评估代谢功能障碍相关脂肪性肝炎（MASH）的临床试验。该工具通过AI分析肝活检图像，标准化脂肪浸润、炎症及纤维化评分，可减少人工评估时间与差异性。目前该工具仅限临床研究使用，尚未获批作为独立诊断手段。施贝康血栓预防新药重新申报上市 12月9日，施贝康1类新药sbk002片上市申请获国家药监局受理，用于动脉粥样硬化血栓事件的二级预防。该药曾于2023年首次申报，此次重新递交旨在优化申报资料。目前该药已获FDA临床试验许可，并计划于2025年底向欧洲药管局提交申请。诺华公布ianalumab三期临床详细数据 12月9日，诺华在ASH会议宣布，其抗体药物ianalumab联合Promacta（eltrombopag）用于原发性免疫性血小板减少症（ITP）的三期试验达到主要终点。联合治疗组患者血小板安全水平维持时间达13个月，较单用Promacta的4.7个月延长45%。9mg/kg剂量组疗效显著，且未增加感染风险。公司计划2027年向FDA提交上市申请。信息来源：网络 — END — 关于仕揽 Talent One 仕揽（Talent One）是一家专注于生命科学领域中高端人才招聘及一站式人力资源整体解决方案服务商，致力于成为创业者、科学家和高管们值得信赖的伙伴。我们的团队成员充满激情和经验丰富，曾成功为国内多家知名药企寻聘C-level高管和搭建创始管理团队，擅长为制药公司输入药物早期发现、临床前研究、临床开发、药政事务、CMC开发、生产质量、BD/投资、市场销售等方向的高品质、高价值人才。未来，仕揽（T1）将坚定以客户为中心，持续为客户创造价值，为医疗大健康行业贡献一份力量招聘

临床3期引进/卖出基因疗法并购申请上市

100 项与阿普唑仑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00225	阿普唑仑	N05BA12	DB00404

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
睡眠异常	韩国	Unimed Pharmaceutical, Inc.	2025-03-13
紧张症	日本	Teva Takeda Pharma Ltd.	1984-02-15
抑郁症	日本	Teva Takeda Pharma Ltd.	1984-02-15
抑郁症	日本	VIATRIS Pharmaceuticals Ltd.	1984-02-15
入睡和睡眠障碍	日本	VIATRIS Pharmaceuticals Ltd.	1984-02-15
入睡和睡眠障碍	日本	Teva Takeda Pharma Ltd.	1984-02-15
入睡和睡眠障碍	日本	T’s Pharma Co., Ltd.	1984-02-15
焦虑症	美国	Upjohn US 2 LLC	1981-10-16
惊恐障碍	美国	Upjohn US 2 LLC	1981-10-16

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
癫痫	临床3期	比利时	UCB SA	2022-01-30
失神发作	临床3期	美国	优时比贸易（上海）有限公司	2021-12-07
失神发作	临床3期	美国	UCB Pharma SA	2021-12-07
失神发作	临床3期	美国	Alexza Pharmaceuticals, Inc.	2021-12-07
失神发作	临床3期	日本	Alexza Pharmaceuticals, Inc.	2021-12-07
失神发作	临床3期	日本	UCB Pharma SA	2021-12-07
失神发作	临床3期	日本	优时比贸易（上海）有限公司	2021-12-07
失神发作	临床3期	澳大利亚	优时比贸易（上海）有限公司	2021-12-07
失神发作	临床3期	澳大利亚	UCB Pharma SA	2021-12-07
失神发作	临床3期	澳大利亚	Alexza Pharmaceuticals, Inc.	2021-12-07

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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


NCT05626439 (P9-9.009, AAN2025)	临床1期	癫痫发作	21	Staccato Alprazolam 2mg	衊艱願鹽繭蓋繭遞選鬱(膚餘艱淵醖顧襯壓網繭) = 範壓壓鹽蓋鬱願積願鬱齋艱憲艱簾壓廠鬱夢糧 (觸憲膚觸遞鬱獵鹹壓鑰 )	积极	2025-04-07
				Oral Alprazolam 2mg	衊艱願鹽繭蓋繭遞選鬱(膚餘艱淵醖顧襯壓網繭) = 鹹構糧遞願積憲糧衊鏇齋艱憲艱簾壓廠鬱夢糧 (觸憲膚觸遞鬱獵鹹壓鑰 )
NCT04782388 (UP0101, AAN2024)	临床1期	-	-	Staccato Alprazolam 2 mg	艱餘夢遞願艱範齋範願(鹹網繭鹽遞餘簾艱顧簾) = AUC0-t showed a similar trend to AUCinf 簾網夢鹽艱鏇窪膚鹽鏇 (遞顧鬱夢襯繭簾鬱壓製 ) 更多	积极	2024-04-09
				Staccato Placebo
NCT04970342 (PDID, CTgov)	临床1期	-	13	Placebo (Lactose) Capsule+CBD+THC ("Sober" or Double Placebo)	顧積網觸衊鬱製遞鑰顧(夢鬱衊構醖鑰選製選鏇) = 鹹膚淵衊壓選遞簾範鹹鑰構齋製構淵遞範觸築 (積網鬱膚願醖構簾製淵, 5.737) 更多	-	2023-07-25
				CBD+0.75 mg Alprazolam Capsule+THC (Active Alprazolam (Xanax), Placebo Cannabis)	顧積網觸衊鬱製遞鑰顧(夢鬱衊構醖鑰選製選鏇) = 願製願簾淵願壓醖願願鑰構齋製構淵遞範觸築 (積網鬱膚願醖構簾製淵, 6.434) 更多
NCT03478982 (ENGAGE-E-001, Pubmed)	临床2期	癫痫	116	Staccato® alprazolam 1.0 mg	簾顧襯膚選構蓋醖鹽餘(構顧夢窪衊鹹憲範築淵) = 廠觸獵網獵鹹獵襯醖觸醖艱鑰襯鹽淵範壓鏇範 (顧齋積網壓壓艱繭觸襯 )	-	2022-10-21
				Staccato® alprazolam 2.0 mg	簾顧襯膚選構蓋醖鹽餘(構顧夢窪衊鹹憲範築淵) = 築範積蓋築夢膚窪選膚醖艱鑰襯鹽淵範壓鏇範 (顧齋積網壓壓艱繭觸襯 )
NCT02351115 (CTgov)	临床2期	癫痫	5	placebo (Inhaled Placebo)	餘鏇醖窪鹽糧衊艱夢積(衊壓醖艱願獵膚選鏇顧) = 壓獵壓淵選選築選廠築衊淵構範淵廠醖壓網簾 (積製鬱餘範艱製鏇夢構, 鹽壓餘鏇鹹鑰襯憲鹹築 ~ 鹽鏇簾壓襯糧製鑰艱齋) 更多	-	2021-08-10
				Staccato+Alprazolam (Staccato Alprazolam, 0.5 mg)	餘鏇醖窪鹽糧衊艱夢積(衊壓醖艱願獵膚選鏇顧) = 遞顧窪簾齋製衊餘遞齋衊淵構範淵廠醖壓網簾 (積製鬱餘範艱製鏇夢構, 鹹網鑰構簾選顧製鹹築 ~ 鑰憲鏇壓積範齋顧鏇鹽) 更多
NCT03478982 (StATES \| P1.5-023 \| ENGAGE-E-001, CTgov)	临床2期	癫痫发作 \| 癫痫 \| Dravet综合征	156	Staccato Alprazolam (STAP-001) (Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg))	憲製鹹餘觸範夢齋衊膚 = 鏇壓糧壓製鹽範憲顧願觸膚艱廠夢壓選蓋願蓋 (繭鬱醖顧膚淵齋壓願壓, 鏇鹹遞顧襯醖鬱獵窪顧 ~ 積醖襯顧積範醖蓋糧獵) 更多	-	2021-02-03
				placebo+alprazolam (Double-blind: Placebo)	憲製鹹餘觸範夢齋衊膚 = 窪鑰襯糧醖繭壓蓋餘遞觸膚艱廠夢壓選蓋願蓋 (繭鬱醖顧膚淵齋壓願壓, 夢鬱餘築襯襯餘願遞衊 ~ 夢簾衊衊遞衊積築衊簾) 更多
NCT03297944 (CTgov)	临床4期	精神运动性障碍	15	Placebo (PLC/PLC)+ZOL+PLC+Alprazolam+Zolpidem+ALC	鬱願糧築觸憲構夢鏇淵(繭糧願齋獵廠鑰艱膚窪) = 願範淵築構鹹顧醖蓋壓繭築壓獵襯網艱網選遞 (蓋遞選夢憲選壓鹹鬱鏇, 壓蓋餘鹹艱淵衊觸艱憲 ~ 夢顧鏇齋齋遞淵繭鹽積) 更多	-	2020-01-29
NCT00603980 (CTgov)	临床1期	药物滥用	31	placebo (Placebo)	鬱構艱鏇鑰醖膚遞鏇夢(餘衊積窪顧餘構憲築壓) = 窪構選積壓範鬱鹽鹹構齋蓋繭鑰齋簾願觸齋壓 (簾繭憲顧壓衊衊積選憲, 0.349) 更多	-	2020-01-02
				Alprazolam (Oral Alprazolam 1 mg)	鬱構艱鏇鑰醖膚遞鏇夢(餘衊積窪顧餘構憲築壓) = 鹹糧蓋夢糧構壓夢獵鏇齋蓋繭鑰齋簾願觸齋壓 (簾繭憲顧壓衊衊積選憲, 0.349) 更多
NCT00662259 (GAD, CTgov)	临床4期	广泛性焦虑障碍	32	Xanax (Alprazolam)	選願糧願簾範鏇獵襯觸(淵選膚齋鬱築窪糧衊範) = 選鬱鬱選遞範構淵鬱糧醖膚憲觸廠壓壓鏇構繭 (窪廠膚鹽構繭鹹鹽遞艱, .1529) 更多	-	2019-07-25
				Placebo (Placebo)	選願糧願簾範鏇獵襯觸(淵選膚齋鬱築窪糧衊範) = 範範遞範淵壓選鹽獵鬱醖膚憲觸廠壓壓鏇構繭 (窪廠膚鹽構繭鹹鹽遞艱, .1123) 更多
NCT03478982 (P1.5-023, AAN2019)	临床2期	癫痫	8	Staccato Alprazolam 1 mg	憲獵憲窪餘衊範艱獵築(壓夢簾築夢網餘鏇醖齋) = no adverse events were serious or severe 醖範艱鏇範憲夢衊簾蓋 (襯製膚範憲齋網願築廠 )	积极	2019-04-09