更新于：2024-11-15

Diazepam

地西泮

更新于：2024-11-15

概要

概要

基本信息

简介Diazepam，一种GABAA受体激动剂，于1963年11月15日在美国由Waylis首次批准上市。它是一种用于治疗多种疾病的药物，包括肌肉痉挛、戒酒、焦虑症和癫痫。其化学名称为7-氯-1,3-二氢-1-甲基-5-苯基-2H-1,4-苯二氮卓-2-酮。Diazepam通过增强大脑中的抑制性神经递质GABA的效果，从而产生镇静作用。自批准以来，Diazepam被广泛使用，并成为精神病学和神经学领域中不可或缺的药物之一。

药物类型

小分子化药

别名

7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one、DBF、DBSF

+ [31]

靶点

GABAA receptor

作用机制

GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂)

治疗领域

神经系统疾病心血管疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

癫痫发作有机磷中毒与非热性惊厥相关的热性惊厥+ [9]

非在研适应症

急性反复发作

原研机构

Waylis Therapeutics LLC

在研机构

Maruishi Pharmaceutical Co., Ltd.

Takeda Pharmaceutical Co., Ltd.

深圳市康哲药业有限公司

+ [7]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (1963-11-15),

戒酒焦虑症癫痫+ [1]

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)

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结构

分子式C16H13ClN2O

InChIKeyAAOVKJBEBIDNHE-UHFFFAOYSA-N

CAS号439-14-5

关联

121

项与地西泮相关的临床试验

ChiCTR2400091512 / Suspended临床4期IIT

A Real World Study on the Safety and Efficacy of Diazepam Nasal Spray in Children with Epilepsy

开始日期2024-11-01

申办/合作机构-

NCT06293989 / Not yet recruiting临床3期

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo: A Randomized Controlled Double Blinded Study

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

开始日期2024-05-01

申办/合作机构

Université de Monastir

NCT06346262 / Recruiting临床4期IIT

Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.
Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.

开始日期2024-03-05

申办/合作机构

University Hospitals Cleveland Medical Center

100 项与地西泮相关的临床结果

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100 项与地西泮相关的转化医学

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100 项与地西泮相关的专利（医药）

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20,982

项与地西泮相关的文献（医药）

2025-02-01·BEHAVIOURAL BRAIN RESEARCH

An unescapable looming threat paradigm for assessing anxiety-like responses in rats

Article

作者: Malkova, Ludise ; Aguilar, Brittany L ; Toib, Jonathan ; Forcelli, Patrick A

Rapidly approaching visual stimuli (i.e. looming objects) are known to evoke unconditioned defense responses across species. In rodents, this threat reactivity repertoire includes freezing and fleeing behavior. Although components of the circuitry underlying unconditioned response to a looming threat have been elucidated, both a temporal characterization and drug effects on the freezing response have not yet been reported. Here, we describe a modified version of a looming threat task in which no escape route is available. In this task, we observed unconditioned freezing prior to, during, and after exposure to a looming threat stimulus. In Long Evans (LE) and Sprague-Dawley (SD) rats, we report looming stimulus-specific freezing response. We further explored the specificity and pharmacosensitivity of this response in male and female LE rats. Administration of a GABA-A receptor negative allosteric modulator (FG-7142) did not re-establish freezing in habituated animals; however, administration of a GABA-A receptor positive allosteric modulator (diazepam) in naïve LEs significantly reduced freezing during the post-looming period in a sex-dependent manner. Presentation of an unescapable looming stimulus results in freezing that extends beyond the acute threat exposure. Because freezing responses outlast the initial threat, and display only modest sensitivity to conventional anxiolytic therapy, this may represent a platform for screening agents in treatment-refractory anxiety.

2025-01-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Repeated lyophilization: A neo-method for urine-based reference materials preparation

Article

作者: Liu, Yu ; Zhi, Yujie ; Jin, Wenhui ; Hu, Jing ; Zhang, Zhen ; Liu, Wei ; Zheng, Qiongying ; Zhang, Wenping ; Lu, Jiayue ; Dou, Quanlu ; Chen, Hang

In urine drug testing, a cut-off value is often imposed to determine whether the sample is negative or positive. A matrix containing a reference substance helps counteract the adverse effects of the urine matrix across different laboratories to improve the consistency of final results. However, as a biological matrix, urine is prone to corruption and other problems that make it difficult to use as a reference sample. In this study, morphine, nitrazepam, lorazepam, buprenorphine, zolpidem, midazolam, diazepam, and clozapine commonly used in clinical practice were selected as target analytes, and the preparation process was further optimized to repeated lyophilization, in order to obtain more effective, stable, and accurate urine matrix reference materials (mRMs). The appropriate urine density (1.010-1.017 kg/m³) for preparing lyophilized samples was investigated through density determination. Conducting repeated lyophilizations resulted in a denser powder with reduced susceptibility to collapse and improved the quality of lyophilized urine samples. Lyophilized urine mRMs could be stored at room temperature for one month or under refrigeration conditions (4 ℃) for six months.

2025-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Lavender improves sleep through olfactory perception and GABAergic neurons of the central amygdala

Article

作者: Wang, Can ; Gao, Jin-Xian ; Yang, Xing-Wen ; Xin, Le ; Lin, Jian-Sheng ; Ren, Yan-Li ; Hou, Yi-Ping ; Chen, Yu-Nong ; Xie, Jun-Fan ; Spruyt, Karen ; Chu, Wei-Wei ; Shao, Yu-Feng ; Yan, Gui-Zhong

ETHNOPHARMACOLOGICAL RELEVANCE:

The use of lavender as sleep aid or hypnotic agent can be traced back as early as ancient Romans and Greeks. Yet, objective experimental data on whether and how lavender enhances sleep duration or/and sleep quality remain lacking.

AIM OF THE STUDY:

We aimed to characterize the sleep-wake regulating effects of lavender in the mouse and to demonstrate the brain targets and neural circuits involved.

MATERIALS AND METHODS:

A self-made precise odor delivery system combined with chronic polysomnographic recordings was employed to assess the sleep-wake effects of inhalation with lavender essential oil (LEO, extracted from lavender) and its different constituents during the light and dark phases in free-moving C57BL/6J mice. Neuroviral labeling, in situ hybridization and pharmacogenetics were combined to identify the neural circuits and targets involved. Finally, an insomniac model of DL-4-Chlorophenylalanine (PCPA)-treated mice was established to examine the sleep-inducing potential of LEO.

RESULTS:

We found that inhalation of LEO with a concentration at 25.0% during the light (inactive) phase significantly shortened the latency to non-rapid eye movement (NREM) sleep, increased the total amount of NREM sleep at the expense of wakefulness (W), and enhanced cortical EEG slow wave activities, notably delta power spectra density. We further identified linalool, d-limonene, 1,8-cineole, linalyl acetate and terpinene-4-ol as the major effective sleep-promoting monomer components. Importantly, we found that LEO no longer produced any of the above sleep-promoting effect following either nasal injection of zinc sulfate which interrupts the olfactory pathway, or pharmacogenetics silencing of central amygdala GABAergic neurons. Finally, LEO reestablished NREM sleep with short latency in PCPA-treated insomniac mice, effects comparable with those induced by a potent sedative diazepam.

CONCLUSIONS:

We have characterized the quantitative and qualitative sleep-promoting effects of LEO and its effective components via the olfactory pathway and central amygdala GABA neuronal targets. The hypnotic property of LEO is reinforced by its ability to restore sleep in insomnia. Our study thus establishes a neurobiological basis for aromatherapy of sleep disorders using lavender.

267

项与地西泮相关的新闻（医药）

2024-11-11

·PRNewswire

NEURELIS TO SHARE CLINICAL STUDY DESIGN INSIGHTS FOR INVESTIGATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 AT CHILD NEUROLOGY SOCIETY ANNUAL MEETING

Presentation highlights study-enrollment challenges and strategies to overcome potential barriers SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Neurelis, Inc., today announced a presentation on insights into study design from the enrollment process for the new Stellina study investigating VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2 to 5 years. This age group is not included in the current indication of treatment of seizure clusters in patients with epilepsy aged ≥6 years. The poster presentation will be given at the 53rd Child Neurology Society Annual Meeting in San Diego, November 11-14th. "Data from clinical studies of repetitive seizures in early childhood are critical to help advance new treatments for a young population with currently limited alternatives," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are pleased to join the child neurology community and exchange learnings at this year's annual meeting as we focus on improving health outcomes for people with epilepsy." Highlights of the presentation include the identification of study-enrollment challenges and strategies to overcome potential barriers in young patients with treatment-resistant epilepsy. Identified findings may be helpful in designing future protocols. The poster titled "Challenges Associated with Enrolling Pediatric Patients with Treatment-Resistant Epilepsy Aged 2–5 Years in a Clinical Trial and Lessons Learned for Future Trials" will be presented on Tuesday November 12th from 12:30 PM-1:45 PM and 5:30 PM-7:00 PM PT. The mission of the Child Neurology Society is to raise awareness about the importance of child neurologists and the health needs of children with chronic neurological conditions. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床1期

2024-11-10

·药筛

山东鲁盛多种维生素(12)获批上市，成都苑东甲磺酸萘莫司他上市申请 | 仿制药周报（11.4-11.10）

统计每周仿制药一致性评价申报、上市申请（11.4-11.10） 1、仿制药上市申请获批药品名称企业名称分类受理号阿戈美拉汀片宝利化（南京）制药有限公司;江苏利泰尔药业有限公司4CYHS2302145阿加曲班注射液海南葫芦娃药业集团股份有限公司4CYHS2300184巴氯芬片重庆士立德医药科技有限公司;福安药业集团庆余堂制药有限公司4CYHS2302507玻璃酸钠滴眼液山东华鲁制药有限公司4CYHS2302277玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301913玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301914布洛芬混悬滴剂天大医药科技（珠海）有限公司;天大药业（珠海）有限公司3CYHS2300001地夸磷索钠滴眼液江苏远恒药业有限公司4CYHS2400248地夸磷索钠滴眼液南京黄龙生物科技有限公司;杭州民生药业股份有限公司4CYHS2300464恩扎卢胺软胶囊Dr. Reddy's Laboratories Limited5.2JYHS2200042二甲双胍恩格列净片天大药业（珠海）有限公司4CYHS2301425法莫替丁注射液四川制药制剂有限公司;成都利尔药业有限公司3CYHS2301317伏立康唑干混悬剂健康元药业集团股份有限公司;深圳市海滨制药有限公司4CYHS2301217复方聚乙二醇电解质散(Ⅱ)南京海纳制药有限公司3CYHS2400148复方聚乙二醇电解质散(Ⅱ)黑龙江博宇制药有限公司;四川科伦药业股份有限公司3CYHS2303588己酮可可碱注射液武汉海特生物制药股份有限公司3CYHS2301000甲氨蝶呤片江苏百奥信康医药科技有限公司;浙江浙北药业有限公司3CYHS2300574聚乙烯醇滴眼液四川海梦智森生物制药有限公司;浙江赛默制药有限公司3CYHS2300897克林霉素磷酸酯外用溶液江苏知原药业股份有限公司4CYHS2300147膦甲酸钠注射液华仁药业股份有限公司3CYHS2301137硫辛酸注射液江苏睿实生物科技有限公司;富祥（大连）制药有限公司4CYHS2301742马来酸阿法替尼片江苏华阳制药有限公司4CYHS2301281马来酸氟伏沙明片上海理想制药有限公司4CYHS2301497麦考酚钠肠溶片山东新时代药业有限公司4CYHS2303659米诺地尔搽剂浙江远力健药业有限责任公司;浙江赛默制药有限公司3CYHS2201287莫匹罗星软膏河南羚锐制药股份有限公司;河南羚锐生物药业有限公司4CYHS2301424帕拉米韦注射液陕西博森生物制药股份集团有限公司3CYHS2302082帕米膦酸二钠注射液仁合益康集团有限公司;河北仁合益康药业有限公司3CYHS2300892屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200412瑞巴派特片福安药业集团宁波天衡制药有限公司;福安药业集团庆余堂制药有限公司4CYHS2301188沙库巴曲缬沙坦钠片山东凤凰制药股份有限公司4CYHS2200423头孢氨苄干混悬剂上海金城素智药业有限公司3CYHS2300839维生素B6注射液江苏润恒制药有限公司3CYHS2402860硝普钠注射液成都新恒创药业有限公司3CYHS2301634熊去氧胆酸胶囊浙江寰领医药科技有限公司;浙江康恩贝制药股份有限公司4CYHS2300582盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300909盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300910盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301169盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301170盐酸多巴酚丁胺注射液成都瑞尔医药科技有限公司;太极集团四川太极制药有限公司3CYHS2301571盐酸多巴酚丁胺注射液浙江沣华医药科技有限公司;浙江赛默制药有限公司3CYHS2300301盐酸环喷托酯滴眼液山东绅联药业股份有限公司;北京汇恩兰德制药有限公司4CYHS2300007盐酸乐卡地平片兆科药业（广州）有限公司4CYHS2201840盐酸美金刚片四川宏明博思药业有限公司4CYHS2201963盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸去氧肾上腺素注射液石家庄四药有限公司3CYHS2300901盐酸去氧肾上腺素注射液南京恒道医药科技股份有限公司;江苏大红鹰恒顺药业有限公司3CYHS2300808伊布替尼胶囊Natco Pharma Limited5.2JYHS2300009依巴斯汀口服溶液湖南金圃医药科技有限公司;南京海纳制药有限公司3CYHS2301495注射用多种维生素(12)山东鲁盛制药有限公司;华北制药股份有限公司4CYHS2201289注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303220注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303219注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303221注射用替考拉宁海南倍特药业有限公司4CYHS2300059注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201552注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201554注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403002注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403004注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403003注射用头孢唑肟钠海南全星制药有限公司4CYHS2301760注射用头孢唑肟钠广州艾奇西新药研究有限公司;福建省福抗药业股份有限公司4CYHS2301641注射用盐酸罗沙替丁醋酸酯郑州维先医药科技有限公司;成都天台山制药股份有限公司3CYHS2301977左卡尼汀口服溶液浙江长典药物技术开发有限公司;浙江凯润药业股份有限公司4CYHS2302108左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301604左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301603左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300334左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300331左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300333左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300332左氧氟沙星滴眼液石家庄凯赛医药科技有限公司;山东海山药业有限公司4CYHS2301194左氧氟沙星片吉林长白山药业集团股份有限公司4CYHS2300552 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号阿莫西林胶囊达嘉维康生物制药有限公司;湖南康尔佳生物医药科技有限公司CYHB2350505阿莫西林颗粒四川依科制药有限公司CYHB2350818达肝素钠注射液南京健友生化制药股份有限公司CYHB2450062地西泮注射液安徽长江药业有限公司CYHB2450278二羟丙茶碱注射液天津金耀药业有限公司CYHB2350754非那雄胺片上海现代制药股份有限公司CYHB2350835氟康唑氯化钠注射液辰欣药业股份有限公司CYHB2350856氟哌啶醇注射液山东鲁抗医药集团赛特有限责任公司CYHB2350827复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350360复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350358复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350362复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350361复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350359铝碳酸镁咀嚼片江西药都仁和制药有限公司CYHB2350887铝碳酸镁咀嚼片修正药业集团长春高新制药有限公司CYHB2250090尼可地尔片锦州九泰药业有限责任公司CYHB2350792葡萄糖酸钙注射液山东新华制药股份有限公司CYHB2350545秋水仙碱片北京嘉林药业股份有限公司CYHB2350922碳酸氢钠片四川德元药业集团有限公司CYHB1950812碳酸氢钠片四川德元药业集团有限公司CYHB1950813碳酸氢钠片青海制药有限公司CYHB1950589头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350538头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350539头孢克肟片苏州东瑞制药有限公司;华北制药河北华民药业有限责任公司CYHB2450064盐酸多巴酚丁胺注射液无锡凯夫制药有限公司CYHB2350783注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350726注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350727注射用头孢呋辛钠海南灵康制药有限公司CYHB2450250注射用头孢呋辛钠海南灵康制药有限公司CYHB2450251注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350695注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350696 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号艾拉莫德片海南合瑞制药股份有限公司4CYHS2403841艾拉莫德片江西科伦药业有限公司;四川科伦药业股份有限公司4CYHS2403842氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403800氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403801氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403763氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403764巴氯芬片浙江诺得药业有限公司4CYHS2403782贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403758贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403759吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;河南福森药业有限公司3CYHS2403808吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;裕松源药业有限公司3CYHS2403809吡美莫司乳膏浙江华海药业股份有限公司4CYHS2403786丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司;浙江赛默制药有限公司4CYHS2403724布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403793布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403794醋酸钠林格葡萄糖注射液山西诺成制药有限公司3CYHS2403756地屈孕酮片新疆特丰药业股份有限公司;新疆新姿源生物制药有限责任公司4CYHS2403843地屈孕酮片上海延安药业有限公司;浙江赛默制药有限公司4CYHS2403799二羟丙茶碱注射液江西人可医药科技有限公司;裕松源药业有限公司3CYHS2403765非布司他片多多药业有限公司4CYHS2403806非布司他片多多药业有限公司4CYHS2403807非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403790非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403791氟伐他汀钠缓释片杭州泓友医药科技有限公司;华益药业科技（安徽）有限公司4CYHS2403826复方聚乙二醇(3350)电解质口服液云南先施药业有限公司;浙江凯润药业股份有限公司3CYHS2403774复方聚乙二醇(3350)电解质散河北智恒医药科技股份有限公司;石家庄龙泽制药股份有限公司3CYHS2403802复方聚乙二醇电解质散(Ⅱ)福州基石医药科技有限公司3CYHS2403839复合磷酸氢钾注射液江苏华阳制药有限公司3CYHS2403766富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403820富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403811富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403810富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403819富马酸福莫特罗吸入溶液齐鲁制药有限公司4CYHS2403814枸橼酸西地那非口崩片江西金世康药业有限公司;济南高华制药有限公司4CYHS2403749黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403813黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403812己酮可可碱缓释片海南皇隆制药股份有限公司3CYHS2403772甲氨蝶呤注射液广东岭南制药有限公司4CYHS2403773甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403780甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403781甲苯磺酸艾多沙班口崩片江苏和晨药业有限公司3CYHS2403760甲磺酸倍他司汀片天津恒翊药业有限公司;江苏诚康药业有限公司4CYHS2403751酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403834酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403833克立硼罗软膏山东诚创蓝海医药科技有限公司;津药和平（天津）制药有限公司4CYHS2403789来特莫韦注射液华北制药股份有限公司4CYHS2403784利那洛肽胶囊成都圣诺生物制药有限公司4CYHS2403816膦甲酸钠注射液海南爱科制药有限公司3CYHS2403785硫酸氨基葡萄糖胶囊江苏贝佳制药有限公司4CYHS2403840硫酸镁注射液河北天成药业股份有限公司3CYHS2403798硫酸镁注射液河北天成药业股份有限公司3CYHS2403797硫辛酸片江苏和晨药业有限公司3CYHS2403769硫辛酸片江苏和晨药业有限公司3CYHS2403768氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403838氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403837罗沙司他胶囊湖南明瑞制药股份有限公司4CYHS2403775吗啉硝唑氯化钠注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403822美阿沙坦钾片江西施美药业股份有限公司4CYHS2403817美阿沙坦钾片江西施美药业股份有限公司4CYHS2403818米库氯铵注射液河南科伦药业有限公司4CYHS2403746米库氯铵注射液河南科伦药业有限公司4CYHS2403747米力农注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403835莫匹罗星软膏北京北陆药业股份有限公司;江苏知原药业股份有限公司4CYHS2403795尼麦角林片华润双鹤利民药业（济南）有限公司3CYHS2403829普拉洛芬滴眼液艾视制药有限公司;杭州民生药业股份有限公司4CYHS2403745氢溴酸依他佐辛注射液成都倍特药业股份有限公司3CYHS2403831曲伏前列素滴眼液海南斯达制药有限公司4CYHS2403832乳酸钠林格注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403821瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403753瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403752瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403754噻托溴铵粉雾剂正大天晴药业集团南京顺欣制药有限公司;正大天晴药业集团股份有限公司4CYHS2403755羧甲司坦口服溶液万特制药（海南）有限公司3CYHS2403779他达拉非片南京方生和医药科技有限公司;江苏利泰尔药业有限公司4CYHS2403796碳酸氢钠注射液海南如康生物科技有限公司;海南爱科制药有限公司3CYHS2403788托拉塞米注射液江苏恒新药业有限公司3CYHS2403762维生素B12滴眼液四川禾亿制药有限公司4CYHS2403830维生素K1注射液海南美康达药业有限公司;安徽长江药业有限公司3CYHS2403776吸入用乙酰半胱氨酸溶液重庆药友制药有限责任公司4CYHS2403757西格列汀二甲双胍缓释片长春海悦药业股份有限公司3CYHS2403771西咪替丁注射液海韬新药研发（江苏）有限公司;山东威智百科药业有限公司3CYHS2403778腺苷钴胺胶囊成都欣捷高新技术开发股份有限公司;广州博济生物医药科技园有限公司3CYHS2403750熊去氧胆酸片美享生物科技（海南）有限公司;宿州亿帆药业有限公司3CYHS2403770盐酸阿莫罗芬搽剂湖北华傲制药有限公司;武汉爱民制药股份有限公司4CYHS2403748盐酸甲氧氯普胺注射液长春海悦药业股份有限公司3CYHS2403836盐酸莫西沙星滴眼液润尔眼科药物（广州）有限公司4CYHS2403815盐酸莫西沙星氯化钠注射液重庆药谷制药有限公司;哈尔滨三联药业股份有限公司4CYHS2403767盐酸莫西沙星片辰欣药业股份有限公司4CYHS2403827盐酸纳美芬注射液海南元盈医药科技有限公司;酒泉大得利制药股份有限公司3CYHS2403823盐酸帕洛诺司琼软胶囊齐鲁制药有限公司4CYHS2403825盐酸屈他维林片石家庄四药有限公司3CYHS2403792盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403805盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403804注射用苯唑西林钠广州艾奇西新药研究有限公司;成都倍特药业股份有限公司3CYHS2403761注射用厄他培南钠广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司4CYHS2403803注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214注射用卡非佐米江苏诚康药业有限公司4CYHS2403787注射用两性霉素B脂质体齐鲁制药（海南）有限公司4CYHS2403828注射用硫酸艾沙康唑湖北凯安晨医药科技有限公司;山西普德药业有限公司4CYHS2403824注射用盐酸地尔硫卓石家庄四药有限公司4CYHS2403777左卡尼汀注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403783 4、新增一致性评价补充申报药品名称企业名称受理号黄体酮注射液河南科伦药业有限公司CYHB2450553己酮可可碱注射液西安高科陕西金方药业公司CYHB2450558马来酸氨氯地平分散片江苏万高药业股份有限公司CYHB2450561马来酸依那普利片上海现代制药股份有限公司CYHB2450556匹维溴铵片北京福元医药股份有限公司CYHB2450557普伐他汀钠片第一三共制药（上海）有限公司CYHB2450551普伐他汀钠片第一三共制药（上海）有限公司CYHB2450552维生素B6注射液桂林南药股份有限公司CYHB2450560盐酸伐昔洛韦片珠海润都制药股份有限公司CYHB2450554盐酸林可霉素注射液江苏吴中医药集团有限公司苏州制药厂CYHB2450555盐酸舍曲林分散片浙江京新药业股份有限公司CYHB2450559 数据来源：摩熵医药相关阅读：黄体酮阴道缓释凝胶仿制申请全被否，伏诺拉生片新增3家仿制申请 | 仿制药周报（10.28-11.3）四川汇宇乙酰半胱氨酸注射液首家过评，南京海纳酮洛芬凝胶贴膏上市申请 | 仿制药周报（10.21-10.27）正大天晴来特莫韦首仿获批，石家庄科仁艾普拉唑肠溶片第2家仿制申请 | 仿制药周报（10.14-10.20） 2个氟比洛芬凝胶贴膏被否，安必生美沙拉秦肠溶缓释颗粒获批 | 仿制药周动态（10.7-10.13）

上市批准一致性评价

2024-11-08

·Business Wire

Xeris Biopharma Reports Third Quarter 2024 Financial Results

CHICAGO--( BUSINESS WIRE )--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the third quarter and nine months ended September 30, 2024. “We are proud to report our record-breaking quarter with total revenue of our $54 million led by strong demand of Recorlev® and Gvoke®. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth," said John Shannon, CEO of Xeris. "We have made investments in areas that drive growth, notably Recorlev®, and we are seeing the benefits of those investments. Given our exceptional year-to-date performance, we are raising our revenue guidance to $198-$202 million from the previous $190-$200 million. Looking ahead, our focus remains on continuing to drive greater than 20% product revenue growth and advancing our robust pipeline - namely our Phase 3 ready, XP-8121." “While delivering exceptional revenue growth, we held our total operating expenses relatively flat to last quarter when you exclude non-routine charges,” said Steven Pieper, CFO of Xeris. “We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.” Third Quarter 2024 Highlights Three Months Ended September 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 22,942 $ 17,735 $ 5,207 29.4 Recorlev 17,726 8,097 9,629 118.9 Keveyis 12,193 15,865 (3,672 ) (23.1 ) Product revenue, net 52,861 41,697 11,164 26.8 Royalty, contract and other revenue 1,407 6,623 (5,216 ) (78.8 ) Total revenue $ 54,268 $ 48,320 $ 5,948 12.3 Commercial Products Gvoke® : Third quarter net revenue was $22.9 million as compared to $17.7 million in the third quarter of 2023 – an increase of approximately 29%. Gvoke prescriptions topped 70,000 for the first time, growing 20% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 36% at the end of October. Recorlev® : Third quarter net revenue was $17.7 million – an increase of 119% compared to the third quarter of 2023. This growth was driven by the average number of patients on Recorlev increasing 125% from the same period in 2023. On a sequential basis, Recorlev net revenue increased 33% versus prior quarter. Keveyis® : Third quarter net revenue was $12.2 million as compared to $15.9 million in the third quarter of 2023 - a decrease of approximately 23% driven by a reduction in patients on therapy. On a sequential basis, net revenue decreased 7% due to pharmacy reimbursement changes. Year-to-Date 2024 Financial Results Nine Months Ended September 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 59,567 $ 48,406 $ 11,161 23.1 Recorlev 41,663 19,741 21,922 111.0 Keveyis 38,406 42,708 (4,302 ) (10.1 ) Product revenue, net 139,636 110,855 28,781 26.0 Royalty, contract and other revenue 3,335 8,669 (5,334 ) (61.5 ) Total revenue $ 142,971 $ 119,524 $ 23,447 19.6 Gvoke® : Net revenue was $59.6 million for the nine months ended September 30, 2024, a 23% increase compared to prior year. Gvoke prescriptions for the nine months were approximately 194,000, growing approximately 24% compared to the same period in 2023. Recorlev® : Net revenue was $41.7 million for the nine months ended September 30, 2024, a 111% increase from last year, driven by an increase in the number of patients on therapy. Keveyis® : Net revenue was $38.4 million for the nine months ended September 30, 2024, a 10% decrease from last year due to a reduction in patients on therapy. Cost of goods sold increased $5.4 million and $6.3 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. These increases were primarily due to a $3.6 million write-off of Gvoke components resulting from manufacturing process changes required to support ongoing Gvoke capacity expansion efforts. Research and development (R&D) expenses increased slightly by $0.9 million and $3.5 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. R&D increased primarily due to higher spending for pipeline and personnel related expenses. Selling, general and administrative (SG&A) expenses increased by $7.7 million and $14.8 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023, primarily due to the costs associated with the CEO succession plan and related restructuring ($6.1 million) as well as higher costs related to the Recorlev expansions, partially offset by lower external spending. Net Loss for the three months ended September 30, 2024, was $15.7 million, or ($0.11) per share, and $49.7 million, or ($0.34) per share, for the nine months ended September 30, 2024. Excluding the impact of the CEO succession plan and related restructuring costs of $6.1 million, earnings per share was ($0.06) for the quarter or ($0.30) for the year-to-date. Cash, cash equivalents, and short-term investments at September 30, 2024 was $69.4 million, compared to $72.5 million at December 31, 2023. Total shares outstanding at October 31, 2024 was 149,081,461. Conference Call and Webcast Details Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results. To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=6c5018a9&confId=72180 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Friday, November 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 906920 To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/232807470 About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol® and XeriJect®, supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com , or follow us on X, LinkedIn , or Instagram . Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline (including XP-8121), and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Product revenue, net $ 52,861 $ 41,697 $ 139,636 $ 110,855 Royalty, contract and other revenue 1,407 6,623 3,335 8,669 Total revenue 54,268 48,320 142,971 119,524 Costs and expenses: Cost of goods sold 13,593 8,201 27,354 21,075 Research and development 5,888 5,034 19,468 15,959 Selling, general and administrative 44,969 37,287 123,342 108,527 Amortization of intangible assets 2,711 2,711 8,132 8,132 Total costs and expenses 67,161 53,233 178,296 153,693 Loss from operations (12,893 ) (4,913 ) (35,325 ) (34,169 ) Other expense (6,169 ) (7,614 ) (16,666 ) (15,709 ) Net loss before benefit from income taxes (19,062 ) (12,527 ) (51,991 ) (49,878 ) Income tax benefit 3,324 338 2,268 1,013 Net loss $ (15,738 ) $ (12,189 ) $ (49,723 ) $ (48,865 ) Net loss per common share - basic and diluted $ (0.11 ) $ (0.09 ) $ (0.34 ) $ (0.36 ) Weighted average common shares outstanding - basic and diluted 148,993,823 138,059,781 145,962,198 137,523,202 XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 59,232 $ 67,449 Short-term investments 10,170 5,002 Trade accounts receivable, net 41,138 39,197 Inventory 45,119 38,838 Prepaid expenses and other current assets 7,140 5,778 Total current assets 162,799 156,264 Property and equipment, net 5,613 5,971 Intangible assets, net 101,632 109,764 Goodwill 22,859 22,859 Operating lease right-of-use assets 22,758 23,204 Other assets 5,443 4,540 Total assets $ 321,104 $ 322,602 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 7,451 $ 11,565 Current portion of long-term debt 15,057 — Current operating lease liabilities 6,042 3,495 Other accrued liabilities 23,543 23,510 Accrued trade discounts and rebates 20,519 22,149 Accrued returns reserve 17,723 14,198 Current portion of contingent value rights — 19,109 Other current liabilities 678 1,167 Total current liabilities 91,013 95,193 Long-term debt, net of unamortized debt issuance costs 216,227 190,932 Non-current contingent value rights — 1,379 Non-current operating lease liabilities 33,639 34,764 Deferred tax liabilities — 2,268 Other liabilities 8,548 4,848 Total liabilities 349,427 329,384 Total stockholders’ equity (deficit) (28,323 ) (6,782 ) Total liabilities and stockholders’ equity (deficit) $ 321,104 $ 322,602

财报

100 项与地西泮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00293	地西泮	N05BA01	DB00829

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
癫痫发作	中国	Neurelis, Inc.	2023-06-07
癫痫发作	中国	深圳市康哲药业有限公司	2023-06-07
有机磷中毒	日本	Maruishi Pharmaceutical Co., Ltd.	2003-12-02
与非热性惊厥相关的热性惊厥	日本	Takata Seiyaku Co., Ltd.	1992-07-03
心脏病	中国	成都第一制药有限公司	1981-01-01
麻醉	日本	Maruishi Pharmaceutical Co., Ltd.	1969-08-30
抽搐	日本	Maruishi Pharmaceutical Co., Ltd.	1969-08-30
抑郁症	日本	Takeda Pharmaceutical Co., Ltd.	1964-11-01
神经症性障碍	日本	Takeda Pharmaceutical Co., Ltd.	1964-11-01
戒酒	美国	Waylis Therapeutics LLC	1963-11-15
焦虑症	美国	Waylis Therapeutics LLC	1963-11-15
癫痫	美国	Waylis Therapeutics LLC	1963-11-15
肌肉痉挛	美国	Waylis Therapeutics LLC	1963-11-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性反复发作	临床3期	美国	Neurelis, Inc.	2016-04-11

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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


NCT01938092 (CTgov)	临床2期	盆腔疼痛 \| 盆底功能障碍	50	Diazepam (Diazepam)	窪襯選膚積鹽簾襯鑰構(襯餘積製艱願艱鏇積齋) = 鹹積製醖繭築淵艱壓築鏇網築夢夢鑰齋獵鏇壓 (齋膚憲顧壓積願顧築夢, 積製膚範鏇網範遞築選 ~ 壓獵觸築範蓋壓衊廠糧) 更多	-	2024-09-03
NCT01938092 (CTgov)	临床2期	盆腔疼痛 \| 盆底功能障碍	50	Placebo (Placebo)	窪襯選膚積鹽簾襯鑰構(襯餘積製艱願艱鏇積齋) = 鏇糧選窪夢鑰鹽觸鏇膚鏇網築夢夢鑰齋獵鏇壓 (齋膚憲顧壓積願顧築夢, 鏇餘遞選蓋蓋鬱鑰鬱齋 ~ 簾壓鹽襯願願網餘獵餘) 更多	-	2024-09-03
FDA_CDER 人工标引	N/A	癫痫	114	Diazepam Rectal Gel (Second Study)	簾範築網糧衊憲顧鹹築(醖構蓋艱鹹鬱觸蓋鑰遞) = 築簾積壓夢觸構壓鬱糧餘糧廠餘範積構積鬱糧 (觸顧窪衊餘簾鑰艱觸壓 ) 更多	积极	2024-04-26
FDA_CDER 人工标引	N/A	癫痫	91	Diazepam Rectal Gel (First Study)	醖衊膚醖選鬱糧壓淵範(簾齋窪鹽艱築窪窪鹽衊) = 遞選鹽餘鹽製網糧鏇願網簾網觸選鹹窪繭餘糧 (膚築鏇艱鹽艱獵蓋壓繭 ) 更多	积极	2024-04-26
AAN2024	临床3期	癫痫发作	163	Diazepam Nasal Spray (Adults (18-65 years))	淵構鏇糧網蓋廠鹽簾夢(膚製衊夢襯築蓋鬱遞範) = 網廠蓋餘鬱積鹹鑰鏇獵積餘糧願襯廠憲廠衊願 (衊襯積齋範廠餘淵糧夢 )	积极	2024-04-09
AAN2024	临床3期	癫痫发作	163	Diazepam Nasal Spray (Pediatric patients (6-17 years))	淵構鏇糧網蓋廠鹽簾夢(膚製衊夢襯築蓋鬱遞範) = 製願鹽憲醖選鏇衊膚製積餘糧願襯廠憲廠衊願 (衊襯積齋範廠餘淵糧夢 )	积极	2024-04-09
NCT03818919 (CTgov)	临床2期	镇痛 \| 肩袖撕裂关节病	70	Acetaminophen+Diazepam+Ketorolac+Celecoxib+Gabapentin (Post-Operative Non Opioid Pain Protocol)	廠蓋艱鹹醖窪獵構獵願(願廠夢構範遞繭膚窪鹽) = 築壓齋網構築糧蓋遞鹽鹽觸艱獵遞選壓艱鏇觸 (艱顧鹹餘憲淵壓蓋鹽憲, 顧壓製觸淵範淵廠願鹹 ~ 鬱廠夢鹹壓膚醖簾鬱餘) 更多	-	2024-04-02
NCT03818919 (CTgov)	临床2期	镇痛 \| 肩袖撕裂关节病	70	Hydrocodone-Acetaminophen (Post-Operative Traditional Pain Protocol)	廠蓋艱鹹醖窪獵構獵願(願廠夢構範遞繭膚窪鹽) = 選鑰壓蓋築淵蓋膚襯獵鹽觸艱獵遞選壓艱鏇觸 (艱顧鹹餘憲淵壓蓋鹽憲, 鏇觸壓廠襯獵廠選觸憲 ~ 鹹膚鏇鑰鹹鹹憲鑰壓構) 更多	-	2024-04-02
NCT02721069 (Pubmed) 人工标引	临床3期	急性反复发作	3,225	NRL-1	衊淵襯鬱築製構選顧鹽(築築獵艱壓網餘夢範觸) = 網構構淵艱蓋製艱範淵鬱鹹廠醖膚糧鹹製鬱餘 (鏇觸鏇觸願鏇艱鏇襯蓋 ) 更多	积极	2024-02-01
NEWS 人工标引	临床3期	癫痫发作	-	diazepam nasal spray	遞廠餘蓋製淵艱衊蓋網(夢艱鑰觸簾襯廠獵糧遞) = proportion of patients who achieved resolution of clinically relevant seizures within 10 minutes after administration of a single dose and who remained free from seizures or convulsions for 30 minutes after a single dose 廠積鬱衊艱憲襯醖簾鬱 (膚廠廠觸願構鑰壓鹽鹹 ) 达到	-	2023-10-18
CNS2023	临床3期	急性反复发作	78	Diazepam nasal spray	鏇艱蓋鬱窪窪願鬱鬱獵(糧醖壓廠鑰齋醖鹹齋夢) = 窪衊獵膚繭簾獵醖襯膚網壓鏇顧構糧齋網齋蓋 (構壓選壓鹹窪壓顧鏇鹽 )	-	2023-10-01
NCT02721069 (DIAZ.001.05, CNS2023)	临床3期	CBD	78	No CBD	廠鑰艱鑰繭範夢廠獵願(淵遞鑰鏇壓製選觸鹹糧) = 壓蓋觸鹽糧製蓋願蓋遞鬱網淵製簾顧壓鹹網廠 (繭艱窪餘憲襯製簾繭壓 ) 更多	-	2023-10-01
NCT02721069 (DIAZ.001.05, CNS2023)	临床3期	CBD	78	Oral-solution CBD	廠鑰艱鑰繭範夢廠獵願(淵遞鑰鏇壓製選觸鹹糧) = 齋簾鹽淵醖夢鬱願蓋艱鬱網淵製簾顧壓鹹網廠 (繭艱窪餘憲襯製簾繭壓 ) 更多	-	2023-10-01
IEC2023	N/A	急性反复发作	175	Diazepam nasal spray	鹽鏇鏇築鹹遞鹹壓淵構(積網獵網鹹廠衊範築鹹) = 艱鑰夢築膚壓鬱夢窪襯網鬱窪繭願遞願衊齋積 (鬱鹹糧齋衊膚繭壓製壓 )	积极	2023-09-04