This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures include body weight, fasting lipids, and prolactin. The specific aims are as follows: Specific aim 1: To establish the safety and tolerability of bromocriptine in patients with schizophrenia and IGT/IR treated with APDs. Specific aim 2: To demonstrate feasibility/proof of concept for an improvement in APD-induced IGT/IR with bromocriptine.

开始日期2024-07-01

申办/合作机构

Va Pittsburgh Healthcare System

NCT06250257 / Recruiting临床3期IIT

Effectiveness of Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age: A Hospital-Based Randomized Open Label Clinical Trial

Dilated cardiomyopathy (DCM) is a condition associated with Left and /or right ventricular (LV) dilatation and systolic dysfunction without coronary artery disease or abnormal loading circumstances proportionate to the severity of LV impairment. It is one of the leading causes of heart failure in younger adults, often requiring cardiac transplantation, and is caused by various factors, including myocarditis, alcohol, drug, and metabolic disturbances. About 35% of patients have genetic mutations affecting cytoskeletal, sarcomere, and nuclear envelope proteins. The prognosis depends on the severity and heart remodeling, with the worst outcomes in patients with low ejection fractions or severe diastolic dysfunction.
Although it is more common in men, DCM also occur in women, and hence hormonal factors can play a role in the development of DCM in women. Bromocriptine has been suggested as a potential treatment option. Bromocriptine is a dopamine agonist that is primarily used to treat conditions such as hyperprolactinemia, and acromegaly. However, it has also been studied in the context of heart failure, and some studies have suggested that it may be beneficial in women with Peripartal cardiomyopathy (PPCM), a form of DCM that occurs in the last month of pregnancy or up to five months postpartum.
The mechanism by which bromocriptine may improve left ventricular function in DCM is not fully understood, but it is thought to be related to its ability to reduce prolactin levels. Prolactin is a hormone that has been shown to be elevated in some cases of DCM, and it may contribute to the development and progression of the condition. To date, the use of bromocriptine is recommended for the treatment of pregnancy-related cardiomyopathy (PPCM) due to a significant increase in prolactin levels. However, prolactin level may increase during menstrual cycles of reproductive-age women, which candidates the use of bromocriptine in women of all reproductive ages. The aims of this study is to assess the use of bromocriptine in terms of LV function improvement, overall improvement of heart failure symptoms and reduced mortality and improved quality of life, in dilated cardiomyopathy among women of reproductive age.

开始日期2023-12-01

申办/合作机构

Jimma University

CTR20233561 / CompletedN/A

甲磺酸溴隐亭片（2.5 mg）健康人体生物等效性研究

主要目的：本研究以杭州沐源生物医药科技有限公司持有的甲磺酸溴隐亭片（2.5 mg）为受试制剂，按生物等效性研究的有关规定，以原研厂家Bridging Pharma GmbH持有的甲磺酸溴隐亭片（规格：2.5 mg，商品名：Parlodel®）为参比制剂，评估受试制剂和参比制剂在餐后条件下给药后的生物等效性。次要目的：观察受试制剂甲磺酸溴隐亭片和参比制剂甲磺酸溴隐亭片（Parlodel®）在健康受试者中的安全性。

开始日期2023-11-23

申办/合作机构

杭州沐源生物医药科技有限公司

100 项与甲磺酸溴隐亭相关的临床结果

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100 项与甲磺酸溴隐亭相关的转化医学

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100 项与甲磺酸溴隐亭相关的专利（医药）

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项与甲磺酸溴隐亭相关的文献（医药）

2024-02-12·Journal of medical case reports

Guyton perspective in managing peripartum cardiomyopathy patient with pulmonary edema: a case report.

Article

作者: Ruth Evlin Margaretha ; Yohanes W H George ; Jefferson Hidayat

BACKGROUND:

Peripartum cardiomyopathy (PPCM) is a potentially life-threatening pregnancy-related condition characterized by left ventricular dysfunction and heart failure, typically occurring in the peripartum period. Individuals with a history of preeclampsia and hypertension are particularly prone to developing PPCM. Recent research suggests that the condition may be triggered by vascular dysfunction influenced by maternal hormones in the late stages of gestation. The onset of left heart failure results in decreased cardiac output, leading to insufficient perfusion, which in turn, contributes to pulmonary edema and exacerbates tissue hypoxia. This cardiovascular response activates the neurohumoral system, causing peripheral vasoconstriction and elevating both mean capillary filling pressure (MCFP) and central venous pressure (CVP). Early administration of furosemide reduces volume overload due to negative cumulative fluid balance gaining and vasodilation, which increases the velocity of intravascular refilling and causes interstitial edema to resolve. This will decrease interstitial fluid pressure, resulting in decreased mechanical compression to systemic capillary and systemic vein pressure, thus decreasing MCFP and CVP subsequently. Reduced CVP also contributes to increased venous return by decreasing the gradient pressure between MCFP and CVP, resulting in increased cardiac output (CO) and improved tissue oxygenation.

CASE:

A 33-year-old Asian woman, para 3 at full term pregnancy, admitted to the intensive care unit (ICU) after c-section and tubectomy due to shortness of breath and palpitation. Based on history taking, physical examination and echocardiography the patient fulfilled the criteria of PPCM which was also complicated by pulmonary edema. Despite impending respiratory failure, the patient rejected intubation and continuous positive airway pressure (CPAP), and was given oxygen supplementation through nasal cannula. Furosemide was given rapidly continued by maintenance dose and CVP was monitored. Antihypertensive drug, anticoagulants, and bromocriptine were also administered. After achieving negative cumulative fluid balance the patient's symptoms resolved and was discharged one week later.

CONCLUSION:

There is a correlation between negative cumulative fluid balance and reduced central venous pressure after early furosemide therapy. Suspicion for PPCM should not be lowered in the presence of preeclampsia, it could delay appropriate treatment and increase the mortality.

2024-02-01·Physical medicine and rehabilitation clinics of North America

Pharmacology in Treatment of Patients with Disorders of Consciousness.

Review

作者: Michael H Marino

Pharmacologic treatment of disorders of consciousness remains a critical but challenging task for clinicians. Amantadine has been shown to promote the rate of neurologic recovery for patients with traumatic disorders of consciousness when administered between 4 and 16 weeks, as demonstrated by a well-designed randomized control trial. While there are no large, randomized controlled trials to support the use of other dopaminergic medicines (bromocriptine, levodopa, apomorphine), there is a large body of literature implicating their role in improving alertness and responsiveness in disorders of consciousness. Zolpidem can increase the level of consciousness in a small subset of patients. Zolpidem and intrathecal baclofen likely increase the level of consciousness via the mesocircuit pathway. Psychostimulant medications can be initiated in patients, even without strong evidence to support their use, as long as basic principles of brain injury medicine are followed, and there are systems in place to evaluate therapeutic response.

2024-02-01·Annals of medicine and surgery (2012)

Bromocriptine: does this drug of Parkinson's disease have a role in managing cardiovascular diseases?

Review

作者: Lakshmi Venkata Simhachalam Kutikuppala ; Sushil Sharma ; Madhavrao Chavan ; Gaurav Rangari ; Arup Kumar Misra ; Sai Ram Innamuri ; Tejus Vijayakumar ; Golla Varshitha

Cardiovascular disease (CVD) is the most common cause of morbidity and mortality worldwide. Bromocriptine is a partial antagonist for D1 dopamine receptors while also serving as a selective agonist on D2 dopamine receptors as a dopamine receptor agonist. Apart from prolactin inhibiting action, bromocriptine has some beneficial effects on the blood pressure, plasma norepinephrine levels and vascular resistance. Dopamine D2 receptor activation of bromocriptine is associated with the antihypertensive effect, which lowers blood pressure via inhibiting sympathetic nerve activity and Na/K ATPase activity. Plasma levels of the pro-inflammatory cytokines such as interleukin (IL)-1B and IL-18, chemokine CCL2/ MCP-1/, and the pro-inflammatory hormone prolactin, all of which are elevated and linked to accelerated cardiometabolic illness, were decreased because of bromocriptine therapy. The most common side effects of Bromocriptine use are dizziness, nausea, headache, vomiting and hypotension. Bromocriptine is mainly contraindicated in patients with syncope with hypotension, psychosis, and type I diabetes mellitus. The authors suggest that developing therapies directed to increase D2 receptor expression and function by drugs like Bromocriptine can provide practical and novelistic approaches to prevent and manage myocardial and renal injury in the cardiovascular disease patients.

项与甲磺酸溴隐亭相关的新闻（医药）

2023-10-23

·行舟Drug

罗红霉素与阿奇霉素的区别与荐药要点

点击上方的行舟Drug ▲ 添加关注罗红霉素与阿奇霉素同属大环内酯类抗生素这个大家族，彼此虽为兄弟，但从来都是单独出场。那这对兄弟之间有什么差别，用药需要注意什么呢？药店人走起，我们一起进入他们的世界吧！结构罗红霉素：14元环大环内酯类阿奇霉素：15元环大环内酯类适应症罗红霉素：1、敏感菌引起的感染：①上呼吸道感染；②下呼吸道感染；③耳鼻喉感染；④生殖器官感染；⑤皮肤感染；2、支原体肺炎、沙眼、衣原体感染及军团病。阿奇霉素罗红霉素的功效阿奇霉素同样具备，但敏感菌引起的感染，罗红霉素作用更强，而在支原体、衣原体感染方面，阿奇霉素比罗红霉素强，其是现今发现对抗支原体、衣原体最强的药物。服用方法进食后服用会降低药物吸收，建议饭前1小时或饭后3~4小时服用。注意，罗红霉素与牛奶同服可增加吸收）药物相互作用罗红霉素：1、不可与麦角胺、二氢麦角胺、溴隐亭、特非那定、酮康唑及西沙必利联用；2、对氨茶碱的代谢影响小，对卡马西平、华法林、雷尼替丁及其他制酸药基本无影响。阿奇霉素1、不宜与含铝或镁的抗酸药同时服用，必须合用时，本品应在服用上述药物前1小时或服后2小时给予；2、与茶碱合用时能提高后者在血浆中的浓度，应注意检测血浆茶碱水平；3、与华法林合用时应注意检查凝血酶原时间；4、不可与利福布汀合用；5、与地高辛、麦角胺、二氢麦角胺三唑仑合用时应密切观察患者。注意事项罗红霉素：1、本品使用会影响驾驶及机械操作能力；2、长期用药时应注意监测肝功能；3、罗红霉素与茶碱合用时，需监测茶碱血药浓度。阿奇霉素1、轻中度肾功能不全患者本品的用法用量与肾功能正常者一样，严重肾功能不全者慎用；2、肝功能不全者慎用，严重肝病患者不应使用；3、用药期间定期监测肝功能。不良反应罗红霉素：不良反应较为少见，常见为腹痛、腹泻、恶心、呕吐等胃肠道症状，但发生率明显低于红霉素。阿奇霉素：随着临床应用范围的扩大，不良反应也逐渐增多，除可引起严重胃肠道不良反应外，还会引发室上性心动过速、严重心律失常、严重肝损害、急性肾衰竭、神经系统损害等。孕妇及哺乳期妇女用药哺乳妊娠期妇女慎用，无适当选择余地时经医生权衡利弊后方可使用本品。禁忌1、对罗红霉素、阿奇霉素或其他任何一种大环内酯类药物过敏者禁用；2、禁止使用含酒精的饮品。同是抗生素，罗红霉素和阿奇霉素各有千秋，没有谁比谁更强之说，只有哪个药更适合哪些人群服用。由以上看来，阿奇霉素和罗红霉素相比，抗菌作用更强劲，但不良反应也更多更严重。（本文仅供专业人士参考）来源：药店人文章信息源于药店人，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug每日更新欢迎订阅+医药大数据|行业动态|政策解读

核酸药物

2023-04-25

·信狐药迅

惠升、万邦司美格鲁肽临床申请，强生尼拉帕利阿比特龙复方进口申请 | 新受理（4.17-4.23）

每周药品注册受理数据，分门别类呈现，一目了然。(4.17-4.23）新药上市申请药品名称企业名称分类受理号LJ01003长春澜江医药科技有限公司2.2CXHS23000452.2CXHS2300046呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS23000432.4CXHS2300044人干扰素α2b注射液长春生物制品研究所有限责任公司3.4CXSS2300019新药临床申请药品名称企业名称分类受理号BAT1308注射液百奥泰生物制药股份有限公司1CXSL2300263BPHY-08胶囊百极弘烨(南通)医药科技有限公司1CXHL23004141CXHL2300415CF04滴眼液上海普佑生物医药有限公司1CXSL23002671CXSL23002681CXSL23002691CXSL2300270CPU-118片南京芩领医药科技有限公司1CXHL2300375CS23546片深圳微芯生物科技股份有限公司1CXHL23003831CXHL2300384D3S-002片德昇济医药(无锡)有限公司1CXHL23003991CXHL23004001CXHL2300401FD-001胶囊成都分迪药业有限公司1CXHL23003901CXHL2300391FT-004注射液方拓生物科技(苏州)有限公司1CXSL2300275HBW-3220胶囊成都海博为药业有限公司1CXHL2300382HRS-4357注射液天津恒瑞医药有限公司1CXHL2300392HS-10518胶囊江苏豪森药业集团有限公司1CXHL2300398IASO-782 注射液上海驯鹿生物技术有限公司1CXSL2300272JMT203注射液上海津曼特生物科技有限公司1CXSL2300278KN056注射液苏州康宁杰瑞生物科技有限公司1CXSL2300266NH300231片江苏恩华药业股份有限公司1CXHL23004061CXHL23004071CXHL2300408SG301 SC注射液杭州尚健生物技术有限公司1CXSL2300283TQ05105片正大天晴药业集团股份有限公司1CXHL2300387TQB2928注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2300276TQB3617胶囊正大天晴药业集团股份有限公司1CXHL23003851CXHL2300386TY-4028胶囊浙江同源康医药股份有限公司1CXHL23004021CXHL2300403WD-890片浙江文达医药科技有限公司1CXHL23003761CXHL23003771CXHL23003781CXHL2300379WS635片中美华世通生物医药科技(武汉)股份有限公司1CXHL2300412靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液上海先博生物科技有限公司1CXSL23002801CXSL23002811CXSL2300282吡罗西尼片轩竹生物科技股份有限公司1CXHL2300413卟硒啉片上海元熙医药科技有限公司1CXHL23003951CXHL23003961CXHL2300397布比卡因脂质体注射液江苏恒瑞医药股份有限公司2.4CXHL23004092.4CXHL23004102.4CXHL23004042.4CXHL2300405抗人CD70 T细胞注射液上海恒润达生生物科技股份有限公司1CXSL2300271马来酸吡咯替尼片江苏恒瑞医药股份有限公司2.4CXHL23003882.4CXHL2300389司美格鲁肽注射液惠升生物制药股份有限公司3.3CXSL2300274江苏万邦生化医药集团有限责任公司3.3CXSL2300279妥拉美替尼胶囊上海科州药物研发有限公司1CXHL23003931CXHL2300394盐酸鲁拉西酮口溶膜四川科伦药业股份有限公司2.2CXHL2300411重组抗CTLA-4全人单克隆抗体注射液上海复宏汉霖生物制药有限公司3.3CXSL2300265重组抗NKG2A人源化单克隆抗体注射液上海怀越生物科技有限公司1CXSL2300277重组人5型腺病毒注射液上海三维生物技术有限公司2.2CXSL2300273注射用AST-006深圳艾欣达伟医药科技有限公司1CXHL2300416注射用MT1002陕西麦科奥特科技有限公司1CXHL23003801CXHL2300381注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2300264仿制药申请药品名称企业名称分类受理号阿戈美拉汀片江苏安必生制药有限公司4CYHS2301079氨溴特罗口服溶液北京韩美生物科技有限公司3CYHS2301124江西仁齐制药有限公司3CYHS2301066巴氯芬口服溶液江苏天士力帝益药业有限公司3CYHS2301070倍他米松磷酸钠注射液湖北民康药业集团有限公司3CYHS2301092丙戊酸钠缓释片（Ⅰ）四川科伦药业股份有限公司4CYHS2301072醋酸曲普瑞林注射液华夏生生药业(北京)有限公司4CYHS2301101醋酸去氨加压素口服溶液合肥恩瑞特药业有限公司3CYHS2301129醋酸维持液（含葡萄糖）石家庄四药有限公司3CYHS23011033CYHS2301104地夸磷索钠滴眼液参天制药(中国)有限公司3CYHL2300055碘美普尔注射液成都克莱蒙医药科技有限公司4CYHS2301067多巴丝肼片石家庄四药有限公司4CYHS2301077恩那度司他片深圳信立泰药业股份有限公司3CYHL23000603CYHL23000613CYHL2300062二羟丙茶碱注射液安徽金太阳生化药业有限公司3CYHS2301131浙江和泽医药科技股份有限公司3CYHS2301086非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司4CYHS23010874CYHS2301088福多司坦口服溶液四川益生智同医药生物科技发展有限公司3CYHS2301118复方氨基酸（16AA）/葡萄糖（12.6%）电解质注射液福建盛迪医药有限公司3CYHS2301098富马酸酮替芬鼻喷雾剂山东泰合医药科技有限公司3CYHS2301084钆布醇注射液上海司太立制药有限公司4CYHS2301071格列齐特缓释片浙江京新药业股份有限公司4CYHS2301097琥珀酸舒马普坦萘普生钠片康缘华威医药有限公司3CYHS2301119黄体酮注射液丽珠集团利民制药厂3CYHS2301111北京布霖生物科技有限公司3CYHS2301078己酮可可碱注射液安徽美来药业股份有限公司3CYHS2301115镓[68Ga]伊索曲肽注射液天津恒瑞医药有限公司3CYHL2300057镓[68Ga]伊索曲肽注射液制备用药盒3CYHL2300058甲氨蝶呤注射液四川汇宇制药股份有限公司4CYHS2301117甲磺酸溴隐亭片浙江泰利森药业有限公司4CYHS2301125甲硫酸新斯的明注射液江苏九旭药业有限公司3CYHS23011203CYHS2301121酒石酸阿福特罗雾化吸入用溶液长风药业股份有限公司3CYHL2300056聚乙二醇4000散重庆赛诺生物药业股份有限公司4CYHS2301127拉考沙胺注射液合肥国药诺和药业有限公司4CYHS23010754CYHS2301076磷酸奥司他韦胶囊宜昌人福药业有限责任公司4CYHS2301116硫酸沙丁胺醇注射液浙江华海药业股份有限公司3CYHS2301128铝碳酸镁咀嚼片河南比福制药股份有限公司4CYHS2301102氯化钾颗粒山西普德药业有限公司3CYHS2301126吗啉硝唑氯化钠注射液山东齐都药业有限公司4CYHS2301112尼麦角林片北京福元医药股份有限公司3CYHS2301063普瑞巴林口服溶液中寰医药有限公司3CYHS2301082温岭市创新生物医药科技股份有限公司3CYHS2301083乳果糖口服溶液华萃国际生物科技(广东)有限公司4CYHS23010804CYHS2301081北京富新安康医药科技有限公司4CYHS2301085沙库巴曲缬沙坦钠片浙江昂利康制药股份有限公司4CYHS2301133舒更葡糖钠注射液福建省宝诺医药研发有限公司4CYHS2301132缩宫素注射液安徽百奥药业有限公司3CYHS2301105酮咯酸氨丁三醇注射液四川诺非特生物药业科技有限公司3CYHS23010943CYHS2301095托吡酯片海南日中天制药有限公司4CYHS2301074吸入用复方异丙托溴铵溶液成都普什制药有限公司4CYHS2301122吸入用乙酰半胱氨酸溶液济南康桥医药科技有限公司4CYHS2301100硝酸异山梨酯注射液石家庄四药有限公司4CYHS2301123安徽美来药业股份有限公司4CYHS2301108盐酸艾司洛尔注射液华夏生生药业(北京)有限公司3CYHS2301093盐酸氨溴索口服溶液陕西博森生物制药股份集团有限公司4CYHS2301106盐酸贝尼地平片重庆圣华曦药业股份有限公司4CYHS2301069盐酸丙美卡因滴眼液合肥立方制药股份有限公司3CYHS2301065盐酸多巴胺注射液湖南先施制药有限公司3CYHS2301089盐酸甲哌卡因注射液济南康桥医药科技有限公司3CYHS2301073盐酸莫西沙星氯化钠注射液河北天成药业股份有限公司4CYHS2301130盐酸羟甲唑啉滴眼液南京恒道医药科技股份有限公司3CYHL2300059盐酸去氧肾上腺素注射液山东威智百科药业有限公司3CYHS2301113盐酸肾上腺素注射液上海葆隆生物科技有限公司3CYHS2301110盐酸溴己新口服溶液安徽新世纪药业有限公司3CYHS2301068右酮洛芬氨丁三醇片湖南诺纳医药科技有限公司3CYHS2301107注射用氯诺昔康西藏诺泽生物医药有限公司4CYHS2301096注射用替莫唑胺北京双鹭药业股份有限公司3CYHS2301114注射用头孢他啶阿维巴坦钠南京恩泰医药科技有限公司4CYHS2301099注射用头孢唑肟钠舒美奇成都生物科技有限公司4CYHS23010904CYHS2301091进口申请药品名称企业名称分类受理号ASP2138 注射液Astellas Pharma Global Development, Inc.1JXSL2300073AZD2936AstraZeneca AB1JXSL2300074BAY 1747846 注射液Bayer AG1JXHL23000851JXHL23000861JXHL2300087IMG-020注射液INMAGENE PTE. LTD.1JXSL2300076Mavacamten胶囊Bristol-Myers Squibb Australia Pty Ltd.5.1JXHS23000365.1JXHS23000375.1JXHS23000385.1JXHS2300039MEDI5752AstraZeneca AB1JXSL2300075STC314注射液Grand Medical Pty Ltd.1JXHL2300088Tiragolumab注射液F. Hoffmann-La Roche Ltd.1JXSL2300069达雷妥尤单抗注射液Janssen-Cilag AG3.4JXSL2300072尼拉帕利醋酸阿比特龙片Janssen-Cilag International NV2.3JXHS23000342.3JXHS2300035萨特利珠单抗注射液F. Hoffmann-La Roche Ltd.2.2JXSL2300071注射用戈沙妥珠单抗Gilead Sciences, Inc.2.2JXSL2300070中药相关申请药品名称企业名称分类受理号脑心清片广州白云山和记黄埔中药有限公司2.3CXZL2300029桃红四物汤颗粒瑞阳制药股份有限公司3.1CXZS2300009杏贝止咳颗粒江苏康缘药业股份有限公司2.3CXZL2300028养阴舒肝颗粒广州医药研究总院有限公司1.1CXZL2300027不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2023-02-27

·PRNewswire

DelveInsight Evaluates a Robust Alzheimer's Disease Pipeline as 150+ Influential Pharma Players to Set Foot in the Domain

LAS VEGAS, Feb. 27, 2023 /PRNewswire/ -- The prevalence of Alzheimer's disease has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Alzheimer's disease and the growing research and development activities to develop novel therapies to treat Alzheimer's disease to drive the market. The companies developing the potential therapies in the last stage of development include Eli Lilly and Company, AB Sciences, AZTherapies, and several others. DelveInsight's ' Alzheimer's Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline Alzheimer's disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Alzheimer's disease pipeline domain. Key Takeaways from the Alzheimer's Disease Pipeline Report DelveInsight's Alzheimer's disease pipeline report depicts a robust space with 150+ active players working to develop 160+ pipeline therapies for Alzheimer's disease treatment. Key Alzheimer's disease companies such as Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others are evaluating new Alzheimer's disease drugs to improve the treatment landscape. Promising Alzheimer's disease pipeline therapies in various stages of development include ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002, CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others. In February 2023, Lantheus Holdings, Inc. announced it had acquired Knoxville-based Cerveau Technologies, Inc. ("Cerveau"). Cerveau's asset is MK-6240, a second-generation F 18-labeled positron emission tomography ("PET") imaging agent that targets Tau tangles in Alzheimer's disease.Under the terms of the agreement, Lantheus will pay an upfront payment and potential additional development and commercial milestone payments. Additionally, Lantheus will pay double-digit royalty payments for research revenue and commercial sales. In January 2023, Prothena Corporation plc announced positive topline Phase I single ascending dose (SAD) study results for PRX005, a potentially best-in-class investigational tri-epitopic antibody for the treatment of Alzheimer's disease that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms. The results of the study found all three dose level cohorts of PRX005 to be generally safe and well tolerated, meeting the Phase 1 SAD study primary objective. None of the treatment emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. In January 2023, Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted.The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. Lilly will continue to work with the FDA to evaluate the fastest pathway to make this potential treatment option widely available to patients. In January 2023, Coya Therapeutics, Inc. announced the recent publication of an article entitled "Ex vivo expanded human regulatory T cells modify neuroinflammation in a preclinical model of Alzheimer's Disease" in the peer-reviewed journal Acta Neuropathologica Communications.Furthermore, Treg-treated mice showed a significant reduction in total and plaque-associated microglia as well as reactive astrocytes in the dentate gyrus and frontal cortex versus untreated mice. The reduction in the number of plaque-associated glial cells and suppression of pro-inflammatory signaling pathways within these cells following Treg therapy may attenuate the contribution of these toxic glial cells in AD pathology resulting in mitigation of amyloid burden. In November 2022, Eli Lilly and Company announced that donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase III TRAILBLAZER-ALZ 4 study, providing the first active comparator data on amyloid plaque clearance in patients with early symptomatic Alzheimer's disease treated with amyloid-targeting therapies. Donanemab is an investigational antibody that targets a modified form of beta-amyloid plaque called N3pG. Request a sample and discover the recent advances in Alzheimer's disease drug treatment @ Alzheimer's Disease Pipeline Report The Alzheimer's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Alzheimer's disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Alzheimer's disease clinical trial landscape. Alzheimer's Disease Overview Alzheimer's disease (AD) is a slowly progressive brain disease that manifests itself many years before symptoms appear. It is the leading cause of dementia, accounting for 60% to 80% of cases. The accumulation of the protein fragment beta-amyloid (plaques) outside neurons in the brain and twisted strands of the protein tau (tangles) inside neurons are the hallmark pathologies of Alzheimer's disease. Alzheimer's disease is a progressive disease, so the symptoms worsen over time. Memory loss is a key feature, and it is often one of the first Alzheimer's disease symptoms to appear. The other Alzheimer's disease symptoms include cognitive deficits, problems with recognition, problems with spatial awareness, and others. A thorough clinical evaluation, a detailed patient history, and various specialized tests are used to make an Alzheimer's disease diagnosis. Clinical diagnosis, which is usually made during the early stages of the disease, lumbar puncture, and imaging studies are all methods of diagnosing Alzheimer's disease. Treatment for Alzheimer's disease includes options that may alleviate symptoms and improve quality of life. To treat cognitive symptoms, the FDA has approved two types of medications to treat cognitive symptoms: cholinesterase inhibitors (Aricept, Exelon, Razadyne) and memantine (Namenda). Other non-pharmacological therapies are also used to maintain or improve cognitive function, daily living ability, or overall quality of life. Find out more about drugs for Alzheimer's disease @ New Alzheimer's Disease Drugs A snapshot of the Alzheimer's Disease Pipeline Drugs mentioned in the report: Learn more about the emerging Alzheimer's disease pipeline therapies @ Alzheimer's Disease Clinical Trials Alzheimer's Disease Therapeutics Assessment The Alzheimer's disease pipeline report proffers an integral view of Alzheimer's disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Alzheimer's Disease Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Amyloid beta-protein inhibitors, Inflammation mediator inhibitors, Immunostimulants, Tumour necrosis factor alpha inhibitors, Microfilament protein modulators, Angiogenesis inhibitors, Colony stimulating factor inhibitors, Coronavirus-3C-like-proteinase inhibitors, Endopeptidase Clp inhibitors, Focal adhesion protein-tyrosine kinase inhibitors, Lyn protein-tyrosine kinase inhibitors, Macrophage colony-stimulating factor receptor modulators, Mast cell inhibitors, Platelet-derived growth factor receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Proto-oncogene protein c-fyn modulators, Type 3 fibroblast growth factor receptor antagonists Key Alzheimer's Disease Companies: Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others. Key Alzheimer's Disease Pipeline Therapies: ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002,CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others. Dive deep into rich insights for new drugs for Alzheimer's disease treatment; visit @ Alzheimer's Disease Medications Table of Contents For further information on the Alzheimer's disease pipeline therapeutics, reach out @ Alzheimer's Disease Drug Treatment Related Reports Alzheimer's Disease Epidemiology Alzheimer's Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted Alzheimer's disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. 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临床结果临床3期临床1期并购

100 项与甲磺酸溴隐亭相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00780	甲磺酸溴隐亭	G02CB01 N04BC01	DB01200

研发状态

适应症	最高研发状态	国家/地区	公司
帕金森病	批准上市	日本更多	Sun Pharma Japan Ltd. 更多
高催乳素血症	批准上市	日本更多	Sun Pharma Japan Ltd. 更多
2型糖尿病	批准上市	美国更多	VeroScience LLC 更多
不孕	批准上市	中国更多	-
巨人症	批准上市	日本更多	Sun Pharma Japan Ltd. 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


NCT00998556 (Pubmed \| Eur Heart J)	临床2期	心肌疾病	63	Short-term bromocriptine treatment (1W)	遞窪夢蓋夢衊構網積觸(糧範遞廠網淵憲獵鹽齋) = 衊網餘衊構觸遞顧遞製衊鏇製餘蓋醖積鹹艱獵 (艱鏇糧鹹淵憲構壓範齋 )	-	2017-09-14
				Long-term bromocriptine treatment (8W)	遞窪夢蓋夢衊構網積觸(糧範遞廠網淵憲獵鹽齋) = 衊鬱廠遞遞餘餘製淵網衊鏇製餘蓋醖積鹹艱獵 (艱鏇糧鹹淵憲構壓範齋 )
ESC2019	N/A	青春期障碍	23,883	Bromocriptine-treated women with hyperprolactinaemic disorders	(蓋簾鹹壓糧繭鑰鹽鑰選): hazard ratio = 1.32 (95% CI, 1.06 ~ 1.64)	-	2019-09-02
				bromocriptine
ARVO2020	N/A	1型糖尿病	12	SKF38393 hydrobromide	鹹襯積鹹構窪遞蓋願糧(鑰遞鬱醖衊窪淵遞醖糧) = 夢觸鬱鹹簾鑰憲鏇構憲構醖鹽淵網窪蓋壓膚願 (醖網窪淵製構鏇壓築蓋 )	-	2020-06-01
				Bromocriptine mesylate	鹹襯積鹹構窪遞蓋願糧(鑰遞鬱醖衊窪淵遞醖糧) = 壓範網繭顧願範鏇夢憲構醖鹽淵網窪蓋壓膚願 (醖網窪淵製構鏇壓築蓋 )
ARVO2023	N/A	低眼压	-	Eticlopride	(蓋蓋構蓋艱窪積廠製積) = 餘鏇膚廠願製糧淵鑰積顧鑰遞蓋蓋鏇齋齋壓窪 (築簾鑰糧淵齋繭構顧繭, 2.3)	-	2023-04-23
				SKF38393	(蓋蓋構蓋艱窪積廠製積) = 選選醖鹽遞獵製獵願鑰顧鑰遞蓋蓋鏇齋齋壓窪 (築簾鑰糧淵齋繭構顧繭, 2.1)
NCT00377676 (Pubmed \| J Diabetes Res)	临床3期	2型糖尿病	1,834	Bromocriptine-QR	繭壓膚鹽積艱窪餘廠糧(鏇艱鹹淵鹹窪鑰膚選衊): HR = 0.52 (95% CI, 0.28 ~ 0.98) 更多	积极	2015-01-01
				Placebo
NCT00377676 (Pubmed \| Postgrad Med)	临床3期	2型糖尿病	60	Bromocriptine-QR	(壓廠顧觸壓築齋願蓋鬱) = 窪糧顧壓鹹醖願鹹觸顧顧積廠願醖淵構獵鹽壓 (繭醖鹽範窪襯選鏇壓遞 ) 更多	-	2017-05-01
AAN2017	N/A	轻度痴呆 \| 轻度认知障碍	84	Bromocriptine	範選範網獵齋醖蓋襯廠(壓築網鏇鏇構窪淵願積) = 廠簾積淵鑰蓋簾衊積繭齋蓋蓋艱艱鬱餘獵壓蓋 (構製夢觸獵齋淵糧觸觸 )	-	2017-04-18
ADA2019	N/A	2型糖尿病追加	15	Bromocriptine-QR	選範艱獵網遞艱醖蓋襯(鏇齋觸醖鑰範廠網鹹衊) = 醖觸遞顧蓋夢顧壓鏇構遞範齋觸繭構蓋製積顧 (鏇艱鏇艱淵鹹憲觸鹹顧 ) 更多	-	2019-06-01
				GLP-1 Receptor Agonist	選範艱獵網遞艱醖蓋襯(鏇齋觸醖鑰範廠網鹹衊) = 選壓鹽選衊積壓夢鏇膚遞範齋觸繭構蓋製積顧 (鏇艱鏇艱淵鹹憲觸鹹顧 ) 更多
NCT00377676 (Pubmed \| Diabetes Care)	临床3期	2型糖尿病	3,095	Bromocriptine-QR	廠繭鹽壓艱鬱鹹願積製(餘製顧鏇築鹽範襯餘齋) = Nausea was the most commonly reported adverse event in the bromocriptine-QR group 繭醖積鏇積艱鬱醖簾觸 (艱蓋鹽願齋積廠襯選膚 )	积极	2010-07-01
				Placebo
NCT05405244 (CTgov)	临床3期	肥胖 \| 暴食症 \| 2型糖尿病 \| 超重	55	Bromocriptine (Bromocriptine)	製簾製範餘鹽鬱願獵膚(範廠鏇糧夢選顧網膚獵): ; 更多	-	2022-08-10
				placebo (Placebo)