A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia

The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.
Efficacy will be evaluated on objective and subjective sleep parameters.

开始日期2024-08-01

申办/合作机构

南京正大天晴制药有限公司

CTR20242252 / CompletedN/A

雷美替胺片人体生物等效性试验

以南京正大天晴制药有限公司研制的雷美替胺片（规格：8 mg）为受试制剂（T），武田药品工业株式会社生产的雷美替胺片（商品名：Rozerem®，规格：8 mg）为参比制剂（R），研究受试制剂和参比制剂在空腹/餐后状态下单剂量给药时的药代动力学参数，进行人体生物等效性评价。评估南京正大天晴制药有限公司研制的雷美替胺片的安全性。

开始日期2024-07-01

申办/合作机构

南京正大天晴制药有限公司

CTR20233366 / Active, not recruitingN/A

在中国健康受试者中开展的一项单中心、随机、开放、两周期、双交叉、单次口服雷美替胺双释片与雷美替胺片的药代动力学比较试验

主要目的：以越洋医药开发（广州）有限公司研制的雷美替胺双释片（规格：8mg）为试验制剂（T），以Takeda Pharmaceuticals America, Inc.生产的雷美替胺片（商品名：Rozerem®，规格：8mg）为对照制剂（R），比较试验制剂与对照制剂之间的体内的血药浓度及主要药代动力学参数，评价试验制剂的相对生物利用度及缓释特性。次要目的：评价中国健康受试者口服试验制剂雷美替胺双释片和对照制剂雷美替胺片后的安全性。

开始日期2024-06-24

申办/合作机构

越洋医药开发（广州）有限公司

100 项与雷美替胺相关的临床结果

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100 项与雷美替胺相关的转化医学

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100 项与雷美替胺相关的专利（医药）

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463

项与雷美替胺相关的文献（医药）

2024-12-01·Current Neurology and Neuroscience Reports

Pharmacological Prevention of Postoperative Delirium in Adults: A Review of Recent Literature

Review

作者: White, Nathan C ; Cowart, Christopher R ; Cios, Theodore J

PURPOSE OF REVIEWPostoperative delirium (POD) is a common complication that has important implications for surgical patients, often leading to both short- and long-term cognitive deficits, worse outcomes, and increased healthcare costs. Given these implications, there may be a benefit in reducing the incidence of POD. Pharmacologic interventions may have the potential to reduce the risk of a patient developing POD.RECENT FINDINGSRecently studied therapies include dexmedetomidine, propofol, haloperidol, ketamine, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, acetaminophen, melatonin/ramelteon, corticosteroids, midazolam, physostigmine, and neostigmine. In addition, the implementation of regional anesthesia and reduction of overall anesthetic depth have been examined. Of these therapies, dexmedetomidine has been studied the most and has the most supporting evidence for prevention of POD, but current studies lack clarity on optimal dosing and timing of dexmedetomidine administration. Acetaminophen, corticosteroids, and melatonin/ramelteon are other plausible medications that have potential for reducing POD incidence, but they all require further investigation. Reduction of anesthetic depth and regional anesthetics are options for anesthetic management that show promise but still lack enough supporting evidence in recent literature to receive a strong recommendation. Future research should focus on identifying optimal strategies for the implementation of the pharmacological options listed, including doses and timing of administration. Attention should be given to dexmedetomidine given its promise demonstrated by recent literature.

2024-10-01·Clinical neuropsychiatry

Effects of Approved Pharmacological Interventions for Insomnia on Mood Disorders: A Systematic Review.

Review

作者: Riemann, Dieter ; Miniati, Mario ; Gemignani, Angelo ; Geoffroy, Pierre A ; Marazziti, Donatella ; Palagini, Laura

ObjectiveInsomnia can be a contributing factor, a comorbid disorder, or a transdiagnostic element to several mental disorders, including mood disorders (MDs). A recent meta-analysis has already shown the effectiveness of cognitive behavioral treatment (CBT) for insomnia that is comorbid with MDs. This work aimed to systematically review data on pharmacological insomnia treatment in the context of MDS. In agreement with the current guidelines, pharmacological interventions for insomnia include gamma-aminobutyric acid (GABA)A receptor agonists such as short-medium acting benzodiazepines and benzodiazepine receptor agonists - Z-drugs, melatonergic receptors agonists, specifically melatonin 2 mg Prolonged Release (PR) and ramelteon, and dual orexin receptors antagonists (DORA) such as daridorexant, lemborexant, and suvorexant.MethodA systematic search was carried out on PUBMED database, according to the PRISMA Guidelines.ResultsThirty-three papers, 15 on gabaergic receptor agonists, 14 on melatonergic receptor agonists and 4 on DORA, were selected.ConclusionsAvailable data suggests that the treatment of insomnia symptoms with specific pharmacological options can improve both insomnia and comorbid conditions. Specifically, eszopiclone and melatonin 2 mg PR have demonstrated promising outcomes. Moreover, daridorexant and suvorexant, both belonging to the DORA class, have demonstrated efficacy in treating insomnia and mood symptoms. To summarize, current literature would suggest that targeting insomnia could potentially regulate the sleep system and, as such, improve mood symptoms.

2024-10-01·Current Oncology Reports

Postoperative Delirium and Neurocognitive Disorders: Updates for Providers Caring for Cancer Patients

Review

作者: Ron, Donna ; Deiner, Stacie

PURPOSE OF REVIEWTo provide up to date information on postoperative delirium and neurocognitive disorders in surgical cancer patients.RECENT FINDINGSEstablished risk factors such as age, psychosocial factors, comorbidities, frailty and preexisting cognitive decline continue to exhibit associations with perioperative neurocognitive disorders (PND); novel risk factors identified recently include microbiome composition and vitamin D deficiency. Prevention measures include cognitive prehabilitation, perioperative geriatric assessment and multidisciplinary care, dexmedetomidine and multimodal analgesic techniques. Studies investigating ciprofol, remimazolam, esketamine, ramelteon and suvorexant have shown encouraging results. Controversy remains regarding the use of inhalational versus intravenous general anesthesia. Innovative approaches to address PND are a rapidly developing area of research, but more studies are needed to identify effective prevention and management interventions. Despite challenges and controversy in the field, implementation of best practice can reduce the detrimental impact of PND on patients, caregivers, and society at large.

项与雷美替胺相关的新闻（医药）

2024-10-19

·动脉网

阳光诺和CRO项目专场—针剂及经皮递送、口服给药等项目寻找有研发需求企业【供需资源对接专场】

-动脉网“供需对接”产业链接平台，高效对接行业资源，助力业绩增长 -截止目前，动脉网已上线链接近千条，每条链接的曝光量1W+，实现企业成功对接次数超2千次 -持续精选链接整理合集发布，并精准推送到动脉网相关领域社群（总覆盖人数超3W+）北京阳光诺和药物研究股份有限公司是科创板上市企业（688621），是专注于仿制和创新药物研究，致力于以技术服务为核心，推动中国医药行业发展，为客户提供「临床前＋临床+CDMO」全过程药物研发服务的综合型CRO公司。阳光诺和从药物发现、到药理药效、药学研究，再到临床研究资源的整合，生物样本检测团队的构建，生产制造能力的整合，成功打造了全过程CRO服务模式。公司主营业务涵盖药理药效、临床研究、CDMO、创新药开发、仿制药开发及一致性评价的综合研发服务，服务内容主要包括药物发现、药理药效、药学研究、临床研究和生物分析。可进行完整的化学药研发、仿制药一致性评价、药物代谢分析与评价研究、多肽药物研发、临床生物等效性试验、药物Ⅰ-Ⅳ期临床研究、生物样品检测、注册申报（国内和进口）、国际合作等服务。本期链接专场为大家带来11个阳光诺和CRO服务项目，招募有研发需求的企业，详情如下：雷美替胺片 1、基本信息产品名称：雷美替胺片英文名称：Ramelteon 商品名称：Rozerem 原研厂家：武田薬品工業株式会社（Takeda Pharmaceutical Co,.Ltd.）产品规格：8mg 注册分类：3类 2、项目优势雷美替胺，2005年9月获FDA批准在美国上市，商品名为Rozerem，可用于治疗难以入睡型失眠症，对慢性失眠和短期失眠也有确切疗效。本品能选择性激动褪黑激素1型受体和2型受体（MT1、MT2），增加慢波睡眠（SWS）和快动眼睡眠（REW），从而减少失眠。雷美替胺是首个没有列为特殊管制的非成瘾失眠症治疗药物。雷美替胺吸收迅速，空腹口服给药后约0.75小时达峰。由于广泛的首过代谢，雷美替胺绝对口服生物利用度仅为1.8%。在人血清中，雷美替胺的体外蛋白结合率约为82%，与浓度无关。与白蛋白的结合占该结合的大部分，因为70%的药物与人血清白蛋白结合。代谢主要包括氧化成羟基和羰基衍生物，次生代谢产生葡糖苷酸结合物。CYP1A2 是参与雷美替胺肝脏代谢的主要同工酶；口服放射性标记的雷美替胺后，84%的总放射性通过尿液排出，约4%通过粪便排出，平均回收率为88%。少于0.1%的剂量作为母体化合物从尿液和粪便中排出。给药后96小时基本消除。由于雷美替胺的消除半衰期短（平均约1至2.6小时），每天重复服用一次不会导致显着蓄积。 3、临床适用于用于治疗难以入睡型失眠症 4、上市情况国内暂无上市企业国外上市情况：2005年7月，ROZEREM片剂在美国被批准用于治疗“以入睡困难为特征的失眠症”。在日本，它因具有“改善失眠症入睡困难”的功效，于2010年4月作为不属于“精神药物”或“注意：成瘾”类别的药物批准生产和销售。2019年6月公布复审结果，再次确认有用性。 5、国内申报情况国内有2家企业申请了临床，分别是南京正大天晴制药有限公司和越洋医药开发（广州）有限公司。 6、参比制剂的选择国家局发布的仿制药参比制剂目录（第三十批），详见如下：参考以上信息，雷美替胺片的处方工艺开发，可选择日本武田薬品工業株式会社上市的Rozerem作为参比制剂，规格为8mg，参比制剂生产商为武田薬品工業株式会社くすり相談室，生产地址为〒103-8668 東京都中央区日本橋本町二丁目1番1号。 7、研发进度阳光诺和拥有雷美替胺原料及制剂的成熟制备工艺，原料中试交接已完成，制剂即将进行中试。非奈利酮片 1、基本信息产品名称：非奈利酮片英文名称：Finerenone Tablets 商品名称：Kerendia（可申达）原研厂家：Bayer 产品规格：10mg和20mg 注册分类：4类 2、项目优势非奈利酮片（通用名：Finelenone，以下简称Finelenone）是拜耳公司开发的一种新型非甾体类选择性盐皮质激素受体拮抗剂（MRA）。适用于与2型糖尿病相关的慢性肾脏病成人患者（肾小球滤过率估计值[eGFR]≥25至<75mL/min/1.73m2，伴白蛋白尿），可降低eGFR持续下降、终末期肾病的风险。非奈利酮是一种非甾体类、选择性盐皮质激素受体（MR）拮抗剂，MR可被醛固酮和皮质醇激活并调节基因转录，MR过度激活会导致纤维化和炎症。非奈利酮是MR的强效和选择性拮抗剂，可阻断上皮（如肾脏）和非上皮（如心脏和血管）组织中MR介导的钠重吸收和MR过度激活，对雄激素、孕激素、雌激素和糖皮质激素受体无亲和力。 3、临床适用于降低2型糖尿病相关的终末期肾病的风险 4、上市情况国内目前仅参比上市，持证商拜尔，规格10mg、20mg。 5、国内申报情况暂无企业申请上市。 6、市场情况 7、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，选择Bayer上市的原研药品，商品名：Kerendia（可申达），作为参比制剂。 8、专利情况化合物专利CN101641352B，保护期至2028年2月19日CN106795155A，原研api合成路线，保护期至2035年 9、研发进度非奈利酮片预BE已完成，项目经验成熟。对乙酰氨基酚布洛芬片 1、基本信息产品名称：对乙酰氨基酚布洛芬片英文名称：Ibuprofen，Acetaminophen tablet 商品名称：Advil Dual Action With Acetaminophen 原研厂家：GlaxoSmithKline Consumer Healthcare 产品规格：对乙酰氨基酚250mg，布洛芬125mg 注册分类：3类 2、项目优势对乙酰氨基酚是一种常用的苯胺类解热镇痛药，患者服用后不会产生过敏反应和积累中毒，临床上多用于治疗头痛、发烧及缓解轻度至中毒疼痛，也适用于治疗由普通感冒和病毒感染所引起的头痛、发烧及全身不适，还可作为有效的止痛药。维生素C具有增强机体对传染病的抵抗力，促进抗体形成，增加白细胞吞噬功能以及抗炎抗过敏作用，并能增加机体对病毒的抵抗力和对毒物的分解能力。布洛芬是一种常用的解热镇痛消炎药，临床上主要用于解热及因为高热引起的关节疼痛、神经痛、痛经及其它疾病所引起的疼痛。布洛芬是由Stewart Adams博士和其导的团队、化学家John Nichokson博士共同发现的。其是在开发治疗类风湿关节炎的“超级阿司匹林”过程中长期研究的产物。将布洛芬誉为“超级阿司匹林”，意味着与当时的其他药物相比，疗效相同，但更具安全性。 3、临床适用于解热镇痛消炎。 4、国内、外上市情况目前国内有一家企业（广州南新）上市复方布洛芬片，每片含布洛芬400mg,对乙酰氨基酚325mg。 5、国内申报情况目前国内有2家企业申报，山东朗诺和长春澜江，申报的规格均为对乙酰氨基酚250mg，布洛芬125mg。 6、市场销售情况对乙酰氨基酚布洛芬片在国内还未上市，暂无销售数据。布洛芬片为OTC，以下为我公司数据库部分样本医院数据： 7、参比制剂的选择 NMPA发布的参比制剂目录信息综上所述，按现行管理法规要求，选用GlaxoSmithKline Consumer Healthcare在美国上市的原研药品，商品名为Advil Dual Action With Acetaminophen，规格：对乙酰氨基酚250mg，布洛芬125mg，作为参比制剂。 8、专利情况无专利限制。 9、研发进度处方工艺开发中。布洛芬盐酸去氧肾上腺素片 1、基本信息产品名称：布洛芬盐酸去氧肾上腺素片英文名称：Ibuprofen and Phenylephrine Hydrochloride Tablets 商品名称：Advil Congestion Relief 原研厂家：GlaxoSmithKline Consumer He 产品规格：布洛芬200mg，盐酸去氧肾上腺素10mg 注册分类：3类 2、项目优势抗感冒药是一个庞大的家族，是最大类别的药品，依据抗感冒药所含血管收缩药的不同种类，可将抗感冒药分为三代：第一代苯丙醇胺类抗感冒药：2000年以前，国内外的抗感冒药以苯丙醇胺（去甲麻黄碱、PPA）类为主。第二代伪麻黄碱类抗感冒药：自2000年开始停用含苯丙醇胺的抗感冒药后，各国相继采用伪麻黄碱组成新的抗感冒药。第三代去氧肾上腺素类抗感冒药：美国的研究证实了口服去氧肾上腺素收缩血管、消除闭塞的作用，确定了其在抗感冒药中的地位。布洛肾素片的原研产品于2010年5月获得FDA批准上市销售，由美国Pfizer INC开发成功。目前该产品由GSK作为持证商在对外销售，是OTC产品。 3、上市情况国内暂无上市企业 4、国内申报情况国内仅阳光诺和申请临床试验 5、参比制剂的选择国家局发布的仿制药参比制剂目录（第二十九批），详见如下：参考以上信息，布洛芬盐酸去氧肾上腺素片的处方工艺开发，可选择美国GlaxoSmithKline Consumer Healthcare上市的Advil Congestion Relief作为参比制剂，规格为布洛芬200mg,盐酸去氧肾上腺素10mg。 6、研发进度阳光诺和拥有布洛芬盐酸去氧肾上腺素片的成熟制备工艺，目前正在准备进行临床试验。阿加曲班注射液 1、基本信息产品名称：阿加曲班注射液英文名称：Argatroban Injection 商品名称：NOVASTAN(诺保思泰) 原研厂家：田边三菱制药株式会社产品规格：2mL:10mg 注册分类：4类 2、项目优势阿加曲班是由日本三菱制药工场株式会社研制合成的抗血栓药，于1990年2月最先上市，首先被应用于临床治疗周围动脉闭塞性疾病，然后开始将其用于治疗急性脑血栓形成，以及心肌梗死溶栓的辅助治疗，并用于在抗凝血酶(AT)缺乏患者进行血透时的抗凝处理。美国食品与药品管理局（FDA）在2000年批准了史克必成和得克萨斯生物技术公司的可注射抗血栓小分子药物阿加曲班应用于治疗和预防血栓形成及肝素诱导的免疫性疾病－血小板减少症（HIT），以及用于对需要进行经皮冠脉介入术（PCI）病人的治疗。阿加曲班2001年在韩国上市。2002年12月，三菱制药公司正式在中国上市，规格：2ml：10mg，商品名：诺保思泰。 3、上市情况目前国内26家上市，其中1家参比，23家过评。本品已经集采。部分上市情况如下： 4、国内申报情况目前国内7家企业申请上市，湖南恒生、浙江华海、华夏生生等。 5、市场情况 6、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，选择田边三菱制药株式会社在国内上市的原研药品，商品名：NOVASTAN(诺保思泰)，作为参比制剂。 7、专利情况无专利限制。 8、研发进度阳光诺和拥有阿加曲班注射液的成熟制备工艺，现已拿到生产批件，可以对外转让。度他雄胺软胶囊 1、基本信息产品名称：度他雄胺软胶囊英文名称：Dutasteride Soft Capsules 商品名称：Avodart(安福达) 原研厂家：GlaxoSmithKline (Ireland) Ltd. 产品规格：0.5mg 注册分类：4类专利情况：无专利限制 2、项目优势度他雄胺（Avodart，葛兰素史克）是第2代5α-还原酶抑制药，是目前第一种也是唯一一种同时抑制I型和II型5α-还原酶的药物，2001年由美国食品与药品管理局（FDA）批准在美国上市，用于治疗良性前列腺增生症。长时间服用能减小前列腺体积，因此目前被FDA批准用于降低急性尿潴留和相关手术风险。在欧洲市场的商品名为Avolvet。国家食品药品监督管理局于2011年4月11日批准了法国Laboratoire GlaxoSmithKline公司的度他雄胺软胶囊（商品名为安福达/Avodart、规格为0.5mg）进口上市申请，进口注册证号为H20110205。 3、临床适用于治疗良性前列腺增生症。 4、上市情况目前国内6家企业上市，1家参比、5家过评。本品已集采。 5、国内申报情况目前无最新申报企业。 6、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，选择GlaxoSmithKline (Ireland) Ltd.在国内上市的原研药品，商品名：Avodart(安福达)，作为参比制剂。 7、研发进度阳光诺和拥有度他雄胺软胶囊的成熟制备工艺，现已拿到生产批件，可以对外转让。盐酸多西环素片 1、基本信息产品名称：盐酸多西环素片英文名称：Doxycycline Hyclate Tablets 商品名称：Vibramycin 原研厂家：Pfizer Japan Inc 产品规格：0.1g 注册分类：3类 2、项目优势多西环素是一种四环素类抗生素，通常用于治疗各种感染。它是一种广谱抗生素和抑菌剂。强力霉素具有抗原生动物特性，是体内MMPs（基质金属蛋白酶）的有效抑制剂。强力霉素经常用于治疗莱姆病，慢性前列腺炎，鼻窦炎，盆腔炎痤疮，酒渣鼻和立克次体感染和预防治疗炭疽（由炭疽芽孢杆菌引起）。对鼠疫菌也有效。治疗与强力霉素抑制胶原合成。 3、临床适用于浅表性皮肤感染、深表性皮肤感染、淋巴管淋巴结炎、慢性脓皮病、外伤烧伤及手术创等二次感染、乳腺炎、骨髓炎、喉咽喉炎、扁桃体炎、急性支气管炎、肺炎等引起的感染。 4、上市情况目前国内有61家上市，仅江苏联环1家通过一致性。部分上市情况如下： 5、国内申报情况目前国内2家申报，特一药业申请一致性，浙江赛默申请上市。 6、市场情况 7、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，选择Pfizer Japan Inc在日本上市的原研药品，商品名：Vibramycin，作为参比制剂。 8、专利情况无专利限制。 9、研发进度阿达帕林过氧苯甲酰凝胶正在进行中试生产，项目经验成熟。苹果酸奈诺沙星胶囊 1、基本信息产品名称：苹果酸奈诺沙星胶囊英文名称：Nemonoxacin Malate Capsules 商品名称：太捷信原研厂家：浙江医药股份有限公司新昌制药厂产品规格：0.25g 注册分类：4类 2、项目优势奈诺沙星（nemonoxacin，TG-873870）具有广谱的抗革兰阳性菌、革兰阴性菌和非典型病原体的体外抗菌活性，包括耐青霉素、耐喹诺酮类的肺炎链球菌并且对耐甲氧西林金黄色葡萄球菌(methicillin-resistant Staphylococcus aureus,MRSA)、耐万古霉素金黄色葡萄球菌和多重耐药病原菌有效。奈诺沙星C-8位点比沿用的喹诺酮类多一个甲基基团，使得与拓扑异构酶Ⅳ和Ⅱ均能结合，从而抗菌谱更广，诱导耐药减少。奈诺沙星是由台湾太景（TaiGen）生物科技公司从宝洁(P&G)制药获得许可研发的一种新型C-6位无氟喹诺酮类药物，并由该公司授权予浙江医药股份有限公司在中国大陆生产与销售。现应用者为苹果酸奈诺沙星（nemonoxacin malate），与沿用的喹诺酮类抗菌药物相比，奈诺沙星对革兰阳性球菌具有更高的抗菌活性。 3、临床适用于抗细菌感染 4、上市情况目前国内苹果酸奈诺沙星胶囊仅1家企业上市，浙江医药股份有限公司新昌制药厂（原研），规格：0.25g(以C20H25N3O4计)。上市情况如下： 5、国内申报情况暂无企业申报仿制上市。 23年1月，浙江医药股份有限公司新昌制药厂（原研）申请临床。 23年6月，治疗单纯性尿路感染III期临床进行中。 6、市场情况苹果酸奈诺沙星胶囊的销售数据如下： 7、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，可以选择原研药品（持证商：浙江医药股份有限公司新昌制药厂；商品名：太捷信）在国内上市的苹果酸奈诺沙星胶囊，作为参比制剂。 8、专利情况 9、研发进度阳光诺和目前正在进行实验室处方工艺研究。阿达帕林过氧苯甲酰凝胶 1、基本信息产品名称：阿达帕林过氧苯甲酰凝胶英文名称：Adapalene and Benzoyl Peroxide Gel 商品名称：Epiduo 原研厂家：Laboratoires Galderma S.A. 产品规格：0.1%,2.5%（15g）注册分类：3→4类 2、项目优势阿达帕林属第三代维A酸，是一种萘甲酸衍生物，它与维A酸核受体有特殊的亲和力，与第一代的维A酸和异维A酸不同，它不与胞腺维A酸蛋白相结合，比原有的维A酸制剂对皮肤的刺激更低。而且其稳定性好，避免了维A酸仅限于晚上使用（维A酸光不稳定，需避光）。过氧化苯甲酰为苯甲酸衍化物，具有广谱抗菌作用，尤其抗厌氧菌性感染，对痤疮丙酸杆菌（痤疮丙酸杆菌）和表皮葡萄球菌（表皮葡萄球菌）具有抗菌活性，且有去角质作用。其最大特点是不会耐药。根据CN101541320B原研专利研究结果可知，BPO可增强阿达帕林的作用，在保持同样的皮肤耐受性的同时，联合应用或组合使用阿达帕林和BPO的治疗方法可以成功地减少痤疮的皮损数量并改善病人的临床症状，疗效显著优于以单独应用阿达帕林或单独应用BPO为基础的治疗方法。 3、临床适用于寻常性痤疮的局部治疗 4、上市情况国内暂无阿达帕林过氧苯甲酰凝胶上市。有阿达帕林凝胶单方和过氧苯甲酰凝胶单方上市，上市情况如下： 5、国内申报情况目前国内有2家申请上市：原研Galderma、苏州高迈。 23年1月，原研Galderma申请上市，预计24年底或25年初获批。 6、市场情况由于国内阿达帕林过氧苯甲酰凝胶还未上市，所以暂无复方的销售数据。阿达帕林凝胶单方和过氧苯甲酰凝胶单方的销售数据如下： 7、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，选择Laboratoires Galderma S.A.上市的原研药品，商品名：Epiduo。 8、专利情况无专利限制。 9、研发进度阿达帕林过氧苯甲酰凝胶正在进行中试生产，项目经验成熟。多替诺雷片 1、基本信息产品名称：多替诺雷/多替诺德片英文名称：Dotinurad Tablets 商品名称：URECE 原研厂家：Fuji Yakuhin Co., Ltd. 产品规格：0.5mg、1mg、2mg 注册分类：3类 2、项目优势多替诺雷片（通用名：ドチヌラド）是一种具有选择性URAT1抑制作用的药物，并且致力于减少肝脏毒性（如线粒体毒性）和CYP2C9抑制引起的药物相互作用，由富士药品公司研发，是一种选择性尿酸再吸收抑制药（Selective Urate Reabsorption Inhibitor：SURI）。多替诺雷片的开发从2009年开始，针对痛风和高尿酸血症患者的临床试验由富士药品公司进行，第Ⅲ期试验则由富士药品公司与持田制药公司共同进行。由于确认了多替诺雷片的有效性和安全性，最终申请了“痛风、高尿酸血症”作为适应症，并于2020年1月23日获得了生产销售许可，商品名为URECE，规格为0.5mg、1mg和2mg。高尿酸血症如果持续存在，会引发痛风关节炎（痛风），并导致生活质量下降。此外，高尿酸血症不仅与痛风相关，还可能与肾脏损伤和心血管事件的发生有关。因此，降低痛风和高尿酸血症患者的血清尿酸值是非常重要的。在治疗痛风和高尿酸血症时，生活习惯的调整是基本原则，药物治疗也同样重要。 3、临床适用于痛风、高尿酸血症 4、上市情况目前国内暂无上市企业 5、国内申报情况原研中国临床3期完成，即将上市（临床做的规格是1和2mg）。 6、市场情况国内暂无上市，所以暂无销售数据。 7、参比制剂的选择 NMPA发布的参比制剂目录信息：综上所述，选择Fuji Yakuhin Co., Ltd.在日本上市的原研药品，商品名：URECE，作为参比制剂。 8、专利情况 9、研发进度多替诺雷原料准备中试，制剂正在做实验室研究。注射用盐酸兰地洛尔 1、项目优势注射用盐酸兰地洛尔是由日本小野制药开发的一款用于治疗快速性心律失常的注射药物制剂，是一种新型的超短效肾上腺素β受体阻滞药。肾上腺素β受体阻滞药是一类作用广泛、重要的心血管治疗药物，超短效肾上腺素β受体阻滞药由于起效快、代谢快、停药后β受体阻滞作用消失快，发生的快速性心律失常的治疗中发挥重要且不可替代的作用。 2、临床适用于 1）手术过程中发生的下列快速性心律失常的紧急治疗：心房纤颤、心房扑动、窦性心动过速； 2）手术后循环系统动态监护时发生的快速性心律失常的紧急治疗：心房纤颤、心房扑动、窦性心动过速； 3）心功能不全患者发生下列快速性心律失常的治疗：心房纤颤、心房扑动；国内无原研产品上市，仅一家仿制药上市 3、项目进度阳光诺和兰地洛尔原料药工艺验证完成，制剂即将工艺验证。对以上项目感兴趣，欢迎扫描下方二维码，与阳光诺和直接对接 -动脉网供需对接平台覆盖：出海、供应链、市场/渠道、成果转化、招商入驻等板块 -通过平台上传供应或需求资源内容，可精准触达目标意向合作伙伴 -高效对接MNC、初创企业、政府园区、投资机构等实体下载动脉网APP，自主发布，高效对接近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

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2024-09-24

·GlobeNewswire-Health Care

Busy Philipps Encourages Women to Take Charge of Their ADHD This Fall in Ongoing Collaboration with Supernus Pharmaceuticals and Qelbree

Ahead of ADHD Awareness Month, Busy is sharing her ADHD diagnosis and Qelbree® (viloxazine extended-release capsules) treatment story to empower women living with ADHD to advocate for their care.ADHD often presents differently in women than in men, which can make it more challenging to recognize in women and ultimately leaving them undiagnosed and untreated.1 ROCKVILLE, Md., Sept. 24, 2024 (GLOBE NEWSWIRE) -- In a continued collaboration with Supernus Pharmaceuticals, actress, author, podcaster, late-night host, and mom, Busy Philipps, is speaking up this fall about her ongoing journey with attention-deficit/hyperactivity disorder (ADHD), bringing awareness to the often-overlooked symptoms of the condition in women and Qelbree, a non-stimulant ADHD treatment that has benefitted her. With summer over and the school year now in full swing, the fall season brings for many adults a return to normal routines or schedules, as well as an opportunity for a fresh start. Busy knows first-hand just how difficult getting ‘back to schedule’ can be for the approximately 10 million adults living with ADHD, who may be experiencing symptoms of inattention, hyperactivity/impulsivity, or both.2 She’s sharing her story to help empower people, and especially women, living with ADHD to take action for a fresh start this fall and talk to their doctors about treatment options to help manage their condition. “For many years living with unmanaged ADHD, I’d often start a task and never remember to finish, frequently feeling restless and unable to stay still. I would ramble on, get easily distracted and have trouble multitasking, and with my busy lifestyle, it was a challenge,” says Busy. “Now that I’m taking Qelbree, I’m relieved that my ADHD symptoms are more manageable. I only wish I’d taken charge of my ADHD sooner. That’s why I’m sharing my story to raise awareness about ADHD and help others who may be struggling with their diagnosis find a treatment option that works for them like Qelbree has worked for me.” Qelbree is a novel, once-a-day, non-stimulant approach for patients 6 years and older with ADHD, and the first non-stimulant approved for adults with ADHD in 20 years. As a non-stimulant, Qelbree has no evidence of abuse or misuse and can be conveniently refilled without needing a new prescription each month. “As a leader in treating ADHD, Supernus is committed to providing treatment options and education to help people living with ADHD like Busy Philipps manage their ADHD symptoms,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We appreciate Busy’s continued support and willingness to share her ADHD story and experience with Qelbree, especially leading into ADHD Awareness Month.” For more information about Qelbree, visit Qelbree.com. Patients should speak to a doctor about all the medications they take, and to see if Qelbree could be right for them. INDICATION Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child: Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, for Qelbree here. 1Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals. 2Culpepper, L., Mattingly, G. (2010). Challenges in Identifying and Managing Attention-Deficit/Hyperactivity Disorder in Adults in the Primary Care Setting: A Review of the Literature. Primary Care Companion Journal of Clinical Psychiatry. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. CONTACTS: Jack A. Khattar, President and CEO Timothy C. Dec, Senior Vice President and CFO Supernus Pharmaceuticals, Inc. Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter Vozzo ICR Westwicke Office: (443) 213-0505 Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Matthew FrappierTel: (646) 358-9683Email: Matthew.Frappier@bcw-global.com

上市批准

2024-05-01

·GlobeNewswire-Health Care

Busy Philipps Shines Spotlight on ADHD in Women and Shares her Qelbree Story

Busy is getting candid about navigating her ADHD diagnosis and treatment experience with Qelbree®The percentage of women newly diagnosed with ADHD between 23-29 and 30-49 years of age nearly doubled in just two years (2020-2022)1Although symptoms are present in childhood, a significant portion of women with ADHD don’t receive a diagnosis until they are adults2 ROCKVILLE, Md., May 01, 2024 (GLOBE NEWSWIRE) -- Actress, author, podcaster, and mother of two, Busy Philipps is teaming up with Supernus Pharmaceuticals to share her personal journey with attention-deficit/hyperactivity disorder (ADHD) – one of the most common psychiatric diagnoses in adults – as well as her experience with Qelbree (viloxazine extended-release capsules), a non-stimulant medication for the treatment of ADHD.3 Busy has been vocal about her personal experience living with ADHD for years, but now she is revealing what it means to be a woman navigating ADHD and wants other women who may be struggling to know they are not alone. Boys are two times more likely than girls to be diagnosed.4 While boys’ symptoms often fit the stereotypical ideas of hyperactive ADHD, girls’ inattentive symptoms are often overlooked. As a result, ADHD often goes undiagnosed in young girls, leading to more adult females being undiagnosed and therefore untreated – a sentiment reflective of Busy’s own experience.2,5 “As women, we tend to mask or overcompensate for our ADHD symptoms and end up working harder to get things done. With the right medication, there’s a sense of relief for women with ADHD – you’re suddenly able to take a deep breath," says Busy. "Since I started treatment with Qelbree, I have been able to better manage my ADHD symptoms and understand what to prioritize versus what can be put on the backburner. I'm excited to collaborate with Supernus as a woman navigating ADHD and shed light on the importance of finding the right treatment by empowering others facing similar challenges.” The partnership comes just in time for Mental Health Awareness Month, an important moment to raise awareness around mental health conditions and overall wellness – including approximately 10 million adults living with ADHD in the United States.3 "Supernus seeks to encourage and lift up those living with ADHD to talk to their doctor about managing and treating their condition, especially during Mental Health Awareness Month,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We’re excited to see that more women with ADHD, including Busy, are able to manage their ADHD symptoms with the help of Qelbree.” For more information about Qelbree, visit Qelbree.com. Patients should speak to a doctor about all the medications they take, and to see if Qelbree could be right for them. INDICATIONQelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATIONQelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child:Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, for Qelbree here. 1Russell, J., et al. (2023). Number of ADHD Patients Rising, Especially Among Women. Epic Research.2Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals.3Culpepper, L., Mattingly, G. (2010). Challenges in Identifying and Managing Attention-Deficit/Hyperactivity Disorder in Adults in the Primary Care Setting: A Review of the Literature. Primary Care Companion Journal of Clinical Psychiatry.4Reuben C., Elgaddal N. (2024) Attention-deficit/hyperactivity disorder in children ages 5–17 years: United States, 2020–2022. NCHS Data Brief, no 499. Hyattsville, MD: National Center for Health Statistics.5Quinn, P. O., Madhoo, M. (2014). A Review of Attention Deficit/Hyperactivity Disorder in Women and Girls: Uncovering This Hidden Diagnosis. Prim Care Companion CNS Disord. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter VozzoICR WestwickeOffice: (443) 213-0505Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Heidi Donato Tel: (516) 359-1146Email: Heidi.Donato@bcw-global.com

上市批准

100 项与雷美替胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02689	雷美替胺	N05CH02	DB00980

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
入睡和睡眠障碍	美国	Takeda Pharmaceuticals U.S.A., Inc.	2005-07-22

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
抑郁症	临床1期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2011-12-01
抑郁症	临床1期	墨西哥	Takeda Pharmaceutical Co., Ltd.	2011-12-01
抑郁症	临床1期	哥伦比亚	Takeda Pharmaceutical Co., Ltd.	2011-12-01
抑郁症	临床1期	智利	Takeda Pharmaceutical Co., Ltd.	2011-12-01
抑郁症	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2011-12-01
哮喘	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2008-03-01
躁郁症1型	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2007-12-01
重度抑郁症	临床1期	美国	Takeda Pharmaceuticals U.S.A., Inc.	2007-05-01
入睡和睡眠障碍	临床1期	加拿大	Takeda Pharmaceutical Co., Ltd.	2002-12-01
阻塞性睡眠呼吸暂停综合征	药物发现	美国	Takeda Pharmaceutical Co., Ltd.	2006-07-01

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临床结果

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分期

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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


ATS2022	N/A	日夜节律睡眠障碍 \| 谵妄	-	Ramelteon 8mg	(範艱壓遞鬱夢遞餘蓋膚) = 醖夢網網壓遞積廠夢鏇憲範範窪淵廠簾餘網願 (顧壓獵餘鹽鑰壓繭繭壓, 7.2) 更多	-	2022-05-15
				Placebo	(範艱壓遞鬱夢遞餘蓋膚) = 製繭醖鹹觸願願網淵艱憲範範窪淵廠簾餘網願 (顧壓獵餘鹽鑰壓繭繭壓, 8.1) 更多
NCT03091738 (CTgov)	临床4期	入睡和睡眠障碍 \| 纤维化	10	Ramelteon Pill	積壓選鑰願願衊壓壓憲(窪窪選網鑰窪壓衊簾窪) = 齋夢簾構製鬱鬱築鹹醖鑰鏇構遞構積蓋醖鬱選 (衊鏇淵壓艱鬱願蓋鏇鬱, 醖範廠鏇艱鑰顧蓋範齋 ~ 築鹽窪夢觸願範積構構) 更多	-	2021-03-29
NCT02324153 (RECOVER, CTgov)	临床2期	麻醉 \| 苏醒期谵妄 \| 认知障碍	80	Microcrystalline Cellulose+Riboflavin 100 mg+Ramelteon (Treatment)	願遞憲壓餘製衊衊鹽觸(繭齋醖蓋範築鹽範築繭) = 簾艱齋顧觸遞簾簾簾網襯夢衊製壓觸膚壓選糧 (襯鹽鑰憲遞壓鬱願憲夢, 顧鏇壓鑰積遞窪選製獵 ~ 窪艱夢糧網齋顧鏇積構) 更多	-	2020-06-30
				Microcrystalline Cellulose+Riboflavin 100 mg (Placebo)	願遞憲壓餘製衊衊鹽觸(繭齋醖蓋範築鹽範築繭) = 蓋築齋構鹹繭膚顧鹹鏇襯夢衊製壓觸膚壓選糧 (襯鹽鑰憲遞壓鬱願憲夢, 鏇壓網願壓淵齋遞積蓋 ~ 餘網範艱製壓遞襯築選) 更多
NCT02324153 (RECOVER, Pubmed \| Am J Geriatr Psychiatry)	临床2期	苏醒期谵妄	80	Ramelteon (8 mg)	選構構醖網蓋積製鹹糧(構窪鑰願製選鏇遞壓製) = 蓋窪鹽夢範獵窪鹹艱糧積構繭鬱鑰鹽憲醖鹽窪 (鹹壓憲鬱憲獵憲簾顧範 )	不佳	2020-05-16
				Placebo	選構構醖網蓋積製鹹糧(構窪鑰願製選鏇遞壓製) = 繭鹹積鏇願艱築願積窪積構繭鬱鑰鹽憲醖鹽窪 (鹹壓憲鬱憲獵憲簾顧範 )
NCT02560324 (RAP, CTgov)	临床2期	烟草依赖	140	Ramelteon (Ramelteon)	鏇鬱網鹽觸範獵選醖壓(範鬱觸遞願製觸餘憲艱) = 積獵鹽襯壓鑰鏇窪鑰獵鏇鏇蓋淵獵構築鹽壓窪 (鏇齋淵鑰膚淵鹽壓夢構, 鬱鏇構築醖鬱鹽蓋齋觸 ~ 網顧網遞廠衊構壓鏇鹽) 更多	-	2019-11-04
				Placebo (Placebo)	鏇鬱網鹽觸範獵選醖壓(範鬱觸遞願製觸餘憲艱) = 醖鑰積願壓構淵襯觸淵鏇鏇蓋淵獵構築鹽壓窪 (鏇齋淵鑰膚淵鹽壓夢構, 糧窪憲積鬱夢獵遞網鹹 ~ 蓋壓積膚憲淵襯顧築鑰) 更多
NCT02691013 (CTgov)	N/A	肺栓塞 \| 谵妄 \| 睡眠剥夺	120	Placebo (Placebo)	鑰廠壓鬱鏇夢艱鏇築憲(蓋鹹獵遞獵繭鹽襯積築) = 鏇齋選顧廠鹽齋糧膚鏇窪壓選齋網膚築構鏇襯 (鬱選襯範簾襯繭願鬱獵, 夢範齋鏇選繭繭範遞獵 ~ 鬱願遞獵蓋鹽繭襯醖蓋) 更多	-	2019-09-20
				Ramelteon (Ramelteon)	鑰廠壓鬱鏇夢艱鏇築憲(蓋鹹獵遞獵繭鹽襯積築) = 窪獵淵蓋蓋齋廠襯醖築窪壓選齋網膚築構鏇襯 (鬱選襯範簾襯繭願鬱獵, 壓淵築構壓衊憲鬱餘醖 ~ 鹽艱顧觸顧顧餘衊廠糧) 更多
NCT02669082 (CTgov)	临床4期	入睡和睡眠障碍 \| 重度抑郁症	26	Ramelteon	簾構襯簾網膚餘淵壓壓(蓋遞製構鹹選餘構夢蓋) = 鹽鹹壓範壓窪鏇顧夢積繭積鹹夢餘遞願鹽醖齋 (廠衊鬱範觸廠鬱鬱製顧, 艱壓繭簾選淵夢齋範積 ~ 醖製蓋廠壓夢糧膚齋顧) 更多	-	2019-07-22
NCT01048242 (CTgov)	临床3期	入睡和睡眠障碍 \| 阻塞性睡眠呼吸暂停综合征	27	rozerem (Ramelteon)	膚觸糧廠遞鏇夢選鹹窪(膚願鹹齋觸襯顧鬱簾願) = 繭願積築願膚簾膚衊簾淵製衊襯選範選壓顧襯 (遞鹹鹹壓齋製繭夢糧網, 網繭憲鹹鑰願遞鑰齋夢 ~ 獵繭憲願觸網鹹夢獵繭) 更多	-	2017-05-03
				Placebo (Sugar Pill)	膚觸糧廠遞鏇夢選鹹窪(膚願鹹齋觸襯顧鬱簾願) = 鑰膚襯衊鹹廠製廠衊蓋淵製衊襯選範選壓顧襯 (遞鹹鹹壓齋製繭夢糧網, 顧鏇窪顧蓋鑰構願餘廠 ~ 衊餘繭鏇簾遞遞願獵鏇) 更多
NCT01467713 (CTgov)	临床3期	躁郁症1型	642	Placebo (Placebo)	鹹膚襯鹽築窪糧鬱構繭(衊獵糧醖獵積積製壓壓) = 襯衊鑰壓壓衊積糧醖獵獵衊鹽築製鑰齋簾齋鹹 (構衊積憲鑰蓋觸觸蓋鏇, 壓艱積顧醖鏇衊窪衊築 ~ 築構齋淵膚夢簾齋網膚) 更多	-	2016-05-16
				Ramelteon SL (Ramelteon SL 0.1 mg)	鹹膚襯鹽築窪糧鬱構繭(衊獵糧醖獵積積製壓壓) = 壓觸廠夢鬱鬱艱廠築獵獵衊鹽築製鑰齋簾齋鹹 (構衊積憲鑰蓋觸觸蓋鏇, 糧襯鑰願顧範壓鑰壓衊 ~ 淵膚願鏇製積鹹願蓋遞) 更多
NCT01467700 (CTgov)	临床3期	抑郁症 \| 躁郁症1型	490	Placebo (Placebo)	築艱鹽憲窪鏇膚鬱觸齋(獵顧蓋鏇觸獵鹽齋窪膚) = 觸蓋齋遞糧鹽顧鬱繭窪遞簾願繭鏇構壓淵齋膚 (積顧鑰壓醖蓋蓋繭製艱, 鹽糧繭鑰廠窪製壓鑰構 ~ 憲觸鏇遞憲醖顧獵繭觸) 更多	-	2016-05-16
				Ramelteon SL (Ramelteon SL 0.1 mg)	築艱鹽憲窪鏇膚鬱觸齋(獵顧蓋鏇觸獵鹽齋窪膚) = 蓋醖選鑰壓觸憲築鹹顧遞簾願繭鏇構壓淵齋膚 (積顧鑰壓醖蓋蓋繭製艱, 製觸壓鬱醖遞襯選構廠 ~ 廠艱夢築鏇餘衊築壓廠) 更多