A cross-sectional, national, multicenter, survey-based study to assess the effectiveness of Risk Minimization Measures related to Depakine® (sodium valproate) in Saudi Arabia. The study duration will be 7 months from 30 November 2024 to 30 May 2025. The end of study is defined as the end of the data collection period. No intervention will be administered, and no study related visits are required.

开始日期2025-05-30

申办/合作机构

Sanofi

CTR20250061

/ CompletedN/A

丙戊酸钠缓释片（Ⅰ）在健康受试者中单中心、随机、开放、两制剂、单次给药、四周期、完全重复交叉空腹/餐后生物等效性试验

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂丙戊酸钠缓释片（I）（规格：0.5g（以丙戊酸钠计），持证商：南京泽恒医药技术开发有限公司）与参比制剂丙戊酸钠缓释片（规格：500mg（以丙戊酸钠计），持证商：SANOFI- AVENTIS FRANCE，商品名：Depakine Chrono®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂丙戊酸钠缓释片（I）和参比制剂丙戊酸钠缓释片在健康受试者中的安全性。

开始日期2025-02-14

申办/合作机构

南京泽恒医药技术开发有限公司

CTR20244560

/ CompletedN/A

仁和堂药业有限公司研制的丙戊酸钠片（规格：0.2 g）与Kyowa Hakko Kirn Co., Ltd.持证的丙戊酸钠片（规格：0.2 g，Depakene®）在中国健康受试者中进行的单中心、随机、开放、单剂量、两序列、四周期、完全重复交叉设计空腹与餐后状态下的生物等效性研究

以仁和堂药业有限公司研制的丙戊酸钠片（规格：0.2 g）为受试制剂，Kyowa Hakko Kirn Co., Ltd.持证的丙戊酸钠片（规格：0.2 g，Depakene®）为参比制剂，考察两制剂在空腹与餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

开始日期2024-12-16

申办/合作机构

仁和堂药业有限公司

100 项与丙戊酸钠相关的临床结果

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100 项与丙戊酸钠相关的转化医学

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100 项与丙戊酸钠相关的专利（医药）

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6,197

项与丙戊酸钠相关的文献（医药）

2025-08-01·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Dual-sulfur-vacancy-enhanced interfacial electric field and photothermal effect for boosting selective photooxidation of 5-hydroxymethylfurfural

Article

作者: Cheng, Baochang ; Xiao, Xiao ; Wu, Yuhao ; Lei, Shuijin ; Xiao, Yanhe ; Xiong, Renzhi ; Liu, Fangde

While photocatalytic oxidation of 5-hydroxymethylfurfural (HMF) into valuable chemicals represents a crucial strategy for advancing carbon neutrality, low conversion rates and poor product selectivity hinder commercialization. In this study, a dual-sulfur-vacancy (S_v)-mediated Cu₂ZnSnS_4-_x/ZnIn₂S_4-_x all-multinary-sulfide p-n heterojunction was designed for high-efficiency photocatalysis. Specifically, S_v introduction significantly enhanced light absorption, photothermal properties, and interfacial electric fields (IEF). Consequently, the Cu₂ZnSnS_4-_x/ZnIn₂S_4-_x heterostructure achieved outstanding photothermal-assisted photocatalytic oxidation of HMF to 2,5-diformylfuran (DFF), with an oxidation rate of 94.1%, which was 9.1 and 4.0 times higher than that of Cu₂ZnSnS₄ and ZnIn₂S₄, respectively. The selectivity of DFF reached 92.8%. Additionally, mechanistic analysis identified primary active species and possible reaction pathways. This study provides a potential strategy for the design of photocatalytic systems for efficient HMF oxidation.

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Utilizing copper-doped graphene quantum dots as a fluorescent sensor for determination of carbamazepine in exhaled breath condensate

Article

作者: Jouyban-Gharamaleki, Vahid ; Rahimpour, Elaheh ; Khoubnasabjafari, Maryam ; Keyvani, Aylar ; Jouyban, Abolghasem ; Soleymani, Jafar

Carbamazepine is a versatile pharmaceutical used mainly for epilepsy and mood stabilization, but like all medications, it requires careful monitoring due to its potential side effects and interactions. In the current work, a fluorescent nanosensor was developed for the carbamazepine determination in the exhaled breath condensate (EBC). The nanosensor consists of graphene quantum dots doped with copper (Cu-doped GQDs). The presence of carbamazepine significantly decreased the fluorescence of Cu-doped GQDs, resulting in a quenching effect within a concentration range of 0.02-2.0 µg/mL, which occurs due to dynamic, rather than static, quenching according to Stern-Volmer plot. The relative standard deviations for intra-day and inter-day analysis of carbamazepine were 1.8 % and 4.8 %, respectively. The validated sensor was effectively employed for carbamazepine analysis in EBC of patients receiving the drug.

2025-06-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Elucidating the dual mechanistic action and synergism of platinum complexes bearing valproic acid as leaving ligand on NF-κB and inflammatory pathways in glioma

Article

作者: Wang, Liping ; Wang, Zerui ; Khan, Abdul Jamil ; Jia, Shuang ; Zhang, Yongmin ; Li, Xinyu ; Yan, Fufu ; Wang, Jie ; Rahman, Faiz-Ur ; Xia, Yan ; Huang, Jinxia ; Liu, Xing ; Li, Yimiao ; Man, Shad ; Li, Jiaqi

The valproic acid (VPA), an anti-epileptic drug, has demonstrated anticancer properties alone or in combination regimens in glioma. It has been shown synergistic activity with cisplatin in resistant cancer cells. In the current study, we synthesized Pt(II) complexes bearing VPA as ancillary/leaving ligand. All these complexes were obtained in good yields through simple reproducible synthetic procedures and characterized by multiple analytical techniques in both solution and solid state. In situ release of ancillary ligand (VPA) by these complexes was studied by ¹H NMR in solution state that was catalysed by water in time dependent manner. The tumor preferential selective VPA-Pt actively controlling NF-kB signaling, culminating in the attenuation of IL-6 expression and the concomitant activation of p53 and caspase-3 pathways in gliomas. VPA-Pt exhibits potent cytotoxicity in human and mice glioma cancer cell lines, inducing apoptosis as evidenced by inhibition of cell proliferation and migration, disruption of mitochondrial membrane potential, and suppression of colony formation. An inhibitory effect of VPA-Pt4 on glioma was clearly evidenced through in vivo live bioluminescence imaging, histopathological examination, immunofluorescence evaluation, and protein expression analysis demonstrated that VPA-Pt4 significantly triggered apoptosis, with elevated levels of P53, caspase-3, cleaved caspase-3, along with a reduction in IL-6. Our discovery reveals a novel and efficient approach to glioma therapy.

179

项与丙戊酸钠相关的新闻（医药）

2025-05-25

·梅斯医学

反复发呆、行为异常、记忆力减退……原来是大脑在攻击自己！

21岁的李婷，从小就被认为“性格古怪”。她安静寡言，偶尔发呆，时常说些让人听不懂的话。家人以为她只是内向，老师觉得她“情绪不稳定”，同学则悄悄疏远她。上了大学后，她变得越来越难以集中注意力，常常记不住刚听过的内容。有一天，舍友发现她独自在宿舍喃喃自语，面容呆滞，眼神游离，甚至突然抽搐倒地。她被紧急送往医院，医生初步判断为癫痫发作，但进一步的观察发现，她还出现了幻觉、行为异常和记忆力严重减退。脑电图显示颞叶区域有癫痫样放电，脑脊液检查提示轻度白细胞升高，MRI未见明显结构异常，但PET显示双侧边缘系统代谢异常。最关键的发现来自脑脊液的抗体检测：抗NMDAR抗体阳性，最终确诊为自身免疫性脑炎。“什么是自身免疫性脑炎自身免疫性脑炎属于自身免疫性疾病诱发的中枢神经系统炎性病变，该疾病患病率占脑炎所有类型的十分之一到十分之二。以抗N－甲基－D－门冬氨酸受体脑炎为最常见的类型，占自身免疫性脑炎的百分之八十。“临床表现自身免疫性脑炎（AIE）可发生于任何年龄，男女发病无明显差异。其起病方式多为急性或亚急性，部分患者病程中可出现复发。部分病例在发病前有前驱症状，例如抗NMDAR脑炎患者常在发病前出现发热、头痛等表现，或继发于单纯疱疹病毒性脑炎之后。临床表现复杂多样，最常见的是近事记忆力减退、精神行为异常、意识水平下降、癫痫发作及局灶性神经功能缺损。某些患者还可出现不自主运动，如舞蹈样动作或肌阵挛等。睡眠障碍也较常见，包括失眠、异常的睡眠行为和活动、睡眠呼吸暂停以及过度嗜睡等。自主神经功能紊乱常表现为血压波动、心动过速和呼吸功能障碍（如通气不足）。此外，一些患者还会出现胃肠道症状，如腹泻、胃轻瘫及便秘等。部分患者表现出周围神经兴奋性增高，如肌张力异常或感觉异常。“诊断根据《中国自身免疫性脑炎诊治专家共识》，自身免疫性脑炎的诊断需结合临床表现、辅助检查、抗体检测以及对其他病因的排除，诊断标准具体总结如下：自身免疫性脑炎的确诊需同时满足以下四项条件：一是临床表现方面，患者多呈急性或亚急性起病，需出现以下一种或多种神经精神症状或临床综合征，包括：边缘系统受累症状（如近事记忆减退、癫痫、精神行为异常）、脑炎综合征表现（弥漫性或多灶性脑损害）、基底核或间脑/下丘脑受累表现，或精神障碍且经精神专科评估排除非器质性疾病。二是辅助检查支持，至少需具备以下之一：脑脊液异常（如白细胞增多、淋巴细胞性炎症、寡克隆区带阳性）、神经影像学或电生理异常（如MRI边缘系统T2/FLAIR异常信号、PET代谢异常、脑电图癫痫样放电或慢波节律）或发现与自身免疫性脑炎相关的特定肿瘤（如抗NMDAR脑炎合并卵巢畸胎瘤、边缘性脑炎合并小细胞肺癌）。三是确诊实验方面，需检测到神经元表面抗原抗体阳性，其中抗NMDAR抗体以脑脊液检测阳性为主要依据。四是需合理排除其他病因，如感染、中毒、代谢性脑病、结构性病变等，排除其他可能导致类似症状的疾病。若仅满足第1、2和4条，则可诊断为可能的自身免疫性脑炎；若四条均满足，方可确诊为自身免疫性脑炎。该诊断标准强调综合评估临床症状、实验室与影像学依据，并重视排除其他病因的重要性，以提高诊断的准确性。“治疗对症治疗：癫痫发作可使用广谱抗癫痫药物，如苯二氮类、丙戊酸钠、拉莫三嗪、拉考沙胺和托吡酯，使用左乙拉西坦需警惕精神副作用。精神症状可用奥氮平、氯硝西泮、喹硫平等，注意意识和锥体外系影响。免疫治疗：应尽早启动免疫治疗。一线治疗包括糖皮质激素、静脉免疫球蛋白（IVIG）、血浆置换（PE）或免疫吸附。甲泼尼龙联合IVIG是常用方案。若10–14天后无效，可采用二线治疗，如利妥昔单抗或环磷酰胺，必要时使用托珠单抗。免疫吸附副作用小，较PE更安全。肿瘤治疗：合并肿瘤者应积极处理。抗NMDAR脑炎合并卵巢畸胎瘤者应尽早手术，恶性肿瘤需多学科治疗。预后：早期治疗、非肿瘤性AIE预后较好。部分患者需二线免疫治疗。抗NMDAR脑炎复发率约12%，抗LGI1和抗CASPR2脑炎复发率分别为31%和10%，部分患者可留有记忆障碍。参考资料：[1]中华医学会神经病学分会神经感染性疾病与脑脊液细胞学学组,王佳伟,关鸿志,赵钢.中国自身免疫性脑炎诊治专家共识(2022年版)[J].中华神经科杂志,2022,55(9):931-949[2]刘磊,谢竹霄,王佳伟.自身免疫性脑炎的分类及诊治[J].中国临床医生杂志,2021,49(6):634-639[3]黄宇.自身免疫性脑炎诊治进展[J].中文科技期刊数据库（引文版）医药卫生,2022(6):258-261来源 | 梅斯医学编辑 | wanny神经系统罕见病交流群↓点击下方“阅读原文”，下载梅斯医学APP吧！

2025-05-25

·信狐药迅

轩竹生物乳腺癌新药吡罗西尼、海思科镇痛药HSK21542和北海康成罕见病用药维拉苷酶β获批上市| 新获批(5.19-5.25）

每周药品注册获批数据，分门别类呈现，一目了然。(5.19-5.25）新药上市申请药品名称企业注册分类受理号HSK21542注射液辽宁海思科制药有限公司1CXHS2300094吡罗西尼片轩竹生物科技股份有限公司1CXHS2300093吡罗西尼片轩竹生物科技股份有限公司1CXHS2300075盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400069盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400068盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400067注射用维拉苷酶β北海康成(上海)生物科技有限公司1CXSS2400119贝莫苏拜单抗注射液正大天晴药业集团南京顺欣制药有限公司2.2CXSS2400082注射用卡瑞利珠单抗苏州盛迪亚生物医药有限公司2.2CXSS2300091新药临床申请药品名称企业注册分类受理号PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500257PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500256PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500255HS-10510片江苏豪森药业集团有限公司1CXHL2500244HS-10510片江苏豪森药业集团有限公司1CXHL2500243SGB-3383注射液苏州圣因生物医药有限公司1CXHL2500238KEM2418缓释直服颗粒深圳珐玛易药品科技有限公司2.2CXHL2500252利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500250利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500249利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500248利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500247利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500246TAP-1503 乳膏上海泽德曼医药科技有限公司2.4CXHL2500231BPR-102胶囊成都倍特益康恩生物医药科技有限公司1CXSL2500210BPR-102胶囊成都倍特益康恩生物医药科技有限公司1CXSL2500209FB1002重组人源化单克隆抗体注射液福贝生物医药科技(北京)有限公司1CXSL2500192皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500195皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500194皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500193仿制药申请药品名称企业注册分类受理号维生素B6注射液上海禾丰制药有限公司3CYHS2501112氨溴特罗口服溶液湖北欣泽霏药业有限公司3CYHS2400652硫酸镁注射液河北一品制药股份有限公司3CYHS2400554美索巴莫注射液广州合和医药有限公司3CYHS2400448氯化钾颗粒福州基石医药科技有限公司3CYHS2400193氯化钾颗粒福州基石医药科技有限公司3CYHS2400192二羟丙茶碱注射液湖南柏齐鹤药物研发有限公司3CYHS2400173美索巴莫注射液海南普利制药股份有限公司3CYHS2400129醋酸葡萄糖维持液山东科伦药业有限公司3CYHS2400053醋酸葡萄糖维持液山东科伦药业有限公司3CYHS2400054重酒石酸间羟胺注射液武汉久安药业有限公司3CYHS2303676美索巴莫注射液北京沃邦医药科技有限公司3CYHS2303661注射用甲磺酸加贝酯石家庄四药有限公司3CYHS2303631复方电解质醋酸钠注射液山东科伦药业有限公司3CYHS2303623注射用比阿培南/氯化钠注射液湖南科伦制药有限公司3CYHS2303536异烟肼注射液广州绿十字制药股份有限公司3CYHS2303510二羟丙茶碱注射液华夏生生药业(北京)有限公司3CYHS2303378硫酸沙丁胺醇注射液山东华鲁制药有限公司3CYHS2303298二羟丙茶碱注射液武汉华尔生物科技有限公司3CYHS2303282硫酸镁注射液江西博泰药业有限公司3CYHS2303278氟马西尼注射液上海旭东海普药业有限公司3CYHS2303241氟马西尼注射液上海旭东海普药业有限公司3CYHS2303240注射用尼可地尔成都地奥九泓制药厂3CYHS2303209硫酸镁注射液焦作市民康药业有限公司3CYHS2303181甲硫酸新斯的明注射液云南先施药业有限公司3CYHS2303137甲硫酸新斯的明注射液云南先施药业有限公司3CYHS2303136生理氯化钠溶液华夏生生药业(北京)有限公司3CYHS2303121甲硫酸新斯的明注射液杭州民生药业股份有限公司3CYHS2303109甲硫酸新斯的明注射液杭州民生药业股份有限公司3CYHS2303108甲硫酸新斯的明注射液杭州民生药业股份有限公司3CYHS2303107重酒石酸去甲肾上腺素注射液中润药业有限公司3CYHS2303046重酒石酸去甲肾上腺素注射液中润药业有限公司3CYHS2303045地奈德软膏杭州领业医药科技有限公司3CYHS2303027复合磷酸氢钾注射液成都米子生物医药科技有限公司3CYHS2303010复合磷酸氢钾注射液成都欣捷高新技术开发股份有限公司3CYHS2303008酮咯酸氨丁三醇注射液广州一品红制药有限公司3CYHS2303001盐酸丙卡特罗颗粒江苏正大清江制药有限公司3CYHS2302905醋酸钠林格葡萄糖注射液成都赛诺联创生物科技有限公司3CYHS2302812复方电解质醋酸钠葡萄糖注射液仁合益康集团有限公司3CYHS2302807复方电解质醋酸钠葡萄糖注射液仁合益康集团有限公司3CYHS2302806醋酸钙口服溶液河北华晨药业集团有限公司3CYHS2302797盐酸去氧肾上腺素注射液安徽长江药业有限公司3CYHS2302659水合氯醛灌肠剂成都硕德药业有限公司3CYHS2302523利伐沙班颗粒南京海纳制药有限公司3CYHS2302484氯化钙注射液广州合和医药有限公司3CYHS2302480钠钾镁钙注射用浓溶液山东豪瑞恩制药有限公司3CYHS2302447盐酸利多卡因注射液云南药科院生物医药股份有限公司3CYHS2302400注射用阿莫西林钠广州艾奇西新药研究有限公司3CYHS2302386注射用阿莫西林钠广州艾奇西新药研究有限公司3CYHS2302385硫代硫酸钠注射液成都倍特药业股份有限公司3CYHS2302223富马酸酮替芬口服溶液海口天行健药物研究有限公司3CYHS2302211甲硫酸新斯的明注射液宝利化(南京)制药有限公司3CYHS2301868米诺地尔外用溶液浙江高跖医药科技股份有限公司3CYHS2301380卡络磺钠注射液海口天行健药物研究有限公司3CYHS2301262卡络磺钠注射液海口天行健药物研究有限公司3CYHS2301261米诺膦酸片安徽博诺美科生物医药有限公司3CYHS2301180利多卡因凝胶贴膏湖南九典制药股份有限公司3CYHS2300719卡络磺钠注射液四川汇宇海玥医药科技有限公司3CYHS2300666卡络磺钠注射液四川汇宇海玥医药科技有限公司3CYHS2300665依巴斯汀口服溶液南京海纳医药科技股份有限公司3CYHS2300635布洛氢可酮片宜昌人福药业有限责任公司3CYHS2201954国;CYHS2201954布洛氢可酮片宜昌人福药业有限责任公司3CYHS2201953国;CYHS2201953多潘立酮片温州海鹤药业有限公司4CYHS2402862甲泼尼龙片武汉九珑人福药业有限责任公司4CYHS2402356氧(液态)侨源气体(眉山)有限公司4CYHS2402288普拉洛芬滴眼液山东辰欣佛都药业股份有限公司4CYHS2401017沙格列汀二甲双胍缓释片江苏万高药业股份有限公司4CYHS2400993沙格列汀二甲双胍缓释片江苏万高药业股份有限公司4CYHS2400992盐酸伐地那非片江苏万高药业股份有限公司4CYHS2400984盐酸伐地那非片江苏万高药业股份有限公司4CYHS2400982吸入用乙酰半胱氨酸溶液海南皇隆制药股份有限公司4CYHS2400970孟鲁司特钠咀嚼片牡丹江恒远药业股份有限公司4CYHS2400855孟鲁司特钠咀嚼片牡丹江恒远药业股份有限公司4CYHS2400854妥布霉素滴眼液浙江赛默制药有限公司4CYHS2400761马来酸氟伏沙明片合肥英太制药有限公司4CYHS2400736马来酸氟伏沙明片合肥英太制药有限公司4CYHS2400735马来酸氟伏沙明片苏州第三制药厂有限责任公司4CYHS2400617马来酸氟伏沙明片苏州第三制药厂有限责任公司4CYHS2400616硫酸氨基葡萄糖胶囊江苏润邦药业有限公司4CYHS2400579马来酸氟伏沙明片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2400595乙酰半胱氨酸泡腾片浙江赛默制药有限公司4CYHS2400520双氯芬酸钠缓释片锦州奥鸿药业有限责任公司4CYHS2400513双氯芬酸钠缓释片锦州奥鸿药业有限责任公司4CYHS2400512丙戊酸钠口服溶液山东达因海洋生物制药股份有限公司4CYHS2400465盐酸决奈达隆片石家庄四药有限公司4CYHS2400464盐酸奥洛他定滴眼液石家庄格瑞药业有限公司4CYHS2400399溴莫尼定噻吗洛尔滴眼液石家庄格瑞药业有限公司4CYHS2400335盐酸伐地那非片广州绿十字制药股份有限公司4CYHS2400334地夸磷索钠滴眼液深圳市华生元基因工程发展有限公司4CYHS2400318间苯三酚注射液常州四药制药有限公司4CYHS2400234吸入用丙酸倍氯米松混悬液河北创健药业有限公司4CYHS2400231盐酸伊立替康脂质体注射液无锡济煜山禾药业股份有限公司4CYHS2400207盐酸奥洛他定滴眼液乐信乐美(海南)生物科技有限公司4CYHS2400163硫酸氨基葡萄糖胶囊武汉维奥制药有限公司4CYHS2400157地夸磷索钠滴眼液郑州卓峰制药有限公司4CYHS2400151奥美沙坦酯氨氯地平片珠海润都制药股份有限公司4CYHS2400029曲伏噻吗滴眼液山东辰欣佛都药业股份有限公司4CYHS2400034注射用头孢唑肟钠安徽省先锋制药有限公司4CYHS2303664注射用头孢唑肟钠安徽省先锋制药有限公司4CYHS2303663利托那韦片福建广生中霖生物科技有限公司4CYHS2303569左氧氟沙星滴眼液山东辰欣佛都药业股份有限公司4CYHS2303542奥美沙坦酯氨氯地平片宁波大红鹰药业股份有限公司4CYHS2303522注射用盐酸美法仑凯信远达医药(无锡)有限公司4CYHS2303513注射用头孢他啶/氯化钠注射液湖南科伦制药有限公司4CYHS2303472注射用氯诺昔康天津梅花生物医药科技有限公司4CYHS2303416布洛芬混悬滴剂山东新华制药股份有限公司4CYHS2303315布洛芬混悬滴剂山东新华制药股份有限公司4CYHS2303314二甲双胍恩格列净片(I)浙江易泽达医药科技有限公司4CYHS2303310罗沙司他胶囊重庆圣华曦药业股份有限公司4CYHS2303284罗沙司他胶囊重庆圣华曦药业股份有限公司4CYHS2303283苯磺酸左氨氯地平片山东鲁抗医药股份有限公司4CYHS2303187苯磺酸左氨氯地平片山东鲁抗医药股份有限公司4CYHS2303186盐酸贝尼地平片上海安必生制药技术有限公司4CYHS2303185利奈唑胺葡萄糖注射液北京吉洛华制药有限公司4CYHS2303183枸橼酸托法替布片国药集团容生制药有限公司4CYHS2303134盐酸乌拉地尔注射液江苏迪赛诺制药有限公司4CYHS2303114达格列净二甲双胍缓释片(IV)浙江华海药业股份有限公司4CYHS2303039达格列净二甲双胍缓释片(III)浙江华海药业股份有限公司4CYHS2303038达格列净二甲双胍缓释片(I)浙江华海药业股份有限公司4CYHS2303037达格列净二甲双胍缓释片(I)浙江华海药业股份有限公司4CYHS2303036黄体酮软胶囊浙江仙琚制药股份有限公司4CYHS2302889黄体酮软胶囊浙江仙琚制药股份有限公司4CYHS2302888碘普罗胺注射液博瑞制药(苏州)有限公司4CYHS2302630碘普罗胺注射液博瑞制药(苏州)有限公司4CYHS2302629注射用硼替佐米瑞阳制药股份有限公司4CYHS2302231莫匹罗星软膏海南紫程众投生物科技有限公司4CYHS2302106注射用头孢哌酮钠舒巴坦钠浙江惠迪森药业有限公司4CYHS2302052盐酸度洛西汀肠溶胶囊北京四环制药有限公司4CYHS2300590盐酸度洛西汀肠溶胶囊北京四环制药有限公司4CYHS2300589盐酸度洛西汀肠溶胶囊北京四环制药有限公司4CYHS2300588多种油脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHL2500048多种油脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHL2500047进口申请药品名称企业注册分类受理号盐酸阿思尼布片Novartis Pharma Schweiz AG2.4JXHS2400043琥珀酸瑞波西利片Novartis Pharma Schweiz AG2.4JXHS2300126乙酰半胱氨酸注射液Zambon Switzerland Ltd.5.1JXHS2200025国;JXHS2200025注射用替奈普酶Boehringer Ingelheim International GmbH2.2JXSS2400001注射用坦昔妥单抗Incyte Biosciences Distribution B.V.3.1JXSS2400050MK-7240注射液Merck Sharp & Dohme LLC1JXSL2500037中药相关申请药品名称企业注册分类受理号开心散上海和黄药业有限公司3.1CXZS2400024注：橙色字体部分结论为不批准或收到通知件；

上市批准申请上市

2025-05-23

·cerenoscientific.com

Cereno Scientific receives endorsement from FDA on plans for Phase IIb trial of CS1 in rare disease pulmonary arterial hypertension (PAH)

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the US Food & Drug Administration (FDA) provided endorsement of the plans for the Phase IIb trial of CS1 as noted by the official meeting minutes from the Type C-meeting held on April 21. The next clinical development step of CS1 is a larger, placebo-controlled Phase IIb trial aiming to further evaluate the encouraging efficacy signs including reverse vascular remodeling and improvement of right heart function as observed in the Phase IIa trial. “This is a very exciting milestone for our pipeline. Receiving an FDA endorsement for the CS1 program in PAH at this stage in development is paving the way for further interactions regarding upcoming Phase IIb and pivotal Phase III trials. The plans for the Phase IIb trial are in alignment with the expectations of the FDA, meaning that we have high confidence that the Phase IIb trial design will include the relevant criteria contributing to the development program’s marketing approval process. We are now continuing steps for preparations ahead of the Phase IIb trial in PAH, with a target of initiating the trial in H1 2026,” said Rahul Agrawal, Chief Medical Officer (CMO) and Head of R&D at Cereno Scientific. “The endorsement from the FDA for CS1 validates that the development plans have sound rationale to be able to support documentation for future marketing approval and adds credibility to our scientific and clinical capabilities. These are important factors in the dialogues we have with potential partners, but also other stakeholders we interact with such as collaborators, investors and the scientific community. We are keen to progress towards the initiation of the Phase IIb trial to further evaluate CS1 as a PAH treatment with favorable safety and tolerability and disease-modifying capacity. Our ultimate ambition is to be able to develop a treatment that could enhance and extend life of patients suffering from this devastating and fatal disease,” said Sörensen, CEO at Cereno Scientific. Drug candidate CS1 is a well-tolerated oral therapy with a favorable safety profile and showed signals of disease-modifying effects as observed in a Phase IIa trial in patients with the rare disease pulmonary arterial hypertension (PAH). The aim for CS1 is to offer an effective disease-modifying treatment with the ability to enhance quality of life and extend life for PAH patients. Unlike standard therapy that focus on managing symptoms, CS1 represents a novel therapeutic approach by targeting the root mechanisms of PAH. Specifically, CS1 aims to reverse the pathological vascular remodeling of the small pulmonary arteries. A successful Phase IIa trial was concluded in 2024. Insights into the long-term use of CS1 are being gathered in an expanded access program with 10 patients from the Phase IIa trial. Preparations are currently underway for a larger placebo-controlled Phase IIb trial to continue advancing CS1 toward regulatory approval and wider patient access. The Phase IIb trial is planned to be initiated in H1 2026. For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as an effective and disease modifying treatment with a favorable safety and tolerability profile for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 has a favorable safety profile, is well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

临床2期临床1期

100 项与丙戊酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	丙戊酸钠	N03AG01	DBSALT001257

研发状态

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适应症	国家/地区	公司	日期
癫痫部分性发作	美国	AbbVie, Inc.	1996-12-30
失神发作	美国	AbbVie, Inc.	1996-12-30
神经系统疾病	中国	江苏恒瑞医药股份有限公司	1982-01-01
躁郁症	日本	Sumitomo Pharma Co., Ltd.	1981-09-01
偏头痛	日本	Sumitomo Pharma Co., Ltd.	1981-09-01
癫痫	日本	Kyowa Kirin Co., Ltd.	1974-05-24

未上市

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适应症	最高研发状态	国家/地区	公司	日期
家族性肺动脉高压	临床2期	瑞典	Cereno Scientific AB	2022-05-05

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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


NCT05224531 (Company_Website) 人工标引	临床2期	肺性高血压	-	CS1	繭觸簾襯範壓憲構鹽鬱(鑰鏇鬱夢願繭製齋觸衊) = 糧襯糧廠醖簾選範鑰糧製範醖醖憲鑰製築窪蓋 (艱鑰襯鏇簾鏇衊獵衊壓 ) 更多	积极	2025-05-13
NCT05224531 (CS1-003, PipelineReview) 人工标引	临床2期	肺动脉高压	21	CS1	簾膚餘鹹遞製壓醖廠齋(膚鹹餘製獵繭膚觸餘醖) = 積餘膚範窪簾範顧製糧遞範蓋醖鏇襯獵糧窪簾 (艱淵繭鬱壓窪齋鑰選構 ) 更多	积极	2024-09-29
EADV2023	N/A	斑秃 beta catenin	66	Topical Sodium Valproate (SV) -loaded nanospanlastics	憲醖鹽選製齋獵憲壓鑰(糧糧鏇構構襯範遞遞網) = Baseline beta catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml 網齋淵鹽鹽繭鏇顧鬱艱 (構壓蓋糧夢鏇鑰淵選鏇 ) 更多	-	2023-10-11
				Topical Mometasone Furoate Lotion
IEC2023	N/A	全身性癫痫	225	Sodium valproate (VPA) up to 700 mg	願範夢鑰範衊積蓋齋膚(鑰簾憲鬱簾壓糧築糧壓) = 遞積築願蓋鹽醖淵鬱鹽顧糧壓餘繭積糧鏇衊鑰 (壓糧範積艱構願簾襯艱 )	积极	2023-09-04
NCT04698525 (CTgov)	临床3期	偏头痛	33	Valproate Sodium (Valproate Group)	壓鬱鹽鏇憲齋膚積壓選(廠簾遞鬱糧願鬱積遞鑰) = 範糧構網積鑰鑰構遞鏇繭鏇簾餘憲繭獵觸醖憲 (簾鬱壓簾壓壓遞願範鬱, 1.11) 更多	-	2023-05-17
				memantine (Memantine)	壓鬱鹽鏇憲齋膚積壓選(廠簾遞鬱糧願鬱積遞鑰) = 鹹蓋繭製廠選觸齋簾觸繭鏇簾餘憲繭獵觸醖憲 (簾鬱壓簾壓壓遞願範鬱, 1.5) 更多
CTRI/2020/01/022781 (ESMO_ASIA2022)	临床2期	铂耐药性卵巢癌	27	Oral etoposide + Sodium valproic acid (VPA)	蓋顧齋廠糧鑰鑰鏇膚壓(顧鹹築鹹積網鏇構範獵) = 襯願繭鏇網蓋範壓積鏇願鬱襯願選醖簾簾觸鏇 (構範憲壓鑰蓋壓選蓋窪 ) 更多	-	2022-12-03
IEC2017	N/A	癫痫持续状态	100	Sodium Valproate	壓願鹽積艱壓蓋鬱鑰繭(遞觸繭簾鬱願構積鹹簾) = 憲網艱顧廠淵鬱範顧糧襯構憲夢築遞蓋獵觸淵 (蓋淵簾蓋願糧積願衊製 ) 更多	积极	2017-09-03
				Levetiracetam	鹹艱鬱鏇鏇範糧淵觸糧(顧願觸簾蓋壓廠築襯壓) = 鏇構夢壓蓋衊艱蓋壓衊壓遞夢網繭範範憲觸襯 (憲構壓遞淵築範簾壓餘 )
EAN2016	N/A	-	-	Valproic acid (VPA)	艱築齋鬱鹽壓廠製獵鬱(夢齋淵鹽醖鏇鑰膚鑰網) = 壓夢醖選衊糧選衊鑰糧蓋積積構鏇願醖鏇鏇範 (憲餘鹽願網顧壓築憲構, 19 ~ 82)	-	2016-06-23
IEC2015	N/A	癫痫 antioxidant parameters	66	Vitamin E	簾齋壓範淵淵遞憲選選(構衊鬱構襯獵觸糧憲獵) = malondialdehyde decreased but was not statistically significant in case (p = 0.1),but in control don ’ t decreased(p = 0.53) 網壓襯夢鹹構餘糧壓鑰 (遞醖憲範願顧製製範範 )	积极	2015-09-08
				Sodium valproate (Placebo)
IRCT201202199014N1 (Pubmed \| PLoS One)	临床3期	偏头痛	104	Intravenous sodium valproate	範鏇選構鑰構範糧膚鑰(鑰鬱網糧壓獵築鹹齋膚) = 繭積遞艱壓鏇糧夢願積窪願築廠壓鏇淵窪夢選 (淵糧鹽襯襯襯積願醖鹽 )	-	2015-01-01
				Intravenous dexamethasone	範鏇選構鑰構範糧膚鑰(鑰鬱網糧壓獵築鹹齋膚) = 鏇鬱齋積選夢艱夢窪鬱窪願築廠壓鏇淵窪夢選 (淵糧鹽襯襯襯積願醖鹽 )