A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

开始日期2025-04-27

申办/合作机构

Universität Leipzig

NCT06714357

/ Not yet recruiting临床2期IIT

Randomized Phase 2 Study of Valproic Acid Combined With Rechallenge Anti-EGFR Based Regimen Regimens in Pretreated Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer - VICTORIA Trial

The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting.
Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti- EGFR treatment strategy.

开始日期2025-03-01

申办/合作机构

National Cancer Institute

NCT05973786

/ Recruiting临床3期IIT

A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

开始日期2025-02-11

申办/合作机构

Universität Leipzig

100 项与丙戊酸相关的临床结果

登录后查看更多信息

100 项与丙戊酸相关的转化医学

登录后查看更多信息

100 项与丙戊酸相关的专利（医药）

登录后查看更多信息

26,878

项与丙戊酸相关的文献（医药）

2025-12-01·FUNCTIONAL & INTEGRATIVE GENOMICS

Combined transcriptomic and proteomic analyses reveal relevant myelin features in mice with ischemic stroke

Article

作者: He, Yi ; Liu, Xiaojia ; Wang, Qiwen ; Shen, Mei ; Wang, Wei ; Lyu, Hao ; Qian, Qiuyang ; Li, Desheng

Ischemic stroke (IS), a leading cause of global disability and mortality, is characterized by white matter damage and demyelination. Despite advances, the molecular mechanisms driving post-IS myelin pathology remain poorly understood, limiting therapeutic development. This study investigates key myelin-related genes (MRGs) and their regulatory networks to identify novel therapeutic targets. A transient middle cerebral artery occlusion (MCAO) model was established in C57BL/6 mice, with brain tissues collected at four timepoints (Sham0D, MCAO0D, MCAO7D, MCAO14D). Transcriptomic and proteomic sequencing were performed, followed by soft clustering (Mfuzz), functional enrichment (GO/KEGG), and ROC analysis to identify key MRGs. Competing endogenous RNA (ceRNA) networks were constructed, and drug prediction was conducted using the Comparative Toxicogenomics Database (CTD) and molecular docking. Expression validation was performed via qRT-PCR and Western blot. Integrated multi-omics analysis identified Wasf3 and Slc25a5 as key MRGs, enriched in mitochondrial respiration, calcium metabolism, and cytoskeletal regulation. The AUC values of the one-to-one model scores were all greater than 0.7, suggesting that Wasf3 and Slc25a5 were able to effectively discriminate between samples from different time points. A ceRNA network revealed critical interactions, including the Wasf3-mmu-miR-423-5p-H19 axis, linking apoptosis and myelin dysfunction. Drug prediction highlighted valproic acid (VPA) as a high-affinity binder for both genes (binding energies: - 4.2 and - 4.7 kcal/mol), suggesting its potential as a therapeutic candidate for IS. Experimental validation confirmed significant downregulation of Wasf3 mRNA (p < 0.01) and protein (p = 0.069) post-IS, while Slc25a5 showed no significant changes, potentially due to sample size limitations. This study establishes Wasf3 and Slc25a5 as pivotal regulators of post-IS myelin pathology and proposes VPA as a promising therapeutic candidate to enhance remyelination. The findings underscore the utility of multi-omics approaches in bridging molecular mechanisms to clinical translation, offering new strategies for IS diagnosis and treatment.

2025-12-01·Acta Epileptologica

Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database

Article

作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan

Abstract:

Background:

Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods:

This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results:

A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.

Conclusions:

This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.

2025-12-01·Acta Epileptologica

Case report: late adverse reactions in an epilepsy patient on combination therapy with valproate and lamotrigine

Article

作者: Zhang, Xiaodong ; Zhang, Yanhua ; Wang, Xiaolong ; Sang, Hui ; Zhao, Liqiao

Abstract:

Background:

Late adverse reactions associated with the combined therapy of valproate and lamotrigine are infrequently documented within the Chinese population.

Case presentation:

This case report describes a 54-year-old female patient who developed adverse reactions following long-term therapy with valproate and lamotrigine, with symptoms emerging five months after the final adjustment of her antiseizure regimen. The patient presented with symptoms of dizziness, ataxia, nystagmus, and postural tremors. Following blood drug concentration monitoring and subsequent minor dosage adjustments to the antiseizure regimen without medication withdrawal, the patient's symptoms were successfully resolved.

Conclusions:

This article underscores the importance of vigilance among clinicians regarding the potential for late adverse reactions and advocates for the proactive monitoring of blood drug concentrations.

194

项与丙戊酸相关的新闻（医药）

2025-04-08

·米内网

【重磅】北京药企首个1类新药来袭！剑指1200亿市场

精彩内容近日，CDE官网显示，北京福元医药申报的1类新药FY101注射液获得临床试验默示许可，用于高脂血症的治疗。米内网数据显示，近年来中国三大终端六大市场（统计范围详见本文末）心脑血管系统化药销售额均超过1200亿元。FY101注射液是一款化药1类新药，其临床申请于2025年1月获得CDE承办受理，并于近日顺利获批临床，用于高脂血症的治疗，为北京福元医药首款获批临床的1类新药。米内网数据显示，受集采影响，近年来中国三大终端六大市场心脑血管系统化药市场承压，但仍维持在1200亿元以上。从治疗亚类看，高血压用药占据“半壁江山”，心脏病治疗用药、血脂调节剂占比均超过17%。近年来中国三大终端六大市场心脑血管系统化药销售情况（单位：万元）来源：米内网格局数据库2024上半年心脑血管系统化药TOP5品牌均为外资品牌，晖致的阿托伐他汀钙片以约5%的市场份额排在首位，诺华的沙库巴曲缬沙坦钠片以约4%的市场份额排位第二，阿斯利康的瑞舒伐他汀钙片以约3%的市场份额排位第三。从销售额增速看，诺华的沙库巴曲缬沙坦钠片同比大涨37.56%。2024H1中国三大终端六大市场心脑血管系统化药TOP5品牌来源：米内网格局数据库在心脑血管系统领域，北京福元医药已拥有20余个产品的生产批文，包括奥美沙坦酯片、替米沙坦片、氯沙坦钾氢氯噻嗪片、依折麦布片、阿托伐他汀钙片、苯磺酸氯地平片等畅销品种。4月1日，福元医药发布2024年业绩报告，报告期内实现营业收入34.46亿元，归母净利润4.89亿元。公司持续加码创新研发，2024年研发费用4.17亿元，同比增加18.13%，占营收比重约12%。2024年，福元医药产品研发成果丰硕，获批19个制剂品种（14个口服+5个外用）和5个原料药品种。19个制剂品种中，依折麦布辛伐他汀片、美阿沙坦钾片、丙戊酸钠缓释片（I）、美沙拉秦肠溶片、夫西地酸乳膏、卡泊三醇软膏、丙酸氟替卡松乳膏和糠酸莫米松乳膏8个品种为国内首家（视同）过评；5个原料药分别为丙戊酸、丙戊酸钠、罗替高汀、达格列净和葡甲胺。资料来源：米内网数据库、CDE官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月8日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

财报申请上市

2025-04-06

·梅斯医学

婴儿反复抽搐、皮肤白斑，6月龄宝宝竟因基因突变引发全身良性肿瘤！

6个月大的乐乐（化名）从出生起就与众不同。别的宝宝酣睡时，他却会突然全身绷直、四肢抽搐，像被"电击"般惊跳起来。起初父母以为只是婴儿正常的惊跳反射，直到乐乐脸上出现几片树叶状的白色斑块，CT检查结果让所有人震惊——这个小小身躯里，大脑、心脏、肾脏竟然都长满了肿瘤！"就像身体里埋了无数个小炸弹。"乐乐的妈妈颤抖着描述。最可怕的是脑部检查发现的"烛泪征"——CT上那些如同融化蜡油般从脑室壁滴落的钙化结节。神经科医生立即安排了基因检测，结果显示TSC1基因存在致病突变，最终确诊为结节性硬化症（TSC）什么是结节性硬化结节性硬化(tuberous sclerosis complex，TSC)是一种常染色显性遗传皮肤神经综合征，最初由Recklinghausen于1862年首次描述，该病临床表现复杂多样，多以皮损、脑内结节、心脏横纹肌瘤、肺血管淋巴瘤、肾血管平滑肌瘤等全身多个器官出现错构瘤病变及神经精神症状为主。临床表现结节性硬化症（TSC）为多系统受累的遗传病，最常见表现为癫痫和面部血管纤维瘤。约80%～90%患儿有癫痫，TSC1突变起病早、多痉挛，TSC2突变起病晚、以局灶发作为主。部分患儿有智力减退、行为异常，MRI/CT可见皮质结节、室管膜下结节或巨细胞星形细胞瘤。皮肤表现见于90%以上患儿，包括面部血管纤维瘤、色素脱失斑、鲨革样斑和甲周纤维瘤，多于婴幼儿期出现，为重要诊断依据。心脏横纹肌瘤见于近半数患者，多在胎儿或出生早期发现，常随年龄缩小或消退。肾脏病变常见，主要为血管平滑肌脂肪瘤和肾囊肿，部分可致大出血和肾功能衰竭，是TSC死亡的重要原因。肺部受累多见于成年女性，表现为肺淋巴管平滑肌瘤病，偶见气胸、乳糜胸。眼部和骨骼亦可见错构瘤。诊断结节性硬化症（TSC）的诊断标准由国际结节性硬化症联盟于1992年制定，1998年和2012年两次修订，2012年版本首次将基因检测纳入标准。TSC可依临床表现或基因检测确诊。基因诊断标准为发现TSC1或TSC2基因突变即可确诊。临床诊断包括11项主要特征（如面部血管纤维瘤、甲周纤维瘤、色素脱失斑、脑皮质结构异常、心脏横纹肌瘤、肾血管平滑肌脂肪瘤等）及6项次要特征（如牙釉质小凹、口腔纤维瘤、斑驳皮肤等）。确诊标准：具TSC基因突变，或满足2项主要特征，或≥1项主要+≥2项次要特征。可能诊断：1项主要或≥2项次要特征。治疗结节性硬化症（TSC）目前尚无根治方法，治疗以控制症状为主。癫痫为常见症状，发作频率与智力倒退密切相关，早期控制癫痫尤为关键。常用抗癫痫药物包括丙戊酸、托吡酯、拉莫三嗪、左乙拉西坦等。若多药联合治疗无效，可加用mTOR抑制剂西罗莫司，已证实对TSC合并癫痫有效。如合并室管膜下巨细胞星形细胞瘤（SEGA）并引起脑积水等情况，应考虑手术治疗，但术后复发率和后遗症发生率较高。不适合手术者可用西罗莫司控制肿瘤生长。西罗莫司及其衍生物对SEGA、肾血管平滑肌脂肪瘤（AML）及肺淋巴管平滑肌瘤病（LAM）均有效。面部血管纤维瘤可行激光治疗，亦可尝试口服西罗莫司改善外观。新型mTOR ATP竞争性抑制剂已研发，抑制作用更强，但尚未进入临床应用。参考资料：1. 蔡燚，李汉忠，张玉石．结节性硬化症相关肾脏血管平滑肌脂肪瘤患者临床表型与基因型的关系[J]．中华泌尿外科杂志， 2016，37(12):912-915. DOI： 10.3760/cma.j.issn.1000-6702.2016.12.009 .2.孙丹，刘智胜，胡家胜，等．结节性硬化症患儿TSC1/TSC2突变基因型与表型的相关性分析[J]．中华实用儿科临床杂志， 2015，30(6):461-466. DOI： 10.3760/cma.j.issn.2095-428X.2015.06.016 .3.Kothare SV , Singh K , Chalifoux JR ，et al. Severity of manifestations in tuberous sclerosis complex in relation to genotype[J]．Epilepsia， 2014，55(7):1025-1029. DOI： 10.1111/epi.12680 .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！

临床研究诊断试剂

2025-04-02

·Business Wire

Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced it has completed its acquisition of Intra-Cellular Therapies, Inc. Intra-Cellular Therapies is now part of Johnson & Johnson and will operate as a business unit within Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, we are committed to transforming care for the millions of people worldwide living with neuropsychiatric and neurodegenerative disorders,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “We are excited to officially welcome the talented Intra-Cellular Therapies team to the Company, and we look forward to working together as we realize our ambition of becoming the number one neuroscience company worldwide.” With this acquisition, Johnson & Johnson adds CAPLYTA® (lumateperone) to its robust portfolio of differentiated medicines. CAPLYTA® is a once-daily oral therapy approved to treat adults with schizophrenia, as well as the first and only U.S. Food and Drug Administration (FDA)-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate. In February 2025, Intra-Cellular Therapies announced that the U.S. FDA accepted its supplemental new drug application for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD). The acquisition also includes ITI-1284, a promising Phase 2 compound being studied in generalized anxiety disorder (GAD) and Alzheimer’s disease-related psychosis and agitation, as well as a clinical-stage pipeline that further complements Johnson & Johnson’s current areas of focus. “We are focused on investing in what we believe is the future of innovation across our targeted therapeutic areas, including neuroscience,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. “We are pleased to finalize this acquisition, which serves as a strategic near- and long-term growth catalyst for Johnson & Johnson, and we look forward to working together to continue transforming treatment and patient care for some of today’s most debilitating neuropsychiatric and neurodegenerative disorders.” The transaction is expected to accelerate 2025 sales growth for Johnson & Johnson by approximately 0.8% with approximately $0.7 billion in incremental sales. Inclusive of the impact of financing costs, Johnson & Johnson expects the transaction to dilute adjusted earnings per share (EPS) by approximately $0.25 in 2025, an improvement from the $0.30 – $0.35 originally estimated on the Company’s Q4 2024 earnings call. In 2026, Johnson & Johnson expects the earnings dilution to be reduced to approximately $0.21 per share as annualized financing costs are partially offset by operational accretion. Johnson & Johnson will include these estimates in its full-year 2025 financial outlook when it reports first quarter results on April 15, 2025. In connection with the completion of the transaction, Intra-Cellular Therapies’ common stock ceased trading on the NASDAQ Global Select Market. Indication CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Contraindications: CAPLYTA® is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA®. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis , including stroke and transient ischemic attack. See Boxed Warning above. Neuroleptic Malignant Syndrome (NMS) , which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. Tardive Dyskinesia (TD) , a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA ® is discontinued. It can also occur after CAPLYTA ® is discontinued. Metabolic Changes , including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA ® and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases) . Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA ® should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors. Decreased Blood Pressure & Dizziness . Patients may feel lightheaded, dizzy, or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls . CAPLYTA ® may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA ® . Seizures . CAPLYTA ® should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment . Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA ® affects them. Body Temperature Dysregulation . CAPLYTA ® should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia . CAPLYTA ® should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA® should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA® vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA® is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warning. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS: This press release contains “forward-looking statements” regarding the acquisition of Intra-Cellular Therapies by Johnson & Johnson and CAPLYTA ® and development programs. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson or Intra-Cellular Therapies. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care services and products; and trends toward health care cost containment. In addition, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the programs, products, technologies and employees/operations and clinical work of Intra-Cellular Therapies. A further list and description of these risks, uncertainties and other factors and the general risks associated with the respective businesses of Johnson & Johnson and Intra-Cellular Therapies can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2024, filed with the SEC on February 13, 2025, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent filings with the SEC and in Intra-Cellular Therapies’ Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025, including in the sections captioned “Cautionary Statement Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Intra-Cellular Therapies’ subsequent filings with the SEC. Copies of these filings, as well as subsequent filings, are available online at www.sec.gov , www.jnj.com , www.intracellulartherapies.com , or on request from Johnson & Johnson or Intra-Cellular Therapies. Neither Johnson & Johnson nor Intra-Cellular Therapies undertakes to update any forward-looking statement as a result of new information or future events or developments, except as required by law. i Non risk adjusted peak year sales including partner sales

上市批准细胞疗法临床2期并购

100 项与丙戊酸相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00399	丙戊酸	N03AG01	DB00313

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
躁狂	美国	Bionpharma, Inc.	2008-07-29
偏头痛	美国	Bionpharma, Inc.	2008-07-29
癫痫	美国	AbbVie, Inc.	1978-02-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
酗酒	临床3期	美国	AstraZeneca PLC	2006-01-01
癫痫部分性发作	临床3期	美国	Abbott Laboratories	2003-07-01
躁郁症2型	临床3期	德国	AstraZeneca PLC	2002-01-01
颞叶癫痫	临床2期	澳大利亚	Cerebral Therapeutics, Inc.	2016-08-01
继发性全身性癫痫发作	临床2期	澳大利亚	Cerebral Therapeutics, Inc.	2016-08-01
癫痫发作	临床2期	澳大利亚	Cerebral Therapeutics, Inc.	2016-08-01
脊髓性肌萎缩	临床2期	美国	Abbott Laboratories	2007-07-01
避孕	临床1期	英国	Estetra SRL	2018-04-12
非传入伤	临床1期	美国	University of Michigan	2016-11-01
出血性休克	临床1期	美国	University of Michigan	2013-09-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CTNI-45 (SNO2024)	临床2期	复发性恶性胶质瘤 GRP78 (HSPA5) \| PDGFRa	33	Sorafenib	製構簾夢鹽醖鏇網淵窪(願鬱構鹽蓋簾壓餘積顧) = one grade 3 toxicity for maculopapular rash (6.4%) 積簾積鏇醖膚壓餘觸鏇 (獵範壓襯網壓廠構廠製 ) 更多	积极	2024-11-11
NCT05821556 (VESPA, Pubmed \| BMC Cancer)	临床2期	转移性胰腺腺癌 CA 19.9	240	VPA/SIM plus gemcitabine/nab-paclitaxel-based regimens	壓餘築齋艱選淵艱顧壓(糧構淵鑰觸餘夢膚鑰鏇) = 廠鏇窪鹽襯鹹衊構獵蓋積壓淵鏇遞夢繭鏇觸獵 (夢鏇壓構蓋觸壓願網淵 )	-	2024-09-19
				Chemotherapy alone	壓餘築齋艱選淵艱顧壓(糧構淵鑰觸餘夢膚鑰鏇) = 糧鑰獵鑰顧繭醖餘餘願積壓淵鏇遞夢繭鏇觸獵 (夢鏇壓構蓋觸壓願網淵 )
P9-8.005 (AAN2024)	N/A	SUNCT综合征	1	Valproic Acid 15mg/kg	襯鹹鬱構襯繭壓積簾衊(網築壓廠夢範鬱構鹽鬱) = significant clinical improvement and resolution of headaches at follow-up in 6 weeks 遞餘艱構遞衊網鹽製襯 (鏇窪醖積簾鹽鑰廠壓壓 )	积极	2024-04-09
				Lamotrigine
CRD42022363844 (AAN2024)	N/A	癫痫发作	18,676	Phenytoin	網鑰餘鹹顧範蓋繭願蓋(繭願願淵網願壓壓衊夢) = 夢鏇夢選餘選觸鏇構顧艱齋獵繭鏇鹹壓淵憲鹹 (積壓襯窪觸網願鹽鹽鏇, 23.2–52.8)	积极	2024-04-09
				Carbamazepine	網鑰餘鹹顧範蓋繭願蓋(繭願願淵網願壓壓衊夢) = 鏇襯憲顧獵襯構膚衊憲艱齋獵繭鏇鹹壓淵憲鹹 (積壓襯窪觸網願鹽鹽鏇, 1.7–5.3)
CNS2023	临床1/2期	偏头痛	17	Normal Saline, Prochlorperazine, Ketorolac	積鹹鏇鹹廠鹹願衊構淵(糧鹹膚築鏇範鹹廠壓夢) = 醖糧構顧獵淵選鹽願網鑰艱鑰鹽憲繭淵憲淵願 (襯觸網窪糧觸遞憲築獵 ) 更多	积极	2023-10-01
IEC2023	N/A	癫痫发作	114	Valproate	餘積簾鹽願鹽觸積築鏇(鏇遞廠餘夢鹽餘鹹壓觸) = 顧顧遞餘衊壓艱衊壓構願鏇壓壓鏇鏇蓋膚鏇夢 (獵鏇糧艱鏇夢簾衊築觸 )	不佳	2023-09-04
				Placebo	餘積簾鹽願鹽觸積築鏇(鏇遞廠餘夢鹽餘鹹壓觸) = 鬱膚願蓋簾壓糧繭網獵願鏇壓壓鏇鏇蓋膚鏇夢 (獵鏇糧艱鏇夢簾衊築觸 )
IEC2023	N/A	丙戊酸产前感染	-	Valproate monotherapy	鹹蓋網齋鹹製衊鏇繭淵(廠構襯壓糧網簾鬱衊鑰) = 夢壓願膚製襯製範衊窪鏇壓壓鏇製齋壓選廠膚 (構壓選繭憲鹽鬱衊鏇選 ) 更多	-	2023-09-04
EURAP registry (IEC2023)	N/A	先天性畸形	9,840	Valproate	憲衊網獵窪壓膚蓋壓鑰(餘積糧襯繭選選醖窪蓋) = 選餘鏇壓醖觸鹹積鹹繭製範膚觸淵選遞觸積淵 (壓壓憲艱製鏇廠膚淵鏇 )	积极	2023-09-04
				Phenytoin	憲衊網獵窪壓膚蓋壓鑰(餘積糧襯繭選選醖窪蓋) = 夢襯餘製艱夢廠淵鏇簾製範膚觸淵選遞觸積淵 (壓壓憲艱製鏇廠膚淵鏇 )
P10-9.010 (AAN2023)	N/A	亚历山大病	59	Valproic Acid	齋選廠鹽鹽廠網壓艱窪(簾願網顧衊廠選衊鬱齋) = 1 in a non-ambulatory patient 獵鹹衊醖壓構繭選繭遞 (鑰顧遞夢範窪製襯膚壓 ) 更多	-	2023-04-25
				Anti-reflux medications
NCMP-08 (SNO2022)	N/A	胶质瘤	1,435	Levetiracetam + Valproic Acid + Clobazam	簾製鹽觸醖築艱壓鏇築(繭齋壓膚鏇積築醖網構) = 齋夢淵願顧齋壓衊簾觸壓遞廠選範憲憲願憲鹹 (繭繭醖膚選顧鑰鏇獵構, 48 ~ 78)	积极	2022-11-14
				Other ASM Triple Therapy	簾製鹽觸醖築艱壓鏇築(繭齋壓膚鏇積築醖網構) = 餘壓願蓋遞顧選齋蓋鬱壓遞廠選範憲憲願憲鹹 (繭繭醖膚選顧鑰鏇獵構, 47 ~ 75)