1. Background and Clinical Need:
Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner.
2. Aims/Hypotheses:
The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium.
3. Methods:
The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium.
The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration.
The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine.
The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied.
4. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease.
Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.

开始日期2022-05-18

申办/合作机构

Tan Tock Seng Hospital Pte Ltd.

NCT04327843

/ Completed临床3期IIT

Reducing the Burden of Chronic Psychotic Disorders in Tanzania

The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

开始日期2019-11-05

申办/合作机构

Case Western Reserve University

[+1]

NCT01949662

/ Active, not recruiting临床2期IIT

A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit

This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.

开始日期2014-01-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

100 项与癸酸氟哌啶醇相关的临床结果

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100 项与癸酸氟哌啶醇相关的转化医学

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100 项与癸酸氟哌啶醇相关的专利（医药）

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项与癸酸氟哌啶醇相关的文献（医药）

2025-10-01·The mental health clinician

Dual long-acting injectable antipsychotic use in treatment-resistant schizophrenia with extensive hospitalization history: A case report

Article

作者: Jhawar, Archana ; Zheng, Lily

Abstract:

Treatment-resistant schizophrenia (TRS) is a challenging condition to manage and can result in the need for dual antipsychotic prescribing especially after oral clozapine failure. Poor medication adherence is prevalent among patients with TRS, and long-acting injectable antipsychotics are frequently used to overcome this barrier. Whereas there is limited data on the risks and benefits of dual long-acting injectable antipsychotic treatment, this is a treatment modality that is being used for patients with TRS who have poor adherence. We contribute a case of successful dual long-acting injectable therapy with intramuscular paliperidone palmitate and haloperidol decanoate in a patient with TRS and an extensive history of hospitalizations who failed treatment with oral clozapine.

2025-06-01·Pharmacological Reports

A single dose of haloperidol decanoate induces short-term hippocampal neuroinflammation: focus on the glial response

Article

作者: da Silva, Amanda ; Schmitz, Izaviany ; Quincozes-Santos, André ; Bobermin, Larissa Daniele ; Schmitz, Felipe ; Wyse, Angela T S ; Leipnitz, Guilhian ; Thomaz, Natalie K ; Brondani, Morgana ; Fachinetto, Roselei ; Gonçalves, Carlos-Alberto ; Weber, Fernanda Becker

BACKGROUND:

Haloperidol is a widely used antipsychotic for the treatment of neuropsychiatric disorders, the pathophysiology of which may involve hippocampal alterations. Hippocampus is affected by long-term use of the drug, but the effects of acute doses on the hippocampus remain unclear. The present study investigated whether a single dose of haloperidol decanoate could induce short-term hippocampal neuroinflammation and changes in cholinergic, glutamatergic and redox homeostasis in adult rats, focusing on the glial response.

METHODS:

Male Wistar rats (60 days old) received a single intramuscular injection of haloperidol decanoate (38 mg/kg) or vehicle. After 7 days, hippocampal tissue was used to assess gene expression of inflammatory mediators, glutamate transporters, and transcriptional factors that regulate neuroinflammation. The enzymatic activities of acetylcholinesterase (AChE), glutamine synthetase (GS), and glutathione peroxidase (GPx), and glutamate uptake and reduced glutathione (GSH) levels were also determined.

RESULTS:

Haloperidol decanoate increased the gene expression of pro-inflammatory cytokines, cyclooxygenase-2 (COX-2), and inducible nitric oxide synthase (iNOS). Moreover, downregulation of the transcriptional factor erythroid 2-related factor 2 (Nrf2) and the peroxisome proliferator-activated receptor-gamma coactivator (PGC-1α) was observed. In contrast, nuclear factor κB (NFκB) transcriptional levels remained unchanged. Haloperidol also increased glutamate uptake, the glutamate transporter GLAST gene expression, and the AChE and GPx activities.

CONCLUSIONS:

Our findings show that a single dose of haloperidol decanoate induces short-term hippocampal neuroinflammation and changes in glial parameters, highlighting the need for future adjuvant glioprotective strategies that can attenuate these effects.

2025-05-01·JOURNAL OF THE AMERICAN GERIATRICS SOCIETY

Use and Discontinuation Rates of Long‐Acting Injectable Antipsychotics Between Race/Ethnicity in Older Adults Using Medicaid Databases

Article

作者: Xu, Jianing ; Hall, Daniel B. ; Cassara, Christopher M. ; Young, Henry N. ; Caballero, Joshua ; Chen, Xianyan

ABSTRACT:

Objective:

The primary objective of this study was to assess the prescribing patterns of long acting injectable (LAI) antipsychotics in an older adult population. Secondary objectives were to determine if there were differences in treatment discontinuation rates between different LAI agents and race/ethnicity.

Methods:

Merative MarketScan Multi‐State Medicaid Databases (2017–2021) were used to identify patients 65 years or older who were prescribed a LAI antipsychotic. Pharmacy claims for LAI antipsychotics were referenced via National Drug Code (NDC) by brand/generic name and dose. International Classification of Diseases, 10th edition (ICD‐10) codes were used to identify older adults diagnosed with schizophrenia, schizotypal or schizoaffective disorders. Those with dementia or related disorders were censored. Conditional associations between race/ethnicity and generation of LAI antipsychotics were investigated using logistic regression controlling for age, sex, and health plan. Cox proportional hazard regression was used to compare the distribution of time until treatment discontinuation among older adults across LAI antipsychotics.

Results:

A total of 526 older adults (59% female) with an average age of 70.4 ± 5.5 years met inclusion for analysis. The most commonly used LAI antipsychotics included paliperidone palmitate‐1 month formulation (~35%), haloperidol decanoate (~24%), and risperidone microspheres (~15%). Overall, approximately 32% received LAI first‐generation antipsychotics and 68% received LAI second generation antipsychotics. Blacks ( n = 204) received LAI first‐generation antipsychotics more often than Whites ( n = 283); (OR: 1.74, 95% [1.18, 2.56], p < 0.01). When controlling for age, sex, and race/ethnicity, LAI first‐generation antipsychotics showed earlier discontinuation rates compared to LAI second‐generation antipsychotics (HR: 2.12, 95% CI [1.45, 3.10], p < 0.001).

Conclusions:

LAI first‐generation antipsychotics showed treatment discontinuation significantly earlier compared to LAI second‐generation antipsychotics. Furthermore, Blacks were prescribed LAI first‐generation antipsychotics at a higher rate than Whites, which may contribute to poorer health outcomes. Futures studies are needed to establish a causal relationship.

项与癸酸氟哌啶醇相关的新闻（医药）

2025-07-27

·TiPLab

CAFC维持Janssen重磅抗精神病药物棕榈酸帕利哌酮的给药方案专利有效

7月8日，Teva挑战Janssen涉及Invega Sustenna（活性成分：棕榈酸帕利哌酮）给药方案的美国专利失败， CAFC维持地区法院判决，即 US9439906B2 并未被证明因显而易见而无效，使得 Invega Sustenna 的独占期延长至2031年。本案中关于数值范围重叠的显而易见性判断值得关注。CAFC维持Janssen重磅抗精神病药物棕榈酸帕利哌酮的给药方案专利有效byTiPLab 木桃关于Invega SustennaInvega Sustenna 的活性成分是棕榈酸帕利哌酮，用于治疗成人精神分裂症或成人分裂情感性障碍。Invega Sustenna 是每月给药一次的长效注射剂型，于2009 年首次在FDA获批，于2011年在中国获批（善思达）。后续Janssen还推出了每三个月注射（Invega Trinza，善妥达）和每半年注射的版本（Invega Hafyera，善久达）。2024 年，棕榈酸帕利哌酮在美国的销售额为 31.3 亿美元。US9439906B2（’906 专利）获得了770天的PTA，预计到期日为2031年1月26日，并登记在橙皮书列表中。’906 专利涉及采用帕利哌酮棕榈酸酯的长效注射剂型的给药方案，其给药频率低于口服药物，从而显著提高患者依从性。代表性权利要求2中具体限定了给药方案，包括对患者先注射约150毫克当量（mg-eq.）的第一负荷剂量（loading doses），随后约一周后再注射约100毫克当量的第二负荷剂量，之后每月给予25–150 毫克当量的维持剂量。案件背景2017年，Teva 递交了 Invega Sustenna 仿制药的上市申请（ANDA）。次月，Janssen 根据 Hatch-Waxman 法案在地区法院起诉Teva侵犯其美国专利US9,439,906。Teva 质疑专利的有效性。地方法院裁定专利有效，Teva提起上诉，中间还经历一轮发回重审和提起上诉，最终，CAFC维持地方法院的判决，认定专利有效。该案争议焦点有两个：1）权利要求 2 是否应当适用显而易见性的推定；2）权利要求2是否具备非显而易见性。CAFC观点：权利要求2不应适用显而易见性推定本案的现有技术中，’548 临床方案披露了两个相同的剂量（150 mg-eq. 或 100 mg-eq.），而 WO ’384 则披露了一个剂量范围，涵盖这两个剂量。Teva援引了数值范围重叠适用推定规则的案例。即，现有技术教导的数值（范围）和权利要求中的数值（范围）有重叠。在许多此类案件中，法院认定这些事实足以确立表面上的显而易见性（prima facie obviousness），并在过去二十年中将其作为触发显而易见性推定的依据。CAFC指出，是否适用显而易见性的推定，应考虑具体的发明背景。某些情况下可能会使该推定不适用，例如：现有技术中的数值范围过于宽泛。’906 专利的主要区别特征在于“递减的负荷剂量 + 特定给药时间”的组合，Janssen 所作出的关键选择是从特定的较高负荷剂量开始，然后给予较低的第二负荷剂量。这个负荷剂量组合体现的是两个剂量数值之间的关系。为了判定涉案专利中的情形是否纳入推定范围，需要考察该选择是否符合本领域技术人员在常规优化过程中的基本逻辑。现有的相关案件大多涉及合金或其他组合物的组成及其制造工艺，均未涉及与本案中关于（精神病）治疗方案中“剂量组合方案”的选择，也没有类似的先例。因此，在此情形下，CAFC认为当前应适用常规的完整显而易见性分析，而非简单援引推定进行审查。CAFC：权利要求 2 具备非显而易见性CAFC认为，Teva 未提供清晰且令人信服的证据证明权利要求 2 显而易见性所需的关键事实，基于以下事实：1. 现有技术（WO ’384 和’544 专利）中均未公开权利要求2中的负荷剂量方案。2. 相关技术人员没有动机采用“较大的初始负载剂量，随后给予较小的第二剂负载剂量”的给药方案：相关技术人员更可能通过减小颗粒尺寸来加快药物在患者体内的吸收，而不是通过增加给药剂量：根据 Janssen的专家证词，“增加剂量并不会帮助患者更快达到治疗阈值”，并进一步认定缺乏支持调整剂量动机的证据。Teva未能证明相关技术人员会合理地从维持剂量减少的教导中推导出减少第二次负荷剂量的动机：Teva 自己的专家作证称“负荷剂量与维持剂量是两个不同的概念”，因此相关技术人员不会从 Ereshefsky 文献中关于维持剂量的教导，合理地推断出应同样适用于加载剂量”。3. Haldol（氟哌啶醇癸酸酯）的说明书不会教导相关技术人员使用不等量、递减的给药方案：该说明书明确指示医生应“从较低的初始剂量开始，并根据需要逐步增加剂量”。双方当事人均认可氟哌啶醇癸酸酯（haloperidol decanoate）与帕利哌酮棕榈酸酯（paliperidone palmitate）在人体内的药代行为存在差异。4. 相关技术人员基于现有技术无法合理预期能够实现本发明的治疗效果。CAFC认为：虽然疗效数据并非总是判断合理成功预期的必要条件，但缺乏疗效数据可能会影响相关技术人员的成功预期。Janssen 专家指出，多剂量给药方案相比单剂量方案会带来更多复杂性（如药物在患者体内的过度累积、给药之间血药浓度波动等），并可能导致不良反应。唯一披露多剂量方案的现有技术文献——即 ’548 临床方案，并未提供任何关于其安全性或疗效的结果，这意味着“多剂量方案对相关技术人员而言更加不可预测”。实践意义CAFC明确，对于数值范围重叠是否适用显而易见性推定，应结合发明背景，考量数值范围的选择是否为本领域技术人员的常规优化手段。因此，如果想要说明显而易见性推定不适用，可以尝试将数值范围特征与其他特征，比如：给药时机、剂量关系或给药途径等关联起来说明其实现的技术效果，并进一步证明其非显而易见性。* 以上文字仅为促进讨论与交流，不构成法律意见或咨询建议。© 作为一家专业服务公司，TiPLab坚持原创的系统的研究，注重系统性知识积累与专业影响力。欢迎读者个人分享转发，各专业平台媒体如需转载请联系TiPLab获得授权。 TiPLab提供基于研究的核心知识产权服务FTO：技术商业化实施的侵权风险防范TiPLab通过对细分技术领域内核心技术和重要专利的长期研究，结合自身在数据检索和分析方面的专长，致力于帮助客户深入了解、积极应对潜在的专利侵权风险。Due Diligence：商业活动中的知识产权尽职调查在企业许可交易、融资、并购、上市等过程中，TiPLab帮助企业和投资方了解目标技术/产品的专利保护强度及产品商业化过程中潜在的专利侵权风险，从而为商业谈判和决策提供支持依据。Patenting：全球范围内高价值专利资产的创设TiPLab熟知全球主要国家和地区的法律实践和细分领域内的前沿技术进展情况，通过前瞻性的专利布局策略，帮助客户通过创设有价值的专利资产而获取、保持和巩固独特的竞争优势。

专利侵权专利无效专利到期

2025-07-13

·信狐药迅

三个1类新药：天晴库莫西利、信诺维亚胺培南西司他丁钠福诺巴坦和先声乐德奇拜单抗提交上市申请|新受理（7.7-7.13）

本周药品注册受理数据，分门别类呈现，一目了然。(7.7-7.13）新药上市申请药品名称企业注册分类受理号库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2500076库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2500075注射用亚胺培南西司他丁钠福诺巴坦苏州信诺维医药科技股份有限公司1CXHS2500074多西他赛注射用浓溶液(自乳化型)北京德立英捷医药科技有限公司2.2CXHS2500079硫酸阿托品滴眼液兆科(广州)眼科药物有限公司2.2CXHS2500078氟维司群注射液正大天晴药业集团股份有限公司2.4CXHS2500077示踪用盐酸米托蒽醌注射液深圳华润九创医药有限公司2.4CXHS2500073乐德奇拜单抗注射液先声药业有限公司1CXSS2500074乐德奇拜单抗注射液先声药业有限公司1CXSS2500073注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSS2500072新药临床申请药品名称企业注册分类受理号IMP9064片上海瑛派药业有限公司1CXHL2500694BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500693BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500692HRS-4642注射液上海恒瑞医药有限公司1CXHL2500691HRS-7058胶囊山东盛迪医药有限公司1CXHL2500689HRS-7058胶囊山东盛迪医药有限公司1CXHL2500688HRS-7058片山东盛迪医药有限公司1CXHL2500687HRS-7058片山东盛迪医药有限公司1CXHL2500686225Ac-LNC1011注射液烟台蓝纳成生物技术股份有限公司1CXHL2500697HJ-004-02片和径医药科技(上海)有限公司1CXHL2500696HJ-004-02片和径医药科技(上海)有限公司1CXHL2500695DF-006口服溶液浙江药苑生物科技有限公司1CXHL2500690GFH375片劲方医药科技(上海)股份有限公司1CXHL2500685HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500684HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500683HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500682CA111注射液重庆宸安生物制药有限公司1CXHL2500678CA111注射液重庆宸安生物制药有限公司1CXHL2500677BIOS-0623-Z4片杭州百诚医药科技股份有限公司1CXHL2500676BIOS-0623-Z4片杭州百诚医药科技股份有限公司1CXHL2500675LXH-1211片山东新华制药股份有限公司1CXHL2500674LXH-1211片山东新华制药股份有限公司1CXHL2500673LXH-1211片山东新华制药股份有限公司1CXHL2500672LXH-1211片山东新华制药股份有限公司1CXHL2500671SGB-3383注射液苏州圣因生物医药有限公司1CXHL2500667BGM0504片博瑞制药(苏州)有限公司1CXHL2500681BGM0504片博瑞制药(苏州)有限公司1CXHL2500680BGM0504片博瑞制药(苏州)有限公司1CXHL2500679注射用TRD208北京泰德制药股份有限公司1CXHL2500666BW-40202注射液上海舶望制药有限公司1CXHL2500668HRS-2129片山东盛迪医药有限公司1CXHL2500664HRS-2129片山东盛迪医药有限公司1CXHL2500663HRS-2129片山东盛迪医药有限公司1CXHL2500662HRS-2129片山东盛迪医药有限公司1CXHL2500661注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500660注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500659TT-00420片药捷安康(南京)科技股份有限公司1CXHL2500658TT-00420片药捷安康(南京)科技股份有限公司1CXHL2500657TT-00420 片药捷安康(南京)科技股份有限公司1CXHL2500656HRS-3095片成都盛迪医药有限公司1CXHL2500655HRS-3095片成都盛迪医药有限公司1CXHL2500654LSCCB-PtNNN注射液金铂药业(深圳)有限公司1CXHL2500653EP-0206SI成都苑东生物制药股份有限公司2.2CXHL2500670EP-0206SI成都苑东生物制药股份有限公司2.2CXHL2500669尼莫地平脂肪乳注射液江苏九旭药业有限公司2.2CXHL2500665盐酸右美托咪定微针贴剂广州新济药业科技有限公司2.2CXHL2500652盐酸右美托咪定微针贴剂广州新济药业科技有限公司2.2CXHL2500651吸附无细胞百白破b型流感嗜血杆菌联合疫苗长春百克生物科技股份公司2.2CXSL2500582人脐带间充质干细胞注射液北京葆来生物科技有限公司1CXSL2500581注射用FH-006江苏恒瑞医药股份有限公司1CXSL2500573注射用IBB0979盛禾(中国)生物制药有限公司1CXSL2500580注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500583注射用SHR-A2102上海恒瑞医药有限公司1CXSL2500575SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500579匹康奇拜单抗注射液信达生物医药科技(杭州)有限公司1CXSL2500571匹康奇拜单抗注射液信达生物医药科技(杭州)有限公司1CXSL2500570GR2301注射液重庆智翔金泰生物制药股份有限公司1CXSL2500569注射用SHR-1802上海恒瑞医药有限公司1CXSL2500572DCTY0801注射液北京鼎成肽源生物技术有限公司1CXSL2500568VGN-R08b上海天泽云泰生物医药有限公司1CXSL2500565Astem-101人脐带间充质干细胞(hUC-MSCs)注射液上海昂昇生物医药科技有限公司1CXSL2500564VGN-R08b上海天泽云泰生物医药有限公司1CXSL2500563脐带间充质干细胞注射液山东佰鸿干细胞生物技术有限公司1CXSL2500562LBM801上海利康瑞生物工程有限公司1CXSL2500560NGGT006注射液苏州诺洁贝生物技术有限公司1CXSL2500559SHR-4298注射液苏州盛迪亚生物医药有限公司1CXSL2500558HC006注射液上海宏成药业有限公司1CXSL2500567注射用HC010上海宏成药业有限公司1CXSL2500566GR1803注射液智翔(上海)医药科技有限公司1CXSL2500553自体自然杀伤细胞注射液广州达博生物制品有限公司1CXSL2500552注射用ZGGS34苏州泽璟生物制药股份有限公司1CXSL2500561SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500577阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500578贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500574阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500576仿制药申请药品名称企业注册分类受理号吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2502485吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2502484西咪替丁注射液森淼(山东)药业有限公司3CYHS2502505复方聚乙二醇电解质散(II)上海朝晖药业有限公司3CYHS2502504复方电解质醋酸钠葡萄糖注射液山东化药医药科技有限公司3CYHS2502503复方电解质醋酸钠葡萄糖注射液山东化药医药科技有限公司3CYHS2502502米诺地尔搽剂科笛生物医药(无锡)有限公司3CYHS2502500米诺地尔搽剂科笛生物医药(无锡)有限公司3CYHS2502499复方电解质醋酸钠葡萄糖注射液南京正大天晴制药有限公司3CYHS2502498复方电解质醋酸钠葡萄糖注射液南京正大天晴制药有限公司3CYHS2502497碳酸氢钠林格注射液(I)南京正科医药股份有限公司3CYHS2502496米诺地尔搽剂湖北午时药业股份有限公司3CYHS2502494米诺地尔搽剂湖北午时药业股份有限公司3CYHS2502493注射用乳糖酸红霉素苏州朗科生物技术股份有限公司3CYHS2502490注射用乳糖酸红霉素苏州朗科生物技术股份有限公司3CYHS2502489盐酸西替利嗪干糖浆海南元盈医药科技有限公司3CYHS2502516注射用苯唑西林钠北京元延医药科技股份有限公司3CYHS2502475注射用苯唑西林钠北京元延医药科技股份有限公司3CYHS2502474盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502473盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502472盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502471盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502470比拉斯汀口服溶液珠海北杉生物科技有限公司3CYHS2502467利格列汀二甲双胍缓释片北京福元医药股份有限公司3CYHS2502482利格列汀二甲双胍缓释片北京福元医药股份有限公司3CYHS2502481马来酸曲美布汀片平光制药股份有限公司3CYHS2502462马来酸曲美布汀片平光制药股份有限公司3CYHS2502461醋酸特利加压素注射液武汉人福药业有限责任公司3CYHS2502457醋酸钠林格葡萄糖注射液(I)南京正科医药股份有限公司3CYHS2502456盐酸毛果芸香碱滴眼液山东华铂凯盛生物科技有限公司3CYHS2502428地拉罗司颗粒裕松源药业有限公司3CYHS2502427洛索洛芬钠凝胶上海延安医药洋浦股份有限公司3CYHS2502451硝酸咪康唑乳膏江苏盈科生物制药有限公司3CYHS2502449复方聚乙二醇电解质散(儿童型)郑州泰丰制药有限公司3CYHS2502447腺苷钴胺胶囊国药集团容生制药有限公司3CYHS2502444钠钾镁钙注射用浓溶液西安安健药业有限公司3CYHS2502439维生素K1注射液江苏安必生制药有限公司3CYHS2502437生理氯化钠溶液四川青山利康药业有限公司3CYHS2502453普瑞巴林口服溶液浙江致新医药科技有限公司3CYHS2502452醋酸钠林格葡萄糖注射液(I)南京正大天晴制药有限公司3CYHS2502429福多司坦口服溶液海南全星制药有限公司3CYHS2502419注射用氢化可的松琥珀酸钠南京泽恒医药技术开发有限公司3CYHS2502416注射用硫酸多黏菌素B烟台鲁银药业有限公司3CYHS2502410葡萄糖酸钙注射液河南普瑞药业有限公司3CYHS2502405盐酸甲氧氯普胺注射液广东南国药业有限公司3CYHS2502403盐酸溴己新注射液成都华宇制药有限公司3CYHS2502423比拉斯汀口服溶液江苏长泰药业股份有限公司3CYHS2502424氯雷他定片华益药业科技(安徽)有限公司4CYHS2502486二十碳五烯酸乙酯软胶囊华北制药股份有限公司4CYHS2502483瑞维那新吸入溶液遂成药业股份有限公司4CYHS2502515腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502514腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502513腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502512腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502511腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502510腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502509恩格列净片广东彼迪药业有限公司4CYHS2502508双氯芬酸二乙胺乳胶剂浙江寰领医药科技有限公司4CYHS2502507恩格列净片广东彼迪药业有限公司4CYHS2502506玻璃酸钠注射液重庆药友制药有限责任公司4CYHS2502501盐酸尼卡地平注射液上海葆隆生物科技有限公司4CYHS2502495替米沙坦氢氯噻嗪片南京黄龙生物科技有限公司4CYHS2502492利格列汀二甲双胍片(II)山东朗诺制药有限公司4CYHS2502491沙库巴曲缬沙坦钠片复星万邦(江苏)医药集团有限公司4CYHS2502488艾拉莫德片璟济生物医药科技(泰州)股份有限公司4CYHS2502487米格列醇片北京北陆药业股份有限公司4CYHS2502479利那洛肽胶囊湖北远大永晟药业有限公司4CYHS2502478巴瑞替尼片海化生命(厦门)科技有限公司4CYHS2502477甲磺酸多沙唑嗪缓释片常州制药厂有限公司4CYHS2502476甲氨蝶呤注射液四川汇宇海玥医药科技有限公司4CYHS2502469甲氨蝶呤注射液四川汇宇海玥医药科技有限公司4CYHS2502468艾普拉唑肠溶片江苏飞马药业有限公司4CYHS2502466双氯芬酸钠盐酸利多卡因注射液山西威奇达光明制药有限公司4CYHS2502465酒石酸溴莫尼定滴眼液成都普什制药有限公司4CYHS2502464噻托溴铵吸入喷雾剂浙江仙琚制药股份有限公司4CYHS2502480吗啉硝唑氯化钠注射液浙江康吉尔药业有限公司4CYHS2502463培哚普利氨氯地平片(III)山东朗诺制药有限公司4CYHS2502460恩格列净片江西施美药业股份有限公司4CYHS2502459恩格列净片江西施美药业股份有限公司4CYHS2502458聚乙烯醇滴眼液合肥利民制药有限公司4CYHS2502433艾普拉唑肠溶片宁波科尔康美诺华药业有限公司4CYHS2502430盐酸曲唑酮缓释片华益泰康药业股份有限公司4CYHS2502426注射用磷丙泊酚二钠成都苑东生物制药股份有限公司4CYHS2502450瑞维那新吸入溶液山东达因金控儿童制药有限公司4CYHS2502448注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2502446注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2502445哌柏西利片浙江麒正药业有限公司4CYHS2502443哌柏西利片浙江麒正药业有限公司4CYHS2502441左氧氟沙星滴眼液重庆药谷制药有限公司4CYHS2502440注射用盐酸表柔比星吉斯美(武汉)制药有限公司4CYHS2502438戊酸雌二醇片扬州奥锐特药业有限公司4CYHS2502436富马酸伏诺拉生片江西山香药业有限公司4CYHS2502455富马酸伏诺拉生片江西山香药业有限公司4CYHS2502454瑞舒伐他汀依折麦布片(I)烟台鲁银药业有限公司4CYHS2502442富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502435富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502434富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502432富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502431二甲硅油乳剂江苏广承药业有限公司4CYHS2502422依伏卡塞片南京正大天晴制药有限公司4CYHS2502421依伏卡塞片南京正大天晴制药有限公司4CYHS2502420达格列净片浙江麒正药业有限公司4CYHS2502418达格列净片浙江麒正药业有限公司4CYHS2502417甲硝唑凝胶杭州呋欧医药科技有限公司4CYHS2502415甲硝唑凝胶杭州呋欧医药科技有限公司4CYHS2502414恩格列净片江西迪赛诺医药集团有限公司4CYHS2502413恩格列净片江西迪赛诺医药集团有限公司4CYHS2502412氟比洛芬凝胶贴膏中曦(福建)药业有限公司4CYHS2502411癸酸氟哌啶醇注射液四川尚锐生物医药有限公司4CYHS2502409癸酸氟哌啶醇注射液四川尚锐生物医药有限公司4CYHS2502408非奈利酮片石家庄四药有限公司4CYHS2502407瑞维那新吸入溶液海南斯达制药有限公司4CYHS2502406非奈利酮片复星万邦(江苏)医药集团有限公司4CYHS2502404比索洛尔氨氯地平片广东大鹏医药科技有限公司4CYHS2502402氟马西尼注射液岳阳新华达制药有限公司4CYHS2502401盐酸达泊西汀片江苏润邦药业有限公司4CYHS2502400盐酸达泊西汀片江苏润邦药业有限公司4CYHS2502399盐酸替罗非班注射用浓溶液安徽丰原药业股份有限公司4CYHS2502398洛索洛芬钠凝胶贴膏河南羚锐制药股份有限公司4CYHS2502397瑞维那新吸入溶液南京力成药业有限公司4CYHS2502396艾拉莫德片东阳祥昇医药科技有限公司4CYHS2502395瑞维那新吸入溶液江西科伦药业有限公司4CYHS2502394丁溴东莨菪碱注射液石家庄四药有限公司4CYHS2502393盐酸维洛沙秦缓释胶囊西安远大科创医药科技有限公司3CYHL2500127盐酸维洛沙秦缓释胶囊西安远大科创医药科技有限公司3CYHL2500126艾氟洛芬贴剂湖南华纳大药厂股份有限公司3CYHL2500125克霉唑阴道片株洲千金药业股份有限公司4CYHL2500124甲型肝炎灭活疫苗(人二倍体细胞)北京科兴生物制品有限公司3.3CXSL2500554仑卡奈单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500555QL2106注射液齐鲁制药有限公司3.3CXSL2500545人纤维蛋白原国药集团昆明血液制品有限公司3.4CXSL2500557人纤维蛋白原国药集团昆明血液制品有限公司3.4CXSL2500556进口申请药品名称企业注册分类受理号洛索洛芬钠凝胶膏LEAD CHEMICAL CO., LTD.5.1JXHS2500076醋酸锌片Nobelpharma Co., Ltd.5.1JXHS2500075醋酸锌片Nobelpharma Co., Ltd.5.1JXHS2500074羧基麦芽糖铁注射液M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500027羧基麦芽糖铁注射液M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500026AZD9574AstraZeneca AB1JXHL2500182AZD9574AstraZeneca AB1JXHL2500181AZD9574AstraZeneca AB1JXHL2500180AZD9574AstraZeneca AB1JXHL2500179RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500178RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500177RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500176RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500175Orforglipron片Eli Lilly and Company1JXHL2500174Orforglipron片Eli Lilly and Company1JXHL2500173Orforglipron片Eli Lilly and Company1JXHL2500172Orforglipron片Eli Lilly and Company1JXHL2500171Orforglipron片Eli Lilly and Company1JXHL2500170Orforglipron片Eli Lilly and Company1JXHL2500169Mezigdomide胶囊Celgene Corporation1JXHL2500168Mezigdomide胶囊Celgene Corporation1JXHL2500167Mezigdomide胶囊Celgene Corporation1JXHL2500166Mezigdomide胶囊Celgene Corporation1JXHL2500165Mezigdomide胶囊Celgene Corporation1JXHL2500164Mezigdomide胶囊Celgene Corporation1JXHL2500163ALXN2420注射液Alexion Pharmaceuticals, Inc.1JXHL2500162注射用六氟化硫微泡Bracco International B.V.2.4JXHL2500183AZD5335AstraZeneca AB1JXSL2500121替利珠单抗注射液Sanofi-Aventis Recherche & Développement2.2JXSL2500120中药相关申请药品名称企业注册分类受理号JIZM01湖南九典制药股份有限公司1.1CXZL2500053JIZM01湖南九典制药股份有限公司1.1CXZL2500052和肤止痒凝胶广东省中医院1.1CXZL2500051JIZM02湖南九典制药股份有限公司1.1CXZL2500050JIZM02湖南九典制药股份有限公司1.1CXZL2500049柴胡鼻腔喷雾剂河南利欣制药股份有限公司2.1CXZS2500029扶正通淋丸山东康众宏医药科技开发有限公司1.1CXZL2500047ZY-A002亚宝药业集团股份有限公司1.1CXZL2500046馥感啉颗粒广州一品红制药有限公司2.2CXZL2500048半夏白术天麻颗粒石家庄以岭药业股份有限公司3.1CXZS2500028淫羊藿素软胶囊北京珅诺基医药科技有限公司2.3CXZL2500045真武颗粒武汉康乐药业股份有限公司3.1CXZS2500027注：绿色字体部分为潜在首仿品种；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

2025-02-13

·Pharmaindustrial

Clinigen and Essential Pharma to Improve Patient Access in JAPAC

Clinigen has extended their JAPAC collaboration, aimed at driving continued patient access to four therapies in Japan and Korea, and strengthening their combined market presence in the region. This expanded collaboration encompasses several new market authorisation transfers and exclusive distribution agreements. Building on their 2024 agreement for IOPIDINE® (apraclonidine) in Korea, Clinigen and Essential Pharma now extend this to Japan. New agreements establish market authorisation transfer and exclusive distribution for HALDOL® (haloperidol) and REMINYL® (galantamine) oral capsules in Korea, and for HALOMONTH® (haloperidol decanoate) in Japan. IOPIDINE 5mg/ml is a short-term adjunctive therapy for patients with chronic glaucoma on maximally tolerated medical therapy to prevent or control intraocular pressure. HALDOL and HALOMONTH are antipsychotic drugs that contain haloperidol and are used in the treatment of schizophrenia and other psychiatric conditions including schizoaffective disorder. Haloperidol is included in the 2023 World Health Organization’s List of Essential Medicines1. REMINYL, a cholinesterase inhibitor, is a central nervous system (CNS) drug used to treat symptomatic mild to moderately severe dementia of the Alzheimer type. Clinigen CEO Jerome Charton and Essential Pharma CEO Emma Johnson held a ceremonial signing event yesterday at Clinigen's London offices. While initially focused on ensuring continuity of patient access in the JAPAC region, both organisations envision further strategic partnering, leveraging Clinigen's rare disease and orphan drug expertise to improve access to innovative medicines globally, supporting Essential Pharma's goal to build on its diversified portfolio and late-stage pipeline focused on central nervous system, gastroenterology, ophthalmology, and rare disease. Jerome Charton, CEO of Clinigen said, “Our biggest achievements are marked by expanding patient access to much-needed medicines. While we are seeing the expansion of life sciences, R&D and clinical trials, population health is also becoming increasingly complex, and it is pertinent that patients do not feel the impact. With our trusted and equally motivated partner, Essential Pharma, Clinigen will further our mission to accelerate access to innovative medicines for patients worldwide.” Emma Johnson, CEO of Essential Pharma, said, “Essential Pharma is delighted to expand our relationship with Clinigen as we continue to execute our strategy to become a leading, global specialty pharma group with a growing rare disease presence. Clinigen’s expertise in providing access to established brands as well as their expertise in the rare disease and orphan drug space makes them the ideal partner as we broaden access to our therapies and reinforce our strategic foothold in JAPAC. Guided by our shared patient-centric values, this collaboration represents a significant step forward in our commitment to serving patients in the JAPAC region and beyond.” This agreement demonstrates Clinigen's commitment to building an integrated offering of high-end pharmaceutical services across the entire drug lifecycle, reinforcing its vision of a world where medicine is global by design. Recent acquisitions (Ascenian Consulting, and Kinesys Consulting) enhance expertise in high-demand areas like Market Access and Regulatory Affairs, while the strategic partnership/minority stake in Tepsivo, a leading digital pharmacovigilance provider, strengthens its competitive advantage in the rapidly growing pharma services market, and underscore Clinigen's commitment to integrated solutions that accelerate access to innovative medicines for patients worldwide.

引进/卖出并购孤儿药

100 项与癸酸氟哌啶醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01898	癸酸氟哌啶醇	N05AD01	DBSALT001195

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
精神分裂症	美国	Janssen Pharmaceuticals, Inc.	1986-01-14
Tourette 综合征	美国	Janssen Pharmaceuticals, Inc.	1986-01-14

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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


NCT01949662 (CTgov)	临床2期	谵妄 \| 晚期癌症	93	Lorazepam+Haloperidol (Intervention Group (Lorazepam & Haloperidol))	築願廠範簾鑰廠夢膚窪(積廠繭醖淵遞蓋鏇餘壓) = 鏇構製鹹範繭醖積鹹艱蓋觸製鏇範繭顧網鹽艱 (選醖構鹽簾構鏇願襯願, 衊獵積糧簾夢膚製衊廠 ~ 鑰夢鹽網鏇鬱糧觸簾衊) 更多	-	2020-10-30
NCT01949662 (CTgov)	临床2期	谵妄 \| 晚期癌症	93	Placebo+Haloperidol (Control Group (Placebo & Haloperidol))	築願廠範簾鑰廠夢膚窪(積廠繭醖淵遞蓋鏇餘壓) = 構醖鹹襯鬱鑰糧選繭壓蓋觸製鏇範繭顧網鹽艱 (選醖構鹽簾構鏇願襯願, 齋製衊獵鹽鑰憲鏇觸鬱 ~ 廠衊顧醖艱觸膚窪築製) 更多	-	2020-10-30
NCT03489551 (PHDC, CTgov)	临床4期	肿瘤 \| 移植并发症 \| 谵妄	17	Haldol	獵範鹹膚繭壓窪淵蓋鹽 = 齋願糧淵鑰膚蓋鬱範淵願壓憲築鏇簾餘餘構窪 (鹽構憲鏇餘築獵醖繭網, 網夢製鹹艱醖鬱艱觸觸 ~ 顧獵淵齋鏇憲蓋範糧醖) 更多	-	2018-05-22
NCT01152697 (CAE-L, CTgov)	N/A	分裂情感性障碍 \| 精神分裂症	30	Customized Adherence Enhancement+haloperidol decanoate+haloperidol	廠淵餘艱顧網範積製簾(夢遞鬱選憲繭範糧窪艱) = 衊鹹繭願遞願製淵襯鹽廠窪願觸繭積憲醖襯積 (獵糧齋選廠壓窪簾積艱, 7.73) 更多	-	2014-06-04