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）

2025-06-01·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 ; Schmitz, Felipe ; Quincozes-Santos, André ; Bobermin, Larissa Daniele ; Leipnitz, Guilhian ; Wyse, Angela T S ; Thomaz, Natalie K ; Fachinetto, Roselei ; Brondani, Morgana ; 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.

2025-03-01·Neuropsychopharmacology reports

Co‐Expression of Tardive Dyskinesia and Drug‐Induced Parkinsonism in Rats Chronically Treated With Haloperidol

Article

作者: Tomiyama, Masahiko ; Hikichi, Hiroki ; Suzuki, Chieko ; Kinoshita, Iku ; Kon, Tomoya ; Nakamura, Takashi ; Shimoyama, Shuji ; Nishijima, Haruo

ABSTRACT:

Aim:

We aimed to create a rat model of drug‐induced parkinsonism and tardive dyskinesia by chronic administration of haloperidol and examine the expression of direct and indirect pathway markers in the striatum of the model rats.

Methods:

We treated 21 rats, 14 with haloperidol decanoate and 7 with placebo. The number of vacuous chewing movements per 2 min was counted, and haloperidol‐treated rats were classified into two groups: mild and severe tardive dyskinesia. Other behavioral analyses were also conducted. After a 6‐month treatment period, rat brains were removed, and protein expression was evaluated by Western blotting.

Results:

All haloperidol‐treated rats exhibited vacuous chewing movements. The frequency of exploratory behavior and rotarod test performance was lower in the mild and severe tardive dyskinesia groups. The number of vacuous chewing movements and frequency of exploratory behavior were positively correlated in haloperidol‐treated rats. The expression of dynorphin, a direct pathway marker, decreased in the severe tardive dyskinesia group. The expression of enkephalin, an indirect pathway marker, decreased both in the mild and severe tardive dyskinesia groups. The expression of dopamine D1 and D2 receptors also decreased with haloperidol treatment.

Conclusion:

Both direct and indirect pathways are involved in haloperidol‐induced movement disorders.

项与癸酸氟哌啶醇相关的新闻（医药）

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

2025-02-07

·GlobeNewswire-Health Care

Essential Pharma and Clinigen Expand Collaboration to Improve Patient Access in JAPAC

Agreement drives continued patient access to four important therapies in Japan and Korea Strengthens Essential Pharma and Clinigen’s combined market presence in the JAPAC region 6th February 2025 – Essential Pharma (“Essential” or “the Company”), an international specialty pharma group focused on ensuring that patients have access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, and Clinigen, the global specialty pharmaceutical services group, today announced an expansion of 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 transfer and exclusive distribution agreements. Building on their 2024 agreement for IOPIDINE® (apraclonidine) in Korea, Essential Pharma and Clinigen 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. Essential Pharma CEO Emma Johnson and Clinigen CEO Jerome Charton held a ceremonial signing event yesterday. While initially focused on ensuring continuity of patient access in the JAPAC region, both organisations envision further strategic partnering, 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, and leveraging Clinigen's rare disease and orphan drug expertise, to improve access to innovative medicines for patients globally. Emma Johnson, CEO of Essential Pharma, says: “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.” Jerome Charton, CEO of Clinigen, says: “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.” Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous supply to patients. Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa, and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year. 1 https://iris-who-int.libproxy1.nus.edu.sg/bitstream/handle/10665/371090/WHO-MHP-HPS-EML-2023.02-eng.pdf The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出孤儿药

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))	齋鹽獵網齋艱製積鑰築(糧壓獵淵積鬱遞艱淵鏇) = 憲齋顧鏇餘願網蓋餘鏇築淵積繭範範齋簾製繭 (膚襯遞顧廠繭網範範觸, 壓構範憲積簾築窪鑰窪 ~ 鬱壓鹽壓襯鑰鬱窪遞選) 更多	-	2020-10-30
NCT01949662 (CTgov)	临床2期	谵妄 \| 晚期癌症	93	Placebo+Haloperidol (Control Group (Placebo & Haloperidol))	齋鹽獵網齋艱製積鑰築(糧壓獵淵積鬱遞艱淵鏇) = 鑰醖願選餘範獵築壓顧築淵積繭範範齋簾製繭 (膚襯遞顧廠繭網範範觸, 膚鑰齋鏇廠製窪餘衊憲 ~ 壓壓鏇廠繭醖觸範壓網) 更多	-	2020-10-30
NCT03489551 (PHDC, CTgov)	临床4期	肿瘤 \| 移植并发症 \| 谵妄	17	Haldol	淵蓋憲蓋窪鏇廠夢顧壓 = 選齋夢齋淵膚鹹鬱艱選選築網餘鹹蓋餘鹹願構 (網壓繭壓構顧衊夢繭鬱, 鹽簾糧鹽衊顧艱繭積選 ~ 餘獵願襯範醖積夢壓簾) 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	築製獵膚選艱窪範選淵(選艱鬱淵簾觸壓膚淵憲) = 鹹夢糧夢獵襯願築鏇構觸範築齋膚願憲蓋築醖 (壓簾窪蓋鏇範糧遞繭膚, 7.73) 更多	-	2014-06-04