主要研究目的：以江苏恩华药业股份有限公司研制生产的盐酸硫必利片（规格：100 mg/片）为受试制剂，以持证商Sanofi S.p.A.、生产商Delpharm Dijon-6或Famar Health Care Services Madrid生产的盐酸硫必利片（商品名：SEREPRILE®; 规格：100 mg/片）为参比制剂，研究两制剂在中国健康成年受试者中于餐后/空腹状态下的吸收速度和吸收程度，评价两制剂间的生物等效性。次要研究目的：评估健康受试者单次餐后/空腹口服盐酸硫必利片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to use the sulpride hydrochloride tablets (specification: 100 mg/tablet) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation, and the sulpride hydrochloride tablets (trade name: SEREPRILE®; specification: 100 mg/tablet) produced by the licensed manufacturer Sanofi S.p.A., the manufacturer Delpharm Dijon-6 or Famar Health Care Services Madrid as the reference preparation, to study the absorption rate and extent of the two preparations in healthy adult Chinese subjects in the fed/fasting state, and to evaluate the bioequivalence between the two preparations. The secondary purpose of the study is to evaluate the safety of the sulpride hydrochloride tablets test preparation and the reference preparation after a single oral administration of the sulpride hydrochloride tablets to healthy subjects after a meal/fasting.

Start Date08 Apr 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

CTR20240869 / CompletedNot Applicable

盐酸硫必利片人体生物等效性试验

[Translation] Bioequivalence study of tiapride hydrochloride tablets in human body

主要研究目的：以江苏恩华药业股份有限公司研制生产的盐酸硫必利片（规格：100 mg/片）为受试制剂，以持证商Sanofi S.p.A.、生产商Delpharm Dijon-6或Famar Health Care Services Madrid生产的盐酸硫必利片（商品名：SEREPRILE® 规格：100 mg/片）为参比制剂，研究两制剂在中国健康成年受试者中于餐后/空腹状态下的吸收速度和吸收程度，评价两制剂间的生物等效性。次要研究目的：评估健康受试者单次餐后/空腹口服盐酸硫必利片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to use the sulpride hydrochloride tablets (specification: 100 mg/tablet) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation, and the sulpride hydrochloride tablets (trade name: SEREPRILE®, specification: 100 mg/tablet) produced by the licensed manufacturer Sanofi S.p.A., the manufacturer Delpharm Dijon-6 or Famar Health Care Services Madrid as the reference preparation, to study the absorption rate and extent of the two preparations in healthy adult Chinese subjects in the postprandial/fasting state, and to evaluate the bioequivalence between the two preparations. Secondary purpose of the study: to evaluate the safety of the test preparation and reference preparation of sulpride hydrochloride tablets after a single oral administration of the test preparation and reference preparation in healthy subjects after a meal/fasting.

Start Date08 Apr 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

CTR20240007 / CompletedNot Applicable

盐酸硫必利片人体生物等效性试验预试验

[Translation] Preliminary study on bioequivalence of tiapride hydrochloride tablets in humans

以江苏恩华药业股份有限公司研制生产的盐酸硫必利片（规格：100 mg/片）为受试制剂，以持证商Sanofi S.p.A.、生产商Delpharm Dijon-6或Famar Health Care Services Madrid生产的盐酸硫必利片（商品名：SEREPRILE® 规格：100 mg/片）为参比制剂，研究两制剂在中国健康成年受试者中于空腹状态下的吸收速度和吸收程度，初步评价两制剂间的生物等效性，并为后期正式生物等效性试验方案的采血点、清洗期设计及样本量方面提供依据。

[Translation]

Tiapride Hydrochloride Tablets (Specification: 100 mg/tablet) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. were used as the test preparation, and Tiapride Hydrochloride Tablets (Trade Name: SEREPRILE® Specification: 100 mg/tablet) produced by the licensed trader Sanofi S.p.A., the manufacturer Delpharm Dijon-6 or Famar Health Care Services Madrid were used as the reference preparation. The absorption rate and extent of the two preparations in healthy adult subjects in the fasting state were studied, and the bioequivalence between the two preparations was preliminarily evaluated. This also provided a basis for the blood collection points, washout period design and sample size of the formal bioequivalence test plan in the later stage.

Start Date03 Jan 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

100 Clinical Results associated with Tiapride Hydrochloride

100 Translational Medicine associated with Tiapride Hydrochloride

100 Patents (Medical) associated with Tiapride Hydrochloride

533

Literatures (Medical) associated with Tiapride Hydrochloride

01 Dec 2024·JOURNAL OF ETHNOPHARMACOLOGY

Volatile oil from Acori graminei Rhizoma affected the synaptic plasticity of rats with tic disorders by modulating dopaminergic and glutamatergic systems

Article

Author: Feng, Peng ; Tian, Yongyan ; Shang, Jing ; Guo, Junxiong ; Xu, Xiaomin ; Ding, Yanqin ; Wei, Xing ; Shi, Zheng Gang ; Sun, Kexin ; Chen, Yuanhuan

ETHNOPHARMACOLOGICAL RELEVANCE:

Acori graminei Rhizoma is a commonly used traditional Chinese medicine for treating TD, with its main component being calamus volatile oil. Volatile Oil from Acori graminei Rhizoma(VOA)can protect nerve cells and alleviate learning and memory disorders. However, the mechanism of anti-tic of VOA is still unclear.

AIM OF THE STUDY:

We aimed to explore the effects of Volatile Oil from Acori Tatarinowii Rhizoma (VOA) on striatal dopaminergic and glutamatergic systems and synaptic plasticity of rats with Tic Disorder (TD), as well as its pharmaceutical mechanism against TD.

MATERIALS AND METHODS:

This study involved 48 (three-week-old) Sprague Dawley (SD) rats, which were randomly divided into two primary groups: Control (8) and TD (40). Rats in the TD group were injected intraperitoneally with 3,3-iminodipropionitrile (IDPN) to construct the TD rat model. They were divided into five subgroups: Model, Tiapride, VOA-high, VOA-medium, and VOA-low (N=8). After modeling, VOA was administrated to rats in the VOA groups through gavage (once/day for four consecutive weeks), while rats in the blank control and model groups received normal saline of the same volume. The animals' behavioral changes were reflected using the stereotypic and motor behavior scores. After interferences, patterns of striatal neurons and the density of dendritic spines were investigated using H&E and Golgi staining, and the ultrastructure of striatal synapses was examined using Transmission Electron Microscopy (TEM). Furthermore, Ca²⁺ content was determined using the Ca²⁺ detector, and Dopamine (DA) and Glutamate (GLU) contents in serum and striatum were detected through ELISA. Finally, DRD1, DRD2, AMPAR1, NMPAR1, DAT, VMAT2, CAMKⅡ, and CREB expression in the striatum was detected using Quantitative real-time PCR (qRT-PCR),Western Blotting (WB) and Immunohistochemical (IHC) methods.

RESULTS:

Compared to rats in the blank control and model groups, rats in the VOA groups showed lower stereotypic behavior scores. Furthermore, rats in the VOA groups exhibited relieved, neuron damage and increased quantities of neuronal dendrites and dendritic spines Additionally, based on TEM images show that, the VOA groups showed a clear synaptic structure and increased amounts of postsynaptic dense substances and synaptic vesicles. The VOA groups also exhibited reduced Ca²⁺ contents, and upregulation of DRD1, DRD2, DAT, AMPAR1, and NMPAR1 and downregulation of VMAT-2, CAMKⅡ, and CREB in the striatum.

CONCLUSIONS:

In summary, VOA could influence synaptic plasticity by tuning the dopaminergic and glutamatergic systems, thus relieving TD.

02 Oct 2024·Expert Review of Neurotherapeutics

An update on the pharmacological management of Tourette syndrome and emerging treatment paradigms

Review

Author: Lenka, Abhishek ; Jankovic, Joseph

INTRODUCTION:

Tourette syndrome (TS) is a childhood-onset neurobehavioral disorder characterized by tics. Pharmacotherapy is advised for patients whose symptoms affect their quality of life.

AREAS COVERED:

The authors review the tic phenomenology and TS diagnostic criteria. The bulk of this article focuses on pharmacotherapeutic options for treating tics. They also highlight pharmacotherapies in the research pipeline.

EXPERT OPINION:

Tic treatment must be tailored to individual needs. Behavioral therapy is the first line of treatment. Most with bothersome tics need pharmacotherapy and rarely, for medication-refractory cases, surgical therapy is indicated. Alpha-2 agonists are considered in patients with mild tics, especially in those with attention deficit with or without hyperactivity. Second-generation antipsychotics like aripiprazole and tiapride may be considered for severe tics. However, prescribers should be mindful of potential side effects, especially drug-induced movement disorders. Botulinum toxin injections may be considered for focal motor tics. Topiramate can be considered when other treatments are ineffective, and its benefits outweigh the risks. The same holds true for vesicular monoamine transporter-2 inhibitors, as they are deemed to be safe and effective in real-world use and open-label trials despite not meeting primary endpoints in placebo-controlled trials. Cannabinoids may be considered in adults if the approaches above do not control tics.

19 Mar 2024·Cureus

Acute Hemichorea in an Elderly Patient With Positive Anti-centromere Antibodies and Lung Tumor

Author: Obara, Koji

Though rare, autoimmune paraneoplastic and non-paraneoplastic chorea can be leading causes of adult-onset acute/subacute chorea. Here, we report a case of acute-onset chorea with suspected autoimmune-mediated mechanisms in a 79-year-old female who exhibited acute-onset choreiform movements on the right side of her body. She tested positive for anti-centromere antibodies (ACAs) without displaying symptoms of scleroderma. Blood sugar levels, genetic testing for Huntington's disease, and an antibody panel related to paraneoplastic neurological syndrome were unremarkable. Brain magnetic resonance imaging revealed no significant abnormalities. Computed tomography (CT) identified an irregularly shaped nodule in the middle lobe of the right lung. An 18F-fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET)-CT scan showed an accumulation of radioactivity in the nodule and slight hypermetabolism in the striatum of both hemispheres. Her choreiform movements almost disappeared with a low dose of tiapride alone, without the need for anti-tumor therapy or immunotherapy. In cases of adult-onset acute/subacute chorea, investigating neoplasms and autoimmune diseases as underlying conditions is recommended. Tiapride, due to its good tolerability, is a valuable symptomatic therapy for elderly patients presenting with chorea, even in cases driven by autoimmune mechanisms.

News (Medical) associated with Tiapride Hydrochloride

13 Jul 2022

·endpts.com

Sanofi CEO Paul Hudson offloads two portfolios to German pharma company in continued effort to prune products

Sanofi warned earlier this year that some serious cuts were in order. CEO Paul Hudson made good on that promise this week, pruning more than a dozen marketed products. Germany-based Neuraxpharm revealed yesterday that it struck a deal for Sanofi’s CNS and pain and vascular disease portfolios. While the companies are keeping the financial terms under wraps for now, Neuraxpharm did say it’s swallowing 17 products representing 38 brands, including neuroleptics Nozinan and Tiapridal, anxiety med Tranxene and antipsychotics Dogmatil and Largactil. Within the pain and vascular portfolio, Neuraxpharm is getting pain narcotic Topalgic and Trental, which is used to improve blood flow. Neuraxpharm expects that the new products will boost sales to about $600 million this year. “There is significant growth potential in the pharmaceutical sector, especially in the CNS market driven by an aging population and an increasing awareness of mental health,” CEO Jörg-Thomas Dierks said in a news release. “With the upcoming acquisition, we will not only strengthen our presence in Europe, but also lay the ground for further expanding our international presence.” The new drugs will contribute to a portfolio of CNS drugs, as well as generics and consumer healthcare products such as nutraceuticals and probiotics, according to Neuraxpharm’s website. The company has main offices in Germany and Spain, with additional locations throughout Europe. Hudson has been on a mission to reshape Sanofi since he took the helm in 2019. He said earlier this year that nothing is off the table when it comes to restructuring, and has already culled a handful of programs. During the Q1 call, EVP of general medicines Olivier Charmeil said the company is looking to shave the general medicines unit down to about 125 product families, either by divesting or discontinuing programs. That’s a big difference from late 2019 and early 2020, when the unit boasted more than 350 product families. The company also revealed in its Q4 results that it plans on axing about 6,000 jobs in an effort to become more “agile.” Execs said at the time that they were aiming for a headcount of around 90,000 by the end of the year.

Generic DrugAcquisition

12 Jul 2022

·www.prnewswire.com

Neuraxpharm to increase branded business through upcoming acquisition of established products from Sanofi

Neuraxpharm, the central nervous system (CNS) specialist, to acquire two portfolios of established products for CNS disorders, pain and vascular diseases DUSSELDORF, Germany and BARCELONA, Spain, July 12, 2022 /PRNewswire/ -- Neuraxpharm Group ("Neuraxpharm") today announced that it has entered into a definitive agreement to acquire two product portfolios for CNS disorders, pain and vascular diseases from Sanofi. With the upcoming acquisition, Neuraxpharm will strengthen its position as a leading European specialty pharmaceutical company focused on CNS. The well-established products that Neuraxpharm will acquire are marketed globally in more than 50 countries. The first portfolio combines 15 products addressing CNS disorders and ranging across psychiatry and neurology. The second portfolio includes two products in pain and vascular diseases. Following the acquisition of these new portfolios, Neuraxpharm's annual gross sales will be around EUR 0.6 billion. The products benefit patients across a large spectrum of diseases including depression, anxiety, psychosis, alcohol dependence, myasthenia gravis and Parkinson disease. The CNS portfolio notably includes Nozinan®, Tranxene®, Tiapridal®, Dogmatil®, Largactil®. The pain and vascular portfolio includes Topalgic® and Trental®. Combined, both portfolios include 17 molecules representing 38 brands. These global brands will further solidify Neuraxpharm's position as a leading CNS pharmaceutical company in Europe and increase the company's global footprint and business. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, said: "There is significant growth potential in the pharmaceutical sector, especially in the CNS market driven by an ageing population and an increasing awareness of mental health. This phenomenon is a global trend. With the upcoming acquisition, we will not only strengthen our presence in Europe, but also lay the ground for further expanding our international presence." About the Group Neuraxpharm – the European CNS specialist Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS) with a direct presence in 19 countries. Backed by funds advised by Permira, Neuraxpharm has a unique understanding of the CNS market built over 35 years. With its focus on CNS, Neuraxpharm develops and commercializes established brands, value added medicines, generics, Consumer Healthcare products, medical cannabis and beyond-the-pill solutions and is continuously striving to offer a wide range of effective, high quality and affordable CNS treatment options in Europe. Present with its products in more than 50 countries, Neuraxpharm also manufactures pharmaceutical products and active pharmaceutical ingredients in its own manufacturing sites, Lesvi and Inke, in Spain. For more information please visit SOURCE Neuraxpharm

Generic DrugAcquisition

100 Deals associated with Tiapride Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01522	Tiapride Hydrochloride	N05AL03	DB13025

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Brain Infarction	JP	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1987
Motor Disorders	JP	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1987
Dyskinesias	CN	Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.	01 Jan 1985
Parkinson Disease	CN	Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.	01 Jan 1985

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tourette Syndrome	Phase 3	-	Tasly Pharmaceuticals, Inc.	01 Jan 2008

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