Comparative Effectiveness of Zonisamide Monotherapy, Tiapride Monotherapy, and Combination Therapy in Pediatric Tic Disorders: A Real-World Prospective Cohort Study

Start Date01 Mar 2025

Sponsor / Collaborator

Children’S Hospital Of Chongqing Medical University

CTR20242255

/ 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 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.

100 Clinical Results associated with Tiapride Hydrochloride

100 Translational Medicine associated with Tiapride Hydrochloride

100 Patents (Medical) associated with Tiapride Hydrochloride

916

Literatures (Medical) associated with Tiapride Hydrochloride

01 Jun 2025·Journal of Chromatography A

Analytical methodology for challenging persistent, mobile, and toxic substances in vegetal matrices after irrigation with contaminated water

Article

Author: Bijlsma, Lubertus ; Pitarch-Motellón, Jorge ; Gregorio-Lozano, Sergi ; Bolos-Sánchez, Victoria ; Pitarch, Elena

Reusing wastewater for irrigation is proposed as a strategy to address water scarcity. However, the long-term environmental consequences of this practice are still unknown, especially when reclaimed water contains contaminants of emerging concern, such as persistent, mobile, and toxic (PMT) compounds, due to the inefficiency of wastewater treatment plants in removing certain pollutants. As a result, irrigation with contaminated water could lead to their uptake by crops and enter the food chain. While data on the presence of PMTs in environmental samples is starting to emerge, the analysis of certain compounds in vegetable matrices remains unexplored. In this study, an analytical methodology was developed and validated for the determination of 8 PMTs (i.e., benzophenone-3, clarithromycin, imazalil, metformin, sulpiride, terbutryn, tiapride, and tramadol) in escarole, tomatoes, and tomato leaves. The proposed analytical methodology used a QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) extraction method prior to mixed-mode liquid chromatography tandem mass spectrometry analysis. Method validation, performed according to SANTE guidelines, presented satisfactory results at studied concentrations (1, 10 and 100 ng·g^-1 for each compound/matrix combination, except for metformin in escarole (50 and 500 ng·g^-1). Recoveries ranged from 70 to 120 %, with a precision of ≤ 20 % for most compounds. Benzophenone-3 and tiapride, for which no isotopically labelled internal standard was available, could be adjusted by applying a correction factor. The limit of quantification was 1 ng·g^-1 for all compounds in the three matrices, except for benzophenone-3 and metformin in both escarole and tomato leaves. The applicability of the method was tested by analysing samples from an experimental greenhouse plot where crops were irrigated with water spiked with the selected PMTs.

01 Apr 2025·Journal of Environmental Chemical Engineering

Ozone injection system based on NETmix technology for quaternary treatment of urban wastewater

Author: Moreira, Francisca C. ; Pituco, Mateus Mestriner ; Mendez, Sandra ; Vilar, Vitor J. P. ; Rodil, Rosario ; Montes, Rosa ; Marrocos, Paulo H.

An innovative high-intensity static mixer technol., known as NETmix, was applied as an ozone (O₃) gas injection system to promote the quaternary treatment of urban wastewater (UWW), focusing on the elimination of contaminants of emerging concern (CECs).The NETmix network with an exclusive geometry boosts mass transfer rates and rapidly develops an O₃-rich stream to react with CECs.The mixer operated in continuous mode promotes a rapid gas (O₃)-liquid (water) dissolutionThe ozonation process' performance was evaluated for the abatement of 19 CECs spiked (10μg dm^-3 each) in demineralized water and two tertiary-treated UWW matrixes, coming from (i) a secondary settler tank after a conventional activated sludge and (ii) the outlet of a membrane biol. reactor (MBR).In addition, the ozonation system was tested for removing a broad range of CECs at natural trace levels from the UWW matrix coming from the MBR.In the realistic wastewater contamination scenario, a maximum transferred O₃ dose of 1.28 gO₃ g^-1DOC and 0.76 gO₃ g^-1DOC resulted in removal values ≥80% for 12 out of the 19 spiked CECs from the secondary settler tank, and 9 out of the 19 spiked CECs from the post-MBR treatment, resp., at a very short hydraulic residence time (55 s).Moreover, removals ≥80% were attained for 22 out of 25 CECs detected in the effluent from the MBR, applying a specific O₃ dose of 0.6 gO3g^-1DOC.The enhanced ozone-water mass transfer provided by the NETmix technol. enabled high removal efficiencies for CECs.

01 Feb 2025·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

Effects of acupuncture combined with bone-setting therapy to treat tourette syndrome: a three-arm randomized controlled trial.

Article

Author: Jianchang, Luo ; Jiawang, Lang ; Lingqing, Jin ; Boxu, Lang

OBJECTIVETo explore the efficacy and safety of acupuncture combined with atlantoaxial joint bone-setting therapy for the treatment of Tourette syndrome.METHODSWe randomly divided 600 patients at a ratio of 1∶1∶1 into three groups: group A (acupuncture combined with atlantoaxial joint bone setting therapy group), group B (acupuncture group), and group C (tiapride group). After two months of treatment, the Yale global tic severity scale (YGTSS) score reduction, improvement in social function impairment, clinical efficacy, and long-term efficacy in the three groups were compared.RESULTSAfter treatment, in the analysis of YGTSS score reduction, social function impairment improvement, the clinical control rate, and long-term efficacy, the results were all Group A > Group B > Group C, with a statistically significant difference (P < 0.05). However, the total clinical efficacy of treatment in group A (94.9%) was not significantly different from that in group B (91.8%). Adverse reactions did not occur in groups A and B, and several adverse reactions occurred in 29% (n = 58) of the group C patients.CONCLUSIONCompared with traditional drug therapy, acupuncture combined with atlantoaxial joint bone setting therapy has better clinical and long-term efficacy. This treatment strategy can improve the social function of children and prevent adverse reactions to drugs.

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	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1987
Motor Disorders	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	31 Mar 1987
Dyskinesias	China	Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.	01 Jan 1985
Parkinson Disease	China	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	Preclinical	-	Tasly Pharmaceuticals, Inc.	01 Jan 2008

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