A Controlled Clinical Trial to Evaluate the Efficacy and Safety of Comprehensive Behavioral Intervention for Tics (CBIT) Combined with Low-Dose Tiapride in Children with Tic Disorders

Start Date16 Jan 2026

Sponsor / Collaborator-

CTIS2024-518769-80-00

/ Active, not recruitingPhase 4

HAMLETT; Handling Antipsychotic Medication: Long-term Evaluation of Targeted Treatment. A pragmatic single blind RCT of continuation versus discontinuation/ dose reduction of antipsychotic medication in patients remitted after a first episode of psychosis

Start Date25 Nov 2024

Sponsor / Collaborator

Universitair Medisch Centrum Groningen

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

750

Literatures (Medical) associated with Tiapride Hydrochloride

01 May 2026·JOURNAL OF NEUROIMMUNOLOGY

Effect of pharmacological intervention and pathogenesis discussion about rats with tic disorders

Article

Author: Chen, Zijia ; Wang, Sumei ; Xue, Xiaona ; Liu, Xiaofang ; Lin, Lvping ; Jiang, Xiaohong

To investigate the pathogenesis of Tic disorders (TD), particularly their relationship with central nervous system inflammation, we conducted an animal experiment. A TD model was established for rats, and their behavior and immune cytokines and receptor in the striatum were compared between a diseased group and healthy control group of rats. After receiving effective drug interventions (the traditional Chinese medicine Jian-Pi-Zhi-Dong decoction (JPZDD) and the Western medicine Tiapride), we observed changes in behavior and immune cytokine and receptor expression in the striatum and analyzed the association between central nervous system inflammation and TD. The results are as follows: (1) Successful modeling: Compared to normal rats, TD diseased rats exhibited increased spontaneous activity, stereotypical exercise, and elevated expression of inflammatory cytokines and receptor in the striatum. (2) Effective pharmacological intervention: Tiapride and JPZDD reduced spontaneous activity, stereotypical exercise, and the expression of inflammatory cytokines and receptor in rats with TD. (3) The number of spontaneous activities and stereotypical exercise scores was positively correlated with central nervous system inflammation. The expression of Toll-like receptor 4 (TLR4), interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-alpha (TNF-α) in the striatum of the diseased group rats were significantly greater than those in the striatum of the normal group rats. Effective pharmacological intervention reduced the expression of inflammatory cytokine and receptor in the striatum, bringing them to expression similar to those in normal rats. Based on these results, we conclude that TD is associated with central nervous system inflammation and that the severity of TD is positively correlated with the severity of central nervous system inflammation. We hypothesize that the pathogenesis of TD may involve elevated TLR4, which triggers overactivation of microglia in the brain resulting in the release of excessive IL-6, IL-8, and TNF-α. This process damages neurons and leads to tic symptoms in patients.

01 Dec 2025·Drugs-Real World Outcomes

Use of Dysphagia-Inducing Drugs and Risk of Aspiration Pneumonia: A Cross-Sectional Analysis Using a Japanese Claims Database

Article

Author: Kobayashi, Noriko ; Ogawa, Masanori ; Kondo, Shingo ; Yamaura, Katsunori ; Hayashi, Naoko ; Maida, Narumi ; Iwata, Hiroki ; Yoshida, Mari

BACKGROUND AND OBJECTIVES:

Oropharyngeal dysphagia (OD), a dysfunction in swallowing food or drink, can result from various diseases and adverse drug reactions. OD is a risk factor for aspiration pneumonia (AP). However, the specific drugs causing OD and their incidence rates are not fully understood. This study aimed to identify drugs associated with OD, their incidence rates, and AP risk factors in patients taking these drugs on the basis of the information provided in package inserts.

METHODS:

This study identified candidate dysphagia-inducing drugs (CDIDs) from Japanese package inserts that listed OD as an adverse reaction. The age, sex, medications, and comorbidities of patients taking CDIDs were analyzed using the JammNet insurance database, purchased from JammNet Co., Ltd. (Tokyo, Japan).

RESULTS:

Overall, 54 ingredients were identified as CDIDs. Out of 24,276 patients taking CDIDs, 146 (0.6%) were diagnosed with OD and 76 (0.3%) with AP. Among those with AP, 23 patients (30%) also had OD. OD or AP occurred in patients taking 28 (52%) of the 54 target ingredients. In addition, 13 ingredients had an adverse reaction incidence of 1% or greater for either condition. The top five CDIDs with the highest incidence rates for each diagnosis were clobazam, baclofen, zonisamide, tiapride hydrochloride, and topiramate. Incidence rates of OD and AP were significantly higher with multiple CDIDs than with a single drug (p < 0.05). Logistic regression analysis showed that AP occurrence was significantly associated with males, late-stage elderly individuals, a diagnosis of OD, and constipation.

CONCLUSIONS:

The results of this study suggest that careful attention should be given to the risk of AP when prescribing CDIDs, particularly for elderly male patients.

01 Nov 2025·IMMUNOBIOLOGY

Changpu Yujin Tang mitigates tourette syndrome by enhancing mitophagy and suppressing NLRP3 inflammasome-mediated pyroptosis

Article

Author: Huang, Liwei ; He, Yuezhen ; Xue, Fuchun ; Sun, Mingyang ; Li, Mengxue ; Sun, Kexin ; Gao, Lv ; Shang, Jing ; Shi, Zhenggang ; Lu, Manqi ; Jiang, Bing ; Wei, Xing ; Huang, Shuang

BACKGROUND:

Changpu Yujin Tang (CPYJT) is an effective Chinese herbal compound for treating Tourette syndrome (TS). However, its precise molecular mechanisms remain to be fully elucidated.

METHODS:

105 SD rats were randomly divided into the Control (n = 15) and the TS (n = 90) groups. The TS group was induced by intraperitoneal injection of 3,3'-iminodipropionitrile. After successful modeling, the TS group was further divided into 6 subgroups (n = 15 in each group): the Model group, the Tiapride group, the CPYJT group, the Rapamycin (RAPA) group, the 3-methyladenine (3-MA) group, and the CPYJT +3-MA group, and were treated with the corresponding drugs for 4 weeks.

RESULTS:

Compared with the Control group, rats in the Model group showed increased stereotyped and motor behaviors, damage to striatal neuronal cells and mitochondrial ultrastructure, decreased PINK1/Parkin-mediated mitophagy, and activation of NLRP3 inflammasome. CPYJT reduced stereotyped and motor behaviors, attenuated neuronal cell damage, and repaired mitochondrial pathology in the TS rats. Furthermore, both CPYJT and RAPA enhanced PINK1/Parkin-mediated mitophagy, eliminated ROS accumulation, and inhibited NLRP3 inflammasome activation. Notably, CPYJT counteracted 3-MA's inhibitory effect on PINK1/Parkin-mediated mitophagy, thereby suppressing NLRP3 inflammasome activation and pyroptosis.

CONCLUSION:

CPYJT inhibits NLRP3 inflammasome activation and reduces pyroptosis by enhancing PINK1/Parkin-mediated mitophagy and attenuating ROS accumulation, which in turn ameliorates TS.

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.

to view more data

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

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