Delving into the Latest Updates on Pinaverium bromide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Pinaverium bromide (INN), Pinaverium bromide (PVB)

+ [5]

Target

VDCCs

Mechanism

VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Digestive System DisordersInfectious DiseasesOther Diseases

Active Indication

GastrospasmSepsis

Inactive Indication-

Originator Organization

Abbott Laboratories

Active Organization

Southern Medical University

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

RegulationPriority Review (CN)

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Structure

Molecular FormulaC26H41Br2NO4

InChIKeyIKGXLCMLVINENI-UHFFFAOYSA-M

CAS Registry53251-94-8

主要研究目的研究餐后状态下口服受试制剂（T）匹维溴铵片（规格：50 mg，华益药业科技（安徽）有限公司生产，广东稳健药业有限公司提供）与参比制剂（R）匹维溴铵片（商品名：Dicetel®，规格：50 mg，Abbott Laboratories Limited）在健康成年受试者体内的药代动力学，评价两种制剂的生物等效性。次要研究目的评价中国健康受试者餐后状态下口服受试制剂（T）匹维溴铵片和参比制剂（R）匹维溴铵片（Dicetel®）后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation (T) Pinaverium Bromide Tablets (Specification: 50 mg, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd., provided by Guangdong Wenjie Pharmaceutical Co., Ltd.) and the reference preparation (R) Pinaverium Bromide Tablets (trade name: Dicetel®, specification: 50 mg, Abbott Laboratories Limited) in healthy adult subjects after oral administration in the fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation (T) Pinaverium Bromide Tablets and the reference preparation (R) Pinaverium Bromide Tablets (Dicetel®) after oral administration in healthy Chinese subjects in the fed state.

Start Date02 Oct 2024

Sponsor / Collaborator

Guangdong Wenjian Pharmaceutical Co.,Ltd.

CTR20241888 / CompletedNot Applicable

匹维溴铵片在健康人群中的生物等效性试验

[Translation] Bioequivalence study of pinaverium bromide tablets in healthy people

研究空腹/餐后状态下单剂量口服受试制剂匹维溴铵片（规格：50 mg，北京福元医药股份有限公司生产）与参比制剂匹维溴铵片（规格：50 mg，商品名：得舒特Dicetel，MYLAN LABORATORIES SAS生产，ABBOTTLABORATORIES LIMITED持证）在健康受试者体内的药代动力学，评价空腹/餐后状态下口服两种制剂的生物等效性。研究受试制剂匹维溴铵片和参比制剂得舒特Dicetel在健康受试者中的安全性。

[Translation]

The pharmacokinetics of the test preparation Pinaverium Bromide Tablets (Specification: 50 mg, produced by Beijing Fuyuan Pharmaceutical Co., Ltd.) and the reference preparation Pinaverium Bromide Tablets (Specification: 50 mg, trade name: Dicetel, produced by MYLAN LABORATORIES SAS, licensed by ABBOTTLABORATORIES LIMITED) in healthy subjects after single oral administration in the fasting/postprandial state were studied to evaluate the bioequivalence of the two preparations taken orally in the fasting/postprandial state. The safety of the test preparation Pinaverium Bromide Tablets and the reference preparation Dicetel in healthy subjects was studied.

Start Date03 Jun 2024

Sponsor / Collaborator

Beijing Winsunny Pharmaceutical Co., Ltd.

CTR20240776 / CompletedNot Applicable

匹维溴铵片在健康受试者中随机、开放、单剂量、两制剂、重复交叉对照空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, repeated crossover controlled bioequivalence study of pinaverium bromide tablets in healthy subjects under fasting and fed conditions

研究空腹及餐后状态下单次口服受试制剂匹维溴铵片（规格：50mg，浙江高跖医药科技股份有限公司持证）与参比制剂匹维溴铵片（商品名：Dicetel®/得舒特®，规格：50mg，Abbott Laboratories Limited持证）在健康成年受试者体内的药代动力学，评价空腹及餐后状态下口服两种制剂的生物等效性。

[Translation]

The pharmacokinetics of the test preparation, Pinaverium Bromide Tablets (Specification: 50 mg, licensed by Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd.) and the reference preparation, Pinaverium Bromide Tablets (Trade name: Dicetel®/Deshute®, Specification: 50 mg, licensed by Abbott Laboratories Limited) were studied in healthy adult subjects after a single oral administration in fasting and fed state, and the bioequivalence of the two preparations after oral administration in fasting and fed state was evaluated.

Start Date12 Apr 2024

Sponsor / Collaborator

Zhejiang Gaozhi Pharmaceutical Technology Co., LtdStartup

100 Clinical Results associated with Pinaverium bromide

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100 Translational Medicine associated with Pinaverium bromide

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100 Patents (Medical) associated with Pinaverium bromide

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167

Literatures (Medical) associated with Pinaverium bromide

01 Nov 2024·Cell Reports

A platform of functional studies of ESCC-associated gene mutations identifies the roles of TGFBR2 in ESCC progression and metastasis

Article

Author: Li, Yaxin ; Zou, Yang ; Wan, Xudong ; Wang, Manli ; Xiong, Xingyu ; Hu, Bing ; Guo, Linjie ; Lin, Huahang ; Chen, Longqi ; Liu, Hongyu ; Zhang, Shiyu ; Chen, Xuelan ; Chen, Chong ; Lu, Zhenghao ; Na, Feifei ; Wang, Jian ; Zhou, Jianfeng ; Lu, Runda ; Dai, Siqi ; Du, Jiajia ; Liu, Yixin ; Li, Yuan ; Wang, Yingjie ; Zhang, Qi ; Zhang, Mengsha ; Pan, Xiangyu ; Liu, Yu ; Luo, Xiangmeng ; Wang, Lu ; Tan, Ping ; Wu, Baohong ; Zhong, Ailing ; Han, Zongkai

Genomics studies have detected numerous genetic alterations in esophageal squamous cell carcinoma (ESCC). However, the functions of these mutations largely remain elusive, partially due to a lack of feasible animal models. Here, we report a convenient platform with CRISPR-Cas9-mediated introduction of genetic alterations and orthotopic transplantation to generate a series of primary ESCC models in mice. With this platform, we validate multiple frequently mutated genes, including EP300, FAT1/2/4, KMT2D, NOTCH2, and TGFBR2, as tumor-suppressor genes in ESCC. Among them, TGFBR2 loss dramatically promotes tumorigenesis and multi-organ metastasis. Paradoxically, TGFBR2 deficiency leads to Smad3 activation, and disruption of Smad3 partially restrains the progression of Tgfbr2-mutated tumors. Drug screening with tumor organoids identifies that pinaverium bromide represses Smad3 activity and restrains Tgfbr2-deficient ESCC. Our studies provide a highly efficient platform to investigate the in vivo functions of ESCC-associated mutations and develop potential treatments for this miserable malignancy.

28 Aug 2024·IUCrData

Pinaverium bromide

Article

Author: Rousselin, Yoann ; Clavel, Alexandre

The structure of pinaverium bromide (systematic name: 4-[(2-bromo-4,5-dimethoxyphenyl)methyl]-4-{2-[2-(6,6-dimethyl-2-bicyclo[3.1.1]heptanyl)ethoxy]ethyl}morpholin-4-ium bromide; C26H41Br2NO4), was determined at 110 K. It has monoclinic (P21) symmetry. It is of interest with respect to its anti-inflammatory properties. The asymmetric unit contains two independent molecules, one of which exhibits disorder of the bicyclo terminal group (occupancy factors: 0.78 and 0.22).

01 Jun 2024·Environmental Toxicology and Pharmacology

Acute exposure and biomarkers assessment in rainbow trout exposed to selected pharmaceuticals

Article

Author: Auclair, J ; Gagné, F ; André, C

Pharmaceuticals released from municipal effluents discharges pose a risk to aquatic organisms. The toxicity of 5 pharmaceuticals with distinct therapeutic actions were assessed in rainbow trout: olanzapine (antipsychotic), erythromycin (antibiotic), mycophenoate (immunosuppression), pinaverium (anti-inflammatory) and trazodone (sedative). Juveniles were exposed to these drugs for 96 h at concentrations between 64 µg/L up to 40 mg/L to reach lethality. Survival was determined and a suite of biomarkers was analyzed for drug biotransformation, oxidative stress/damage and metabolic activity at sublethal concentrations. The data revealed the following toxicity: olanzapine >trazodone>mycophenolate>pinaverium∼erythromycin based on mortality. The data also revealed that toxicity was associated to mass, pKa and hydrophobicity and the following sublethal effects: GST, LPO and DNA strand breaks. Pharmaceuticals with lower molecular weight, physiological pKa, moderate hydrophobicity, low biotransformation and DNA strand breaks were generally more toxic to fish. However, this should be considered as a general guide in identifying toxic pharmaceuticals in non-target organisms.

100 Deals associated with Pinaverium bromide

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External Link

KEGG	Wiki	ATC	Drug Bank
D07094	Pinaverium bromide	A03AX04	DBSALT001130

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrospasm	CN	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sepsis	Preclinical	CN	Southern Medical University	01 Jan 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2014	Not Applicable	Irritable Bowel Syndrome	-	Pinaverium bromide 100 mg + simethicone 300 mg	eirowzszdb(cwxvnpqpsr) = cfsnyzojjx kvqhyejchu (hiuyslqkee )	-	01 Oct 2014