Delving into the Latest Updates on Acotiamide Hydrochloride Hydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Acofide, Acotiamide, Acotiamide hydrochloride (USAN)

+ [9]

Target

A1R x AChE x M1 receptor x M2 receptor

Mechanism

A1R antagonists(Adenosine A1 receptor antagonists), AChE inhibitors(Acetylcholinesterase inhibitors), M1 receptor antagonists(Muscarinic acetylcholine receptor M1 antagonists)

+ [1]

Therapeutic Areas

Digestive System DisordersUrogenital Diseases

Active Indication

DyspepsiaUrinary Bladder, Underactive

Inactive Indication

Nausea

Originator Organization

Zeria Pharmaceutical Co., Ltd.

Active Organization

Zeria Pharmaceutical Co., Ltd.

Hunan Warrant Pharmaceutical Co., Ltd.

Hunan Jiudian Pharmaceutical Co., Ltd.

Inactive Organization

Astellas Pharma, Inc.

Nanjing Haina Pharmaceutical Technology Co Ltd.

Drug Highest PhaseApproved

First Approval Date

JP (25 Mar 2013),

Dyspepsia

Regulation-

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Structure

Molecular FormulaC21H37ClN4O8S

InChIKeyNPTDXIXCQCFGKC-UHFFFAOYSA-N

CAS Registry773092-05-0

View All Structures (2)

主要目的：以持证商为ゼリア新薬工業株式会社/アステラス製薬株式会社的盐酸阿考替胺片（商品名：Acofide®），规格：100mg）为参比制剂，以南京海纳医药科技股份有限公司研发的盐酸阿考替胺片（0.1g）为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两序列、四周期、完全重复交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Taking acotiamide hydrochloride tablets (trade name: Acofide®, specification: 100mg), which is licensed by Alyas Shinsui Industrial Co., Ltd./Asui Rakusu Co., Ltd., as the reference preparation, Nanjing Haina Pharmaceutical Technology Co., Ltd. The acotiamide hydrochloride tablets (0.1g) developed by the company are the test preparations and were evaluated through a single-center, randomized, open-label, single-dose, two-preparation, two-sequence, four-cycle, fully repeated crossover design clinical trial. Bioequivalence of two formulations in fasting and postprandial states in Chinese healthy subjects. Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.

Start Date07 Jun 2024

Sponsor / Collaborator

Nanjing Haina Pharmaceutical Technology Co Ltd.

CTRI/2022/08/044700 / Not yet recruitingPhase 4IIT

Randomized placebo controlled single blind study of the effectiveness of ACOTIAMIDE in functional dyspepsia

Start Date16 Aug 2022

Sponsor / Collaborator-

100 Clinical Results associated with Acotiamide Hydrochloride Hydrate

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100 Translational Medicine associated with Acotiamide Hydrochloride Hydrate

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100 Patents (Medical) associated with Acotiamide Hydrochloride Hydrate

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123

Literatures (Medical) associated with Acotiamide Hydrochloride Hydrate

28 Sep 2024·Cureus

Long-Term Vonoprazan and Acotiamide-Refractory Patients With Functional Dyspepsia Partly Exhibit Pancreatic Enzyme Abnormalities

Article

Author: Nakamura, Ken ; Futagami, Seiji ; Iwakiri, Katsuhiko ; Ueki, Nobue ; Agawa, Shuhei ; Higashida, Sakura ; Kawawa, Rie ; Habiro, Mayu ; Onda, Takeshi

BACKGROUNDAlthough a new potassium-competitive acid blocker (P-CAB) vonoprazan has been developed in Japan, no data are available regarding long-term vonoprazan or vonoprazan and acotiamide combination treatment in patients with functional dyspepsia (FD).METHODOLOGYA total of 73 consecutive patients with FD diagnosed according to the Rome III classification were enrolled. Forty-two patients with FD were treated with vonoprazan monotherapy and thirty-one patients with FD were treated with vonoprazan and acotiamide combination therapy for 24 weeks. The levels of five pancreatic enzymes were measured, and the overall treatment efficacy (OTE) was defined as the ratio of FD patients with improved or unchanged in all items of GSRS and FD symptom scores after the treatment.RESULTSTreatment with vonoprazan monotherapy and vonoprazan and acotiamide combination therapy significantly improved FD symptoms. There were no significant differences in OTE between patients treated with vonoprazan monotherapy (42.9%) and those treated with vonoprazan and acotiamide combination therapy (52%). There were no significant differences in duodenal eosinophilic infiltration between the improved and unimproved groups treated with vonoprazan alone and vonoprazan and acotiamide combination therapy, respectively. In contrast, there was a significant difference (P = 0.004) in the ratio of pancreatic enzyme abnormalities between the improved and unimproved patients treated with vonoprazan monotherapy and those treated with vonoprazan and acotiamide combination therapy.CONCLUSIONSLong-term vonoprazan alone or vonoprazan and acotiamide combination therapy significantly improved each FD symptom. The OTE in patients treated with vonoprazan alone or vonoprazan and acotiamide combination therapy was only 50%. Long-term vonoprazan and acotiamide combination therapy may differentiate patients with pancreatic enzyme abnormalities from those with FD.

31 Oct 2023·BMC gastroenterology

Prokinetics for the treatment of functional dyspepsia: an updated systematic review and network meta-analysis.

Review

Author: Liu, Han ; Qi, Qingqing ; Li, Yanqing ; Wang, Nana

BACKGROUNDSince the previous network meta-analysis assessing the efficacy of prokinetics for functional dyspepsia (FD), there have been a number of new studies and cinitapride is a new prokinetic agent for FD. This updated meta-analysis aimed to explore the efficacy and safety of prokinetics for FD.METHODSAn updated study search in Pubmed, EMBASE, Cochrane Library and Web of Science was conducted in literatures published from July 2015 to March 2023. Randomized controlled trials investigating the use of prokinetics in adult FD patients were included. The primary outcome was the total efficacy rate and the secondary outcome was adverse events. A Bayesian network meta-analysis was performed using R software.RESULTSA total of 28 studies were included. Network meta-analysis showed that metoclopramide had a higher total efficacy rate than mosapride (OR: 3.53, 95%CI: 1.70-7.47), domperidone (OR: 2.29, 95%CI: 1.16-4.63), itopride(OR: 2.77, 95%CI: 1.41-5.59), acotiamide(OR: 2.63, OR: 1.33-5.36), and placebo(OR: 5.68, 95%CI: 2.98-11.10), however similar to cinitapride (OR: 1.62, 95%CI: 0.75-3.53). Cinitapride had a higher total efficacy rate than mosapride (OR: 2.18, 95%CI: 1.16-4.14) and placebo (OR: 3.52, 95%CI: 2.01-6.24). Cinitapride had lower risk of total adverse events than domperidone. There was no difference in the risk of drug-related adverse events between the prokinetics.CONCLUSIONSMetoclopramide and cinitapride may have a better efficacy than other prokinetics in the treatment of FD, and cinitapride may have a lower risk of total adverse events. Further studies using uniform definitions or validated tools to measure the total efficacy rate are needed.

18 Jul 2023·Trials

Evaluating the efficacy and safety of acotiamide in patients with esophagogastric junction outflow obstruction: study protocol for an investigator-initiated, multi-center, randomized, double-blind, placebo-controlled phase II trial.

Article

Author: Esaki, Mitsuru ; Kawami, Noriyuki ; Watanabe, Hiroko ; Kuribayashi, Shiko ; Ogawa, Yoshihiro ; Ihara, Eikichi ; Ogino, Haruei ; Suzuki, Maya ; Uraoka, Toshio ; Kishimoto, Junji ; Iwakiri, Katsuhiko ; Misumi, Akiko ; Manabe, Noriaki ; Akiyama, Junichi ; Chinen, Takatoshi

BACKGROUNDWe have determined that the impaired accommodation of the lower esophageal sphincter (LES) underlies the pathogenesis of esophagogastric junction outflow obstruction (EGJOO). We have also found that acotiamide may treat EGJOO by improving impaired LES accommodation. The effects of acotiamide in patients with EGJOO need to be further confirmed in a prospective study.METHODSThis trial is a multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of acotiamide (300 mg/day or 600 mg/day) with those of a placebo in the treatment of patients with EGJOO. The primary endpoint will be the proportion of patients who report an improvement in symptom of food sticking in the chest after 4 weeks of treatment period 1. The secondary endpoints will be the proportion of patients with normalized integrated relaxation pressure (IRP), the value of change from baseline in the distal contractile integral, basal LES pressure, EGJOO-quality of life score, Gastrointestinal Symptom Rating Scale, and the correlation between IRP and each symptom score. During the 2-year trial period, 42 patients from five institutions will be enrolled.DISCUSSIONThis trial will provide evidence to clarify the efficacy and safety of acotiamide as a treatment for patients with EGJOO. Acotiamide might help improve the quality of life of patients with EGJOO and is expected to prevent the progression of EGJOO to achalasia.TRIAL REGISTRATIONThis study was approved by the Institutional Review Board (IRB) of Kyushu University Hospital as well as the local IRBs of the participating sites for clinical trials and registered in the Japan Registry of Clinical Trials (jRCT: 2071210072). The registration date is on October 11, 2021.

100 Deals associated with Acotiamide Hydrochloride Hydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D08838	Acotiamide Hydrochloride Hydrate	A16A	DB12482

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dyspepsia	JP	Zeria Pharmaceutical Co., Ltd.	25 Mar 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Bladder, Underactive	Phase 2	-	Zeria Pharmaceutical Co., Ltd.	-
Dyspepsia	Phase 1	JP	Astellas Pharma, Inc.	01 Aug 2008
Dyspepsia	Phase 1	JP	Astellas Pharma, Inc.	01 Aug 2008
Nausea	Discovery	US	Astellas Pharma, Inc.	10 Mar 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	Esophageal motor dysfunction	-	ACOTIAMIDE (Patients with EGJOO)	ysfscpainm(uwykckanlm) = Acotiamide was administered to address severe symptoms in six out of 13 patients with EGJOO. Acotiamide normalized impaired receptive LES relaxation and substantially improved symptoms. xwvwaoanqx (gaezrvdusg )	-	01 Oct 2016
				ACOTIAMIDE (Normal subjects)
NCT00761358 (Pubmed \| Gut)	Phase 3	Dyspepsia	-	Acotiamide 100 mg	(yihxzyxhcv) = ukmxwfqscv vivzokaalo (fpipvxsnnu )	Positive	01 Jun 2012
				Placebo	(yihxzyxhcv) = bizrobreig vivzokaalo (fpipvxsnnu )