西维美林(Cevimeline Hydrochloride) - 药物靶点：M1 receptor x M3 receptor_在研适应症：干燥综合征，抗合成酶综合征，口干症_专利_临床

A Phase 2, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Efficacy and Safety of Cevimeline Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

开始日期2024-12-31

申办/合作机构

Biotheravision, Inc.

ChiCTR2000033420

/ Recruiting早期临床1期IIT

Investigating the clinical efficacy of cevimeline in improving the symptoms of primary sjogren syndrome

开始日期2020-06-01

申办/合作机构-

NCT01903109

/ Completed早期临床1期

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fed conditions

开始日期2009-02-01

申办/合作机构

Roxane Laboratories, Inc.

100 项与西维美林相关的临床结果

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100 项与西维美林相关的转化医学

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100 项与西维美林相关的专利（医药）

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311

项与西维美林相关的文献（医药）

2025-07-01·Pharmacology Biochemistry and Behavior

The dosage-dependent effects of cevimeline in preventing clozapine-induced dyslipidaemia in female rats

Article

作者: Deng, Chao ; Lian, Jiamei ; Pan, Bo

Clozapine is the most effective second-generation antipsychotic drug, especially for the therapy of treatment-resistant schizophrenia. However, it is associated with metabolic side-effects. Clozapine has a high antagonistic affinity to muscarinic M3 receptors, which has been reported to play a significant role in these side-effects. This study aimed to investigate whether co-administration of cevimeline (an M3 receptor agonist) could prevent the metabolic disorders induced by clozapine. Female Sprague Dawley rats were treated orally with clozapine (20 mg/kg, 3 times daily) and/or cevimeline at three dosages (3, 6, 9 mg/kg, 3 times daily), or a vehicle for two weeks. Body weight gain, food/water intake, and temperature were recorded. Open field tests were performed to assess motor activity. Clozapine only treatment significantly decreased body weight gain, feeding efficiency, perirenal, periovary, inguinal, total white fat mass, and NEFA levels. The reduction in body weight gain and feeding efficiency caused by clozapine was partially reversed by co-treatment with 3 or 6 mg/kg cevimeline. Clozapine also significantly increased the liver mass, LDL, and HDL level, which were reversed by the co-treatment with cevimeline at all tested dosages. These results support further clinical trials to evaluate cevimeline's potential in controlling clozapine-induced dyslipidemia.

2025-01-01·Current Therapeutic Research

Efficacy of Cevimeline on Xerostomia in Sjögren's Syndrome Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Review

作者: Vaezzadeh, Seyed Hossein ; Karimi, Mehdi ; Hajikolaei, Fatemeh Ahmadi ; Hashemi, Seyed-Ali ; Hoseinpour, Fahime ; Pakmehr, Seyed-Abbas ; Fatehi, Anita ; Belbasi, Mohaddeseh ; Khoshravesh, Sahar ; Naziri, Mahdyieh ; Deravi, Niloofar

BackgroundXerostomia, or dry mouth, is a common and debilitating symptom in patients with Sjögren's syndrome, affecting their quality of life. Although Cevimeline, a muscarinic agonist, has been investigated as a potential treatment, its efficacy and optimal dosage remain uncertain. This study aims to assess the effectiveness of Cevimeline in relieving xerostomia in patients with Sjögren's syndrome by a meta-analysis of randomized clinical trials (RCT).MethodA comprehensive search was conducted across PubMed, Scopus, Cochrane, and Web of Science databases, utilizing Medical Subject Headings terms and keywords related to "cevimeline," "xerostomia," and "Sjögren's syndrome" from inception until January 3, 2024. Studies were selected based on predefined inclusion criteria, focusing on clinical trials involving human subjects treated with cevimeline for xerostomia in Sjögren's syndrome. Data extraction was performed systematically, and statistical analysis was conducted using STATA software.ResultThis meta-analysis included three RCTs with a total of 302 patients with Sjögren's syndrome (Cevimeline = 187; Placebo = 115). The analysis demonstrated that Cevimeline significantly reduces xerostomia (regarded as salivary flow, mouth dryness) in patients with Sjögren's syndrome with a pooled odds ratio -5.79 (95% CI [-10.55, -1.03]; I ²  = 39.6%).ConclusionsIn summary, cevimeline significantly increases salivary flow secretion rates in patients with Sjögren's syndrome. With a favorable safety profile at recommended dosages, cevimeline represents a viable therapeutic option for managing xerostomia, particularly in patients with mild to moderate salivary gland destruction.

2024-09-01·British Journal of Pharmacology

Activation of M₄ muscarinic receptors in the striatum reduces tic‐like behaviours in two distinct murine models of Tourette syndrome

Article

作者: Thomsen, Morten Skøtt ; Cadeddu, Roberto ; Bortolato, Marco ; Braccagni, Giulia ; Branca, Caterina ; van Luik, Easton R. ; Pittenger, Christopher

Background and PurposeCurrent pharmacotherapies for Tourette syndrome (TS) are often unsatisfactory and poorly tolerated, underscoring the need for novel treatments. Insufficient striatal acetylcholine has been suggested to contribute to tic ontogeny. Thus, we tested whether activating M1 and/or M4 receptors—the two most abundant muscarinic receptors in the striatum—reduced tic‐related behaviours in mouse models of TS.Experimental ApproachStudies were conducted using CIN‐d and D1CT‐7 mice, two TS models characterized by early‐life depletion of striatal cholinergic interneurons and cortical neuropotentiation, respectively. First, we tested the effects of systemic and intrastriatal xanomeline, a selective M1/M4 receptor agonist, on tic‐like and other TS‐related responses. Then, we examined whether xanomeline effects were reduced by either M1 or M4 antagonists or mimicked by the M1/M3 agonist cevimeline or the M4 positive allosteric modulator (PAM) VU0467154. Finally, we measured striatal levels of M1 and M4 receptors and assessed the impact of VU0461754 on the striatal expression of the neural marker activity c‐Fos.Key ResultsSystemic and intrastriatal xanomeline reduced TS‐related behaviours in CIN‐d and D1CT‐7 mice. Most effects were blocked by M4, but not M1, receptor antagonists. VU0467154, but not cevimeline, elicited xanomeline‐like ameliorative effects in both models. M4, but not M1, receptors were down‐regulated in the striatum of CIN‐d mice. Additionally, VU0467154 reduced striatal c‐Fos levels in these animals.Conclusion and ImplicationsActivation of striatal M4, but not M1, receptors reduced tic‐like manifestations in mouse models, pointing to xanomeline and M4 PAMs as novel putative therapeutic strategies for TS.

100 项与西维美林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00661	西维美林	N07AX03	DB00185

研发状态

批准上市

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适应症	国家/地区	公司	日期
干燥综合征	日本	Daiichi Sankyo Co., Ltd.	2001-06-20
干燥综合征	日本	Alfresa Pharma Corp.	2001-06-20
干燥综合征	日本	Nippon Kayaku Co., Ltd.	2001-06-20
抗合成酶综合征	美国	Cosette Pharmaceuticals, Inc.	2000-01-11
口干症	美国	Cosette Pharmaceuticals, Inc.	2000-01-11

未上市

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适应症	最高研发状态	国家/地区	公司	日期
Crouzon综合征伴黑棘皮症	申请上市	加拿大	KYE Pharmaceuticals, Inc.	2022-09-12
干眼综合征	临床2期	中国台湾	Biotheravision, Inc.	2024-12-31
干眼综合征	临床2期	澳大利亚	Biotheravision, Inc.	2024-12-31
并发症	药物发现	美国	Daiichi Sankyo, Inc.	2001-06-01
头颈部肿瘤	药物发现	美国	Daiichi Sankyo, Inc.	2001-06-01
毒性	药物发现	美国	Daiichi Sankyo, Inc.	2001-06-01
口干症	药物发现	美国	Daiichi Sankyo, Inc.	2001-06-01
阿尔茨海默症	药物发现	日本	Nippon Kayaku Co., Ltd.	-
痴呆	药物发现	日本	Snow Brand Milk Products Co., Ltd.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01690052 (CTgov)	N/A	口干症	15	Cevimeline (Cevimeline)	衊簾獵憲繭憲壓顧餘獵(衊淵選淵簾衊製遞遞製) = 選廠衊壓網簾鑰廠夢廠窪網繭糧選築廠壓壓顧 (廠觸願鏇窪簾選衊衊鹽, 衊醖繭願鑰繭簾製顧夢 ~ 築願窪鹽鹽鑰鑰繭鹽遞) 更多	-	2014-08-06
				Pilocarpine (Pilocarpine)	衊簾獵憲繭憲壓顧餘獵(衊淵選淵簾衊製遞遞製) = 衊憲鏇膚積鑰顧醖選鏇窪網繭糧選築廠壓壓顧 (廠觸願鏇窪簾選衊衊鹽, 網衊窪積蓋糧鑰餘鹽觸 ~ 鏇憲選製鬱衊鏇願艱築) 更多
Pubmed	N/A	原发性干燥综合征	118	pilocarpine	壓鹹遞積顧糧鬱襯蓋齋(壓襯鬱淵築築構鏇廠鬱) = 製襯積遞構艱製鬱簾餘鏇襯廠襯夢鏇蓋製廠繭 (築鹹觸鹽憲網襯齋夢製 ) 更多	-	2014-07-23
				cevimeline	壓鹹遞積顧糧鬱襯蓋齋(壓襯鬱淵築築構鏇廠鬱) = 鏇獵醖顧選構鑰製糧觸鏇襯廠襯夢鏇蓋製廠繭 (築鹹觸鹽憲網襯齋夢製 ) 更多