富马酸托特罗定(Tolterodine Fumarate) - 药物靶点：M2 receptor x M3 receptor_在研适应症：膀胱过度活动症_专利_临床

概要

基本信息

药物类型

小分子化药

别名-

靶点

M2 receptor x M3 receptor

作用机制

M2 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M2拮抗剂)、M3 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M3拮抗剂)

治疗领域

泌尿生殖系统疾病

在研适应症

膀胱过度活动症

非在研适应症-

原研机构

Pfizer Inc.

在研机构

Pfizer Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2005-12-09),

膀胱过度活动症

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C26H35NO5

InChIKeyHKTZTYRSKPLEIQ-BOQYJDHWSA-N

CAS号615254-93-8

关联

36

项与富马酸托特罗定相关的临床试验

IRCT20210714051893N1 / Suspended临床3期

Recurrence of primary enuresis after treatment with desmopressin compare with combination therapy desmopressin and tolterodine in children aged 5-16 years

开始日期2021-09-23

申办/合作机构

Qazvin University of Medical Sciences

NCT04500860 / Completed临床1期IIT

Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up

Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome

开始日期2020-12-01

申办/合作机构

Qasr El Eyni Hospital

IRCT20160924029935N2 / Completed临床3期

Comparison of the effect of Terazosin, Tolterodine, and their combination in the treatment of double J stent-related urinary symptoms in patients with ureteral stones

开始日期2019-03-20

申办/合作机构

Mashhad University of Medical Sciences

100 项与富马酸托特罗定相关的临床结果

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100 项与富马酸托特罗定相关的转化医学

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100 项与富马酸托特罗定相关的专利（医药）

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6

项与富马酸托特罗定相关的文献（医药）

2016-07-01·Female pelvic medicine & reconstructive surgery3区 · 医学

3区 · 医学

Article

作者: Richter, Holly Elizabeth ; Ellington, David Rich ; Gerten, Kimberly Anne ; Malek, Joseph Michael ; Szychowski, Jeffery Michael ; Burgio, Kathryn Larsen

Objectives:

The aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder (OAB) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy.

Methods:

A single-site randomized, open-label trial in women with urinary frequency, urgency, nocturia, and/or urgency urinary incontinence symptoms was performed. Fifty-eight participants were randomized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week. The primary outcome was change in Overactive Bladder Questionnaire (OAB-q) symptom bother score at 12 weeks. Secondary outcomes included the Health-Related Quality of Life Questionnaire (HRQL) of the OAB-q and a 3-day bladder diary. At 12 weeks, subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks.

Results:

There was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks (20.6 ± 21.7, −15.8 ± 23.3, respectively, P = 0.45). There was a significant within-group decrease in symptom bother score from baseline to 12 weeks (tolterodine, P < 0.0001, and intravaginal estradiol, P = 0.002). Secondary outcome improvement within groups was noted in the HRQL total, urinary incontinence episodes, and median voiding frequency (all P ≤ 0.03) in the tolterodine group and in the HRQL total score (P = 0.03) in the intravaginal estradiol group, with no differences between groups. Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks (20.0 ± 23.9, P = 0.008; −16.7 ± 23.3, P = 0.02, respectively).

Conclusions:

Significant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms, with no difference between groups. Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol. The role of combined medical therapy for OAB symptoms needs further investigation.

2006-07-01·Der Urologe. Ausg. A4区 · 医学

Vergleich der Effektivität und Verträglichkeit von Solifenacin und Tolterodin retard in der Behandlung der überaktiven Blase

4区 · 医学

Article

作者: Goepel, M

1995-01-01·Neurourology and urodynamics3区 · 医学

3区 · 医学

Article

作者: A. Mattiasson ; B. Sparf ; K.‐E. Andersson ; M. M. S. Stahl ; B. Ekström

Abstract:

Tolterodine, a novel compound intended for treatment of urgency and urge incontinence, has been characterized as a potent muscarinic receptor antagonist in pharmacological in vitro and in vivo studies. In cats, tolerodine was shown to reduce bladder pressure at doses significantly lower than those affecting salivation. To predict clinical effectiveness, an open pilot study was performed in healthy male volunteers. Efficacy was measured by cystometry and by spontaneously reported effects after administration of a single oral dose of tolterodine. 6.4 mg, given as a water solution. Tolterodine had distinct inhibitory effects on urinary bladder function, both at 1 and 5 hours post‐dose. At 1 hour, but not at 5 hours post‐dose tolterodine also significantly reduced stimulated salivation. In addition to the objectively demonstrated changes in urodynamic parameters, most volunteers experienced voiding difficulties. No significant changes in blood pressure, heart rate, or near point of accommodation were registered. Tolterodine, in the dosage used, was both objectively and subjectively shown to exert a marked inhibitory effect on micturition in healthy subjects, and the data suggest a more pronounced effect on bladder function than on salivation. © 1995 Wiley‐Liss, Inc.

5

项与富马酸托特罗定相关的新闻（医药）

2024-06-28

·美通社

Pierre Fabre Laboratories宣布授予OBGEMSA™ （ vibegron ）膀胱过度活跃的欧洲上市许可。

法国卡斯特尔 2024年6月29日 /美通社/ -- 欧盟委员会（ EC ）已授权Pierre Fabre Laboratories销售OBGEMSA™ （ vibegron ），用于对症治疗成人膀胱过度活跃综合征，这是一种特别令人衰弱的疾病，影响着欧洲7000多万患者*。 2022年， Pierre Fabre Laboratories从Urovant Sciences Gmbh获得了vibegron的独家许可，用于在欧洲经济区注册和商业化这种创新的治疗方法。欧盟委员会的决定将适用于所有欧盟成员国以及冰岛、列支敦士登和挪威。 OBGEMSA™是Urovant Sciences拥有的商标。 PDF - https://mma.prnewswire.com/media/2451098/Pierre_Fabre.pdf " 我们对这一发展感到高兴，这将使欧洲患者受益于膀胱过度活跃综合征的新治疗选择，并进一步加强我们 40 多年的泌尿外科专业知识。这一决定证实了 Pierre Fabre Laboratories 致力于为患者提供创新的治疗方法，以更好地管理慢性衰弱性疾病， "Pierre Fabre Laboratories首席执行官Eric Ducournau 说。欧盟委员会的决定遵循欧洲药品管理局（ EMA ）人用药品委员会（ CHMP ）于4月25日发布的赞成意见。它是基于在膀胱过度活动症状的成年人中进行的两项关键性、多中心、双盲、随机3期研究的结果。研究RVT-901-3003 （ EMPOWUR ）评估了振子（剂量为每天75 mg ）在12周内与安慰剂和托特罗定作为阳性对照相比的有效性、耐受性和安全性。其扩展，研究RVT-901-3004 （ EMPOWUR扩展），以托特罗定为活性对照药，在52周内双盲评估了振子的长期安全性、耐受性和有效性。在这些研究中， vibegron作为β-3肾上腺素能受体（增强现实（ AR ））的新型选择性激动剂，在过度活动性膀胱综合征患者中可能发生的紧急性、排尿频率增加和尿急性尿失禁（ UUI ）的对症治疗中显示出良好的获益-风险曲线。联系人： Laurence MARCHAL laurence.marchal@pierre-fabre.com

临床3期申请上市临床成功

2023-05-22

·PRNewswire

Pierre Fabre announces start of EU marketing authorization application procedure for Vibegron in overactive bladder

CASTRES, France, May 22, 2023 /PRNewswire/ -- Following the exclusive licensing agreement with Urovant Sciences GmbH, Pierre Fabre announced today the start of the EU marketing authorization application procedure (centralized procedure) for Vibegron, a novel, potent, and selective human β3 adrenergic receptor (β 3-AR) agonist inducing muscle relaxation to increase bladder capacity and relieve symptoms of overactive bladder (OAB). The submission is based on positive data from the pivotal, randomized, double-blind, and active (tolterodine)-controlled multicenter Phase 3 studies in patients with symptoms of overactive bladder, Study RVT-901-3003, which assessed the efficacy, tolerability and safety of Vibegron (at a dose of 75 mg) and its extension, Study RVT-901-3004, which assessed the long-term safety, tolerability and efficacy of Vibegron. The results demonstrated that Vibegron possesses multiple favorable qualities that support its use as a new β3-AR agonist for the symptomatic treatment of urgency, increased micturition number and/or urge urinary incontinence as may occur in adult patients with OAB syndrome. The submission also includes clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of Vibegron (at a dose of 75 mg or placebo for 28 days) at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that Vibegron 75 mg had no statistically significant or clinically meaningful effects on BP or HR in patients with symptoms of OAB. "The submission of the Vibegron application to the EMA is another important milestone for Pierre Fabre, which reinforces its long-standing commitment to the field of urology. We look forward to providing an effective and safe therapeutic response to patients suffering from overactive bladder, to bring them a significant improvement in their quality of life, and thus strengthen our raison d'être "Every time we care for a single person, we make the whole world better", said Eric Ducournau, group CEO at Pierre Fabre. For more information about Pierre Fabre, please visit . Urovant Sciences and GEMTESA are trademarks of Urovant Sciences GmbH. Logo: Press contact: Anne Kerveillant [email protected] SOURCE Pierre Fabre

临床结果临床3期临床1期引进/卖出

2022-12-05

·Business Wire

$4.2 Billion Overactive Bladder Treatment (OAB) Markets - Global Forecasts to 2027: Growing R&D Investments and the Launch of Novel Therapies in the Coming Years - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Overactive Bladder Treatment (OAB) Market by Drug type ( Anticholinergic (Solifenacin, Oxybutynin, Tolterodine, Darifenacin), Mirabegron), Botox, Neuromodulation, Disease Type (Idopathic OAB and Neurogenic OAB) and Region - Global Forecasts to 2027" report has been added to ResearchAndMarkets.com's offering. The global overactive bladder treatment market is projected to reach USD 4.2 billion by 2027 from USD 3.5 billion in 2022, at a CAGR of 3.6% Rising prevalence of overactive bladder across the globe coupled with rising awareness about treatment options available is driving the growth of the market. Additionally, use of neuromodulation techniques for the treatment of OAB is further expected to have a significant positive impact. The adoption of novel treatments and the launch of new drugs for OAB treatment are also likely to support market growth in the coming years. Mirabegron segment dominates the overactive bladder (OAB) treatment market in 2021. Based on type, the overactive bladder treatment market is segmented into anticholinergics, mirabegron, BOTOX, neuromodulation, and other treatments. Mirabegron held a dominant share of the market in 2021, owing to the lesser side-effects associated with this drug compared to other drug classes available in the market. Furthermore, neuromodulation segment is expected to grow at faster pace owing to launch of new SNM & PTNS for OAB in market. The idiopathic overactive bladder segment will witness the highest growth in overactive bladder treatment market during the forecast period. Based on disease type, the overactive bladder treatment market is segmented into idiopathic overactive bladder and neurogenic overactive bladder. The idiopathic overactive bladder segment accounted for a larger market share due to the higher prevalence of idiopathic overactive bladder disorders and increased use of drugs for the treatment. North America held dominant share in 2021. In 2021, North America accounted for the major share in the OAB treatment market. North America holds majority of the key market players leading to maturity of OAB treatment market in this region. Furthermore, favorable reimbursement policies in US is one of the leading factor projecting market growth in North America. Competitive landscape The prominent players in this market are Astellas Pharma Inc. (Japan), Teva Pharmaceutical Industries Ltd. (Israel), Pfizer Inc. (US), Medtronic Plc (Ireland), AbbVie Inc. (US), Viatris Inc. (US), Hisamitsu Pharmaceutical Co., Inc. (Japan), Johnson & Johnson Services, Inc. (US), and Endo Pharmaceuticals Inc. (Ireland). Market Dynamics Market Drivers Rising Prevalence of Overactive Bladder Syndrome Rapidly Aging Population and Subsequent Rise in Incidence of Diseases Characterized by Oab Development and Use of Innovative Intravesical Therapies Growing R&D Investments and the Launch of Novel Therapies in the Coming Years Market Restraints Frequent Product Recalls Increased Side-Effects of Anticholinergic Drugs Market Opportunities Novel Treatments, Robust Pipelines, and Patent Cliff of Certain Drugs Market Challenges Social Stigma and Lack of Awareness About OAB Companies mentioned: Abbvie Inc Ajanta Pharma Altherx Pharmaceuticals Amneal Pharmaceuticals LLC Apotex Inc Astellas Pharma Inc Bayer Ag Endo Pharmaceuticals Inc Glenmark Granules India Limited Hisamitsu Pharmaceutical Co Inc Hugel, Inc Intas Pharmaceuticals Ltd Johnson & Johnson Services, Inc Laborie Lupin Macleods Pharmaceuticals Ltd Medtronic Medytox Pfizer Inc Sun Pharmaceutical Industries Ltd Taiho Pharmaceutical Co Ltd Teva Pharmaceutical Industries Ltd Urovant Sciences Viatris Inc For more information about this report visit https://www.researchandmarkets.com/r/2n1a4y About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

100 项与富马酸托特罗定相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
膀胱过度活动症	中国	Pfizer Inc.	2005-12-09

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临床结果

适应症

分期

评价

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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


NCT01741454 (CTgov)	临床4期	尿路梗阻 \| 输尿管梗阻 \| 下尿路症状	181	Tamsulosin (Tamsulosin Plus Placebo 7-day Treatment)	糧鬱壓鹹選簾餘廠築鬱(蓋餘鑰壓鏇構鏇糧鏇糧) = 艱構構觸觸製糧積鏇構鹽遞鬱憲觸壓窪鑰簾窪 (積選餘遞鹹衊製壓夢鹹, 築夢製廠鏇築觸鑰憲鹽 ~ 鹽築築顧齋獵鹹簾繭築) 更多	-	2019-07-10
				Tamsulosin+Tolterodine ER (Tamsulosin Plus Tolterodine ER 7-day Treatment)	糧鬱壓鹹選簾餘廠築鬱(蓋餘鑰壓鏇構鏇糧鏇糧) = 廠襯鏇壓廠積醖醖簾糧鹽遞鬱憲觸壓窪鑰簾窪 (積選餘遞鹹衊製壓夢鹹, 鹹憲獵網齋醖製製蓋積 ~ 簾壓襯襯鏇範蓋鹽鏇衊) 更多
NCT02138747 (PREFER, CTgov)	临床4期	膀胱过度活动症	376	Mirabegron+Tolterodine ER (AB: Mirabegron/Tolterodine ER)	觸鏇鹽襯構顧範獵窪壓(積蓋壓醖窪夢齋構選廠) = 膚廠繭鑰獵遞遞鏇廠鏇遞醖鹽鑰淵網襯觸獵廠 (衊窪鏇鏇選鏇觸鑰積願, 艱襯觸艱鹹選選顧衊廠 ~ 繭壓夢艱鬱獵淵願願製) 更多	-	2017-02-14
				Mirabegron+Tolterodine ER (BA: Tolterodine ER /Mirabegron)	觸鏇鹽襯構顧範獵窪壓(積蓋壓醖窪夢齋構選廠) = 遞鑰製餘膚範鏇簾選鹹遞醖鹽鑰淵網襯觸獵廠 (衊窪鏇鏇選鏇觸鑰積願, 餘獵積窪廠壓憲鑰鏇鏇 ~ 遞顧窪壓鏇網製夢齋簾) 更多
NCT01530243 (CTgov)	临床2/3期	并发症 \| 泌尿系疾病	104	Placebo (Placebo)	築簾選蓋繭襯窪獵鬱鏇(鏇範壓繭範繭醖願範築) = 齋獵鏇繭選鬱顧鹹積遞襯壓築醖餘鹹夢築壓壓 (餘衊膚鏇艱遞鏇鬱襯顧, 窪鹽壓簾鏇鹽艱糧醖網 ~ 獵範壓壓構糧積襯醖願) 更多	-	2015-03-02
				Terazosine (Terazosin)	築簾選蓋繭襯窪獵鬱鏇(鏇範壓繭範繭醖願範築) = 選憲鹹衊鑰選積網鏇餘襯壓築醖餘鹹夢築壓壓 (餘衊膚鏇艱遞鏇鬱襯顧, 獵簾繭網築壓廠醖簾獵 ~ 積廠膚衊鏇選齋憲壓膚) 更多
NCT00323635 (CTgov)	临床4期	尿失禁 \| 夜尿	19	tolterodine (Tolterodine)	糧繭齋遞齋繭鹽蓋淵願(鹹醖觸鹽憲觸鬱襯醖醖) = 壓夢窪餘醖廠淵網鹽鏇鹽襯顧積製壓醖憲積壓 (廠醖繭鹽衊憲夢遞餘願, 衊製鑰鬱範膚構衊繭廠 ~ 範壓鹹選顧鑰顧觸繭糧) 更多	-	2014-12-04
				tolterodine (Placebo)	糧繭齋遞齋繭鹽蓋淵願(鹹醖觸鹽憲觸鬱襯醖醖) = 衊選顧淵選衊觸網糧願鹽襯顧積製壓醖憲積壓 (廠醖繭鹽衊憲夢遞餘願, 淵蓋醖構糧鏇願築範鏇 ~ 淵齋鹹構範鑰蓋蓋餘簾) 更多
NCT00448175 (CTgov)	临床4期	膀胱过度活动症	100	Urgent PC Neuromodulation System+Tolterodine	鏇選觸積蓋窪艱簾遞範(餘積齋蓋襯範鹹糧選顧) = 淵製衊艱鹽鹹艱鬱壓願鹹廠鬱醖蓋糧簾廠網鹽 (鏇繭艱鹹鹹網蓋獵衊觸, 觸餘構餘窪壓衊蓋憲齋 ~ 範獵觸齋範製網廠餘鏇) 更多	-	2013-05-16
NCT00465894 (CTgov)	N/A	膀胱过度活动症综合征	58	Extended Release Tolterodine LA	鹽觸網選範築鹽襯鬱選(鬱艱糧憲築願繭齋築淵) = 範糧壓壓醖遞築鑰淵襯襯積選簾膚築遞蓋衊築 (遞蓋壓製淵網觸廠衊鹽, 衊範顧齋鑰夢範觸淵衊 ~ 製繭簾築顧鏇獵鬱夢艱) 更多	-	2012-10-23