The Efficacy of Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort (CRBD) Inside the Intensive Care Unit (ICU): a Prospective, Randomized,Comparative Clinical Study

Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder.

开始日期2024-02-24

申办/合作机构

Ain Shams University

NCT05658874 / Recruiting临床3期IIT

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.

开始日期2022-12-01

申办/合作机构-

IRCT20160606028304N2 / Completed临床4期

Efficacy of Solifenacin and trospium chloride on neurogenic bladder after stroke: a multicentric three arms placebo-controlled trial

开始日期2021-07-01

申办/合作机构

Tabriz University of Medical Sciences

100 项与曲司氯铵相关的临床结果

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100 项与曲司氯铵相关的转化医学

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100 项与曲司氯铵相关的专利（医药）

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项与曲司氯铵相关的文献（医药）

2024-01-01·Lancet (London, England)1区 · 医学

Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline–trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial

1区 · 医学

Article

作者: Correll, Christoph U ; Paul, Steven M ; Zhu, Haiyuan ; Sawchak, Sharon ; Kaul, Inder ; Miller, Andrew C ; Brannan, Stephen K ; Kakar, Rishi ; Breier, Alan

BACKGROUND:

New treatments with new mechanisms are urgently needed for people with schizophrenia. Xanomeline is a dual M₁ and M₄-preferring muscarinic receptor agonist that does not block D₂ dopamine receptors, unlike all currently approved treatments for schizophrenia. Xanomeline-trospium (KarXT) combines xanomeline with the peripherally restricted muscarinic receptor antagonist trospium chloride with the goal of ameliorating xanomeline-related adverse events associated with peripheral muscarinic receptors. The EMERGENT-2 trial aimed to assess the efficacy and safety of KarXT in people with schizophrenia experiencing acute psychosis.

METHODS:

EMERGENT-2 was a randomised, double-blind, placebo-controlled, flexible-dose, 5-week, inpatient, phase 3 trial in people with schizophrenia. Participants were adults aged 18-65 years with a diagnosis of schizophrenia who had a recent worsening of psychosis warranting hospital admission, a Positive and Negative Syndrome Scale (PANSS) score of 80 or higher, and a Clinical Global Impression-Severity score of 4 or higher. The participants were recruited from 22 inpatient sites in the USA, and were randomly assigned (1:1) to KarXT or placebo twice per day. Participants randomly assigned to KarXT received 50 mg xanomeline and 20 mg trospium twice per day for the first 2 days and then 100 mg xanomeline and 20 mg trospium twice per day for days 3-7. Beginning on day 8, KarXT dosing was flexible with an optional increase to 125 mg xanomeline and 30 mg trospium twice per day and the option to return to 100 mg xanomeline and 20 mg trospium based on tolerability. The primary endpoint was change from baseline to week 5 in PANSS total score. Efficacy analyses used the modified intention-to-treat population (all randomly assigned participants who received at least one trial medication dose and had at least one post-baseline PANSS assessment). Least squares mean change from baseline, SE, and least squares mean difference between the KarXT and placebo groups at week 5, along with the 95% CI and two-sided p values were calculated for the primary and secondary continuous efficacy endpoints. Safety analyses included all participants receiving at least one trial medication dose and used descriptive statistics. This trial is registered with ClinicalTrials.gov (NCT04659161).

FINDINGS:

From Dec 16, 2020, to April 13, 2022, of 407 people who were screened, 252 participants meeting enrolment criteria were randomly assigned to the KarXT (n=126) or placebo (n=126). Baseline PANSS total scores were 98·3 (KarXT; n=126) and 97·9 (placebo; n=125). The trial met the primary endpoint with a mean change from baseline to week 5 in PANSS total score that favoured KarXT (-21·2 points, SE 1·7) versus placebo (-11·6 points, 1·6; least squares mean difference -9·6; 95% CI -13·9 to -5·2; p<0·0001, Cohen's d effect size=0·61). All secondary endpoints were also met, and favoured KarXT versus placebo (p<0·05). The most common adverse events with KarXT versus placebo were constipation (27 [21%] vs 13 [10%]), dyspepsia (24 [19%] vs 10 [8%]), headache (17 [14%] vs 15 [12%]), nausea (24 [19%] vs seven [6%]), vomiting (18 [14%] vs one [1%]), hypertension (12 [10%] vs one [1%]), dizziness (11 [9%] vs four [3%]), gastro-oesophageal reflux disease (eight [6%] vs zero [0%]), and diarrhoea (seven [6%] vs four [3%]). Treatment-emergent adverse event rates of extrapyramidal motor symptoms (KarXT, zero [0%] vs placebo, zero [0%]), akathisia (one [1%] vs one [1%]), weight gain (zero [0%] vs one [1%]), and somnolence (six [5%] vs five [4%]) were similar between the KarXT and placebo groups, as were adverse event-related discontinuation rates (nine [7%] vs seven [6%]).

INTERPRETATION:

In the EMERGENT-2 trial, KarXT was effective in reducing positive and negative symptoms and was generally well tolerated. These results support the potential for KarXT to represent a new class of effective and well tolerated antipsychotic medicines based on activating muscarinic receptors, not the D₂ dopamine receptor-blocking mechanism of all current antipsychotic medications. Results from additional trials, including the identical EMERGENT-3 trial and the 52-week, open-label EMERGENT-4 and EMERGENT-5 trials, will provide additional information on the efficacy and safety of KarXT in people with schizophrenia.

FUNDING:

Karuna Therapeutics.

2023-12-02·Expert opinion on therapeutic patents

The patent review of the biological activity of tropane containing compounds

Review

作者: Farghaly, Thoraya A ; Masaret, Ghada S ; Abdulwahab, Hanan Gaber

INTRODUCTION:

Tropane-derived medications have historically played a substantial role in pharmacotherapy. Both natural and synthetic derivatives of tropane find application in addressing diverse medical conditions. Prominent examples of tropane-based drugs include hyoscine butylbromide, recognized for its antispasmodic properties, atropine, employed as a mydriatic, maraviroc, known for its antiviral effects. trospium chloride, utilized as a spasmolytic for overactive bladder, and ipratropium, a bronchodilator.

AREAS COVERED:

We compiled patents pertaining to the biological activity of substances containing tropane up to the year 2023 and categorized them according to the specific type of biological activity they exhibit. ScienceFinder, ScienceDirect, and Patent Guru were used to search for scientific articles and patent literature up to 2023.

EXPERT OPINION:

Pharmaceutical researchers in academic and industrial settings have shown considerable interest in tropane derivatives. Despite this, there remains a substantial amount of work to be undertaken. A focused approach is warranted for the exploration and advancement of both natural and synthetic bioactive molecules containing tropane, facilitated through collaborative efforts between academia and industry. Leveraging contemporary techniques and technologies in medicinal and synthetic chemistry, including high throughput screening, drug repurposing,and biotechnological engineering, holds the potential to unveil novel possibilities and accelerate the drug discovery process for innovative tropane-based pharmaceuticals.

2023-09-01·Pharmaceutical research

Is the One-Compartment Model with First Order Absorption a Useful Approximation?

Article

作者: Weiss, Michael

PURPOSE:

The one-compartment model with first order absorption (ka1C) has been extensively used to fit oral data. But when the disposition parameters of the drug are not available, the bias in the parameter estimates remains unclear. In this paper, the effect of potential misspecification of the area under the curve (AUC) and the mean absorption time (MAT) was evaluated for three relatively slowly absorbed drugs/formulations.

METHODS:

Assuming a three-compartment disposition model with an input (absorption) rate described as a sum of two inverse Gaussian functions (2IG3C) as the true model, the deviations of AUC and MAT estimated with simpler models were analyzed. Simpler models, as the ka1C model (Bateman function), the one-compartment model with IG input function (IG1C) and the gamma density function were fitted to the oral data alone, and compared to the fits obtained with the 2IG3C model which also uses the 3C disposition parameters of the drug. Data from pharmacokinetic studies of trospium, propiverine and ketamine in healthy volunteers were analyzed using a population approach.

RESULTS:

The Bateman function (ka1C) allowed a robust estimation of the population mean AUC, but the individual estimates were highly biased. It failed in evaluating MAT. The simple alternative models did not improve the situation.

CONCLUSIONS:

The Bateman function appears to be useful for estimating the population mean value of AUC after oral administration. The results reemphasize the fact that insight into the absorption process can be only gained when also intravenous reference data are available.

项与曲司氯铵相关的新闻（医药）

2024-06-27

·生物制品圈

生物制药领域十大最明智交易

在过去的几年里，大型制药公司掏出钱包，在抗体药物偶联物、放射性药物和肥胖药物等炙手可热的竞赛中下注。让我们来看看在生物制药领域在过去一年中最引人注意的交易。百时美施贵宝&Karuna Therapeutics 2023年12月22日，BMS宣布以140亿美元收购Karuna Therapeutics。该公司的pipeline只有两款产品处于临床：1）M1-M4激动剂KarXT，目前已进入NDA，预计明年9月有望获FDA批准上市；2）处于临床1期的TRPC4/5抑制剂KAR-2618。 BMS热衷于达成这笔交易原因是正是KarXT。KarXT是今年最受期待的药物之一，预计到2028年，它可能会带来28亿美元的销售额。预计FDA将在第三季度做出决定。KarXT是一种用于成人精神分裂症患者的xanomeline-trospium组合，也正在阿尔茨海默病精神病中进行测试。 KarXT研发管线在3期试验中，与安慰剂相比，KarXT在精神分裂症阳性和阴性症状方面具有统计学意义和临床意义的改善。与安慰剂相比，Xanomeline-trospium治疗与体重增加无关，治疗组之间锥体外系运动症状或静坐不能的发生率低且相似。并且2021年再鼎医药从Karuna Therapeutics引入该药物，获得其在大中华区开发、生产和商业化KarXT的权利。并且目前正在国内开展三期临床试验UNITE-1研究。罗氏&Carmot Therapeutics 诺和诺德和礼来是肥胖治疗领域的两大巨头，而罗氏也想在此分得一杯羹。 2023年12月4日，罗氏与Carmot Therapeutics达成协议，以31亿美元的价格收购这家肥胖症药物开发公司，以期在寸土寸金的减肥药领域同诺和诺德和礼来进行角逐。此次收购使罗氏能够获得差异化的肠促胰岛素产品组合，包括： Carmot研发管线 CT-388 ：一种即将进入II期阶段的GLP-1/GIP 受体双激动剂，用于治疗 2 型糖尿病和非 2 型糖尿病患者的肥胖症。每周皮下注射一次，它有可能作为一种独立和联合疗法来改善减肥并扩展到其他适应症。 CT-996：一种每日一次口服小分子 GLP-1 受体激动剂，目前处于I期，旨在治疗 2 型糖尿病患者和非 2 型糖尿病患者的肥胖症。 CT-868 ：一种处于II期阶段、每日一次皮下注射的双重GLP-1/GIP 受体激动剂，用于治疗超重或肥胖的 1 型糖尿病患者。诺和诺德&Inversago Pharma 诺和诺德持续加码糖尿病和肥胖等相关代谢性疾病领域，2023年8月10日，诺和诺德和Inversago Pharma宣布，如果实现某些开发和商业里程碑，诺和诺德将以高达10.75亿美元的现金收购Inversago。 Inversago专注于阻断大麻素CB1受体的药物，用于治疗肥胖、糖尿病和与代谢紊乱相关的并发症。Inversago公司的核心药物为口服CB1反向激动剂INV-202。 Inversago Pharma研发管线 INV-202 在1b期试验中展示了减肥潜力，目前正在进行糖尿病肾病 (DKD) 的 2 期试验。还正在开发针对代谢和纤维化疾病的其他管道资产。诺和诺德打算研究 INV-202 治疗肥胖和肥胖相关并发症的潜力。 GSK&Bellus Health 2023年4月18日，葛兰素史克（GSK）宣布与BELLUS Health达成收购协议，总交易额为20亿美元（16亿英镑）。收购完成后，GSK将获得BELLUS的核心产品camlipixant，进一步扩充呼吸领域管线。 GSK收购BELLUS Health Camlipixant（BLU-5937）是一种具有best-in-class潜力的高选择性P2X3受体拮抗剂，已经登记启动了一项国际多中心（含中国）3期临床研究，以评估BLU-5937治疗难治性慢性咳嗽（包括不明原因的慢性咳嗽）的安全性和有效性。在一项2b期临床研究中，camlipixant（50mg和200mg，每日两次给药）使难治性慢性咳嗽患者经安慰剂调整的24小时咳嗽频率降低了34%，具有临床意义和统计学显著性。渤健&Reata Pharmaceuticals 2023年7月29日，渤健将以约73亿美元价格收购Reata。通过这次收购，渤健将获得Reata在今年2月获美国FDA批准的药品Skyclarys（omaveloxolone），强化罕见病布局。渤健神经肌肉疾病管线 Skyclarys已获美国FDA批准用于治疗Friedreich共济失调症，是首个Friedreich共济失调药物。且获得了美国FDA孤儿药、快速通道和罕见儿科疾病认定，此外还获得了EMA的孤儿药认定。在随机、双盲的MOXIe第2部分试验中，经每天150毫克Skyclarys治疗的患者在48周后，在无严重高弓足患者中，其mFARS评分相较于安慰剂组改善2.41分（p=0.014）；当高弓足患者纳入统计时，相对于安慰剂组Skyclarys改善评分1.93分（p=0.034）。礼来&Versanis Bio 2023年7月14日，礼来公司宣布以19.25亿美元收购Versanis Bio，这是一家专注于开发治疗心脏代谢疾病新药的私人临床阶段生物制药公司。 bimagrumab正处于Ⅱ期研究 Versanis的主要资产是bimagrumab，这是一种结合激活素II型A和B受体以阻断激活素和肌肉抑制素信号传导的单克隆抗体。Bimagrumab目前正在BELIEVE 2b期研究中单独进行评估，并与Semaglutide（司美格鲁肽）联合治疗成人超重或肥胖。诺华&Chinook Therapeutics 2023年8月11日，诺华宣布，公司已完成对Chinook Therapeutics的收购，交易价值高达35亿美元，并将其与新成立的一家诺华子公司合并。进一步拓展肾脏疾病领域管线。 Chinook Therapeutics研发管线 Chinook Therapeutics是一家总部位于华盛顿州西雅图的处于临床阶段的生物制药公司，专注于肾病领域精准药物的发现、开发和商业化，这笔交易将给诺华带来两项正在开发第三阶段的资产：口服内皮素A受体拮抗剂atrasentan和抗APRIL单克隆抗体zigakibart。 Atrasentan治疗IgA肾病的3期试验结果表明相比于安慰剂组患者（上图灰线），阿曲生坦组患者（上图蓝线）的尿蛋白下降了36.1%，安全性方面也表现良好。 Zigakibart目前处于临床Ⅲ期。其1/2期试验数据结果显示，zigakibart的耐受性良好。在所有患者中，接受zigakibart治疗后12周时，其平均蛋白尿减少20%，在治疗24周时减少39%，在治疗52周时减少67%，在治疗76周时，7名患者的蛋白尿平均减少了67%，在治疗100周时，5名患者的平均蛋白尿减少了72%。罗氏&Telavant 2023年10月23日，罗氏宣布已与Roivant Sciences子公司Telavant达成收购协议，以获得Telavant在研核心产品TL1A抗体RVT-3101在美国及日本的研发、生产和商业化权利。根据协议，罗氏将向Telavant支付71亿美元首付款和1.5亿美元的近期里程碑付款。处于Ⅱ期的RVT-3101（罗氏项目号为RG6631） RVT-3101是一款潜在的first-in-class药物，通过抑制肿瘤坏死因子样配体1A（TL1A）来阻遏炎症和纤维化途径，进而发挥疗效。TL1A抗体具备抗炎、抗纤维化的双重特性，目前主要的适应症开发方向为炎症性肠病（IBD）。 RVT-3101治疗中重度克罗恩病（UC）的II期TUSCANY-2研究数据结果显示，在第56周时，在诱导期和维持期接受RVT-3101治疗的所有患者中，临床缓解率为36%（14周为29%），内窥改善率为50%（14周为36%），内镜缓解率为21%（14周为11%）；在生物标志物阳性患者中，第56周时临床缓解率为43%（14周为33%），内镜改善率为64%（14周为47%），内镜缓解率为36%（第14周为13%）。安全性方面，所有剂量RVT-3101耐受性均良好，没有患者在治疗后产生中和抗体。百时美施贵宝&RayzeBio 2023年12月26日，百时美施贵宝宣布将以41亿美元的价格收购核药生物技术公司RayzeBio。 RayzeBio成立于2020年，2023年9月在纳斯达克挂牌上市。专注于开发靶向核药，主要采用锕-225。成立3年以来，RayzeBio建立起多条靶向核药研发管线，首发管线已经进入三期临床阶段。 RayzeBio研发管线 RayzeBio的核心产品是RYZ101，RYZ101针对SSTR阳性GEP-NET适应症已进入III期临床，ES-SCLC适应症也已进入II期临床阶段。阿斯利康&Fusion Pharmaceuticals 2024年3月19日，阿斯利康宣布以的价格将Fusion Pharmaceuticals纳入旗下，使其成为公司全新的全资子公司。 Fusion Pharmaceuticals研发管线 Fusion是一家临床阶段的肿瘤学公司，专注于开发作为精准药物的下一代放射性药物。其研发的FPI-2265项目备受瞩目。目前，FPI-2265目前正针对mCRPC患者进行II期试验，预计将于2024年第二季度开始，到年底完成招募。参考资料： 1.各公司官网 2.Top 10 smartest deals in biopharma.By James WaldronJun 24, 2024 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期并购临床2期临床结果临床1期

2024-05-23

·医药观澜

再鼎医药引进，这款潜在重磅疗法在中国启动阿尔茨海默病3期临床！

▎药明康德内容团队编辑中国药物临床试验登记与信息公示平台近日公示，Karuna公司等在中国启动了一项评价KarXT治疗阿尔茨海默病相关的精神行为症状的国际多中心（含中国）3期临床研究。该研究拟在中国招募80名受试者，在国际范围内纳入360名受试者。公开资料显示，KarXT是一种潜在“first-in-class”毒蕈碱类抗精神病药物，再鼎医药拥有KarXT在大中华区（包括中国内地、香港、澳门和台湾地区）的开发、生产和商业化权益。KarXT治疗成人精神分裂症的新药上市申请已获美国FDA受理，PDUFA日期为2024年9月26日。值得一提的是，该药曾被行业媒体Evaluate Pharma列为2024年有望获批的10款潜在重磅疗法之一。截图来源：中国药物临床试验登记与信息公示平台官网KarXT（xanomeline trospium）是由Karuna公司所开发的一款口服M1/M4型毒蕈碱乙酰胆碱受体激动剂，代表了一种创新的抗精神/神经类疾病作用机制。据《柳叶刀》（The Lancet）报道，如果KarXT能获FDA批准，它将成为第一种不直接阻断多巴胺受体的抗精神分裂症药物。从作用机制来看，KarXT由xanomeline和trospium chloride两种有效成分构成。其中，通过刺激毒蕈碱受体M1和M4受体，xanomeline可缓解负面症状，如冷漠、社会驱动力减少、提高认知能力，并对改善其它精神症状，如幻觉和妄想很有帮助；trospium chloride为毒蕈碱受体拮抗剂，可抑制xanomeline于外周神经中的副作用。KarXT旨在激活大脑中的毒蕈碱型乙酰胆碱受体的同时，减少对外周毒蕈碱型乙酰胆碱受体的作用。2021年11月，再鼎医药与Karuna公司就在大中华区开发、生产及商业化KarXT达成独家许可协议。2023年12月，百时美施贵宝公司宣布以总额约为140亿美元收购Karuna公司，从而获得这款产品。根据再鼎医药此前新闻稿，该公司将于年中在大中华区加入KarXT针对阿尔茨海默病相关的精神疾病的全球3期研究。在中国，KarXT此前也已经启动针对精神分裂症的3期临床研究。本次启动的3期临床针对阿尔茨海默病相关的精神行为症状。其主要目的是根据神经精神问卷-临床医生等级评定量表（NPI-C）中的幻觉和妄想评分，评价KarXT相较于安慰剂治疗阿尔茨海默病相关的精神行为症状受试者的有效性。图片来源：123RF阿尔茨海默病（AD）是痴呆症的主要类型之一，这种疾病剥夺了患者的记忆和自主能力，给他们的生活带来了沉重的打击。同时，这也激发了全球科学家和研究者们寻找新的治疗方法。公开资料显示，全球范围内已经有数十款阿尔茨海默病创新疗法获批上市，它们针对的靶点主要包括乙酰胆碱酯酶和N-甲基-D-天冬氨酸（NMDA）受体等。近年来，AD药物的研发则主要集中于靶向β淀粉样蛋白（Aβ）和Tau蛋白，这类疗法被称为“疾病修饰疗法”，其核心在于对阿尔茨海默病的疾病发病机制进行干预，靶向清除患者大脑中过多的Aβ原纤维和Aβ斑块，从“源头”解决问题。比如，卫材（Eisai）/渤健（Biogen）的抗Aβ单克隆抗体仑卡奈单抗注射液已于今年1月在中国获批上市，治疗早期阿尔茨海默病。另外，礼来公司（Eli Lilly and Company）开发的靶向Aβ的单抗产品donanemab也已经在中国申报上市，并被NMPA纳入优先审评。根据中国药物临床试验登记与信息公示平台官网查询，除了上述提到的产品，礼来公司另一款抗β淀粉样蛋白亚型N3pG单抗remternetug也在中国开展3期临床研究，该产品包括静脉注射和皮下注射剂型，其中皮下注射剂型的给药方案为每周一次，给药便利性有所提升。此外，诺和诺德（Novo Nordisk）的GLP-1受体激动剂口服司美格鲁肽也在开展阿尔茨海默病3期临床研究。已有研究显示，给予GLP-1受体激动剂可以改善记忆和学习能力，增加神经元数量，减少β淀粉样蛋白（Aβ），并防止Tau蛋白累积。部分正在中国开展3期临床的阿尔茨海默病新药▲数据来源：中国药物临床试验登记与信息公示平台及公开资料。本表为不完全统计，如有遗漏，欢迎补充。希望这些产品后续临床研究顺利进行，早日取得突破，造福患者！参考资料：[1]中国药物临床试验登记与信息公示平台官网.Retrieved May 20，2024, From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml[2] 再鼎医药和Karuna Therapeutics宣布在大中华区就KarXT开发和商业化达成战略合作 . Retrieved Nov. 9，2021, from https://mp.weixin.qq.com/s/gtk5csq1McBUY8rHfBFtLw[3] Time for renewed optimism for schizophrenia? . Retrieved Jan 13 , 2024, from https://www-thelancet-com.libproxy1.nus.edu.sg/journals/lancet/article/PIIS0140-6736(24)00047-3/fulltext本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期并购申请上市上市批准临床成功

2024-05-23

·BioSpace

Bristol Myers Squibb to Present Data at the 2024 American Society of Clinical Psychopharmacology Annual Meeting

Consistent with short-term studies, KarXT was not associated with clinically meaningful changes in movement disorder scale scores and a low incidence rate of extrapyramidal symptoms was reported over long-term trials in adults with schizophrenia In-trial qualitative interviews found that the majority of participants treated with KarXT in the long-term EMERGENT-5 trial perceived improvements in positive, negative and cognitive symptoms of schizophrenia PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb Company (NYSE: BMY) today announced the presentation of data at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 28-31, 2024 in Miami, FL. “The presentation of additional data from the EMERGENT program continues to illustrate the potential of KarXT as a novel treatment for schizophrenia, with its differentiated mechanism of action and safety and efficacy profile,” said Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb. “The impact of KarXT for patients and their care partners is promising, and we look forward to continuing our conversations with the U.S. Food & Drug Administration this year.” Research to be presented at the meeting continues to demonstrate the potential of KarXT as a differentiated treatment option for adults living with schizophrenia. Notable data poster presentations include: Low Long-Term Risk of Extrapyramidal Symptoms (EPS) with Muscarinic Agonist KarXT (Xanomeline and Trospium) (W86) Among pooled interim data from the Phase 3 outpatient, 52-week, open-label EMERGENT-4 and EMERGENT-5 studies, the incidence of extrapyramidal symptoms (EPS) adverse events (AEs) deemed to be treatment-related was 1% and the most commonly reported treatment-related EPS AE was akathisia (0.6%). KarXT was not associated with clinically meaningful changes from baseline in movement disorder scale scores on the Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) over short or long-term studies. Assessing Participant Experience with KarXT Treatment Using In-Trial Qualitative Interviews: Initial Findings from a Long-Term Phase 3 Trial in Schizophrenia (W24) In the Phase 3 outpatient, 52-week, open-label EMERGENT-5 trial evaluating the safety, tolerability and efficacy of KarXT in adults with schizophrenia, in-trial interviews were conducted with participants to provide qualitative insights to characterize their experience during the trial to better understand changes in symptoms and define meaningful treatment. Initial findings showed participants perceived an improvement in positive, negative, and cognitive symptoms of schizophrenia since initiating KarXT. Complete abstracts may be accessed online here, and a full overview of abstracts to be presented at ASCP by BMS can be found below. Abstract Title Primary Author Type/# Session Title Time (ET) Wednesday, May 29, 2024 Assessing Participant Experience with KarXT Treatment Using In-Trial Qualitative Interviews: Initial Findings from a Long-Term Phase 3 Trial in Schizophrenia Horan, W. Poster W24 Poster Session I 11:15 AM – 1:15 PM Characterizing the Safety Pro KarXT Relative to Anticipated D2-Dopamine-based Antipsychotic Medications in FAERS Ramsay, I. Poster W52 Low Long-Term Risk of EPS with Muscarinic Agonist KarXT (Xanomeline and Trospium) Novak, K. Poster W86 Thursday, May 30, 2024 KarXT (Xanomeline and Trospium) for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and likelihood to Be Helped or Harmed Citrome, L. Poster T58 Poster Session II 12:30 PM - 2:15 PM Responses to KarXT in Short-Term Placebo-Controlled Trials in Schizophrenia Ramsay, I. Poster T76 Measurement of Positive and Negative Symptoms Through Speech Analysis from PANSS Interview Recordings in Patients with Schizophrenia Abbas, A. Poster T78 About KarXT KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia. About Schizophrenia Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 30% of people do not respond to therapy, with an additional 50% experiencing only a partial improvement in symptoms or unacceptable side effects. Bristol Myers Squibb: Delivering Breakthrough Science for Meaningful Interventions in Neuroscience Neurological conditions represent some of the greatest challenges of our time because of their impact on society, including patients, caregivers, families and healthcare systems. At Bristol Myers Squibb, we are committed to advancing our robust pipeline of potential medicines for neurological disorders with the goal of modifying disease and improving quality of life. Leveraging genetics, biomarkers and predictive sciences, we target key pathways involved in the initiation and progression of neurological diseases to develop therapies with the potential to optimize patient outcomes. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that KarXT may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether KarXT for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

临床3期临床结果ASCO会议

100 项与曲司氯铵相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01103	曲司氯铵	G04BD09	-

研发状态

批准上市

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	法国	Allergan Ltd. (Ireland)	1999-06-28

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性阻塞性肺疾病	临床2期	美国	Endo Pharmaceuticals, Inc.	2007-04-01

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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


NCT04090190 (CTgov)	临床4期	尿失禁 \| 尿急 \| 炎症	20	Oxybutynin+Tolterodine+Trospium+Solifenacin+Fesoterodine	範糧範製糧製製製襯蓋(齋築壓獵夢繭鏇窪衊顧) = 鏇遞鏇鑰艱簾鏇壓築繭積窪糧網願築獵窪鹹繭 (觸膚願鑰積鹽遞鹹範醖, 齋製積窪製繭範構衊餘 ~ 獵願鑰糧淵憲觸窪築積) 更多	-	2022-10-03
NCT03697252 (EMERGENT-1, Pubmed \| Br Dent J) 人工标引	临床2期	精神分裂症	182	xanomeline	壓獵衊衊壓顧鹽觸膚繭(糧憲積艱構製夢築網選) = 積製廠醖鑰膚網選築蓋顧觸壓鹽構鹽觸顧糧製 (艱鹹夢遞衊鏇鑰淵獵鑰 )	积极	2021-02-25
				Placebo	壓獵衊衊壓顧鹽觸膚繭(糧憲積艱構製夢築網選) = 選廠鏇窪製廠構糧鏇襯顧觸壓鹽構鹽觸顧糧製 (艱鹹夢遞衊鏇鑰淵獵鑰 )
NCT02831231 (Corporate Publications) 人工标引	临床1期	-	70	Xanomeline+trospium	觸顧憲製餘鬱網襯齋選(憲鏇膚衊鏇廠鏇構繭衊) = 衊醖艱鏇醖遞鹹糧衊鬱衊醖廠簾齋簾壓餘壓簾 (製鏇網築襯繭壓獵範積 ) 更多	积极	2019-08-14
				Placebo+Xanomeline	觸顧憲製餘鬱網襯齋選(憲鏇膚衊鏇廠鏇構繭衊) = 遞範鏇壓糧網齋觸築膚衊醖廠簾齋簾壓餘壓簾 (製鏇網築襯繭壓獵範積 ) 更多
NCT01922115 (CTgov)	临床4期	认知 \| 膀胱过度活动症	59	Trospium Chloride (TROSPIUM CHLORIDE)	鏇壓網齋壓鏇築憲壓膚(簾窪醖鹹觸願蓋鹹淵範) = 製鹽膚壓選膚顧繭願鏇鹹膚醖衊鏇遞襯積築餘 (觸選憲糧醖網鑰壓製築, 鬱選膚鏇蓋醖顧顧築襯 ~ 艱繭壓構選襯簾積壓襯) 更多	-	2016-07-12
				Placebo (PLACEBO)	鏇壓網齋壓鏇築憲壓膚(簾窪醖鹹觸願蓋鹹淵範) = 壓鹹構鬱製築醖獵鏇齋鹹膚醖衊鏇遞襯積築餘 (觸選憲糧醖網鑰壓製築, 淵築願壓糧鏇遞網齋窪 ~ 獵範願鹽鹽獵鏇壓積蓋) 更多
NCT01089751 (CTgov)	临床4期	膀胱过度活动症综合征	322	trospium chloride (Sanctura XR®)	積鏇選壓選鏇衊簾廠壓(築餘膚製築鹽醖壓構糧) = 繭壓壓網壓構遞築積構壓廠構積構構鹹艱鹽窪 (簾積齋鏇觸觸顧獵淵鏇, 衊獵構構糧衊顧膚繭糧 ~ 鹹範鑰積鏇糧齋憲築壓) 更多	-	2013-09-26
				placebo (Placebo)	積鏇選壓選鏇衊簾廠壓(築餘膚製築鹽醖壓構糧) = 顧壓遞鏇窪淵繭鹹鹽衊壓廠構積構構鹹艱鹽窪 (簾積齋鏇觸觸顧獵淵鏇, 壓醖廠範繭衊鹽齋製齋 ~ 願範繭餘選糧願觸糧鹽) 更多
NCT01178827 (CTgov)	临床4期	膀胱过度活动症	20	trospium chloride (Sanctura XR®)	願構遞憲壓鏇窪製範憲(餘鏇蓋範築網遞繭壓醖) = 窪淵窪齋築鬱構憲繭窪獵鏇夢鹽獵廠選鬱蓋遞 (膚窪築鬱製壓淵壓壓觸, 窪鬱觸鹽糧鏇顧鹽遞齋 ~ 繭糧壓鏇築簾網襯鬱顧) 更多	-	2012-08-16
				oxybutynin IR (Oxybutynin IR)	遞襯選窪淵鹽鬱淵鏇醖(蓋製構積製製製願壓遞) = 鹽鹹糧鹹獵鹹鹽窪願廠願廠簾選繭餘廠鏇鏇網 (襯觸廠夢鏇製齋繭淵廠, 製繭築遞艱壓選簾願齋 ~ 淵膚鏇餘網鹽願積壓廠) 更多
NCT00863551 (1501 SANCTURA XR, CTgov)	临床4期	膀胱过度活动症	12	Trospium Chloride	遞構壓網醖糧蓋網積製(醖艱觸鑰鑰鹹襯鏇廠鏇) = 鏇積鏇衊鑰襯淵繭遞鹽網衊製憲窪選齋願製選 (遞構醖衊蓋簾夢遞窪憲, 糧淵艱願簾製憲淵餘憲 ~ 繭壓醖鬱齋繭膚蓋鹽網) 更多	-	2011-12-19
NCT00863551 (1501 SANCTURA XR, AUA2010)	临床4期	膀胱过度活动症	12	TrCl XR	繭餘遞膚積蓋壓餘鹹淵(願窪製製齋壓齋壓願獵) = 糧壓餘壓醖觸醖憲襯艱繭廠壓憲鹹簾憲衊積窪 (衊艱蓋築憲膚餘夢網夢 )	-	2010-04-01