Clinical Effect of Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A in Patients With Upper Extremity Complex Regional Pain Syndrome: A Prospective Randomized, Double-blind, and Comparative Clinical Trial

Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion. It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient. The temperature of the affected arm is often lower than that of the opposite side. As a result of the procedure, the patient may experience sympathetic pain relief, such as coldness, stinging, numbness of the upper extremity. If the procedure does not last long, repetitive block or chemical neurolysis or radiofrequency thermocoagulation for the sympathetic ganglion is performed.
However, even though in rare cases, chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion. Therefore, it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury.
Recently, it has been reported that botulinum toxin (BTX) has been successfully used for the treatment of pain disorders. BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings. Therefore, the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic. It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity. Therefore, Botulinum toxin type A (BTA) is recommended for the treatment of migraine, myofascial pain syndrome, and neuropathic pain accompanied by allodynia. This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized, double-blind, parallel group, and comparative clinical trials.

开始日期2024-07-01

申办/合作机构

Seoul National University

NCT04589364

/ Not yet recruiting临床3期IIT

A 50-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of100 Unit of Abobotulinum Toxin Type A (Dysport®) Versus 33.33 Unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients

A 50-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 100 unit of Abobotulinum Toxin Type A (Dysport®) versus 33.33 unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients, designed gor comparing the effectiveness of Total intensity score after 4. 12. 16 and 24 weeks of treatment and to compare the long-term safety of the injections. Abobotulinum toxin A (Dysport *) dose 100 units compared ot neubotulinum toxin A injection (Neuronox / Neuronox®) dose 33.33 units. that it si non-inferiority (non-inferiority) ni the treatment of hemifacial spasm after administration of the drug ni the 0, 12" ,26", and 38" weeks ni the treatment of patients with hemi facial spasm, with a wash out period of 2 weeks between treatments. By proving the non-inferiority of Total intensity score at ,4 ,8 and12 week after treatment which calculated by severity score and duration of facial muscle spasm (hour per day)., as well as severity score and duration of functional impairment (hour per day) recorded for 4,8, and 21 weeks after each treatment between 33.33 unit of Neubotulinum Toxin Type A(Neuronox*) and 100 unit of Abobotulinum Toxin Type A (Dysport*)

开始日期2024-05-01

申办/合作机构-

NCT05321979

/ Completed临床3期

Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.

开始日期2022-02-07

申办/合作机构

Medytox Inc.

100 项与 A型肉毒毒素 (Medytox) 相关的临床结果

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100 项与 A型肉毒毒素 (Medytox) 相关的转化医学

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100 项与 A型肉毒毒素 (Medytox) 相关的专利（医药）

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项与 A型肉毒毒素 (Medytox) 相关的文献（医药）

2025-09-09·DERMATOLOGIC SURGERY

NivobotulinumtoxinA in the Treatment of Lateral Canthal Lines Alone and With Concurrent Treatment of Glabellar Lines.

Article

作者: Enfield, Kim ; DuBois, Janet C ; Rivers, Jason K ; Duggan, Sara ; Friedmann, Daniel P ; Palm, Melanie D ; Weinkle, Susan H ; Donofrio, Lisa M ; Carruthers, Jean ; LaTowsky, Brenda

BACKGROUND:

Botulinum neurotoxins in aesthetic medicine require reconstitution, which may cause administration errors.

OBJECTIVE:

To evaluate liquid nivobotulinumtoxinA treatment of lateral canthal lines (LCL) and glabellar lines (GL).

MATERIALS AND METHODS:

Participants with moderate-to-severe LCL with/without moderate-to-severe GL were enrolled in 2 double-blind randomized clinical trials. Study 002 participants received nivobotulinumtoxinA 24 U or placebo for LCL treatment. Study 006 participants received nivobotulinumtoxinA 24 U (LCL), nivobotulinumtoxinA 44 U (LCL+GL), or placebo. Each study allowed up to 2 additional doses. The composite primary end point was the proportion of participants achieving ≥2-grade improvement on the Facial Wrinkle Scale (FWS) by investigator and participant assessment at maximum smile; the coprimary end point was investigator- and participant-assessed FWS "none or mild" rating.

RESULTS:

At Day 30, significant responder rates versus placebo were observed for LCL in Study 002 (30.3% vs 2.6%, p < .001) and for LCL and LCL+GL in Study 006 (20.6% and 22.8% vs 0%, p < .001) for the composite end point. "None or mild" investigator/participant assessment of LCL (Study 002: 62.7%/56.5%; Study 006: 56.4%/43.6%) and LCL+GL (60.8%/47.3%) were significantly higher versus placebo (p < .001). Headache was the most common adverse event.

CONCLUSION:

Liquid nivobotulinumtoxinA was effective and well-tolerated for treating moderate-to-severe LCL with/without GL.

2025-03-17·Aesthetic Surgery Journal

NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials

Article

作者: Weiss, Robert A ; Kaufman-Janette, Joely ; Coleman, William ; Wirta, David ; Keaney, Terrence ; Pariser, David ; Bertucci, Vince ; Humphrey, Shannon ; Solish, Nowell

ABSTRACT:

Background:

Botulinum neurotoxins in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors.

Objectives:

The aim of this study was to evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with or without treatment of lateral canthal lines (LCL).

Methods:

Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL + LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20 U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20 U (GL), nivobotulinumtoxinA 44 U (GL + LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement on a facial wrinkle scale at maximum frown on investigator and participant assessment; coprimary endpoints were investigator- and participant-assessed FWS “none or mild” ratings.

Results:

At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL + LCL (Study 005, 41.3%) vs placebo (0%; all P < .001). Responder rates of “none or mild” by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL + LCL (Study 005, 74.0% and 61.2%) vs placebo (all P < .001). Adverse events were similar between treatment groups and placebo.

Conclusions:

Liquid nivobotulinumtoxinA was effective and well tolerated for treating moderate-to-severe GL alone or with LCL.

Level of Evidence: 1 (Therapeutic):

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study

Article

作者: Kim, Beom Joon ; Won, Chong Hyun ; Lee, Yang Won ; Kim, Won-Serk ; Choi, Sun Young ; Lee, Wooshun ; Han, Hye Sung

Purpose Following the introduction of new type of botulinum toxin (MBA-P01), a recent phase 3 study demonstrated that MBA-P01 showed comparable efficacy and safety to onabotulinumtoxin A for reducing glabellar lines. The primary objective of this study was to evaluate the long-term safety of repeated MBA-P01 administration for the treatment of glabellar lines.Materials and methods This multicenter, single-group, repeated-dose, long-term open-label extension study evaluated repeated treatment with MBA-P01 (20 U, five treatments over 16 months), with posttreatment evaluation performed up to 52 weeks.Results Based on the safety assessment results, no specific irreversible adverse reactions were associated with the safety profile of MBA-P01. Repeated treatment with MBA-P01 was effective for a treatment duration of 3-5 months.Conclusion In conclusion, multiple cycles of treatment of glabellar lines with MBA-P01 at a dose of 20 U were well tolerated.Clinical trial registration information: This study is registered in ClincalTrials.gov (NCT05321979).

项与 A型肉毒毒素 (Medytox) 相关的新闻（医药）

2025-11-11

·药事纵横

爆了！FDA一日连发17封警告信

2025年11月05日，FDA罕见地一次性发布了17封警告信，目标直指多家在美国境内或通过互联网向美国消费者销售非法注射用肉毒毒素产品的企业。这一大规模执法行动不仅彰显了FDA对公共卫生安全的高度重视，也揭示了当前跨境非法药品流通的严峻形势。本次收到警告信的17家企业遍布全球多个司法管辖区，包括中国（含香港特别行政区）、韩国、美国本土、荷兰、巴拿马等。它们通过自营网站（如 www.acecosm.com, www.filleroutlet.com, www.koreanfillers.com 等）直接面向美国消费者进行销售。尽管地理位置分散，但其违规行为呈现出显著的共性： u 销售未经批准的肉毒毒素产品：所有企业均在销售未获得FDA批准的A型肉毒毒素注射剂。这些产品品牌繁多，包括但不限于NABOTA、Innotox、Meditoxin、Botulax、Rentox、Wondertox、Hutox、Liztox等。FDA明确指出，这些产品未按照FD&C Act第505(a)节的要求提交并获得有效的新药申请（NDA）批准。 u 非法宣称医疗用途：这些产品被定义为“药品”的关键证据，来源于其网站或标签上明确列出的治疗性宣称。例如：AceCosm销售的“NABOTA 200U”声称用于“预防成人慢性偏头痛”、“治疗神经源性逼尿肌过度活动引起的尿失禁”、“管理局灶性腋窝多汗症”。Filler Outlet销售的“Innotox 50u”声称用于“减少多汗症”和“治疗不自主眼睑抽搐”。Korean Aesthetic销售的“MEDITOXIN BOTULINUM TOXIN”声称用于“治疗特发性眼睑痉挛”和“控制脑瘫及帮助减少中风后上肢痉挛”。其他产品也普遍声称用于治疗眉间纹、颈肌张力障碍、慢性唾液分泌过多、斜视、肌肉痉挛等多种病症。这些宣称使其产品符合FD&C Act第201(g)节对“药品”的定义，即旨在用于疾病的诊断、治愈、缓解、治疗或预防，和/或旨在影响身体的结构或功能。由于这些用途未经FDA的全面审评以确认其安全性和有效性，这些产品同时构成了“新药”，在未获批准的情况下上市即属违法。 u 面向消费者直接销售处方药：肉毒毒素产品因其特性（如毒性、使用方法复杂、需专业监督）在美国被归类为处方药。FDA在警告信中反复强调，经批准的肉毒毒素产品（如BOTOX®、DAXXIFY®、MYOBLOC®）仅能在有执照的医疗专业人员开具处方后使用。而这些网站直接向消费者销售这些高风险产品，未要求提供处方，严重违反了处方药分销规定。 FDA在每封信中都以显著篇幅强调了使用这些非法产品的潜在致命风险： 1.缺乏安全保障：未经FDA审查批准的药品，其安全性、有效性、质量和纯度均无法得到保证。它们可能被污染、是假冒产品、有效成分含量不均甚至含有完全不同的成分。 2.注射剂的特殊风险：注射剂绕过人体的许多天然防御屏障，一旦含有有毒成分、毒素或危险微生物，可能导致败血症等严重、危及生命的状况。 3.肉毒毒素的固有风险：FDA特别指出，即使是经批准的肉毒毒素产品，也携带最严格的“黑框警告”，提示其存在严重或危及生命的副作用风险。这包括毒素效应远距离扩散的风险（可能引起肉毒中毒症状），以及可能危及生命的吞咽和呼吸困难，已有死亡报告。未经批准的产品这些风险更不可控。面对这些严峻的违法行为和风险，FDA要求这17家企业立即停止向美国消费者提供所有未经批准和错误标识的药品销售。企业必须全面审查其网站、产品标签及其他标签和宣传材料，确保不再虚假宣传其产品对未经FDA批准的用途安全有效，并停止分销所有违反FD&C Act的非法药品。企业必须在收到警告信后的15个工作日内，向FDA提交书面回复，详细说明为纠正违规行为和防止复发所采取的具体步骤，包括解释每项措施并提供相关文件副本。 FDA明确指出，未能充分解决此事可能导致法律行动，包括但不限于查封产品和禁制令，且无需进一步通知。对于位于美国境外的企业，FDA警告，这些看似错误标识或未经批准的新药可能在入境口岸被扣留或拒绝入境。同时，FDA可能会通知该企业所在国家的监管机构。此次FDA一日连发17封警告信，绝非偶然，其背后反映了深层次的监管动向和行业问题，表明FDA正在加强对非法药品，尤其是通过互联网跨境销售的处方药的监管力度。线上销售的隐蔽性和便捷性使得非法药品更容易触达消费者，FDA通过监控网站和发出警告信，旨在从源头遏制这一趋势。涉事产品多为在韩国、中国等地区已获批，但未在美国履行上市许可程序的肉毒毒素品牌。这些产品通过跨境电商、“代购”等形式流入美国，形成了一个潜在的“灰色市场”。FDA此举是对该市场的直接打击，重申了其药品准入的权威性。FDA在信中反复强调风险，核心目的是保护美国公众健康。直接向消费者销售未经专业医疗干预的注射用肉毒毒素，无异于将消费者置于极大的健康风险之下，特别是考虑到肉毒毒素已知的严重副作用。任何面向美国消费者销售药品的企业，都必须确保其产品符合FDA规定。声称医疗用途、销售处方药而不要求处方，将面临严厉的执法行动。强烈警示消费者不要从网上购买未经FDA批准的注射剂，尤其是肉毒毒素这类高风险处方药。产品的廉价和便捷不应以牺牲安全和健康为代价。提醒从业者应仅使用经FDA批准的药品，并确保采购渠道合法合规。这17封警告信，是一次针对全球范围内非法销售未经批准肉毒毒素产品的集中、有力的执法行动。它清晰地勾勒出FDA在数字经济时代维护药品安全的执法策略：严密监控线上渠道，依据明确的法律框架（未经批准新药和错误标识），对违规者采取快速、公开的警告并要求立即整改。这不仅是对17家涉事企业的严厉警告，也是对整个行业和广大消费者的重要提醒：药品安全无小事，尤其是在高风险注射剂领域，任何绕过监管体系的行为都将面临法律的严惩。随着监管技术的进步和跨境合作的深化，FDA对类似非法活动的打击或将持续加强，以构筑更坚固的公共卫生安全防线。来源：FDA官网立即扫码加入药事纵横交流群

申请上市

2022-08-04

·GBIHealth

歌礼ASC10在美获批临试；华熙生物与Medytox终止合作；普方生物PRO1184获FDA批准临试

药讯精选GBI NEWS歌礼口服新冠候选药ASC10在美获批临试，中国临试申请获受理8月4日，歌礼制药有限公司宣布，其新冠口服候选药物聚合酶（RdRp）抑制剂ASC10的新药临床试验（IND）申请已获中国国家药监局受理；在美国提交的IND申请已获得FDA批准，将在轻度至中度新冠患者中开展Ib期临床试验，以收集ASC10的临床安全性、药代动力学以及初步疗效数据。ASC10是一款口服双前药，同单前药莫努匹韦（molnupiravir）相比具有差异化的新化学结构。口服给药后，ASC10和莫努匹韦均可在体内快速、完全转换为相同的活性代谢物ASC10-A，也称β-D-N4-羟基胞苷（NHC）。ASC10由歌礼完全自主研发，歌礼已在全球范围内提交多项ASC10及其用途的专利申请。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯普方生物PRO1184在美获批临试，Naomi Hunder出任首席医学官普方生物宣布PRO1184在晚期癌症患者中的临床试验申请已获得美国食品和药物管理局（FDA）的批准，并正式宣布任命Naomi Hunder医学博士为首席医学官。PRO1184是一款以叶酸受体α（FRα）为靶点、以依喜替康作为有效载荷的抗体偶联药物，采用了具有自主专利的新型亲水性连接子。临床前实验的数据显示，PRO1184拥有良好的体内活性和安全性。I期试验将评估PRO1184在卵巢癌、子宫内膜癌、乳腺癌、非小细胞肺癌和间皮瘤患者中的安全性、活性和药代动力学。Hunder博士在肿瘤药物开发方面拥有15年的丰富经验，曾全程参与药物最初的分子设计到全球获批和商业化。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯可吸收再生氧化纤维素止血颗粒获批上市国家药品监督管理局经审查，批准Ethicon,LLC生产的创新产品“可吸收再生氧化纤维素止血颗粒”注册。该产品由型号3013SP即再生氧化纤维素可吸收止血颗粒（预装含装置）和型号3123SPEA即再生氧化纤维素可吸收止血颗粒内窥镜施用导管装置组成。两者均经辐射灭菌，一次性使用。型号3013SP为预装3g经专利工艺压实细纤维制成的止血颗粒的施用装置，用于开放手术；型号3123SPEA，可配合3013SP用于内窥镜手术。该产品适用于外科手术或内窥镜手术中（眼科、神经外科、泌尿外科除外）结扎法或其他传统控制方法不适用或无效时，作为辅助控制毛细血管、小静脉和小动脉出血。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯企业动态GBI NEWS硕迪生物再获3300万美元超额认购，推进重点研究项目硕迪生物技术有限公司（前身为ShouTi Inc.）宣布，在2021年10月完成的一亿美元B轮融资的基础上，获得了3300万美元的超额认购。此次扩展融资包括新投资者Deep Track Capital和Piper Heartland Healthcare Capital。所得资金将用于推进硕迪生物的重点临床研究项目，进一步拓展下一代基于结构的药物发现平台的应用，从而推动研发创新的G蛋白偶联受体（GPCR）靶向治疗药物。另外，硕迪生物的GSBR-1290（用于治疗2型糖尿病和肥胖症）单剂量递增Ⅰ期临床研究已完成受试者给药。GSBR-1290是一种口服小分子GLP-1受体激动剂，用于治疗2型糖尿病和肥胖症，其Ⅰ期首次人体试验在48名健康受试者中进行。基于硕迪生物研发平台设计的口服GLP-1R偏向激动剂GSBR-1290可避免β-arrestin介导的受体内化和脱敏。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯华熙生物终止与韩国Medytox就肉毒素等产品的合作华熙生物发布公告称，公司全资子公司钜朗公司（英文名：Gentix Limited）已委托律师于2022年7月29日向Medytox发出律师函，要求终止/撤销/解除二者之间围绕肉毒素等医疗美容产品达成的合作协议，原因是Medytox自合资协议签署后从未提供任何相关产品以供销售。2015年5月7日，华熙生物科技有限公司（目前已退市，简称“开曼华熙”）与韩国公司 Medytox Inc.签署合资协议，约定成立合资公司华熙美得妥股份有限公司（英文名：Medybloom Limited），在中国大陆地区开发、拓展及销售Medytox生产的特定注射用A型肉毒毒素及其他医疗美容产品。2018年9月，钜朗公司向开曼华熙收购其持有的华熙美得妥50%股权，并承接开曼华熙于合资协议下的权益。2020年3月，钜朗公司及Medytox决议共同按持股比例向华熙美得妥各增资1,700万港币。之后2020年，韩国食品药品安全部对Medytox一系列产品（其中包括肉毒素产品）发布召回、销毁、取消产品批准程序、以及暂停制造销售和使用等多项行政命令。Medytox于中国注册的肉毒素产品自2019年11月11日起至今一直在CDE审评审批中，至今未完成产品注册手续。钜朗公司就此认为，双方的合作目的在可预见的未来无法实现。华熙生物称，与Medytox的协议终止后，不排除寻求其他肉毒素产品的合作机会。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯重磅推荐*点击图片阅读详情点击阅读原文定制/订阅医疗行业新闻资讯

合作小分子药物抗体并购

2021-06-08

·GlobeNewswire

Overactive Bladder Pipeline Shows Rapid Advancements in the

Los Angeles, USA, June 07, 2021 (GLOBE NEWSWIRE) -- Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight Overactive Bladder therapies with different mechanisms of action are currently being studied with excellent market potential. Ongoing scientific research has provided with greater sophistication and a clearer understanding of the mechanisms of therapeutic interventions, combined with improved outcome measures to assess the efficacy and patient satisfaction, as well as high-quality Overactive Bladder clinical trials with proper design, which would translate into more refined and directed therapies in future years. DelveInsight’s “Overactive Bladder Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Overactive Bladder pipeline landscapes. It comprises Overactive Bladder pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Overactive Bladder therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Overactive Bladder pipeline products. Some of the key takeaways from the Overactive Bladder Pipeline Report Get an overview of pipeline landscape @ Overactive Bladder Clinical Trials Analysis Overactive Bladder (OAB) causes a frequent and sudden urge to urinate that may be difficult to control. One may need to pass urine many times during the day and night and may also experience unintentional loss of urine. There are six antimuscarinic agents available for the OAB treatment worldwide- oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. Overactive Bladder Emerging Drugs Neuronox, an acetylcholine inhibitor is being developed by Medy-Tox for the treatment of the Overactive Bladder. The active ingredients involve Clostridium botulinum toxin type A. It is currently in the phase III stage of development. In September 2020, US drugmaker Allergan entered into a license agreement with South Korea’s Medytox under the terms of which, on closing, Allergan would pay Medytox an upfront of USD 65 million and Medytox would grant Allergan exclusive rights, worldwide outside of Korea, to develop and, if approved, commercialise certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. In May 2020, AbbVie announced that it had finished its acquisition of Allergan plc. following receipt of regulatory approval from all government authorities needed by the transaction agreement and approval by the Irish High Court. Research and DevelopmentPhase III NCT04113941: In August 2019, Medy-Tox initiated a phase III trial, a randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of Meditoxin in subject with Idiopathic Overactive Bladder. This study is for patients who have idiopathic overactive bladder symptoms. This study will assess the efficacy and safety of Neuronox against placebo. The trial is currently in the active not recruiting stage with an estimated enrollment of 216 participants and anticipated to be completed in August 2021. Urovant Sciences is developing URO-902 for the treatment of the Overactive Bladder. URO-902 has the potential to be the first gene therapy for OAB patients. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to existing third-line OAB treatments. It is currently in the phase II stage of development. Research and DevelopmentPhase II NCT04211831: In December 2019, Urovant Sciences GmbH initiated a phase II trial titled “An exploratory phase IIa study evaluating the efficacy and safety of URO-902 in subjects with Overactive Bladder and Urge Urinary Incontinence”. This study will investigate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose. The trial is currently in recruiting stage with an estimated enrollment of 78 participants and expected to be completed in September 2022. Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for Overactive Bladder treatment. Solabegron has been tested in over 800 study subjects in a twice-a-day formulation and demonstrated efficacy in treating OAB and Irritable bowel syndrome (IBS). A once-daily formulation designed to optimise patient convenience and effectiveness has been developed and is currently being evaluated in phase 2b dose-ranging clinical trials. Research and DevelopmentPhase II NCT03594058: In July 2018, Velicept Therapeutics initiated a phase IIb, multicenter, randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of oral solabegron modified-release tablets in the treatment of Overactive Bladder in adult female subjects. The trial enrolled 1413 participants and was completed in May 2019. Results Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients. In the study, twice-daily administration of solabegron showed a statistically major improvement compared to placebo at week 12, as measured by the mean change in the number of micturitions per day, the study’s primary endpoint. Solabegron also showed statistical significance across various secondary endpoints, comprising a percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes. For further information, refer to the detailed report @ Overactive Bladder Pipeline Therapeutics Scope of Overactive Bladder Pipeline Drug Insight Key Questions regarding Current Overactive Bladder Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Overactive Bladder Drugs Pipeline Report Related Reports DelveInsight’s Overactive Bladder Market Insights, Epidemiology and Market Forecast report provides a detailed overview of the disease and a depth understanding of historical data. DelveInsight's Overactive Bladder - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Overactive Bladder in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight's "Interstitial Lung Disease - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Interstitial Lung Disease, historical and forecasted epidemiology. DelveInsight's Interstitial Cystitis - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. DelveInsight's Bronchiolitis Obliterans Syndrome - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. Checkpoint Kinase Inhibitor Pipeline Insights, 2021 report by DelveInsight offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Checkpoint Kinase Inhibitor development. Browse ASCO 2021 Abstracts here:- About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

基因疗法合作并购ASCO会议

100 项与 A型肉毒毒素 (Medytox) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M03AX01	DB00083

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
良性基础型眼睑痉挛	韩国	Medytox Inc.	2006-03-16
足部畸形	韩国	Medytox Inc.	2006-03-16
肌肉痉挛	韩国	Medytox Inc.	2006-03-16
眉间纹	韩国	Medytox Inc.	2006-03-16
脑瘫	韩国	Medytox Inc.	-
外眦皱纹	韩国	Medytox Inc.	-
上下肢痉挛	韩国	Medytox Inc.	-
斜颈	韩国	Medytox Inc.	-

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
膀胱过度活动症	临床3期	韩国	Medytox Inc.	2019-08-23
原发性腋窝多汗症	临床3期	韩国	Medytox Inc.	2018-08-03
咀嚼肌肥大	临床3期	韩国	Medytox Inc.	2018-04-09
先天性斜颈	临床3期	韩国	Medytox Inc.	2017-07-06
眼睑痉挛	临床3期	中国	Medytox Inc.	2016-05-25
颈肌张力障碍	临床3期	-	Medytox Inc.	2013-01-09

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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


NCT04157686 (CTgov)	临床3期	眉间纹 \| 外眦皱纹	957	MT10109L Dose 1 (Placebo/MT10109L Dose 1)	網獵鬱齋選蓋襯齋艱齋 = 遞夢衊鏇餘餘鬱夢網積範鹽鬱觸餘鏇鹹遞膚餘 (觸醖襯窪範夢齋齋築夢, 膚襯衊鹹淵淵製鬱夢鹽 ~ 壓糧膚獵觸觸鬱積餘鏇) 更多	-	2024-08-09
				MT10109L Dose 2 (Placebo/MT10109L Dose 2)	網獵鬱齋選蓋襯齋艱齋 = 糧餘淵鹽鬱鹽艱艱壓鏇範鹽鬱觸餘鏇鹹遞膚餘 (觸醖襯窪範夢齋齋築夢, 衊願廠築構鬱願願遞顧 ~ 糧網夢壓鑰艱夢襯艱糧) 更多
NCT01485601 (CTgov)	临床2期	眉间纹	121	MT10109	鏇鏇廠製構餘範顧製構 = 衊獵壓網選艱襯繭艱鑰網選襯鏇襯範繭鹽膚網 (遞遞築齋餘餘積製繭顧, 齋鹹遞夢顧鬱窪淵窪鏇 ~ 窪襯選獵廠壓鑰夢醖艱) 更多	-	2024-02-22
NCT03785145 (CTgov)	临床3期	外眦皱纹	235	Placebo (Placebo)	鏇網願選膚遞廠觸觸襯 = 構繭膚網獵觸選製願範壓鑰願蓋願顧鬱繭糧積 (衊廠遞鑰遞願襯鹽憲觸, 網願襯廠襯壓範醖範襯 ~ 鏇廠壓鹹鑰憲齋築繭廠) 更多	-	2023-10-05
				MT10109L (MT10109L)	鏇網願選膚遞廠觸觸襯 = 網糧觸鑰選繭艱鹹繭襯壓鑰願蓋願顧鬱繭糧積 (衊廠遞鑰遞願襯鹽憲觸, 遞遞積憲築醖糧築網獵 ~ 築遞網襯鑰鬱艱繭糧顧) 更多
NCT03732833 (CTgov)	临床3期	眉间纹 \| 外眦皱纹	425	Placebo	網糧餘襯廠鬱壓築膚夢 = 積願鏇顧觸襯簾顧範獵糧構觸鹹衊膚醖鹽網憲 (範淵憲簾壓窪選廠繭壓, 簾壓簾窪獵顧繭壓淵衊 ~ 廠廠壓積餘築憲鬱餘壓) 更多	-	2023-07-17
NCT03795922 (CTgov)	临床3期	眉间纹	234	Placebo (Placebo)	積選選餘範顧衊鏇顧蓋 = 製積餘淵鹽憲廠鹹積艱餘糧蓋齋廠鹹鹹選廠製 (壓壓築網廠齋醖鑰壓構, 繭衊齋衊顧願醖憲願鏇 ~ 製襯艱積願獵憲鏇齋積) 更多	-	2023-06-27
				MT10109L (MT10109L)	積選選餘範顧衊鏇顧蓋 = 憲鹹築鹹憲選獵簾選獵餘糧蓋齋廠鹹鹹選廠製 (壓壓築網廠齋醖鑰壓構, 蓋網簾廠艱夢壓壓遞膚 ~ 獵夢製願夢選積鹹襯蓋) 更多
NCT03721016 (CTgov)	临床3期	眉间纹 \| 外眦皱纹	415	Placebo (Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL))	遞憲齋鏇簾構鹽醖願餘 = 夢窪網糧願獵鏇選顧選廠壓範餘鏇範餘窪簾餘 (獵積製鑰淵觸窪襯鹹衊, 襯簾範繭鹹鹹鏇齋鹽範 ~ 願鹹艱壓壓鹹觸願鏇築) 更多	-	2023-04-21
				MT10109L+Placebo (MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL))	遞憲齋鏇簾構鹽醖願餘 = 鬱構顧選繭淵鬱蓋膚遞廠壓範餘鏇範餘窪簾餘 (獵積製鑰淵觸窪襯鹹衊, 繭範艱獵憲鹹壓築顧憲 ~ 醖獵簾廠艱淵襯繭網淵) 更多