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

Rajavithi Hospital

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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303

项与 A型肉毒毒素 (Medytox) 相关的文献（医药）

2024-02-01·Journal of oral rehabilitation

Adverse effect of botulinum toxin‐A injections on mandibular bone: A systematic review and meta‐analysis

Review

作者: Moussa, Mahmoud S ; Bachour, Dona ; Komarova, Svetlana V

Abstract:

Introduction:

Botulinum toxin‐A (BTX) is a potent neurotoxin that is emerging in the scope of dental practice for its ability to temporarily paralyse musculature and reduce hyperfunction. This may be desirable in diseases/disorders associated with hyperactive muscles such as the muscles of mastication, most implicated in painful temporomandibular disorders (TMDs). The use of BTX extends beyond its indications with off‐label use in TMD's and other conditions, while potential adverse effects remain understudied. BTX is well‐established hindlimb paralysis model in animals leading to significant bone loss with underlying mechanisms remaining unclear. The objective of this study is to systematically review the literature for articles investigating changes in mandibular bone following BTX injections and meta‐analyse available data on reported bone outcomes.

Methods:

Comprehensive search of Medline, Embase and Web of Science retrieved 934 articles. Following the screening process, 36 articles in animals and humans were included for quantitative synthesis. Articles in human individuals (6) and three different animal species (14) presented mandibular bone outcomes that were included in the meta‐analysis.

Results:

The masseter and temporalis muscles were frequently injected across all species. In humans, we observe a decrease of about 6% in cortical thickness of mandibular regions following BTX injection with no evident changes in either volume or density of bone structures. In animals, bone loss in the condylar region is significantly high in both cortical and trabecular compartments.

Discussion:

Our analysis supports the concept of BTX‐induced bone‐loss model in animal mandibles. Further, bone loss might be confined to the cortical compartments in humans. Most studies did not address the reality of repeated injections and excessive dosing, which occur due to the reversible action of BTX. More rigorous trials are needed to draw a full picture of potential long‐term adverse effects on bone.

2023-10-01·Archives of physical medicine and rehabilitation

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke

Article

作者: Seim, Caitlyn ; Okamura, Allison M ; Han, Chuzhang ; Chen, Bingxian ; Lowber, Alexis ; Vacek, David ; Lansberg, Maarten

OBJECTIVE:

To test the feasibility and efficacy of the VibroTactile Stimulation (VTS) Glove, a wearable device that provides VTS to the impaired limb to reduce spastic hypertonia.

DESIGN:

Prospective 2-arm intervention study-including 1 group of patients who use Botulinum toxin (BTX-A) for spasticity and 1 group of patients who do not use BTX-A.

SETTING:

Participants were recruited through rehabilitation and neurology clinics.

PARTICIPANTS:

Patients with chronic stroke (N=20; mean age=54 years, mean time since stroke=6.9 years). Patients who were previously receiving the standard of care (BTX-A injection) were eligible to participate and started the intervention 12 weeks after their last injection.

INTERVENTION:

Participants were instructed to use the VTS Glove for 3 hours daily, at home or during everyday activities, for 8 weeks.

MAIN OUTCOME MEASURES:

Spasticity was assessed with the Modified Ashworth Scale and the Modified Tardieu Scale at baseline and then at 2-week intervals for 12 weeks. Primary outcomes were the difference from baseline and at week 8 (end of VTS Glove use) and week 12 (4 weeks after stopping VTS Glove use). Patients who were receiving BTX-A were also assessed during the 12 weeks preceding the start of VTS Glove use to monitor the effect of BTX-A on spastic hypertonia. Range of motion and participant feedback were also studied.

RESULTS:

A clinically meaningful difference in spastic hypertonia was found during and after daily VTS Glove use. Modified Ashworth and Modified Tardieu scores were reduced by an average of 0.9 (P=.0014) and 0.7 (P=.0003), respectively, at week 8 of daily VTS Glove use, and by 1.1 (P=.00025) and 0.9 (P=.0001), respectively, 1 month after stopping VTS Glove use. For participants who used BTX-A, 6 out of 11 showed greater change in Modified Ashworth ratings during VTS Glove use (mean=-1.8 vs mean=-1.6 with BTX-A) and 8 out of 11 showed their lowest level of symptoms during VTS Glove use (vs BTX-A).

CONCLUSIONS:

Daily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of the participants who had regularly used BTX-A, the VTS Glove provided equal or greater symptom relief.

2023-09-16·Cell death & disease

Blocking insulin-like growth factor 1 receptor signaling pathway inhibits neuromuscular junction regeneration after botulinum toxin-A treatment.

Article

作者: Miyajima, Hisao ; Otani, Yoshinori ; Tanaka, Kazuki ; Ishihara, Hiroki ; Fujitani, Masashi ; Ngo, Huy Xuan

Botulinum toxin-A (BTX) administration into muscle is an established treatment for conditions with excessive muscle contraction. However, botulinum therapy has short-term effectiveness, and high-dose injection of BTX could induce neutralizing antibodies against BTX. Therefore, prolonging its effects could be beneficial in a clinical situation. Insulin-like growth factor-1 receptor (IGF1R) and its ligands, insulin-like growth factor (IGF) -I and II, regulate the physiological and pathological processes of the nervous system. It has been suggested that IGF1R is involved in the process after BTX administration, but the specific regeneration mechanism remains unclear. Therefore, this study aimed to determine how inhibition of IGF1R signaling pathway affects BTX-induced muscle paralysis. The results showed that anti-IGF1R antibody administration inhibited the recovery from BTX-induced neurogenic paralysis, and the synaptic components at the neuromuscular junction (NMJ), mainly post-synaptic components, were significantly affected by the antibody. In addition, the wet weight or frequency distribution of the cross-sectional area of the muscle fibers was regulated by IGF1R, and sequential antibody administration following BTX treatment increased the number of Pax7⁺-satellite cells in the gastrocnemius (GC) muscle, independent of NMJ recovery. Moreover, BTX treatment upregulated mammalian target of rapamycin (mTOR)/S6 kinase signaling pathway, HDAC4, Myog, Fbxo32/MAFbx/Atrogin-1 pathway, and transcription of synaptic components, but not autophagy. Finally, IGF1R inhibition affected only mTOR/S6 kinase translational signaling in the GC muscle. In conclusion, the IGF1R signaling pathway is critical for NMJ regeneration via specific translational signals. IGF1R inhibition could be highly beneficial in clinical practice by decreasing the number of injections and total dose of BTX due to the prolonged duration of the effect.

项与 A型肉毒毒素 (Medytox) 相关的新闻（医药）

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

2022-08-02

·生物制药小编

华熙生物终止肉毒素引进；恒瑞医药吡咯替尼一线乳腺癌适应症三期临床成功

2015年，为布局肉毒素领域，华熙生物与韩国企业Medytox携手，成立合资公司。不过，几年时间过去，二者关系却变了质。今日（8月1日），华熙生物发布公告，子公司向Medytox发出律师函，要求行使权利终止合资协议及相关协议。是什么使得曾经的合作伙伴，如今对簿公堂？对此，华熙生物给出了答案。由于Medytox的肉毒素产品一直未完成产品注册手续，导致Medytox无法通过合法方式向合资公司华熙美得妥提供肉毒素产品。这才使得华熙生物做出此举。恒瑞医药乳腺癌布局迎来好消息。恒瑞医药发布公告表示，泛 ErbB 受体酪氨酸激酶抑制剂马来酸吡咯替尼片联合曲妥珠单抗和多西他赛，一线治疗HER2阳性复发/转移性乳腺癌的III 期临床达到主要终点。此外，不少药企发布上半年业绩公告，包括日本公司盐野义制药，国内公司和黄医药、海特生物等，他们的表现如何？可在下文寻找答案。过去一天，国内外医药市场还有哪些热点值得关注呢？让氨基君带你一起看看吧。PS：每个工作日晚上，「氨基观察」每日“药”闻，准时更新，带你追踪医药市场热点。/ 01 /行业速递1) 华熙生物子公司向Medytox发出律师函8月1日，华熙生物公告，由于Medytox无法通过合法方式向合资公司华熙美得妥提供肉毒素产品，全资子公司已向Medytox发出律师函。2) 海特生物上半年净利1887.2万元，同比增长161.49%8月1日，海特生物公告，上半年实现营业收入3.87亿元，同比增长71.69%；净利润1887.2万元，同比增长161.49%。3) 山河药辅上半年净利6615.9万元，同比增长24.21%8月1日，山河药辅公告，上半年度实现营业收入3.6亿元，同比增长17.82%；净利润6615.9万元，同比增长24.21%。4) 和黄医药上半年总收入增长28%至2.02亿美元8月1日，和黄医药公告，上半年总收入增长28%至2.02亿美元，股东应占净亏损为1.629亿美元，同比扩大约59.05%。5) 九安医疗美国子公司日常经营重大合同履行完毕7月31日，九安医疗公告，国子公司已经收到美国ACC针对本合同支付的17.75亿美元货款，合同履行完毕。6) 太极集团子公司青霉素V钾片抽检不合格7月31日，太极集团公告，公司控股子公司西南药业生产的青霉素V钾片有关物质检测不合格。7) 华润双鹤拟收购神舟生物科技50.11%股权8月1日，华润双鹤公告，拟以5.02亿元收购神舟生物科技有限责任公司50.11%股权。8) 药审中心发布新冠状病毒新药非临床和临床评价标准的问答8月1日，国家药监局药审中心发布《关于新型冠状病毒新流行株感染抗病毒新药非临床和临床评价标准的问与答》通知。9) 沃森生物累计回购200万股，占总股本0.1248%8月1日，沃森生物公告，截至7月31日公司累计回购股份数量为200万股，占公司目前总股本的0.1248%，成交总金额约为9264万元。/ 02 /产品跟踪1) 和黄医药在国内启动达唯珂的桥接研究8月1日，和黄医药表示，在中国启动EZH2甲基转移酶抑制剂达唯珂的桥接研究，首名患者已于2022年7月29日接受首次给药治疗。2) 首药控股SY-3505胶囊获得II期临床试验伦理审批报告8月1日，首药控股公告表示，公司三代ALK抑制剂CT-3505胶囊治疗ALK阳性非小细胞肺癌患者的I/II期临床符合伦理要求，可以在临床研究中使用。3) 恒瑞医药吡咯替尼一线乳腺癌适应症 III 期临床达到终点8 月 1 日，恒瑞医药发布公告，泛 ErbB 受体酪氨酸激酶抑制剂马来酸吡咯替尼片联合曲妥珠单抗和多西他赛，一线治疗HER2阳性复发/转移性乳腺癌的III 期临床达到主要终点。4) 礼来高血糖素鼻用粉雾剂上市申请获得受理8 月 1 日，据 CDE 官网显示，礼来紧急治疗严重低血糖的高血糖素鼻用粉雾剂，上市申请获受理。5) 迈威生物Nectin-4 ADC获批临床8 月 1 日，迈威生物宣布，其自主研发的靶向 Nectin-4 ADC 创新药，临床试验申请获 FDA 批准，用于治疗实体瘤。6) afuresertib+信迪利单抗+化疗三药联合疗法完成首例受试者给药8月1日，来凯医药与信达生物共同宣布，由双方合作的afuresertib+信迪利单抗+化疗三药联合，针对抗PD-1/PD-L1耐药的特定实体瘤患者的1/2期临床研究，已于近日完成首例受试者给药。7) 远大医药放射性核素偶联药物TLX591-CD临床申请获得受理8月1日，远大医药公告，放射性核素偶联药物TLX591-CD临床申请获得受理，用于诊断前列腺癌x。8) 远大医药放射性核素偶联药物TLX250-CDx临床申请获得受理8月1日，远大医药公告，放射性核素偶联药物TLX250-CDx临床申请获得受理，用于诊断透明细胞肾细胞癌。/ 03 /海外要闻1) FDA解除对Celyad公司CyAD-101临床试验的限制8月1日，Celyad宣布，在公司对试验的资格标准进行更改后，FDA解除对同种异体CAR-T与KEYTRUDA联合临床试验CyAD-101的1b临床试验限制。2) 盐野义制药归母净利润347亿日元，同比增长7.7% 8月1日，盐野义制药上半年营收718亿日元，同比增长4.2%；归母净利润347亿日元，同比增长7.7%。3) 日本首相称将讨论下调新冠肺炎的传染病级别7月31日，据朝日新闻，日本首相岸表示，在当前日本第七波疫情过后，将讨论下调新冠肺炎的传染病级别。4) Beam 公司BEAM-201临床申请已被搁置8月1日，Beam Therapeutics宣布，收到FDA消息，公司CAR-T疗法BEAM-201用于治疗复发/难治性T细胞急性淋巴细胞白血病/T细胞淋巴母细胞淋巴瘤的临床申请已被搁置。文／方涛之免责声明:本文（报告）基于已公开的资料信息或受访人提供的信息撰写，但氨基观察及文章作者不保证该等信息资料的完整性、准确性。在任何情况下，本文（报告）中的信息或所表述的意见均不构成对任何人的投资建议。

免疫疗法财报抗体细胞疗法创新药

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
眉间纹	俄罗斯	Medytox Inc.	2022-08-25
眉间纹	中国台湾	Medytox Inc.	2022-08-25
良性基础型眼睑痉挛	韩国	Medytox Inc.	-
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
颈肌张力障碍	临床3期	韩国	Medytox Inc.	2017-07-06
肌张力障碍	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
多汗症	临床1期	韩国	Medytox Inc.	2018-03-20

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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)	齋願鹽觸淵簾餘積膚網(觸憲蓋糧壓齋願願製積) = 範蓋廠廠窪構餘選鬱鑰選製艱糧膚築鬱淵鬱齋 (鬱窪鹹膚鹽窪憲齋網餘, 願範膚鬱製鏇壓選築獵 ~ 願鑰蓋淵艱遞繭鑰糧選) 更多	-	2024-08-09
				MT10109L Dose 2 (Placebo/MT10109L Dose 2)	齋願鹽觸淵簾餘積膚網(觸憲蓋糧壓齋願願製積) = 廠膚選憲壓襯製鏇構壓選製艱糧膚築鬱淵鬱齋 (鬱窪鹹膚鹽窪憲齋網餘, 夢製繭繭膚糧製繭觸糧 ~ 網簾夢獵夢醖醖憲構醖) 更多
NCT01485601 (CTgov)	临床2期	眉间纹	121	MT10109	繭淵夢齋遞鏇壓遞積衊(蓋餘夢襯選糧構獵醖餘) = 鏇淵製選範齋淵壓構廠衊網憲蓋衊蓋醖襯獵繭 (壓夢選獵獵齋鑰願襯壓, 觸夢積觸鹽夢獵壓獵餘 ~ 簾淵糧願繭獵齋齋範製) 更多	-	2024-02-22
NCT03785145 (CTgov)	临床3期	外眦皱纹	235	Placebo (Placebo)	選膚鏇鹽醖糧淵簾壓簾(鏇餘醖憲齋鑰膚壓繭鏇) = 窪廠構網鏇築夢艱獵膚艱淵鹹鏇鏇積願壓鏇壓 (鹽糧鹽願廠襯壓憲壓醖, 鹽醖齋繭餘鏇淵遞壓鹽 ~ 構鑰鹽遞壓齋齋淵獵齋) 更多	-	2023-10-05
				MT10109L (MT10109L)	選膚鏇鹽醖糧淵簾壓簾(鏇餘醖憲齋鑰膚壓繭鏇) = 鏇繭顧夢簾積膚獵願積艱淵鹹鏇鏇積願壓鏇壓 (鹽糧鹽願廠襯壓憲壓醖, 鬱艱積淵鏇簾窪齋遞餘 ~ 衊繭範醖鹹餘簾願憲簾) 更多
NCT03732833 (CTgov)	临床3期	眉间纹 \| 外眦皱纹	425	Placebo	衊繭鑰鏇範齋鏇蓋鏇鑰(壓壓鏇繭夢積廠憲鏇簾) = 蓋艱夢製網鹽網獵鏇積選鹹鹽壓廠鬱糧鏇膚廠 (鏇積衊遞製構衊艱選淵, 窪網膚願蓋襯積鹽膚糧 ~ 選鏇壓艱選積觸鬱醖獵) 更多	-	2023-07-17
NCT03795922 (CTgov)	临床3期	眉间纹	234	Placebo (Placebo)	壓顧糧築糧憲鬱襯選廠(襯壓襯膚顧鑰鹽壓顧襯) = 壓糧鑰膚膚膚積積積觸積齋淵範顧選淵襯淵鹽 (製廠網鹹壓顧繭鹹艱艱, 餘淵膚鹽壓顧蓋製膚憲 ~ 齋構觸衊衊鬱醖鹹艱築) 更多	-	2023-06-27
				MT10109L (MT10109L)	壓顧糧築糧憲鬱襯選廠(襯壓襯膚顧鑰鹽壓顧襯) = 夢築簾鏇膚遞窪餘選簾積齋淵範顧選淵襯淵鹽 (製廠網鹹壓顧繭鹹艱艱, 齋鏇積壓繭憲構餘構簾 ~ 築餘糧製鏇顧糧壓醖衊) 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))	廠簾鑰淵醖選選鏇淵顧(製齋選蓋艱選夢淵獵簾) = 醖製築繭膚衊鹹鏇獵築淵鏇鹹壓醖遞構築蓋鑰 (製壓壓襯齋願憲鬱積製, 鹹衊艱簾鹹齋醖構遞糧 ~ 衊繭窪鑰淵膚範窪積艱) 更多	-	2023-04-21
				MT10109L+Placebo (MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL))	廠簾鑰淵醖選選鏇淵顧(製齋選蓋艱選夢淵獵簾) = 壓顧獵壓製遞糧鑰繭鏇淵鏇鹹壓醖遞構築蓋鑰 (製壓壓襯齋願憲鬱積製, 簾鹽鏇鹹艱鹹繭繭遞獵 ~ 艱顧簾憲糧顧鏇選蓋築) 更多