A型肉毒毒素 (Biotecon)(Incobotulinum toxinA (Biotecon)) - 药物靶点：SNAP25_在研适应症：颈肌张力障碍，鱼尾纹，额头皱纹_专利_临床

概要

基本信息

药物类型

毒素

别名

Botulinum toxin A、Botulinum toxin A (Merz Pharma)、Incobotulinum toxin A

+ [9]

靶点

SNAP25

作用方式

抑制剂

作用机制

SNAP25 抑制剂(突触相关蛋白25 抑制剂)

治疗领域

神经系统疾病眼部疾病口颌疾病+ [4]

在研适应症

颈肌张力障碍鱼尾纹额头皱纹+ [24]

非在研适应症

阿尔茨海默症肌萎缩侧索硬化癌症疼痛+ [21]

原研机构

Biotecon Therapeutics GmbH

在研机构

Merz Pharmaceuticals GmbH

Merz Aesthetics, Inc.Merz Pharmaceuticals LLC

+ [4]

非在研机构

权益机构

+ [1]

最高研发阶段批准上市

首次获批日期

奥地利 (2007-10-24),

流涎痉挛

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (美国)

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结构/序列

Sequence Code 20749948

关联

153

项与 A型肉毒毒素 (Biotecon) 相关的临床试验

CTIS2026-525669-33-00

/ Not yet recruiting临床2期IIT

Botulinum toxin A in the Treatment of Chronic Postsurgical Pain in Lung Cancer Patients: A feasibility study

开始日期2026-09-01

申办/合作机构

Aalborg University Hospital

NCT07537855

/ Not yet recruiting临床2期IIT

Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.

开始日期2026-09-01

申办/合作机构

Northwestern University

[+1]

NCT07624045

/ Not yet recruiting临床2期IIT

A Phase IIb, Randomized, Double-blind, Multicenter Study Evaluating the Efficacy of Botulinum Toxin Versus Placebo on Pain and Health Related Quality of Life of Patients With Piriformis Muscle Syndrome

Piriformis muscle syndrome (PMS) is characterized by symptoms caused by compression or irritation of the sciatic nerve by the piriformis muscle as it exits the sciatic notch. PMS commonly evokes the symptoms of sciatica and is likely underdisagnosed. Patients who experience pain related to piriformis syndrome will complain of aggravated pain after prolonged periods of sitting or upon rising from a seated position. Around 98% of patients evoke positional buttock pain, especially during prolonged sitting (car journeys, for example). This is less true for sciatic pain radiation, which is still found in 63% of cases, systematically associated with the notion of buttock pain. Treatments for PMS aim to reduce or eliminate sciatic pain and also control buttock pain. Reducing these pains can improve the physical condition and emotional state of the patient. Several approaches have been proposed including physical therapy (massage-physiotherapy, self-rehabilitation techniques) combined with the use of anti-inflammatory drugs, analgesics and muscle relaxants to reduce inflammation, spasm and pain. Many patients do not respond to conventional care. Surgery may be considered only in those cases who do not improve with conservative therapy or injections. However, decompressive surgery is an invasive treatment, indicated in case of complete failure of all medical strategies, with physical and functional consequences. In recent years, several published studies showed the use of botulinum toxin (BT) injection as a new therapeutic option to reduce buttock and sciatic pain induced by PMS. The study team previously observed the efficacy of BT/A1 administration into the piriformis muscle in patients who were previously treated with medication and rehabilitation protocols with no pain improvement. Pain relief was considered as "very good" or "good" for 77% of the patients, "average" for 7.4% and "poor" for 15.6%. No adverse events were reported. More recently, Fishman and colleagues reported the results of a randomized, double-blind, controlled study including 56 patients and comparing physical therapy, incobotulinum toxin A and placebo. Data are sparse concerning BT injection for PMS and no multicenter randomized clinical trial have been performed. Two out of three randomized trials (Fishman 2004, 2017) are based on highly selected patients (3 standard deviations or more beyond on the prolongation of the posterior tibial or fibular nerve H-reflex in FAIR test). Therefore, BT efficacy may be overestimated and remains to be evaluated among unselected PMS patients, regardless of analgesic treatments or physical therapy. Finally, no randomized studies have reported the heatlh-related quality of life of PMS patients.

开始日期2026-07-01

申办/合作机构

Centre Hospitalier Universitaire de Nimes

100 项与 A型肉毒毒素 (Biotecon) 相关的临床结果

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100 项与 A型肉毒毒素 (Biotecon) 相关的转化医学

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100 项与 A型肉毒毒素 (Biotecon) 相关的专利（医药）

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465

项与 A型肉毒毒素 (Biotecon) 相关的文献（医药）

2026-07-01·PM&R

Effects of incobotulinumtoxinA in children and adolescents with spastic cerebral palsy: A systematic review of randomized controlled trials

Review

作者: Taype‐Rondan, Alvaro ; De la Cerna‐Luna, Roger ; Caira‐Chuquineyra, Brenda ; Fernandez‐Guzman, Daniel ; Tapia‐Sequeiros, Gustavo

Abstract:

Objective:

To evaluate the effects of incobotulinumtoxinA (incoBoNT‐A) in children and adolescents with spastic cerebral palsy (CP).

Literature survey:

CP is a leading cause of childhood disability, with spasticity present in >90% of cases. BoNT‐A is widely used to manage spasticity, improving function and quality of life. IncoBoNT‐A, a highly purified BoNT‐A formulation, offers reduced immunogenicity and greater stability across storage conditions. Although previous reviews have evaluated BoNT‐A in CP, none have focused specifically on incoBoNT‐A.

Methodology:

For this systematic review, we searched databases and trial registries through February 2025 for randomized controlled trials (RCTs) comparing incoBoNT‐A with placebo, other BoNT‐A formulations, or different doses in patients ≤18 years with spastic CP. Meta‐analyses used random‐ or fixed‐effects models; evidence certainty was rated with Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Synthesis:

We included four RCTs. IncoBoNT‐A showed very uncertain effects compared to onabotulinumtoxinA (onaBoNT‐A) on spasticity, gait, and adverse events. Higher doses of incoBoNT‐A (≥6 units/kg) showed minimal improvement in spasticity (mean difference: −0.19, 95% confidence interval [CI]: −0.36 to −0.01; moderate certainty) compared to lower doses (≤4 units/kg), with no meaningful differences in motor function, global impression of change, or adverse events. Certainty ranged from moderate to very low.

Conclusions:

The available evidence is insufficient to determine whether incoBoNT‐A offers any advantages or disadvantages compared to onaBoNT‐A in children with spastic CP, given the very low certainty of the data. Similarly, using a higher dose of incoBoNT‐A is unlikely to yield a meaningful clinical benefit compared to a lower dose. Further high‐quality trials are needed to reduce uncertainty and guide clinical decision‐making.

2026-06-01·UROLOGY

IncobotulinumtoxinA Versus OnabotulinumtoxinA for Treatment of Overactive Bladder Syndrome: A Randomized Single-blinded Non-inferiority Trial

Article

作者: Gisseman, Jordan D ; Olsen, Cara ; Hamade, Sara J ; Vaccaro, Christine M ; Trikhacheva, Anna S ; Dengler, Katherine L

OBJECTIVE:

To compare the efficacy of incobotulinumtoxinA to onabotulinumtoxinA for the treatment of idiopathic overactive bladder syndrome.

METHODS:

This study is a single-blinded, randomized, non-inferiority trial. Participants received intradetrusor injections of either 100 units of incobotulinumtoxinA or 100 units of onabotulinumtoxinA. The primary outcome was measured as a change in the mean number of urgency urinary incontinence episodes from baseline to 2-6 weeks post-procedure.

RESULTS:

Data from 59 participants were analyzed (29 incobotulinumtoxinA, 30 onabotulinumtoxinA). Most participants were between 40 and 59 years of age and postmenopausal. There were significantly more postmenopausal participants in the onabotulinumtoxinA group (51.72% incobotulinumtoxinA, 80% onabotulinumtoxinA, P<.05). Comparing incobotulinumtoxinA to onabotulinumtoxinA, the difference in mean reduction of urgency urinary incontinence episodes from baseline to 2-6 weeks post-treatment was 0.41 (90% confidence interval -0.88 to 1.71), meeting the predetermined non-inferiority margin of -1. The mean daytime voids decreased by 0.97 ± 2.54 from baseline of 7.28 ± 2.77 in the incobotulinumtoxinA group, and by 2.97 ± 4.74 from baseline of 9.57 ± 5.61 in the onabotulinumtoxinA group (P<.05). The Patient Global Impression of Improvement scores were significantly different between the 2 groups (2.57 ± 1.34 IncobotulinumtoxinA, 1.93 ± 0.83 OnabotulinumtoxinA [P<.05]). However, the number of participants answering "very much better" and "much better" was similar between the groups (64% IncobotulinumtoxinA, 71% OnabotulinumtoxinA). There was no statistically significant difference in other secondary outcomes or with adverse events between the 2 groups.

CONCLUSION:

Intradetrusor incobotulinumtoxinA was found to be non-inferior to onabotulinumtoxinA in the treatment of idiopathic overactive bladder syndrome and offers a more pure, cost-effective, and logistically convenient alternative.

2026-06-01·AESTHETIC PLASTIC SURGERY

Challenging Interchangeability: Dynamic Dose-Response Modelling of Botulinum Toxin A Products

Article

作者: Webb, William Richard ; Wu, Woffles T L ; Rao, Parinitha ; Avelar, Rui ; Rahman, Eqram ; Sayed, Karim ; Carruthers, Jean D A

INTRODUCTION:

Botulinum Neurotoxin type A (BoNT-A) formulations are used worldwide for both aesthetic and therapeutic indications, yet dose conversion between products remains based on empirical ratios that ignore pharmacodynamic variability. This study aimed to generate dynamic, time-resolved dose equivalence estimates for six FDA-approved BoNT-A formulations, onabotulinumtoxinA (ONA), abobotulinumtoxinA (ABO), incobotulinumtoxinA (INCO), daxibotulinumtoxinA (DAXI), prabotulinumtoxinA (PRABO), and letibotulinumtoxinA (LETI) and to assess how their clinical performance differs over time.

METHODS:

A hybrid, time-resolved in silico pharmacodynamic model was developed to simulate onset, peak effect, and decay kinetics using data aggregated from 49 clinical trials and regulatory submissions. Each formulation was modelled in 10,000 virtual patients to capture real-world variability in EC₅₀, maximal efficacy, and decay rate. Dose equivalence relative to 20 U of ONA was determined using two independent metrics: the area under the response curve (AURC) and time above a standardized efficacy threshold. External validation was performed against independent clinical datasets.

RESULTS:

Simulated durations ranged from 10.6 weeks (ABO) to 14.5 weeks (PRABO), matching published clinical means within ±1.2 weeks. Time-resolved conversion ratios revealed significant temporal drift: ABO increased from 2.0 to 2.7 (≈35% drift), LETI from 1.1 to 1.4 (≈27 %), while DAXI and PRABO demonstrated decreasing ratios (≈15% drift), reflecting superior persistence. Efficiency analysis ranked PRABO and DAXI highest (AURC/unit = 0.059 and 0.057), followed by ONA (0.050), INCO (0.040), LETI (0.035), and ABO (0.031). Global sensitivity analysis identified decay rate (koff) as the dominant determinant of efficacy duration (Sobol index = 0.52).

CONCLUSION:

Static dose conversion ratios fail to represent the dynamic pharmacodynamic behaviour of BoNT-A formulations. This simulation-based, data-driven approach reproduces clinical outcomes with high fidelity and provides a robust framework for effect-based dose equivalence, improving precision in product substitution and individualized treatment planning.

LEVEL OF EVIDENCE IV:

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

80

项与 A型肉毒毒素 (Biotecon) 相关的新闻（医药）

2026-09-17

·BioSpace

Merz Therapeutics Receives EU/EEA Approval for XEOMIN® for the Treatment of Pediatric Spasticity Associated With Pes Equinus

Approval expands XEOMIN use to include the symptomatic treatment of spasticity associated with pes equinus in children and adolescents with cerebral palsy aged 2 to 17 years. Approval includes both children and adolescents who are able to walk and those who are non-ambulant, broadening the population eligible for XEOMIN treatment FRANKFURT AM MAIN, Germany--(BUSINESS WIRE)--Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has received approval in the European Union (EU) / European Economic Area (EEA) for XEOMIN® (incobotulinumtoxinA) for the symptomatic treatment of spasticity associated with pes equinus, a condition in which tight calf muscles cause the foot to point downward, in ambulant and non-ambulant children and adolescents with cerebral palsy (CP) aged 2 to 17 years. 1,2 This approval expands access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe. Spasticity is a common and often disruptive symptom in children and adolescents with neurological conditions, including CP. This condition is associated with muscle tightness that can severely restrict physical movement, daily functioning, and personal autonomy. Among children and youth, CP stands as a primary driver of this symptom and remains the most prevalent childhood motor disability, with spastic variants representing roughly 80% of all diagnoses. In more severe presentations, children with CP may additionally experience difficulties with speaking, swallowing and fine motor tasks. 3,4 “We are proud to announce this first approval for the symptomatic treatment in pediatric lower limb spasticity in Europe, marking another significant milestone in our long-term commitment to improving standards of care for children and adolescents living with spasticity,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer, Merz Therapeutics. “This achievement reflects our continued investment in advancing innovative approaches to neurology and addressing significant unmet patient needs.” The regulatory decision is based on a comprehensive clinical program, including the positive results of the Phase 3 ELLIE study, submitted to the National Competent Authorities in the EU/EEA. The prospective, randomized, placebo-controlled study demonstrated that XEOMIN significantly improved spasticity associated with pes equinus in children and adolescents with CP, while showing a favorable safety and tolerability profile. 1,2 “The approval of XEOMIN for the treatment of pediatric spasticity represents exactly what we're building here at Merz Therapeutics – the ability to move quickly across European healthcare systems to pave the way for life-changing therapies to reach the patients who need them most," said Dan Staner, President Region Europe, Merz Therapeutics. "Across diverse regulatory landscapes and reimbursement frameworks, we've worked tirelessly to clear the path for children and adolescents to benefit from this treatment. For us, this is proof of how collaborative leadership and a relentless focus on patient access can transform specialty neurology in Europe. About Merz Therapeutics Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and patient experience as its focus, the company relentlessly pursues innovative treatments and partnerships to address unmet needs in movement disorders, neurodegenerative conditions, liver disease, and other health conditions that severely impact patients’ quality of life. Merz Therapeutics is headquartered in Frankfurt am Main, Germany, and is active in more than 80 countries. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company with an 118-year legacy. With passion and purpose, Merz Therapeutics continues to advance care in specialty neurology in ways that benefit both patients and society. Please visit . References Banach M, Makedonska I, Mykhaylenko V, et al. IncobotulinumtoxinA for the treatment of lower limb spasticity in children and adolescents with cerebral palsy: Evaluation of Lower Limb IncobotulinumtoxinA Efficacy (ELLIE). Toxicon. 2026;271 (Suppl. 1): 108685. . Heinen F, Kanovský P, Schroeder AS, et al. IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study. J Pediatr Rehabil Med . 2021;14(2):183-197. doi:10.3233/PRM-210040 Cerebral Palsy Guide. Spastic cerebral palsy. Accessed June 17, 2026. Centers for Disease Control and Prevention. Data and Statistics for Cerebral Palsy. Accessed June 17, 2026. Contacts Press Contact: Merz Therapeutics GmbH Luke Anthony Mircea-Willats Head of Global Communications & Strategic Affairs merztherapeutics@merz.com

临床3期上市批准临床结果

2026-09-14

·allsci.com

Revelyx reports positive Phase II data for recombinant liquid botulinum toxin

Nashville-based Revelyx Bio reported positive Phase II results for YY003, a recombinant botulinum toxin type A supplied as a ready-to-use liquid, supporting plans for an FDA End-of-Phase-II meeting and potential Phase III development. Currently approved US botulinum toxin type A products are supplied as lyophilized formulations requiring reconstitution, whereas YY003 would be the first recombinant, pre-mixed alternative if it reaches approval. In the Phase II trial, 153 adults with moderate-to-severe glabellar lines were randomized across two parts. The double-blind Part B evaluated 30 U and 40 U doses against vehicle. The primary composite endpoint — requiring both investigator and participant to independently record a Facial Wrinkle Scale score of none or mild and at least a two-grade improvement from baseline — was met by 80.8% of participants in the 40 U group and 66.7% in the 30 U group at Week 4, versus 0% for vehicle (p<0.001 for each dose). By Week 1, 90.4% of participants receiving 40 U had already reached a score of none or mild, approaching the Week 4 rate of 92.3% on investigator assessment. No neutralizing antibodies were detected in any participant, and only one of 106 evaluable participants (0.9%) tested positive for anti-drug antibodies while maintaining clinical response. No treatment-related serious adverse events occurred, and there were no discontinuations due to adverse events. YY003 is produced via recombinant expression in E. coli rather than purification from Clostridium botulinum cultures, yielding a neurotoxin Revelyx describes as structurally identical to the naturally derived protein. The ready-to-use liquid format removes the manual reconstitution step required for currently approved products. Revelyx launched in August 2026 around an exclusive license from Chongqing Claruvis Pharmaceutical covering YY003 in all territories outside mainland China, Hong Kong, and Macau. Claruvis has already taken a related recombinant botulinum toxin product, the lyophilized YY001 (Retoxin), through regulatory approval in China, providing manufacturing and regulatory precedent for its recombinant BoNT/A platform. YY003 is a distinct asset differentiated by its ready-to-use liquid formulation. The competitive field for glabellar lines includes AbbVie's Botox Cosmetic (onabotulinumtoxinA), Ipsen's Dysport (abobotulinumtoxinA), Merz's Xeomin (incobotulinumtoxinA), Evolus's Jeuveau (prabotulinumtoxinA), Hugel's Letybo (letibotulinumtoxinA), and Revance Therapeutics' Daxxify (daxibotulinumtoxinA-lanm). The FDA cleared the investigational new drug application for YY003 in September 2024. The company said its next step is to request an End-of-Phase-2 meeting with the FDA to discuss the proposed Phase III dose and pivotal development program. Spot something wrong? Report an issue with this article

临床结果临床2期临床3期引进/卖出临床申请

2026-09-01

·allsci.com

Revelyx launches with recombinant botulinum toxin ready for Phase II readout

Nashville-based Revelyx Bio has launched as a clinical-stage company built around an exclusive license from China-based Chongqing Claruvis Pharmaceutical for YY003, a recombinant botulinum toxin type A (rBoNT/A) in a ready-to-use liquid formulation. Revelyx holds rights to develop and commercialize YY003 for aesthetic and therapeutic indications globally, excluding mainland China, Hong Kong, and Macau. Financial terms were not disclosed. YY003 is produced via recombinant expression in E. coli rather than conventional Clostridium botulinum fermentation, a manufacturing distinction Claruvis describes as offering greater control over neurotoxin identity and purity. The ready-to-use prefilled syringe format eliminates the reconstitution step required for currently approved leading botulinum toxin products. The US FDA cleared an investigational new drug application for YY003 in September 2024, and a Phase II study in adults with moderate-to-severe glabellar lines has been completed. Revelyx said it expects to report topline data in Q3 2026. Claruvis's platform credentials are anchored by Retoxin (YY001), a related lyophilized rBoNT/A that received approval from China's National Medical Products Administration in March 2026 — the first approved recombinant botulinum toxin type A anywhere in the world. YY003 is a distinct asset, differentiated from Retoxin primarily by its liquid formulation. Claruvis is separately advancing Retoxin in a Phase III trial in China for upper-limb spasticity secondary to stroke. The deal is Revelyx's founding transaction. The company is backed by NRL Capital, whose founding partner Xianghong Lin also founded BioBay, a major life sciences park in Suzhou. Dustin Sjuts, appointed CEO at launch, most recently served as president of Revance Therapeutics, where he oversaw the FDA approvals and US commercial launches of daxibotulinumtoxinA-lanm (Daxxify) for glabellar lines and cervical dystonia. The structure — a purpose-built Western company formed around a single-asset exclusive license from an Asian originator, with the originator retaining Greater China rights — resembles the model used by Evolus, which was built around an exclusive license from South Korea's Daewoong Pharmaceutical for prabotulinumtoxinA (Jeuveau) covering the US and Europe. In the botulinum toxin market, approved competitors — including onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA (Jeuveau), and letibotulinumtoxinA (Letybo) — are all derived from bacterial fermentation and require reconstitution before injection. No rBoNT/A has been approved by the FDA. Revelyx has stated its goal is to deliver the first FDA-approved recombinant botulinum neurotoxin type A. Spot something wrong? Report an issue with this article

100 项与 A型肉毒毒素 (Biotecon) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	A型肉毒毒素 (Biotecon)	M03AX01	DB00083

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
颈肌张力障碍	澳大利亚	Merz Australia Pty Ltd.	2023-11-28
鱼尾纹	澳大利亚	Merz Australia Pty Ltd.	2023-11-28
额头皱纹	澳大利亚	Merz Australia Pty Ltd.	2023-11-28
下肢痉挛	日本	Teijin Pharma Ltd.	2020-06-29
上肢痉挛	日本	Teijin Pharma Ltd.	2020-06-29
上下肢痉挛	美国	Merz Pharmaceuticals LLC	2015-12-22
眉间纹	美国	Merz Pharmaceuticals LLC	2011-07-20
眼睑痉挛	美国	Merz Pharmaceuticals LLC	2010-07-30
斜颈	美国	Merz Pharmaceuticals LLC	2010-07-30
流涎	奥地利	Merz Pharmaceuticals GmbH	2007-10-24
流涎	比利时	Merz Pharmaceuticals GmbH	2007-10-24
流涎	保加利亚	Merz Pharmaceuticals GmbH	2007-10-24
流涎	克罗地亚	Merz Pharmaceuticals GmbH	2007-10-24
流涎	塞浦路斯	Merz Pharmaceuticals GmbH	2007-10-24
流涎	捷克	Merz Pharmaceuticals GmbH	2007-10-24
流涎	丹麦	Merz Pharmaceuticals GmbH	2007-10-24
流涎	爱沙尼亚	Merz Pharmaceuticals GmbH	2007-10-24
流涎	芬兰	Merz Pharmaceuticals GmbH	2007-10-24
流涎	法国	Merz Pharmaceuticals GmbH	2007-10-24
流涎	德国	Merz Pharmaceuticals GmbH	2007-10-24

未上市

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
慢性盆腔疼痛综合征	临床3期	法国	Merz Pharmaceuticals GmbH	2026-02-09
原发性痛经	临床3期	法国	Merz Pharmaceuticals GmbH	2026-02-09
颈阔肌突出	临床3期	美国	Merz Aesthetics, Inc.	2025-08-27
偏头痛	临床3期	美国	Merz Therapeutics GmbH	2025-08-21
偏头痛	临床3期	奥地利	Merz Therapeutics GmbH	2025-08-21
偏头痛	临床3期	加拿大	Merz Therapeutics GmbH	2025-08-21
偏头痛	临床3期	捷克	Merz Therapeutics GmbH	2025-08-21
偏头痛	临床3期	丹麦	Merz Therapeutics GmbH	2025-08-21
偏头痛	临床3期	法国	Merz Therapeutics GmbH	2025-08-21
偏头痛	临床3期	德国	Merz Therapeutics GmbH	2025-08-21

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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


NCT04766723 (CTgov)	临床2期	特发性震颤	78	NT 201 (Unilateral Treatment Period: NT 201)	醖蓋艱膚繭願願顧範廠(獵鹽築艱醖鹽選範網簾) = 襯範繭遞遞願築鹹廠構鬱鬱構壓夢淵鏇繭餘願 (鹽窪觸鏇網膚齋構蓋夢, 0.140) 更多	-	2026-04-28
				Placebo (Unilateral Treatment Period: Placebo)	醖蓋艱膚繭願願顧範廠(獵鹽築艱醖鹽選範網簾) = 遞獵築製衊餘簾簾構繭鬱鬱構壓夢淵鏇繭餘願 (鹽窪觸鏇網膚齋構蓋夢, 0.180) 更多
MDS2025	N/A	流涎	35	IncobotulinumtoxinA 100 U	鬱鹽憲醖製鑰選觸夢蓋(觸觸壓鹹餘鹽醖淵壓淵) = Dry mouth, swallowing difficulties and taste disturbances were the only treatment-related adverse events observed. Overall in 32/213 treatment cycles (15.0 % of overall cycles) did side-effects occur. Swallowing difficulties occurred in 18 cycles (8.5%). These side-effects spontaneously resolved. In six patients (17,1%) a dose reduction to 75 U incobotulinum toxin or lower was warranted because of moderate swallowing difficulties. Treatment interruption was never warranted. 齋繭鏇憲鏇製鑰觸顧鏇 (齋壓壓選齋顧顧鏇範簾 )	积极	2025-10-05
NCT04965311 (CTgov)	临床2期	胰腺瘘 \| 胰腺癌	4	Botulinum Toxin Type A	簾鏇繭鑰廠蓋繭淵觸選 = 蓋選簾範鏇餘觸壓鹹鏇鬱範憲醖鑰壓窪鑰顧顧 (鏇壓製積廠壓願觸襯遞, 觸鑰築鹹齋選範餘夢壓 ~ 顧餘膚夢夢餘襯鏇構蓋) 更多	-	2025-05-13
MDS2024	N/A	流涎	36	IncobotulinumtoxinA 100 U	範築衊獵鏇鹹襯夢艱簾(範憲繭齋蓋醖艱鹽壓廠) = 築遞憲艱鹹築繭鹹壓獵構壓願積網醖蓋壓簾簾 (蓋鏇鏇顧衊遞鑰衊遞衊, 1.6) 更多	积极	2024-09-27
TOWER (MDS2024)	N/A	肌肉痉挛	70	IncobotulinumtoxinA (spasticity due to cerebral causes)	鹽獵獵獵醖襯壓淵餘艱(獵衊網製蓋網衊鑰願襯) = 鏇觸餘衊鑰鑰鹹襯製蓋蓋憲網簾窪醖積繭鹹選 (糧醖襯鏇襯壓鹹蓋鏇範 ) 更多	积极	2024-09-27
NCT04622254 (ULTRA II, CTgov)	临床3期	-	368	Placebo (Main Period: Placebo (Group P))	淵鹽繭膚觸範窪醖廠襯 = 選窪積網繭選鏇製構範鬱遞艱襯蓋蓋艱網鬱繭 (憲積餘鏇鏇鑰憲艱觸淵, 壓憲製範艱鏇鏇獵襯醖 ~ 獵鑰鏇壓遞襯選醖鏇選) 更多	-	2024-08-06
				NT 201 (Main Period: NT 201 (Group U))	淵鹽繭膚觸範窪醖廠襯 = 遞積簾糧夢窪鏇蓋選築鬱遞艱襯蓋蓋艱網鬱繭 (憲積餘鏇鏇鑰憲艱觸淵, 糧獵構淵壓選願淵鏇襯 ~ 繭夢膚積廠憲築廠鹹衊) 更多
NCT04594213 (ULTRA I, CTgov)	临床3期	-	362	Placebo (Main Period: Placebo (Group P))	憲窪鹹鏇願淵壓鬱膚觸 = 糧築遞遞觸膚繭衊鑰顧淵積餘醖繭構膚製選糧 (範鏇鑰築積積顧糧築顧, 醖獵構範夢窪夢糧壓鹹 ~ 壓鑰顧願獵衊壓襯鹹壓) 更多	-	2024-05-08
				NT 201 (Main Period: NT 201 (Group U))	憲窪鹹鏇願淵壓鬱膚觸 = 範窪襯繭鹽獵鏇窪鏇衊淵積餘醖繭構膚製選糧 (範鏇鑰築積積顧糧築顧, 觸鑰艱糧夢蓋鬱顧製壓 ~ 構鬱衊獵鑰築壓築製壓) 更多
P8-3.004 (AAN2024)	N/A	颈肌张力障碍	451	IncobotulinumtoxinA	鏇觸築願獵構鹽積鏇繭(窪蓋窪製鏇構憲觸鑰製) = 顧艱醖憲築餘鑰積壓壓鬱選鏇範蓋願製夢積繭 (觸獵廠齋窪糧壓齋衊構 ) 更多	积极	2024-04-09
				Placebo	鏇觸築願獵構鹽積鏇繭(窪蓋窪製鏇構憲觸鑰製) = 觸範鏇繭觸憲築壓鏇鑰鬱選鏇範蓋願製夢積繭 (觸獵廠齋窪糧壓齋衊構 ) 更多
NCT03806933 (CTgov)	临床2期	-	241	MP+NT 201 (Stage 1 and 2 Pooled: NT 201 20 U)	顧鏇繭鏇簾夢鏇願齋鹹(鏇網窪獵齋鹹淵窪鬱積) = 鑰醖網觸選獵壓網積遞淵築獵齋繭廠製襯鏇範 (築鏇範築鹹衊衊餘繭簾, 繭齋糧淵窪襯糧鬱鑰願 ~ 範襯觸願醖選蓋憲醖構) 更多	-	2023-10-04
				MP+NT 201 (NT 201 50 U)	顧鏇繭鏇簾夢鏇願齋鹹(鏇網窪獵齋鹹淵窪鬱積) = 製積鬱簾觸積繭範齋網淵築獵齋繭廠製襯鏇範 (築鏇範築鹹衊衊餘繭簾, 壓積網築築壓壓醖築壓 ~ 願積顧簾衊壓醖糧糧蓋) 更多
MDS2023	N/A	-	451	IncobotulinumtoxinA	齋糧鑰窪觸廠壓壓淵顧(積憲壓襯鑰顧鹹膚鏇齋) = 艱範壓積繭鏇鹽廠齋衊糧壓鹽艱繭窪製簾餘鏇 (遞鹹餘構築顧壓獵構築 )	-	2023-08-27
				Placebo	齋糧鑰窪觸廠壓壓淵顧(積憲壓襯鑰顧鹹膚鏇齋) = 獵範網選鹽觸構選築觸糧壓鹽艱繭窪製簾餘鏇 (遞鹹餘構築顧壓獵構築 )