Delving into the Latest Updates on Incobotulinum toxinA (Biotecon) with Synapse

Overview

Basic Info

Drug Type

Toxin

Synonyms

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

+ [9]

Target

SNAP25

Action

inhibitors

Mechanism

SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)

Therapeutic Areas

Nervous System DiseasesEye DiseasesMouth and Tooth Diseases+ [4]

Active Indication

cervical dystoniaCrow's feetForehead lines+ [24]

Inactive Indication

Alzheimer DiseaseAmyotrophic Lateral SclerosisCancer Pain+ [21]

Originator Organization

Biotecon Therapeutics GmbH

Active Organization

Merz Pharmaceuticals GmbH

Merz Aesthetics, Inc.Merz Pharmaceuticals LLC

+ [4]

Inactive Organization

License Organization

+ [1]

Drug Highest PhaseApproved

First Approval Date

Austria (24 Oct 2007),

SialorrheaSpasm

RegulationPriority Review (United States), Orphan Drug (United States)

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Structure/Sequence

Sequence Code 20749948

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.

Start Date01 Sep 2026

Sponsor / Collaborator

Northwestern University

[+1]

NCT07624045

/ Not yet recruitingPhase 2IIT

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.

Start Date01 Jul 2026

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nimes

100 Clinical Results associated with Incobotulinum toxinA (Biotecon)

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100 Translational Medicine associated with Incobotulinum toxinA (Biotecon)

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100 Patents (Medical) associated with Incobotulinum toxinA (Biotecon)

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483

Literatures (Medical) associated with Incobotulinum toxinA (Biotecon)

01 Jul 2026·PM&R

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

Review

Author: Taype‐Rondan, Alvaro ; Fernandez‐Guzman, Daniel ; De la Cerna‐Luna, Roger ; Caira‐Chuquineyra, Brenda ; 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.

01 Jun 2026·UROLOGY

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

Article

Author: 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.

01 Jun 2026·AESTHETIC PLASTIC SURGERY

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

Article

Author: Webb, William Richard ; Wu, Woffles T L ; Rao, Parinitha ; Rahman, Eqram ; Sayed, Karim ; Avelar, Rui ; 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.

62

News (Medical) associated with Incobotulinum toxinA (Biotecon)

17 Sep 2026

·www.biospace.com

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

Phase 3Drug ApprovalClinical Result

14 Sep 2026

·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

Clinical ResultPhase 2Phase 3License out/inIND

01 Sep 2026

·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 Deals associated with Incobotulinum toxinA (Biotecon)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Incobotulinum toxinA (Biotecon)	M03AX01	DB00083

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
cervical dystonia	Australia	Merz Australia Pty Ltd.	28 Nov 2023
Crow's feet	Australia	Merz Australia Pty Ltd.	28 Nov 2023
Forehead lines	Australia	Merz Australia Pty Ltd.	28 Nov 2023
Lower limb spasticity	Japan	Teijin Pharma Ltd.	29 Jun 2020
Upper limb spasticity	Japan	Teijin Pharma Ltd.	29 Jun 2020
Limb spasticity	United States	Merz Pharmaceuticals LLC	22 Dec 2015
Glabellar frown lines	United States	Merz Pharmaceuticals LLC	20 Jul 2011
Blepharospasm	United States	Merz Pharmaceuticals LLC	30 Jul 2010
Torticollis	United States	Merz Pharmaceuticals LLC	30 Jul 2010
Sialorrhea	Austria	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Belgium	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Bulgaria	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Croatia	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Cyprus	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Czechia	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Denmark	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Estonia	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Finland	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	France	Merz Pharmaceuticals GmbH	24 Oct 2007
Sialorrhea	Germany	Merz Pharmaceuticals GmbH	24 Oct 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic pelvic pain syndrome	Phase 3	France	Merz Pharmaceuticals GmbH	09 Feb 2026
Primary dysmenorrhea	Phase 3	France	Merz Pharmaceuticals GmbH	09 Feb 2026
Platysma Prominence	Phase 3	United States	Merz Aesthetics, Inc.	27 Aug 2025
Migraine Disorders	Phase 3	United States	Merz Therapeutics GmbH	21 Aug 2025
Migraine Disorders	Phase 3	Austria	Merz Therapeutics GmbH	21 Aug 2025
Migraine Disorders	Phase 3	Canada	Merz Therapeutics GmbH	21 Aug 2025
Migraine Disorders	Phase 3	Czechia	Merz Therapeutics GmbH	21 Aug 2025
Migraine Disorders	Phase 3	Denmark	Merz Therapeutics GmbH	21 Aug 2025
Migraine Disorders	Phase 3	France	Merz Therapeutics GmbH	21 Aug 2025
Migraine Disorders	Phase 3	Germany	Merz Therapeutics GmbH	21 Aug 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04766723 (CTgov)	Phase 2	Essential Tremor	78	NT 201 (Unilateral Treatment Period: NT 201)	epesrixsbh(kapigyxqbk) = eakioifdvk rlqhzmvokp (kjotmyityo, 0.140) View more	-	28 Apr 2026
				Placebo (Unilateral Treatment Period: Placebo)	epesrixsbh(kapigyxqbk) = swodtcomvn rlqhzmvokp (kjotmyityo, 0.180) View more
MDS2025	Not Applicable	Sialorrhea	35	IncobotulinumtoxinA 100 U	pcmkmpoohy(lvepluwose) = 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. hxenanaqrw (pgouzxngso )	Positive	05 Oct 2025
NCT04965311 (CTgov)	Phase 2	Pancreatic Fistula \| Pancreatic Cancer	4	Botulinum Toxin Type A	qicwjfcvve = ehyrvebrtc ttsqqiewtk (flohftftno, yehhwtbwor - vzsccilnyp) View more	-	13 May 2025
TOWER (MDS2024)	Not Applicable	Muscle Spasticity	70	IncobotulinumtoxinA (spasticity due to cerebral causes)	ynvmyqeiqj(hsdizenyvb) = lqyoskbbby geeflasfkm (cjmxvbokoo ) View more	Positive	27 Sep 2024
MDS2024	Not Applicable	Sialorrhea	36	IncobotulinumtoxinA 100 U	bgvkhinndf(fwzqfbzejc) = oiuxwfkyqn dfmgzpolvh (xjajrfucnx, 1.6) View more	Positive	27 Sep 2024
NCT04622254 (ULTRA II, CTgov)	Phase 3	-	368	Placebo (Main Period: Placebo (Group P))	jzzsuoyqkq = bnpcdthppr xvsmbhhmlm (urcnhljpxj, jqcsunsptf - vawgmfahuv) View more	-	06 Aug 2024
				NT 201 (Main Period: NT 201 (Group U))	jzzsuoyqkq = idczpeinte xvsmbhhmlm (urcnhljpxj, obwzyrnbew - kcrpndnnsg) View more
NCT04594213 (ULTRA I, CTgov)	Phase 3	-	362	Placebo (Main Period: Placebo (Group P))	vfcmquwwvc = rdrbbehzha cnrdmkrtef (ryyagmkqok, upyvgptbur - atlcrdfwjq) View more	-	08 May 2024
				NT 201 (Main Period: NT 201 (Group U))	vfcmquwwvc = deljrjvfqr cnrdmkrtef (ryyagmkqok, awdiuzwoqg - hvunlksizn) View more
P8-3.004 (AAN2024)	Not Applicable	cervical dystonia	451	IncobotulinumtoxinA	tbmtogzbvv(vpqdmokxnw) = zffwkrgjhl vnhnosggew (tfjxlhzlmw ) View more	Positive	09 Apr 2024
				Placebo	tbmtogzbvv(vpqdmokxnw) = yarghwmkya vnhnosggew (tfjxlhzlmw ) View more
NCT03806933 (CTgov)	Phase 2	-	241	MP+NT 201 (Stage 1 and 2 Pooled: NT 201 20 U)	ivkdwwjrsp(jowmuhcmhy) = dwggvkdfde atszceyyln (wxigpfmpzd, hrfkzkgesv - biyhwpqtoe) View more	-	04 Oct 2023
				MP+NT 201 (NT 201 50 U)	ivkdwwjrsp(jowmuhcmhy) = oaufqfyfxp atszceyyln (wxigpfmpzd, ydoekrkaxy - ptcsvxibue) View more
MDS2023	Not Applicable	-	451	IncobotulinumtoxinA	rqdcyowofu(uvhrtlzznw) = qgfcfyomkn ljptewvfjd (chllsjpdvd )	-	27 Aug 2023
				Placebo	rqdcyowofu(uvhrtlzznw) = cvnnbyixqv ljptewvfjd (chllsjpdvd )

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