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+ [23]

Inactive Indication

Alzheimer DiseaseAmyotrophic Lateral SclerosisCancer Pain+ [19]

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 Jun 2026

Sponsor / Collaborator

Northwestern University

[+1]

NCT07486830

/ RecruitingPhase 2IIT

A Double Blind, Placebo Controlled Study of IncobotulinumtoxinA in Patients With Provoked Vestibulodynia Associated With Overactive Pelvic Floor Muscle Dysfunction

This is a double-blind, placebo-controlled study evaluating the safety and efficacy of incobotulinumtoxinA (Merz) for the treatment of provoked vestibulodynia (PVD) associated with overactive pelvic floor muscle dysfunction. Eligible participants are premenopausal females aged 18 years and older with a confirmed diagnosis of PVD with hypertonic pelvic floor muscles, established by both an expert physician and an expert pelvic floor physical therapist. Participants must have bilateral provoked pain at the posterior vestibule on cotton swab testing and a pain score of 5 or greater on an 11-point Numeric Rating Scale (NRS) during standardized dilator testing at baseline. Key outcome measures include change in pain during dilator testing and Patient Global Impression of Change (PGI-C). Participants with anterior vestibular pain, prior botulinum toxin injection in the genitopelvic area within the past 12 months, or significant genitourinary conditions that may confound assessment are excluded.

Start Date27 Feb 2026

Sponsor / Collaborator

Merz Pharmaceuticals GmbH

NCT06995287

/ RecruitingPhase 3IIT

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study

The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.

Start Date09 Feb 2026

Sponsor / Collaborator

Nantes University Hospital

[+1]

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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467

Literatures (Medical) associated with Incobotulinum toxinA (Biotecon)

01 Mar 2026·EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY

Assessing the effects of botulinum toxin therapy for spasmodic dysphonia: An Austria-Germany registry

Article

Author: Leonhard, Matthias ; Volk, Gerd Fabian ; Kurz, Annabella ; Galvan, Oliver ; Schneider-Stickler, Berit ; Nawka, Tadeus

Abstract:

Objective:

Injection of Botulinum neurotoxin (BoNT) is regarded as standard treatment for spasmodic dysphonia (SD), reducing the overactivity of the affected muscles. Due to the lack of standardized outcome parameters for diagnosing SD or assessing its treatment over time, the evaluation of systematic clinical evidence on the effects of BoNT therapy on SD symptom control is difficult. The registry presented in this article aimed to evaluate outcomes after BoNT treatment in SD patients in Austria and Germany, based on selected subjective and objective voice parameters.

Methods:

41 patients with SD were included in this multicentric registry, after drop-out of 2 patients the results of 39/41 (95.1%) patients could be analyzed per protocol. Demographic and treatment characteristics as well as the occurrence of therapy-related side effects were recorded. Perceptual voice sound evaluation (RBH scale), voice range profile measurements (VRP), number of spasms, and severity of voice strain were assessed. Patients were asked to complete the Voice Handicap Index (VHI-9i), the Communicative Participation Item Bank (CPIB), and indicate their perceived phonation effort on a VAS scale. The parameters were compared between baseline and 1-month post-BoNT treatment.

Results:

The patients received all BoNT type A (Xeomin ® /Merz, Allergan ® /Allergan or Dysport ® /Ipsen). SD symptoms did not affect the frequency or dynamic range of the singing voice nor did they affect MPT; in contrast all the other parameters assessed were aberrant at baseline. BoNT treatment improved Jitter-%, Dysphonia Severity Index (DSI), degrees of roughness and hoarseness, but failed to restore them to normal. BoNT significantly reduced the voice spasm and strain. Phonation effort improved by approximately 50%. VHI-9i classification was reduced from moderate to mild after treatment, and CPIB from moderate to mild. The VHI-9i results were significantly positively correlated with the CPIB results.

Conclusion:

The results of this registry showed that BoNT injection, the current off-label treatment of SD symptoms, failed to restore normal voice quality. This registry’s outcomes also indicate that the choice of the applied BoNT brand is site-specific and does not appear to be associated with differences in efficacy. We also showed that the effects of the BoNT on the SD symptoms are best described by semi-quantitative outcome measures such as spasm counts and voice strain, and by patients-reported outcome measures (PROMs), such as CPIB and VHI-9i than by more objective parameters such as frequency and dynamic range of the singing voice.

01 Jan 2026·Movement Disorders Clinical Practice

Efficacy and Safety of IncobotulinumtoxinA for Treatment of Sialorrhea: A Multicenter, Phase 3 Study in Japan

Article

Author: Kazuko Hasegawa ; Yasuyoshi Kimura ; Hirohisa Watanabe ; Morinobu Seki ; Ryota Nakamura ; Masahiko Tomiyama ; Nobutaka Hattori ; Noriko Nishikawa ; Shohei Tateishi ; Yusaku Matsushita ; Kenji Sekiguchi ; Yuishin Izumi ; Yoshio Tsuboi ; Ryosuke Takahashi ; Yusaku Nakamura ; Yohei Mukai

Abstract:

Background:

Sialorrhea, caused by various neurological diseases, impairs patient health and quality of life. After the results of a randomized controlled trial, incobotulinumtoxinA was approved for the treatment of chronic sialorrhea in the United States and Europe; however, no pharmacotherapy has been approved in Japan.

Objective:

The aim was to evaluate the efficacy and safety of incobotulinumtoxinA treatment for chronic sialorrhea in a single‐arm phase 3 study in Japan.

Methods:

Patients with chronic sialorrhea caused by neurological diseases (Parkinson's disease, atypical parkinsonism, and stroke, group A) and broader diseases (eg, muscular dystrophy and amyotrophic lateral sclerosis, group B) were enrolled. IncobotulinumtoxinA 100 U was injected into the salivary glands once every 16 weeks for 48 weeks. A primary endpoint was assessed in group A, whereas secondary endpoints and safety were assessed in both groups.

Results:

From November 2021 to August 2023, 92 patients (58 and 34 in groups A and B, respectively) received incobotulinumtoxinA at 28 institutions. The primary endpoint, the least square mean (standard error) of change in unstimulated salivary flow rate from baseline to 4 weeks, was −0.08 (0.009, 95% confidence interval [CI]: −0.10, −0.06) g/min, achieving the prespecified efficacy criteria (upper limit of the 95% CI <−0.04). The secondary endpoints were consistent across efficacy measures, indicating that reduced salivary secretion and improved drooling symptoms persisted for 48 weeks. The most common adverse events were dry mouth and dysphagia.

Conclusions:

The first study in Japan confirmed the efficacy of incobotulinumtoxinA treatment for chronic sialorrhea with good patient tolerability and no new safety concerns.

01 Jan 2026·JOURNAL OF THE NEUROLOGICAL SCIENCES

Factors influencing the long-term maintenance of spasticity neurotoxin treatment

Article

Author: Chang, Lucas ; Zarghami, Ariana ; Slatton, Jack ; Berry, Kevin ; Abdou, Eli A ; Harper, Kelly ; Hacker, Mallory L ; Plummer, C J ; Eaves, Ashley ; Butler, Emily ; Charles, David ; Sharp, Sheffield

INTRODUCTION:

Spasticity is a motor disorder often impairing mobility, daily function, and quality of life. While botulinum neurotoxin (BoNT) is safe and effective for spasticity, treatment discontinuation is common. This study aimed to identify the factors influencing long-term BoNT therapy maintenance among spasticity patients.

METHODS:

Forty participants with spasticity who received at least five BoNT cycles completed a structured cross-sectional telephone interview. Interviews covered key dimensions of living with spasticity, such as impact on daily activities, experience of pain associated with spasticity, and the broader implications for quality of life. Data were summarized using descriptive statistics.

RESULTS:

The cohort (60 % male, aged 45.1 ± 14.8 years) featured multiple etiologies of spasticity, including cerebral palsy (35 %), stroke (20 %), and traumatic brain injury (20 %). Most were treated with onabotulinumtoxinA (36/40), three were receiving abobotulinumtoxinA, and one was treated with incobotulinumtoxinA. Primary reasons for maintaining BoNT treatment included reduction of symptoms (55 %), improvement in mobility/movement (27 %), and relief of pain or tension (12 %). A majority of subjects (95 %) stated their treatment met or exceeded their expectations. Over 90 % of participants maintained a strong relationship with their physician and were well-informed about the therapy, including what to expect from treatment (98 %), potential side effects (90 %), and treatment duration (90 %).

CONCLUSION:

Results suggest spasticity patients are likely to continue treatment if they are properly educated on BoNT therapy, experience improvement in spasms and mobility, and have a strong physician-patient relationship. These findings highlight the importance of effective physician-patient relationships and proper education on BoNT therapy.

55

News (Medical) associated with Incobotulinum toxinA (Biotecon)

28 Apr 2026

·www.businesswire.com

Vensica Medical Receives FDA IND Clearance to Initiate Phase 2 Study of ViXe, Its Needle-Free Xeomin Delivery System for Overactive Bladder

NEW YORK--(BUSINESS WIRE)--Vensica Medical, a clinical-stage company developing needle-free therapeutic delivery solutions for urologic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to initiate a Phase 2 clinical trial of ViXe. The study will evaluate the Vibe® ultrasound-based, needle-free drug delivery system in combination with Xeomin® (incobotulinumtoxinA) for the treatment of overactive bladder (OAB). Overactive bladder affects an estimated 33 million adults in the United States and is characterized by urinary urgency, frequency, and incontinence. While intravesical botulinum toxin injection is an established second-line treatment, the invasive procedure limits patient access and acceptance. The ViXe program is designed to enable effective delivery of botulinum toxin into the bladder wall without the need for needles. The Phase 2 study is expected to enroll approximately 210 patients across sites in the United States and Europe and will evaluate the safety and efficacy of Vibe-enabled delivery of botulinum toxin type A. The Company anticipates initiating patient enrollment in [Q3 2026]. “FDA clearance of this IND is an important milestone for Vensica and validates the clinical rationale behind the ViXe program,” said Avner Geva, Chief Executive Officer of Vensica Medical. “Botulinum toxin is a proven therapy for OAB, but needle-based delivery remains a barrier for many patients. We believe ViXe has the potential to expand access to a much broader population.” “The Vibe platform was specifically engineered to overcome biological barriers that have historically limited needle-free delivery of large-molecule drugs,” said Avi Eftel, Co-Founder and Chief Technology Officer of Vensica Medical. “We look forward to executing this study and generating data to further demonstrate the clinical value of our approach.” “This IND clearance represents a key milestone in Vensica’s development and highlights the potential of the ViXe program,” said Ken Berlin, Executive Chairman of the Board of Vensica Medical. “A needle-free approach to botulinum toxin delivery could meaningfully expand patient access and create significant value for patients, partners, and investors.” The IND clearance triggers a contractual development milestone payment from Vensica’s strategic partners, supporting execution of the Phase 2 trial. Vensica is supported by its investors and strategic partners, including Merz Pharma, Laborie, and Israel Biotech Fund. About Vensica Medical Vensica Medical is a clinical-stage company developing needle-free therapeutic delivery solutions for urologic diseases. The Company’s proprietary Vibe® platform uses focused ultrasound to enable localized delivery of biologic and small-molecule drugs into the bladder wall. Vensica’s lead program, ViXe, combines the Vibe system with Xeomin® (incobotulinumtoxinA) for the treatment of overactive bladder. For more information, please visit [www.vensica.com].

26 Jan 2026

·www.biospace.com

Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity

Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA). If approved, the indication would expand access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe. Spasticity is a common and often debilitating condition in children and adolescents with certain neurological conditions, leading to increased muscle tone that can significantly limit movement, function and independence. One of the most common underlying causes of spasticity in children is cerebral palsy (CP), the most frequent motor disability in childhood, with spastic forms accounting for approximately 80% of all cases. In more severe cases, spasticity associated with CP can also affect speech, swallowing and fine motor skills.1,2 “We have made the conscious and ethical decision to advance our pediatric spasticity program. The submission of this important application for an indication extension in Europe represents another 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. The regulatory package submitted to the European Medicines Agency includes a comprehensive update of the clinical dossier, with data from the Phase 3 ELLIE study and prior pediatric spasticity investigations evaluating multipattern treatment of the lower limb, and, where appropriate, concomitant upper‑limb treatment. The positive results of the prospective, randomized, placebo-controlled, two-stage, double-blind, multicenter, 28-week Phase 3 clinical trial ELLIE were recently presented at the TOXINS 2026 8th International Congress on Neurotoxins from January 14 to 17, 2026. The Phase 3 trial investigated incobotulinumtoxinA in the treatment of lower limb spasticity in children and adolescents with CP and showed how incobotulinumtoxinA significantly improved lower limb spasticity in children and adolescents with CP, while demonstrating a favorable safety and tolerability profile.3 Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and the 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 a 118-year legacy. With passion and purpose, Merz Therapeutics continues to advance care in specialty neurology in ways that benefit both patients and society. References: 1 Cerebral Palsy Guide. Spastic cerebral palsy. . Last accessed: 19.01.2026. 2 Centers For Disease Control and Prevention. Data and Statics for Cerebral Palsy. . Last accessed: 19.01.2026. 3 Banach M et al. IncobotulinumtoxinA for treatment of lower limb spasticity in children/adolescents with CP (ELLIE). Toxicon. 2026;271(S1):7. Abstract 0076.

Clinical Result

08 Dec 2025

·www.businesswire.com

Merz Therapeutics to Present Broad Range of Clinical, Real-World and Mechanistic Data at TOXINS 2026

Merz Therapeutics to present more than 20 abstracts and posters at the TOXINS 2026 8 th International Conference, taking place January 14-17 2026 in Madrid, Spain. FRANKFURT, Germany--(BUSINESS WIRE)--Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that the company will present more than 20 clinical and non-clinical abstracts and posters spanning spasticity, movement disorders, and neurotoxin science at the TOXINS 2026 8th International Conference, taking place January 14–17, 2026, in Madrid, Spain. These presentations underscore the company’s commitment to addressing unmet needs in neurological disorders. “Our research reflects a relentless focus on improving patient outcomes through innovation in neurotoxin science,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “Our research reflects a relentless focus on improving patient outcomes through innovation in neurotoxin science,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “By presenting these new data at TOXINS 2026, we aim to foster scientific exchange and advance treatment strategies that address real-world challenges for patients and clinicians.” Merz Therapeutics will share new findings reflecting its continued dedication to advancing neurotoxin science. These include: Lower Limb Spasticity IncobotulinumtoxinA for the Treatment of Lower Limb Spasticity in Children and Adolescents with Cerebral Palsy: Evaluation of Lower Limb IncobotulinumtoxinA Efficacy (ELLIE) Authors: Marta Banach, Iryna Makedonska, Veronika Mykhaylenko, Angelika Hanschmann, Thorin Geister, Andrzej Dekundy Presenter: Sebastian Schröder, MD (Germany) Location and Time: Clinical Track 1B – Thursday, 15 January 2026, 17:40 – 17:55 p.m. Upper Limb Spasticity – Shoulder Management Pathways for diagnosis and multimodal management, including botulinum neurotoxin therapy, in shoulder conditions following central lesions Authors: Bo Biering-Sørensen, Carlos Cordero-García, Chris Boulias, Damon Hoad, Djamel Bensmail, Franco Molteni, François Genêt, Jörg Wissel, Philippe Marque, Steffen Berweck, Jorge Jacinto Location and Time: Poster and Exhibit Hall, 14-17 January 2026 Cervical Dystonia Real-world Evidence of Longevity of BoNT/A in Cervical Dystonia (RELY-CD) Authors: Benjamin Wäschle, John Ih Lee, Tristan Kölsche, Robin Jansen, Piotr Sobolewski, Sara Sánchez Valiente, Eva López Valdés, Pablo Mir, Silvia Jesús, Elena Ojeda Lepe, Ewa Papuć, Pilar Sánchez Alonso, Gabriel Salazar, Georg Comes, Holger Stark, Philipp Albrecht Location and Time: Poster and Exhibit Hall, 14-17 January 2026 Pain Evaluating the efficacy and safety of IncobotulinumtoxinA in adults with moderate to severe chronic peripheral neuropathic pain - The Phase 2 PaiNT Study Design Authors: Nadine Attal, Irena Pulte, Ilona Bicker, Ralf Baron, Nanna B. Finnerup, Thorin L. Geister, Eric Viel Location and Time: Poster and Exhibit Hall, 14-17 January 2026 Immunogenicity and Secondary Treatment Failure A systematic review and meta-analysis of neutralizing antibodies after treatment with abobotulinumtoxinA, incobotulinumtoxinA and onabotulinumtoxinA across multiple indications Authors: Uwe Walter, Phillipp Albrecht, Warner Carr, Harald Hefter Location and Time: Poster and Exhibit Hall, 14-17 January 2026 Secondary treatment failure with abobotulinumtoxinA, incobotulinumtoxinA and onabotulinumtoxinA: A systematic review and meta-analysis Authors: Uwe Walter, Phillipp Albrecht, Warner Carr, Harald Hefter Location and Time: Poster and Exhibit Hall, 14-17 January 2026 Toxins congress attendees can connect with Merz Therapeutics at the booth to learn more about the company, its pipeline and ongoing research. About Merz Therapeutics Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and the 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 a 117-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 www.merztherapeutics.com.

Phase 2

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)	insbdrpjba(fdzsmtybff) = epmgnbysai kcgpmohzwc (jkozukppdo, 0.140) View more	-	28 Apr 2026
				Placebo (Unilateral Treatment Period: Placebo)	insbdrpjba(fdzsmtybff) = ndnywckfhl kcgpmohzwc (jkozukppdo, 0.180) View more
MDS2025	Not Applicable	Sialorrhea	35	IncobotulinumtoxinA 100 U	zgcadpbqvv(gxzzrvfcwh) = 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. efkebuijfq (krrbumagpt )	Positive	05 Oct 2025
NCT04965311 (CTgov)	Phase 2	Pancreatic Fistula \| Pancreatic Cancer	4	Botulinum Toxin Type A	gxbobfnrit = xlqgapboyh gsjrxtydny (oaxgsmvzoq, cusdlzjmml - xkakxexual) View more	-	13 May 2025
TOWER (MDS2024)	Not Applicable	Muscle Spasticity	70	IncobotulinumtoxinA (spasticity due to cerebral causes)	sgvqqxasfi(rpqzwsiwmw) = gajrdtagdy oevjhyvryc (lrvbeqgsuw ) View more	Positive	27 Sep 2024
MDS2024	Not Applicable	Sialorrhea	36	IncobotulinumtoxinA 100 U	nntwayzuzr(rqfdqdiyyp) = kkxbkpntct slqfdxvtso (zfotwfgbnp, 1.6) View more	Positive	27 Sep 2024
NCT04622254 (ULTRA II, CTgov)	Phase 3	-	368	Placebo (Main Period: Placebo (Group P))	skmgqbtlzi = hndlbsutua tksalznsht (khpxlyzncb, pemntryqgd - hkpcqfvvpa) View more	-	06 Aug 2024
				NT 201 (Main Period: NT 201 (Group U))	skmgqbtlzi = polxwszwto tksalznsht (khpxlyzncb, depdqivlai - nbixqpjdyh) View more
NCT04594213 (ULTRA I, CTgov)	Phase 3	-	362	Placebo (Main Period: Placebo (Group P))	ceyntglkdh = zcvbeyljpv fhllhzlige (pjckkujrzx, uzlqbynnep - sntdtktgyu) View more	-	08 May 2024
				NT 201 (Main Period: NT 201 (Group U))	ceyntglkdh = qyriasdhdz fhllhzlige (pjckkujrzx, fbhcvtticx - zrtzgmqzkl) View more
P8-3.004 (AAN2024)	Not Applicable	cervical dystonia	451	IncobotulinumtoxinA	gouiugolah(nrycsimqrt) = fzonihqcnf bscongcfst (gipiipsahr ) View more	Positive	09 Apr 2024
				Placebo	gouiugolah(nrycsimqrt) = qtpzcgygib bscongcfst (gipiipsahr ) View more
NCT03806933 (CTgov)	Phase 2	-	241	MP+NT 201 (Stage 1 and 2 Pooled: NT 201 20 U)	hjprtxeqek(ghvihxtvvp) = ddednqidby nlxrzczbvf (ozhjdvfgev, qiozbwojcn - lykjoedkwl) View more	-	04 Oct 2023
				MP+NT 201 (NT 201 50 U)	hjprtxeqek(ghvihxtvvp) = xdpinnyreu nlxrzczbvf (ozhjdvfgev, xkxiwjbkmj - rjdqsazgjj) View more
MDS2023	Not Applicable	-	451	IncobotulinumtoxinA	rwwpfpjamt(rsstxrareh) = qjzaiuiwki hwojhuoria (ocfcuqwijm )	-	27 Aug 2023
				Placebo	rwwpfpjamt(rsstxrareh) = wqwdahbahp hwojhuoria (ocfcuqwijm )

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Incobotulinum toxinA (Biotecon)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation