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

NCT07537855

/ Not yet recruitingPhase 2IIT

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.

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

100 Clinical Results associated with Incobotulinum toxinA (Biotecon)

100 Translational Medicine associated with Incobotulinum toxinA (Biotecon)

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

475

Literatures (Medical) associated with Incobotulinum toxinA (Biotecon)

01 Apr 2026·Journal of Cosmetic Dermatology

Global Pharmacovigilance of Aesthetic Botulinum Toxin Type A: Analysis of Adverse Event Reports From the USA , Europe, Canada, and Australia

Article

Author: Zargaran, David ; Mosahebi, Afshin ; Zargaran, Alexander ; Woollard, Alex ; Pirayesh, Ali

ABSTRACT:

Background:

Monitoring of adverse events for aesthetic BoNT‐A (BoNT‐A) through pharmacovigilance databases provides critical insight into real‐world safety profiles. Previous analyses suggested substantial underreporting, yet comprehensive international multi‐database analysis remains absent.

Methods:

Adverse event reports for aesthetic BoNT‐A indications were extracted from FDA FAERS, EMA EudraVigilance, Health Canada MedEffect, and TGA DAEN databases from 2002 to 2025. Reports were filtered for cosmetic indications using procedure codes, anatomical sites, and indication descriptions. Events were categorized by clinical manifestation and severity using MedDRA classification.

Results:

Analysis identified 43,809 adverse event reports across four databases. FDA FAERS contributed 38,321 reports (87.5%), EudraVigilance 3,526 (8.0%), Health Canada 1,835 (4.2%), and TGA DAEN 127 (0.3%). Effectiveness issues comprised 57.3% of reports ( n = 25,092), followed by local injection‐site reactions (19.7%, n = 8,611), facial paresis/ptosis/asymmetry (9.9%, n = 4,348), and headache (6.0%, n = 2,650). Peak reporting occurred in 2018 for FAERS (1,375 reports) and 2020 for Health Canada (242 reports). Among FAERS reports with brand attribution, onabotulinumtoxinA accounted for 86.8%, abobotulinumtoxinA 9.7%, and incobotulinumtoxinA 2.4%. Co‐reported adverse event analysis revealed drug ineffective with therapeutic response decreased as the most frequent pairing ( n = 2,947), followed by drug ineffective with off‐label use ( n = 1,102).

Conclusions:

The predominance of effectiveness issues over traditional safety concerns distinguishes aesthetic BoNT‐A pharmacovigilance from typical pharmaceutical surveillance. Geographic concentration of reporting in the United States despite global market distribution indicates systematic underreporting internationally. These findings suggest current pharmacovigilance systems inadequately capture aesthetic medicine adverse events, with direct implications for patient safety and regulatory oversight.

01 Apr 2026·EUROPEAN JOURNAL OF NEUROLOGY

Systematic Review and Meta‐Analysis of Secondary Treatment Failure and Immunogenicity with Botulinum Neurotoxin A in Multiple Indications—Comment on Recommending IncobotulinumtoxinA as First‐Line to Prevent Secondary Treatment Failure [Letter]

Letter

Author: Magacho‐Vieira, Fabiano Nadson

01 Mar 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.

News (Medical) associated with Incobotulinum toxinA (Biotecon)

12 May 2026

·www.biospace.com

Merz Therapeutics’ Activities at ISPRM 2026 Highlight the Importance of Patient-Centric Management in Upper and Lower Limb Spasticity: From Goal Setting to Optimal Dosing for Better Patient Outcomes

Merz Therapeutics to present 11 abstracts at ISPRM World Congress 2026, highlighting its commitment to improving outcomes for people living with movement disorders Updated analysis indicates that optimizing botulinum toxin dosing over multiple injection cycles may be an important factor in improving outcomes in people living with limb spasticity, with available clinical data suggesting support for flexible, individualized dosing with incobotulinumtoxinA (XEOMIN ® ) Updated meta-analyses examining secondary treatment failure and neutralizing antibodies suggest a potential for sustained long-term treatment response with incobotulinumtoxinA (XEOMIN ® ) FRANKFURT, Germany--(BUSINESS WIRE)--Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced it will present 11 scientific abstracts at the International Society of Physical and Rehabilitation Medicine (ISPRM) 2026 World Congress. Taking place from May 17 th to May 21 st in Vancouver, Canada, the presentations will feature key data on optimal dosing strategies, immunogenicity and the potential for sustained long-term treatment response with XEOMIN ® (incobotulinumtoxinA), underscoring the company's commitment to advancing the science behind durable clinical outcomes in neurorehabilitation. "Our presence at ISPRM underscores our deep commitment to advancing the science behind improved patient care," said Stefan König, CEO, Merz Therapeutics. "We believe that by furthering the understanding of long-term treatment efficacy, we can empower clinicians to better support people affected in achieving their functional goals. Our patient-centric research complements this by ensuring we never lose sight of the outcomes that truly matter to patients." Spasticity is a chronic condition requiring long-term management, and treatment success can be influenced by factors such as appropriate dose, injection intervals and the potential for a patient to develop an immune response that reduces efficacy. 1-3 The data presented provides clinicians with valuable insights into optimizing patient care, supporting the principle of persisting with treatment while also addressing how a low risk of immunogenicity is crucial for maintaining therapeutic response. "Treating spasticity is a long-term journey we take together with people affected by the condition,” said Dr. Stefan Albrecht, CSO, Merz Therapeutics. "Our aim is to offer a therapy option that meets people’s needs today and remains a reliable choice for years to come. This research delivers robust data on key aspects such as immunogenicity, an important factor in ensuring treatment durability and sustained effectiveness as patients’ needs evolve over time." ISPRM congress attendees can connect with Merz Therapeutics at booth 306 to learn more about the company's research and commitment to improving outcomes in people with spasticity and other movement disorders. Merz Therapeutics presentations at ISPRM 2026 Topic Abstract title Location and Time IncobotulinumtoxinA dose optimization Goal Attainment and Ambulation With Increasing Doses of IncobotulinumtoxinA: A Post Hoc Analysis of the TOWER Study Tuesday, May 19, 2026 6:00 PM - 7:30 PM 300 Section Immunogenicity and potential for long-term efficacy with IncobotulinumtoxinA A systematic review and meta-analysis of neutralizing antibodies after treatment with abobotulinumtoxinA, incobotulinumtoxinA and onabotulinumtoxinA across multiple indications Secondary treatment failure with abobotulinumtoxinA, incobotulinumtoxinA and onabotulinumtoxinA: a systematic review and meta-analysis IncobotulinumtoxinA in upper-limb spasticity Improvement in upper limb spasticity patterns in the elderly following treatment with incobotulinumtoxinA: a pooled analysis Tuesday, May 19, 2026 6:00 PM - 7:30 PM 300 Section Moderate-to-severe upper limb spasticity patterns in the elderly are improved following treatment with incobotulinumtoxinA: a pooled analysis Tuesday, May 19, 2026 6:00 PM - 7:30 PM 300 Section IncobotulinumtoxinA in 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) Paratonia management Botulinum neurotoxin type-A in the treatment of patients with paratonia Digital integration Use of a Smartphone App (iFlexo) to Support Rehabilitation in Post-Stroke Spasticity: A Proof-of-Concept Study Patient and caregiver perspectives in spasticity Measuring spasticity in clinical trials – which endpoints are most relevant to patients? Barriers and facilitators to clinical trial involvement for patients with spasticity Peripheral neuropathic pain Paving the Way for a New Local Peripheral Neuropathic Pain Treatment: Proof-of-concept Clinical Trial with IncobotulinumtoxinA (PaiNT) 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 more than 115-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: Shtefan V, Fletcher J, Duclos OA. Causes of Botulinum Toxin Treatment Failure. Clin Cosmet Investig Dermatol . 2022;15:1045-1049. Published 2022 Jun 7. doi:10.2147/CCID.S363321. Ketchum N, Carda S, O'Dell M, Säterö P, Jacinto J, Deltombe T, Francisco G. Module 4: Optimizing Outcomes in Spasticity Treatment. The Journal of the International Society of Physical and Rehabilitation Medicine 5(Suppl 1):p S50-S60, June 2022. | DOI: 10.4103/2349-7904.347810. U.Walter, P.Albrecht, W.Carr, and H.Hefter, “Systematic Review and Meta-Analysis of Secondary Treatment Failure and Immunogenicity With Botulinum Neurotoxin A in Multiple Indications,” European Journal of Neurology 32, no. 8 (2025): e70289, . Contacts Media Contact: Merz Therapeutics GmbH Luke Anthony Mircea-Willats Global Communications & Strategic Affairs merztherapeutics@merz.com

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

100 Deals associated with Incobotulinum toxinA (Biotecon)

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.

to view more data

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

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)	vywjeupnwf(dpzrmnrnrx) = qeohamwxpu mynvcnlwtx (hrzjrbnivz, 0.140) View more	-	28 Apr 2026
				Placebo (Unilateral Treatment Period: Placebo)	vywjeupnwf(dpzrmnrnrx) = okcrfjsnbk mynvcnlwtx (hrzjrbnivz, 0.180) View more
MDS2025	Not Applicable	Sialorrhea	35	IncobotulinumtoxinA 100 U	plmbseomob(abhvghcxhy) = 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. zzyeiojtno (ieqzappetz )	Positive	05 Oct 2025
NCT04965311 (CTgov)	Phase 2	Pancreatic Fistula \| Pancreatic Cancer	4	Botulinum Toxin Type A	kxsggjuhez = bwdfdjfowl mfycovbgle (uagiizttwx, tzyslahkhz - piifnjkpnl) View more	-	13 May 2025
TOWER (MDS2024)	Not Applicable	Muscle Spasticity	70	IncobotulinumtoxinA (spasticity due to cerebral causes)	tikreimhfr(xiveiujtaf) = mtwxfissfj peilweoqwf (weewzonfnn ) View more	Positive	27 Sep 2024
MDS2024	Not Applicable	Sialorrhea	36	IncobotulinumtoxinA 100 U	kjmczocekt(ktxhbzwzka) = prklnhtsuk gaweksdyhy (lahuhywhiu, 1.6) View more	Positive	27 Sep 2024
NCT04622254 (ULTRA II, CTgov)	Phase 3	-	368	Placebo (Main Period: Placebo (Group P))	tkfxjjdsup = ailzywocer dslilnkkcf (gwixymjspi, xzflmcnhpb - lparhljaba) View more	-	06 Aug 2024
				NT 201 (Main Period: NT 201 (Group U))	tkfxjjdsup = fdlluwlgfo dslilnkkcf (gwixymjspi, ggdjqlqqmr - tcddwbyxcb) View more
NCT04594213 (ULTRA I, CTgov)	Phase 3	-	362	Placebo (Main Period: Placebo (Group P))	mxcvtywrqe = dyryjobxuo wxdkotfcrv (pxokiszmjz, qwemomqraj - emheymzmxh) View more	-	08 May 2024
				NT 201 (Main Period: NT 201 (Group U))	mxcvtywrqe = qxxrtawbvp wxdkotfcrv (pxokiszmjz, xabkngbrry - rpplqipaer) View more
P8-3.004 (AAN2024)	Not Applicable	cervical dystonia	451	IncobotulinumtoxinA	hswewbidqr(xdxctxrbwf) = friyyfppjz qbfztcdayg (wiuexupuae ) View more	Positive	09 Apr 2024
				Placebo	hswewbidqr(xdxctxrbwf) = xnhslryauq qbfztcdayg (wiuexupuae ) View more
NCT03806933 (CTgov)	Phase 2	-	241	MP+NT 201 (Stage 1 and 2 Pooled: NT 201 20 U)	wzxanlkvhy(bsowejbtvx) = durodpqbgx lrkjtxsixc (bgvhqdwdpi, dndnfttnih - mbabofcrjh) View more	-	04 Oct 2023
				MP+NT 201 (NT 201 50 U)	wzxanlkvhy(bsowejbtvx) = fnnpjtdnox lrkjtxsixc (bgvhqdwdpi, ecxbbtukjm - djzumqngzz) View more
MDS2023	Not Applicable	-	451	IncobotulinumtoxinA	mzoasumlaa(qwiimwisvv) = rezhjyrsbb nkkejqcteh (cccryjshow )	-	27 Aug 2023
				Placebo	mzoasumlaa(qwiimwisvv) = lgdvgoskgw nkkejqcteh (cccryjshow )

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