Xeomin (incobotulinumtoxinA) / Merz Pharma - LARVOL DELTA

Factors influencing the long-term maintenance of spasticity neurotoxin treatment. (PubMed, J Neurol Sci) - "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."

Journal • Cardiovascular • Cerebral Palsy • CNS Disorders • Movement Disorders • Pain • Vascular Neurology

PINBOT: Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Rigshospitalet, Denmark | Trial completion date: Feb 2026 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain

LET: Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia (clinicaltrials.gov) - P=N/A | N=13 | Terminated | Sponsor: Centre Hospitalier Universitaire de Nīmes | Completed ➔ Terminated; Discontinuation of production of the investigational medicinal product (PRP)

Trial termination • Musculoskeletal Pain

Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Uniformed Services University of the Health Sciences

New trial • CNS Disorders • Migraine • Pain • Vascular Neurology

Hypersensitivity Reactions Associated With Aesthetic Botulinum Toxin A Injections: A Case Series. (PubMed, Cureus) - "In the first case, a 44-year-old woman developed severe angioedema after resuming abobotulinumtoxinA injections following a 12-month pause. Subsequent intradermal tests with onabotulinumtoxinA and incobotulinumtoxinA produced localized reactions, suggesting hypersensitivity to a shared component across formulations, possibly the 150 kDa BoNT/A neurotoxin itself. In the second case, a 38-year-old woman experienced delayed erythema and swelling after letibotulinumtoxinA treatment but tolerated subsequent incobotulinumtoxinA injections, suggesting possible reactivity to complexing proteins or other non-core components rather than the neurotoxin. In the third case, a 50-year-old woman developed systemic symptoms and localized swelling after prabotulinumtoxinA administration, consistent with a delayed-type hypersensitivity reaction...Overall, this case series underscores the importance of clinical vigilance, appropriate patient selection, and awareness of rare but meaningful..."

Journal • Aesthetic Medicine • Cardiovascular • Dermatology • Immunology

Functional Effects of BoNT-A Application in Masseter Muscle in Patients with Symptoms of Bruxism. (PubMed, Toxins (Basel)) - "The objective biomechanical changes correlated with the duration of BoNT-A's therapeutic effects. These findings establish myotonometry as a valuable tool for objective assessment of masticatory muscle function and demonstrate that BoNT-A produces measurable, long-lasting biomechanical changes in masseter muscle parameters, supporting its possible clinical application in this challenging condition."

Journal • Dental Disorders

Xeomin® and Gait Related Mobility After Stroke (clinicaltrials.gov) - P4 | N=20 | Recruiting | Sponsor: Wake Forest University Health Sciences | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Cardiovascular

Improvement of spinal sensorimotor adaptation in children with cerebral palsy with various locomotor patterns using botulinum therapy and compression orthoses (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Based on the analysis of modern research, a range of botulinum toxins has registered an effective and favorable safety profile for BTX-A (incobotulinumtoxin A) use in children with CP. The combination of botulinum toxin therapy, orthoses, and physical therapy is a dominant factor in rehabilitation."

Journal • Review • Cerebral Palsy • CNS Disorders • Movement Disorders

Effects of incobotulinumtoxinA in children and adolescents with spastic cerebral palsy: A systematic review of randomized controlled trials. (PubMed, PM R) - "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."

Journal • Review • Cerebral Palsy • CNS Disorders • Movement Disorders

Moose Technique: A New Anatomical Perspective Treatment in Botulinum Toxin. (PubMed, J Cosmet Dermatol) - "The MOOSE technique provides an anatomically guided approach to botulinum toxin injections, enhancing aesthetic results while reducing complications. Its effectiveness underscores the value of individualized treatment based on muscle dynamics. Further research is needed to refine its application and assess long-term effects."

Journal • Aesthetic Medicine

Botulinum Toxin Treatment in Hereditary Spastic Paraplegia-A Comprehensive Review and Update. (PubMed, Toxins (Basel)) - "The injected toxin in the open-label studies was botulinumtoxin-A (Botox or Dysport or Xeomin), whereas in the blinded study, the investigators used Prosigne. The novelty of this review is that it represents a comprehensive and critical literature review on this subject, with no other studies of this kind published previously. It also includes data not present in previous reviews of this subject."

Journal • Review • Genetic Disorders • Movement Disorders • Urology

Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Kalpna Kay Durairaj, MD, FACS | Active, not recruiting ➔ Completed

Trial completion

A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU) (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Merz Aesthetics GmbH | Not yet recruiting ➔ Recruiting

Enrollment open

IncobotulinumtoxinA to Treat Sialorrhea in Parkinson's Disease: a Real-life Study: 6-year Interim Results (MDS Congress 2025) - "Our interim results confirm the efficacy and safety of repeated incobotulinumtoxinA injections for sialorrhea in PD patients in a real-world setting. An increased duration of effect (up to 6 months or longer) is being observed in 14 patients (40,0%). We recommend starting with 75 U incobotulinum toxin in patients with pre-existing swallowing difficulties."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Characteristics of IncobotulinumtoxinA Treatment for Limb Spasticity in a Real-World Setting: Dosing and Muscles Injected (MDS Congress 2025) - "The doses of incobotulinumtoxinA and muscles injected for LS are very unique to the patient, indicating individualized care. Average doses were below the labeled maximum dose for incobotulinumtoxinA for most patient encounters regardless of the type of LS. Very little waste was recorded in clinical notes."

Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders

Characteristics of IncobotulinumtoxinA Treatment for Cervical Dystonia in a Real-World Setting: Dosing and Muscles Injected (MDS Congress 2025) - "The doses of incobotulinumtoxinA and muscles injected for CD were found to be highly individualized in this retrospective EHR-based analysis. The assessment of clinical notes was key as information on dosing and muscles cannot typically be obtained from administrative claims or structured EHR data. Very little wastage of incobotulinumtoxinA units was recorded in clinical notes."

Clinical • Real-world • Real-world evidence • CNS Disorders • Dystonia • Movement Disorders

BOTULINUM TOXIN IN PAIN RELATED POST STROKE UPPER LIMB SPASTICITY: A META-ANALYSIS ON EARLY AND LATE INJECTIONS (WCN 2025) - "The search included studies from January 2000 until January 2024. Twelve RCTs were analyzed wherein 8 used abobotulinumtoxinA, 2 used onabotulinumtoxinA, 1 used Neu-BoNT/A and 1 used incobotulinumtoxinA. Based on the pooled data from the multiple studies, there is no significant difference in the scores measuring pPSS between patients who received early BoNT injections and those who received placebo. Based on the pooled data from the multiple studies, there is no significant difference in the scores measuring pPSS between patients who received early BoNT injections and those who received placebo. This finding suggests that within the early treatment period, BoNT may not be more effective than a placebo in reducing pPSS. However, it is important to note that the data for early BoNT injections is still limited indicating that more research is needed to draw definitive conclusions [z= 1.08 (p= 0.28)]."

Retrospective data • CNS Disorders • Movement Disorders • Pain

A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU) (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Merz Aesthetics GmbH

New P3 trial

Effectiveness, safety, and quality of life outcomes of neurotoxin injections in the treatment of essential tremors: a systematic review. (PubMed, J Neural Transm (Vienna)) - "BoNT injections demonstrated effectiveness in reducing tremor severity and is a promising approach for those experiencing symptoms that are refractory to conventional oral medications. Further controlled trials are necessary to confirm these observations."

Clinical • HEOR • Journal • Review • Essential Tremor • Gastrointestinal Disorder • Movement Disorders • Otorhinolaryngology • Pain

Efficacy and safety of intracavernosal incobotulinumtoxinA (Xeomin) as add-on therapy to sildenafil for the treatment of erectile dysfunction insufficiently responsive to phosphodiesterase type 5 inhibitors. (PubMed, J Sex Med) - "Despite negative ITT effectiveness results, this study demonstrated the safety of intracavernosal BTX/A. The results raise hypotheses regarding its potential role in combination with PDE5-Is, warranting further investigation. Future trials should refine patient selection and injection technique, assess dose-response effects, and improve protocol adherence to yield more reliable results for ED resistant to PDE5-Is."

Journal • Erectile Dysfunction

Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines. (PubMed, J Cosmet Dermatol) - P3 | "Additional endpoints, including pGAIS, iGAIS, and MAS scores, corroborate prior ULTRAI/II findings and demonstrate the efficacy of incobotulinumtoxinA for simultaneous treatment of UFLs."

Clinical • Journal

Perineural incobotulinumtoxin-A for Complex Regional Pain Syndrome – protocol for an open-label pilot study investigating feasibility and tolerability (NeuPSIG 2025) - "This pilot study will provide essential feasibility data on the perineural administration of incobotulinumtoxin-A for CRPS. By focusing on tolerability, patient experience, and symptom tracking, the study aims to establish foundational evidence to support larger, controlled trials. The results will contribute to the development of novel treatment strategies for CRPS, addressing a significant unmet need in pain management."

Clinical • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain

A Pilot Study of Differences in Antibody Responses of Intradermal and Intramuscular Injections of Botulinum Toxin Type A. (PubMed, Dermatol Ther (Heidelb)) - "Intradermal injection of BoNT/A appears to elicit a stronger immunogenic response than intramuscular administration, although antibody levels did not reach clinically significant thresholds. These findings underscore the importance of injection technique and interval planning to mitigate immunogenicity. Given the widespread use of intradermal techniques in aesthetic practice, this study provides important clinical insight into optimizing BoNT/A administration."

Journal

PLATINUM US: A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Merz North America, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Injectable Aesthetic Treatments for Improving Facial Skin Quality in Transgender Patients With or Without Gender-Affirming Hormone Therapy. (PubMed, J Cosmet Dermatol) - "This new treatment plan for skin quality improvement offers gender-affirming care to the transgender community, based on clinical expertise."

Journal • Aesthetic Medicine