Xeomin (incobotulinumtoxinA) / Merz Pharma - LARVOL DELTA

Botulinum Toxin Plus Scopalamine as a Protective Strategy Against Salivary Gland Toxicity in Patients Treated with 225Ac- and 177Lu- PSMA-Targeted Radioligand Therapy (TANDEM PSMA-RLT) (SNMMI 2025) - " 14 patients (mean age: 68.0 ± 8.1 years) were enrolled in the study, receiving injections of BTX IncoA (Xeomin®) prior to their scheduled TANDEM PRLT, one patient receiving two injections before his treatment, and another undergoing two cycles of TANDEM RLT with BTX administered prior to each cycle... This study demonstrates that BTX, administered at recommended doses in combination with transdermal scopolamine, offers a promising therapeutic strategy for reducing radiation-induced salivary gland toxicity without compromising PSMA tumor uptake. This approach enhances patient quality of life following PSMA radioligand therapy, particularly with alpha-emitting radionuclides, while preserving its excellent therapeutic efficacy. Further studies with larger patient cohorts and longer follow-up periods are warranted."

Clinical • Castration-Resistant Prostate Cancer • Dental Disorders • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Salivary Gland Cancer • Solid Tumor • Thrombocytopenia • Xerostomia

MINT-E: A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine (clinicaltrials.gov) - P3 | N=990 | Not yet recruiting | Sponsor: Merz Therapeutics GmbH

New P3 trial • CNS Disorders • Migraine • Pain

MINT-C: A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: Merz Therapeutics GmbH

New P3 trial • CNS Disorders • Migraine • Pain

HYSTEROXINE: Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea (clinicaltrials.gov) - P3 | N=222 | Not yet recruiting | Sponsor: Nantes University Hospital

New P3 trial • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Single-Dose IncobotulinumtoxinA in the Treatment of Early-Stage Knee Osteoarthritis: Results from a Preliminary Single-Arm Clinical Trial. (PubMed, Toxins (Basel)) - "Patients showed a significant reduction in total WOMAC score (p < 0.001), from a mean baseline of 44.6 (95% CI; 41.4, 47.8) to 4.4 at day 90 (95% CI; 0.2, 0.3). Our results show that IncobotulinumtoxinA applied in the retro-patellar bursa is a safe and effective treatment for pain in patients with early-stage KOA, offering a potential alternative for symptomatic control in KOA."

Clinical • Journal • Hematological Disorders • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Perineural incobotulinumtoxin-A for Complex Regional Pain Syndrome – Protocol for an open-label pilot study investigating feasibility and tolerability (NeuPSIG 2025) - No abstract available

Clinical • CNS Disorders • Musculoskeletal Pain • Pain

Efficacy and Safety of Incobotulinumtoxin-A for Trapezius Muscle Reduction: Quantitative Evaluation With Imaging Studies. (PubMed, Plast Reconstr Surg Glob Open) - "INCO injections effectively reduced trapezius muscle size, with sustained results up to 6 months posttreatment. This study supports the use of INCO as a safe and effective option for managing trapezius hypertrophy."

Journal

Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Oct 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular

BOTOX® vs. XEOMIN® for Chronic Migraine (clinicaltrials.gov) - P3 | N=128 | Recruiting | Sponsor: Naval Medical Center Camp Lejeune | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

PATTERN: Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (clinicaltrials.gov) - P3 | N=603 | Active, not recruiting | Sponsor: Merz Pharmaceuticals GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • CNS Disorders • Movement Disorders • Vascular Neurology

Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: OHSU Knight Cancer Institute | N=63 ➔ 4 | Trial completion date: May 2025 ➔ Jul 2024 | Recruiting ➔ Terminated | Trial primary completion date: May 2025 ➔ Jul 2024; low enrollment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Single Session of Calcium Hydroxylapatite, Incobotulinumtoxin A, and Hyaluronic Acid for Gluteal Aesthetic Improvement. (PubMed, J Cosmet Dermatol) - "A single-session combined application of CaHA-CMC, IncoBoNT-A, and CPM-HA effectively improved flaccidity and cellulite, resulting in high patient satisfaction."

Journal • Observational data • Retrospective data

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial of incobotulinumtoxinA Treatment for Upper Limb Tremor. (PubMed, Mov Disord Clin Pract) - "Single dose incobotulinumtoxinA injections are effective in reducing objective measures of proximal upper limb tremor and function. This did not translate into improved patient-rated outcomes in this single therapeutic dose study."

Clinical • Journal • Essential Tremor • Movement Disorders

Protocol and Demographics of the RELY-CD Study: Assessing Long-Term Clinical Response to Botulinum Neurotoxin in Cervical Dystonia. (PubMed, Toxins (Basel)) - "This retrospective study focused on patients treated with complex-free (incobotulinumtoxinA) and complex-containing (onabotulinumtoxinA and abobotulinumtoxinA) BoNT/A formulations over an up to 10-year period. The primary endpoint was a comparison of a clinically meaningful worsening in DEff in treatment year 7 compared to year 2 between complex-free and complex-containing botulinum neurotoxin type A. The RELY-CD study provides unique insights into long-term treatment patterns, clinical resistance phenomena, and the implications of formulation differences on treatment outcomes, addressing a critical gap in the literature on real-world botulinum neurotoxin type A application. The study methodology, including the definition and calculation of the novel DEff, as well as clinical baseline characteristics, are presented."

Journal • Retrospective data • CNS Disorders • Dystonia • Movement Disorders

Exploring Nonresponse to Botulinum Toxin in Aesthetics: Narrative Review of Key Trigger Factors and Effective Management Strategies. (PubMed, JMIR Dermatol) - "Neutralizing antibodies developed with first-generation formulations, such as onabotulinumtoxinA and abobotulinumtoxinA that contain clostridial proteins, but not with second-generation BoNT-As, such as incobotulinumtoxinA and daxibotulinumtoxinA, which lack these proteins...Considering the potential for immunogenicity is essential when selecting a BoNT-A formulation. Preventing SNR is crucial, given the lack of solid data on effective treatments."

Journal • Review • Aesthetic Medicine • Infectious Disease

Switox: Retrospective Analysis of Botulinum Toxin Switching in Management of Spasticity. (PubMed, Toxins (Basel)) - "The majority of patients switched from Botox to Xeomin (73.66%), while others switched from Botox to Dysport (14.63%) or from Xeomin to Dysport (11.71%). While differences between groups were observed, they were not statistically significant. Placebo and nocebo effects may influence perceptions of efficacy and side effects during treatment changes."

Journal • Retrospective data • Fatigue • Movement Disorders

Innovative Botulinum Toxin Injection: A Promising Nonsurgical Solution for Carpometacarpal Osteoarthritis. (PubMed, Clin J Sport Med) - "This case report introduces a novel approach involving intra-articular incobotulinumtoxinA (BoNTA) injection for CMCJ OA, resulting in significant and prolonged pain relief and enhanced functionality. This groundbreaking intervention effectively bridges the gap between nonsurgical and surgical treatments, offering a promising alternative for individuals with CMCJ OA."

Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Intradermal Microdroplet Injection of Standard-Diluted Incobotulinumtoxin A for the Treatment of Erythematotelangiectatic Rosacea: A Study From a Dermatology Center in Medellín, Colombia. (PubMed, Cureus) - "Standard 2mL dilution INCO, used for aesthetic indications, may be a safe and effective option for treating ETR-related erythema and flushing."

Journal • Dermatology • Rosacea

Successful Treatment of Sialorrhea with Daxibotulinum Toxin A (AAN 2025) - "Currently, IncobotulinumtoxinA (USA and Europe) and RimabotulinumtoxinB (USA) are approved for this indication. All surveys suggest DaxibotulinumtoxinA provided sustained improvement of sialorrhea and may provide a novel alternative option for those refractory to other treatments."

CNS Disorders • Movement Disorders • Parkinson's Disease

Insights from Clinical Experience with DaxibotulinumtoxinA for the Treatment of Cervical Dystonia (AAN 2025) - "Our cohort consisted of both toxin-naïve and toxin-experienced individuals allowing for a broad evaluation of dosing strategies and treatment outcomes.Patients received doses ranging between 60-570U, with toxin-experienced individuals transitioning from OnabotulinumtoxinA or IncobotulinumtoxinA using a conversion ratio ranging from 1:1 to 1:3. Daxxify is a good treatment option in patients with CD, particularly in patients unsatisfied with the outcomes of previous therapies. Further studies may be warranted to explore its broader applications in the treatment of other conditions and to optimize dosing strategies for individualized patient care."

Clinical • CNS Disorders • Dystonia • Gastrointestinal Disorder • Infectious Disease • Migraine • Movement Disorders • Pain • Parkinson's Disease

Ultrasound-Guided Botulinum Toxin Infiltrations in Essential Tremor Patients: A 36-week Follow Up. (PubMed, Tremor Other Hyperkinet Mov (N Y)) - "Essential tremor patients often face limited options, as oral therapies often yield only partial efficacy, and invasive interventions, like Deep Brain Stimulation, may not always be viable. In this open-label study, 18 patients received ultrasound-guided IncobotulinumtoxinA injections, showing significant tremor improvement and enhanced quality of life, with minimal adverse events reported."

Journal • Essential Tremor • Movement Disorders • Pain

Pilot Study on the Efficacy of Incobotulinumtoxin-A for Refractory Chronic Migraine (AAN 2025) - "Onabotulinumtoxin-A was approved by the FDA in 2010 and is the only type of botulinum toxin approved for migraine, with its efficacy demonstrated in multiple clinical trials, meta-analyses, and real-world studies (3). Incobotulinumtoxin-A proved to be effective, it has a lower price than other types of toxins and does not require a cold chain, making it a better candidate for centers that do not have the correct cold chain storage facilities."

Clinical • CNS Disorders • Migraine • Pain

Secondary Treatment Failure with AbobotulinumtoxinA, IncobotulinumtoxinA, and OnabotulinumtoxinA: A Systematic Review and Meta-analysis (AAN 2025) - "Our meta-analysis found that incobotulinumtoxinA was associated with a significantly lower risk of developing STF compared with abobotulinumtoxinA (CD and spasticity) and onabotulinumtoxinA (CD). IncobotulinumtoxinA is recommended to avoid developing neutralising antibody-induced STF, particularly for patients who require higher doses and repeated treatments."

Retrospective data • Review • CNS Disorders • Dystonia • Movement Disorders

A Systematic Review and Meta-analysis of Neutralizing Antibodies After Treatment with AbobotulinumtoxinA, IncobotulinumtoxinA and OnabotulinumtoxinA Across Multiple Indications (AAN 2025) - "Our meta-analysis identified no patients exclusively treated with incobotulinumtoxinA that developed persistent NAbs, supporting the low antigenicity of this BoNT-A formulation. The potential cumulative exposure to different BoNT-A formulations for different indications is something that clinicians need to be increasingly aware of. Therefore, incobotulinumtoxinA may be recommended to avoid developing immunogenicity, particularly for patients who require higher doses and repeated treatments."

Retrospective data • Review • CNS Disorders • Dystonia • Movement Disorders

Pilot Study on the Efficacy of Incobotulinumtoxin-A for Refractory Chronic Migraine (AAN 2025) - No abstract available

Clinical • CNS Disorders • Migraine • Pain