Dysport (abobotulinumtoxinA) / Ipsen - LARVOL DELTA

A Non-inferiority Clinical Trial to Compare Efficacy and Safety of Abobotulinumtoxin A (Espad Pharmed) Versus AbobotulinumtoxinA (Dysport®, Ipsen Co.) for Correction of Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P3 | N=146 | Completed | Sponsor: Espad Pharmed

Head-to-Head • New P3 trial

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

A 12-Week Prospective, Double-Blind, Multicenter, Randomized Study Comparing 100 Units of Abobotulinum Toxin Type A (Dysport®) and 33.33 Units of Neubotulinum Toxin Type A (Neuronox®) for the Treatment of Hemifacial Spasm. (PubMed, Toxins (Basel)) - "Both Neu-BoNT-A and Abo-BoNT-A were safe and effective in treating HFS. However, Neu-BoNT-A was more effective in HFS with minimal symptoms without disability and Abo-BoNT-A more effective in HFS with greater duration of disability."

Clinical • Journal • CNS Disorders • Depression • Psychiatry

Botulinum Toxin in the Treatment of Hair and Scalp Disorders: Current Evidence and Clinical Applications. (PubMed, Toxins (Basel)) - "BoNT-A and B showed consistent efficacy in treating craniofacial hyperhidrosis with minimal side effects. Additional scalp conditions may benefit from BoNT therapy, but the evidence is limited, and larger, controlled studies are needed to better understand BoNT's clinical value in these conditions."

Journal • Review • Alopecia • Dermatitis • Dermatology • Immunology • Pain • Scleroderma • Seborrheic Dermatitis • Solid Tumor • Systemic Sclerosis

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

Cost-utility analysis of botulinum toxin type A versus oral drug treatment in patients with severe blepharospasm in Thailand. (PubMed, PLoS One) - "Among patients with severe blepharospasm, both onaBoNT-A and aboBoNT-A were considered a cost-effective strategy under the Thai willingness to pay threshold of 4,613 USD/QALY. Having aboBoNT-A was slightly more favorable due to lower cost, using a conversion ratio of 1U of onaBoNT-A: 3U of aboBoNT-A."

Clinical • HEOR • Journal • CNS Disorders • Depression • Movement Disorders • Pain • Psychiatry

Dysport: Data readout from P3 C-BEOND trial (NCT06047444) for chronic migraine in 2026 (Ipsen) - Q1 2025 Results: Data readout from P3 E-BEOND trial (NCT06047457) for episodic migraine in 2026

P3 data • CNS Disorders • Migraine

A pilot assessment of intra-detrusor Alluzience botulinum toxin in patients with detrusor overactivity refractory to Allergan Botox (AUA 2025) - "Alluzience abobotulinumtoxinA (Galderma SA, Lausanne, Switzerland) is an alternative showing promise in aesthetic medicine, and may circumvent toxin resistance. This pilot assessment of Alluzience shows clear benefit in continence and quality of life. At the lowest dose, it has not been associated with unexpected complications. In a patient population refractory to Allergan Botox who are considering more invasive surgical interventions, it provides an alternative option."

Clinical • Aesthetic Medicine • Pain • Urinary Incontinence

The Effects of Preoperative Botulinum Toxin A Injection on Respiratory System Function (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: Swissmed Hospital | Recruiting ➔ Completed | N=10 ➔ 30 | Trial completion date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastroenterology

Long-Term Improvement of Gait Kinematics in Young Children with Cerebral Palsy Treated with Botulinum Toxin Injections and Integrated/Intensive Rehabilitation: A 5-Year Retrospective Observational Study. (PubMed, Toxins (Basel)) - "The data from our retrospective observational study show a significant, long-term, positive effect of integrated treatment on gait kinematics in patients with CP in a homogenous group of young children with bilateral spastic cerebral palsy."

Journal • Observational data • Retrospective data • Cerebral Palsy • CNS Disorders

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

Influence of the cosmetic use of botulinum toxin type a on temperature measurements using infrared thermography. (PubMed, Arch Dermatol Res) - "The substance used in the patients was Botulinum Toxin type A DYSPORT® 500 IU...Considering the mean temperature difference, at the temporal ROI, a reduction of the M2 temperature was observed (ΔT = 0.3 ℃) and an increase at M3 (ΔT = 0.6 ℃). The cosmetic use of BTX-A may alter skin temperature values assessed using IT, and this effect can last for days."

Journal

Antinociceptive properties of intravesical/needle-free administration of abobotulinumtoxinA in a rodent model of chronic visceral pain: in vivo and histological evidence. (PubMed, J Neural Transm (Vienna)) - "While interstitial cystitis along with bladder pain syndrome (IC/BPS) is still poorly treated, published clinical evidence suggests that onabotulinumtoxinA (natural botulinum neurotoxin type A (BoNT/A)) intradetrusor injections is efficient in IC/BPS...Cyclophosphamide (CYP) was used to induce IC/BPS in rats...AboBoNT-A displayed analgesic properties that could translate into better therapies for visceral pain. Interestingly, intravesical (needle-free) administration seems like a promising and reproducible route for botulinum toxin therapy in patients with IC/BPS."

Journal • Preclinical • Interstitial Cystitis • Musculoskeletal Pain • 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

Cross induction of anti-complexing antibodies in botulinum treatment patients injected with botulinum toxin containing complexing proteins (AAD 2025) - "One-hundred participants were divided into 5 subgroups for using 5 types of BoNT/A (incobotulinumtoxinA(IncoA), onabotulinumtoxinA(OnaA), abobotulinumtoxinA(AboA), letibotulinumtoxinA(LetiA), and prabotulinumtoxinA(ProboA). AboA which has difference molecular weight can induce only some type of antibody against CPs. IncoA which do not contain complexing protein is not induced antibody against CPs."

Clinical

Intradermally injected abobotulinumtoxinA administered preemptively before surgery alleviates post-surgical pain and normalizes behavior in a translational animal model. (PubMed, Sci Rep) - "Thus, aboBoNT-A administered ID 15 days before surgery represents the most optimal condition for postoperative analgesia. These findings warrant for clinical investigation of preemptively administered aboBoNT-A in postsurgical pain."

Journal • Preclinical • CNS Disorders • Depression • Pain • Psychiatry

Phase 2 randomized study of abobotulinumtoxinA in patients with provoked vestibulodynia: dose-finding results. (PubMed, J Sex Med) - P2 | "aboBoNT-A was well tolerated in patients with PVD with no safety signals reported. Further studies are warranted to demonstrate clinically meaningful benefits with repeated treatment."

Journal • P2 data • Musculoskeletal Pain • Pain • Sexual Disorders • Urinary Incontinence • Urology • Women's Health

Abobotulinumtoxin A injections for the chronic sialorrhea correction in children: Russian retrospective multicenter study (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "AbobotulinumtoxinA injections have shown effectiveness and safety in the correction of chronic sialorrhea in children, also in combination with concomitant spasticity treatment. Further research is needed to determine the optimal dose and treatment protocols."

Clinical • Journal • Retrospective data • Cerebral Palsy • CNS Disorders • Developmental Disorders • Gastrointestinal Disorder • Movement Disorders • Psychiatry

Muscle selection and dosing in patients undergoing treatment with abobotulinumtoxinA for lower limb spasticity in real-world practice. (PubMed, J Rehabil Med) - "This study demonstrates how a diversity of muscle patterns are currently treated in routine practice where the primary goal was related to the lower limb and highlights important issues for further debate, such as potential underdosing and the need to balance upper and lower limb priorities when devising a treatment plan."

Journal • Observational data • Real-world evidence • Movement Disorders

EARLY BOT-SPAS: Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Instituto Mexicano del Seguro Social

New P1 trial • Cardiovascular • Movement Disorders

Kiss and Smile HIT (Holistic Individualized Treatment) (clinicaltrials.gov) - P4 | N=24 | Completed | Sponsor: Erevna Innovations Inc. | Active, not recruiting ➔ Completed | Phase classification: PN/A ➔ P4 | Trial completion date: Nov 2025 ➔ Dec 2024

Phase classification • Trial completion • Trial completion date

DIRECTION: A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity. (clinicaltrials.gov) - P4 | N=464 | Active, not recruiting | Sponsor: Ipsen | Trial completion date: Mar 2026 ➔ Oct 2025 | Trial primary completion date: Mar 2026 ➔ Oct 2025

Trial completion date • Trial primary completion date • Movement Disorders

CLIN-52120-456: Effectiveness and Safety of SMART [Spastic Muscle Palpation by Anatomic Landscape for BoNT-A (Botulinumtoxin-A) Injection to Reduce Muscle Tone] BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity (ULS) in Real-life Setting. (clinicaltrials.gov) - P=N/A | N=116 | Active, not recruiting | Sponsor: Ipsen | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Movement Disorders • Muscle Spasticity

Delphi Consensus on the Management of Spanish Patients with Post-Stroke Hemiplegic Shoulder Pain Treated with Botulinum Toxin A: Result Study. (PubMed, Toxins (Basel)) - "In case of lack of response, experts suggested increasing the dose or number of treated muscles or considering alternative treatments. These consensus-based recommendations offer clinicians an approach to the management of post-stroke HSP with BoNT-A, supporting informed decision making."

Journal • Cardiovascular • Movement Disorders • Musculoskeletal Pain • Pain