Jeuveau (prabotulinumtoxinA-xvfs) / Daewoong Pharma, AEON Biopharma - LARVOL DELTA

BoTox Into the Sternocleidomastoid Muscles (SCM) (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Boston Medical Center | Trial completion date: Aug 2026 ➔ Mar 2027 | Trial primary completion date: Aug 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date

Study of DWP450 in Japanese Subjects With Glabellar Lines (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P3 trial

Establishing structural and functional comparability between ABP 450 and onabotulinumtoxinA to support biosimilarity (AHS 2026) - "Integrated genomic, proteomic, and functional analyses demonstrate that ABP 450 and onabotulinumtoxinA share identical primary structures and highly similar biological activity. The absence of structural variants, high peptide coverage, and matched potency profiles collectively support the molecular and functional comparability required for biosimilarity. These findings strengthen the totality of evidence supporting ABP 450 as a biosimilar candidate."

CNS Disorders

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism (clinicaltrials.gov) - P=N/A | N=72 | Completed | Sponsor: Recep Tayyip Erdogan University | Active, not recruiting ➔ Completed

Trial completion • Dental Disorders • Musculoskeletal Diseases

Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (clinicaltrials.gov) - P=N/A | N=756 | Completed | Sponsor: Evolus, Inc. | Active, not recruiting ➔ Completed

Trial completion

BoTox Into the Sternocleidomastoid Muscles (SCM) (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Boston Medical Center | Trial completion date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date

Scrotal Botulinum Toxin Exposure and Male Fertility: Mechanistic Insights and Clinical Evidence. (PubMed, Cureus) - "Current evidence is insufficient to determine the reproductive safety of scrotal or peritesticular botulinum toxin injections in humans. Preclinical data raise concern for potential spermatotoxicity with higher-dose and/or anatomically proximal exposure, while human studies remain indirect and lack fertility-specific monitoring. Standardized dosing and technique reporting, incorporation of semen and hormonal outcomes, direct thermophysiological assessment, and longitudinal follow-up are needed. Until such data exist, clinicians should counsel men desiring future fertility that mechanistic risk is plausible and definitive human fertility outcomes have not been established."

Journal • Review • Pain

Establishing Primary Structure Comparability Between ABP-450 (probotulinumtoxinA) and OnabotulinumtoxinA (Botox®) to Support Biosimilarity (AAN 2026) - "Conclusions The dual-method approach confirmed that ABP-450 and Botox® share identical primary structures at both the genomic and proteomic levels. These findings support the molecular comparability required for biosimilarity."

Morphea En Coup De Sabre Treated With Combination Hyaluronic Acid Filler and Neuromodulator: A Case Report. (PubMed, Cureus) - "Targeted prabotulinumtoxin-A was administered to hyperfunctional temporalis, corrugator supercilii, and depressor supercilii muscles to reduce dynamic deforming forces...This combination approach provided immediate, natural-appearing correction maintained with small-volume retreatments every six to 12 months without complications. This case illustrates that neuromodulator and hyaluronic acid filler, delivered with a cannula, may offer a safe, minimally invasive option for aesthetic rehabilitation of burned-out morphea en coup de sabre by addressing muscle imbalance while reshaping and contouring the forehead."

Journal • Immunology • Scleroderma • Systemic Sclerosis

Cross-Induction of Anti-Complexing Antibodies in Patients Treated with Botulinum Toxin Formulations Containing Complexing Proteins. (PubMed, Toxins (Basel)) - "One hundred participants were allocated into five treatment groups, each receiving a single BoNT/A formulation: incobotulinumtoxinA (IncoA), onabotulinumtoxinA (OnaA), abobotulinumtoxinA (AboA), letibotulinumtoxinA (LetiA), or prabotulinumtoxinA (PraboA). These findings demonstrate that CP-containing formulations can induce cross-reactive antibody responses, whereas CP-free incobotulinumtoxinA exhibits minimal immunogenicity. This study highlights the importance of CP composition in guiding clinical product selection, particularly in patients requiring repeated BoNT/A administration."

Journal

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism (clinicaltrials.gov) - P=N/A | N=69 | Active, not recruiting | Sponsor: Recep Tayyip Erdogan University

New trial • Dental Disorders • Musculoskeletal Diseases

Daewoong to re-enter China with Botox rival Nabota as NMPA accepts filing (Korea Biomedical Review) - "Data posted by China’s Center for Drug Evaluation (CDE), an arm of the National Medical Products Administration (NMPA), show that an import application for “botulinum toxin type A for injection” from Daewoong was accepted last Saturday, with the Korean drugmaker listed alongside its local Chinese entity, Beijing Daewoong Pharmaceutical R&D Center."

China filing • Immunology

Challenging Interchangeability: Dynamic Dose-Response Modelling of Botulinum Toxin A Products. (PubMed, Aesthetic Plast Surg) - "Static dose conversion ratios fail to represent the dynamic pharmacodynamic behaviour of BoNT-A formulations. This simulation-based, data-driven approach reproduces clinical outcomes with high fidelity and provides a robust framework for effect-based dose equivalence, improving precision in product substitution and individualized treatment planning."

Journal

Korean botulinum toxins. (PubMed, J Neural Transm (Vienna)) - "These are PrabotulinumtoxinA (Daewoong/Evolus) and LetibotulinumtoxinA (Hugel/Croma Pharma). There are 12 Class 2 drugs from 10 Korean manufacturers registered in Korea for export and domestic use, including Neuronox®, the first Korean BT drug registered in 2006, NivobotulinumtoxinA/Innotox®, the world-wide first liquid BT type A preparation and Coretox®, the world-wide second BT drug without complexing proteins...5 Korean manufacturers have 5 drug projects in Korea in advanced development phases. With this, Korea is now the country with the worldwide largest number of BT manufacturers and BT drugs."

Journal

EXPRESS: Evaluation of Stress Biomarkers in individuals with Migraine or Tension-Type headached before and after Botulinum Toxin Injection. (PubMed, Mol Pain) - "The PREEMPT (Onabotulinum toxinS AntIpOde for chronic migraiNe) treatment protocol, a systematic procedure for treating chronic migraines, was administered to the patients. Biomarkers measured during the study were analyzed as surrogate measures of stress to shed light on potential physiological action of the intervention. Context In patients with chronic migraine and tension-type headaches, the effect of Nabota (Botulinum toxin type A) on specific stress-related indicators was evaluated.The results demonstrated a statistically significant (p<0.05) rise in salivary cortisol and a statistically significant (p<0.05) decrease in salivary alpha amylase following Botulinum toxin intervention for both research groups (chronic migraine, chronic tension headaches)."

Biomarker • Journal • CNS Disorders • Migraine • Pain

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

Computational Model-Informed Comparative Evaluation of Botulinum Toxin A Formulations: A 20-Year Simulation of Onset, Diffusion, Duration, and Immunogenicity. (PubMed, Toxicon) - "LetibotulinumtoxinA and PrabotulinumtoxinA predicted the most balanced profiles, combining high efficacy (mean peak strain reduction 72% and 68%, respectively), rapid onset (2.7-3.1 days), and minimal predicted neutralizing antibody incidence over 20 years (0.4-0.6%). DaxibotulinumtoxinA showed the longest modelled duration of effect (median 142 days), whereas AbobotulinumtoxinA and Relatox exhibited broader diffusion and higher immunogenicity risk...These simulations align closely with available empirical data and suggest that formulation-specific differences in protein structure, diffusion behaviour, and antigenicity may contribute to observed clinical variability. Model-informed comparative analysis can complement real-world and prospective studies to optimize product selection and dosing strategies in aesthetic and therapeutic applications."

Clinical • Journal

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 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

In Silico Multiscale Computational Modelling of Botulinum toxin A Diffusion for Glabellar Wrinkle Treatment: Optimizing Injection Volumes across formulations. (PubMed, Toxicon) - "Simulations encompassed five formulations- AbobotulinumtoxinA (ABO), DaxibotulinumtoxinA (DAXI), IncobotulinumtoxinA (INCO), OnabotulinumtoxinA (ONA), and PrabotulinumtoxinA (PRABO)-across injection volumes from 0.025 to 0.1 mL, at fixed toxin unit dosing, within anatomically realistic glabellar meshes (n=10,000 synthetic patient variants)...This study provides the first in-silico quantitative, multiscale evidence that reducing BoNT/A reconstitution volume to ≤0.045 mL/site significantly enhances target localization while minimizing off-target effects. Contrary to prevailing clinical heuristics, dilution amplifies mechanical spread and immune clearance risk."

Journal

Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Kalpna Kay Durairaj, MD, FACS | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Aug 2025 | Trial primary completion date: Jan 2025 ➔ Aug 2025

Enrollment closed • Trial completion date • Trial primary completion date

Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (clinicaltrials.gov) - P=N/A | N=756 | Active, not recruiting | Sponsor: Evolus, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study Comparing the Safety, Efficacy, and Diffusion of Letibotulinum Toxin A Versus Other Botulinum Toxin Products in Adults With Moderate-to-Severe Forehead Wrinkles (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Yonsei University

New P4 trial

Decades of Scientific Data and Global Media Reporting on Complications in Non-surgical Aesthetic Treatments for a Transparent Safety Profile: Kissing Snow White Awake. (PubMed, Aesthetic Plast Surg) - "While advancements like standardised complication registries and ultrasound-guided techniques herald progress, transformative measures are imperative. These include mandating adverse event reporting, harmonising global regulatory frameworks, and integrating AI-driven surveillance systems. The field must prioritise transparency, rigorous credentialling, and patient-centred ethics to ensure its evolution aligns with uncompromising safety standards."

Journal • Aesthetic Medicine • Immunology • Infectious Disease • Pain

The Role of Toxins and Fillers in Optimizing Perioral Rejuvenation. (PubMed, Facial Plast Surg) - "Changes in the perioral region are significant contributors to the visible signs of aging.Ideal candidates for perioral rejuvenation with toxin and filler are individuals experiencing age-related rhytids or volume loss who are interested in minimally invasive, nonsurgical interventions.Neurotoxins like Botox, Xeomin, Dysport, Jeuveau, and Daxxify are used to relax muscles that contribute to rhytids...Dermal fillers such as hyaluronic acid, calcium hydroxyapatite, and poly-L-lactic acid restore volume in areas like the nasolabial folds, lips, marionette lines, chin, prejowl sulcus, and perioral rhytids.Neurotoxins and dermal fillers offer effective, minimally invasive solutions for perioral rejuvenation. With an understanding of underlying anatomy, proper patient selection, and precise injection techniques, facial plastic surgeons can achieve natural, youthful results with minimal downtime."

Journal • Aesthetic Medicine