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

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

Establishing Primary Structure Comparability Between ABP-450 (probotulinumtoxinA) and OnabotulinumtoxinA (Botox®) to Support Biosimilarity (AAN 2026) - "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."

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

BoTox Into the Sternocleidomastoid Muscles (SCM) (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Boston Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open

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

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

BoTox Into the Sternocleidomastoid Muscles (SCM) (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Boston Medical Center

New P4 trial

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

Daewoong Pharmaceutical Launches Nabota in Ecuador... Enters 13 South American Countries [Google translation] (HIT News) - "Nabota will be officially launched in Ecuador. Daewoong Pharmaceutical announced on the 7th that it held a launching symposium in Gayaquil and Quito, Ecuador on the 27th and 28th of last month and officially launched Nabota...We will build and promote reliable official distribution channels, while operating medical staff education and reward programs on topics such as the latest trends in combination procedures. Through these, we aim to build long-term customer relationships and increase Nabota’s credibility among local medical staff in Ecuador....At the launching symposium event, attended by approximately 240 Ecuadorian plastic surgery medical professionals, Key Opinion Leaders in the plastic surgery field in Central and South America were invited to provide various educational programs on not only Nabota but also Skin Booster and Hyaluronic Acid (HA) fillers."

Launch non-US • Dermatology

Daewoong Pharm marks record-breaking performance driven by new drugs and global expansion plan (Korea Biomedical Review) - "Fexuclu, Korea's 34th homegrown new drug, surpassed 1 trillion won in global and domestic cumulative sales within just three years of launch, earning blockbuster status...Envlo, Korea’s 36th new drug, achieved annual sales exceeding 10 billion won for the first time last year, solidifying its presence in the SGLT-2 inhibitor market with strong blood sugar-lowering effects...Ursosan, a drug that treats liver diseases such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related cholestasis, generated 96.2 billion won in revenue and is expected to reach the 1 trillion won milestone this year....In 2024, Nabota recorded 186.4 billion won in sales, marking 27 percent compared to the previous year. Export sales accounted for approximately 84 percent of the total revenue."

Sales • Gastroesophageal Reflux Disease • Migraine • Overactive Bladder • Primary Biliary Cholangitis • Type 2 Diabetes Mellitus

[HIT Algong] Daewoong Pharmaceutical, Nabota product exclusive supply contract extension [Google translation] (HIT News) - "On the 14th, the company announced that it had extended the exclusive supply contract for Nabota products in the Brazilian region with Moksha8 until 2029. The contract period is from January 31, 2018 to December 31, 2029, and the contract amount is 124.47 million dollars (180.54919 billion won)."

Licensing / partnership • CNS Disorders • Dermatology