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

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

Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Kalpna Kay Durairaj, MD, FACS

New P1 trial

Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention (clinicaltrials.gov) - P2 | N=466 | Terminated | Sponsor: AEON Biopharma, Inc. | N=666 ➔ 466 | Enrolling by invitation ➔ Terminated; Study was terminated due to the analysis of the data not meeting the intended primary endpoint and key secondary endpoints.

Enrollment change • Trial termination • CNS Disorders • Migraine • Pain

Investigation of Safety and Efficacy of ABP-450 for Migraine Prevention in Adults (clinicaltrials.gov) - P2 | N=797 | Completed | Sponsor: AEON Biopharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Post Hoc Analysis Comparing the Safety and Efficacy of PrabotulinumtoxinA in Millennials and Nonmillennials With Moderate to Severe Glabellar Lines. (PubMed, Dermatol Surg) - "PrabotulinumtoxinA was highly effective in treating moderate to severe glabellar lines. The greater efficacy seen in millennials may reflect physiological differences related to aging as well as botulinum toxin-mediated effects on mood. The results align well with their aesthetic expectations."

Clinical • Journal • Retrospective data • Aesthetic Medicine

Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention (clinicaltrials.gov) - P2 | N=666 | Enrolling by invitation | Sponsor: AEON Biopharma, Inc. | Trial completion date: Sep 2025 ➔ Aug 2024 | Trial primary completion date: Jun 2025 ➔ Aug 2024

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

DaxibotulinumtoxinA (Daxxify) for frown lines. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Investigating the impact of botulinum toxin type a on the migration of normal human dermal fibroblasts: An in vitro wound healing assay. (PubMed, J Cosmet Dermatol) - "Different types and dilutions of BoNT-A demonstrated variable inhibitory effects on NHDF migration in vitro. The selection of BoNT-A formulation may significantly impact the clinical outcome of scar prevention related to fibroblast migration."

Journal • Preclinical • Fibrosis • Immunology

A new injection paradigm of prabotulinumtoxinA for episodic and chronic migraine (AHS 2024) - P2 | "Medical professionals with experience in administering injections of both onabotulinumtoxinA in the PREEMPT paradigm (31–39 injections) and ABP-450 in the novel injection paradigm (26 injections) in the clinical trial, participated in an anonymous online migraine injector survey. A key design feature of the ABP-450 paradigm is fewer injections (i.e., 26 injections). This paradigm is currently being evaluated in a randomized, double-blind, placebo-controlled phase 2 trial. ABP-450 treatment coupled with this novel injection paradigm is anticipated to present a safe and effective treatment option for EM and CM."

CNS Disorders • Migraine • Musculoskeletal Pain • Pain

Real-World Patient Experience With PrabotulinumtoxinA in the United Kingdom: A Single-Center Survey and Analysis of 254 Patients. (PubMed, Aesthet Surg J Open Forum) - "Among survey respondents, 83% rated their treatment positively (5-point satisfaction scale), and 72% would choose prabotulinumtoxinA again. These data support safety and effectiveness of prabotulinumtoxinA in a diverse, real-world population, and confirm patient satisfaction among experienced BoNT-A patients, as well as suggest a rapid time to onset and peak effect."

Journal • Real-world • Real-world evidence • Aesthetic Medicine

Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (clinicaltrials.gov) - P=N/A | N=750 | Recruiting | Sponsor: Evolus, Inc. | Trial completion date: May 2026 ➔ Jan 2026 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date

Comparative Study on the Duration and Efficacy of Various Botulinum Toxin Type A Injections for Reducing Masseteric Muscle Bite Force and Treating Facial Wrinkles. (PubMed, Dermatol Ther (Heidelb)) - "The structural differences among BoNT/A brands did not significantly affect the longevity and efficacy of bite force reduction and wrinkle treatment."

Journal • Aesthetic Medicine

DWP450 for Treating Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P3 | N=473 | Completed | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P3 trial

Commentary on Efficacy and Safety of prabotulinumtoxinA in Subjects With Benign Masseteric Hypertrophy. (PubMed, Dermatol Surg) - No abstract available

Journal

Efficacy and Safety of PrabotulinumtoxinA in Subjects With Benign Masseteric Hypertrophy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase 3 Trial and Open-Label Extension Study. (PubMed, Dermatol Surg) - "PrabotulinumtoxinA could effectively ameliorate MMH without major complications."

Journal • P3 data