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

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

Botulinum Toxin for Scalp Conditions: A Systematic Review (AAD 2024) - "Where specified, formulations of botulinum toxin used for scalp conditions included onabotulinumtoxinA, Chinese botulinum toxin type A, abobotulinumtoxinA, prabotulinumtoxinA, and rimabotulinumtoxinB. Botulinum toxin may be a promising therapeutic option for patients with various scalp conditions, but future studies are needed to better understand its efficacy and safety. Disclosure: The U.S. Food and Drug Administration has not yet approved the use of botulinum toxin for the conditions discussed in this abstract."

Review • Alopecia • Dermatology • Fibrosis • Immunology • Pain • Scleroderma • Seborrheic Dermatitis • Systemic Sclerosis

Safety and Duration of Effect of 40U PrabotulinumtoxinA-xvfs for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients: A Phase II, Multi-Center, Randomized, Double Blind, Active-Controlled Trial. (PubMed, Aesthet Surg J) - "In this Phase II pilot study, 40U prabotulinumtoxinA-xvfs was observed to be safe and had a duration of 6 months."

Journal • P2 data

Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Lupo Center for Aesthetic and General Dermatology | Recruiting ➔ Completed

Trial completion

AEON Biopharma aligns with FDA on Phase 3 migraine trials (Investing.com) - "AEON Biopharma, Inc...has announced a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the upcoming Phase 3 trials for ABP-450 (prabotulinumtoxinA) injection, a treatment aimed at preventing both episodic and chronic migraine. Following positive Phase 2 data in episodic migraine released in October 2023, AEON is now set to conduct an interim analysis of its ongoing Phase 2 study in chronic migraine, with results expected in the second quarter of 2024."

FDA event • P2 data • Migraine • Pain

Applications for Neurotoxins in the Face and Neck. (PubMed, Atlas Oral Maxillofac Surg Clin North Am) - No abstract available

Journal • Review • Aesthetic Medicine