botulinum toxin A (MBA-P01) / Medytox - LARVOL DELTA

Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19. (PubMed, Toxins (Basel)) - "MBA-P01 is a newly developed botulinum toxin A (BoNT-A) product designed to provide similar clinical effects as OnabotulinumtoxinA (ONA-BoNT-A), thereby providing an alternative treatment option for glabellar lines. The limitations of this study include the predominance of female participants and the exclusive enrollment of Korean patients. MBA-P01 is expected to be clinically useful in terms of the efficient and safe reduction of glabellar wrinkles, which will provide patients with additional treatment options."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study. (PubMed, J Dermatolog Treat) - P3 | "Purpose Following the introduction of new type of botulinum toxin (MBA-P01), a recent phase 3 study demonstrated that MBA-P01 showed comparable efficacy and safety to onabotulinumtoxin A for reducing glabellar lines. Repeated treatment with MBA-P01 was effective for a treatment duration of 3-5 months.Conclusion In conclusion, multiple cycles of treatment of glabellar lines with MBA-P01 at a dose of 20 U were well tolerated. Clinical trial registration information: This study is registered in ClincalTrials.gov (NCT05321979)."

Journal

Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P3 | N=253 | Completed | Sponsor: Medytox Korea | Recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ May 2023

Trial completion • Trial completion date

A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Medytox Korea | Recruiting ➔ Completed | Trial completion date: Nov 2022 ➔ Jun 2022

Trial completion • Trial completion date

Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines (clinicaltrials.gov) - P3 | N=318 | Completed | Sponsor: Medytox Korea | Recruiting ➔ Completed | Trial primary completion date: Sep 2021 ➔ Dec 2021

Trial completion • Trial primary completion date

Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Medytox Korea

New P3 trial

A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Medy-Tox

New P2 trial