Article

Article

Review Article

The AESTHETICS 2023; 4(1): 6-9

Published online April 30, 2023

https://doi.org/10.46738/Aesthetics.2023.4.1.6

© Korean Association For Laser Dermatology And Trichology

A New Botulinum Neurotoxin: DaxibotulinumtoxinA Approved by Food and Drug Administration

Kyu-Ho Yi, MD, PhD1, Hyun-Jun Park, MD2, Wook Oh, MD3, Je Hyuk Lee, MD4, Gwahn Woo Cheon, MD5, Min-Soo Park, MD6, Yoo-Seock Ree, MD6, Hyoung Moon Kim, MD, PhD7

1Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, Seoul, Korea
2Maylin Anti-Aging Center Apgujeong, Seoul, Korea
3Maylin Clinic (The Hyundae), Seoul, Korea
4Doctorbom Clinic, Seoul, Korea
5Maylin Clinic (Pangyo), Seongnam, Korea
6Gangnam View Best Clinic, Seoul, Korea
7Maylin Clinic (Ilsan), Goyang, Korea

Correspondence to: Hyoung Moon Kim
Maylin Clinic, Goyang 10391, Korea
E-mail: drmac12@me.com
https://orcid.org/0000-0001-9068-5813

Received: March 13, 2023; Accepted: March 25, 2023

This is an open access article distributed under the terms of the Creative Commons Attribution Non- Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A (BoNTA) product that contains a highly purified 150-kDa core neurotoxin and a proprietary stabilizing excipient peptide (RTP004) instead of human serum albumin. DAXI produces robust and extended efficacy in reducing glabellar lines and improving Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores in adults with cervical dystonia. DAXI has a consistent median time to loss of none or mild glabellar line severity of 24 weeks and a median time until return to baseline of up to 28 weeks. Overall, DAXI is well-tolerated and has the potential to improve the management of both aesthetic and therapeutic conditions due to its consistent and extended duration of effect. The US FDA approved the development of daxibotulinumtoxinA (DAXI) for injection on September 16, 2022, based on positive results from clinical trials (SAKURA 1, 2, and 3). DAXI’s extended duration of effect could make it a reliable and safe option for reducing the appearance of wrinkles caused by muscle activity, and it has the potential to improve the treatment of both therapeutic and cosmetic disorders.

Keywords: Glabellar lines, Botulinum neurotoxin, DaxibotulinumtoxinA, SAKURA, Wrinkles