Botox (Botulinum Toxin Type A)
Korean: 보톡스 (Botokseu) · Full term: 보툴리눔 독소 주사 · Category: Injectables · Last reviewed: 2026-05-01
A purified bacterial neurotoxin injected in small doses into facial muscles to temporarily relax them and reduce the appearance of dynamic wrinkles. Korea has the world's most competitive domestic portfolio of approved BTX-A biosimilar products.
What it is
Botulinum toxin type A (BTX-A) is a purified protein produced by Clostridium botulinum. Standard formulations are supplied as a lyophilized powder, reconstituted with saline, and injected in small doses directly into target muscles. Korean injectors and clients commonly refer to all brands as "보톡스" regardless of manufacturer.
In Korea, BTX-A is the most common non-surgical aesthetic procedure. Common indications go beyond glabellar and forehead wrinkle reduction to include masseter reduction for facial slimming, hyperhidrosis, micro-botox skincare protocols, and platysma band treatment. Major Korean producers include Medytox (Meditoxin, Innotox, Coretox), Daewoong Pharmaceutical (Nabota), and Hugel (Botulax, marketed in the US as Letybo).
How it works
BTX-A binds to the presynaptic membrane of cholinergic nerve terminals at the neuromuscular junction. After receptor-mediated endocytosis, the toxin's light chain cleaves SNAP-25, a component of the SNARE protein complex required for acetylcholine vesicle fusion. This prevents neurotransmitter release and produces selective, reversible chemodenervation of the target muscle.
Formulations differ in their complexing protein profiles. Standard products (onabotulinumtoxinA, abobotulinumtoxinA) carry 900-kDa complexing proteins. IncobotulinumtoxinA (Xeomin) and Medytox's Coretox are 150-kDa "naked" toxin preparations marketed as having reduced immunogenicity.
Origin and development
Allergan received FDA approval for BOTOX Cosmetic for glabellar lines on April 12, 2002, based on placebo-controlled trials with 405 patients (FDA approval letter; CIDRAP, April 2002).
Korean manufacturers entered the global market through subsequent regulatory milestones. Daewoong Pharmaceutical's Nabota received MFDS approval in 2013 (MFDS Biological Products listing) and FDA approval as Jeuveau (prabotulinumtoxinA-xvfs) on February 1, 2019 (FDA approval letter, BLA 761085). Hugel's Botulax received FDA approval as Letybo (letibotulinumtoxinA-wlbg) on February 29, 2024 (FDA Drug Trials Snapshots — Letybo).
Medytox's Innotox was approved by MFDS in 2013 as the first ready-to-use liquid botulinum toxin type A formulation, eliminating the need for saline reconstitution (Medytox Innotox product page).
In a notable regulatory event, MFDS revoked manufacturing and sales licenses for Meditoxin 50U, 100U, and 150U effective June 25, 2020, after finding evidence of unapproved raw ingredients and falsified test documents from 2012 to 2015 (Korea Times, June 2020; Korea JoongAng Daily, June 2020). The 200U formulation was not revoked. The revocation was later overturned in court; in March 2025 the Korean Supreme Court dismissed MFDS's final appeal, upholding lower-court rulings in favor of Medytox (Chosun Biz, September 2025).
Regulatory status
| Jurisdiction | Status | Notes |
|---|---|---|
| Korea (MFDS) | Multiple brands approved | Pharmaceutical drug (의약품). Meditoxin 50U/100U/150U revoked June 25, 2020; revocation overturned, MFDS appeal dismissed by Supreme Court March 2025 |
| United States (FDA) | Multiple brands approved | Botox Cosmetic (glabellar lines, April 12, 2002); Jeuveau (February 1, 2019); Letybo (February 29, 2024). Korean brands Meditoxin, Innotox, and Coretox under their domestic names are NOT FDA-approved |
Clinical evidence
Hugel's pivotal Phase III BLESS I/II/III program supporting Letybo enrolled 1,271 patients across efficacy trials. Treatment-success rates at Week 4 were 47%, 49%, and 65% versus 0%, 2%, and 0% for placebo (FDA Drug Trials Snapshots — Letybo).
A 2020 Phase III randomized controlled trial (Yoo et al., Dermatologic Surgery, n=267) of HU-014 (Hugel) versus onabotulinumtoxinA found Week 4 response rates of 90.15% versus 92.31% on investigator live assessment, confirming non-inferiority for moderate-to-severe glabellar lines (Yoo et al., 2020).
A 2016 meta-analysis (Jia et al., Aesthetic Plastic Surgery, 16 RCTs, N=42,405) found BTX-A facial-rejuvenation patients had significantly more adverse events than placebo (RR 1.24; 95% CI 1.07–1.43; p=0.003), with the frown-line subgroup showing higher relative risk (RR 1.47; 95% CI 1.23–1.77) (Jia et al., 2016).
A 2022 systematic review and meta-analysis (Zargaran et al., 24 studies, 4,268 BoNT-A injection sessions) reported an overall complication rate of 16% (95% CI 8–26%) for cosmetic glabellar and forehead BoNT-A. Most complications were mild and transient; headache 6.3%, local skin reactions 3.8% (Zargaran et al., 2022).
Safety considerations
Within the Jia 2016 frown-line subgroup, BTX-A injections showed significantly elevated rates versus placebo for headache (RR 1.53; 95% CI 1.15–2.03), eyelid ptosis (RR 5.56; 95% CI 1.68–18.38), and heavy eyelids (RR 6.94; 95% CI 1.27–37.93) (Jia et al., 2016).
Counterfeit and mishandled product is a documented risk. As of June 24, 2024, the U.S. CDC reported 17 people across 9 states had harmful reactions from counterfeit, unverified-source, or non-compliant-injector botulinum toxin products (CDC Investigation Update). On November 5, 2025, the FDA issued warning letters to 18 websites illegally marketing unapproved or misbranded botulinum toxin products, citing adverse events including botulism symptoms (FDA Press Announcement, November 2025).
In Korea, only licensed physicians may perform medical injections. Medical Service Act Article 27(1) prohibits non-medical personnel from performing medical practices, and Article 87 makes violations punishable by up to five years imprisonment or a fine not exceeding KRW 20 million (Medical Service Act, Article 27(1) and 87).
Korean market
Hugel reported 2024 botulinum toxin net sales of KRW 203.2 billion, up 20.2% year-on-year, with overseas botulinum toxin sales up 39.6% (Hugel press release, February 2025). Hugel's total 2024 consolidated revenue was KRW 373 billion (MarketScreener — Hugel).
Medytox (KOSDAQ: 086900) reported FY2024 revenue of KRW 228.62 billion, up 3.39% year-on-year (Stock Analysis — Medytox).
Daewoong Pharmaceutical (KOSPI: 069620), the manufacturer of Nabota, saw Q1 2025 Nabota sales of KRW 50.6 billion, up 10.9% year-on-year, with full-year Nabota projection of KRW 263.5 billion (Seoul Economic Daily, April 2026).
Korean session pricing varies widely by brand and clinic. For current pricing, the Gangnam Unni and Babitalk platforms publish verified clinic listings.
US pricing per the American Society of Plastic Surgeons 2023 fee data averages approximately $435 per treatment, with typical out-of-pocket ranging from $300 to $600 (ASPS 2023 Cosmetic Procedures Average Cost).
What to research before
- Verify the brand and the operator. A Korean clinic listing "보톡스" without a brand name could be using any of multiple domestic products. Ask which specific brand is being used and confirm at the appointment.
- Be aware of the Meditoxin license history. Meditoxin 50U/100U/150U formulations were revoked by MFDS in 2020. The revocation was later overturned in court. Active product lines today (such as Coretox and the 200U Meditoxin formulation) were not revoked, but the history is worth knowing.
- Confirm the clinic and injector are licensed. Our Safety Guide covers Korean specialty registry verification.
Related procedures
- HA fillers — volumizing dermal filler with a different mechanism
- Skin boosters — adjacent injectable category for hydration and texture
- Thread lifts — alternative non-surgical lift modality