What Is Botulax? South Korea’s Leading Neurotoxin Brand — Complete Guide

Written by FillersFairy Editorial · Reviewed by FillersFairy Clinical Team · Last updated: 2026-06-28

Hugel Pharma: The Company Behind Botulax

Botulax isn’t made by a startup — it’s the flagship product of Hugel Pharma Co., Ltd. (KOSDAQ: 145020), a publicly traded Korean pharmaceutical company with a substantial global distribution network.

Hugel operates a cGMP manufacturing facility in Chuncheon, South Korea. The company’s botulinum toxin portfolio has expanded to 22+ countries, making Botulax one of the most widely distributed Korean BTX-A products in international markets.

The company’s public listing on KOSDAQ means Hugel is subject to Korean financial reporting requirements, regulatory compliance disclosure and public accountability — an additional layer of transparency that private manufacturers cannot offer.

Product Specifications

Reconstitution: unpreserved 0.9% sterile saline. Inject gently to avoid denaturing the protein.

The CBFC26 Strain — Same DNA as Botox

One of the most important facts about Botulax for practitioners evaluating the product: according to clinical trial documentation filed with the FDA (BLESS II, NCT02677805; BLESS III, NCT04763265), the CBFC26 strain’s genomic DNA sequence encoding the toxin is identical to that of the Hall strain A (ATCC 3502) used in Botox.

This means the neurotoxin protein itself — the molecule that blocks acetylcholine release at the neuromuscular junction — is structurally the same. A double-blind, randomised phase 3 trial of 272 participants demonstrated noninferiority to onabotulinumtoxinA (Botox) at equivalent 20-unit doses with a 16-week follow-up. The clinical implication: a 1:1 unit conversion ratio. No protocol adjustment needed when switching.

The differences between Botulax and Botox lie in the manufacturing process, excipients and complexing proteins — not in the active neurotoxin itself. For practitioners, this means familiarity with Botox dosing translates directly to Botulax dosing.

100U vs 200U vs 300U: Which Format for Your Clinic

Inventory tip: Most clinics stock 100U as their standard format and keep 200U or 300U for high-volume days or body treatments. The larger formats deliver better per-unit pricing and reduce vial waste — but require sufficient patient flow to use the reconstituted product within 24 hours. Check Botulax 100U wholesale pricing →

Margin advantage: Botulax at wholesale pricing delivers the same clinical outcomes as premium Western brands at a significantly lower per-unit cost. Clinics switching from Botox to Botulax typically see a 40–50% reduction in product cost per treatment without changing any clinical protocols — directly improving treatment margins.

How Botulax Compares to Other Korean Toxins

All three are excellent products. The choice comes down to clinic workflow: Botulax for high-volume practices that benefit from the 300U format. Nabota for clinics that prioritise the FDA/Hi-Pure purity story. Innotox for clinics that want zero-reconstitution convenience. Many clinics stock two or all three to serve different patient and workflow needs. Browse all Korean BTX-A products →

The Letybo Connection: FDA-Approved Active Ingredient

On February 29, 2024, Hugel received US FDA approval for Letybo (letibotulinumtoxinA-wlbg, BLA 761225) for the temporary improvement of moderate to severe glabellar lines in adults. The approval was based on three clinical trials (BLESS I, II and III) involving 1,271 patients. Letybo is the sixth botulinum toxin to achieve FDA approval globally.

Letybo and Botulax share the same active ingredient from the same CBFC26 strain, manufactured in the same Hugel facility. Botulax is the international market brand name; Letybo is the US market brand name — the same model that Daewoong uses with Nabota (international) and Jeuveau (US).

What this means for clinic buyers: When purchasing Botulax, you’re sourcing a product whose active ingredient has passed the FDA’s rigorous approval process. This provides an additional layer of manufacturing quality confidence beyond the KFDA approval alone.

Frequently Asked Questions

Is Botulax the same as Botox?

Botulax uses the CBFC26 strain, whose toxin-encoding DNA is identical to the Hall strain used in Botox. The active neurotoxin is structurally the same, producing a 1:1 unit conversion. The differences are in excipients, manufacturing process and brand — not in the neurotoxin molecule itself.

Is Botulax FDA approved?

Botulax is KFDA (MFDS) approved in Korea and exported to 22+ countries. Hugel’s botulinum toxin type A also received US FDA approval in 2024 under the brand name Letybo. The active ingredient (letibotulinumtoxinA) is the same; Botulax is the international market name, Letybo is the US market name.

What sizes does Botulax come in?

100U, 200U and 300U vials. The 300U format is unique among Korean toxins and designed for high-volume clinics — allowing multi-patient use from a single reconstitution, improving unit economics and reducing preparation time.

How long does Botulax last?

Effects onset within 24–72 hours, peak at approximately 14 days, and last 4–6 months. This is consistent with other BTX-A products using the same 900 kDa complex type. Duration varies with treatment area, muscle mass and individual metabolism.

How does Botulax compare to Nabota and Innotox?

All three are quality Korean BTX-A products. Botulax offers the widest format range (up to 300U) for high-volume practices. Nabota offers Hi-Pure Technology for maximum purity. Innotox offers liquid formulation for zero-reconstitution convenience. Many clinics stock multiple brands to match different workflow needs.

Disclosure: FillersFairy is a wholesale supplier of Botulax and other aesthetic products. This article is for educational purposes only and does not constitute medical advice.

References

1. FDA Drug Trials Snapshots: LETYBO. Approval date February 29, 2024. BLA 761225. fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-letybo.
2. Hugel Inc. “Hugel Receives FDA Approval in the United States of Letybo.” PRNewswire. March 4, 2024.
3. BLESS II Clinical Trial Protocol (NCT02677805). CBFC26 strain genomic identity to Hall strain A ATCC 3502. clinicaltrials.gov.
4. BLESS III Clinical Trial Protocol (NCT04763265). Same CBFC26 strain characterisation. clinicaltrials.gov.
5. Nestor MS, et al. “An Update on Neurotoxin Products and Administration Methods.” MDedge Dermatology. Phase 3 noninferiority data, 272 participants.
6. FillersFairy product specifications. Botulax 100U/300U. MFDS Approval No. 3-48905.