What is Botulax?

FDA Approved
Available in 63+ countries (including USA, Europe & China)
#1 toxin in South Korea for 8 consecutive years

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Botulax® contains the active ingredient, letibotulinumtoxinA (~900 kDa), derived from the Clostridium Botulinum CBFC26 strain
Powered by HUGEL's purification technology, Botulax® undergoes multiple purification processes to ensure its safety, potency, and high-quality standards, providing effective and optimal results for your patients.
Manufactured at an EU GMP-certified facility with:
- State-of-the-art facility that uses automated guided vehicle (AGV)
- Patented purification technology
- Strict quality control that inspects every vial

Watch Hugel Botulinum Toxin Manufacturing

Key Benefits

• Effectiveness and safety in mature patients
• High patient satisfaction rate
• Consistent potency as it goes through stricter quality control than required by global standards
• No history of antibody formation in clinical trials and pharmacovigilance
• Effective for men, who frequently present more difficult cases

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Indications

It’s important to note that the specific areas treated with Botulax may vary depending on individual needs and the recommendations of the healthcare professional administering the treatment.
  • 1 .

    Glabellar lines

  • 2 .

    Lateral canthal lines

  • 3 .

    Blepharospasm

  • 4 .

    Post-stroke upper limb spasticity

  • 5 .

    Dynamic equinus foot deformity in children with cerebral palsy

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Efficacy

BOTULAX DELIVERS GOLD STANDARD RESULTS:

  • 1

    Botulax®’s efficacy in the treatment of moderate to severe glabellar lines was confirmed in multiple non-inferiority studies with over 900 subjects in total reporting a numerically higher response rates in the Botulax® group comparing with OnabotulinumtoxinA Group
    Kim BJ, Kwon HH, Park SY, et al. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1761-7.

  • 2

    Botulax®’s efficacy in the treatment of glabellar lines was further highlighted in a randomized, placebo-controlled study conducted in Europe and the U.S with below results:
    - 94% response rate four weeks after treatment
    - 48.5% of subjects with severe glabellar lines before treatment showing no lines at week 4
    - 20 weeks duration of treatment effect
    Mueller DS, Prinz V, Adelglass J, et al. Aesthet Surg J. 2022 May;42(6):677-688.

  • 3

    Botulax® showed stronger performance in patient group of women between 35 and 50 years of age with below results:
    - 97.7% response rate four weeks after treatment
    - Mean duration of response of more than 19 weeks
    - Median time to onset of effect was two days, with almost one third of subjects reporting improvement within 24 hours
    Gold M, Taylor S, Mueller DS, et al. Aesthet Surg J Open Forum. 2024;6:ojae010. Published 2024 Feb 23.

  • 4

    Nonetheless, Botulax® was shown to be effective in men as well, having greater facial muscle mass than women:
    - 75.7% response rate at week 4, with more than half of the male subjects showing mild or no lines, as assessed by the investigator
    - 22.2% experienced a 1-point reduction only one day after treatment

Safety

Botulax®’s gold standard safety in the treatment of moderate to severe glabellar lines was confirmed in three randomized, placebo-controlled studies recently conducted in Europe and the U.S. with over 1,200 subjects in total.
- No serious adverse events were reported.
- No neutralizing antibodies found in any subject after treatment.
- Consistent safety profile maintained with repeated injections.
Kim BJ, Kwon HH, Park SY, et al. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1761-7.

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Dilution & Injection

• The recommended dose in treating glabellar lines is 20U divided into five intramuscular injections of 4U (0.1mL) each: two into each corrugator supercilii muscle and one into the procerus muscle.
• Given that, it is ideal to reconstitute Botulax® in a way that yields a concentration of 4 units per 0.1mL. Therefore:
- For Botulax® 50U, the recommended diluent volume is 1.25mL
- For Botulax® 100U, the recommended diluent volume is 2.5mL
- For Botulax® 200U, the recommended diluent volume is 5mL

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Botulax® should be refrigerated (2-8 °C) when stored or transported

Shelf life of unopened Botulax® is 36 months from the date of manufacture
Chemical and physical in-use stability of reconstituted Botulax® demonstrated for 24 hours at 2°C

Medica Group

About Hugel, Inc.

Established in 2001, HUGEL is a global biopharmaceutical company specialized in medical aesthetics.
HUGEL leads the botulinum toxin and hyaluronic filler categories in South Korea, and has presence in over 50 countries with high-quality aesthetics solutions.
Today, HUGEL is taking a bold leap forward to become a top-tier provider of health and beauty to clinicians and consumers around the world – to create value for a happy life.

Medica Group