LETYBO®

Why Injectors Choose LETYBO®

LETYBO® has FDA approval for moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in adults, supported by a phase 3 clinical program. [1] Hugel Inc. is the only Korean botulinum toxin manufacturer to hold regulatory approvals in the US, EU, and China simultaneously — a meaningful signal for injectors assessing a non-Allergan toxin type A option. LETYBO® is often used by injectors in a familiar dosing framework for glabellar lines, while recognizing that its potency units are product-specific and not interchangeable with those of BOTOX®, DYSPORT®, XEOMIN®, or any other botulinum toxin product. [1] For practices already working within established neuromodulator protocols, LETYBO® is more straightforward to evaluate than products that require a significantly different unit conversion.

Contact Med Supply Solutions About LETYBO®

Licensed healthcare professionals may contact the Med Supply Solutions support team for general information about LETYBO®, including sourcing considerations, product documentation, and availability-related inquiries.

What Is LETYBO® Used For?

LETYBO® is FDA-approved for the temporary improvement of moderate-to-severe glabellar lines caused by activity of the corrugator and/or procerus muscles in adults.[1] Its mechanism is consistent with other botulinum toxin type A products. The active component cleaves SNAP-25, which inhibits acetylcholine release at the neuromuscular junction and temporarily reduces activity in the injected muscles. In aesthetic practice, neuromodulators may also be used off-label for areas such as forehead lines, lateral canthal lines, brow elevation, masseter reduction, and platysmal bands. These treatments should be documented accordingly and considered in relation to the practitioner’s training, the patient’s anatomy, and any applicable local regulations.

LETYBO® vs BOTOX® and Other Neuromodulators

For injectors evaluating LETYBO®, the primary comparison is with the BOTOX® neuromodulator. Both are botulinum toxin type A products for glabellar-line treatment; BOTOX® is the long-established Allergan/AbbVie reference brand, while LETYBO® is Hugel's FDA-approved letibotulinumtoxinA-wlbg. The comparison for most practices turns on acquisition cost, handling, and injector familiarity — not on a meaningfully different clinical mechanism. Compared with the DYSPORT® neuromodulator, LETYBO® differs most notably in its product-specific unit system and reported diffusion characteristics. DYSPORT® uses a distinct dosing framework, while LETYBO® may feel more familiar to injectors accustomed to similar established protocols. Some practitioners also associate DYSPORT® with broader diffusion, which may be considered useful in selected treatment areas depending on the anatomy, indication, and injection technique. Compared with XEOMIN®, LETYBO® is a complexed formulation; XEOMIN® is free of complexing proteins, which some practitioners prefer where immunogenicity is a clinical consideration. Neither formulation approach has been shown to produce superior clinical outcomes. Across all comparisons: LETYBO® units are product-specific and must not be converted into units of any other botulinum toxin product. [1]

LETYBO® Product Range & Presentations

LETYBO® 50u and 100-unit single-dose vials are supplied as a lyophilized powder for reconstitution. The product is reconstituted with preservative-free 0.9% sodium chloride; final concentration should follow prescribing information and practitioner protocol. [1] LETYBO® is the US and EU designation; BOTULAX® is the Korean brand name used by Hugel for the same product family. Practitioners should verify the exact SKU, regional labeling, vial size, and product documentation relevant to their jurisdiction before use. Storage: refrigerate at 2°C–8°C and protect from light. Reconstituted product should be used within the timeframe specified in the prescribing information.

LETYBO® Safety Profile

The effects of all botulinum toxin products may spread from the injection site and produce symptoms consistent with botulism, including difficulty swallowing and breathing, which can be life-threatening. This warning applies to LETYBO® and all other botulinum toxin products regardless of indication or dose. [1] Common adverse reactions reported in clinical trials for glabellar-line treatments include headache, injection-site reactions, and eyelid ptosis. Class-related effects to counsel on include bruising, localized discomfort, asymmetry, and transient unwanted muscle weakness. Contraindications include known hypersensitivity to any botulinum toxin preparation or to any component of the formulation, and active infection at the proposed injection site. Patients with neuromuscular junction disorders — including myasthenia gravis and Lambert-Eaton syndrome — are at increased risk of clinically significant systemic effects and require particular caution. [1]

About LETYBO® (Hugel)

LETYBO® is manufactured by Hugel Inc., founded in 2001 and South Korea's largest botulinum toxin manufacturer. LETYBO® is distributed in the United States by Hugel America. Hugel holds regulatory approvals for its letibotulinumtoxinA product in over 35 countries, and the company states that it is the first Korean botulinum toxin manufacturer to hold approvals in the US, EU, and China simultaneously. BOTULAX® is the brand name Hugel uses in South Korea for a product in the same botulinum toxin family, while LETYBO® is the name used in the United States and European markets. This distinction is useful for practitioners who may encounter the product under different names depending on the market or supply chain.

LETYBO® Regulatory Status

The FDA approved LETYBO® (letibotulinumtoxinA-wlbg) on February 29, 2024, for the temporary improvement of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.[1] It joins BOTOX®, DYSPORT®, and XEOMIN® among the botulinum toxin type A products approved in the United States for this indication. LETYBO® is a prescription product intended for administration by licensed health care professionals trained in facial anatomy, reconstitution, injection technique, and the recognition and management of treatment-related complications.

FAQs

What is LETYBO® and who manufactures it?

LETYBO® is the brand name for letibotulinumtoxinA-wlbg, a botulinum toxin type A neuromodulator manufactured by Hugel Inc. The FDA approved it in February 2024 for the temporary improvement of moderate-to-severe glabellar lines in adults.[1]

How do LETYBO® units compare to BOTOX® units?

LETYBO® is often used by injectors in a familiar dosing framework for glabellar lines, but its potency units are product-specific and should not be converted to units of BOTOX®, DYSPORT®, XEOMIN®, or any other botulinum toxin product. [1]

How long do LETYBO® results last?

Onset and duration are consistent with botulinum toxin type A — typically within the first several days, with a duration of approximately 3–4 months, depending on patient response, dose, and treatment area.

How can licensed professionals obtain information about LETYBO®?

Licensed health care professionals can contact the Med Supply Solutions support team for general information about LETYBO®, including product details and documentation.

Citations and Resources

[1] FDA. LETYBO (letibotulinumtoxinA-wlbg) for injection, for intramuscular use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761225s000lbl.pdf. [2] HUGEL. https://www.hugel-inc.com/en/solution/brands For licensed healthcare professionals only. The content of this page is provided for informational purposes and does not constitute medical advice.