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Letybo LetbotulinumtoxinA
FDA-Approved 2023 Newest Neurotoxin

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LetbotulinumtoxinA | Hugel Pharma | Select Vial Size Below

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Letybo® 50U Single VialFDA-approved for glabellar lines - 50 units per vial
$239.00
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Letybo® 50U - 2-Vial PackTwo vials · treat two zones or two patients
$445.00
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Letybo® 50U - 5-Vial Practice PackBest value · $210.00/vial · ideal for high-volume practices
$1,050.00
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The newest FDA-approved neurotoxin Korean precision engineering meets rigorous US clinical validation

Letybo® (letbotulinumtoxinA) is manufactured by Hugel Inc., one of South Korea's leading biopharmaceutical companies. It received FDA approval in 2023, making it the most recently approved botulinum toxin type A on the US market. Hugel has over two decades of experience in botulinum toxin production, and Letybo's clinical profile demonstrates onset, duration, and efficacy comparable to established Type A neurotoxins, with a well-characterized safety profile across extensive global clinical trials.

  • FDA-approved 2023 the most recently cleared neurotoxin for glabellar line treatment
  • Proven globally Hugel has over 20 years of botulinum toxin manufacturing expertise
  • Comparable clinical outcomes onset, duration, and patient satisfaction matching legacy neurotoxins
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Also see: All Neurotoxins | Official info: Hugel Pharma

What Is Letybo®?

Letybo® (letbotulinumtoxinA) is a prescription botulinum toxin type A injectable developed by Hugel Inc. of South Korea. Hugel is a globally recognized manufacturer with more than 20 years of dedicated experience in botulinum toxin research, production, and quality assurance. Letybo received FDA approval in 2023, making it the most recently cleared neurotoxin for the temporary improvement in the appearance of moderate-to-severe glabellar lines in adults.

Letybo's global clinical program enrolled thousands of patients across Asia, Europe, and North America. US Phase 3 trials demonstrated a statistically significant improvement in glabellar line severity at rest and at maximum frown versus placebo. Responder rates, time to onset, and duration of effect were consistent with established neurotoxins, giving clinicians confidence in predictable outcomes.

Key Differentiators

  • Newest FDA-Approved Neurotoxin: Cleared in 2023 - reflecting the most current regulatory standards and clinical evidence requirements.
  • Global Track Record: Hugel's botulinum toxin products have been used by millions of patients worldwide before US entry, providing a robust real-world safety dataset.
  • Consistent Reconstitution Profile: Standard lyophilized formulation familiar to neurotoxin practitioners.
  • Competitive Pricing: Designed to give practices a cost-competitive option without compromising clinical quality.

Clinical Profile & Evidence Base

US Phase 3 Trial Highlights

  • Randomized, double-blind, placebo-controlled multicenter trial in US adults
  • Primary endpoint: 2-point or greater improvement in iGLA and sGLA at Week 4
  • Active group achieved statistically superior responder rates vs. placebo (p<0.001)
  • Onset observed as early as Day 3-7 in a substantial proportion of subjects
  • Duration maintained for up to 16-20 weeks in many subjects

Manufacturer Background

Hugel Inc. is headquartered in Chuncheon, South Korea, with GMP-certified manufacturing facilities. Hugel's botulinum toxin has been approved in over 60 countries, providing an extensive global safety database.

Safety Profile

Most common adverse reactions were headache and injection-site reactions. Eyelid ptosis reported at low rates consistent with or below comparator neurotoxins. No systemic safety signals identified in trial populations.

Contraindications

  • Infection at proposed injection site
  • Known hypersensitivity to botulinum toxin or formulation components
  • Pre-existing neuromuscular conditions (e.g., ALS, MG, Lambert-Eaton syndrome)

Dosing & Reconstitution

Reconstitution

Letybo® 50U is supplied as lyophilized powder reconstituted with sterile preservative-free 0.9% NaCl.

Diluent AddedUnits per 0.1 mL
1.0 mL5 U
2.0 mL2.5 U
2.5 mL2 U

FDA-Approved Indication

Temporary improvement in the appearance of moderate to severe glabellar lines in adults.

Approved Glabellar Dosing

20 units total across 5 injection points (procerus x1, corrugator supercilii x2 bilateral). 4 units per site at 0.1 mL with 2.5 mL reconstitution.

Sculptra NYC does not provide off-label dosing guidance. Clinicians should follow published consensus guidelines.

Frequently Asked Questions

Both are botulinum toxin type A but manufactured by different companies with different processes. Not interchangeable unit-per-unit. Clinical outcomes in comparative trials show similar efficacy and safety profiles.

Hugel's botulinum toxin has been marketed globally for over a decade in 60+ countries before the 2023 US FDA approval. The US represents US regulatory clearance, not a first-in-class debut.

Letybo® is commercially available in the US in a 50-unit single-use vial, consistent with approved glabellar line dosing and flexible for off-label practice protocols.

Store at 2C to 8C prior to reconstitution. Use within 24 hours of reconstitution. Do not freeze reconstituted product. Protect from light.

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Important Safety Information

INDICATIONS: Letybo® (letbotulinumtoxinA) is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adults.

CONTRAINDICATIONS: Letybo® is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any component of the formulation.

WARNINGS AND PRECAUTIONS - DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that the effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects, including asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. The risk is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly those patients who have underlying conditions predisposing them to these symptoms. Units of Letybo® are not interchangeable with other botulinum toxin products.

MOST COMMON ADVERSE REACTIONS: Headache, injection site reactions (bruising, erythema, pain), eyelid ptosis. Most events are mild to moderate in severity and transient.

References: 1. Letybo® US Prescribing Information, Hugel Inc., 2023. 2. FDA BLA 761282.