Letybo (letibotulinumtoxinA) is a newer botulinum toxin type A formulation developed by Hugel, a South Korean biopharmaceutical company. It joins a growing list of botulinum neurotoxin serotype A (BoNT-A) products used in aesthetic and therapeutic medicine. The primary competitors of Letybo include onabotulinumtoxinA (Botox®), abobotulinumtoxinA (Dysport®), incobotulinumtoxinA (Xeomin®), and prabotulinumtoxinA (Jeuveau®). The following is a comparative analysis based on current scientific literature and available clinical data:
1. Molecular Composition & Formulation
| Product | Active Ingredient | Complexing Proteins | Manufacturing Origin |
|---|---|---|---|
| Letybo | LetibotulinumtoxinA | Yes (similar to Botox) | Hugel (South Korea) |
| Botox | OnabotulinumtoxinA | Yes (900 kDa complex) | Allergan (AbbVie) |
| Dysport | AbobotulinumtoxinA | Yes (500–900 kDa complex) | Ipsen/Galderma |
| Xeomin | IncobotulinumtoxinA | No (naked toxin) | Merz |
| Jeuveau | PrabotulinumtoxinA | Yes | Evolus (Daewoong) |
Implication: The presence of complexing proteins may affect immunogenicity and diffusion, although clinical relevance is still debated. Letybo is structurally similar to Botox, both being 900 kDa complexes.
2. Potency and Dose Equivalence
Letybo’s units are not bioequivalent to other BoNT-As on a 1:1 basis, but early studies suggest its clinical potency is comparable to Botox when administered at equal unit doses.
| Product | Approximate Conversion Ratio to Botox |
|---|---|
| Letybo | 1:1 (preliminary clinical data) |
| Dysport | ~2.5–3:1 |
| Xeomin | 1:1 |
| Jeuveau | 1:1 |
3. Clinical Efficacy
Most studies on Letybo focus on glabellar line treatment, with Phase III trials conducted in Asian and, more recently, European populations.
- Efficacy Onset: Similar to Botox (2–3 days).
- Peak Effect: 1–2 weeks post-injection.
- Duration: ~12–16 weeks (comparable to Botox and Jeuveau).
Head-to-head data comparing Letybo with Botox or other agents in diverse populations (especially non-Asian) are currently limited. A Korean Phase III study (Lee et al., Dermatol Ther, 2021) found non-inferiority to Botox for glabellar lines at week 4.
4. Safety and Adverse Event Profile
Letybo has shown a favorable safety profile consistent with other BoNT-As in trials. No unique adverse effects have been reported.
| Common AEs | All Products (Including Letybo) |
|---|---|
| Headache | Yes |
| Eyelid ptosis | Yes |
| Local injection site reactions | Yes |
5. Immunogenicity
Theoretically, toxins without complexing proteins (e.g., Xeomin) might have lower antigenicity, but clinically relevant immunogenicity remains low across all BoNT-As when used in aesthetic doses. No long-term data yet confirm differences in neutralizing antibody development for Letybo.
6. Regulatory & Market Access
- Letybo: Approved in South Korea, China, Canada, and EU (2022). FDA approved (2024) in the U.S.
- Botox/Xeomin/Dysport/Jeuveau: All approved in U.S. and globally widespread.
7. Cost and Economic Consideration
Letybo has been marketed as a cost-effective alternative in regions like South Korea and China. Its competitive pricing may drive adoption, particularly in aesthetic markets sensitive to cost margins.
Conclusion
Letybo is a viable alternative to existing BoNT-A products with comparable efficacy, safety, and pharmacologic properties, particularly similar to Botox in terms of molecular weight and clinical onset/duration. However, due to its limited longitudinal data and fewer global head-to-head trials, particularly in diverse patient populations, broader clinical acceptance (especially in Western markets) may depend on further robust, comparative trials and real-world experience.
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