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Uncomplicated Partnership.
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LetibotulinumtoxinA - the active ingredient
#1
1
#1 in South Korea
65+
2
Approved in 65+ countries
31M
3
Over 31M vials sold worldwide
Proven Results
See real results
*Actual Patients, Individual results may vary
Before
4 Weeks
16 Weeks
RELIABLE OUTCOMES VALIDATED IN EXTENSIVE CLINICAL STUDIES
5
Responder Rates
≥2
GRADE IMPROVEMENT
Composite Responder Rate at Week 4
65%
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from baseline and achieving a composite score of None or Mild
on the Glabellar Line Scale score
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79%
per investigator assessment
vs 1% for placebo
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69%
per subject assessment
vs 0% for placebo
In other studies, Letybo® met the primary endpoint composite responder rate at 47% and 45%
1. *Proportion of subjects achieving score of 0 or 1 (none or mild) and ≥2 grade improvement from baseline at maximum frown at Week 4, as assessed independently by both investigator and subject on the Glabellar Line Scale (GLS), a 4-point grading scale (0=none, 1=mild, 2=moderate, 3=severe) Study subjects (with moderate to severe glabellar lines at maximum frown at baseline) received either 20 units Letybo or an equal volume of placebo.
Efficacy demonstrated in 3 international phase III trials: identically designed, randomized, multi center, double blind, placebo-controlled studies.
Primary Endpoint From Bless III
ESTABLISHED SAFETY PROFILE
4
0.5%
RATE OF EYELID PTOSIS
0 Neutralizing antibodies detected in clinical studies, including repeat treatments
Backed by extensive BLESS clinical studies
Adverse Reaction | Letybo® Bless I, II, III N=911 n=(%) | Placebo Bless I, II, III N=310 n=(%) |
|---|---|---|
Headache* | 17 (2%) | 2 (1%) |
Brow Ptosis** | 3 (1%) | 0 |
Eyelid Ptosis | 3 (1%) | 0 |
Blepharospasm | 2 (1%) | 0 |
Over 1,200 patients across 31 study centers
* Includes headache, head discomfort, migraine, and procedural headache.
** Includes brow ptosis and brow heaviness.
Letybo Prescribing Information
Please see additional safety information below
RAPID, CONSISTENT TIME TO ONSET
5
Secondary Endpoint In Bless III
Patients Reported ≥1 Point Improvement
Letybo may start to work as early as day 1 and typically within 3 days
3. Subjects assessed the onset of a ≥1 improvement daily for two weeks post-treatment, recording their findings in a diary. Subject diaries provide valuable patient-reported data and highlight patient-centricity in study design. The data have limitations influenced by subjective perception, recall bias, and variability in self-reporting. Generally, these factors limit precision when compared to objective clinical measures and assessments.
5. Mueller DS, Prinz V, Adelglass J, Cox SE, Gold MH, et al. Efficacy and safety of letibotulinumtoxin A in the treatment of glabellar lines: a randomized, double-blind, multicenter, placebo-controlled phase 3 study. ASJ. 2022:42(6):677-688. doi:10.1093/asj/sjac019
WITH EFFECTS LASTING UP TO 16 WEEKS
5
Secondary Endpoint In Bless III
Time to re-treatment was approximately 4 months - consistent with most practitioners' treatment schedule
3. †Exploratory analysis; based on subjects’ diary data In BLESS III, duration of treatment was defined as the time point at which a statistically significant difference of responder rate still existed between the active treatment group and placebo.
5. Mueller DS, Prinz V, Adelglass J, Cox SE, Gold MH, et al. Efficacy and safety of letibotulinumtoxin A in the treatment of glabellar lines: a randomized, double-blind, multicenter, placebo-controlled phase 3 study. ASJ. 2022:42(6):677-688. doi:10.1093/asj/sjac019
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WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of all botulinum toxin products, including Letybo, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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. Letybo is not approved for the treatment of spasticity or any conditions other than glabellar lines.
INDICATION
Letybo (letibotulinumtoxinA-wlbg) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Letybo contraindications include known hypersensitivity to any botulinum toxin preparation or to any of the components in the Letybo formulation and infection at the injection site.
WARNINGS AND PRECAUTIONS
Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur. The potency Units of Letybo are not interchangeable with other preparations of botulinum toxin products. Potential serious adverse reactions after Letybo injections for unapproved uses. If a hypersensitivity reaction occurs, discontinue Letybo and immediately initiate appropriate therapy. Adverse reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. Use with caution in patients with compromised respiratory function or dysphagia.
ADVERSE REACTIONS
The most common adverse reaction was headache (2%).
DRUG INTERACTIONS
Co-administration of Letybo and aminoglycosides, anticholinergic agents, or any other agents that interfere with neuromuscular transmission may potentiate the effect of Letybo; co-administer only with caution and close observation.
USE IN SPECIFIC POPULATIONS
Letybo is not recommended for use in children, pregnant or lactating women.
Please see Letybo full Prescribing Information, including Boxed Warning and Medication Guide at bit.ly/3UbRZtP
REFERENCES
1. Based on total reported revenue 2016-2024. Data on file.
2. Data on file. List of approved countries. Hugel, Inc.; 2023.
3. Data on file. Total toxin sales 2010-2022. Hugel; February 23, 2023.
4. Letybo Prescribing Information. bit.ly/3UbRZtP
5. Mueller DS, Prinz V, Adelglass J, Cox SE, Gold MH, et al. Efficacy and safety of letibotulinumtoxin A in the treatment of glabellar lines: a randomized, double-blind, multicenter, placebo-controlled phase 3 study. ASJ. 2022:42(6):677-688. doi:10.1093/asj/sjac019
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To report Adverse Events with Letybo:
Please Call 877-390-2906 or Email HugelAesthetics.sm@druginfo.com
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Important Safety Information for Letybo - LetibotulinumtoxinA
The effects of all botulinum toxin products, including Letybo, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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. Letybo is not approved for the treatment of spasticity or any conditions other than glabellar lines. Read More