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LETYBO (LETIBOTULINUMTOXINA-WLBG)
LETYBO (generic name: LETIBOTULINUMTOXINA-WLBG) is a Acetylcholine Release Inhibitor [EPC] drug developed by HUGEL INC. It is currently FDA-approved.
At a glance
| Generic name | LETIBOTULINUMTOXINA-WLBG |
|---|---|
| Sponsor | HUGEL INC |
| Drug class | Acetylcholine Release Inhibitor [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 [see Warnings and Precautions ( 5.1 )] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. 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. ( 5.1 )
Common side effects
- Headache
- Injection site reactions
- Eyelid ptosis
- Brow ptosis/brow heaviness
- Administrative site swelling
- Facial pain
- Folliculitis
- Periorbital hematoma
- Injection site bruising
- Injection site pain
- Injection site hematoma
- Injection site nodule
Serious adverse events
- Anti-drug antibody formation
- Spread of toxin effects
- Hypersensitivity reactions
Key clinical trials
- A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Extended Periorbital Rejuvenation Procedure (N/A)
- Head-to-Head Comparison of the Efficacy and Safety of All Five Commercially Available Botulinum Neurotoxin Type A Products for the Treatment of Glabellar Rhytides: A Multicenter, Triple-Blind, Randomi (Phase 4)
- A Prospective, Non-interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A (N/A)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LETYBO CI brief — competitive landscape report
- LETYBO updates RSS · CI watch RSS
- HUGEL INC portfolio CI
Frequently asked questions about LETYBO
What is LETYBO?
LETYBO (LETIBOTULINUMTOXINA-WLBG) is a Acetylcholine Release Inhibitor [EPC] drug developed by HUGEL INC.
Who makes LETYBO?
LETYBO is developed and marketed by HUGEL INC (see full HUGEL INC pipeline at /company/hugel-inc).
What is the generic name of LETYBO?
LETIBOTULINUMTOXINA-WLBG is the generic (nonproprietary) name of LETYBO.
What drug class is LETYBO in?
LETYBO belongs to the Acetylcholine Release Inhibitor [EPC] class. See all Acetylcholine Release Inhibitor [EPC] drugs at /class/acetylcholine-release-inhibitor-epc.
What development phase is LETYBO in?
LETYBO is FDA-approved (marketed).
What are the side effects of LETYBO?
Common side effects of LETYBO include Headache, Injection site reactions, Eyelid ptosis, Brow ptosis/brow heaviness, Administrative site swelling, Facial pain. Serious adverse events: Anti-drug antibody formation, Spread of toxin effects, Hypersensitivity reactions.
Related
- Drug class: All Acetylcholine Release Inhibitor [EPC] drugs
- Manufacturer: HUGEL INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing