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Identification
- Summary
LetibotulinumtoxinA is a purified type A botulinum neurotoxin protein complex used to improve the appearance of glabellar lines.
- Generic Name
- LetibotulinumtoxinA
- DrugBank Accession Number
- DB16820
- Background
The aesthetic utility of botulinum toxin was discovered incidentally following its initial use in the treatment of facial spasmodic disorders in the early 1970s.1 The first aesthetic use of botulinum toxin was reported in 1989, when onabotulinumtoxinA (Botox) was used as a treatment for facial asymmetry resulting from iatrogenic facial nerve damage.1 It was subsequently approved by the FDA in 1992 for use in aesthetic procedures and has since become one of the most popular cosmetic procedures worldwide.1
LetibotulinumtoxinA is a type A botulinum neurotoxin produced from fermentation of Clostridium botulinum strain CBFC26.2 It is a 900 kDa multimeric complex comprising a 150 kDa toxin, a 130 kDa non-toxic non-haemagglutinating protein, and various other haemagglutinins.2 LetibotulinumtoxinA has been a market-leading cosmetic product in South Korea for a number of years and was subsequently approved in the European Union.3 It was approved for use in the treatment of glabellar lines in Canada in June 20222,3 and in the US in March 2024.5,6
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- BoNT/A-DS
- Letibotulinumtoxina
Pharmacology
- Indication
LetibotulinumtoxinA is indicated for the temporary improvement of the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients ≤65 years of age.2,6
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Management of Moderate to severe glabellar lines •••••••••••• ••••• •••••••••• ••••••• ••• •••••••• Management of Moderate to severe glabellar lines •••••••••••• ••••• •••••••••• ••••••• ••• •••••••• - Contraindications & Blackbox Warnings
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The intramuscular injection of botulinum neurotoxin results in a dose-related muscle weakness resulting from the irreversible blockade of acetylcholine release from pre-synaptic vesicles.2
- Mechanism of action
LetibotulinumtoxinA, like other botulinum toxins, exerts its therapeutic effects via action directly on motor neurons.4 The toxin heavy chain mediates binding to surface receptors on nerve endings, after which the toxin is internalized via receptor-mediated endocytosis.2 The toxin light chain is subsequently translocated into the cytosol where it cleaves SNAP25,2,4 a cytosolic protein that forms a portion of the SNARE complex involved in vesicle fusion prior to exocytosis. The cleavage of SNAP25 prevents the formation of the SNARE complex, which subsequently prevents the exocytosis of acetylcholine into the neuromuscular junction, thereby inducing flaccid paralysis of the affected muscle(s).2
Target Actions Organism ASynaptosomal-associated protein 25 cleavageHumans - Absorption
Pharmacokinetic studies of letibotulinumtoxinA are not feasible due to an extremely high affinity for its pre-synaptic cholinergic binding sites - as affinity is in the picomolar range, no detectable amount of toxin appears in the blood following administration.2
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
As with other exogenously administered proteins, letibotulinumtoxinA is expected to undergo non-specific enzymatic degradation to smaller peptides and amino acids.2
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
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Overdosage of letibotulinumtoxinA is likely to result in excessive neuromuscular weakness with a variety of associated symptoms. Patients should be monitored closely in the event of an overdose, and may require respiratory support if respiratory paralysis occurs.2
Symptoms of overdosage are not likely to be present immediately following injection, and patients should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.2
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAcetyldigitoxin The risk or severity of Cardiac Arrhythmia can be increased when Letibotulinumtoxina is combined with Acetyldigitoxin. Atracurium The risk or severity of neuromuscular blockade can be increased when Atracurium is combined with Letibotulinumtoxina. Atracurium besylate The risk or severity of neuromuscular blockade can be increased when Atracurium besylate is combined with Letibotulinumtoxina. Baclofen The therapeutic efficacy of Letibotulinumtoxina can be increased when used in combination with Baclofen. Beclomethasone dipropionate The risk or severity of myopathy and weakness can be increased when Letibotulinumtoxina is combined with Beclomethasone dipropionate. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Letybo Injection, powder, lyophilized, for solution 100 U/1 Intramuscular Hugel, Inc. 2024-07-30 Not applicable US 
Letybo Powder, for solution 50 unit / vial Intramuscular Croma Aesthetics Canada, Ltd. Not applicable Not applicable Canada 
Letybo Injection, powder, lyophilized, for solution 50 U/1 Intramuscular Hugel, Inc. 2024-07-30 Not applicable US Letybo Powder, for solution 100 unit / vial Intramuscular Croma Aesthetics Canada, Ltd. 2023-06-20 Not applicable Canada
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- W5O50S8A59
- CAS number
- 1800016-51-6
References
- General References
- Gart MS, Gutowski KA: Overview of Botulinum Toxins for Aesthetic Uses. Clin Plast Surg. 2016 Jul;43(3):459-71. doi: 10.1016/j.cps.2016.03.003. Epub 2016 May 4. [Article]
- Health Canada Product Monograph: Letybo (letibotulinumtoxinA) powder for solution for intramuscular injection [Link]
- BusinessWire: Croma Aesthetics Canada Ltd. Receives Canadian Market Authorization for Letybo (LetibotulinumtoxinA for Injection) for the Treatment of Glabellar Lines [Link]
- Botox Medical: BOTOX Mechanism of Action [Link]
- BioSpace: Hugel Receives FDA Approval in the United States of Letybo (letibotulinumtoxinA-wlbg) for Injection for the Treatment of Glabellar Lines [Link]
- FDA Approved Drug Products: Letybo (letibotulinumtoxinA-wlbg) for intramuscular injection [Link]
- External Links
- 2689280
- Wikipedia
- Botulinum_toxin
Clinical Trials
- Clinical Trials
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Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Intramuscular 100 U/1 Injection, powder, lyophilized, for solution Intramuscular 50 U/1 Powder, for solution Intramuscular 100 unit / vial Powder, for solution Intramuscular 50 unit / vial - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Cleavage
- General Function
- t-SNARE involved in the molecular regulation of neurotransmitter release. May play an important role in the synaptic function of specific neuronal systems. Associates with proteins involved in vesicle docking and membrane fusion. Regulates plasma membrane recycling through its interaction with CENPF. Modulates the gating characteristics of the delayed rectifier voltage-dependent potassium channel KCNB1 in pancreatic beta cells
- Specific Function
- Calcium-dependent protein binding
- Gene Name
- SNAP25
- Uniprot ID
- P60880
- Uniprot Name
- Synaptosomal-associated protein 25
- Molecular Weight
- 23314.905 Da
References
- Health Canada Product Monograph: Letybo (letibotulinumtoxinA) powder for solution for intramuscular injection [Link]
Drug created at July 04, 2022 18:22 / Updated at March 29, 2024 06:25