DaxibotulinumtoxinA
Identification
- Summary
DaxibotulinumtoxinA is a botulinum toxin used to treat glabellar lines and cervical dystonia in adults.
- Brand Names
- Botox, Botox Cosmetic, Daxxify, Dysport, Jeuveau, Xeomin
- Generic Name
- DaxibotulinumtoxinA
- DrugBank Accession Number
- DB17929
- Background
DaxibotulinumtoxinA is an acetylcholine release inhibitor and neuromuscular blocking agent. It is a botulinum toxin without accessory proteins purified from the bacterium Clostridium botulinum type A,4 the gram-positive anaerobic bacterium primarily present in soil. C. botulinum is known to produce toxins that can cause botulism in humans.1,5
DaxibotulinumtoxinA was first approved by the FDA on September 8, 2022, for the temporary improvement of glabellar lines.6 On August 14, 2023, the drug was also approved for the treatment of cervical dystonia.7 DAXI or DAXXIFY, a product of daxibotulinumtoxinA, incorporates RTP004, a proprietary synthetic stabilizing peptide for enhanced product stability.2,3
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- 150000.0 Da (approximate)
- Sequences
- Not Available
- Synonyms
- Not Available
- External IDs
- RT002
- RTI150
Pharmacology
- Indication
DaxibotulinumtoxinA is 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. It is also used for the treatment of cervical dystonia in adult patients.4
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Management of Dystonia, cervical •••••••••••• ••••• Management of Moderate glabellar frown lines (gl) •••••••••••• ••••• Management of Severe glabellar frown lines (gl) •••••••••••• ••••• - Contraindications & Blackbox Warnings
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- Pharmacodynamics
DaxibotulinumtoxinA is a neuromuscular blocking agent that causes partial paralysis at the injection site.1 In clinical studies, daxibotulinumtoxinA was shown to reduce the appearance of frown lines and ameliorate neck spasms in cervical dystonia. DaxibotulinumtoxinA had a median effect duration of 24 weeks and its effects lasted up to six months.2
- Mechanism of action
DaxibotulinumtoxinA blocks neuromuscular transmission at the neuromuscular junction by binding to glycoprotein structures on cholinergic presynaptic nerve terminals, inhibiting the pre-synaptic release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a soluble N-ethylmaleimide-sensitive factor attachment receptor protein. SNAP-25 facilitates the docking and release of synaptic vesicle membrane contents, such as acetylcholine, within nerve endings. Recovery of neurotransmission occurs gradually as the neuromuscular junction recovers from SNAP25 cleavage and as new nerve endings are formed.4 Inhibition of acetylcholine release is reversible; however, the duration of action of daxibotulinumtoxinA decreases as there is a subsequent reduction in neurotransmitter release at the neuromuscular junction. This leads to decreased muscular contractions near the injection site.1,5
- Absorption
Using currently available analytical technology, it is not possible to detect daxibotulinumtoxinA in the peripheral blood following intramuscular injection at the recommended dose.4 Botulinum toxins are predominantly absorbed at the injection site.5
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
Botulinum toxins may be degraded by circulating proteases or dislodged and transported via the bloodstream to the liver for cleavage and conjugation.5
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
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- Toxicity
There is limited information regarding acute toxicity (LD50) of daxibotulinumtoxinA. The estimated human LD50 of botulinum toxins falls ranges from 1 to 3 ng/kg.5
Excessive doses of daxibotulinumtoxinA may produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. In the event of an overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment may be necessary. Symptoms of overdose are not likely to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis. The antitoxin raised against botulinum toxin may be requested through the Centers for Disease Control and Prevention (CDC) in the US; however, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.4
- 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 DaxibotulinumtoxinA is combined with Acetyldigitoxin. Aclidinium Aclidinium may increase the neuromuscular blocking activities of DaxibotulinumtoxinA. Amantadine Amantadine may increase the neuromuscular blocking activities of DaxibotulinumtoxinA. Amikacin Amikacin may increase the neuromuscular blocking activities of DaxibotulinumtoxinA. Amitriptyline Amitriptyline may increase the neuromuscular blocking activities of DaxibotulinumtoxinA. - 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 Botox Injection, powder, lyophilized, for solution 100 [USP'U]/1 Intradermal; Intramuscular Allergan, Inc. 1989-12-15 Not applicable US Botox Injection, powder, lyophilized, for solution 200 [USP'U]/1 Intradermal; Intramuscular Allergan, Inc. 2010-01-11 Not applicable US BOTOX Cosmetic Injection, powder, lyophilized, for solution 100 [USP'U]/1 Intramuscular Allergan, Inc. 2008-05-20 Not applicable US BOTOX Cosmetic Injection, powder, lyophilized, for solution 50 [USP'U]/1 Intramuscular Allergan, Inc. 2008-07-15 Not applicable US Daxxify Injection, powder, lyophilized, for solution 100 U/1.2mL Intramuscular Revance Therapeutics, Inc. 2022-09-20 Not applicable US
Categories
- ATC Codes
- M03AX01 — Botulinum toxin
- 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
- Not Available
Chemical Identifiers
- UNII
- E211KPY694
- CAS number
- 93384-43-1
References
- General References
- Mussarat A, Mustafa MS, Azam ST, Nafees Uddin MM, Nasrullah RMU, Siddiq MA: DAXI (DaxibotulinumtoxinA) - An Innovative Approach for Frown Lines. Int J Gen Med. 2023 Apr 10;16:1267-1269. doi: 10.2147/IJGM.S406563. eCollection 2023. [Article]
- Solish N, Carruthers J, Kaufman J, Rubio RG, Gross TM, Gallagher CJ: Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs. 2021 Dec;81(18):2091-2101. doi: 10.1007/s40265-021-01631-w. Epub 2021 Nov 17. [Article]
- Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG: DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29. [Article]
- FDA Approved Drug Products: DAXXIFY (daxibotulinumtoxinA-lanm) for injection, for intramuscular use (August 2023) [Link]
- StatPearls: DaxibotulinumtoxinA-Ianm [Link]
- Fierce Pharma; With long-awaited FDA nod, Revance set to take on AbbVie's Botox with its longer-lasting Daxxify [Link]
- Business Wire: U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia [Link]
- External Links
- 2612452
- Wikipedia
- Botulinum_toxin
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Not Yet Recruiting Treatment Benign Essential Blepharospasm / Hemifacial Spasm 1 4 Recruiting Treatment Aging 1 3 Completed Treatment Cervical Dystonia 2 3 Completed Treatment Glabellar Frown Lines (GL) 3 2 Completed Treatment Frown Lines 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Intradermal; Intramuscular 100 [USP'U]/1 Injection, powder, lyophilized, for solution Intradermal; Intramuscular 200 [USP'U]/1 Injection, powder, lyophilized, for solution Intramuscular 100 [USP'U]/1 Injection, powder, lyophilized, for solution Intramuscular 50 [USP'U]/1 Injection, powder, lyophilized, for solution Intramuscular 100 U/1.2mL Injection, powder, lyophilized, for solution Intramuscular 300 U/1 Injection, powder, lyophilized, for solution Intramuscular 500 U/1 Powder Intramuscular 100 [USP'U]/1 Injection, powder, lyophilized, for solution Intramuscular 200 [USP'U]/1 - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at June 24, 2023 04:26 / Updated at December 06, 2023 04:53