BLASINGLE-USEVIAL1 Generic Approved
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
BOTOX COSMETIC (onabotulinumtoxina) by AbbVie is acetylcholine release inhibitors [moa]. Approved for acetylcholine release inhibitor [epc]. First approved in 1991.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BOTOX COSMETIC is an injectable formulation of onabotulinumtoxinA, a neurotoxin that inhibits acetylcholine release at the neuromuscular junction. It is approved for temporary improvement of moderate to severe glabellar lines, crow's feet, and forehead lines in adults. The drug works by blocking nerve signals to facial muscles, causing temporary paralysis and smoothing of wrinkles.
LOE Approaching
As a category-defining product nearing loss of exclusivity, BOTOX COSMETIC teams are likely focused on defensive strategies, market share protection, and organizational optimization ahead of generic/biosimilar competition.
Mechanism of Action
Acetylcholine Release Inhibitors
Pharmacologic Class:
Acetylcholine Release Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)
Started Feb 2025
132 enrolled
Glabellar Lines
A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants
Started Jan 2025
150 enrolled
Forehead Lines
A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products
Started Jan 2025
130 enrolled
Facial Contouring
A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique
Started May 2024
0Ventral HerniaAbdominal Hernia
A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
Started Feb 2024
100 enrolled
Upper Facial Lines
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.