Onabotulinumtoxina
How it works: Treating relapses and symptoms →
Botox, Botox Cosmetic
EU: Approved nationally (not via EMA)US: FDA approved 1991
- Molecule type
- Unknown
- Mechanism (ChEMBL)
- Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor
- Targets
- Synaptosomal-associated protein 25
Approvals
- USBotox|Botox Cosmetic · Approved9 December 1991 Source
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
77,979 reports in total, 15,452 marked serious.
- Drug ineffective26,774
- Off label use11,721
- Therapeutic response decreased4,513
- Headache4,136
- Product preparation error3,646
- Injection site pain3,468
- Eyelid ptosis3,149
- Multiple use of single-use product2,866
- Migraine2,406
- Nausea2,247
Trials
Key trials
Large trials with a reported result on their main goal.
- Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of U
Completed · Phase 3 · MS (type not specified) · Met its main goal
Running now
- Cryoneurolysis to treat pain in the context of spasticity
Ongoing (inferred) · Phase 4 · MS (type not specified) · Still running
- Antibiotic strategy and asymptomatic bacteriuria in the context of int
Ongoing · Phase 3 · MS (type not specified) · Still running
Other trials (9)
Completed small trials, dose-finding studies and trials in other diseases.
- Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactiv
Terminated · Phase 4 · MS (type not specified) · Stopped
- Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated
Completed · Phase 3 · Relapsing and progressive · No results found
- Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neu
Terminated · Phase 3 · MS (type not specified) · Stopped
- Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neu
Terminated · Phase 3 · MS (type not specified) · Stopped
- Central Nervous System Changes Following OnabotulinumtoxinA Injection
Completed · MS (type not specified) · Met its main goal
- Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Tri
Completed · MS (type not specified) · No results found
- Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multi
Completed · Phase 2 · MS (type not specified) · Missed its main goal
- A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With
Completed · Phase 3 · MS (type not specified) · Results posted, not judged
- Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogen
Completed · Phase 3 · MS (type not specified) · No results found
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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