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 · Approved1991-12-09 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.
76,740 reports in total, 14,947 marked serious.
- Drug ineffective26,602
- Off label use11,542
- Therapeutic response decreased4,511
- Headache4,083
- Product preparation error3,647
- Injection site pain3,439
- Eyelid ptosis3,129
- Multiple use of single-use product2,857
- Migraine2,351
- Nausea2,181
Trials
Key trials
Large trials with a reported result on their main goal.
- Botulinum toxin type a, phase 3
Completed · Phase 3 · MS (type not specified) · Main goal met
Running now
- ICE Trial
Ongoing (inferred) · Phase 4 · MS (type not specified) · ongoing
- Onabotulinumtoxina, phase 3
Ongoing · Phase 3 · MS (type not specified) · ongoing
Other trials (9)
Completed small trials, dose-finding studies and trials in other diseases.
- SEPTOX
Terminated · Phase 4 · MS (type not specified) · stopped_other
- Onabotulinumtoxina, phase 3
Completed · Phase 3 · Relapsing and progressive · no_result_found
- CONTENT2
Terminated · Phase 3 · MS (type not specified) · stopped_other
- CONTENT1
Terminated · Phase 3 · MS (type not specified) · stopped_other
- Onabotulinumtoxina
Completed · MS (type not specified) · Main goal met
- GAITOX
Completed · MS (type not specified) · no_result_found
- Botulinum toxin type a, phase 2
Completed · Phase 2 · MS (type not specified) · Main goal not met
- Botulinum toxin type a, phase 3
Completed · Phase 3 · MS (type not specified) · results_posted_no_test
- Onabotulinumtoxina, phase 3
Completed · Phase 3 · MS (type not specified) · no_result_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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