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botulinum toxin Type A (12 U)
botulinum toxin Type A (12 U) is a Biologic drug developed by Allergan. It is currently in Phase 3 development. Also known as: BOTOX®.
Botulinum toxin Type A works by blocking the release of acetylcholine, a neurotransmitter that causes muscle contraction.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | botulinum toxin Type A (12 U) |
|---|---|
| Also known as | BOTOX® |
| Sponsor | Allergan |
| Modality | Biologic |
| Phase | Phase 3 |
Mechanism of action
This results in temporary muscle paralysis, which can help alleviate symptoms of conditions such as blepharospasm and cervical dystonia. The toxin binds to the SNARE complex on the presynaptic neuron, preventing the release of acetylcholine into the synaptic cleft.
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults (PHASE3)
- A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults (PHASE3)
- Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin A Injection (NA)
- Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine (PHASE3)
- The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia (PHASE4)
- Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC) (PHASE4)
- Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial (PHASE4)
- Botulinum Toxin a Vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients with Multiple Sclerosis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- botulinum toxin Type A (12 U) CI brief — competitive landscape report
- botulinum toxin Type A (12 U) updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about botulinum toxin Type A (12 U)
What is botulinum toxin Type A (12 U)?
How does botulinum toxin Type A (12 U) work?
Who makes botulinum toxin Type A (12 U)?
Is botulinum toxin Type A (12 U) also known as anything else?
What development phase is botulinum toxin Type A (12 U) in?
Related
- Manufacturer: Allergan — full pipeline
- Also known as: BOTOX®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing