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botulinum toxin Type A (24 U)
botulinum toxin Type A (24 U) is a Neurotoxin Biologic drug developed by Allergan. It is currently in Phase 3 development for Focal spasticity in patients with upper limb spasticity due to stroke or cerebral palsy, Severe primary axillary hyperhidrosis. Also known as: BOTOX®.
Botulinum toxin Type A works by blocking the release of acetylcholine, a neurotransmitter that causes muscle contraction.
Botulinum toxin Type A works by blocking the release of acetylcholine, a neurotransmitter that causes muscle contraction. Used for Focal spasticity in patients with upper limb spasticity due to stroke or cerebral palsy, Severe primary axillary hyperhidrosis.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 (24 U) |
|---|---|
| Also known as | BOTOX® |
| Sponsor | Allergan |
| Drug class | Neurotoxin |
| Target | SNARE complex |
| Modality | Biologic |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
This results in temporary muscle paralysis, which can be used to treat a variety of conditions, including muscle spasms and excessive sweating. The toxin binds to the SNARE complex on the presynaptic neuron, preventing the release of acetylcholine into the synaptic cleft.
Approved indications
- Focal spasticity in patients with upper limb spasticity due to stroke or cerebral palsy
- Severe primary axillary hyperhidrosis
Common side effects
- Eyelid ptosis
- Diplopia
- Headache
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)
- Treatment of Hypertrophic Scars Using Fractional CO2 Laser Alone in Comparison With Adding Botulinum Toxin Either Through Intralesional Injection or Assisted Drug Delivery (NA)
- Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine (PHASE3)
- Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain (PHASE2)
- Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment (PHASE2, PHASE3)
- Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines (PHASE3)
- Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines (PHASE3)
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 (24 U) CI brief — competitive landscape report
- botulinum toxin Type A (24 U) updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about botulinum toxin Type A (24 U)
What is botulinum toxin Type A (24 U)?
How does botulinum toxin Type A (24 U) work?
What is botulinum toxin Type A (24 U) used for?
Who makes botulinum toxin Type A (24 U)?
Is botulinum toxin Type A (24 U) also known as anything else?
What drug class is botulinum toxin Type A (24 U) in?
What development phase is botulinum toxin Type A (24 U) in?
What are the side effects of botulinum toxin Type A (24 U)?
What does botulinum toxin Type A (24 U) target?
Related
- Drug class: All Neurotoxin drugs
- Target: All drugs targeting SNARE complex
- Manufacturer: Allergan — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Focal spasticity in patients with upper limb spasticity due to stroke or cerebral palsy
- Indication: Drugs for Severe primary axillary hyperhidrosis
- Also known as: BOTOX®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing