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Botulinum toxin type A injection
Botulinum toxin type A injection is a Neurotoxin; botulinum toxin preparation Small molecule drug developed by Hugel. It is currently FDA-approved for Cervical dystonia, Blepharospasm, Hemifacial spasm. Also known as: Botulax®, Botox® 100 U, Allergan Pharmaceuticals Westport, Ireland, Botox, onabotulinumtoxinA.
Botulinum toxin type A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis.
Botulinum toxin type A injections are used to treat various conditions, including cutaneous leiomyomas, high tone pelvic floor dysfunction, facial corrections, and facial lines. The injections are administered with or without EMG guidance to help manage these conditions.
At a glance
| Generic name | Botulinum toxin type A injection |
|---|---|
| Also known as | Botulax®, Botox® 100 U, Allergan Pharmaceuticals Westport, Ireland, Botox, onabotulinumtoxinA, BOTOX® |
| Sponsor | Hugel |
| Drug class | Neurotoxin; botulinum toxin preparation |
| Target | SNAP-25 (synaptosome-associated protein of 25 kDa) |
| Modality | Small molecule |
| Therapeutic area | Neurology; Aesthetics; Dermatology |
| Phase | FDA-approved |
Mechanism of action
The toxin irreversibly cleaves SNAP-25, a protein essential for acetylcholine vesicle fusion and release at motor nerve terminals. This prevents muscle contraction in the injected area, producing a temporary paralytic effect that lasts 3–4 months. The effect is reversible as the body gradually regenerates new nerve terminals and SNARE proteins.
Approved indications
- Cervical dystonia
- Blepharospasm
- Hemifacial spasm
- Glabellar lines (aesthetic)
- Crow's feet (aesthetic)
- Forehead lines (aesthetic)
- Chronic migraine
- Hyperhidrosis
- Spasticity
Common side effects
- Injection site pain or bruising
- Headache
- Eyelid ptosis
- Muscle weakness
- Neck pain
- Flu-like symptoms
Key clinical trials
- DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (PHASE1, PHASE2)
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- 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 (PHASE4)
- DaxibotulinumtoxinA for Blepharospasm (PHASE2)
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine (PHASE3)
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine (PHASE3)
- Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PHASE3)
- Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy (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 injection CI brief — competitive landscape report
- Botulinum toxin type A injection updates RSS · CI watch RSS
- Hugel portfolio CI
Frequently asked questions about Botulinum toxin type A injection
What is Botulinum toxin type A injection?
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What is Botulinum toxin type A injection used for?
Who makes Botulinum toxin type A injection?
Is Botulinum toxin type A injection also known as anything else?
What drug class is Botulinum toxin type A injection in?
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What does Botulinum toxin type A injection target?
Related
- Drug class: All Neurotoxin; botulinum toxin preparation drugs
- Target: All drugs targeting SNAP-25 (synaptosome-associated protein of 25 kDa)
- Manufacturer: Hugel — full pipeline
- Therapeutic area: All drugs in Neurology; Aesthetics; Dermatology
- Indication: Drugs for Cervical dystonia
- Indication: Drugs for Blepharospasm
- Indication: Drugs for Hemifacial spasm
- Also known as: Botulax®, Botox® 100 U, Allergan Pharmaceuticals Westport, Ireland, Botox, onabotulinumtoxinA, BOTOX®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing