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Botulinum toxin A (GSK1358820)
Botulinum toxin A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis.
Botulinum toxin A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis. Used for Cervical dystonia, Blepharospasm, Hemifacial spasm.
At a glance
| Generic name | Botulinum toxin A (GSK1358820) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Botulinum toxin |
| Target | SNAP-25 (synaptosome-associated protein of 25 kDa) |
| Modality | Small molecule |
| Therapeutic area | Neurology; Aesthetics |
| Phase | Phase 3 |
Mechanism of action
GSK1358820 is a recombinant botulinum toxin A that irreversibly cleaves SNAP-25, a protein essential for acetylcholine vesicle fusion and release. This prevents neuromuscular transmission, leading to localized muscle relaxation. The effect is temporary, typically lasting 3–4 months, after which nerve terminals regenerate and muscle function returns.
Approved indications
- Cervical dystonia
- Blepharospasm
- Hemifacial spasm
- Chronic migraine
- Spasticity
- Aesthetic/cosmetic indications (wrinkles, hyperhydrosis)
Common side effects
- Injection site pain or bruising
- Headache
- Muscle weakness or paralysis (off-target)
- Ptosis (eyelid drooping)
- Dry mouth or dysphagia
Key clinical trials
- Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity (PHASE3)
- Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder (PHASE3)
- A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity (PHASE3)
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity (PHASE3)
- Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity (PHASE3)
- A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity (PHASE3)
- Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus (PHASE3)
- GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis (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 A (GSK1358820) CI brief — competitive landscape report
- Botulinum toxin A (GSK1358820) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI