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Dysport (R)
Dysport (R) is a Botulinum toxin type A Small molecule drug developed by Department of Medical Services Ministry of Public Health of Thailand. It is currently in Phase 3 development for Cervical dystonia, Blepharospasm, Hemifacial spasm.
Dysport is a botulinum toxin type A preparation that blocks acetylcholine release at the neuromuscular junction, causing temporary muscle paralysis.
Dysport is a botulinum toxin type A preparation that blocks acetylcholine release at the neuromuscular junction, causing temporary muscle paralysis. Used for Cervical dystonia, Blepharospasm, Hemifacial spasm.
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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 | Dysport (R) |
|---|---|
| Sponsor | Department of Medical Services Ministry of Public Health of Thailand |
| Drug class | Botulinum toxin type A |
| Target | SNARE complex (synaptosome-associated protein) |
| Modality | Small molecule |
| Therapeutic area | Neurology, Aesthetics, Movement Disorders |
| Phase | Phase 3 |
Mechanism of action
Dysport contains botulinum toxin type A, which cleaves SNARE proteins required for acetylcholine vesicle fusion and release. This prevents neuromuscular transmission, leading to temporary paralysis of injected muscles. The effect is reversible as the body gradually regenerates the cleaved proteins over several months.
Approved indications
- Cervical dystonia
- Blepharospasm
- Hemifacial spasm
- Glabellar lines (aesthetic indication)
- Spasticity associated with stroke or cerebral palsy
Common side effects
- Injection site pain or bruising
- Headache
- Muscle weakness or paralysis (off-target)
- Ptosis (eyelid drooping)
- Dry mouth
- Flu-like symptoms
Key clinical trials
- Botulinum Toxin Injection in the UES for R-CPD (PHASE4)
- Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain (PHASE2)
- Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC) (NA)
- Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome (PHASE4)
- Evaluation of Efficacy and Patient Satisfaction of Local Anaesthesia Versus Sedoanalgesia for Botox (R) Injection in the Urinary Bladder for the Treatment of Idiopathic Overactive Bladder (NA)
- Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients. (NA)
- Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia (PHASE3)
- OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER (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:
- Dysport (R) CI brief — competitive landscape report
- Dysport (R) updates RSS · CI watch RSS
- Department of Medical Services Ministry of Public Health of Thailand portfolio CI
Frequently asked questions about Dysport (R)
What is Dysport (R)?
How does Dysport (R) work?
What is Dysport (R) used for?
Who makes Dysport (R)?
What drug class is Dysport (R) in?
What development phase is Dysport (R) in?
What are the side effects of Dysport (R)?
What does Dysport (R) target?
Related
- Drug class: All Botulinum toxin type A drugs
- Target: All drugs targeting SNARE complex (synaptosome-associated protein)
- Manufacturer: Department of Medical Services Ministry of Public Health of Thailand — full pipeline
- Therapeutic area: All drugs in Neurology, Aesthetics, Movement Disorders
- Indication: Drugs for Cervical dystonia
- Indication: Drugs for Blepharospasm
- Indication: Drugs for Hemifacial spasm
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing