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Neuronox
Neuronox is a Small molecule drug developed by Medy-Tox. It is currently in Phase 3 development. Also known as: Meditoxin, Clostridium Botulinum Toxin A 100 U, Botulinum Toxin Type A for injection, Neuronox ® 50 unit or 100 unit.
Neuronox is a botulinum toxin type A, classified as a hydrolytic enzyme that targets synaptosomal-associated protein 25 (SNAP-25). It has been studied for various conditions, including skin aging, essential blepharospasm, muscle spasticity, and glabellar frown lines, in clinical trials.
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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 | Neuronox |
|---|---|
| Also known as | Meditoxin, Clostridium Botulinum Toxin A 100 U, Botulinum Toxin Type A for injection, Neuronox ® 50 unit or 100 unit |
| Sponsor | Medy-Tox |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Patients (PHASE3)
- Neubotulinum Toxin Injection in Cerivical Dystonia (PHASE3)
- Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia (PHASE3)
- Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines (PHASE4)
- Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder (PHASE3)
- MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity (PHASE4)
- MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity (PHASE3)
- Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity (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:
- Neuronox CI brief — competitive landscape report
- Neuronox updates RSS · CI watch RSS
- Medy-Tox portfolio CI
Frequently asked questions about Neuronox
What is Neuronox?
Who makes Neuronox?
Is Neuronox also known as anything else?
What development phase is Neuronox in?
Related
- Manufacturer: Medy-Tox — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Also known as: Meditoxin, Clostridium Botulinum Toxin A 100 U, Botulinum Toxin Type A for injection, Neuronox ® 50 unit or 100 unit
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing