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Tolperisone Hydrochloride
Tolperisone Hydrochloride is a Centrally acting muscle relaxant Small molecule drug developed by Neurana Pharmaceuticals, Inc.. It is currently in Phase 3 development for Muscle spasticity associated with neurological disorders, Post-stroke spasticity, Spinal cord injury-related spasticity. Also known as: Tolperisone, EV product code: PRD4558977, miderizone tablet, ATC:M03BX04.
Tolperisone hydrochloride is a centrally acting muscle relaxant that reduces muscle tone and spasticity by modulating neural pathways in the spinal cord.
Tolperisone hydrochloride is a centrally acting muscle relaxant that reduces muscle tone and spasticity by modulating neural pathways in the spinal cord. Used for Muscle spasticity associated with neurological disorders, Post-stroke spasticity, Spinal cord injury-related spasticity.
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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 | Tolperisone Hydrochloride |
|---|---|
| Also known as | Tolperisone, EV product code: PRD4558977, miderizone tablet, ATC:M03BX04 |
| Sponsor | Neurana Pharmaceuticals, Inc. |
| Drug class | Centrally acting muscle relaxant |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Tolperisone acts as a non-selective muscle relaxant with analgesic properties, primarily through depression of polysynaptic spinal reflexes and reduction of muscle hypertonicity. It is believed to work via multiple mechanisms including sodium channel blockade and modulation of monoaminergic neurotransmission, leading to decreased muscle stiffness and improved motor function in conditions characterized by spasticity.
Approved indications
- Muscle spasticity associated with neurological disorders
- Post-stroke spasticity
- Spinal cord injury-related spasticity
Common side effects
- Dizziness
- Drowsiness
- Headache
- Nausea
- Gastrointestinal disturbances
Key clinical trials
- The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA" (PHASE3)
- Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (PHASE3)
- Treatment and Companion Diagnostics of Lower Back Pain Using SCENAR and Passive Medical Radiometry (MWR) (NA)
- Effects of Tolperisone on Measures of Drowsiness and Cognitive Function (PHASE1)
- Driving Simulation to Assess Non-Sedative Effects of Tolperisone (PHASE1)
- A Phase 1 PK Study of Tolperisone in Healthy Subjects (PHASE1)
- Tolperisone in Acute Muscle Spasm of the Back (PHASE2)
- Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis (PHASE2)
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:
- Tolperisone Hydrochloride CI brief — competitive landscape report
- Tolperisone Hydrochloride updates RSS · CI watch RSS
- Neurana Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about Tolperisone Hydrochloride
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Related
- Drug class: All Centrally acting muscle relaxant drugs
- Manufacturer: Neurana Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Muscle spasticity associated with neurological disorders
- Indication: Drugs for Post-stroke spasticity
- Indication: Drugs for Spinal cord injury-related spasticity
- Also known as: Tolperisone, EV product code: PRD4558977, miderizone tablet, ATC:M03BX04