Clinical Trials

Multiple clinical trials have evaluated Tolperisone HCl across Phase 2 and Phase 3 studies targeting acute pain and neuromuscular conditions involving elevated muscle tone. An active, non-recruiting Phase 3 investigator-initiated trial sponsored by Semmelweis University alongside MEDITOP Pharmaceutical and Hungary's National Research Development and Innovation Fund evaluates its efficacy and prognostic biomarkers in acute low back pain. Additionally, a Phase 2 trial sponsored by Avigen evaluated the compound's safety and tolerability in muscle spasticity, though this study was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05544656 Active not recruiting
Low Back Pain
Semmelweis University|National Research Develpment and Innovation Fund Hungary|MEDITOP Pharmaceutical LTD Hungary
 2019-12-13 Phase 3
NCT00532532 Terminated
Muscle Spasticity
Avigen
 2007-09 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Tolperisone HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tolperisone HCl functions as a centrally-acting muscle relaxant that binds to and blocks voltage-gated ion channels, thereby inhibiting ion influx and suppressing monosynaptic and polysynaptic spinal reflex transmission. This cellular suppression reduces excessive motor neuron excitability and lowers reflex-mediated muscle tone, demonstrating clinical relevance by alleviating painful muscular spasms associated with low back pain and muscle spasticity.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.