Tizanidine Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate the pharmacokinetics, safety, bioequivalence, and electrocardiographic effects of tizanidine across Phase I and Phase II studies. Sponsored by industry organizations including Hoffmann-La Roche, Acorda Therapeutics, Syneos Health, and Dr. Reddy's Laboratories, these completed and terminated investigations encompass healthy volunteers as well as patients with spasticity, cerebral palsy-related spasticity, and malignant melanoma neoplasms. Specific evaluations included pharmacokinetic interactions with vemurafenib and formulation bioequivalence.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01844674	Completed	Malignant Melanoma Neoplasms	Hoffmann-La Roche	2013-09-02	Phase 1
NCT01839279	Completed	Spasticity	Acorda Therapeutics	2013-04	Phase 2
NCT01405950	Terminated	Spasticity Due to Cerebral Palsy	Acorda Therapeutics\|Syneos Health	2011-05	Phase 1
NCT01065987	Completed	Healthy	Dr. Reddy''s Laboratories Limited	2001-09	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tizanidine selectively binds as an agonist to presynaptic alpha-2 adrenergic receptors within the central nervous system, which blocks the presynaptic release of excitatory amino acid neurotransmitters from spinal interneurons. This suppression of excitatory neurotransmission attenuates polysynaptic spinal reflex pathways and decreases motor neuron excitability, ultimately reducing pathologically elevated muscle tone to alleviate spasticity and acute muscle spasms, including spasticity due to cerebral palsy.

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>).