Thiocolchicoside Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials evaluate thiocolchicoside across various painful musculoskeletal and neuromuscular conditions, including acute low back pain, myofascial pain syndromes, temporomandibular disorders, and inflammatory bowel diseases. Spanning early-stage through post-marketing phases, these investigations are sponsored by pharmaceutical leaders such as Sanofi alongside academic institutions including Medipol University and Yuzuncu Yil University. While the majority of these clinical trials have reached completed recruitment status, select studies remain active but not recruiting to assess the drug's analgesic efficacy, functional recovery, and patient-reported quality of life.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06261320	ACTIVE_NOT_RECRUITING	Inflammatory Bowel Diseases	Polyclinique de l'Europe	2024-02-28	PHASE2
NCT05529290	COMPLETED	Temporomandibular Disorder	Yuzuncu Yil University	2019-07-16	PHASE4
NCT05261971	COMPLETED	Occlusion; Quality of Life	Yuzuncu Yil University	2018-12-01
NCT04110119	COMPLETED	Low Back Pain, Mechanical	Medipol University	2018-10-01	PHASE2
NCT00679146	COMPLETED	Low Back Pain	Sanofi	2008-04	PHASE3
NCT00917436	COMPLETED	Low Back Pain	Sanofi	2004-12	PHASE4
NCT00272532	COMPLETED	Myofascial Pain Syndromes	Sanofi	2005-04	PHASE4

(data from https://clinicaltrials.gov, updated on 2025-05-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thiocolchicoside acts as a competitive antagonist at gamma-aminobutyric acid type A (GABAA) receptors and inhibitory glycine receptors, suppressing central spinal reflex pathways to attenuate elevated muscle tone. This pharmacodynamic inhibition reduces hyperactive spinal motor neuron discharge to alleviate spastic muscle contractions, demonstrating clinical relevance through muscle relaxation and pain relief in conditions such as acute low back pain and myofascial pain syndromes.

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>).