Cyclobenzaprine HCl Clinical Trials

Size	Price	Qty
100mg	USD 97
500mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated cyclobenzaprine hydrochloride across diverse therapeutic indications and phases of development. Completed research includes Phase I pharmacokinetic and bioequivalence studies in healthy adults sponsored by Tonix Pharmaceuticals Inc., alongside a Phase IV clinical trial by Vanderbilt University Medical Center in patients undergoing breast reconstruction requiring transverse abdominis plane block anesthesia. Additionally, a Phase II clinical trial investigating pain management and sleep disorders, sponsored by the University of Michigan Rogel Cancer Center and the Damon Runyon Cancer Research Foundation, was terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03700970	Completed	Breast Reconstruction\|Anesthesia\|Transverse Abdominis Plane Block	Vanderbilt University Medical Center	2019-06-13	Phase 4
NCT03443960	Completed	Healthy Subjects	Tonix Pharmaceuticals Inc.	2018-01-29	Phase 1
NCT03168022	Completed	Healthy Adults	Tonix Pharmaceuticals Inc.	2015-12-16	Phase 1
NCT01921296	Terminated	Sleep Initiation and Maintenance Disorders\|Pain	Lynn Henry\|Damon Runyon Cancer Research Foundation\|University of Michigan Rogel Cancer Center	2013-08	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cyclobenzaprine hydrochloride acts primarily as a 5-HT2 receptor antagonist, binding to central serotonin receptors to inhibit downstream serotonergic neurotransmission and reduce tonic somatic motor output. This suppression of motor neuron hyperexcitability diminishes skeletal muscle hyperactivity, providing therapeutic relevance for treating muscle spasms, acute pain, and sleep initiation and maintenance disorders investigated in clinical trials.

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>).