Dantrolene Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials spanning Phase I, Phase II, and Phase III evaluate dantrolene across various indications, including multiple sclerosis, psychostimulant drug toxicity, cerebral vasospasm after subarachnoid hemorrhage, statin-induced myopathy, lumbar spine injury, hyperthermia, and Wolfram syndrome. Sponsored by academic medical centers, government entities such as the National Institute of Allergy and Infectious Diseases, and industry partners including Eagle Pharmaceuticals, these studies range in recruitment status from actively recruiting and completed to terminated and not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06966843	NOT_YET_RECRUITING	Statins Induced Myopathy	Tanta University	2027-10	PHASE2; PHASE3
NCT03109288	RECRUITING	Multiple Sclerosis	National Institute of Allergy and Infectious Diseases (NIAID)	2017-08-11	PHASE1; PHASE2
NCT04134845	COMPLETED	Ventricular Tachycardia	Vanderbilt University Medical Center	2020-08-21	PHASE2; PHASE3
NCT03762109	COMPLETED	Lumbar Spine Injury	Beth Israel Deaconess Medical Center	2019-07-29	PHASE2
NCT02829268	COMPLETED	Wolfram Syndrome; Diabetes Mellitus; Optic Nerve Atrophy; Ataxia	Washington University School of Medicine	2017-01	PHASE1; PHASE2
NCT01950520	COMPLETED	Healthy Volunteers	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2014-02-07	PHASE2
NCT03189433	TERMINATED	Drug Toxicity Psychotropic Agents Psychostimulants	Eagle Pharmaceuticals, Inc.	2017-08-12	PHASE2
NCT02513095	COMPLETED	Heat Stroke	Eagle Pharmaceuticals, Inc.	2015-09	PHASE2
NCT01024972	COMPLETED	Subarachnoid Hemorrhage; Cerebral Vasospasm	University of Massachusetts, Worcester	2009-10	PHASE1; PHASE2
NCT00796900	TERMINATED	Hyperthermia	Medical University of Vienna	2008-05	PHASE2; PHASE3
NCT00964548	COMPLETED	Cerebral Vasospasm After Subarachnoid Hemorrhage	University of Massachusetts, Worcester	2007-07	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-05-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dantrolene acts as an antagonist of the ryanodine receptor, inhibiting sarcoplasmic reticulum calcium release and producing a dose-dependent reduction in myoplasmic free calcium levels. This blockade of intracellular calcium signaling relaxes postsynaptic skeletal muscle, mitigating hypermetabolic responses and addressing clinical conditions such as malignant hyperthermia, cerebral vasospasm, and statin-induced myopathy.

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>).