Dantrolene

Overview

Chemically, dantrolene is a hydantoin derivative, but does not exhibit antiepileptic activity like other hydantoin derivates such as phenytoin.

Indication

For use, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Also used preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

Associated Conditions

Malignant Hyperthermia
Spasticity

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Dantrolene in Statin-induced Myopathy	2025/05/13	NCT06966843	Phase 2	Not yet recruiting	Tanta University
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery	2018/12/03	NCT03762109	Phase 2	Completed	Beth Israel Deaconess Medical Center
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS	2018/07/26	NCT03600376	Phase 3	Completed	Eagle Pharmaceuticals, Inc.
Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)	2017/06/16	NCT03189433	Phase 2	Terminated	Eagle Pharmaceuticals, Inc.
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)	2017/04/12	NCT03109288	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)
A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	2016/07/12	NCT02829268	Phase 1	Completed	Washington University School of Medicine
Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)	2015/07/31	NCT02513095	Phase 2	Completed	Eagle Pharmaceuticals, Inc.
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate	2013/09/25	NCT01950520	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Safety Study of Dantrolene in Subarachnoid Hemorrhage	2009/12/03	NCT01024972	Phase 1	Completed	University of Massachusetts, Worcester
Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage	2009/08/25	NCT00964548	Phase 1	Completed	University of Massachusetts, Worcester

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Dantrium	Par Pharmaceutical, Inc.	42023-123	INTRAVENOUS	20 mg in 60 mL	10/31/2017
Dantrium	Par Pharmaceutical, Inc.	42023-126	ORAL	100 mg in 1 1	4/12/2021
Dantrolene	Hikma Pharmaceuticals USA Inc.	0143-9297	INTRAVENOUS	20 mg in 1 1	2/9/2022
Revonto	USWM, LLC	78670-003	INTRAVENOUS	20 mg in 60 mL	4/7/2021
Dantrolene Sodium	AvPAK	50268-217	ORAL	25 mg in 1 1	1/9/2024
dantrolene sodium	Bryant Ranch Prepack	72162-1497	ORAL	25 mg in 1 1	12/5/2017
Dantrolene Sodium	Bryant Ranch Prepack	72162-2046	ORAL	50 mg in 1 1	3/7/2023
Dantrolene Sodium	Elite Laboratories, Inc.	64850-840	ORAL	25 mg in 1 1	3/7/2023
RYANODEX dantrolene sodium	Eagle Pharmaceuticals, Inc.	42367-540	INTRAVENOUS	250 mg in 5 mL	8/31/2020
dantrolene sodium	Bryant Ranch Prepack	63629-2170	ORAL	100 mg in 1 1	12/5/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DANTRIUM CAPSULES	par pharmaceutical companies	01997653	Capsule - Oral	100 MG	12/31/1993
DANTROLENE SODIUM FOR INJECTION, USP	hikma canada limited	02529998	Powder For Solution - Intravenous	20 MG / VIAL	3/29/2023
DANTRIUM CAP 100MG	norwich eaton canada inc.	00452521	Capsule - Oral	100 MG	12/31/1979
DANTRIUM CAP 25MG	norwich eaton canada inc.	00452513	Capsule - Oral	25 MG	12/31/1979

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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