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 |
|---|---|---|---|---|---|
2025/05/13 | Phase 2 | Not yet recruiting | |||
2018/12/03 | Phase 2 | Completed | |||
2018/07/26 | Phase 3 | Completed | |||
2017/06/16 | Phase 2 | Terminated | |||
2017/04/12 | Phase 1 | Recruiting | |||
2016/07/12 | Phase 1 | Completed | |||
2015/07/31 | Phase 2 | Completed | |||
2013/09/25 | Phase 2 | Completed | |||
2009/12/03 | Phase 1 | Completed | University of Massachusetts, Worcester | ||
2009/08/25 | Phase 1 | Completed | University of Massachusetts, Worcester |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Par Pharmaceutical, Inc. | 42023-123 | INTRAVENOUS | 20 mg in 60 mL | 10/31/2017 | |
| Par Pharmaceutical, Inc. | 42023-126 | ORAL | 100 mg in 1 1 | 4/12/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9297 | INTRAVENOUS | 20 mg in 1 1 | 2/9/2022 | |
| USWM, LLC | 78670-003 | INTRAVENOUS | 20 mg in 60 mL | 4/7/2021 | |
| AvPAK | 50268-217 | ORAL | 25 mg in 1 1 | 1/9/2024 | |
| Bryant Ranch Prepack | 72162-1497 | ORAL | 25 mg in 1 1 | 12/5/2017 | |
| Bryant Ranch Prepack | 72162-2046 | ORAL | 50 mg in 1 1 | 3/7/2023 | |
| Elite Laboratories, Inc. | 64850-840 | ORAL | 25 mg in 1 1 | 3/7/2023 | |
| Eagle Pharmaceuticals, Inc. | 42367-540 | INTRAVENOUS | 250 mg in 5 mL | 8/31/2020 | |
| 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 |
|---|---|---|---|---|---|
| Dantrolene Sodium for Injection | 国药准字H20203530 | 化学药品 | 注射剂 | 10/21/2020 | |
| Dantrolene Sodium Capsules | 国药准字H10970372 | 化学药品 | 胶囊剂 | 6/9/2022 | |
| Dantrolene Sodium Capsules | 国药准字H20194062 | 化学药品 | 胶囊剂 | 4/22/2024 |
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. | |||||
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