Drugs / Dantrolene
Dantrolene
also known as
dantrolene sodium · Ryanodex · Agilus · Dantamacrin · Dantrium · Dantrolen · Dantrolene sodium hemiheptahydrate · Dantrolene sodium heptahydrate · +6 more
Small molecule targets RYR1, RYR2, RYR3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Agilus | — | 2024-05-29 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | DANTRIUM | — | 1982-02-26 – 1987-05-12 | fda.gov ↗ |
| Approved | US (FDA) | DANTRIUM | — | 1974-01-15 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03109288 | Aug 2017 → Jan 2027 expected | multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02829268 | Jan 2017 → Feb 2023 | Wolfram syndrome, atactic disorder, diabetes mellitus, optic atrophy | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT01024972 | Oct 2009 → Jul 2013 | intracranial vasospasm, subarachnoid hemorrhage | University of Massachusetts, Worcester | Completed | No outcome recorded |
| Phase 1/2 | NCT00964548 | Jul 2007 → Oct 2009 | intracranial vasospasm | University of Massachusetts, Worcester | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT03762109 | Jul 2019 → Jun 2024 | spinal cord injury | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02513095 | Sep 2015 | exercise-induced malignant hyperthermia | Eagle Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 2 | NCT01950520 | Feb 2014 → Dec 2022 | — | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06966843 | Oct 2027 → Jan 2029 expected | drug-induced myopathy | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT04134845 | Aug 2020 → May 2025 | ventricular tachycardia | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT00796900 | May 2008 → Mar 2011 | — | Medical University of Vienna | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03600376 | Aug 2018 → Aug 2019 | exercise-induced malignant hyperthermia | Eagle Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03189433 Comparator | Aug 2017 → Dec 2018 | poisoning | Eagle Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-03-26 | Norgine | Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia norgine.com ↗ |
| 2019-06-28 | Lannett Company, Inc. | Lannett Enters Into Distribution Agreement For Dantrolene Capsules, Commences Product Launch investorroom.com ↗ |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dantrolene | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00964548 ↗ |
| Known as | Agilus | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantamacrin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantrium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantrolen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | dantrolene sodium | “Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be...” NCT03189433 ↗3“Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.” NCT03600376 ↗ |
| Known as | Dantrolene sodium hemiheptahydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantrolene sodium heptahydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantrolene sodium hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantrolene sodium salt hemiheptahydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Dantroleno | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | F-440 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | NSC-758403 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Revonto | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201288 ↗ |
| Known as | Ryanodex | “Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be...” NCT03189433 ↗1“Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.” NCT03600376 ↗ |
| Action | Inhibit | “Dantrolene, a currently available drug that inhibits RyR2” NCT04134845 ↗1“Ryanodine receptor 3 antagonist” CHEMBL1201288 ↗ |
| Modality | Small molecule | “This study justifies further investigation into using dantrolene sodium and other small molecules targeting the ER for treatment of Wolfram syndrome.” PMID 34185708 ↗ Aug 2021 |
| Route | Intravenous | “Dantrolene will be given in the following dose: 5 mg/kg BW given intravenously over 30 minutes.” NCT00796900 ↗ |
| Target | RYR1 | “Dantrolene's inhibition of RyR1 will also be studied” NCT04134845 ↗ |
| Target | RYR2 | “Dantrolene, a currently available drug that inhibits RyR2” NCT04134845 ↗ |
| Target | RYR3 | “Ryanodine receptor 3 antagonist” CHEMBL1201288 ↗ |