Dantrolene
As of the edition of 20 October 2026, Dantrolene is a small molecule: marketed, first approved in 1978 (FR); acts on RYR1 and RYR3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1983
- Kind
- Small molecule
- Brand name
- Dantrium
- First approved
- 29 June 1978 (FR)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Eagle Pharmaceuticals; 3 holders in all
- Registered trials
- 11, 1 stopped early
- Disease areas
- Nervous system; Heart and blood vessels; Injuries; Ear, nose and throat; Eye; Hormones
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Dantrolene.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 7 | 6 | 1 | 0 |
| Phase 3 | 4 | 2 | 1 | 1 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Norgine | Applicant | 1983 to now |
| Eagle Pharmaceuticals | Later holder and Lead sponsor of trials | 2014 to now |
| Ph Health | Acquired holder | 2025 to now |
| Procter And Gamble | Earlier holder |