Primidone
As of the edition of 20 October 2026, Primidone is a small molecule: marketed, first approved in 1952 (CH); acts on GABRB1, GABRB2 and GABRB3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Mysoline
- First approved
- 15 October 1952 (CH)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Apsen Farmaceutica; 5 holders in all
- Registered trials
- 5, 1 stopped early
- Disease areas
- Nervous system
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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Primidone.
See the 3 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 not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 0 | 0 | 1 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Apsen Farmaceutica | Applicant | 1997 to now |
| Bausch Health | Acquired holder | 2005 to now |
| Pfizer | Earlier holder |