Tizanidine
As of the edition of 20 October 2026, Tizanidine is a small molecule: marketed, first approved in 1990 (ES); acts on ADRA2A, ADRA2B and ADRA2C.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Zanaflex
- First approved
- 1 November 1990 (ES)
- Approvals on record
- 7 in 2 regions
- Holder of the most recent approval
- Fidelity Biopharma; 3 holders in all
- Registered trials
- 30, 2 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Injuries; Immune system; Mental health; Heart and blood vessels
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 Tizanidine.
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 | 6 | 2 | 3 | 0 |
| Phase 1 | 7 | 4 | 2 | 1 |
| Phase 2 | 5 | 3 | 1 | 1 |
| Phase 3 | 6 | 4 | 1 | 0 |
| Phase 4 | 6 | 4 | 2 | 0 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Elan Pharmaceuticals | Earlier holder | 1996 to now |
| Fidelity Biopharma | Later holder | 2024 to now |
| Legacy Pharma Inc Sezc | Acquired holder | 2026 to now |