Tolperisone
As of the edition of 20 October 2026, Tolperisone is a small molecule: marketed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed
- Kind
- Small molecule
- Brand name
- Flexirizon
- Approvals on record
- 11 in 11 regions
- Holder of the most recent approval
- Gedeon Richter; 5 holders in all
- Registered trials
- 6, 1 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Immune 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 2 | 1 | 0 | 0 |
| All trials | 6 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Avigen | Lead sponsor of trials | 2007 to now |
| Neurana Pharmaceuticals | Lead sponsor of trials | 2019 to now |