Cyclobenzaprine
As of the edition of 20 October 2026, Cyclobenzaprine is a small molecule: marketed, first approved in 1982 (US); acts on HTR2A; no US protection of its own is listed.
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
- Flexeril
- First approved
- 1 January 1982 (US)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Tonix Pharmaceuticals; 5 holders in all
- Registered trials
- 37, 9 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Mental health; Injuries; Skin and connective tissue; Cancer
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Tonix Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Cyclobenzaprine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR2A | 5-hydroxytryptamine receptor 2A | P28223 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 5 | 1 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 7 | 3 | 2 | 2 |
| Phase 3 | 15 | 8 | 1 | 6 |
| Phase 4 | 5 | 2 | 2 | 1 |
| All trials | 37 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Acquired holder and Lead sponsor of trials | 2012 to now |
| Tonix Pharmaceuticals | Later holder and Lead sponsor of trials | 2013 to now |
| Teva | Acquired holder | 2016 to now |
| Merck & Co. | Earlier holder |