Tramadol
As of the edition of 20 October 2026, Tramadol is a small molecule: marketed, first approved in 1992 (ES); acts on OPRM1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Ultram
- First approved
- 1 June 1992 (ES)
- Approvals on record
- 37 in 5 regions
- Holder of the most recent approval
- KOWA PHARMACEUTICALS AMERICA INC; 15 holders in all
- Registered trials
- 192, 9 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Mental health; Chemically induced; Cancer; Digestive 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 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Tramadol.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 44 | 32 | 5 | 1 |
| Phase 1 | 22 | 20 | 0 | 0 |
| Phase 2 | 23 | 16 | 1 | 1 |
| Phase 3 | 42 | 34 | 0 | 4 |
| Phase 4 | 61 | 43 | 6 | 3 |
| All trials | 192 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder, Later holder and Lead sponsor of trials | 2000 to now |
| Johnson & Johnson | Acquired holder, Later holder and Lead sponsor of trials | 2002 to now |
| Purdue Pharma | Applicant | 2006 to now |
| Purdue Pharma | Later holder | 2008 to now |
| Cipher Pharmaceuticals | Later holder | 2010 to now |
| Nippon Shinyaku | Applicant | 2010 to now |
| Shionogi | Acquired holder | 2011 to now |