Entacapone
As of the edition of 20 October 2026, Entacapone is a small molecule: marketed, first approved in 1998 (EU); acts on COMT.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Comtan
- First approved
- 16 September 1998 (EU)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- LobSor Pharmaceuticals; 4 holders in all
- Registered trials
- 39, 3 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Chemically induced; Digestive system; 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
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 Entacapone.
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 |
|---|---|---|
| COMT | Catechol O-methyltransferase | P21964 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 16 | 13 | 1 | 0 |
| Phase 2 | 8 | 3 | 2 | 2 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 10 | 7 | 0 | 1 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Orion Pharma | Applicant | 1998 to now |
| Novartis | Applicant and Lead sponsor of trials | 2003 to now |