Tolcapone
As of the edition of 20 October 2026, Tolcapone is a small molecule: marketed, first approved in 1997 (EU); acts on COMT.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Tasmar
- First approved
- 27 August 1997 (EU)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Bausch Health; 2 holders in all
- Withdrawn from market
- 1 January 1998 (in some regions)
- Registered trials
- 19, 2 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Injuries; Nutrition and metabolism; Cancer
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 A because of this drug.
Companies on route A for this drug
In the product1 company is on route A because of Tolcapone.
See the 1 company on route A 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 | 1 | 1 | 0 | 0 |
| Phase 1 | 8 | 6 | 0 | 1 |
| Phase 2 | 7 | 5 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Viatris | Acquired holder | 1997 to now |
| Roche | Applicant | 1998 to now |
| Bausch Health | Acquired holder | 2019 to now |