Metyrosine
As of the edition of 20 October 2026, Metyrosine is a small molecule: marketed, first approved in 1982 (US); acts on TH; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Demser
- First approved
- 1 January 1982 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Ono Pharmaceutical; 2 holders in all
- Registered trials
- 1, 1 stopped early
- Disease areas
- Blood and lymph; Bones, joints and muscles; Heart and blood vessels; Hormones; Inherited and neonatal; Mental health
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this 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 Metyrosine.
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 |
|---|---|---|
| TH | Tyrosine 3-monooxygenase | P07101 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 0 | 0 | 1 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 2010 to now |
| Ono Pharmaceutical | Applicant | 2019 to now |
| Merck & Co. | Earlier holder |