Levodopa
As of the edition of 20 October 2026, Levodopa is a small molecule: marketed, first approved in 1973 (CH); acts on DRD3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Larodopa
- First approved
- 27 June 1973 (CH)
- Approvals on record
- 57 in 7 regions
- Holder of the most recent approval
- Zambon; 16 holders in all
- Withdrawn from market
- 2 April 2019 (in some regions)
- Registered trials
- 173, 13 stopped early
- Disease areas
- Nervous system; Mental health; Eye; Heart and blood vessels; Chemically induced; Inherited and neonatal
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
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Levodopa.
See the 4 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DRD3 | Dopamine receptor D3 | P35462 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 16 | 4 | 1 |
| Phase 1 | 39 | 36 | 1 | 0 |
| Phase 2 | 54 | 44 | 2 | 5 |
| Phase 3 | 19 | 18 | 0 | 1 |
| Phase 4 | 37 | 21 | 6 | 6 |
| All trials | 173 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant | 1973 to now |
| Organon | Later holder | 1973 to now |
| Orion Pharma | Applicant | 2003 to now |
| Novartis | Applicant and Lead sponsor of trials | 2004 to now |
| Takeda | Acquired holder | 2005 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2006 to now |
| Acorda Therapeutics | Later holder and Lead sponsor of trials | 2012 to now |
| Merz Pharma GmbH & Co. KGaA | Acquired holder and Lead sponsor of trials | 2025 to now |
| Tanabe Pharma | Later holder | 2026 to now |
| Zambon | Later holder | 2026 to now |
| Bausch Health | Later holder |