Ropinirole
As of the edition of 20 October 2026, Ropinirole is a small molecule: marketed, first approved in 1996 (FR); acts on DRD2, DRD3 and DRD4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Requip
- First approved
- 8 July 1996 (FR)
- Approvals on record
- 21 in 5 regions
- Holder of the most recent approval
- Hisamitsu Pharmaceutical; 2 holders in all
- Registered trials
- 46, 4 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Urinary and reproductive; Blood and lymph; Bones, joints and muscles
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 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Ropinirole.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 4 | 0 | 0 |
| Phase 1 | 11 | 11 | 0 | 0 |
| Phase 2 | 10 | 6 | 0 | 3 |
| Phase 3 | 15 | 13 | 0 | 1 |
| Phase 4 | 6 | 5 | 0 | 0 |
| All trials | 46 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 1996 to now |
| Hisamitsu Pharmaceutical | Applicant | 2019 to now |