Pramipexole
As of the edition of 20 October 2026, Pramipexole is a small molecule: marketed, first approved in 1997 (US); acts on DRD2, DRD3 and DRD4; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Mirapex
- First approved
- 1 July 1997 (US)
- Approvals on record
- 23 in 5 regions
- Holder of the most recent approval
- Boehringer Ingelheim; 2 holders in all
- Withdrawn from market
- 13 April 2022 (in some regions)
- Registered trials
- 94, 7 stopped early
- Disease areas
- Nervous system; Mental health; Pregnancy and women's health; Urinary and reproductive; Bones, joints and muscles; Chemically induced
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
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Pramipexole.
See the 5 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 | 19 | 17 | 1 | 1 |
| Phase 1 | 13 | 12 | 1 | 0 |
| Phase 2 | 17 | 11 | 2 | 2 |
| Phase 3 | 22 | 19 | 1 | 2 |
| Phase 4 | 23 | 17 | 1 | 2 |
| All trials | 94 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Acquired holder and Lead sponsor of trials | 1998 to now |
| Pfizer | Originator | 1997 to 2004 |