Clopidogrel
As of the edition of 20 October 2026, Clopidogrel is a small molecule: marketed, first approved in 1997 (US); acts on P2RY12; no US protection is listed.
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
- Plavix
- First approved
- 17 November 1997 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Sanofi; 4 holders in all
- Withdrawn from market
- 13 January 2020 (in some regions)
- Registered trials
- 386, 37 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Nutrition and metabolism; Hormones; Lungs and airways; Inherited and neonatal
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 Clopidogrel.
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 |
|---|---|---|
| P2RY12 | P2Y purinoceptor 12 | Q9H244 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 82 | 37 | 16 | 7 |
| Phase 1 | 61 | 52 | 1 | 6 |
| Phase 2 | 34 | 24 | 2 | 3 |
| Phase 3 | 66 | 39 | 8 | 9 |
| Phase 4 | 143 | 88 | 16 | 12 |
| All trials | 386 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant, Later holder and Lead sponsor of trials | 1997 to now |
| Zentiva k.s | Later holder | 2008 to now |