Cilostazol
As of the edition of 20 October 2026, Cilostazol is a small molecule: marketed, first approved in 1999 (US); acts on PDE3A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Pletal
- First approved
- 15 January 1999 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Italfarmaco; 3 holders in all
- Registered trials
- 94, 6 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Hormones; Mental health; Nutrition and metabolism; Skin and connective tissue
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Cilostazol.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDE3A | cGMP-inhibited 3',5'-cyclic phosphodiesterase 3A | Q14432 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 8 | 2 | 0 |
| Phase 1 | 18 | 15 | 1 | 1 |
| Phase 2 | 13 | 5 | 4 | 2 |
| Phase 3 | 13 | 6 | 5 | 1 |
| Phase 4 | 37 | 23 | 3 | 2 |
| All trials | 94 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Applicant and Lead sponsor of trials | 1992 to now |
| Libbs Farmacêutica LTDA | Applicant | 2002 to now |