Cisplatin
As of the edition of 20 October 2026, Cisplatin is a small molecule: marketed, first approved in 1982 (US); 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
- Platinol
- First approved
- 1 January 1982 (US)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- TEVA SANTE; 5 holders in all
- Registered trials
- 2,970, 420 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Urinary and reproductive; Pregnancy and women's health; Mouth and teeth
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 120 | 36 | 31 | 18 |
| Phase 1 | 437 | 260 | 78 | 78 |
| Phase 2 | 1,696 | 760 | 406 | 243 |
| Phase 3 | 685 | 275 | 188 | 81 |
| Phase 4 | 32 | 10 | 8 | 0 |
| All trials | 2,970 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1997 to now |
| Hq Specialty Pharma | Acquired holder | 2013 to now |
| Bristol Myers Squibb | Earlier holder | |
| Nippon Kayaku | Applicant |