Dexrazoxane
As of the edition of 20 October 2026, Dexrazoxane is a small molecule: marketed, first approved in 1995 (US); acts on TOP2A and TOP2B; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Zinecard
- First approved
- 26 May 1995 (US)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- Kissei Pharmaceutical; 5 holders in all
- Registered trials
- 52, 13 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Chemically induced; Injuries
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 Dexrazoxane.
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 | 1 | 0 | 0 | 1 |
| Phase 1 | 13 | 7 | 1 | 4 |
| Phase 2 | 21 | 8 | 7 | 5 |
| Phase 3 | 17 | 8 | 6 | 3 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Applicant | 1995 to now |
| CNX Therapeutics | Applicant | 2006 to now |
| Kissei Pharmaceutical | Applicant and Lead sponsor of trials | 2014 to now |
| Clinigen | Acquired holder | 2020 to now |