Mitoxantrone
As of the edition of 20 October 2026, Mitoxantrone is a small molecule: marketed, first approved in 1987 (US); acts on TOP2A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Small molecule
- Brand name
- Novantrone
- First approved
- 23 December 1987 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- SERONO INC; 2 holders in all
- Registered trials
- 304, 50 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Urinary and reproductive; Inherited and neonatal; 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
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 Mitoxantrone.
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 |
|---|---|---|
| TOP2A | DNA topoisomerase 2-alpha | P11388 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 2 | 4 | 0 |
| Phase 1 | 58 | 31 | 7 | 14 |
| Phase 2 | 171 | 79 | 30 | 32 |
| Phase 3 | 51 | 29 | 8 | 4 |
| Phase 4 | 10 | 7 | 1 | 0 |
| All trials | 304 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Earlier holder | 1987 to now |
| Merck KGaA | Acquired holder | 2008 to now |