Daunorubicin
As of the edition of 20 October 2026, Daunorubicin is a small molecule: marketed, first approved in 1968 (ES); acts on TOP2A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Cerubidine
- First approved
- 1 November 1968 (ES)
- Approvals on record
- 12 in 7 regions
- Holder of the most recent approval
- Jazz Pharmaceuticals; 9 holders in all
- Registered trials
- 303, 31 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Inherited and neonatal; Infections; Nervous system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
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 Daunorubicin.
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 |
|---|---|---|
| TOP2A | DNA topoisomerase 2-alpha | P11388 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 8 | 4 | 1 |
| Phase 1 | 50 | 25 | 15 | 7 |
| Phase 2 | 123 | 60 | 39 | 20 |
| Phase 3 | 94 | 53 | 23 | 3 |
| Phase 4 | 15 | 11 | 2 | 0 |
| All trials | 303 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Nexstar Pharmaceuticals | Later holder and Lead sponsor of trials | 1996 to now |
| Galen | Acquired holder | 2011 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2012 to now |
| Jazz Pharmaceuticals | Applicant | 2018 to now |
| Meiji Seika Pharma | Applicant | 2021 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |