Doxorubicin
As of the edition of 20 October 2026, Doxorubicin is a small molecule: marketed, first approved in 1982 (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 1996
- Kind
- Small molecule
- Brand name
- Doxil (liposomal)
- First approved
- 1 January 1982 (US)
- Approvals on record
- 25 in 7 regions
- Holder of the most recent approval
- Accord Healthcare; 8 holders in all
- Withdrawn from market
- 22 September 2025 (in some regions)
- Registered trials
- 1,654, 237 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Doxorubicin.
See the 3 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 | 81 | 42 | 9 | 10 |
| Phase 1 | 238 | 138 | 46 | 44 |
| Phase 2 | 922 | 467 | 183 | 146 |
| Phase 3 | 384 | 198 | 82 | 34 |
| Phase 4 | 29 | 15 | 4 | 3 |
| All trials | 1,654 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sequus Pharmaceuticals | Later holder and Lead sponsor of trials | 1995 to now |
| Baxter Healthcare | Applicant, Acquired holder and Lead sponsor of trials | 1996 to now |
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 1997 to now |
| Cheplapharm Arzneimittel | Later holder | 2000 to now |
| Pfizer | Applicant, Earlier holder and Lead sponsor of trials | 2010 to now |
| Accord Healthcare | Later holder | 2022 to now |
| Nippon Kayaku | Later holder |