Valrubicin
As of the edition of 20 October 2026, Valrubicin is a small molecule: marketed, first approved in 1998 (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 1998
- Kind
- Small molecule
- Brand name
- Valstar Preservative Free
- First approved
- 25 September 1998 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Endo
- Registered trials
- 6, 1 stopped early
- Disease areas
- Cancer; Pregnancy and women's health; Urinary and reproductive
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TOP2A | DNA topoisomerase 2-alpha | P11388 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 3 | 1 | 0 | 1 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Endo | Acquired holder and Lead sponsor of trials | 1993 to now |
| Anthra Pharmaceuticals | Originator and Lead sponsor of trials | 1996 to now |