Belotecan
As of the edition of 20 October 2026, Belotecan is a small molecule: marketed, first approved in 2003 (KR); acts on TOP1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- First approved
- 10 December 2003 (KR)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Chong Kun Dang Pharmaceutical
- Registered trials
- 7, 0 stopped early
- Disease areas
- Cancer; Lungs and airways; Pregnancy and women's health; Urinary and reproductive
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
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 Belotecan.
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 |
|---|---|---|
| TOP1 | DNA topoisomerase 1 | P11387 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 5 | 4 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Chong Kun Dang Pharmaceutical | Originator and Lead sponsor of trials | 2003 to now |