Topotecan
As of the edition of 20 October 2026, Topotecan is a small molecule: marketed, first approved in 1996 (US); acts on TOP1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Hycamtin
- First approved
- 28 May 1996 (US)
- Approvals on record
- 16 in 6 regions
- Holder of the most recent approval
- Meitheal Pharmaceuticals; 8 holders in all
- Withdrawn from market
- 15 January 2019 (in some regions)
- Registered trials
- 345, 53 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Hormones; Lungs and airways; Blood and lymph
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 and 1 company on route A because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Topotecan.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Companies on route A for this drug
In the product1 company is on route A because of Topotecan.
See the 1 company on route A 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 not stated | 12 | 7 | 0 | 4 |
| Phase 1 | 118 | 81 | 14 | 17 |
| Phase 2 | 170 | 109 | 22 | 30 |
| Phase 3 | 43 | 29 | 7 | 2 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 345 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 1996 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2010 to now |
| Teva | Later holder | 2012 to now |
| Sandoz | Acquired holder | 2023 to now |
| Meitheal Pharmaceuticals | Acquired holder | 2024 to now |
| Nippon Kayaku | Applicant |