Irinotecan
As of the edition of 20 October 2026, Irinotecan is a small molecule: marketed, first approved in 1996 (US); acts on TOP1; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Camptosar
- First approved
- 14 June 1996 (US)
- Approvals on record
- 13 in 6 regions
- Holder of the most recent approval
- SUN Pharmaceutical Industries; 8 holders in all
- Registered trials
- 1,249, 172 stopped early
- Disease areas
- Cancer; Digestive system; Hormones; Lungs and airways; Nervous system; Skin and connective tissue
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Ipsen holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.
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 Irinotecan.
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 |
|---|---|---|
| TOP1 | DNA topoisomerase 1 | P11387 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 35 | 6 | 11 | 8 |
| Phase 1 | 274 | 188 | 41 | 33 |
| Phase 2 | 773 | 340 | 177 | 119 |
| Phase 3 | 152 | 67 | 46 | 12 |
| Phase 4 | 15 | 5 | 6 | 0 |
| All trials | 1,249 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 1996 to now |
| Yakult Honsha | Applicant and Lead sponsor of trials | 2006 to now |
| Merrimack Pharmaceuticals | Later holder and Lead sponsor of trials | 2011 to now |
| Servier | Applicant | 2016 to now |
| Ipsen | Acquired holder | 2017 to now |