Mitomycin
As of the edition of 20 October 2026, Mitomycin is a small molecule: marketed, first approved in 1982 (US); 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 2022
- Kind
- Small molecule
- Brand name
- Mutamycin
- First approved
- 1 January 1982 (US)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- UroGen Pharma; 7 holders in all
- Registered trials
- 167, 26 stopped early
- Disease areas
- Cancer; Digestive system; Urinary and reproductive; Pregnancy and women's health; Eye; Lungs and airways
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.
UroGen Pharma holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 2 | 3 | 2 |
| Phase 1 | 22 | 14 | 6 | 1 |
| Phase 2 | 69 | 30 | 14 | 13 |
| Phase 3 | 53 | 20 | 13 | 9 |
| Phase 4 | 9 | 3 | 1 | 1 |
| All trials | 167 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Later holder and Lead sponsor of trials | 1999 to now |
| Bristol Myers Squibb | Acquired holder | 2003 to now |
| UroGen Pharma | Later holder and Lead sponsor of trials | 2020 to now |
| Kyowa Kirin | Applicant | 2022 to now |
| Glaukos | Acquired holder | 2025 to now |