Hexaminolevulinate
As of the edition of 20 October 2026, Hexaminolevulinate is a small molecule: marketed, first approved in 2005 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Cysview Kit
- First approved
- 6 July 2005 (ES)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Photocure
- Registered trials
- 17, 4 stopped early
- Disease areas
- Cancer; Pregnancy and women's health; Urinary and reproductive; Digestive system
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 1 | 0 |
| Phase 2 | 4 | 1 | 0 | 3 |
| Phase 3 | 7 | 6 | 1 | 0 |
| Phase 4 | 2 | 0 | 1 | 1 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Photocure | Originator and Lead sponsor of trials | 2001 to now |