Fluorescein
As of the edition of 20 October 2026, Fluorescein is a small molecule: marketed, first approved in 1980 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- Brand name
- FUNDUSCEIN-25
- First approved
- 31 December 1980 (CA)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- Bausch Health; 7 holders in all
- Registered trials
- 34, 9 stopped early
- Disease areas
- Cancer; Nervous system; Heart and blood vessels; Skin and connective tissue; Digestive system; Hormones
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 | 13 | 6 | 1 | 6 |
| Phase 1 | 6 | 4 | 1 | 1 |
| Phase 2 | 8 | 4 | 2 | 1 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 4 | 2 | 0 | 1 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Applicant | 1980 to now |
| Bausch Health | Later holder and Lead sponsor of trials | 1995 to now |
| Novartis | Acquired holder | 2004 to now |
| Akorn | Later holder | 2008 to now |
| Long Grove Pharmaceuticals | Acquired holder | 2023 to now |