Loteprednol etabonate
As of the edition of 20 October 2026, Loteprednol etabonate is a small molecule: marketed, first approved in 1998 (US); acts on NR3C1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Lotemax
- First approved
- 9 March 1998 (US)
- Approvals on record
- 13 in 2 regions
- Holder of the most recent approval
- Alcon; 3 holders in all
- Registered trials
- 33, 2 stopped early
- Disease areas
- Eye; Immune system; Blood and lymph; Bones, joints and muscles; Cancer; Mouth and teeth
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
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 Loteprednol etabonate.
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 |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 5 | 0 | 1 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 9 | 8 | 0 | 1 |
| Phase 4 | 9 | 9 | 0 | 0 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 2003 to now |
| Kala Pharmaceuticals | Later holder and Lead sponsor of trials | 2018 to now |
| Alcon | Acquired holder | 2022 to now |
| Pharmos | Originator | 1998 to 2003 |