Epinastine
As of the edition of 20 October 2026, Epinastine is a small molecule: marketed, first approved in 2003 (FR); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Elestat
- First approved
- 16 July 2003 (FR)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Santen Pharmaceutical; 3 holders in all
- Registered trials
- 14, 1 stopped early
- Disease areas
- Immune system; Ear, nose and throat; Eye; Lungs and airways; Skin and connective tissue
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.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Epinastine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 4 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Originator and Lead sponsor of trials | 2003 to now |
| Santen Pharmaceutical | Applicant and Lead sponsor of trials | 2013 to now |