Emedastine
As of the edition of 20 October 2026, Emedastine is a small molecule: marketed, first approved in 1997 (US); acts on HRH1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Emadine
- First approved
- 29 December 1997 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Hisamitsu Pharmaceutical; 3 holders in all
- Registered trials
- 2, 0 stopped early
- Disease areas
- Ear, nose and throat; Immune system; Lungs and airways
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 Emedastine.
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 |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Originator | 1997 to now |
| Novartis | Applicant | 1997 to now |
| Immedica Pharma | Applicant | 1999 to now |
| Hisamitsu Pharmaceutical | Applicant | 2018 to now |