Azelastine
As of the edition of 20 October 2026, Azelastine is a small molecule: marketed, first approved in 1993 (ES); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Astelin
- First approved
- 1 February 1993 (ES)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Bayer; 7 holders in all
- Registered trials
- 36, 2 stopped early
- Disease areas
- Lungs and airways; Ear, nose and throat; Immune system; Infections
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 4 | 3 | 0 | 1 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 13 | 12 | 0 | 0 |
| Phase 4 | 12 | 5 | 3 | 1 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Viatris | Acquired holder, Later holder and Lead sponsor of trials | 2006 to now |
| Bayer | Later holder and Lead sponsor of trials | 2007 to now |
| Rising Pharma | Acquired holder | 2025 to now |