Product Description
Azelastine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. (Sourced from: https://www.mayoclinic.org/drugs-supplements/azelastine-nasal-route/description/drg-20068252)
Mechanisms of Action: H1 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Topical,Nasal
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Rhinitis | Rhinitis, Allergic | Rhinitis, Allergic, Seasonal | Rhinitis, Vasomotor | Rhinitis | Rhinitis, Allergic | Rhinitis, Allergic, Perennial | Rhinitis, Allergic, Seasonal
Known Adverse Events: Dizziness | Headache | Pharyngitis | Epistaxis | Rhinitis | Sinusitis | Sneezing | Dysgeusia | Pain Unspecified | Dermatitis | Dermatitis, Contact | Otitis | Otitis Media
Company: Meda
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, Canada, China, Germany, India, Latvia, Lithuania, Moldova, Poland, Russia
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Asthma, Allergic|COVID-19|Conjunctivitis, Allergic|Dust mite Hypersensitivity|Environmental Hypersensitivity|Rhinitis, Allergic|Rhinitis, Allergic, Perennial|Rhinitis, Allergic, Seasonal
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| PM/0059 | P3 |
Not yet recruiting |
Conjunctivitis, Allergic|Environmental Hypersensitivity|Dust mite Hypersensitivity|Rhinitis, Allergic|Asthma, Allergic |
2026-08-31 |
|
| AZEL-NS-2001 | P2 |
Completed |
Rhinitis, Allergic, Seasonal |
2024-02-23 |
35% |
| 2021-006485-20 | P3 |
Active, not recruiting |
COVID-19 |
2023-08-22 |
|
| CLK21001/SAN-0677 | P3 |
Completed |
Rhinitis, Allergic, Seasonal |
2023-06-20 |
66% |
| CLK21001/SAN-0677 | P3 |
Completed |
Rhinitis, Allergic, Seasonal |
2023-06-20 |
66% |