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: *
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: None
Known Adverse Events: None
Company: Meda
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Bulgaria, Canada, Germany, India, Latvia, Lithuania, Moldova, Poland, Russia
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Asthma, Allergic|COVID-19|Conjunctivitis, Allergic|Dust mite Hypersensitivity|Environmental Hypersensitivity|Rhinitis, Allergic|Rhinitis, Allergic, Seasonal
Phase 1: Rhinitis, Allergic, Perennial
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06180083 |
C1B01728 | P1 |
Completed |
Rhinitis, Allergic, Seasonal|Rhinitis, Allergic, Perennial |
2023-04-26 |
2023-12-23 |
Primary Endpoints|Treatments |
|
NCT06126952 |
AZEL-NS-2001 | P2 |
Completed |
Rhinitis, Allergic, Seasonal |
2024-02-23 |
10% |
2024-03-21 |
Primary Endpoints |
2023-504942-75-01 |
PM/0059 | P3 |
Active, not recruiting |
Conjunctivitis, Allergic|Dust mite Hypersensitivity|Environmental Hypersensitivity|Rhinitis, Allergic|Asthma, Allergic |
2026-08-31 |
2025-05-02 |
Treatments |
|
2024-515717-17-00 |
T502-SIT-073 | P3 |
Active, not recruiting |
Conjunctivitis, Allergic|Rhinitis, Allergic |
2025-06-13 |
2025-05-02 |
Treatments |
|
2021-006485-20 |
2021-006485-20 | P3 |
Active, not recruiting |
COVID-19 |
2023-08-22 |
|||
NCT05311475 |
CLK21001/SAN-0677 | P3 |
Completed |
Rhinitis, Allergic, Seasonal |
2023-06-20 |
13% |
2023-07-12 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05590598 |
SAN-0727 | P3 |
Completed |
Rhinitis, Allergic, Seasonal |
2023-06-14 |
32% |
2023-08-05 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
2021-004050-31 |
non available | P3 |
Active, not recruiting |
Rhinitis, Allergic, Seasonal |
2022-12-04 |
13% |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/20/2025 |
News Article |
Intranasal Corticosteroids Market to Sustain USD 11.57 Billion by 2034, Driven by Rising Allergic Rhinitis Cases |
|
03/26/2025 |
News Article |
InMarket Releases Its "Breakthrough Moments" Leaders of Top-Performing Advertising Campaigns |
|
01/06/2025 |
News Article |
Perrigo Expands its Scientific Office; Appoints Abbie Lennox as Executive Vice President and Chief Scientific Officer |
|
02/09/2024 |
News Article |
PRODUCT OF THE YEAR USA NAMES 2024 AWARD WINNERS |