Product Description
Indacaterol is used for the long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing). Indacaterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes. (Sourced from: https://www.mayoclinic.org/drugs-supplements/indacaterol-inhalation-route/side-effects/drg-20075006?p=1)
Mechanisms of Action: LAB Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Inhalant
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: Europe
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, China, Czech Republic, Greece, Hungary, Italy, Portugal, Romania, Spain
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Asthma
Phase 2: Chronic Obstructive Pulmonary Disease
Phase 1: Bronchitis, Chronic|Emphysema
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
CTR20241209 |
CTR20241209 | P1 |
Completed |
Bronchitis, Chronic|Emphysema|Chronic Obstructive Pulmonary Disease |
2024-07-16 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20243686 |
CTR20243686 | P2 |
Completed |
Chronic Obstructive Pulmonary Disease |
2025-06-26 |
2025-07-27 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2022-501899-26-00 |
CQMF149G2301 | P3 |
Recruiting |
Asthma |
2026-08-31 |
2025-05-02 |
Treatments |
