Product Description
Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older.
Mechanisms of Action: LT Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | 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 | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Asthma | Asthma, Exercise-Induced | Rhinitis | Rhinitis, Allergic | Rhinitis, Allergic, Perennial | Rhinitis, Allergic, Seasonal
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Otitis | Otitis Media | Sinusitis | Diarrhea | Influenza, Human
Company: Organon
Company Location: JERSEY CITY NJ 07302
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Post Acute COVID-19 Syndrome
Phase 2: Alzheimer Disease|Asthma, Allergic|Rhinitis, Allergic, Seasonal
Phase 1: Asthma, Exercise-Induced|Rhinitis, Allergic, Perennial
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| Montelukast in Mild-moderate Respiratory Symptoms in Patients with Long-COVID | P3 |
Active, not recruiting |
Post Acute COVID-19 Syndrome |
2024-07-06 |
|
| BUENA | P2 |
Completed |
Alzheimer Disease |
2024-03-13 |
32% |
| CTR20230958 | P1 |
Not yet recruiting |
Asthma, Exercise-Induced|Rhinitis, Allergic, Perennial|Rhinitis, Allergic, Seasonal|Asthma, Allergic |
None |
|
| DREAM-SAR | P2 |
Active, not recruiting |
Rhinitis, Allergic, Seasonal|Asthma, Allergic |
None |