Product Description
Fexofenadine is an antihistamine. It is used to relieve the symptoms of hay fever (seasonal allergic rhinitis) and hives of the skin (chronic idiopathic urticaria) . Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. (Sourced from: https://www.mayoclinic.org/drugs-supplements/fexofenadine-oral-route/side-effects/drg-20067082?p=1)
Mechanisms of Action: H1 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 | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | 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: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bangladesh, Brazil, Canada, China, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Common Cold|Influenza, Human|Rhinitis|Rhinitis, Allergic, Seasonal
Phase 2: Kidney Calculi|Nephrolithiasis
Phase 1: Dermatitis, Atopic|Exanthema|Healthy Volunteers|Inflammation|Pruritus|Psoriasis|Sneezing|Urticaria
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| RESFRIN | P3 |
Not yet recruiting |
Common Cold|Influenza, Human |
2025-10-30 |
34% |
| RESFRIN | P3 |
Not yet recruiting |
Common Cold|Influenza, Human |
2025-10-30 |
34% |
| RESFRIN | P3 |
Not yet recruiting |
Common Cold|Influenza, Human |
2025-10-30 |
34% |
| AAAT0219 | P2 |
Completed |
Kidney Calculi|Nephrolithiasis |
2024-06-30 |
|
| BDR17987 | P1 |
Completed |
Healthy Volunteers |
2024-05-08 |
28% |
| FEXPRESAR | P3 |
Completed |
Rhinitis, Allergic, Seasonal |
2023-03-14 |