Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fexofenadine M016455 · 1 trial · 1 indication
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3
| Arm | Type | Description |
|---|---|---|
| Fexofenadine | EXPERIMENTAL | Fexofenadine, single administration |
| Placebo | PLACEBO_COMPARATOR | Placebo, single administration |
| Name | Type | Description |
|---|---|---|
| Fexofenadine M016455 | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Placebo | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria: * Males or females between the ages of 18 and 65 suffering from seasonal allergic rhinitis provoked by ragweed pollen. * Having a 2-year history of seasonal allergic rhinitis with positive skin prick test to ragweed allergen at screening with a wheal diameter at least 3 mm large...
Fexofenadine M016455 is being developed for seasonal allergic rhinitis, also called hay fever. The Phase 3 study of this asset evaluated its use in subjects suffering from seasonal allergic rhinitis in the presence of pollutants. It is a small molecule therapeutic in the respiratory area.
Fexofenadine M016455 targets HRH1, the histamine H1 receptor, and acts as an antagonist. By blocking this receptor, the drug is designed to counter histamine-driven allergic responses. This mechanism is relevant to its development for seasonal allergic rhinitis.
Fexofenadine M016455 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with this asset in the clinical development program for seasonal allergic rhinitis.
Fexofenadine M016455 is in Phase 3 development. The program includes one completed Phase 3 trial, and no active trials are currently listed. The asset remains in clinical development and is not described as approved.
Fexofenadine M016455 has been studied in one completed Phase 3 trial, NCT03664882, titled Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants. It enrolled 240 participants in Canada, was randomized, double-blind, and placebo-controlled, with participants aged 18 years and older.