Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fexofenadine Hydrochloride, ALLEGRA
Fexofenadine · 5 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Fexofenadine Hydrochloride Orally Disintegrating | EXPERIMENTAL | Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr.Reddy's Laboratories Ltd |
| ALLEGRA | ACTIVE_COMPARATOR | ALLEGRA orally disintegrating tablets 30 mg of Sanofi Aventis |
| Fexofenadine HCl + Pseudoephedrine HCl | EXPERIMENTAL | Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories |
| Allegra-D 24 hour ER Tablets | ACTIVE_COMPARATOR | Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA. |
| Fexofenadine | EXPERIMENTAL | Fexofenadine Hydrochloride 180 mg Tablets of Dr. Reddy's Laboratories Limited |
| Name | Type | Description |
|---|---|---|
| Fexofenadine Hydrochloride | DRUG | Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg |
| Fexofenadine HCl + Pseudoephedrine HCl | DRUG | Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories Limited |
| Fexofenadine | DRUG | Fexofenadine Hydrochloride 180 mg Tablets |
Inclusion Criteria: i. Provide written informed consent. ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2. iv. Must be of ...
Fexofenadine is a small molecule antihistamine drug. It is also known as fexofenadine hydrochloride, and combination products pair fexofenadine HCl with pseudoephedrine HCl. Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY, is developing fexofenadine. The specific therapeutic indication being studied is undisclosed.
Fexofenadine targets HRH1, the histamine H1 receptor. It acts as an antagonist at this receptor, meaning it blocks histamine H1 receptor signaling. This target class is consistent with its classification as an antihistamine small molecule.
Dr. Reddy's Laboratories Ltd is developing fexofenadine. The company trades under the ticker RDY. Its clinical program includes bioequivalence studies of fexofenadine hydrochloride tablets and of a combination product containing fexofenadine HCl plus pseudoephedrine HCl extended-release tablets.
Fexofenadine is in Phase 1 clinical development. Five Phase 1 trials have been completed and none are currently active. The program has enrolled 246 participants in total, and the trials used randomized, active-controlled designs.
Completed Phase 1 trials include NCT01888718, a bioequivalence study of fexofenadine hydrochloride 30 mg orally disintegrating tablets under fasting conditions; NCT01133483 and NCT01133470, bioequivalence studies of fexofenadine HCl 180 mg plus pseudoephedrine HCl 240 mg extended-release tablets; and NCT01066767, a bioequivalence study of fexofenadine hydrochloride 180 mg tablets.