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Fexofenadine

Generic Name
Fexofenadine
Brand Names
Allegra, Allegra-D, Mucinex Non-drowsy Allergy, Wal-fex, Telfast
Drug Type
Small Molecule
Chemical Formula
C32H39NO4
CAS Number
83799-24-0
Unique Ingredient Identifier
E6582LOH6V
Background

Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms. It is selective for the H receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier - this is in contrast to previous first-generation antihistamines, such as diphenhydramine, which readily bind to off-targets that contribute to side effects such as sedation. Fexofenadine is the major active metabolite of terfenadine and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.

Indication

In the United States, fexofenadine is indicated for the symptomatic treatment of allergic rhinitis in patients ≥2 years old and chronic idiopathic urticaria in patients ≥6 months old. In Canada, fexofenadine carries the same indications but is approved only for patients ≥12 years old. Fexofenadine is also available in combination with pseudoephedrine for the symptomatic treatment of season allergic rhinitis in patients ≥12 years old.

Associated Conditions
Allergic Rhinitis (AR), Chronic Idiopathic Urticaria, Seasonal Allergic Rhinitis
Associated Therapies
Antihistamine

Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
First Posted Date
2008-03-18
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
72
Registration Number
NCT00637455
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen

Phase 4
Completed
Conditions
Allergic Rhinitis
First Posted Date
2008-03-18
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
48
Registration Number
NCT00638118
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms

Phase 4
Completed
Conditions
Cat Induced Allergic Rhinitis
First Posted Date
2008-03-18
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
70
Registration Number
NCT00637884

Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

Phase 4
Completed
Conditions
Allergic Rhinitis
First Posted Date
2008-03-18
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
42
Registration Number
NCT00637585
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
First Posted Date
2008-03-18
Last Posted Date
2011-01-12
Lead Sponsor
Sanofi
Target Recruit Count
1010
Registration Number
NCT00637611
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine

Phase 4
Completed
Conditions
Allergic Rhinitis
First Posted Date
2008-03-17
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
220
Registration Number
NCT00636870
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

Phase 2
Completed
Conditions
Allergic Rhinitis
Interventions
First Posted Date
2007-11-21
Last Posted Date
2014-04-16
Lead Sponsor
Pfizer
Target Recruit Count
21
Registration Number
NCT00562120
Locations
🇺🇸

Pfizer Investigational Site, Omaha, Nebraska, United States

Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.

Phase 4
Completed
Conditions
Allergy
First Posted Date
2007-10-23
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
36
Registration Number
NCT00547768
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

Phase 2
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2007-01-09
Last Posted Date
2012-04-05
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
75
Registration Number
NCT00420082
Locations
🇦🇹

Allergy Center Vienna West, Vienna, Austria

Fexofenadine in Pruritic Skin Disease

Phase 4
Completed
Conditions
Pruritus
First Posted Date
2005-12-02
Last Posted Date
2007-11-07
Lead Sponsor
Handok Inc.
Target Recruit Count
435
Registration Number
NCT00261079
Locations
🇰🇷

Handok, Seoul, Korea, Republic of

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