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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

Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-03
Last Posted Date
2009-08-20
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
24
Registration Number
NCT00835640
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-03
Last Posted Date
2009-08-20
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
60
Registration Number
NCT00835276
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Preference for Clarinex Tablets vs Allegra Tablets in Patients With Seasonal Allergies (P03178)

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2008-11-20
Last Posted Date
2022-02-17
Lead Sponsor
Organon and Co
Target Recruit Count
118
Registration Number
NCT00794768

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03179)

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2008-11-20
Last Posted Date
2022-02-17
Lead Sponsor
Organon and Co
Target Recruit Count
122
Registration Number
NCT00794248

Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2008-10-31
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
722
Registration Number
NCT00783211

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2008-10-31
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
131
Registration Number
NCT00783133

Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR) (Study P04054)

Phase 4
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2008-10-31
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
728
Registration Number
NCT00783146

Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis

Phase 4
Completed
Conditions
Rhinitis, Allergic, Perennial
Interventions
First Posted Date
2008-08-26
Last Posted Date
2009-09-15
Lead Sponsor
Sanofi
Target Recruit Count
264
Registration Number
NCT00741897
Locations
🇵🇭

Sanofi-aventis administrative office, Makati City, Philippines

Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
68
Registration Number
NCT00649376
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
28
Registration Number
NCT00647985
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

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