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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

Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?

Not Applicable
Completed
Conditions
Food-drug Interaction
Interventions
First Posted Date
2012-02-03
Last Posted Date
2017-05-30
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
18
Registration Number
NCT01526213
Locations
🇺🇸

North Carolina Clinical and Translational Research Center, Chapel Hill, North Carolina, United States

A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

First Posted Date
2011-11-10
Last Posted Date
2015-03-11
Lead Sponsor
Bayer
Target Recruit Count
255
Registration Number
NCT01469234

Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

First Posted Date
2011-03-02
Last Posted Date
2013-10-16
Lead Sponsor
Sanofi
Target Recruit Count
520
Registration Number
NCT01306721
Locations
🇯🇵

Investigational Site Number 392003, Osaka-Shi, Japan

🇯🇵

Investigational Site Number 392001, Shinjuku-Ku, Japan

🇯🇵

Investigational Site Number 392002, Koganei-Shi, Japan

Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.

Phase 3
Completed
Conditions
Perennial Allergic Rhinitis
Interventions
Drug: Cloratadd-D
First Posted Date
2010-10-26
Last Posted Date
2016-04-11
Lead Sponsor
Azidus Brasil
Target Recruit Count
156
Registration Number
NCT01228630
Locations
🇧🇷

Lal Clínica Pesquisa E Desenvolvimento Ltda, Valinhos, Sao Paulo, Brazil

Topical Treatment of Under Eye Dark Circles and Swelling

Phase 2
Completed
Conditions
Edema
Interventions
Drug: Placebo
First Posted Date
2010-07-29
Last Posted Date
2015-02-19
Lead Sponsor
The Connecticut Sinus Center, PC
Target Recruit Count
30
Registration Number
NCT01172522
Locations
🇺🇸

TKL Research, Paramus, New Jersey, United States

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-28
Last Posted Date
2010-06-14
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
38
Registration Number
NCT01133483
Locations
🇮🇳

Veeda Clinical Research Pvt. Ltd.,, Ahmedabad, Gujrat, India

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-28
Last Posted Date
2010-06-14
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
54
Registration Number
NCT01133470
Locations
🇮🇳

Veeda Clinical Research Pvt. Ltd.,, Ahmedabad, Gujrat, India

Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-02-10
Last Posted Date
2010-02-10
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
30
Registration Number
NCT01066767
Locations
🇨🇦

Anapharm Inc.,, Sainte-Foy Quebec, Canada

Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-02-10
Last Posted Date
2010-02-10
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
44
Registration Number
NCT01066754
Locations
🇨🇦

Anapharm Inc.,, Sainte-Foy Quebec, Canada

The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

Phase 2
Completed
Conditions
Allergic Rhinitis
Interventions
First Posted Date
2009-12-16
Last Posted Date
2010-08-17
Lead Sponsor
Pfizer
Target Recruit Count
64
Registration Number
NCT01033396
Locations
🇨🇦

Pfizer Investigational Site, Kingston, Ontario, Canada

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