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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 As Adjuvant Therapy in Parkinson Disease

Phase 2
Recruiting
Conditions
Parkinson Disease
Interventions
First Posted Date
2025-01-21
Last Posted Date
2025-01-21
Lead Sponsor
Tanta University
Target Recruit Count
46
Registration Number
NCT06785298
Locations
🇪🇬

Tanta University, Tanta, Egypt

Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial

Phase 2
Not yet recruiting
Conditions
ST-segment Elevation Myocardial Infarction (STEMI)
Interventions
First Posted Date
2024-08-12
Last Posted Date
2024-08-12
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
165
Registration Number
NCT06548204

Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Phase 4
Completed
Conditions
Hemodialysis
End-stage Renal Disease
Uremic Pruritus
Chronic Kidney Disease-associated Pruritus
Renal Replacement Therapy
ESRD
Interventions
First Posted Date
2024-06-20
Last Posted Date
2025-04-27
Lead Sponsor
Tanta University
Target Recruit Count
60
Registration Number
NCT06466421
Locations
🇪🇬

Tanta University, Tanta, Elgharbia, Egypt

Bioavailability Study of Fexofenadine HCl New Formulation Tablet

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2024-02-29
Last Posted Date
2024-06-11
Lead Sponsor
Opella Healthcare Group SAS, a Sanofi Company
Target Recruit Count
25
Registration Number
NCT06284902
Locations
🇨🇦

Syneos Health Clinic inc., Quebec, Canada

Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2024-01-16
Last Posted Date
2025-03-26
Lead Sponsor
Aeovian Pharmaceuticals, Inc.
Target Recruit Count
89
Registration Number
NCT06205381
Locations
🇦🇺

Q-Pharm, Herston, Queensland, Australia

🇦🇺

Nucleus Network Pty Ltd, Melbourne, Victoria, Australia

A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

Phase 4
Completed
Conditions
Fabry's Disease
Interventions
First Posted Date
2023-08-31
Last Posted Date
2025-02-26
Lead Sponsor
Sanofi
Target Recruit Count
8
Registration Number
NCT06019728
Locations
🇺🇸

UCLA Medical Center Site Number : 1003, Santa Monica, California, United States

🇺🇸

Emory University School of Medicine Site Number : 1005, Atlanta, Georgia, United States

🇺🇸

Infusion Associates Site Number : 1001, Grand Rapids, Michigan, United States

and more 2 locations

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

First Posted Date
2023-07-06
Last Posted Date
2023-10-30
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
22
Registration Number
NCT05932277
Locations
🇺🇸

ICON Lenexa, Lenexa, Kansas, United States

Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above

Phase 4
Not yet recruiting
Conditions
Rhinitis Allergic
Interventions
First Posted Date
2023-02-09
Last Posted Date
2024-12-04
Lead Sponsor
Sanofi
Target Recruit Count
203
Registration Number
NCT05720455

A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
Drug: Placebo
First Posted Date
2023-01-20
Last Posted Date
2024-05-16
Lead Sponsor
Opella Healthcare Group SAS, a Sanofi Company
Target Recruit Count
95
Registration Number
NCT05692154
Locations
🇨🇦

Investigational Site Number : 1240001, Kingston, Ontario, Canada

Bioavailability and Tolerability of Fexofenadine Hydrochloride Topical Lotion 1%

Phase 1
Completed
Conditions
Atopic Dermatitis Eczema
Urticaria
Atopic Rash
Rash
Psoriasis Vulgaris
Skin Rash
Eczema
Atopic Dermatitis
Pruritus
Urticaria Chronic
Interventions
First Posted Date
2022-07-18
Last Posted Date
2023-03-29
Lead Sponsor
OrchestratePharma GmbH
Target Recruit Count
12
Registration Number
NCT05461456
Locations
🇧🇩

BCT Ltd., Dhaka, Ramna, Bangladesh

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