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Fexofenadine

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Fexofenadine development status

FDA approval on record Feb 25, 2000
Approval holderChattem Sanofi
ApplicationNDA020872
Highest phase Phase 4 run by Sanofi (NCT00741897)
Phase scored for VTRSPhase 1
Registered trials 24 across 12 sponsors since Sep 2002

Label indication Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring. FDA label

Fexofenadine target and mechanism

Molecular targetHRH1
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL914

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Fexofenadine clinical trials

Fexofenadine · 2 trials · 1 indication

Phase 1 2
NCT00647985Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mgHealthy
COMPLETED28 Analytics
NCT00649376Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mgHealthy
COMPLETED68 Analytics
PHASE1COMPLETED
Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFexofenadine Tablets 180 mg
2ACTIVE_COMPARATORAllegra® Tablets 180 mg

Interventions

NameTypeDescription
Fexofenadine Tablets 180 mgDRUG180mg, single dose fed
Allegra® Tablets 180 mgDRUG180mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening...

Countries:United States
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Frequently asked questions about Fexofenadine

What is Fexofenadine?

Fexofenadine is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an HRH1 antagonist. The specific indications for this asset are undisclosed. It has been studied in Phase 1 clinical trials involving healthy volunteers.

What does Fexofenadine target?

Fexofenadine targets HRH1, the histamine H1 receptor. It acts as an antagonist at this receptor. This mechanism is consistent with its classification as an antihistamine small molecule.

Who makes Fexofenadine?

Fexofenadine is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development of this asset.

What phase is Fexofenadine in?

Fexofenadine is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The program includes two completed Phase 1 trials.

What clinical trials is Fexofenadine in?

Fexofenadine has been evaluated in two completed Phase 1 trials: NCT00649376, a fasting study with 68 healthy volunteers, and NCT00647985, a food study with 28 healthy volunteers. Both were conducted in the United States and were active-controlled.