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Fexofenadine Coated

Phase 1

Undisclosed | Small molecule | Other |Sanofi|Trials Updated: Sep 12, 2025

Fexofenadine Coated target and mechanism

Molecular targetHRH1
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL914

Also known as Fexofenadine HCl Coated tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Fexofenadine Coated clinical trials

Fexofenadine Coated · 1 trial · 1 indication

Phase 1 1
NCT06284902Bioavailability Study of Fexofenadine HCl New Formulation TabletHealthy Volunteers
COMPLETED25 Analytics
PHASE1COMPLETED
Bioavailability Study of Fexofenadine HCl New Formulation Tablet
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Study Endpoints

Primary Endpoints

Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine
Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hours (hrs) post-dose
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine
Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Maximal Observed Concentration (Cmax) of Fexofenadine
Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

Secondary Endpoints

Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine
Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine
Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine
Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence Group 1EXPERIMENTAL -
Treatment Sequence Group 2EXPERIMENTAL -
Treatment Sequence Group 3EXPERIMENTAL -
Treatment Sequence Group 4EXPERIMENTAL -
Treatment Sequence Group 5EXPERIMENTAL -
Treatment Sequence Group 6EXPERIMENTAL -

Interventions

NameTypeDescription
Fexofenadine HCl Coated tabletDRUGFilm-coated tablet.
Fexofenadine HCl New Formulation TabletDRUGNew formulation tablet.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body-mass-index (BMI) \>18 and \<29.9 kilogram per meter square (kg/m\^2) and body weight ≥50.0 kg to ≤100.0 kg for males and ≥40.0 kg to ≤90...

Countries:Canada
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Frequently asked questions about Fexofenadine Coated

What is Fexofenadine Coated?

Fexofenadine Coated is an investigational small molecule formulation developed by Sanofi. It is a coated tablet version of fexofenadine HCl that has been studied in healthy adult volunteers. The specific therapeutic indication for this coated formulation has not been disclosed.

What does Fexofenadine Coated target?

Fexofenadine Coated targets HRH1, the histamine H1 receptor, and acts as an antagonist at this receptor. By blocking HRH1, the drug interferes with histamine signaling at the receptor level. This target class is consistent with the antihistamine activity associated with fexofenadine.

Who makes Fexofenadine Coated?

Fexofenadine Coated is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor behind the clinical development of this coated tablet formulation of fexofenadine HCl.

What phase is Fexofenadine Coated in?

Fexofenadine Coated is in Phase 1 clinical development. It is an investigational formulation and is not approved. The Phase 1 program consists of one completed trial, with no active trials currently listed.

What clinical trials is Fexofenadine Coated in?

Fexofenadine Coated has been evaluated in one completed Phase 1 trial, NCT06284902, titled Bioavailability Study of Fexofenadine HCl New Formulation Tablet. The trial enrolled 25 healthy adult volunteers in Canada, used a randomized controlled design, and included both male and female participants aged 18 years and older.

Is Fexofenadine Coated the same as Fexofenadine HCl Coated tablet?

Yes, Fexofenadine Coated is also known as Fexofenadine HCl Coated tablet. Both names refer to the same Sanofi investigational product, a coated tablet formulation of fexofenadine HCl that has been studied in a Phase 1 bioavailability trial.