Skip to main content

fexofenadine

Generic: FEXOFENADINE HYDROCHLORIDE·Brand: ALLEGRA, ALLEGRA ALLERGY, ALLEGRA HIVES, Allegra, Allegra-D, CHILDREN'S ALLEGRA ALLERGY, CHILDREN'S ALLEGRA HIVES, CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE HIVES, Wal-Fex, Wal-Fex D

fexofenadine: developed by 2 companies · 5 clinical trials tracked · 6 FDA decisions.

fexofenadine evidence translation

What we can confirm

6 FDA records · 5 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about fexofenadine, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 1 study sponsors

Related indications

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throatHealthy VolunteersSeasonal Allergic Rhinitis
Development Pipeline (2)
CompanyPhase
DR REDDYS LABORATORIES LTD (RDY)Approved
Sanofi (SNY)
Uses temporarily relieves these symptoms due to hay fever or…
Approved
Clinical Trials (5)

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

NCT07118215·Phase 1·BMY
Completed

Primary endpoint: Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT

Interventionalopen62 enrolledStarted 2025-09Completion 2026-061 site · United StatesKaruna Therapeutics, Inc., a Bristol Myers Squibb company

A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)

NCT05720455·Phase 4·SNY
Completed

Primary endpoint: Number of participants with treatment-emergent adverse events (TEAEs)

Interventionalopen203 enrolledStarted 2025-06Completion 2025-1211 sites · IndiaSanofi

A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion

NCT06019728·Phase 4·SNY
Completed

Primary endpoint: Percent Reduction in Shortest Tolerated Infusion Duration From Pre-study Average of Recent 3 Infusions

Interventionalopen8 enrolledStarted 2023-11Completion 2024-105 sites · United StatesSanofi

A Phase IIIb, Single-center, Double-blind, Two-arms, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of 2-day Pre-treatment With Fexofenadine in Patients Suffering From Seasonal Allergic Rhinitis

NCT05692154·Phase 3·SNY
Completed

Primary endpoint: Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3)

InterventionalRandomizedquadruple95 enrolledStarted 2023-01Completion 2023-031 site · CanadaOpella Healthcare Group SAS, a Sanofi Company

Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)

NCT05263206·Phase 3·SNY
Recruiting

Primary endpoint: Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24

InterventionalRandomizedquadruple284 targetStarted 2022-02Completion 2027-0850 sites · Argentina, Canada, China, France…Sanofi
FDA Decisions6 records
ApprovalUse(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose(RDY)FDA ↗
ANDA215434UNKNOWNStandardOralTablet, Extended Release
Approval(RDY)FDA ↗
ANDA076667OralTablet, Extended Release
Approval(RDY)FDA ↗
ANDA202978UNKNOWNOralTablet, Orally Disintegrating
ApprovalUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat(SNY)FDA ↗
NDA201373Type 8 - Partial Rx to OTC SwitchStandardOralSuspension
ApprovalUse(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose(RDY)FDA ↗
ANDA079043OralTablet, Extended Release
ApprovalUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat(SNY)FDA ↗
NDA021909Type 3 - New Dosage FormStandardOralTablet, Orally Disintegrating

Frequently asked questions

Who is developing fexofenadine?

fexofenadine is being developed by DR REDDYS LABORATORIES LTD, Sanofi.

How many clinical trials involve fexofenadine?

BioSniper tracks 5 clinical trials involving fexofenadine.

What is fexofenadine's latest FDA decision?

The most recent tracked FDA decision for fexofenadine is Approval for Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose, dated May 31, 2022.