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fexofenadine HCL (M016455)
Fexofenadine HCL is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergy symptoms.
Fexofenadine HCL is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergy symptoms. Used for Seasonal allergic rhinitis, Perennial allergic rhinitis.
At a glance
| Generic name | fexofenadine HCL (M016455) |
|---|---|
| Sponsor | Sanofi |
| Drug class | Histamine H1 receptor antagonist |
| Target | H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy |
| Phase | Phase 3 |
Mechanism of action
Fexofenadine HCL is a non-sedating antihistamine that selectively inhibits peripheral H1-receptors. This results in the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, runny nose, and itchy, watery eyes.
Approved indications
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
Common side effects
- Headache
- Dizziness
- Nausea
- Fatigue
- Dry mouth
Key clinical trials
- Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants (PHASE3)
- Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD) (PHASE2, PHASE3)
- Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR) (PHASE2, PHASE3)
- Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- fexofenadine HCL (M016455) CI brief — competitive landscape report
- fexofenadine HCL (M016455) updates RSS · CI watch RSS
- Sanofi portfolio CI