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fexofenadine HCl
Fexofenadine is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses without crossing the blood-brain barrier.
Fexofenadine is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses without crossing the blood-brain barrier. Used for Allergic rhinitis (seasonal and perennial), Chronic idiopathic urticaria.
At a glance
| Generic name | fexofenadine HCl |
|---|---|
| Also known as | Allegra |
| Sponsor | Sanofi |
| Drug class | Second-generation H1-receptor antagonist (non-sedating antihistamine) |
| Target | H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy/Immunology |
| Phase | FDA-approved |
Mechanism of action
Fexofenadine competitively binds to peripheral H1 histamine receptors on mast cells and basophils, preventing histamine-induced allergic symptoms such as itching, hives, and rhinitis. Unlike first-generation antihistamines, it is highly selective for peripheral H1 receptors and does not significantly penetrate the central nervous system, resulting in minimal sedation.
Approved indications
- Allergic rhinitis (seasonal and perennial)
- Chronic idiopathic urticaria
Common side effects
- Headache
- Nausea
- Dyspepsia
- Fatigue
Key clinical trials
- A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With Alcohol (PHASE1, PHASE2)
- Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) (PHASE3)
- A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer (PHASE1)
- A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin (PHASE1)
- 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 (PHASE4)
- The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction (PHASE3)
- Fexofenadine as Adjuvant Therapy in Parkinson Disease (PHASE2, PHASE3)
- Excipient Effect on Drug Absorption in Humans (EARLY_PHASE1)
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 CI brief — competitive landscape report
- fexofenadine HCl updates RSS · CI watch RSS
- Sanofi portfolio CI