NDAORALCAPSULE
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
Drug data last refreshed 21h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cetirizine HCl is a second-generation H1-receptor antagonist indicated for allergic rhinitis and urticaria. Administered orally as a capsule, it crosses the blood-brain barrier minimally, reducing sedation compared to first-generation antihistamines. The drug works by selectively blocking histamine H1 receptors, thereby reducing allergic symptoms.
LOE Approaching
As LOE approaches, commercial teams face significant generic erosion; expect smaller dedicated teams and shift toward cost-management and brand-line extension strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Started Jul 2012
779 enrolled
Seasonal Allergic Rhinitis
Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg
Started Nov 2002
18 enrolled
Healthy
Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg
Started Nov 2002
26 enrolled
Healthy
Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)
Started Mar 2001
683 enrolled
Allergic RhinitisHay FeverSAR+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.