NDAORALSOLUTION
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
3/8 — Basic
ZYRTEC (cetirizine hydrochloride) by Johnson & Johnson is mechanism of actions cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral h 1 receptors. First approved in 1996.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYRTEC (cetirizine hydrochloride) is a second-generation selective peripheral H1-receptor antagonist indicated for allergic rhinitis and urticaria. It works by inhibiting histamine-mediated allergic responses without significant central nervous system penetration, providing non-sedating allergy relief.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and transitioning focus to lifecycle extensions or defending market share against generic erosion.
Mechanism of Action
Mechanism of Actions Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
Started Mar 2020
34 enrolled
Oncology Patients Receiving Chemotherapy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Started Jan 2006
30 enrolled
Healthy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Started Jan 2006
30 enrolled
Healthy
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Started Oct 2005
466 enrolled
DermatitisEczema
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Started Jul 2005
40 enrolled
Allergies
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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.