NDAORALSOLUTION
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
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. Approved for seasonal allergic rhinitis. First approved in 1996.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYRTEC (cetirizine hydrochloride) is a second-generation H1-receptor antagonist antihistamine approved in 1996 for seasonal allergic rhinitis. It works by selectively inhibiting peripheral H1 receptors with negligible central nervous system penetration, offering non-sedating allergy symptom relief. The drug is administered orally as a solution and represents a foundational antihistamine in the OTC allergy market.
LOE Approaching
LOE approaching signals defensive positioning and potential transition to lifecycle management or portfolio optimization roles rather than growth-oriented expansion.
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 (1)
Clinical Trials (7)
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.