NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
May 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ZERVIATE (cetirizine) by Ichnos Glenmark Innovation is histamine h1 receptor antagonists [moa]. First approved in 2017.
Drug data last refreshed 4h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZERVIATE is a topical ophthalmic solution containing cetirizine, a histamine H1 receptor antagonist approved in 2017 for allergic conjunctivitis. It works by blocking histamine-mediated immune responses at the ocular surface to relieve itching and allergic symptoms. This is the only ophthalmic formulation of cetirizine, differentiating it from systemic antihistamines.
$9.0MPart D
Peak6.3 years to LOEPeak lifecycle positioning with $9M in Part D spending suggests mature market presence; teams are likely stable in size and focused on maintenance rather than aggressive growth.
Mechanism of Action
Histamine H1 Receptor Antagonists
Pharmacologic Class:
Histamine-1 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
Started Mar 2020
34 enrolled
Oncology Patients Receiving Chemotherapy
Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab
Started Feb 2020
19 enrolled
Multiple SclerosisInfusion Reaction
Cetirizine Chewable Bioequivalence and Food Effect Study
Started Dec 2018
40 enrolled
Allergy
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
Started May 2018
72 enrolled
Rhinitis
The Effect of Cetirizine on Bronchoconstriction
Started May 2018
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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.