Zyrtec
(Cetirizine)ApprovedSmall molecule
Cetirizine is used to relieve allergy symptoms like sneezing, itchy eyes, runny nose, and hives. It's an antihistamine that helps reduce the effects of allergic reactions in your body.[2] Zyrtec is currently approved and in use across 22 indications[4].[1]
Zyrtec is one of 462 small molecule programs targeting Eye Allergy. It is currently in Approved.
22
Indications
49
Total Trials
2
Active Trials
461
Competitors
8
FDA Applications
NDA/BLA/ANDA regulatory filings
11
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 21 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Zyrtec
KKenvue Brands
Approved
Spikevax
ModernaPreclinical
Bnt162b2
BioNTechPreclinical
COVID-19 Vaccine
ModernaPreclinical
Biaxin
AbbViePreclinical
Nexavar
BayerPreclinical
Singulair
AstraZenecaPreclinical
Stivarga
BayerPreclinical
Aimovig
AmgenPreclinical
Aldactone
PfizerPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Seasonal Allergic Rhinitis7 trials
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)
Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT02932774·683 enrolled
Show 4 more trials
Allergic Rhinitis5 trials
Show 2 more trials
Allergies3 trials
Prospective2 trials
Chronic Idiopathic Urticaria2 trials
26 more indications
Children2 trials
Androgenetic Alopecia2 trials
Topical Cetirizine in Androgenetic Alopecia in Females
Completed·—·Phase 2/3·NCT04481412·66 enrolled
Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia
Unknown status·—·Phase 4·NCT04293822·60 enrolled
Acute Lymphoblastic Leukemia2 trials
Urticaria2 trials
Premedication1 trial
Single Dose1 trial
Adult1 trial
Infusion1 trial
Clinical Trial1 trial
Dermatitis1 trial
Double-blind1 trial
Multiple Sclerosis1 trial
Unspecified1 trial
Cetirizine Chewable Bioequivalence and Food Effect Study
Completed·JJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·Phase 1·NCT03772158·40 enrolled
Regulatory
FDA Approval Timeline[5]
Sep 27, 1996
ZYRTEC
NDA NDA020346
Nov 16, 2007
ZYRTEC ALLERGY
NDA NDA019835
Nov 16, 2007
CHILDREN'S ZYRTEC ALLERGY
NDA NDA022155
Jul 23, 2009
CETIRIZINE HYDROCHLORIDE ALLERGY
NDA NDA022429
Sep 3, 2010
ZYRTEC ALLERGY
NDA NDA022578
May 30, 2017
ZERVIATE
NDA NDA208694
Oct 4, 2019
QUZYTTIR
NDA NDA211415
Nov 30, 2020
CHILDREN'S ZYRTEC ALLERGY
NDA NDA021621
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Zyrtec drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Cetirizine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Zyrtec. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Histamine H1 Receptor Antagonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- KKenvue Brands
Patent Landscape[6]
Patent Cliff
Feb 11, 2030
Earliest patent expiration — generic entry possible after this date
Patent #Expires
9119771Feb 11, 2030
9180090Feb 11, 2030
8513259Feb 11, 2030
8314083Feb 28, 2030
8263581Feb 28, 2030
6 more patents
9993471Mar 15, 2030
8829005Mar 15, 2030
9750684Mar 15, 2030
8829005*PEDSep 15, 2030
9254286Jul 9, 2032
9254286*PEDJan 9, 2033