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Cetirizine

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Cetirizine development status

FDA approval on record Aug 10, 2001
Approval holderKenvue Brands
ApplicationNDA021150
Highest phase Phase 4 run by GlaxoSmithKline (NCT01916226)
Phase scored for VTRSPhase 1
Registered trials 11 across 7 sponsors since Jun 2007

Cetirizine target and mechanism

Molecular targetHRH1
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment44

FDA Designations

No designations recorded

Cetirizine clinical trials

Cetirizine · 2 trials · 1 indication

Phase 1 2
NCT00649857Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mgHealthy
COMPLETED18 Analytics
NCT00650065Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mgHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCetirizine HCl Tablets 10 mg
2ACTIVE_COMPARATORZyrtec® 10 mg

Interventions

NameTypeDescription
Cetirizine HCl Tablets 10 mgDRUG10mg, single dose fed
Zyrtec® 10 mgDRUG10mg, single dose fed
Zyrtec® Tablets 10 mgDRUG10mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...

Countries:United States
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Frequently asked questions about Cetirizine

What is Cetirizine?

Cetirizine is a small molecule drug developed by Viatris Inc., which trades under the ticker VTRS. It is also known as Cetirizine HCl Tablets 10 mg. The drug is in Phase 1 clinical development, and its studied indications are undisclosed.

What does Cetirizine target?

Cetirizine targets HRH1, the histamine H1 receptor. It acts as an antagonist at this receptor. This target class places Cetirizine among histamine H1 receptor antagonists, which is the mechanism described for this small molecule asset.

Who makes Cetirizine?

Cetirizine is developed by Viatris Inc., a company that trades on the stock market under the ticker symbol VTRS. Viatris is the sponsor associated with the clinical trials of Cetirizine HCl Tablets 10 mg.

What phase is Cetirizine in?

Cetirizine is in Phase 1 clinical development. It is an investigational drug and is not approved. Two Phase 1 trials of Cetirizine have been completed, and no trials are currently active.

What clinical trials is Cetirizine in?

Two completed Phase 1 trials have studied Cetirizine. NCT00650065 was a fasting study comparing Cetirizine HCl Tablets 10 mg with Zyrtec tablets 10 mg in 26 healthy volunteers. NCT00649857 was a food study of the same comparison in 18 healthy volunteers. Both enrolled adults in the United States.