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Drug ReportsLevocetirizine
Levocetirizine
Levocetirizine, Xyzal (levocetirizine) is a small molecule pharmaceutical. Levocetirizine was first approved as Xyzal on 2007-05-25. It is used to treat allergic rhinitis perennial, allergic rhinitis seasonal, and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Levocetirizine, Xyzal (discontinued: Levocetirizine, Xyzal)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levocetirizine dihydrochloride
Tradename
Company
Number
Date
Products
XYZAL ALLERGY 24HRSanofiN-209089 OTC2017-01-31
1 products, RLD, RS
XYZAL ALLERGY 24HRSanofiN-209090 OTC2017-01-31
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
12 hour allergy dANDA2020-09-03
24 hour allergyNew Drug Application2024-04-01
24hr allergy reliefANDA2024-10-22
all dayANDA2020-06-18
all day allergyANDA2023-03-20
all day allergy dANDA2020-08-31
all day allergy reliefANDA2024-08-05
all day allergy relief dANDA2018-12-06
all day allergy-dANDA2022-06-13
allergyANDA2024-06-03
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Levocetirizine Dihydrochloride, Xyzal Allergy 24hr, Chattem Sanofi
86331942027-10-16DP
ATC Codes
R: Respiratory system drugs
R06: Antihistamines for systemic use
R06A: Antihistamines for systemic use
R06AE: Piperazine derivatives, systemic antihistamines
R06AE09: Levocetirizine
HCPCS
No data
Clinical
Clinical Trials
195 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RhinitisD012220EFO_0008521J3141023291278
Allergic rhinitisD065631J30.921021291173
Allergic rhinitis seasonalD006255EFO_0003956J307513530
UrticariaD014581EFO_0005531L502299223
Allergic rhinitis perennialD012221EFO_1001417J30.891910121
Healthy volunteers/patients1212217
Chronic urticariaD000080223L50.8126816
HypersensitivityD006967HP_0012393T78.40613111
AsthmaD001249EFO_0000270J452438
DermatitisD003872HP_0011123L30.9113117
Show 21 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis bD00650944
Chronic hepatitis bD019694EFO_0004239B18.144
HepatitisD006505HP_0012115K75.944
Hepatitis aD006506EFO_0007305B1544
DiseaseD004194EFO_0000408R691123
SyndromeD013577213
Nephrotic syndromeD009404EFO_0004255N0422
NephrosisD00940122
Colorectal neoplasmsD01517911
Hepatitis dD003699EFO_000730411
Show 19 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E4644
FastingD005215EFO_000275622
Chronic progressive multiple sclerosisD020528EFO_000384011
ProstatitisD011472EFO_0003830N4111
Pelvic painD01769911
Migraine disordersD008881EFO_0003821G4311
Larva migransD007815EFO_0007391B76.911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Irritable bowel syndromeD043183EFO_0000555K5811
DiarrheaD003967HP_0002014R19.711
CognitionD003071EFO_000392511
Actinic keratosisD055623L57.011
KeratosisD00764211
SinusitisD012852EFO_0007486J3211
Peripheral nervous system diseasesD010523HP_0009830G6411
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLevocetirizine
INNlevocetirizine
Description
2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid is a diarylmethane.
Classification
Small molecule
Drug classSecond generation antihistamines
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)COCCN1CCN([C@H](c2ccccc2)c2ccc(Cl)cc2)CC1
Identifiers
PDB
CAS-ID130018-77-8
RxCUI
ChEMBL IDCHEMBL1201191
ChEBI ID
PubChem CID1549000
DrugBankDB06282
UNII ID6U5EA9RT2O (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Levocetirizine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,774 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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53,002 adverse events reported
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