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
Trade Name
FDA
EMA
Xyzal (generic drugs available since 2010-11-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| childrens xyzal allergy | New Drug Application | 2021-07-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| allergic rhinitis seasonal | EFO_0003956 | D006255 | J30 |
| urticaria | EFO_0005531 | D014581 | L50 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levocetirizine Dihydrochloride, Xyzal Allergy 24hr, Chattem Sanofi | |||
| 8633194 | 2027-10-16 | DP | |
HCPCS
No data
Clinical
Clinical Trials
164 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 8 | 2 | 1 | 5 | 16 |
| Peripheral arterial disease | D058729 | EFO_0004265 | 2 | — | 1 | 1 | — | 4 | |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | 1 | 2 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | 2 | — | 3 |
| Muscle weakness | D018908 | HP_0001324 | — | — | — | 1 | 1 | 2 | |
| Poisoning | D011041 | EFO_0008546 | T65.91 | — | 1 | — | 1 | — | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | — | 1 | — | 2 |
| Intermittent claudication | D007383 | EFO_0003876 | I73.9 | — | — | 1 | 1 | — | 2 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | 1 | 1 | — | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 1 | 5 | — | 1 | 6 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 4 | 2 | — | — | 4 |
| Septic shock | D012772 | A48.3 | 2 | 2 | 1 | — | — | 4 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 1 | 1 | — | — | 3 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | — | 1 | 3 |
| Neoplasms | D009369 | C80 | — | 1 | 1 | — | 1 | 3 | |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | 2 | — | — | 3 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | 1 | 1 | — | — | 2 |
| Hyperthyroidism | D006980 | E05.9 | — | — | 1 | — | 1 | 2 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 6 | — | — | — | 6 |
| Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | — | 3 | 4 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | 1 | 2 |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | 1 | 2 | |
| Patient compliance | D010349 | — | 1 | — | — | 1 | 2 | ||
| Hyperbilirubinemia | D006932 | — | 1 | — | — | — | 1 | ||
| Prostatic neoplasms | D011471 | C61 | — | 1 | — | — | — | 1 | |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | — | — | — | 1 | |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 1 | — | — | — | 1 |
| Body weight changes | D001836 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diet therapy | D004035 | 1 | — | — | — | 1 | 2 | ||
| Healthy volunteers/patients | — | 1 | — | — | — | 1 | 2 | ||
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | 1 | 2 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | — | — | — | — | 1 |
| Ventricular heart septal defects | D006345 | Q21.0 | 1 | — | — | — | — | 1 | |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | 1 | — | — | — | — | 1 | ||
| Familial primary pulmonary hypertension | D065627 | I27.0 | 1 | — | — | — | — | 1 | |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | 1 | — | — | — | — | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 3 | 3 |
| Hepatic encephalopathy | D006501 | K72.91 | — | — | — | — | 3 | 3 | |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 2 | 2 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | — | — | 2 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 2 | 2 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | — | 1 | 1 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | 1 | |
| Musculoskeletal pain | D059352 | — | — | — | — | 1 | 1 | ||
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LEVOCETIRIZINE |
| INN | levocetirizine |
| Description | 2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid is a diarylmethane. |
| Classification | Small molecule |
| Drug class | Second generation antihistamines |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)COCCN1CCN([C@H](c2ccccc2)c2ccc(Cl)cc2)CC1 |
Identifiers
| PDB | 5DQF |
| CAS-ID | 130018-77-8 |
| RxCUI | 356887 |
| ChEMBL ID | CHEMBL1201191 |
| ChEBI ID | — |
| PubChem CID | 1549000 |
| DrugBank | DB06282 |
| UNII ID | 6U5EA9RT2O (ChemIDplus, GSRS) |
Target
Variants
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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338 adverse events reported
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