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
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 12 hour allergy d | ANDA | 2020-09-03 |
| 24 hour allergy | New Drug Application | 2024-04-01 |
| 24hr allergy relief | ANDA | 2024-10-22 |
| all day | ANDA | 2020-06-18 |
| all day allergy | ANDA | 2024-12-11 |
| all day allergy d | ANDA | 2025-02-12 |
| all day allergy relief | ANDA | 2024-12-20 |
| all day allergy relief d | ANDA | 2018-12-06 |
| allergy | ANDA | 2024-06-03 |
| allergy and congestion relief d | ANDA | 2023-05-30 |
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Indications
FDA
EMA
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
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Clinical
Clinical Trials
78 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rhinitis | D012220 | EFO_0008521 | J31 | 3 | 2 | 13 | 18 | 6 | 42 |
| Allergic rhinitis | D065631 | — | J30.9 | 1 | 2 | 11 | 18 | 5 | 37 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | 3 | 6 | 6 | 1 | 16 |
| Chronic urticaria | D000080223 | — | L50.8 | 1 | 3 | 5 | 6 | — | 14 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | 1 | — | 3 | 6 | 1 | 11 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 3 | 5 | 1 | 10 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 1 | — | 5 |
| Dermatitis | D003872 | — | L30.9 | 1 | — | 2 | 1 | — | 4 |
| Pruritus | D011537 | — | L29 | — | — | — | 2 | 1 | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | 4 | — | — | 4 |
| Vasomotor rhinitis | D012223 | EFO_0007533 | J30.0 | — | — | 1 | — | 1 | 2 |
| Seasonal affective disorder | D016574 | — | — | — | 1 | 1 | — | — | 2 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Cough | D003371 | — | R05 | — | 1 | — | — | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Fasting | D005215 | EFO_0002756 | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
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 | — |
| CAS-ID | 130018-77-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201191 |
| ChEBI ID | — |
| PubChem CID | 1549000 |
| DrugBank | DB06282 |
| UNII ID | 6U5EA9RT2O (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Levocetirizine
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Trends
PubMed Central
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Safety
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Adverse Events
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11,343 adverse events reported
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