Loratadine
Alavert, Claritin (loratadine) is a small molecule pharmaceutical. Loratadine was first approved as Claritin on 2002-11-27. It is used to treat allergic rhinitis perennial and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor. In addition, it is known to target sodium-dependent neutral amino acid transporter B(0)AT2.
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Commercial
Trade Name
FDA
EMA
Alavert, Claritin (generic drugs available since 2003-01-21)
CombinationsClaritin (generic drugs available since 2003-01-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Loratadine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CLARITIN HIVES RELIEF | Bayer | N-019658 OTC | 2003-11-19 | 1 products, RLD, RS |
| CLARITIN | Bayer | N-019658 OTC | 2002-11-27 | 1 products, RLD, RS |
| CLARITIN | Bayer | N-020641 OTC | 2002-11-27 | 1 products, RLD, RS |
| CLARITIN HIVES RELIEF REDITAB | Bayer | N-020704 OTC | 2003-11-19 | 1 products, RLD, RS |
| CLARITIN REDITABS | Bayer | N-020704 OTC | 2002-11-27 | 1 products, RLD, RS |
| CLARITIN | Bayer | N-021891 OTC | 2018-11-21 | 1 products, RLD, RS |
| CHILDREN'S CLARITIN | Bayer | N-021891 OTC | 2006-08-23 | 1 products, RLD |
| CLARITIN | Bayer | N-021952 OTC | 2008-06-16 | 1 products, RLD, RS |
| CLARITIN REDITABS | Bayer | N-021993 OTC | 2006-12-12 | 1 products, RLD, RS |
| ALAVERT | Foundation Consumer Healthcare | N-021375 OTC | 2002-12-19 | 1 products |
Show 1 marketed
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alavert | ANDA | 2021-12-07 |
| allergy relief | ANDA | 2023-06-14 |
| claritin | ANDA | 2023-05-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| urticaria | EFO_0005531 | D014581 | L50 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
67 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | — | 9 | 3 | 1 | 13 |
| Allergic rhinitis | D065631 | J30.9 | — | 3 | 3 | 5 | — | 11 | |
| Healthy volunteers/patients | — | 2 | — | — | 1 | 4 | 7 | ||
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | 1 | 1 | 2 | 2 | 6 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | 1 | 2 | 3 | — | 6 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | 2 | — | — | 3 |
| Conjunctivitis | D003231 | H10 | — | — | 2 | — | — | 2 | |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | 1 | 1 | — | — | 2 | |
| Pruritus | D011537 | HP_0000989 | L29 | — | — | 1 | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | 1 | — | — | 1 |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Chronic urticaria | D000080223 | L50.8 | — | 1 | — | — | — | 1 | |
| Bone nails | D001858 | — | 1 | — | — | — | 1 | ||
| Lymphangioleiomyomatosis | D018192 | J84.81 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | 1 | 2 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | C90.0 | 1 | — | — | — | — | 1 | |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | — | — | — | — | 1 | 1 | |
| Urticaria | D014581 | EFO_0005531 | L50 | — | — | — | — | 1 | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LORATADINE |
| INN | loratadine |
| Description | Loratadine is a benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders. It has a role as a geroprotector, a H1-receptor antagonist, an anti-allergic agent and a cholinergic antagonist. It is an ethyl ester, a N-acylpiperidine, a tertiary carboxamide, an organochlorine compound and a benzocycloheptapyridine. It is functionally related to a desloratadine. |
| Classification | Small molecule |
| Drug class | tricyclic histaminic-H1 receptor antagonists, loratadine derivatives (formerly-tadine) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 79794-75-5 |
| RxCUI | 28889 |
| ChEMBL ID | CHEMBL998 |
| ChEBI ID | — |
| PubChem CID | 3957 |
| DrugBank | DB00455 |
| UNII ID | 7AJO3BO7QN (ChemIDplus, GSRS) |
Target
Alternate
SLC6A15
SLC6A15
Organism
Homo sapiens
Gene name
SLC6A15
Gene synonyms
B0AT2, NTT73, SBAT1
NCBI Gene ID
Protein name
sodium-dependent neutral amino acid transporter B(0)AT2
Protein synonyms
homolog of rat orphan transporter v7-3, orphan sodium- and chloride-dependent neurotransmitter transporter NTT73, orphan transporter v7-3, Sodium- and chloride-dependent neurotransmitter transporter NTT73, Sodium-coupled branched-chain amino-acid transporter 1, sodium/chloride dependent neurotransmitter transporter Homo sapiens orphan neurotransmitter transporter NTT7, solute carrier family 6 (neurotransmitter transporter), member 15, solute carrier family 6 (neutral amino acid transporter), member 15, Solute carrier family 6 member 15, Transporter v7-3
Uniprot ID
Mouse ortholog
Slc6a15 (103098)
sodium-dependent neutral amino acid transporter B(0)AT2 (Q8BG16)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18,180 adverse events reported
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