Fexofenadine
Allegr, Allegra (fexofenadine) is a small molecule pharmaceutical. Fexofenadine was first approved as Allegra on 1996-07-25. It is used to treat allergic rhinitis perennial and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Trade Name
FDA
EMA
Allegra (generic drugs available since 2005-09-01)
CombinationsAllegr (generic drugs available since 2005-09-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fexofenadine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ALLEGRA ALLERGY | Sanofi | N-020872 OTC | 2011-01-24 | 1 products, RLD |
ALLEGRA HIVES | Sanofi | N-020872 OTC | 2011-01-24 | 1 products, RLD, RS |
ALLEGRA ALLERGY | Sanofi | N-020872 OTC | 2011-01-24 | 1 products, RLD, RS |
CHILDREN'S ALLEGRA ALLERGY | Sanofi | N-201373 OTC | 2011-01-24 | 1 products, RLD, RS |
Show 8 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
allegra hives 24hr | New Drug Application | 2023-04-10 |
fexofenadine | ANDA | 2023-06-20 |
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
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Fexofenadine Hydrochloride, Children'S Allegra Allergy, Chattem Sanofi | |||
8933097 | 2030-08-02 | DP |
HCPCS
No data
Clinical
Clinical Trials
74 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 | — | 1 | 1 | 9 | — | 11 |
Allergic rhinitis | D065631 | J30.9 | — | 2 | — | 8 | — | 10 | |
Pruritus | D011537 | HP_0000989 | L29 | 1 | 1 | 1 | 2 | — | 5 |
Rhinitis | D012220 | EFO_0008521 | J31 | — | 1 | 3 | 1 | — | 4 |
Gout | D006073 | EFO_0004274 | M10 | — | — | — | 2 | — | 2 |
Urticaria | D014581 | EFO_0005531 | L50 | 1 | — | — | 1 | — | 2 |
Chronic urticaria | D000080223 | L50.8 | 1 | — | — | 1 | — | 2 | |
Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 1 | 1 | — | 2 |
Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | 1 | — | 1 |
Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Asthma | D001249 | EFO_0000270 | J45 | — | — | 3 | — | — | 3 |
Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 1 | 1 | — | — | 2 |
Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | 1 | |
Chronic progressive multiple sclerosis | D020528 | — | — | 1 | — | — | 1 | ||
Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | — | — | 1 | |
Cold temperature | D003080 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | 1 | — | — | — | 1 |
Nephrolithiasis | D053040 | N20.0 | — | 1 | — | — | — | 1 | |
Edema | D004487 | R60.9 | — | 1 | — | — | — | 1 | |
Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 13 | — | — | — | 1 | 14 | ||
Drug interactions | D004347 | 2 | — | — | — | — | 2 | ||
Magnetic resonance imaging | D008279 | 1 | — | — | — | — | 1 | ||
Oral administration | D000284 | 1 | — | — | — | — | 1 | ||
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | — | 1 |
Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
Pulmonary arterial hypertension | D000081029 | 1 | — | — | — | — | 1 | ||
Non-small-cell lung carcinoma | D002289 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | 1 | |
Food-drug interactions | D018565 | — | — | — | — | 1 | 1 | ||
Renal colic | D056844 | EFO_1001412 | N23 | — | — | — | — | 1 | 1 |
Transcatheter aortic valve replacement | D065467 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | FEXOFENADINE |
INN | fexofenadine |
Description | Fexofenadine is a piperidine-based anti-histamine compound. It has a role as a H1-receptor antagonist and an anti-allergic agent. It is a member of piperidines and a tertiary amine. It is functionally related to an isobutyric acid. |
Classification | Small molecule |
Drug class | Antihistamine; H1 receptor antagonist |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC(C)(C(=O)O)c1ccc(C(O)CCCN2CCC(C(O)(c3ccccc3)c3ccccc3)CC2)cc1 |
Identifiers
PDB | — |
CAS-ID | 83799-24-0 |
RxCUI | 87636 |
ChEMBL ID | CHEMBL914 |
ChEBI ID | 5050 |
PubChem CID | 3348 |
DrugBank | DB00950 |
UNII ID | E6582LOH6V (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,369 adverse events reported
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