Fexofenadine
Allegr, Allegra, Fexofenadine (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
Therapeutic Areas
Trade Name
FDA
EMA
Allegra, Fexofenadine (discontinued: Allegra, Fexofenadine)
CombinationsAllegr, Fexofenadine pseudoephedrine (discontinued: Fexofenadine pseudoephedrine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fexofenadine hydrochloride
+
Pseudoephedrine hydrochloride
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 |
|---|---|---|
| 12hr allergy and congestion relief | ANDA | 2024-10-29 |
| 12hr allergy relief | ANDA | 2021-09-24 |
| 24hr allergy relief | ANDA | 2021-06-15 |
| allegra allergy | New Drug Application | 2025-02-19 |
| allegra allergy 24 hour | C200263 | 2025-02-11 |
| allegra allergy allegra allergy, travel basix | New Drug Application | 2024-11-19 |
| allegra allergy childrens allegra allergy | New Drug Application | 2014-03-24 |
| allegra d 12 hour allergy and congestion | New Drug Application | 2014-03-19 |
| allegra d-12 hour | New Drug Application | 2009-12-08 |
| allegra hives 24hr | New Drug Application | 2024-11-18 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fexofenadine Hydrochloride, Children'S Allegra Allergy, Chattem Sanofi | |||
| 8933097 | 2030-08-02 | DP | |
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Clinical
Clinical Trials
104 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 | D065631 | — | J30.9 | — | 4 | 5 | 20 | — | 28 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | 4 | 5 | 20 | — | 28 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 3 | 11 | — | 15 |
| Pruritus | D011537 | — | L29 | 1 | 1 | 1 | 4 | — | 7 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | 1 | — | 2 | — | 4 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | 3 | — | 3 |
| Chronic urticaria | D000080223 | — | L50.8 | 1 | 1 | — | 1 | — | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | 1 | 1 | 3 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | 1 | 2 | 1 | — | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 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 | — | — | 3 | — | — | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 1 | 1 | — | — | 2 |
| Eczema | D004485 | — | L30.9 | 1 | 1 | 1 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | 1 | 1 | 1 | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | 1 | — | — | 1 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | 1 | — | — | 1 |
| Sclerosis | D012598 | — | — | — | — | 1 | — | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | — | 1 |
| Cold temperature | D003080 | — | — | — | — | 1 | — | — | 1 |
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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 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | — | 1 | — | — | — | 1 |
| Nephrolithiasis | D053040 | — | N20.0 | — | 1 | — | — | — | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | 1 | — | — | — | 1 |
| Edema | D004487 | — | R60.9 | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | — | — | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | 1 | — | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | — | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | 1 | — | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 18 | — | — | — | 1 | 19 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 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 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transcatheter aortic valve replacement | D065467 | — | — | — | — | — | — | 4 | 4 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | — | — | — | 4 | 4 |
| Exercise | D015444 | EFO_0000483 | — | — | — | — | — | 2 | 2 |
| Histamine release | D006636 | — | — | — | — | — | — | 2 | 2 |
| Pathologic constriction | D003251 | — | — | — | — | — | — | 2 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 2 | 2 |
| Post-exercise hypotension | D057774 | EFO_1001828 | — | — | — | — | — | 2 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
Show 10 more
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 | — |
| ChEMBL ID | CHEMBL914 |
| ChEBI ID | 5050 |
| PubChem CID | 3348 |
| DrugBank | DB00950 |
| UNII ID | E6582LOH6V (ChemIDplus, GSRS) |
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Fexofenadine
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Fexofenadine
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Pseudoephedrine
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Safety
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30,542 adverse events reported
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