Ketotifen
Alaway, Zaditor (ketotifen) is a small molecule pharmaceutical. Ketotifen was first approved as Ketotifen fumarate on 2006-05-09. It is used to treat allergic conjunctivitis in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| eye diseases | D005128 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Alaway, Zaditor (generic drugs available since 2006-05-09)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ketotifen fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CHILDREN'S ALAWAY | Bausch Health Companies | N-021996 OTC | 2015-02-11 | 1 products, RLD |
| ALAWAY | Bausch Health Companies | N-021996 OTC | 2006-12-01 | 1 products, RLD, RS |
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic conjunctivitis | EFO_0007141 | D003233 | H10.44 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
KETOTIFEN FUMARATE, ACUVUE THERAVISION WITH KETOTIFEN, JOHNSON JOHNSON VISN | |||
| 2025-02-25 | NP | ||
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AX: Other antihistamines for systemic use in atc
— R06AX17: Ketotifen
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX08: Ketotifen
HCPCS
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Clinical
Clinical Trials
38 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 conjunctivitis | D003233 | EFO_0007141 | H10.44 | 1 | 2 | 11 | 1 | 1 | 16 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 1 | — | 1 |
| Pleural effusion | D010996 | HP_0002202 | J90 | — | — | — | 1 | — | 1 |
| Dengue | D003715 | — | A90 | — | — | — | 1 | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 2 | — | — | 2 |
| Lens subluxation | D007906 | HP_0001132 | H27.1 | — | — | 1 | — | — | 1 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | 1 | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 1 | — | — | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | 1 | — | — | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | 1 | — | — | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 1 | — | — | 1 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Visual acuity | D014792 | — | — | — | 1 | — | — | — | 1 |
| Peanut hypersensitivity | D021183 | EFO_0007425 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pruritus | D011537 | HP_0000989 | L29 | — | — | — | — | 1 | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 1 | 1 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 1 | 1 |
| Fuchs' endothelial dystrophy | D005642 | EFO_0003946 | H18.51 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ketotifen |
| INN | ketotifen |
| Description | Ketotifen is an organic heterotricyclic compound that is 4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one which is substituted at position 4 by a 1-methylpiperidin-4-ylidene group. A blocker of histamine H1 receptors with a stabilising action on mast cells, it is used (usually as its hydrogen fumarate salt) for the treatment of asthma, where it may take several weeks to exert its full effect. It has a role as a H1-receptor antagonist and an anti-asthmatic drug. It is an organosulfur heterocyclic compound, an organic heterotricyclic compound, a cyclic ketone, a member of piperidines, an olefinic compound and a tertiary amino compound. It is a conjugate base of a ketotifen(1+). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCC(=C2c3ccccc3CC(=O)c3sccc32)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 34580-13-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL534 |
| ChEBI ID | — |
| PubChem CID | 3827 |
| DrugBank | DB00920 |
| UNII ID | X49220T18G (ChemIDplus, GSRS) |
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Ketotifen
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PubMed Central
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Safety
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Adverse Events
Top Adverse Reactions
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5,352 adverse events reported
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