Ketotifen
Alaway, Ketotifen, 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, Ketotifen, Zaditor (discontinued: Acuvue theravision with ketotifen, Alaway, Zaditor)
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 |
|---|---|---|---|---|
| ALAWAY | Bausch Health Companies | N-021996 OTC | 2006-12-01 | 1 products, RLD, RS |
| CHILDREN'S ALAWAY | Bausch Health Companies | N-021996 OTC | 2015-02-11 | 1 products, RLD |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acuvue theravision with ketotifen | New Drug Application | 2022-03-11 |
| alaway | New Drug Application | 2022-05-01 |
| allergy eye drops | ANDA | 2022-01-25 |
| equate eye itch relief | New Drug Application | 2021-03-23 |
| eye itch | ANDA | 2022-02-10 |
| eye itch releif | New Drug Application | 2024-07-22 |
| eye itch relief | ANDA | 2025-09-12 |
| good neighbor pharmacy eye itch relief | ANDA | 2013-07-18 |
| itchy eye | ANDA | 2022-02-11 |
| ketotifen fumarate | ANDA | 2025-07-11 |
Show 3 more
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
No data
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 | 12 | 1 | — | 16 |
| Conjunctivitis | D003231 | — | H10 | 1 | — | 4 | 1 | — | 6 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 1 | — | 1 |
| Pleural effusion | D010996 | — | J90 | — | — | — | 1 | — | 1 |
| Dengue | D003715 | — | A90 | — | — | — | 1 | — | 1 |
| Severe dengue | D019595 | — | A91 | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 2 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | 2 | — | — | 2 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 2 | — | — | 2 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | 1 | — | — | 1 |
| Eosinophilia | D004802 | — | D72.1 | — | — | 1 | — | — | 1 |
| Lens subluxation | D007906 | — | H27.1 | — | — | 1 | — | — | 1 |
| Elbow tendinopathy | D000070639 | — | M77.0 | — | — | 1 | — | — | 1 |
| Elbow injuries | D000092464 | — | — | — | — | 1 | — | — | 1 |
| Elbow fractures | D000092482 | — | — | — | — | 1 | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Visual acuity | D014792 | — | — | — | 1 | — | — | — | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | 1 | — | — | — | 1 |
| Contracture | D003286 | EFO_0003899 | M62.4 | — | 1 | — | — | — | 1 |
| Joint dislocations | D004204 | — | — | — | 1 | — | — | — | 1 |
| Peanut hypersensitivity | D021183 | EFO_0007425 | — | — | 1 | — | — | — | 1 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pruritus | D011537 | — | 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 |
| Ocular physiological phenomena | D009799 | — | — | — | — | — | — | 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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Estimated US medical usage
Ketotifen
Total medical expenditures per year (USD, in millions)
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Safety
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Adverse Events
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5,377 adverse events reported
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