Ketotifen fumarate
Alaway, Ketotifen, Zaditor (ketotifen fumarate) is a small molecule pharmaceutical. Ketotifen fumarate was first approved as Ketotifen fumarate on 2006-05-09. It is used to treat allergic conjunctivitis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| eye diseases | D005128 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
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 |
| alaway preservative free | ANDA | 2022-05-04 |
| 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 | New Drug Application | 2024-10-01 |
| good neighbor pharmacy eye itch relief | ANDA | 2013-07-18 |
| itchy eye | ANDA | 2022-02-11 |
Show 4 more
Indications
FDA
EMA
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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 |
| Conjunctivitis | D003231 | HP_0000509 | H10 | 1 | 2 | 10 | 1 | 1 | 15 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 1 | — | 1 |
| Pleural effusion | D010996 | HP_0002202 | J90 | — | — | — | 1 | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | — | — | — | 1 | — | 1 |
| Dengue | D003715 | — | A90 | — | — | — | 1 | — | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | 1 | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | 1 | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | 1 | — | 1 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contracture | D003286 | HP_0001371 | M62.4 | — | 1 | 1 | — | — | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 2 | — | — | 2 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | 2 | — | — | 2 |
| Allergic rhinitis | D065631 | — | J30.9 | — | — | 2 | — | — | 2 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | — | 2 | — | — | 2 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 2 | — | — | 2 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | 1 | — | — | 1 |
| Eosinophilia | D004802 | HP_0001880 | D72.1 | — | — | 1 | — | — | 1 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | 1 | — | — | 1 |
| Lens subluxation | D007906 | HP_0001132 | H27.1 | — | — | 1 | — | — | 1 |
Show 10 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Visual acuity | D014792 | — | — | — | 1 | — | — | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 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 |
| Ocular physiological phenomena | D009799 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ketotifen fumarate |
| 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.O=C(O)/C=C/C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 34580-13-7 |
| RxCUI | 6146 |
| ChEMBL ID | CHEMBL1633 |
| ChEBI ID | — |
| PubChem CID | 3827 |
| DrugBank | DB00920 |
| UNII ID | X49220T18G (ChemIDplus, GSRS) |
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Safety
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Adverse Events
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6,088 adverse events reported
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