Ketotifen fumarate
Alaway, 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. It is known to target histamine H1 receptor.
Download report
Favorite
Top OTC Drugs
Commercial
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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alaway | New Drug Application | 2021-09-22 |
| ketotifen fumarate | NDA authorized generic | 2023-05-11 |
| zaditor | ANDA | 2020-10-16 |
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
35 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | — | 15 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 1 | — | 1 |
| Pleural effusion | D010996 | 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 | 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
No data
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 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,261 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
14,286 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more