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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 diseasesD005128
immune system diseasesD007154
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 ALAWAYBausch Health CompaniesN-021996 OTC2015-02-11
1 products, RLD
ALAWAYBausch Health CompaniesN-021996 OTC2006-12-01
1 products, RLD, RS
ACUVUE THERAVISION WITH KETOTIFENJohnson & JohnsonN-022388 PEND2022-02-25
1 products, RLD
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
alawayNew Drug Application2021-09-22
ketotifen fumarateNDA authorized generic2023-05-11
zaditor ANDA2020-10-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic conjunctivitisEFO_0007141D003233H10.44
Agency Specific
FDA
EMA
Expiration
Code
KETOTIFEN FUMARATE, ACUVUE THERAVISION WITH KETOTIFEN, JOHNSON JOHNSON VISN
2025-02-25NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Ketotifen Fumarate, Acuvue Theravision With Ketotifen, Johnson Johnson Visn
99623762030-06-27DP
94747462028-03-27DP
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
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19111——2
Multidrug-resistant tuberculosisD018088EFO_0007381—12——2
Extensively drug-resistant tuberculosisD054908—11——1
Colorectal neoplasmsD015179——1——1
Indications Phases 2
No data
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
Hiv infectionsD015658EFO_0000764B20————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameKETOTIFEN
INNketotifen
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-ID34580-13-7
RxCUI6146
ChEMBL IDCHEMBL534
ChEBI ID—
PubChem CID3827
DrugBankDB00920
UNII IDX49220T18G (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 2,261 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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267 adverse events reported
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