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Drug ReportsMontelukast
Montelukast
Montelukast, Singulair (montelukast) is a small molecule pharmaceutical. Montelukast was first approved as Singulair on 1998-02-20. It is used to treat allergic rhinitis perennial and asthma in the USA. The pharmaceutical is active against cysteinyl leukotriene receptor 1. In addition, it is known to target uracil nucleotide/cysteinyl leukotriene receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
Trade Name
FDA
EMA
Singulair (generic drugs available since 2012-08-03)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Montelukast sodium
Tradename
Company
Number
Date
Products
SINGULAIROrganonN-020829 RX1998-02-20
1 products, RLD, RS
SINGULAIROrganonN-020830 RX1998-02-20
2 products, RLD, RS
SINGULAIROrganonN-021409 RX2002-07-26
1 products, RLD, RS
Labels
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03D: Other systemic drugs for obstructive airway diseases in atc
— R03DC: Leukotriene receptor antagonists for obstructive airway diseases
— R03DC03: Montelukast
— R03DC53: Montelukast, combinations
HCPCS
No data
Clinical
Clinical Trials
350 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J451329404630153
Allergic rhinitisD065631—J30.942210422
Healthy volunteers/patients———16——1219
Allergic rhinitis seasonalD006255EFO_0003956J30—1124118
Allergic rhinitis perennialD012221EFO_1001417J30.89——62—8
Exercise-induced asthmaD001250—J45.9901—4218
Bronchiolitis obliteransD001989EFO_0007183——4—116
CoughD003371HP_0012735R05—1—236
Obstructive sleep apneaD020181EFO_0003918G47.33——2215
Atopic dermatitisD003876EFO_0000274L20———314
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1—33—27
BronchiolitisD001988HP_0011950——21—36
Rheumatoid arthritisD001172EFO_0000685M06.9311——5
Lung diseasesD008171HP_0002088J98.4—21—24
Status asthmaticusD013224———32—14
Multiple myelomaD009101—C90.0111——3
Eosinophilic esophagitisD057765EFO_0004232K20.01—1—13
Sickle cell anemiaD000755EFO_0000697D57—21——2
DiseaseD004194EFO_0000408R69——1——1
DengueD003715—A90—11——1
Show 13 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bronchiolitis obliterans syndromeD000092122—D89.811—1——12
Alzheimer diseaseD000544EFO_0000249F03—2———2
Bronchopulmonary dysplasiaD001997—P27.811———2
Interstitial lung diseasesD017563HP_0006530J84.89—1———1
Cryptogenic organizing pneumoniaD018549EFO_1001300J84.116—1———1
Ovarian neoplasmsD010051EFO_0003893C56—1———1
Fallopian tube neoplasmsD005185———1———1
Peritoneal neoplasmsD010534———1———1
Food-drug interactionsD018565———1———1
Immune system diseasesD007154—D89.911———1
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.91———12
Hiv infectionsD015658EFO_0000764B202————2
Respiration disordersD012120—J00-J992————2
Anterior cruciate ligament injuriesD000070598——1————1
Neonatal sepsisD000071074HP_0040187—1————1
Drug interactionsD004347——1————1
Hepatitis cD006526—B19.21————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EosinophiliaD004802HP_0001880D72.1————22
DyspepsiaD004415EFO_0008533K30————22
InflammationD007249MP_0001845—————22
Nephrotic syndromeD009404EFO_0004255N04————11
Crest syndromeD017675—M34.1————11
DepressionD003863—F33.9————11
AnxietyD001007EFO_0005230F41.1————11
Gastroesophageal refluxD005764EFO_0003948K21————11
Chronic renal insufficiencyD051436—N18————11
Conductive hearing lossD006314HP_0000405H90.2————11
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMontelukast
INNmontelukast
Description
Montelukast is a member of quinolines, a monocarboxylic acid and an aliphatic sulfide. It has a role as a leukotriene antagonist, an anti-asthmatic drug and an anti-arrhythmia drug. It is a conjugate acid of a montelukast(1-).
Classification
Small molecule
Drug classantiasthmatics/antiallergics (not acting primarily as antihistamines): leukotriene receptor antagonists
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Structure (InChI/SMILES or Protein Sequence)
CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Identifiers
PDB—
CAS-ID158966-92-8
RxCUI—
ChEMBL IDCHEMBL787
ChEBI ID50730
PubChem CID5281040
DrugBankDB00471
UNII IDMHM278SD3E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP2C8
CYP2C8
Organism
Homo sapiens
Gene name
CYP2C8
Gene synonyms
NCBI Gene ID
Protein name
cytochrome P450 2C8
Protein synonyms
CYPIIC8, Cytochrome P450 form 1, Cytochrome P450 IIC2, Cytochrome P450 MP-12, Cytochrome P450 MP-20, cytochrome P450, family 2, subfamily C, polypeptide 8, cytochrome P450, subfamily IIC (mephenytoin 4-hydroxylase), polypeptide 8, flavoprotein-linked monooxygenase, microsomal monooxygenase, P450 form 1, S-mephenytoin 4-hydroxylase, xenobiotic monooxygenase
Uniprot ID
Mouse ortholog
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—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Singulair – Organon
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Singulair – Merck Sharp & Dohme
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Estimated US medical usage
Montelukast
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,394 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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28,056 adverse events reported
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