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
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Montelukast, Singulair (discontinued: Montelukast)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| montelukast | ANDA | 2025-08-27 |
| montelukast sodium | ANDA | 2025-08-28 |
| singulair | New Drug Application | 2025-04-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
Agency Specific
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Clinical
Clinical Trials
361 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 15 | 29 | 42 | 50 | 34 | 165 |
| Allergic rhinitis | D065631 | — | J30.9 | 4 | 3 | 21 | 19 | 7 | 54 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 6 | 3 | 21 | 18 | 6 | 54 |
| Healthy volunteers/patients | — | — | — | 17 | — | — | 1 | 2 | 20 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 12 | 4 | 1 | 18 |
| Bronchiolitis | D001988 | — | — | — | 6 | 1 | 3 | 5 | 15 |
| Covid-19 | D000086382 | — | U07.1 | — | 3 | 4 | 1 | 3 | 10 |
| Cough | D003371 | — | R05 | — | 1 | — | 5 | 4 | 10 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | 2 | 3 | 3 | 2 | 9 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 7 | 2 | — | 9 |
Show 58 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 1 | 2 | 2 | — | — | 5 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | 1 | 1 | — | — | 5 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 3 | 1 | 1 | — | — | 5 |
| Status asthmaticus | D013224 | — | — | — | 3 | 2 | — | 1 | 4 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | 1 | — | 1 | — | 2 | 4 |
| Communicable diseases | D003141 | — | — | — | 1 | 1 | — | 1 | 3 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | — | 1 | — | 2 | 3 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | — | 1 | — | 1 | 3 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | 1 | — | — | 2 |
| Dengue | D003715 | — | A90 | — | 2 | 2 | — | — | 2 |
Show 20 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | 1 | 1 | — | — | 3 | 5 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 3 | — | — | — | 3 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | 2 | 2 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | — | — | — | 2 |
| Birth weight | D001724 | EFO_0004344 | — | 1 | 1 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 2 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | — | — | — | 2 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 1 | — | — | — | 1 |
| Cryptogenic organizing pneumonia | D018549 | EFO_1001300 | J84.116 | — | 1 | — | — | — | 1 |
Show 17 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 7 | — | — | — | — | 7 |
| Respiratory tract diseases | D012140 | — | — | 3 | — | — | — | — | 3 |
| Respiration disorders | D012120 | — | J00-J99 | 3 | — | — | — | — | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | — | — | — | 1 |
| Anterior cruciate ligament injuries | D000070598 | — | — | 1 | — | — | — | — | 1 |
| Tibial meniscus injuries | D000070600 | — | — | 1 | — | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eosinophilia | D004802 | — | D72.1 | — | — | — | — | 3 | 3 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | — | 2 | 2 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | — | — | — | 1 | 1 |
| Nephrosis | D009401 | — | — | — | — | — | — | 1 | 1 |
| Crest syndrome | D017675 | — | M34.1 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 1 | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 1 | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
Show 15 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Montelukast |
| INN | montelukast |
| 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 class | antiasthmatics/antiallergics (not acting primarily as antihistamines): leukotriene receptor antagonists |
| Image (chem structure or protein) |  |
| 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-ID | 158966-92-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL787 |
| ChEBI ID | 50730 |
| PubChem CID | 5281040 |
| DrugBank | DB00471 |
| UNII ID | MHM278SD3E (ChemIDplus, GSRS) |
Target
Agency Approved
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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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Singulair – Organon
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Singulair – Merck & Co
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Estimated US medical usage
Montelukast
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Montelukast, Montelukast sodium, Singulair
Adverse Events
Top Adverse Reactions
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39,999 adverse events reported
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