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 and cytochrome P450 2C8.
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Commercial
Trade Name
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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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| montelukast sodium | ANDA | 2023-06-07 |
| singulair | New Drug Application | 2021-06-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| asthma | EFO_0000270 | D001249 | J45 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
306 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 | 13 | 30 | 40 | 43 | 19 | 140 |
| Healthy volunteers/patients | — | 15 | — | — | 1 | 2 | 18 | ||
| Allergic rhinitis | D065631 | J30.9 | 3 | 2 | 2 | 9 | 1 | 17 | |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 11 | 3 | 1 | 16 |
| Exercise-induced asthma | D001250 | J45.990 | 1 | — | 4 | 2 | 1 | 8 | |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 5 | 2 | — | 7 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | — | 3 | — | 1 | — | 4 | |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | 2 | 2 | — | 4 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | 3 | 1 | 4 |
| Cough | D003371 | HP_0012735 | R05 | — | 1 | — | 2 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 1 | 3 | — | 2 | 6 | |
| Bronchiolitis | D001988 | HP_0011950 | — | 2 | 1 | — | 3 | 6 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | 1 | 1 | — | — | 5 |
| Status asthmaticus | D013224 | — | 2 | 2 | — | 1 | 3 | ||
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | 1 | — | 1 | — | 1 | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | 1 | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | 1 | — | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 1 | — | — | 1 |
| Dengue | D003715 | A90 | — | 1 | 1 | — | — | 1 | |
| Severe dengue | D019595 | A91 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 1 | 1 | — | — | — | 2 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | — | — | — | 2 |
| Bronchopulmonary dysplasia | D001997 | P27.8 | 1 | 1 | — | — | — | 2 | |
| Myeloid leukemia acute | D015470 | C92.0 | — | 1 | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | 1 | — | — | — | 1 | |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | — | 1 | — | — | — | 1 |
| Cryptogenic organizing pneumonia | D018549 | EFO_1001300 | J84.116 | — | 1 | — | — | — | 1 |
| Food-drug interactions | D018565 | — | 1 | — | — | — | 1 | ||
| Immune system diseases | D007154 | D89.9 | 1 | 1 | — | — | — | 1 | |
| Sars-cov-2 | D000086402 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 1 | 2 |
| Respiration disorders | D012120 | J00-J99 | 2 | — | — | — | — | 2 | |
| Anterior cruciate ligament injuries | D000070598 | 1 | — | — | — | — | 1 | ||
| Neonatal sepsis | D000071074 | HP_0040187 | 1 | — | — | — | — | 1 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | — | — | — | — | 2 | 2 | ||
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | — | — | — | 1 | 1 |
| Eosinophilia | D004802 | HP_0001880 | D72.1 | — | — | — | — | 1 | 1 |
| Crest syndrome | D017675 | M34.1 | — | — | — | — | 1 | 1 | |
| Depression | D003863 | F33.9 | — | — | — | — | 1 | 1 | |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 1 | 1 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | — | 1 | 1 | |
| Conductive hearing loss | D006314 | HP_0000405 | H90.2 | — | — | — | — | 1 | 1 |
| Erythema nodosum | D004893 | HP_0012219 | L52 | — | — | — | — | 1 | 1 |
| Leprosy | D007918 | EFO_0001054 | A30 | — | — | — | — | 1 | 1 |
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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 |
Target
Agency Approved
CYSLTR1
CYSLTR1
Alternate
GPR17
GPR17
CYP2C8
CYP2C8
Organism
Homo sapiens
Gene name
GPR17
Gene synonyms
NCBI Gene ID
Protein name
uracil nucleotide/cysteinyl leukotriene receptor
Protein synonyms
G-protein coupled receptor 17, P2Y-like receptor, R12, UDP/CysLT receptor
Uniprot ID
Mouse ortholog
Gpr17 (574402)
uracil nucleotide/cysteinyl leukotriene receptor (Q80UD2)
Variants
Clinical Variant
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Financial
Singulair - Organon
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Singulair - Merck Sharp & Dohme
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 7,567 documents
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Safety
Black-box Warning
Black-box warning for: Montelukast sodium, Singulair
Adverse Events
Top Adverse Reactions
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809 adverse events reported
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