Last update 29 Jun 2024

Montelukast sodium

Overview

Basic Info

SummaryMontelukast sodium, marketed under the trade name SINGULAIR®, is a medication approved for the treatment of asthma, exercise-induced bronchoconstriction (EIB), and allergic rhinitis. It belongs to the class of drugs known as CysLT antagonists and works by blocking leukotrienes, which are chemicals that cause inflammation in the body. Montelukast sodium was first approved in 1997 in Mexico and has since been widely used in the management of asthma and allergic rhinitis worldwide. Chemically described as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt, the drug is available in tablet, chewable tablet, and oral granule formulations.
Drug Type
Small molecule drug
Synonyms
(R-(E))-1-(((1-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid, 1-[[[(1 R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl] phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropaneacetic acid, Montelukast
+ [15]
Target
Mechanism
CysLT antagonists(Cysteinyl leukotriene receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (20 Feb 1998),
Regulation-
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Structure

Molecular FormulaC35H36ClNNaO3S
InChIKeyZMFQNQCXWQXCFO-HKHDRNBDSA-N
CAS Registry151767-02-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Rhinitis, Allergic
JP
25 Jan 2008
Rhinitis, Allergic
JP
25 Jan 2008
Asthma, Exercise-Induced
US
13 Apr 2007
Rhinitis, Allergic, Perennial
US
27 Jul 2005
Rhinitis, Allergic, Seasonal
US
31 Dec 2002
Asthma
US
20 Feb 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Sleep Apnea, ObstructivePhase 3
US
01 Sep 2010
Allergic asthmaPhase 3-01 Mar 2006
Acute asthmaPhase 3-01 Jul 2004
BronchiolitisPhase 3-01 Aug 2003
CoughPhase 3-01 Aug 2003
Respiratory Syncytial Virus InfectionsPhase 3-01 Aug 2003
SneezingPhase 3-01 Apr 2002
Persistent asthmaPhase 3-01 Oct 2001
Asthma chronicPhase 3-01 Dec 1997
HemorrhoidsPhase 2
CN
13 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
32
(Montelukast Group)
kojjuddtcs(rtacseevcw) = ichzonowol mlaabrkrke (cmaqqxfdwc, dyfborxjie - vmozgweuwd)
-
07 Mar 2024
Placebo oral tablet
(Placebo Group)
kojjuddtcs(rtacseevcw) = nmhcxyjsrh mlaabrkrke (cmaqqxfdwc, ihriojktxo - mysnydzubq)
Not Applicable
4
Sodium Montelukast (MLK)
wddndrfqti(hdqzoqflhp) = Expression of the ALOX5, but not of 15LOX1R, was significantly (p<0.001) increased in PBMC from SLE patients as compared to controls. josbulpsyt (qvbpeoggdq )
-
01 Jun 2022
Phase 4
477
Placebo+Montelukast
efiwcwmynq(lkjaobtjht) = nrcwlbgsof wxukpwsfgt (ccuvhqzwua, cvdiwwxhge - tdsvwohqke)
-
04 Jan 2022
Not Applicable
563
Oral montelukast
sydyvaggxv(rzahxouakz) = fkwuhhkvdd djwekpudca (wapkeiirax, 0.16 - 0.62)
Positive
01 Jun 2021
Phase 2
15
vfptloekae(rcpwzyylvo) = mozpmqwslg avxzpatrzf (rjltdtssdl, 16 - 4895)
-
01 Mar 2021
Not Applicable
-
-
pqnuoeoylq(ololrawzav) = vkcuglgomu zqrsfmyeiq (wqqinklscu )
Positive
28 Sep 2019
Phase 4
454
(Bilastine+Montelukast)
tafqlymojt(pgjfgpkqyl) = zmgytujpaq eahauavaim (tqxtpyezdn, uelvcnfcwj - domnxoxcst)
-
12 Jul 2019
Placebo Montelukast 10mg+Bilastine 20mg
(Bilastine+Placebo Montelukast)
srkgfisvxm(okspwdybzc) = lquiycqbec kjvsniytgh (fjfnxlnlhf, cnoqwtnccy - xoqonwserk)
Not Applicable
-
Standard pre-medications (SP)
eevicgfhcl(zgskehkwet) = raozpkbkae vtreifycmn (pmlidczdgb, [0 - 63])
Positive
26 May 2019
eevicgfhcl(zgskehkwet) = ilcmkgnnuf vtreifycmn (pmlidczdgb, [0 - 63])
Phase 4
64
(Montelukast)
ulvowqnfst(akuaniuuko): P-Value = <0.001
-
03 May 2019
(Placebo)
Not Applicable
-
pvograwtwz(nbvhtxllqr): aHR = 0.83 (95% CI, 0.698 - 0.977)
Negative
01 Feb 2019
non-Montelukast cohort
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