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Drug

Montelukast

Regulatory activity · MHRA
Emerging researchLate-stage developmentCooling momentum

Also known 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, Singulair, Montelukast Sodium, Montelukastum.

RxNorm88249ChEMBLCHEMBL787UNIIMHM278SD3E
12
Research papers
15
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Clinical trial2026-07-06Results expected Q2 2031 · ClinicalTrials.gov

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

Clinical trial2026-05-14Results expected Q1 2030 · ClinicalTrials.gov

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial

Clinical trial2026-04-21Results posted · ClinicalTrials.gov

Comparison of Intranasal Corticosteroid Plus Oral Antihistamine Versus Intranasal Corticosteroid Plus Oral Antileukotriene in Patients With Allergic Rhinitis

Clinical trial2026-04-16Results expected Q1 2027 · ClinicalTrials.gov

Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Clinical trial2026-03-24Results expected Q1 2027 · ClinicalTrials.gov

Drug Safety Update: Montelukast: reminder of the risk of neuropsychiatric reactions

Regulatory2024-04-29MHRA

Drug Safety Update: Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions

Regulatory2019-09-19MHRA

Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber).

Research2018-01-01Allergy & rhinology (Providence, R.I.)

Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study.

Research2014-05-06Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology

Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma.

Research2013-10-08The journal of allergy and clinical immunology. In practice

Effect of montelukast for treatment of asthma in cigarette smokers.

Research2013-02-04The Journal of allergy and clinical immunology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Montelukast
Aliases & brands
(R-(E))-1-(((1-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acidSingulairMontelukast SodiumMontelukastum
RxNorm CUI
88249
ChEMBL ID
CHEMBL787
UNII
MHM278SD3E
Regulatory jurisdictions
mhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
2
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2024-04-29Safety communicationSafety
Drug Safety Update: Montelukast: reminder of the risk of neuropsychiatric reactions
Evidence ↗
2019-09-19Safety communicationSafety
Drug Safety Update: Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

191 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
191
registered trials across all phases
LATEST COMPLETION 2025
15
Active studies
11
Recruiting
134
Late-stage (III+)
137
Completed
39
Discontinued
PHASE DISTRIBUTIONn = 191
Early Phase 18Phase 117Phase 1 / 22Phase 230Phase 2 / 39Phase 347Phase 460Phase N / A18

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Not yet recruitingPH IVUniversity of Colorado, Denvern=1102031

Comparison of Intranasal Corticosteroid Plus Oral Antihistamine Versus Intranasal Corticosteroid Plus Oral Antileukotriene in Patients With Allergic Rhinitis

Not yet recruitingPH IVLiaquat National Hospital & Medical Collegen=322027

Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough：A Prospective, Open Label, Randomized and Placebo-Controlled Trial

SuspendedPH IVBeijing Chao Yang Hospitaln=2002026

Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

Active, not recruitingPH IVHouse Ear Instituten=392025

The Impact of Particulate Matters Air Pollution on Accelerated Atherosclerosis: A Montelukast Interventional Study for Atherosclerosis Prevention in Modernizing China

Unknown statusPH IVChinese University of Hong Kongn=2002025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis

CompletedPH IVKafrelsheikh Universityn=782025

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial

CompletedPH IIIChildren's Hospital Medical Center, Cincinnatin=1162024

A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion

CompletedPH IVSanofin=82024

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

CompletedPH IIIKey trialSusanna Naggie, MDn=10,9562024

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

CompletedPH IIIKey trialSusanna Naggie, MDn=1,4532024

A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

CompletedPH IBristol-Myers Squibbn=182023

Research activity

12 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992018
Most influential

Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years.

Pediatrics · 2001 · 225 cites

Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group.

American journal of respiratory and critical care medicine · 1999 · 213 cites

Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions.

Pediatric pulmonology · 2009 · 53 cites

Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2004 · 42 cites

Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma.

Current medical research and opinion · 2005 · 41 cites

Effect of montelukast for treatment of asthma in cigarette smokers.

The Journal of allergy and clinical immunology · 2013 · 40 cites
Recent papers

Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber).

Allergy & rhinology (Providence, R.I.) · 2018 · 1 cites

Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study.

Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2014 · 9 cites

Effect of montelukast for treatment of asthma in cigarette smokers.

The Journal of allergy and clinical immunology · 2013 · 40 cites

Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma.

The journal of allergy and clinical immunology. In practice · 2013 · 7 cites

Intermittent or daily montelukast versus placebo for episodic asthma in children.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2011 · 29 cites

Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions.

Pediatric pulmonology · 2009 · 53 cites
Journals, researchers & institutions
Top journals
  • Allergy and asthma proceedings2
  • Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology2
  • Allergy & rhinology (Providence, R.I.)1
  • Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology1
  • American journal of respiratory and critical care medicine1
  • Current medical research and opinion1
Leading researchers
  • Reiss TF7
  • Philip G5
  • Tozzi CA4
  • Knorr B3
  • Bisgaard H2
  • Boza ML2
  • Chervinsky P2
  • Lu S2
Leading institutions
free-text, unnormalised
  • Merck Research Laboratories4
  • Allergy Clinic1
  • Bispebjerg University Hospital1
  • Centre de Recherche de l'Hôpital Laval1
  • Centre of Academic Primary Care1
  • Danish Pediatric Asthma Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.