Montelukast

also known as montelukast sodium · Singulair · MK0476 · MON · Brondilat · GW483100 · MK-476 · MKT-N2 · +7 more

Other / unclassified targets ACE2, CYP2C8, CYSLTR1 via inhibition

Developed for: asthma · allergic rhinitis · seasonal allergic rhinitis · exercise-induced bronchoconstriction · perennial allergic rhinitis · COVID-19 · rheumatoid arthritis · atopic eczema
+75 more
· bronchiolitis · bronchopulmonary dysplasia · chronic asthma · status asthmaticus · type 2 diabetes mellitus · acute asthma · allergic respiratory disease · Alzheimer disease · bronchiolitis obliterans syndrome · cough variant asthma · eosinophilic esophagitis · lung disorder · metabolic dysfunction-associated steatohepatitis · otitis media with effusion · rhinitis · transplant-related bronchiolitis obliterans · acute bronchiolitis · atherosclerosis · brain neoplasm · childhood onset asthma · chronic graft versus host disease · chronic obstructive pulmonary disease · chronic rhinosinusitis · colorectal cancer · cryptogenic organizing pneumonia · dengue disease · diabetic kidney disease · dyspepsia · endometrial cancer · environmental induced asthma · eosinophilic gastroenteritis · erythema nodosum · idiopathic nephrotic syndrome · infectious disease with sepsis · kidney disorder · limb ischemia · lower respiratory tract disorder · Meniere disease · multiple sclerosis · nasal cavity polyp · neonatal sepsis · obstructive sleep apnea syndrome · osteoarthritis, knee · ovarian cancer · ovarian hyperstimulation syndrome · peripheral arterial disease · persian gulf syndrome · pneumonia · proteinuria · reactive airway disease · respiratory syncytial virus bronchiolitis · retinal disorder · sarcoma · severe acute respiratory syndrome · sickle cell disease · sinusitis · sleep apnea syndrome · ST-elevation myocardial infarction · transplant rejection · vascular disorder · viral respiratory tract infection · acne · acute coronary syndrome · acute myocardial infarction · bronchitis · chemotherapy-induced toxicity · chronic kidney disease · chronic periodontitis · conjunctivitis · coronary artery disorder · coronary atherosclerosis · obstructive lung disease · otitis media · Parkinson disease · post-COVID-19 disorder
Investigated by: Organon and Co · Merck Sharp & Dohme LLC · Bristol-Myers Squibb · GlaxoSmithKline · National Heart, Lung, and Blood Institute (NHLBI) · Vanderbilt University Medical Center
+147 more
· Hanmi Pharmaceutical Company Limited · University of Colorado, Denver · Ajou University School of Medicine · Assaf-Harofeh Medical Center · Beijing Chao Yang Hospital · Children's Hospital Medical Center, Cincinnati · Children's Mercy Hospital Kansas City · Duke University · Hormozgan University of Medical Sciences · Indiana University · Medical College of Wisconsin · Milton S. Hershey Medical Center · National Cancer Institute (NCI) · National Center for Advancing Translational Sciences (NCATS) · Phramongkutklao College of Medicine and Hospital · Sadat City University · Susanna Naggie, MD · University of California, San Francisco · University of Massachusetts, Worcester · ViiV Healthcare · 1st Allergy & Clinical Research Center · Act For Chronic Diseases · Ain Shams University · Ambulatory Pediatric Association · American Academy of Pediatrics · American College of Clinical Pharmacy · American Lung Association Asthma Clinical Research Centers · Arkansas Children's Hospital Research Institute · Assiut University · AstraZeneca · Austin V Stone · Azienda Ospedaliera Universitaria Policlinico · Bahçeşehir University · Baylor College of Medicine · Beijing Tongren Hospital · Benha University · Bernstein, Jonathan A., M.D. · Biogen · Brigham and Women's Hospital · Brighton and Sussex University Hospitals NHS Trust · Bugra Kerget · Cantonal Hosptal, Baselland · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) · Clinision · Corrie Fletcher · Creighton University · Cures Within Reach · Damanhour University · Direction Générale de l'Offre de Soins · East Carolina University · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Firestone Institute for Respiratory Health · First Affiliated Hospital, Sun Yat-Sen University · Gangnam Severance Hospital · Government Medical College, Bhavnagar · Guangzhou Institute of Respiratory Disease · H. Lundbeck A/S · Hal C Charles · Hallym University Medical Center · Hawaa Fertility Center · House Ear Institute · Hyundai Pharmaceutical Co., LTD. · Indira Gandhi Medical College, Shimla · Inje University · Institut Català de la Salut · IntelGenx Corp. · Isala · Istanbul Training and Research Hospital · JHSPH Center for Clinical Trials · Jagiellonian University · Janssen Research & Development, LLC · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · all 153 on the full record

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (7)	US (FDA)	SINGULAIR	—	2000-03-03 – 2012-03-26	fda.gov ↗
Approved	US (FDA)	SINGULAIR	—	1998-02-20	fda.gov ↗

Trials 197 · started per year

today

US approved 1998

1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 05 trials
Phase 0	NCT07409714	Oct 2026 → Dec 2030 expected	type 2 diabetes mellitus	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 0	NCT06887673	Mar 2025 → Mar 2026 overdue	brain neoplasm, colorectal cancer, endometrial cancer, ovarian cancer +1	University of South Florida	Not yet recruiting	No outcome recorded
Phase 0	NCT04572256	Feb 2021 → Jun 2027 expected	osteoarthritis, knee	Austin V Stone	Recruiting	No outcome recorded
Phase 0	NCT04075110	Jul 2019 → Jun 2022	type 2 diabetes mellitus	Sadat City University	Completed	No outcome recorded
Phase 0	NCT04077892	Jun → Sep 2016	allergic rhinitis	Beijing Tongren Hospital	Completed	No outcome recorded
Phase 127 trials · 2 met primary · 2 missed
Phase 1	NCT05992311	Aug 2025 → Apr 2028 expected	persian gulf syndrome	Baylor College of Medicine	Recruiting	No outcome recorded
Phase 1	NCT07838987	Dec 2023 → Jun 2026	—	Terns, Inc.	Completed	No outcome recorded
Phase 1	NCT05852769	May → Aug 2023	—	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT05607446	Sep 2022 → May 2023	allergic rhinitis	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Terminated	No outcome recorded
Phase 1	NCT04425902	Dec 2020 → Mar 2021	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT04474327	Jul 2020 → Feb 2021	neonatal sepsis	Mansoura University Children Hospital	Completed	Missed primary
Phase 1	NCT04275115	Feb → Apr 2020	—	H. Lundbeck A/S	Completed	No outcome recorded
Phase 1	NCT04097951	Nov 2019 → Jan 2020	respiratory system disorder	Hyundai Pharmaceutical Co., LTD.	Unknown	No outcome recorded
Phase 1	NCT03371849	Jul → Aug 2017	—	Hanmi Pharmaceutical Company Limited	Completed	Met primary
Phase 1	NCT03131973	May → Nov 2017	rheumatoid arthritis	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02762123	May → Aug 2016	rheumatoid arthritis	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02578277	Nov → Dec 2015	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT02456844	May → Jul 2015	rheumatoid arthritis	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02322671	Feb → Apr 2015	respiratory system disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02321748	Dec 2014 → Apr 2015	—	Maruho Europe Limited	Completed	No outcome recorded
Phase 1	NCT02227173	Sep → Nov 2014	—	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02045966	Feb → Apr 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02029313	Nov 2013 → Jan 2014	allergic respiratory disease	PharmaKing	Completed	No outcome recorded
Phase 1	NCT01621386	Jan 2013 → Sep 2015	asthma	Hal C Charles	Completed	No outcome recorded
Phase 1	NCT01651481	Jul → Sep 2012	rhinitis	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT01061333	Jun 2010 → Feb 2011	asthma	Merck Sharp & Dohme LLC	Completed	Mixed
Phase 1	NCT01086527	Mar 2010 → Sep 2014	asthma	Nemours Children's Clinic	Completed	No outcome recorded
Phase 1	NCT00739297	Jul → Dec 2008	chronic asthma	Organon and Co	Completed	Met primary
Phase 1	NCT00636207	Aug 2007 → Sep 2008	asthma	Organon and Co	Completed	No outcome recorded
Phase 1	NCT00511316	Aug 2007 → Sep 2015	eosinophilic esophagitis	Mayo Clinic	Completed	Missed primary
Phase 1	NCT00492102	Mar 2007 → Jun 2011	bronchopulmonary dysplasia	Children's Hospital Medical Center, Cincinnati	Completed	No outcome recorded
Phase 1	NCT00273013	Nov 2004 → Oct 2005	asthma	GlaxoSmithKline	Completed	No outcome recorded

Phase 1/23 trials · 1 met primary
Phase 1/2	NCT07101640	Feb 2026 → Jun 2027 expected	bronchopulmonary dysplasia	Duke University	Recruiting	No outcome recorded
Phase 1/2	NCT05143502	Jan 2022 → Jan 2024	chronic rhinosinusitis	Assiut University	Unknown	No outcome recorded
Phase 1/2	NCT04080947	Aug 2019 → Aug 2021	metabolic dysfunction-associated steatohepatitis	Sadat City University	Completed	Met primary
Phase 226 trials · 3 met primary · 5 missed
Phase 2	NCT03277170	Sep 2025 → Aug 2028	acute asthma, childhood onset asthma, status asthmaticus	Vanderbilt University Medical Center	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT05819541	Oct 2023 → Mar 2026	status asthmaticus	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 2	NCT05663866	May 2023 → Mar 2024 overdue	non-small cell lung carcinoma	Janssen Research & Development, LLC	Active not recruiting	Met primary
Phase 2	NCT05447520	Dec 2021 → Dec 2022	rheumatoid arthritis	Noha Mansour	Completed	No outcome recorded
Phase 2	NCT04718285	May 2021 → May 2022	COVID-19	Bahçeşehir University	Unknown	No outcome recorded
Phase 2	NCT04198623	Mar 2020 → Jul 2024	—	University of California, San Francisco	Completed	No outcome recorded
Phase 2	NCT03991988	Sep 2019 → Nov 2022	Alzheimer disease	Emory University	Completed	No outcome recorded
Phase 2	NCT04374981	Jul → Nov 2019	—	Damanhour University	Completed	No outcome recorded
Phase 2	NCT03794037	Dec 2018 → Dec 2023	ovarian hyperstimulation syndrome	Benha University	Suspended	No outcome recorded Stop: Business
Phase 2	NCT03402503	Nov 2018 → Mar 2024	Alzheimer disease	IntelGenx Corp.	Completed	No outcome recorded
Phase 2	NCT02352545	Aug 2014 → Aug 2015	—	Beijing Chao Yang Hospital	Unknown	No outcome recorded
Phase 2	NCT01960413	Nov 2013 → Mar 2018	sickle cell disease	Vanderbilt University Medical Center	Completed	Missed primary
Phase 2	NCT01804400	Oct 2012 → Oct 2013	allergic rhinitis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01656395	Aug 2012 → Jun 2014	asthma	Merck Sharp & Dohme LLC	Terminated	Missed primary
Phase 2	NCT02108886	Dec 2011 → Jul 2014	—	University of Sherbrooke	Unknown	No outcome recorded
Phase 2	NCT01717625	Nov 2011 → Oct 2013	bronchopulmonary dysplasia	Ajou University School of Medicine	Completed	No outcome recorded
Phase 2	NCT01432080	Sep 2011 → Dec 2012	bronchiolitis obliterans syndrome, cryptogenic organizing pneumonia	Maisonneuve-Rosemont Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT01307462	Jun 2011 → Sep 2014	transplant-related bronchiolitis obliterans	Stephanie Lee	Completed	Met primary
Phase 2	NCT01241422	Nov 2010 → Jun 2011	asthma	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	Missed primary
Phase 2	NCT00947453	Jul 2009 → Dec 2011	asthma	University of East Anglia	Completed	No outcome recorded
Phase 2	NCT00656058	Jun 2008 → May 2014	chronic graft versus host disease, transplant-related bronchiolitis obliterans	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 2	NCT00213252	Sep 2005 → Feb 2008	asthma	The Hospital for Sick Children	Completed	Missed primary
Phase 2	NCT00394160	Dec 2004 → Oct 2005	bronchiolitis	Organon and Co	Completed	No outcome recorded
Phase 2	NCT00783601	Oct 2004 → May 2005	asthma	Merck Sharp & Dohme LLC	Completed	Missed primary
Phase 2	NCT00446186	Feb → Mar 2004	allergic rhinitis	Organon and Co	Completed	Met primary
Phase 2	NCT00394069	Jul → Dec 2003	bronchiolitis	Organon and Co	Completed	No outcome recorded

Phase 2/35 trials · 1 met primary · 1 missed
Phase 2/3	NCT06747130	Jan 2025 → Jan 2027 expected	dengue disease	Phramongkutklao College of Medicine and Hospital	Recruiting	No outcome recorded
Phase 2/3	NCT04389411	Nov 2022 → Jan 2023	COVID-19	McGill University	Unknown	No outcome recorded
Phase 2/3	NCT05293132	Feb 2022 → Jun 2023	infectious disease with sepsis	Ain Shams University	Completed	Met primary
Phase 2/3	NCT04673422	Jan 2021 → Jun 2023	dengue shock syndrome	Phramongkutklao College of Medicine and Hospital	Completed	Missed primary
Phase 2/3	NCT00115297	Sep 2004 → Oct 2016	asthma, lung disorder	University of Massachusetts, Worcester	Completed	No outcome recorded
Phase 357 trials · 11 met primary · 6 missed
Phase 3	NCT07320625	Feb 2026 → Feb 2027 expected	ST-elevation myocardial infarction	Shanghai Zhongshan Hospital	Recruiting	No outcome recorded
Phase 3	NCT05894577	Jan → Jul 2023	COVID-19	Susanna Naggie, MD	Completed	Missed primary
Phase 3	NCT05362474	Jul 2022 → Jun 2023	diabetic kidney disease	University of Colorado, Denver	Terminated	No outcome recorded Stop: Business
Phase 3	NCT04695704	Aug 2021 → Jul 2023	COVID-19, severe acute respiratory syndrome	Jordi Gol Institute for Primary Care Research	Terminated	No outcome recorded
Phase 3	NCT04885530	Jun 2021 → Apr 2024	COVID-19	Susanna Naggie, MD	Completed	No outcome recorded
Phase 3	NCT04277702	May 2020 → Oct 2023	atherosclerosis, limb ischemia, peripheral arterial disease	Jagiellonian University	Unknown	No outcome recorded
Phase 3	NCT03545997	Nov 2019 → Mar 2020	obstructive sleep apnea syndrome	University Hospital, Grenoble	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT04324918	Oct 2018 → Jun 2019	perennial allergic rhinitis	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 3	NCT02793375	Aug 2018 → Nov 2024	—	Children's Hospital Medical Center, Cincinnati	Completed	No outcome recorded
Phase 3	NCT02541760	Apr 2014 → Mar 2015	otitis media with effusion	Hormozgan University of Medical Sciences	Completed	No outcome recorded
Phase 3	NCT01857063	Jun → Sep 2013	seasonal allergic rhinitis	Organon and Co	Completed	Missed primary
Phase 3	NCT01852812	Jun → Dec 2013	perennial allergic rhinitis	Organon and Co	Completed	Missed primary
Phase 3	NCT01606306	Feb 2013 → Apr 2015	asthma	Milton S. Hershey Medical Center	Completed	Met primary
Phase 3	NCT01673620	Jul → Oct 2012	allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT01640535	Jun 2012 → Feb 2013	perennial allergic rhinitis	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 3	NCT00551382	Nov 2007 → Dec 2009	viral respiratory tract infection	Assaf-Harofeh Medical Center	Unknown	No outcome recorded
Phase 3	NCT00540839	Nov 2007 → Mar 2008	asthma	Organon and Co	Withdrawn	No outcome recorded
Phase 3	NCT00395304	Mar 2007 → Dec 2011	asthma	Milton S. Hershey Medical Center	Completed	Met primary
Phase 3	NCT00442338	Mar → Aug 2007	asthma	Organon and Co	Completed	Missed primary
Phase 3	NCT00423995	Nov 2006 → Mar 2007	seasonal allergic rhinitis	Organon and Co	Completed	Met primary
Phase 3	NCT00461032	Jun → Nov 2006	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00755794	Jun 2006 → Sep 2007	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00284856	May 2006 → Apr 2010	asthma	Organon and Co	Completed	Met primary
Phase 3	NCT00319995	Mar → Jun 2006	seasonal allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00289874	Mar 2006 → Jul 2007	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00127166	Dec 2005 → Nov 2008	exercise-induced bronchoconstriction	Organon and Co	Completed	Met primary
Phase 3	NCT00245570	Dec 2005 → Sep 2006	exercise-induced bronchoconstriction	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00445107	Nov 2005 → May 2006	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00328718	Oct 2005 → Apr 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00229970	Sep 2005 → Oct 2006	asthma	Organon and Co	Completed	Met primary
Phase 3	NCT00398151	Aug 2005 → Jan 2006	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00252863	Dec 2004 → May 2006	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00127647	Nov 2004 → Apr 2005	seasonal allergic rhinitis	Organon and Co	Completed	Met primary
Phase 3	NCT00771160	Sep 2004 → Feb 2005	allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00092989	Jul 2004 → Mar 2007	asthma	Organon and Co	Completed	Met primary
Phase 3	NCT00090142	May → Oct 2004	exercise-induced bronchoconstriction	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00092144	Feb → Jun 2004	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00092118	Oct 2003 → May 2004	perennial allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00076973	Aug 2003 → Jun 2006	respiratory syncytial virus bronchiolitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00092131	Jun → Nov 2003	exercise-induced bronchoconstriction	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00116324	Apr 2003 → Dec 2006	asthma	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 3	NCT00092885	Mar → Oct 2003	asthma, seasonal allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00092105	Apr 2002 → Jan 2003	asthma, perennial allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00045955	Feb 2002 → Nov 2003	asthma	Sanofi	Completed	No outcome recorded
Phase 3	NCT00974571	Nov 2001 → May 2002	perennial allergic rhinitis	Organon and Co	Completed	Missed primary
Phase 3	NCT00489346	Oct 2001 → Jun 2002	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00963469	Aug → Nov 2001	seasonal allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00972738	Apr → Jul 2001	seasonal allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00943397	Apr → Oct 2001	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00968149	Mar → Jun 2001	seasonal allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00700661	Jan 2001 → Dec 2002	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00960141	Aug → Oct 2000	seasonal allergic rhinitis	Organon and Co	Completed	Met primary
Phase 3	NCT00979901	Mar → May 2000	seasonal allergic rhinitis	Organon and Co	Completed	Met primary
Phase 3	NCT00162864	Dec 1999 → Apr 2002	asthma, chronic obstructive pulmonary disease	Kaiser Permanente	Completed	No outcome recorded
Phase 3	NCT00963599	Sep → Nov 1999	seasonal allergic rhinitis	Organon and Co	Completed	Missed primary
Phase 3	NCT00968201	Dec 1997 → Mar 2001	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00911547	Mar 1995 → Apr 1996	asthma	Organon and Co	Completed	Met primary

Phase 452 trials · 4 met primary · 5 missed
Phase 4	NCT07685886	Sep 2026 → Jun 2031 expected	kidney disorder, retinal disorder, type 2 diabetes mellitus, vascular disorder	University of Colorado, Denver	Not yet recruiting	No outcome recorded
Phase 4	NCT05498116	Jan 2023 → Feb 2027 expected	proteinuria	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 4	NCT05651750	Nov 2022 → May 2023	—	Assaf-Harofeh Medical Center	Unknown	No outcome recorded
Phase 4	NCT05094596	Oct → Dec 2021	pneumonia	Bugra Kerget	Unknown	No outcome recorded
Phase 4	NCT04815187	Jun 2021 → Sep 2025 overdue	Meniere disease, allergic rhinitis	House Ear Institute	Active not recruiting	No outcome recorded
Phase 4	NCT04957927	Dec 2020 → Sep 2021	allergic rhinitis	Usama Azhar	Unknown	No outcome recorded
Phase 4	NCT04537780	Aug 2019 → Aug 2020	metabolic dysfunction-associated steatohepatitis	Tanta University	Completed	No outcome recorded
Phase 4	NCT03380975	Aug 2018 → Mar 2019	allergic respiratory disease	Clinision	Completed	No outcome recorded
Phase 4	NCT03269318	Jul 2017 → Aug 2019	asthma	Brighton and Sussex University Hospitals NHS Trust	Terminated	No outcome recorded
Phase 4	NCT03096327	May → Dec 2017	asthma	PharmEvo Pvt Ltd	Completed	No outcome recorded
Phase 4	NCT02761252	Apr → Nov 2016	asthma, seasonal allergic rhinitis	Menarini International Operations Luxembourg SA	Completed	Missed primary
Phase 4	NCT02655562	Apr 2016 → Dec 2024	—	Beijing Chao Yang Hospital	Suspended	No outcome recorded Stop: Enrollment
Phase 4	NCT02635334	Nov 2015 → Jun 2016	asthma	Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.	Completed	No outcome recorded
Phase 4	NCT02534467	Jul 2015 → Dec 2018	atopic eczema	Murdoch Childrens Research Institute	Completed	No outcome recorded
Phase 4	NCT02410278	Mar 2015 → Feb 2017	multiple sclerosis	Biogen	Completed	No outcome recorded
Phase 4	NCT02110654	Jun 2014 → Nov 2020	asthma, nasal cavity polyp, sinusitis	First Affiliated Hospital, Sun Yat-Sen University	Completed	No outcome recorded
Phase 4	NCT02565212	May → Oct 2014	allergic rhinitis	Istanbul Training and Research Hospital	Completed	No outcome recorded
Phase 4	NCT02551536	Apr 2014 → Apr 2015	allergic rhinitis	Indira Gandhi Medical College, Shimla	Completed	No outcome recorded
Phase 4	NCT02401256	Jul 2013 → May 2016	—	Indiana University	Completed	No outcome recorded
Phase 4	NCT01279668	May 2011 → Oct 2012	pertussis	University of Oxford	Unknown	Missed primary
Phase 4	NCT01211509	Oct 2010 → Mar 2015	bronchiolitis obliterans syndrome, transplant rejection	Universitaire Ziekenhuizen KU Leuven	Completed	No outcome recorded
Phase 4	NCT01147510	Jul 2010 → Sep 2012	chronic asthma	Ajou University School of Medicine	Completed	No outcome recorded
Phase 4	NCT00775697	Sep 2009 → Dec 2013	asthma	University of Verona	Unknown	No outcome recorded
Phase 4	NCT00770900	Sep 2008 → Dec 2009	asthma	University of Brasilia	Completed	No outcome recorded
Phase 4	NCT00557284	Mar 2008 → May 2009	atopic eczema	1st Allergy & Clinical Research Center	Completed	No outcome recorded
Phase 4	NCT00534976	Feb 2008 → Mar 2010	exercise-induced bronchoconstriction	Organon and Co	Completed	Met primary
Phase 4	NCT00453765	Dec 2007 → Sep 2010	cough variant asthma, reactive airway disease	Isala	Completed	No outcome recorded
Phase 4	NCT00545844	Apr 2007 → Jan 2008	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00712335	Feb 2007 → May 2011	environmental induced asthma	Inje University	Completed	No outcome recorded
Phase 4	NCT01725360	Jan 2007 → Dec 2011	asthma	Cantonal Hosptal, Baselland	Completed	No outcome recorded
Phase 4	NCT00406094	Nov 2006 → Dec 2009	rhinitis	Bernstein, Jonathan A., M.D.	Unknown	No outcome recorded
Phase 4	NCT00295022	Jul → Oct 2006	seasonal allergic rhinitis	UCB Pharma	Completed	Met primary
Phase 4	NCT00832455	Jun 2006 → Oct 2008	asthma	Organon and Co	Completed	Met primary
Phase 4	NCT00471809	Mar 2006 → Mar 2007	asthma	National Heart, Lung, and Blood Institute (NHLBI)	Terminated	Missed primary
Phase 4	NCT00721240	Feb 2006 → Dec 2008	asthma	Marien Hospital Wesel	Completed	No outcome recorded
Phase 4	NCT00273689	Dec 2005 → Sep 2007	exercise-induced bronchoconstriction	University of New Mexico	Completed	No outcome recorded
Phase 4	NCT00296530	Sep 2005 → Jul 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00196547	Sep → Nov 2005	asthma	Firestone Institute for Respiratory Health	Completed	No outcome recorded
Phase 4	NCT00380705	Mar → Jul 2005	allergic rhinitis, asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00299910	Mar 2005 → ?	sleep apnea syndrome	Soroka University Medical Center	Unknown	No outcome recorded
Phase 4	NCT00442559	Jan 2005 → Oct 2007	allergic rhinitis, asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00148408	Dec 2003 → Dec 2005	asthma	American Lung Association Asthma Clinical Research Centers	Completed	Missed primary
Phase 4	NCT00446056	Sep 2003 → Jun 2004	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00490243	Jul 2003 → Oct 2006	asthma	Medical University of Lodz	Completed	No outcome recorded
Phase 4	NCT00756418	Jun 2003 → Aug 2004	asthma	Organon and Co	Completed	Met primary
Phase 4	NCT00156819	Jun 2003 → Aug 2005	asthma	JHSPH Center for Clinical Trials	Completed	Missed primary
Phase 4	NCT00157937	Feb 2003 → Jun 2005	allergic rhinitis, asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00092092	Oct 2002 → Jun 2004	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00545324	Sep 2002 → Dec 2003	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00140881	Jun 2000 → Feb 2003	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00395408	Jun 2000 → Dec 2003	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00140946	Mar 1998 → Oct 2000	asthma	Organon and Co	Completed	No outcome recorded

Phase not applicable22 trials · 1 met primary
—	NCT04322422	Jun 2020 → Jul 2022	anxiety, asthma, depressive disorder, eosinophil disorder +1	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
—	NCT04818723	Feb 2019 → May 2020	idiopathic nephrotic syndrome	Nishtar Medical University	Completed	No outcome recorded
—	NCT03039101	Sep 2017 → Jul 2018	allergic rhinitis	Mitchell Grayson	Completed	No outcome recorded
—	NCT02758873	Feb 2016 → Jul 2019	asthma	University of Sussex	Completed	Met primary
—	NCT01967498	Nov 2013 → Dec 2015	conductive hearing loss disorder, otitis media with effusion	Tel-Aviv Sourasky Medical Center	Unknown	No outcome recorded
—	NCT01770899	Jan → Dec 2013	status asthmaticus	Corrie Fletcher	Unknown	No outcome recorded
—	NCT01841164	May 2012 → Jun 2014	asthma	Karolinska University Hospital	Unknown	No outcome recorded
—	NCT01458418	Dec 2011 → Feb 2015	eosinophilic esophagitis	Children's Mercy Hospital Kansas City	Terminated	No outcome recorded Stop: Enrollment
—	NCT01329939	Apr 2011 → Sep 2014	asthma, obesity disorder	Northwell Health	Completed	No outcome recorded
—	NCT01370187	Jul 2010 → Apr 2011	acute bronchiolitis, cough variant asthma	Hormozgan University of Medical Sciences	Completed	No outcome recorded
—	NCT01414868	Mar → Sep 2010	asthma	Guangzhou Institute of Respiratory Disease	Completed	No outcome recorded
—	NCT00903357	Aug 2009 → Aug 2010	atopic eczema	Pyun BokYang	Completed	No outcome recorded
—	NCT00863317	Dec 2008 → Jul 2011	bronchiolitis	Medical College of Wisconsin	Completed	No outcome recorded
—	NCT01055041	Dec 2008 → Jun 2009	chronic asthma	Government Medical College, Bhavnagar	Completed	No outcome recorded
—	NCT00814281	May 2007 → Mar 2009	lower respiratory tract disorder	Marywood University	Completed	No outcome recorded
—	NCT00424580	Jan → Aug 2007	asthma	University of Saskatchewan	Completed	No outcome recorded
—	NCT00406861	Dec 2006 → Jun 2009	erythema nodosum, leprosy	The Leprosy Mission Bangladesh	Unknown	No outcome recorded
—	NCT00375232	Oct 2006 → ?	exercise-induced bronchoconstriction	Indiana University	Withdrawn	No outcome recorded
—	NCT00385463	Apr 2006 → Apr 2007	asthma, seasonal allergic rhinitis	Creighton University	Withdrawn	No outcome recorded
—	NCT00148603	Sep 2005 → Dec 2006	dyspepsia, eosinophilic gastroenteritis	Children's Mercy Hospital Kansas City	Completed	No outcome recorded
—	NCT00353184	Sep 2001 → Oct 2004	acute asthma	Washington University School of Medicine	Terminated	No outcome recorded
—	NCT00943683	Aug 2000 → Feb 2001	asthma	Organon and Co	Completed	No outcome recorded

Comparator or background therapy113 trials
Phase 0	NCT05381207 Comparator	Oct 2022 → Oct 2024	allergic rhinitis	Assiut University	Unknown	No outcome recorded
Phase 1	NCT01998971 Background	Feb 2014 → Jan 2019	plasma cell myeloma	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT01491503 Comparator	Nov 2011 → Jan 2012	—	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT00856687 Comparator	Apr → Dec 2009	asthma	Pfizer	Completed	No outcome recorded
Phase 1	NCT00664937 Comparator	May 2007 → Oct 2008	exercise-induced bronchoconstriction	Organon and Co	Completed	No outcome recorded
Show all 113 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2018-10-10	Hanmi Pharmaceutical Company Limited	Results <보도자료> 美 흉부의사협회, 한미약품 몬테리진 3상 결과에 ‘주목’ hanmi.co.kr ↗ 연구결과에 따르면, 몬테리진 투여군은 몬테루카스트 단일제 투여군 대비 후반 2주(3~4주차) MDNSS 변화량에서 우월한 효과를 나타냈으며, 이상반응에서도 단일제 대비 유의한 차이를 보이지 않았다.
2018-08-20	Hanmi Pharmaceutical Company Limited	Results <보도자료> 한미약품 ‘몬테리진캡슐’ 임상 3상 결과 SCI급 국제학술지 등재 hanmi.co.kr ↗ 연구 결과에 따르면, 몬테리진캡슐 투여군은 몬테루카스트 단일제 투여군 대비 후반 2주(3~4주)차 MDNSS(Mean Daytime Nasal Symptom Score/낮 시간 동안의 코 증상 평균 수치) 변화량에서 우월한 효과를 입증했다.
2017-08-18	Hanmi Pharmaceutical Company Limited	Results <보도자료> “한미 몬테리진 전국 달군다”…서울 심포지엄 ‘스타트’ hanmi.co.kr ↗ 실제로, 한미약품이 천식과 알레르기 비염을 동반한 환자 210명을 대상으로 몬테루카스트 단일제 투약군과 몬테리진 투약군으로 나누어 4주간 비교한 결과, 몬테리진 투여군이 단일제 투여군 대비 후반 2주(3-4주)차 MDNSS(Mean Daytime Nasal Symptom Score, 낮 시간 동안의 코 증상 수치)에서 우월한 효과가 나타났다.
2017-05-17	Hanmi Pharmaceutical Company Limited	Regulatory <보도자료> 한미, 천식+알레르기비염 치료 복합제 세계 첫 허가 hanmi.co.kr ↗ 한미약품(대표이사 우종수·권세창)은 천식과 통년성 알레르기비염을 동반한 환자 치료(알레르기비염 증상 개선)에 쓰이는 복합제 ‘몬테리진’ 시판허가를 식품의약품안전처로부터 받았다고 17일 밝혔다.

All press releases naming this drug 5 releases

Date	Issuer	Release
2018-10-10	Hanmi Pharmaceutical Company Limited	<보도자료> 美 흉부의사협회, 한미약품 몬테리진 3상 결과에 ‘주목’ hanmi.co.kr ↗
2018-08-20	Hanmi Pharmaceutical Company Limited	<보도자료> 한미약품 ‘몬테리진캡슐’ 임상 3상 결과 SCI급 국제학술지 등재 hanmi.co.kr ↗
2017-08-18	Hanmi Pharmaceutical Company Limited	<보도자료> “한미 몬테리진 전국 달군다”…서울 심포지엄 ‘스타트’ hanmi.co.kr ↗
2017-05-17	Hanmi Pharmaceutical Company Limited	<보도자료> 한미, 천식+알레르기비염 치료 복합제 세계 첫 허가 hanmi.co.kr ↗
2009-08-19	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Provides Update On Generic Singulair® Litigation tevapharm.com ↗

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 314 sources stand behind the page.

Field	Value	Cited text
Known as	montelukast	“Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin)...” NCT02578277 ↗ 300 “Cocktail = Caffeine 200 mg, Metoprolol 50 mg, Montelukast 10 mg, Flurbiprofen 50 mg, Omeprazole 40 mg, Midazolam 5 mg, Digoxin 0.25 mg, and Pravastatin 40 mg” NCT02045966 ↗ “Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial.” PMID 28894551 ↗ Jul 2017 “The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.” NCT04324918 ↗ “Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor.” NCT00551382 ↗ “Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc” NCT06429475 ↗ “Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)” NCT04275115 ↗ “receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks” NCT04077892 ↗ “a tablet treatment for asthma called Singulair (montelukast)” NCT00273013 ↗ “Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD” NCT04621513 ↗ “oral montelukast sodium chewable tablets 4mg QD” NCT05325489 ↗ Show 290 more sources
Known as	Brondilat	ChEMBL registry synonym — accepted as the source's own label CHEMBL787 ↗
Known as	GW483100	“It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 1: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.” NCT02322671 ↗
Known as	MK-476	ChEMBL registry synonym — accepted as the source's own label CHEMBL787 ↗
Known as	MK0476	“The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)” NCT00739297 ↗ 15 “MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks” NCT00545324 ↗ “MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks” NCT00380705 ↗ “MK0476, montelukast sodium / Duration of Treatment: 12 Weeks” NCT00398151 ↗ “MK0476, montelukast sodium / Duration of Treatment: 2 Weeks” NCT00446186 ↗ “MK0476, Montelukast Sodium /Duration of Treatment : 14 Days” NCT00394160 ↗ “MK0476, montelukast sodium / Duration of Treatment: 8 Weeks” NCT00445107 ↗ “MK0476, montelukast sodium / Duration of Treatment: 4 Weeks” NCT00446056 ↗ “MK0476, montelukast sodium / Duration of Treatment: 4 weeks” NCT00092144 ↗ “MK0476, montelukast sodium / Duration of Treatment: 1 Year” NCT00489346 ↗ “MK0476; montelukast sodium/Duration of Treatment: 16 weeks” NCT00157937 ↗ Show 5 more sources
Known as	MKT-N2	“MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma” NCT02029313 ↗
Known as	MLKT	“10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.” NCT00295022 ↗
Known as	MNT	“receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks” NCT04077892 ↗
Known as	MON	“Limited information exists comparing fluticasone propionate/salmeterol combination (FSC) versus montelukast (MON) in patients with coexistent asthma and allergic rhinitis.” PMID 20167147 ↗ Jan 2010 2 “Investigating the efficacy and safety of rupatadine (RUP) versus montelukast (MON) as adjuvant therapy for patients with rheumatoid arthritis (RA).” PMID 34218304 ↗ Jul 2021 “montelukast (MON)” NCT00296491 ↗
Known as	Montelukast (as sodium)	ChEMBL registry synonym — accepted as the source's own label CHEMBL787 ↗
Known as	montelukast (Singulair)	“montelukast (Singulair)” NCT00462592 ↗
Known as	Montelukast monosodium salt	ChEMBL registry synonym — accepted as the source's own label CHEMBL787 ↗
Known as	Montelukast Oral Tablet	“Drug: Montelukast Oral Tablet” NCT05381207 ↗
Known as	montelukast sodium	“A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in...” NCT00284856 ↗ 47 “The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.” NCT00755794 ↗ “A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma” NCT00832455 ↗ “Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis.” NCT02494466 ↗ “Montelukast sodium is a leukotriene-receptor antagonist approved as a controller medication for chronic asthma and allergic rhinitis in children and adults.” PMID 28639856 ↗ Jun 2017 “Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .” NCT02352545 ↗ “Singulair (Montelukast Sodium):5-10 mg (weight based dosing) by mouth (PO) hour of sleep (HS)” NCT00656058 ↗ “Montelukast sodium (Singulair) will be given at a dose according to body weight.” NCT04474327 ↗ “MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma” NCT02029313 ↗ “MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks” NCT00545324 ↗ “MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks” NCT00380705 ↗ Show 37 more sources
Known as	NSC-759107	ChEMBL registry synonym — accepted as the source's own label CHEMBL787 ↗
Known as	Singulair	“A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic...” NCT00557284 ↗ 19 “A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma” NCT00832455 ↗ “Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)” NCT00395304 ↗ “determining how intervention with montelukast (singulair) affects symptoms and the rate of recurrent wheezing.” NCT00115297 ↗ “Montelukast (Singulair) is a drug that has been used for many years to treat asthma.” NCT00656058 ↗ “MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma” NCT02029313 ↗ “MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks” NCT00545324 ↗ “MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks” NCT00380705 ↗ “montelukast sodium (Singulair), for the management of asthma” NCT00162864 ↗ “At the remission stage: Singulair, once daily for 3 months.” NCT02341573 ↗ “Singulair: Montelukast sodium (leukotriene modulator)” NCT01424124 ↗ Show 9 more sources
Action	Inhibit	“Oral leukotriene receptor antagonists (eg montelukast)” NCT00045955 ↗
Modality	Other / unclassified	“leukotriene receptor antagonist (montelukast)” NCT00156819 ↗
Route	Oral	“Oral leukotriene receptor antagonists (eg montelukast)” NCT00045955 ↗
Target	CYP2C8	“montelukast is an powerful CYP2C8 inhibitor” NCT00453765 ↗