Drug

Montelukast clinical trials

Also written Singulair and MK0476.

studies test it: 233
open now: 16
in phase 3: 69
first study started: 1995

Keep track of what changes. Save the montelukast studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.

Watch these studies

How studies write it

Studies that test it under each name

Name

Montelukast: 121
montelukast sodium: 48
Comparator: Montelukast: 7
Montelukast 10mg: 7
Montelukast 10 Mg Oral Tablet: 4

Brand

Singulair: 76

Development codes

MK0476: 12
MK-0476A: 1

Written with another drug

Comparator: montelukast/loratadine: 2

Studies by the year they started

231 studies that test it; most in 2007 (22)

Studies that test montelukast, by start year
Year	Studies
1995	1
1997	1
1999	2
2000	4
2001	7
2002	3
2003	10
2004	10
2005	17
2006	17
2007	22
2008	10
2009	4
2010	18
2011	12
2012	11
2013	9
2014	7
2015	5
2016	3
2017	4
2018	5
2019	8
2020	6
2021	8
2022	6
2023	8
2024	2
2025	4
2026	7

By phase

A phase 1/2 study counts in both.

Early Phase 1: 9
Phase 1: 34
Phase 2: 42
Phase 3: 69
Phase 4: 69
No phase: 24

What it is tested for

Each study’s main condition, where its own words name it.

Asthma: 70
Rhinitis, Allergic: 16
Rhinitis, Allergic, Seasonal: 13
COVID-19: 6
Bronchiolitis: 6
Sleep Apnea, Obstructive: 5
Status Asthmaticus: 4
Arthritis, Rheumatoid: 4
Asthma, Exercise-Induced: 3
Bronchial Spasm: 3
Chronic Cough: 3
Bronchiolitis Obliterans Syndrome: 3

Who runs them

Industry 86 · Other 147

Organon and Co (45) · GlaxoSmithKline (6) · Dr. Reddy's Laboratories Limited (5) · Merck Sharp & Dohme LLC (4) · Roxane Laboratories (4) · Medical University of Lodz (4) · University of Colorado, Denver (4) · Assiut University (3)

Often tested with

Tested in the same studies.

Fluticasone (9) · Salmeterol Xinafoate (7) · Budesonide (6) · Prednisone (4) · Loratadine (4) · Flurbiprofen (4) · Digoxin (4) · Levocetirizine (4)

Related medicines

As reviewed, each with the page that says it.

One of Leukotriene Antagonists source

Studies

Open first, then newest update. How each study uses montelukast is read from its arms, and is right about nine times in ten.

Testing it · 233

See all 233 studies that test montelukast →

Given in every arm · 18 — montelukast is usual care beside what is tested

As the comparator · 21 — what is tested is compared with montelukast

Showing 20 of 21.

Codes

What other systems call montelukast · ClinicalTrials.gg INT003850

MeSH (NLM) C093875montelukastConfirmed ClinicalTrials.gov, NLM, Wikidata
UNII (FDA) MHM278SD3EMONTELUKASTConfirmed FDA, NLM, Wikidata
RxNorm 88249Confirmed FDA, Wikidata
Wikidata Q417767montelukastConfirmed FDA, NLM, Wikidata
NCI Thesaurus C66189MontelukastOne source FDA
DrugBank DB00471One source Wikidata

System	Code	Name there	Checked by
MeSH (NLM)	C093875	montelukast	Confirmed ClinicalTrials.gov, NLM, Wikidata
UNII (FDA)	MHM278SD3E	MONTELUKAST	Confirmed FDA, NLM, Wikidata
RxNorm	88249	—	Confirmed FDA, Wikidata
Wikidata	Q417767	montelukast	Confirmed FDA, NLM, Wikidata
NCI Thesaurus	C66189	Montelukast	One source FDA
DrugBank	DB00471	—	One source Wikidata

Also registered as montelukast sodium (UNII U1O3J18SFL · RxNorm 115713).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.