Montelukast sodium has been evaluated across numerous Phase 1 through Phase 4 clinical trials sponsored by academic medical centers, NHS hospital trusts, and pharmaceutical companies such as Organon and Co. Spanning completed, ongoing, and upcoming studies in pediatric and adult populations, research primarily addresses respiratory and inflammatory conditions—including pediatric asthma, perennial allergic rhinitis, wheezing, and exercise-induced bronchospasm—alongside exploratory applications in non-alcoholic steatohepatitis, sickle cell disease with sleep-disordered breathing, and COVID-19.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07685886 | NOT_YET_RECRUITING | Diabetes; Kidney Disease; Vascular Disease; Retinopathy |
University of Colorado, Denver |
2026-09-01 | PHASE4 |
| NCT04270409 | ACTIVE_NOT_RECRUITING | Plasma Cell Myeloma |
Sanofi |
2020-06-16 | PHASE3 |
| NCT07409714 | NOT_YET_RECRUITING | Type 2 Diabetes |
University of Colorado, Denver |
2026-07 | EARLY_PHASE1 |
| NCT05896228 | RECRUITING | Refractory Multiple Myeloma; Relapsed Multiple Myeloma |
Benjamin T Diamond, MD |
2024-02-20 | PHASE2 |
| NCT03277170 | WITHDRAWN | Asthma; Status; Asthma in Children; Asthma Acute; Asthma Attack; Acute Asthma Exacerbation |
Vanderbilt University Medical Center |
2025-09-01 | PHASE2 |
| NCT05992311 | RECRUITING | Gulf War Syndrome |
Baylor College of Medicine |
2025-08-15 | PHASE1 |
| NCT06597682 | NOT_YET_RECRUITING | Post-acute Sequelae of SARS-COV-2 Infection |
Huashan Hospital |
2025-03 | |
| NCT05922761 | RECRUITING | Bronchiolitis Obliterans Syndrome; Bronchiolitis Obliterans; Lung Diseases; Chronic Graft Versus Host Disease |
Dana-Farber Cancer Institute |
2024-05-31 | PHASE2 |
| NCT07101640 | RECRUITING | Bronchopulmonary Dysplasia (BPD); Premature Births; Critical Illness |
Duke University |
2026-02-23 | PHASE1; PHASE2 |
| NCT04572256 | RECRUITING | ACL Injury; Meniscus Tear; Post-traumatic Osteoarthritis |
Austin V Stone |
2021-02-01 | EARLY_PHASE1 |
| NCT07537868 | RECRUITING | Acute Myocardial Infarction (AMI) |
October 6 University |
2026-04-20 | PHASE2 |
| NCT07320625 | RECRUITING | Myocardial Infarction (MI) |
Shanghai Zhongshan Hospital |
2026-02-01 | PHASE3 |
| NCT04268498 | ACTIVE_NOT_RECRUITING | Multiple Myeloma |
University of Miami |
2020-02-11 | PHASE2 |
| NCT07532993 | NOT_YET_RECRUITING | Allergic Rhinitis (AR) |
Liaquat National Hospital & Medical College |
2026-09 | PHASE4 |
| NCT05498116 | RECRUITING | Albuminuria |
University of Colorado, Denver |
2023-01-26 | PHASE4 |
| NCT06356571 | RECRUITING | Plasma Cell Myeloma Refractory |
Sanofi |
2025-03-17 | PHASE2 |
| NCT06747130 | RECRUITING | Dengue; Montelukast; Transaminases |
Phramongkutklao College of Medicine and Hospital |
2025-01-31 | PHASE2; PHASE3 |
| NCT07101445 | RECRUITING | Multiple Myeloma |
Emory University |
2025-09-24 | PHASE4 |
| NCT06113640 | RECRUITING | Parkinson Disease |
Mostafa Bahaa |
2023-11-05 | PHASE2; PHASE3 |
| NCT03770923 | RECRUITING | Rheumatoid Arthritis |
Sherief Abd-Elsalam |
2018-10-01 | PHASE3 |
| NCT07770464 | RECRUITING | Acute Bronchiolitis |
Pakistan Institute of Medical Sciences |
2026-01-01 | PHASE2 |
| NCT05819541 | COMPLETED | Status Asthmaticus |
Vanderbilt University Medical Center |
2023-10-20 | PHASE2 |
| NCT06887673 | NOT_YET_RECRUITING | Colorectal Cancer; Sarcoma; Brain Tumors; Endometrial Cancer; Ovarian Cancer |
University of South Florida |
2025-03 | EARLY_PHASE1 |
| NCT05704049 | ACTIVE_NOT_RECRUITING | Relapsed/Refractory Multiple Myeloma |
Sanofi |
2023-04-05 | PHASE2 |
| NCT04815187 | ACTIVE_NOT_RECRUITING | Meniere Disease; Allergic Rhinitis; Vertigo |
House Ear Institute |
2021-06-07 | PHASE4 |
| NCT07533565 | COMPLETED | Cirrhosis; Asthma |
Kafrelsheikh University |
2024-07-01 | PHASE4 |
| NCT04762472 | UNKNOWN | Atherosclerosis, Coronary |
Chinese University of Hong Kong |
2023-09 | PHASE4 |
| NCT02655562 | SUSPENDED | Coughing |
Beijing Chao Yang Hospital |
2016-04 | PHASE4 |
| NCT05959889 | COMPLETED | Breast Cancer; Doxorubicin Induced Cardiotoxicity |
Damanhour University |
2023-03-01 | |
| NCT02793375 | COMPLETED | Pain |
Children's Hospital Medical Center, Cincinnati |
2018-08-02 | PHASE3 |
| NCT05405166 | ACTIVE_NOT_RECRUITING | Plasma Cell Myeloma Recurrent |
Sanofi |
2022-06-23 | PHASE3 |
| NCT06340984 | UNKNOWN | Acne Vulgaris |
South Valley University |
2024-06 | PHASE3 |
| NCT06019728 | COMPLETED | Fabry's Disease |
Sanofi |
2023-11-10 | PHASE4 |
| NCT05381207 | UNKNOWN | Allergic Rhinitis |
Assiut University |
2022-10 | EARLY_PHASE1 |
| NCT04351698 | UNKNOWN | Anemia, Sickle Cell; Sleep-Disordered Breathing |
Great Ormond Street Hospital for Children NHS Foundation Trust |
2023-10-16 | PHASE2; PHASE3 |
| NCT04198623 | COMPLETED | Infusion Reaction; Monoclonal Antibody |
University of California, San Francisco |
2020-03-20 | PHASE2 |
| NCT04294641 | COMPLETED | Chronic GVHD |
National Cancer Institute (NCI) |
2021-05-10 | PHASE2 |
| NCT06340984 | Not yet recruiting | Acne Vulgaris |
South Valley University |
2024-06 | Phase 3 |
| NCT04885530 | COMPLETED | Covid19 |
Susanna Naggie, MD |
2021-06-08 | PHASE3 |
| NCT05663866 | ACTIVE_NOT_RECRUITING | Carcinoma, Non-Small-Cell Lung |
Janssen Research & Development, LLC |
2023-05-18 | PHASE2 |
| NCT03402503 | COMPLETED | Alzheimer Disease |
IntelGenx Corp. |
2018-11-26 | PHASE2 |
| NCT05143502 | UNKNOWN | Montelukast; Chronic Rhinosinusitis With Nasal Polyps |
Assiut University |
2022-01-01 | PHASE1; PHASE2 |
| NCT04613180 | UNKNOWN | Acute Bronchiolitis |
Samarkand State Medical Institute |
2018-01-03 | PHASE4 |
| NCT03794037 | SUSPENDED | Ovarian Hyperstimulation Syndrome |
Benha University |
2018-12-05 | PHASE2 |
| NCT04277702 | UNKNOWN | Peripheral Arterial Disease; Peripheral Vascular Diseases; Lower Limb Ischemia; Atherosclerosis of Artery |
Jagiellonian University |
2020-05 | PHASE3 |
| NCT04351698 | Recruiting | Anemia Sickle Cell|Sleep-Disordered Breathing |
Great Ormond Street Hospital for Children NHS Foundation Trust|Guy''s and St Thomas'' NHS Foundation Trust|University College London Hospitals|North Middlesex University Hospital|King''s College Hospital NHS Trust|The Whittington Hospital NHS Trust |
2023-10-16 | Phase 2|Phase 3 |
| NCT05852769 | COMPLETED | Healthy Volunteers |
Bristol-Myers Squibb |
2023-05-31 | PHASE1 |
| NCT05894577 | COMPLETED | Covid19 |
Susanna Naggie, MD |
2023-01-27 | PHASE3 |
| NCT04695704 | TERMINATED | Covid19; SARS (Disease) |
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
2021-08-11 | PHASE3 |
| NCT05362474 | TERMINATED | Diabetic Kidney Disease |
University of Colorado, Denver |
2022-07-01 | PHASE3 |
| NCT04673422 | COMPLETED | Dengue; Dengue With Warning Signs; Dengue Shock Syndrome |
Phramongkutklao College of Medicine and Hospital |
2021-01-15 | PHASE2; PHASE3 |
| NCT05293132 | COMPLETED | Sepsis |
Ain Shams University |
2022-02-01 | PHASE2; PHASE3 |
| NCT05651750 | UNKNOWN | To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy; To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results |
Assaf-Harofeh Medical Center |
2022-11-15 | PHASE4 |
| NCT05607446 | TERMINATED | Allergic Rhinitis |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2022-09-14 | PHASE1 |
| NCT04389411 | UNKNOWN | COVID-19 |
McGill University |
2022-11-01 | PHASE2; PHASE3 |
| NCT05447520 | COMPLETED | Rheumatoid Arthritis |
Noha Mansour |
2021-12-15 | PHASE2 |
| NCT03991988 | COMPLETED | Alzheimer Disease |
Emory University |
2019-09-25 | PHASE2 |
| NCT05651750 | Unknown status | To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy|To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results |
Assaf-Harofeh Medical Center |
2022-11-15 | Phase 4 |
| NCT04322422 | UNKNOWN | Asthma; Chest Syndrome; Clinical Anxiety; Clinical Depression; Lung Function; Quality of Life; Eosinophilia; Nitric Oxide; Airway Responsiveness; Induced Sputum |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2020-06-01 | |
| NCT04075110 | COMPLETED | Obesity; Endocrine; Diabetes Type 2 |
Sadat City University |
2019-07-01 | EARLY_PHASE1 |
| NCT04294459 | TERMINATED | Immune System Disorder |
Sanofi |
2020-06-18 | PHASE1; PHASE2 |
| NCT04718285 | UNKNOWN | COVID-19; SARS-CoV-2 |
Bahçeşehir University |
2021-05-15 | PHASE2 |
| NCT05064631 | Recruiting | Respiratory Tract Infections|Pediatric Respiratory Diseases|Wheezing |
Queen Mary University of London|Queensland University of Technology |
2022-01-12 | Phase 2 |
| NCT05094596 | UNKNOWN | COVID-19 Pneumonia |
Bugra Kerget |
2021-10-22 | PHASE4 |
| NCT05710081 | Recruiting | Wheezing|Bronchiolitis|Asthma in Children |
Barts & The London NHS Trust|University of Aberdeen|University of Edinburgh|King''s College London|University of Southampton|Menzies School of Health Research |
2021-11-30 | Phase 3 |
| NCT04957927 | UNKNOWN | Allergic Rhinitis |
Usama Azhar |
2020-12-12 | PHASE4 |
| NCT04561687 | UNKNOWN | Allergic Rhinitis |
Shiraz University of Medical Sciences |
2020-01-16 | |
| NCT04080947 | COMPLETED | Steatohepatitis, Nonalcoholic |
Sadat City University |
2019-08-01 | PHASE1; PHASE2 |
| NCT02889809 | COMPLETED | Asthma |
GlaxoSmithKline |
2017-07-10 | PHASE4 |
| NCT04425902 | COMPLETED | HIV Infections |
ViiV Healthcare |
2020-12-16 | PHASE1 |
| NCT04474327 | COMPLETED | Neonatal Sepsis |
Mansoura University Children Hospital |
2020-07-24 | PHASE1 |
| NCT05447039 | COMPLETED | Post COVID-19 |
Assiut University |
2020-09-01 | |
| NCT02110654 | COMPLETED | Sinusitis; Nasal Polyps; Asthma |
First Affiliated Hospital, Sun Yat-Sen University |
2014-06 | PHASE4 |
| NCT05040828 | COMPLETED | Allergic Rhinitis Due to Weed Pollen; Montelukast |
Beijing Tongren Hospital |
2020-07-01 | PHASE4 |
| NCT04537780 | COMPLETED | Non Alcoholic Steatohepatitis |
Tanta University |
2019-08-20 | PHASE4 |
| NCT04818723 | COMPLETED | Nephrotic Syndrome |
Nishtar Medical University |
2019-02-01 | |
| NCT04275115 | COMPLETED | Healthy |
H. Lundbeck A/S |
2020-02-10 | PHASE1 |
| NCT03545997 | TERMINATED | Sleep Apnea, Obstructive |
University Hospital, Grenoble |
2019-11-29 | PHASE3 |
| NCT04374981 | COMPLETED | Food-drug Interaction |
Damanhour University |
2019-07-01 | PHASE2 |
| NCT03269318 | TERMINATED | Asthma |
Brighton and Sussex University Hospitals NHS Trust |
2017-07-01 | PHASE4 |
| NCT02758873 | COMPLETED | Asthma |
University of Sussex |
2016-02 | |
| NCT05531994 | COMPLETED | Healthy Volunteers |
Qilu Pharmaceutical Co., Ltd. |
2018-11-27 | |
| NCT05528198 | COMPLETED | Healthy Volunteers |
Qilu Pharmaceutical Co., Ltd. |
2018-12-28 | |
| NCT03898193 | COMPLETED | Healthy Adults |
Pharmtechnology LLC |
2019-03-23 | PHASE1 |
| NCT03380975 | COMPLETED | Asthma and Allergic Rhinitis |
Clinision |
2018-08-28 | PHASE4 |
| NCT01998971 | COMPLETED | Multiple Myeloma |
Janssen Research & Development, LLC |
2014-02-18 | PHASE1 |
| NCT02534467 | COMPLETED | Dermatitis, Atopic |
Murdoch Childrens Research Institute |
2015-07-09 | PHASE4 |
| NCT03039101 | COMPLETED | Nasal Allergy |
Mitchell Grayson |
2017-09-06 | |
| NCT01960413 | COMPLETED | Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0) |
Vanderbilt University Medical Center |
2013-11 | PHASE2 |
| NCT03096327 | COMPLETED | Asthma |
PharmEvo Pvt Ltd |
2017-05-01 | PHASE4 |
| NCT03131973 | COMPLETED | Rheumatoid Arthritis |
Bristol-Myers Squibb |
2017-05-13 | PHASE1 |
| NCT02720081 | COMPLETED | Asthma |
Merck Sharp & Dohme LLC |
2016-05-11 | PHASE2 |
| NCT03371849 | COMPLETED | Healthy |
Hanmi Pharmaceutical Company Limited |
2017-07-19 | PHASE1 |
| NCT01702701 | WITHDRAWN | Eosinophilic Esophagitis; Dysphagia |
Medical College of Wisconsin |
2012-01 | PHASE3 |
| NCT02410278 | COMPLETED | Multiple Sclerosis |
Biogen |
2015-03-12 | PHASE4 |
| NCT02479074 | COMPLETED | Cough |
Hull University Teaching Hospitals NHS Trust |
2016-01 | PHASE4 |
| NCT02761252 | COMPLETED | Seasonal Allergic Rhinoconjunctivitis; Asthma |
Menarini International Operations Luxembourg SA |
2016-04-13 | PHASE4 |
| NCT00115297 | COMPLETED | Lung Diseases; Asthma |
University of Massachusetts, Worcester |
2004-09 | PHASE2; PHASE3 |
| NCT04077892 | COMPLETED | Allergic Rhinitis |
Beijing Tongren Hospital |
2016-06-01 | EARLY_PHASE1 |
| NCT02762123 | COMPLETED | Rheumatoid Arthritis |
Bristol-Myers Squibb |
2016-05 | PHASE1 |
| NCT02483975 | COMPLETED | Asthma |
GlaxoSmithKline |
2015-10-09 | PHASE3 |
| NCT02635334 | COMPLETED | Asthma |
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. |
2015-11 | PHASE4 |
| NCT02401256 | COMPLETED | Healthy |
Indiana University |
2013-07 | PHASE4 |
| NCT03372473 | COMPLETED | Asthma in Children |
Innovacion y Desarrollo de Estrategias en Salud |
2016-01-10 | PHASE3 |
| NCT02104674 | COMPLETED | Asthma |
Hoffmann-La Roche |
2014-06-07 | PHASE3 |
| NCT02578277 | COMPLETED | HIV Infections |
ViiV Healthcare |
2015-11-09 | PHASE1 |
| NCT01967498 | UNKNOWN | Chronic Otitis Media With Effusion; Conductive Hearing Loss |
Tel-Aviv Sourasky Medical Center |
2013-11 | |
| NCT02658422 | COMPLETED | Respiratory Disorders; Asthma and Rhinitis |
GlaxoSmithKline |
2015-08-18 | PHASE1 |
| NCT01621386 | COMPLETED | Asthma |
Hal C Charles |
2013-01 | PHASE1 |
| NCT00511316 | COMPLETED | Eosinophilic Esophagitis |
Mayo Clinic |
2007-08 | PHASE1 |
| NCT01581710 | COMPLETED | Mild Persistent Asthma |
CHA University |
2012-05 | |
| NCT02352545 | UNKNOWN | Cough |
Beijing Chao Yang Hospital |
2014-08 | PHASE2 |
| NCT02559388 | COMPLETED | Renal Insufficiency, Chronic |
Shiraz University of Medical Sciences |
2015-04 | |
| NCT02303600 | UNKNOWN | Coughing |
Beijing Chao Yang Hospital |
2014-08 | |
| NCT02456844 | COMPLETED | Rheumatoid Arthritis |
Bristol-Myers Squibb |
2015-05 | PHASE1 |
| NCT02494466 | COMPLETED | Airway Reactivity |
Umraniye Education and Research Hospital |
2014-05 | PHASE4 |
| NCT01618929 | COMPLETED | Bronchial Asthma; Food Allergy; Children |
Hacettepe University |
2013-03 | PHASE4 |
| NCT01696214 | COMPLETED | Asthma |
University of California, San Diego |
2012-10 | PHASE4 |
| NCT02322671 | COMPLETED | Respiratory Disorders |
GlaxoSmithKline |
2015-02-23 | PHASE1 |
| NCT02551536 | COMPLETED | Allergic Rhinitis |
Indira Gandhi Medical College, Shimla |
2014-04 | PHASE4 |
| NCT02321748 | COMPLETED | Healthy |
Maruho Europe Limited |
2014-12 | PHASE1 |
| NCT01606306 | COMPLETED | Asthma; Wheezing |
Milton S. Hershey Medical Center |
2013-02 | PHASE3 |
| NCT01211509 | COMPLETED | Bronchiolitis Obliterans; Lung Transplantation; Graft Rejection |
Universitaire Ziekenhuizen KU Leuven |
2010-10 | PHASE4 |
| NCT01458418 | TERMINATED | Eosinophilic Esophagitis |
Children's Mercy Hospital Kansas City |
2011-12 | |
| NCT01730027 | COMPLETED | Asthma |
Pulmagen Therapeutics |
2013-04 | PHASE2 |
| NCT02227173 | COMPLETED | Drug-drug Interaction Study |
Bristol-Myers Squibb |
2014-09 | PHASE1 |
| NCT01224964 | TERMINATED | Asthmatic Patients |
Universitaire Ziekenhuizen KU Leuven |
2011-01 | |
| NCT02565212 | COMPLETED | Allergic Rhinitis |
Istanbul Training and Research Hospital |
2014-05 | PHASE4 |
| NCT00513760 | COMPLETED | Asthma |
Nemours Children's Clinic |
2007-06 | |
| NCT01329939 | COMPLETED | Asthma; Obesity; Inflammation |
Northwell Health |
2011-04 | |
| NCT01307462 | COMPLETED | Bronchiolitis Obliterans |
Stephanie Lee |
2011-06 | PHASE2 |
| NCT01086527 | COMPLETED | Asthma |
Nemours Children's Clinic |
2010-03 | PHASE1 |
| NCT01027806 | TERMINATED | Obstructive Sleep Apnea |
University of Chicago |
2010-07 | PHASE4 |
| NCT01404013 | UNKNOWN | Asthma |
The First Affiliated Hospital of Guangzhou Medical University |
2012-02 | PHASE4 |
| NCT02480049 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2014-08 | PHASE1 |
| NCT02108886 | UNKNOWN | Preterm Labor |
Université de Sherbrooke |
2011-12 | PHASE2 |
| NCT01656395 | TERMINATED | Asthma |
Merck Sharp & Dohme LLC |
2012-08-23 | PHASE2 |
| NCT01089647 | COMPLETED | Obstructive Sleep Apnea |
Romaker & Associates |
2010-09 | PHASE3 |
| NCT01841164 | UNKNOWN | Asthma |
Karolinska University Hospital |
2012-05 | |
| NCT01624974 | COMPLETED | Asthma |
Merck Sharp & Dohme LLC |
2012-08-09 | PHASE2 |
| NCT00656058 | COMPLETED | Bronchiolitis Obliterans; Chronic Graft Versus Host Disease; Leukotriene; Montelukast; Stem Cell Transplant |
National Cancer Institute (NCI) |
2008-06-17 | PHASE2 |
| NCT02479854 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2014-04 | PHASE1 |
| NCT02045966 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-02 | PHASE1 |
| NCT01142505 | COMPLETED | Wheezing |
Queen Mary University of London |
2010-11 | PHASE3 |
| NCT02029313 | COMPLETED | Asthma and Allergic Rhinitis |
PharmaKing |
2013-11 | PHASE1 |
| NCT01852812 | COMPLETED | Perennial Allergic Rhinitis |
Organon and Co |
2013-06-07 | PHASE3 |
| NCT00775697 | UNKNOWN | Wheezing |
Universita di Verona |
2009-09 | PHASE4 |
| NCT01951898 | UNKNOWN | Asthma |
Kurume University |
2012-06 | PHASE2; PHASE3 |
| NCT01770899 | UNKNOWN | Status Asthmaticus |
Corrie Fletcher |
2013-01 | |
| NCT00961155 | UNKNOWN | Asthma |
Medical University of Lodz |
2009-08 | PHASE2 |
| NCT01266772 | UNKNOWN | Bronchial Asthma |
Medical University of Lodz |
2011-01 | PHASE3 |
| NCT01437735 | COMPLETED | Asthma |
Novartis Pharmaceuticals |
2011-08 | PHASE2 |
| NCT00488176 | UNKNOWN | Seasonal Allergic Rhinitis |
Medical University of Lodz |
2007-04 | PHASE4 |
| NCT01016847 | TERMINATED | Asthma |
Duke University |
2010-01 | PHASE4 |
| NCT01804400 | COMPLETED | Allergic Rhinitis |
Novartis Pharmaceuticals |
2012-10 | PHASE2 |
| NCT01717625 | COMPLETED | Premature Birth; Infant, Very Low Birth Weight; Bronchopulmonary Dysplasia |
Ajou University School of Medicine |
2011-11 | PHASE2 |
| NCT01765192 | COMPLETED | Asthma |
AstraZeneca |
2013-02 | PHASE2 |
| NCT01857063 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2013-06-10 | PHASE3 |
| NCT01615874 | WITHDRAWN | Asthma |
Organon and Co |
2013-01 | PHASE2 |
| NCT02014532 | COMPLETED | Chronic Periodontitis |
Tatyasaheb Kore Dental College |
2012-03 | PHASE4 |
| NCT01551147 | COMPLETED | Asthma |
Ono Pharma USA Inc |
2012-06 | PHASE2 |
| NCT01640535 | COMPLETED | Perennial Allergic Rhinitis |
Hanmi Pharmaceutical Company Limited |
2012-06 | PHASE3 |
| NCT01432080 | TERMINATED | Respiratory Tract Infections; Bronchiolitis Obliterans; Cryptogenic Organizing Pneumonia; Lung Diseases, Interstitial |
Maisonneuve-Rosemont Hospital |
2011-09 | PHASE2 |
| NCT01754220 | COMPLETED | Coughing |
Association Asthma, Bulgaria |
2012-03 | PHASE4 |
| NCT01536041 | COMPLETED | Asthma |
Ono Pharma USA Inc |
2012-03 | PHASE2 |
| NCT01673620 | COMPLETED | Allergic Rhinitis |
Organon and Co |
2012-07-04 | PHASE3 |
| NCT03369119 | COMPLETED | Acute Asthma; Acute Wheezy Bronchitis |
Kecioren Education and Training Hospital |
2011-08 | PHASE4 |
| NCT01279668 | UNKNOWN | Persistent Cough; Whooping Cough |
University of Oxford |
2011-05 | PHASE4 |
| NCT01147510 | COMPLETED | Persistent Asthma; Elderly |
Ajou University School of Medicine |
2010-07 | PHASE4 |
| NCT00699062 | COMPLETED | Asthma |
Chinese Academy of Medical Sciences |
2010-01 | PHASE4 |
| NCT01491503 | COMPLETED | Healthy |
Hanmi Pharmaceutical Company Limited |
2011-11 | PHASE1 |
| NCT00947453 | COMPLETED | Asthma |
University of East Anglia |
2009-07 | PHASE2 |
| NCT00395304 | COMPLETED | Asthma |
Milton S. Hershey Medical Center |
2007-03 | PHASE3 |
| NCT01725360 | COMPLETED | Asthma |
Cantonal Hospital, Baselland |
2007-01 | PHASE4 |
| NCT01147744 | COMPLETED | Asthma |
GlaxoSmithKline |
2010-06-28 | PHASE2 |
| NCT01156792 | COMPLETED | Asthma |
GlaxoSmithKline |
2010-09 | PHASE2 |
| NCT01248975 | COMPLETED | Asthma |
GlaxoSmithKline |
2010-12 | PHASE2 |
| NCT00875082 | COMPLETED | Asthma |
Universita di Verona |
2010-02 | PHASE4 |
| NCT01103349 | COMPLETED | Asthma |
Boehringer Ingelheim |
2010-04-20 | PHASE2 |
| NCT00863317 | COMPLETED | Bronchiolitis |
Medical College of Wisconsin |
2008-12 | |
| NCT01240889 | COMPLETED | Allergy |
Creighton University |
2010-11 | |
| NCT00492102 | COMPLETED | Bronchopulmonary Dysplasia |
Children's Hospital Medical Center, Cincinnati |
2007-03 | PHASE1 |
| NCT01241422 | COMPLETED | Asthma |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2010-11 | PHASE2 |
| NCT01121016 | UNKNOWN | Nonasthmatic Eosinophilic Bronchitis |
Guangzhou Medical University |
2010-06 | PHASE4 |
| NCT00936624 | COMPLETED | Asthma |
SK Chemicals Co., Ltd. |
2009-07 | PHASE2 |
| NCT00712335 | COMPLETED | Asthmatic Smokers; Non-asthmatic Smokers |
Inje University |
2007-02 | PHASE4 |
| NCT01370187 | COMPLETED | Bronchiolitis; Wheezing; Cough |
Hormozgan University of Medical Sciences |
2010-07 | |
| NCT01061333 | COMPLETED | Asthma |
Merck Sharp & Dohme LLC |
2010-06 | PHASE1 |
| NCT01691456 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2011-01 | PHASE1 |
| NCT01691469 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2011-01 | PHASE1 |
| NCT01304901 | COMPLETED | Asthma; Acute Asthma |
Kecioren Education and Training Hospital |
2010-04 | PHASE4 |
| NCT01414868 | COMPLETED | Bronchial Asthma |
Guangzhou Institute of Respiratory Disease |
2010-03 | |
| NCT00453765 | COMPLETED | Cough; Bronchial Hyperreactivity |
Isala |
2007-12 | PHASE4 |
| NCT00903357 | COMPLETED | Atopic Dermatitis |
Pyun BokYang |
2009-08 | |
| NCT00351364 | TERMINATED | Coronary Artery Disease; Acute Coronary Syndrome |
University of Calgary |
2006-07 | PHASE4 |
| NCT01526161 | COMPLETED | Asthma |
Professor Warren Lenney |
2009-04 | PHASE4 |
| NCT01863654 | COMPLETED | Asthma |
GlaxoSmithKline |
2010-05-16 | PHASE1 |
| NCT01943942 | COMPLETED | Asthma |
GlaxoSmithKline |
2010-05-16 | PHASE1 |
| NCT00912171 | COMPLETED | Obstructive Sleep Apnea Syndrome |
University of Bologna |
2009-01 | PHASE4 |
| NCT01007721 | COMPLETED | Rhinitis, Allergic, Seasonal; Asthma |
Boehringer Ingelheim |
2009-10 | PHASE2 |
| NCT00284856 | COMPLETED | Asthma |
Organon and Co |
2006-05 | PHASE3 |
| NCT01671709 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2010-02 | PHASE1 |
| NCT00534976 | COMPLETED | Exercise-induced Bronchoconstriction (EIB) |
Organon and Co |
2008-02 | PHASE4 |
| NCT01671722 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2010-02 | PHASE1 |
| NCT01674517 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2010-02 | PHASE1 |
| NCT00494572 | UNKNOWN | Status Asthmaticus; Asthma |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2006-12 | PHASE2; PHASE3 |
| NCT01674504 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2010-01 | PHASE1 |
| NCT00491790 | UNKNOWN | Status Asthmaticus; Asthma |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2006-12 | PHASE2; PHASE3 |
| NCT00599534 | WITHDRAWN | Sleep Apnea |
University of Louisville |
2007-12 | PHASE2 |
| NCT00770900 | COMPLETED | Asthma |
University of Brasilia |
2008-09 | PHASE4 |
| NCT01928069 | COMPLETED | Healthy |
Torrent Pharmaceuticals Limited |
PHASE1 | |
| NCT00551382 | UNKNOWN | Upper Respiratory Tract Infection |
Assaf-Harofeh Medical Center |
2007-11 | PHASE3 |
| NCT01928056 | COMPLETED | Healthy |
Torrent Pharmaceuticals Limited |
PHASE1 | |
| NCT00856687 | COMPLETED | Asthma |
Pfizer |
2009-04 | PHASE1 |
| NCT00406094 | UNKNOWN | Rhinitis |
Bernstein, Jonathan A., M.D. |
2006-11 | PHASE4 |
| NCT00394355 | COMPLETED | Asthma |
Organon and Co |
2006-09 | PHASE4 |
| NCT00337675 | COMPLETED | Asthma |
Organon and Co |
2006-10 | PHASE3 |
| NCT00655616 | COMPLETED | Asthma |
University of Dundee |
2007-08 | |
| NCT00379808 | COMPLETED | Coronary Heart Disease |
University of Florida |
2006-07 | |
| NCT00462592 | COMPLETED | Asthma |
Hamilton Health Sciences Corporation |
2007-03 | PHASE3 |
| NCT01055041 | COMPLETED | Moderate to Severe Persistent Bronchial Asthma |
Government Medical College, Bhavnagar |
2008-12 | |
| NCT00557284 | COMPLETED | Atopic Dermatitis |
1st Allergy & Clinical Research Center |
2008-03 | PHASE4 |
| NCT00676468 | COMPLETED | Asthma |
Indiana University |
2008-09 | PHASE1 |
| NCT00814281 | COMPLETED | Airway Inflammation |
Marywood University |
2007-05 | |
| NCT00666679 | COMPLETED | Asthma |
Organon and Co |
2008-05 | PHASE2 |
| NCT00590772 | COMPLETED | Perennial Allergic Rhinitis |
Penn State University |
2003-05 | PHASE4 |
| NCT00543686 | COMPLETED | Asthma |
Johann Wolfgang Goethe University Hospital |
2007-08 | PHASE2 |
| NCT00359073 | COMPLETED | Asthma |
University of Wisconsin, Madison |
2006-10 | |
| NCT00739297 | COMPLETED | Chronic Asthma |
Organon and Co |
2008-07 | PHASE1 |
| NCT00721240 | COMPLETED | Asthma |
Marien Hospital Wesel |
2006-02 | PHASE4 |
| NCT00127166 | COMPLETED | Exercise Induced Asthma |
Organon and Co |
2005-12 | PHASE3 |
| NCT00832455 | COMPLETED | Asthma |
Organon and Co |
2006-06 | PHASE4 |
| NCT00565955 | COMPLETED | Bronchial Asthma |
All India Institute of Medical Sciences |
2007-03 | PHASE3 |
| NCT00664937 | COMPLETED | Asthma, Exercise-induced |
Organon and Co |
2007-05 | PHASE1 |
| NCT00487773 | COMPLETED | Asthma |
Medical University of Lodz |
2007-09 | PHASE4 |
| NCT00636207 | COMPLETED | Asthma |
Organon and Co |
2007-08 | PHASE1 |
| NCT01659892 | COMPLETED | Asthma |
Roxane Laboratories |
2008-08 | EARLY_PHASE1 |
| NCT01659905 | COMPLETED | Asthma |
Roxane Laboratories |
2008-08 | EARLY_PHASE1 |
| NCT00935415 | COMPLETED | Exercise-Induced Asthma; Asthma |
Universita di Verona |
2007-01 | PHASE4 |
| NCT00119015 | TERMINATED | Rhinitis, Allergic, Perennial |
University of Chicago |
2005-07 | PHASE4 |
| NCT00934713 | COMPLETED | Lung Disease, Obstructive; Signs and Symptoms, Respiratory |
University of Helsinki |
2004-09 | PHASE4 |
| NCT00540839 | WITHDRAWN | Asthma, Bronchial |
Organon and Co |
2007-11 | PHASE3 |
| NCT00117338 | COMPLETED | Asthma |
Organon and Co |
2005-07 | PHASE3 |
| NCT00380484 | COMPLETED | Asthma |
Children´s Clinic, Randers |
2006-09 | PHASE4 |
| NCT01659931 | COMPLETED | Asthma |
Roxane Laboratories |
2008-02 | EARLY_PHASE1 |
| NCT01931514 | COMPLETED | Healthy |
Torrent Pharmaceuticals Limited |
PHASE1 | |
| NCT01931501 | COMPLETED | Healthy |
Torrent Pharmaceuticals Limited |
PHASE1 | |
| NCT01659918 | COMPLETED | Asthma |
Roxane Laboratories |
2008-02 | EARLY_PHASE1 |
| NCT00213252 | COMPLETED | Asthma, Bronchial |
The Hospital for Sick Children |
2005-09 | PHASE2 |
| NCT00545844 | COMPLETED | Asthma |
Organon and Co |
2007-04-01 | PHASE4 |
| NCT00296491 | COMPLETED | Asthma |
GlaxoSmithKline |
2005-09 | PHASE4 |
| NCT00442559 | COMPLETED | Asthma; Allergic Rhinitis |
Organon and Co |
2005-01 | PHASE4 |
| NCT00273689 | COMPLETED | Exercise Induced Bronchospasm |
University of New Mexico |
2005-12 | PHASE4 |
| NCT00755794 | COMPLETED | Asthma |
Organon and Co |
2006-06 | PHASE3 |
| NCT00442338 | COMPLETED | Asthma |
Organon and Co |
2007-03 | PHASE3 |
| NCT00424580 | COMPLETED | Asthma |
University of Saskatchewan |
2007-01 | |
| NCT00289874 | COMPLETED | Asthma |
Organon and Co |
2006-03 | PHASE3 |
| NCT00296530 | COMPLETED | Asthma |
GlaxoSmithKline |
2005-09 | PHASE4 |
| NCT00189475 | COMPLETED | Upper Respiratory Infection |
Deborah Gentile |
2003-10 | PHASE4 |
| NCT00385463 | WITHDRAWN | Asthma; Seasonal Allergic Rhinitis |
Creighton University |
2006-04 | |
| NCT00328718 | COMPLETED | Asthma |
GlaxoSmithKline |
2005-10 | PHASE3 |
| NCT00423995 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2006-11-01 | PHASE3 |
| NCT00504946 | COMPLETED | Asthma |
Medical University of Lodz |
2005-09 | PHASE3 |
| NCT00092989 | COMPLETED | Asthma |
Organon and Co |
2004-07 | PHASE3 |
| NCT00319488 | COMPLETED | Asthma; Lung Diseases |
National Heart, Lung, and Blood Institute (NHLBI) |
2004-02 | |
| NCT00461032 | COMPLETED | Asthma |
Organon and Co |
2006-06 | PHASE3 |
| NCT00295022 | COMPLETED | Rhinitis, Allergic, Seasonal |
UCB S.A. - Pharma Sector |
2006-07-29 | PHASE4 |
| NCT00315523 | COMPLETED | Rhinitis, Allergic, Seasonal |
UCB Pharma |
2006-07 | PHASE3 |
| NCT00229970 | COMPLETED | Asthma |
Organon and Co |
2005-09 | PHASE3 |
| NCT00245570 | COMPLETED | Asthma, Exercise-Induced |
Organon and Co |
2005-12 | PHASE3 |
| NCT00675285 | COMPLETED | Asthma |
Catholic University of the Sacred Heart |
2005-09 | PHASE3 |
| NCT00319995 | COMPLETED | Rhinitis, Allergic, Seasonal |
Organon and Co |
2006-03-01 | PHASE3 |
| NCT00076973 | COMPLETED | Bronchiolitis |
Organon and Co |
2003-08 | PHASE3 |
| NCT00445107 | COMPLETED | Asthma |
Organon and Co |
2005-11-01 | PHASE3 |
| NCT00913328 | COMPLETED | Asthma |
Hvidovre University Hospital |
2002-08 | PHASE4 |
| NCT00398151 | COMPLETED | Asthma |
Organon and Co |
2005-08-01 | PHASE3 |
| NCT00148408 | COMPLETED | Asthma |
American Lung Association Asthma Clinical Research Centers |
2003-12 | PHASE4 |
| NCT00189462 | COMPLETED | Acute Otitis Media; Otitis Media; Ear Infection |
Deborah Gentile |
2004-03 | PHASE4 |
| NCT00394160 | COMPLETED | Bronchiolitis |
Organon and Co |
2004-12 | PHASE2 |
| NCT00156819 | COMPLETED | Asthma |
JHSPH Center for Clinical Trials |
2003-06 | PHASE4 |
| NCT00380705 | COMPLETED | Asthma; Rhinitis Allergic |
Organon and Co |
2005-03-18 | PHASE4 |
| NCT00157937 | COMPLETED | Asthma; Allergic Rhinitis |
Organon and Co |
2003-02 | PHASE4 |
| NCT00783601 | COMPLETED | Asthma |
Merck Sharp & Dohme LLC |
2004-10 | PHASE2 |
| NCT00127647 | COMPLETED | Rhinitis, Allergic, Seasonal |
Organon and Co |
2004-11 | PHASE3 |
| NCT00641472 | COMPLETED | Asthma |
AstraZeneca |
2002-10 | PHASE4 |
| NCT00771160 | COMPLETED | Rhinitis, Allergic |
Organon and Co |
2004-09 | PHASE3 |
| NCT00090142 | COMPLETED | Asthma, Exercise-Induced |
Organon and Co |
2004-05 | PHASE3 |
| NCT00353184 | TERMINATED | Asthma |
Washington University School of Medicine |
2001-09 | |
| NCT00756418 | COMPLETED | Asthma |
Organon and Co |
2003-06-01 | PHASE4 |
| NCT01011452 | COMPLETED | Acute Asthma Exacerbation |
University of East Anglia |
2001-05 | PHASE4 |
| NCT00446056 | COMPLETED | Asthma |
Organon and Co |
2003-09-25 | PHASE4 |
| NCT00092144 | COMPLETED | Asthma |
Organon and Co |
2004-02-26 | PHASE3 |
| NCT00092092 | COMPLETED | Asthma, Bronchial |
Organon and Co |
2002-10 | PHASE4 |
| NCT00092118 | COMPLETED | Rhinitis, Allergic, Perennial |
Organon and Co |
2003-10 | PHASE3 |
| NCT00446186 | COMPLETED | Rhinitis Allergic |
Organon and Co |
2004-02 | PHASE2 |
| NCT00545324 | COMPLETED | Asthma |
Organon and Co |
2002-09 | PHASE4 |
| NCT00395408 | COMPLETED | Asthma |
Organon and Co |
2000-06 | PHASE4 |
| NCT00394069 | COMPLETED | Bronchiolitis |
Organon and Co |
2003-07 | PHASE2 |
| NCT00045955 | COMPLETED | Asthma |
Sanofi |
2002-02 | PHASE3 |
| NCT00092131 | COMPLETED | Asthma, Exercise-Induced |
Organon and Co |
2003-06 | PHASE3 |
| NCT00092885 | COMPLETED | Rhinitis, Allergic, Seasonal; Asthma, Bronchial |
Organon and Co |
2003-03 | PHASE3 |
| NCT00140881 | COMPLETED | Asthma |
Organon and Co |
2000-06-01 | PHASE4 |
| NCT00092105 | COMPLETED | Asthma, Bronchial; Rhinitis, Allergic, Perennial |
Organon and Co |
2002-04-01 | PHASE3 |
| NCT00700661 | COMPLETED | Asthma |
Organon and Co |
2001-01 | PHASE3 |
| NCT00489346 | COMPLETED | Asthma, Bronchial |
Organon and Co |
2001-10 | PHASE3 |
| NCT00974571 | COMPLETED | Perennial Allergic Rhinitis |
Organon and Co |
2001-11 | PHASE3 |
| NCT00963469 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2001-08 | PHASE3 |
| NCT00943397 | COMPLETED | Asthma |
Organon and Co |
2001-04 | PHASE3 |
| NCT00972738 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2001-04 | PHASE3 |
| NCT00968149 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2001-03 | PHASE3 |
| NCT00968201 | COMPLETED | Asthma |
Organon and Co |
1997-12 | PHASE3 |
| NCT00943683 | COMPLETED | Asthma |
Organon and Co |
2000-08 | |
| NCT00140946 | COMPLETED | Asthma |
Organon and Co |
1998-03 | PHASE4 |
| NCT00960141 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2000-08 | PHASE3 |
| NCT00979901 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2000-03 | PHASE3 |
| NCT00963599 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
1999-09 | PHASE3 |
| NCT00911547 | COMPLETED | Asthma |
Organon and Co |
1995-03 | PHASE3 |
| NCT00162864 | COMPLETED | Asthma; COPD |
Kaiser Permanente |
1999-12 | PHASE3 |
| NCT00311051 | WITHDRAWN | Asthma |
Research Center Borstel |
2005-04 | PHASE2; PHASE3 |
| NCT00148603 | COMPLETED | Eosinophilic Gastroenteritis; Dyspepsia |
Children's Mercy Hospital Kansas City |
2005-09 | |
| NCT00299910 | UNKNOWN | Sleep Disordered Breathing |
Soroka University Medical Center |
2005-03 | PHASE4 |
| NCT00375232 | WITHDRAWN | Exercise-Induced Bronchospasm |
Indiana University |
2006-10 | |
| NCT00196547 | COMPLETED | Asthma |
Firestone Institute for Respiratory Health |
2005-09 | PHASE4 |
| NCT00471809 | TERMINATED | Asthma |
National Heart, Lung, and Blood Institute (NHLBI) |
2006-03 | PHASE4 |
| NCT00490243 | COMPLETED | Asthma |
Medical University of Lodz |
2003-07 | PHASE4 |
| NCT00550758 | TERMINATED | Asthma; Recurrent Cough |
Rambam Health Care Campus |
2004-05 | |
| NCT00637611 | COMPLETED | Seasonal Allergic Rhinitis |
Sanofi |
2003-02 | PHASE4 |
| NCT00638118 | COMPLETED | Allergic Rhinitis |
Sanofi |
2003-02 | PHASE4 |
| NCT00524693 | COMPLETED | Bronchiolitis |
Ziv Hospital |
2006-01 | |
| NCT00559546 | COMPLETED | Seasonal Allergic Rhinitis; Allergic Conjunctivitis; Atopic Eczema; Asthma |
University of Helsinki |
2007-03 | PHASE4 |
| NCT00116324 | COMPLETED | Asthma |
Brigham and Women's Hospital |
2003-04 | PHASE3 |
| NCT00406861 | UNKNOWN | Erythema Nodosum Leprosum; Leprosy |
The Leprosy Mission Bangladesh |
2006-12 |
(data from https://clinicaltrials.gov, updated on 2026-07-06)
Check the
Montelukast Sodium
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.