Montelukast

Generic Name: Montelukast

Brand Names: Singulair

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₃₆ClNO_₃S

CAS Number: 158966-92-8

Unique Ingredient Identifier: MHM278SD3E

Background: Montelukast was first approved for clinical use by the US FDA in 1998 as Merck's brand name Singulair. The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs. Although capable of demonstrating effectiveness, the use of such LTRAs like montelukast is typically in addition to or complementary with the use of inhaled corticos...

Indication: Montelukast is indicated for:
...

Associated Conditions: Asthma, Exercise-Induced Bronchospasm, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis

Associated Therapies: -

Clinical Trials

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Phase 2

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Dexamethasone
Drug: Montelukast
Drug: Methotrexate
Drug: Amivantamab
Drug: Lazertinib

First Posted Date: 2022-12-23

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 73

Registration Number: NCT05663866

Locations: 🇫🇷
Hopital Europeen Georges-Pompidou, Paris, France
🇫🇷
CHU Rouen Hopital Charles Nicolle, Rouen, France
🇰🇷
Seoul National University Bundang Hospital, Gyeonggi-do, Korea, Republic of

and more 33 locations

Medical vs Surgical Treatment in OSA Among Children

Phase 4

Conditions: To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results
To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy

Interventions: Drug: Fluticasone Furoate
Drug: Montelukast

First Posted Date: 2022-12-15

Last Posted Date: 2022-12-15

Lead Sponsor: Assaf-Harofeh Medical Center

Target Recruit Count: 90

Registration Number: NCT05651750

Locations: 🇮🇱
Assaf-Harofeh Medical Center, Be'er Ya'aqov, Israel

Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Phase 4

Recruiting

Conditions: Albuminuria

Interventions: Other: Placebo
Drug: Montelukast

First Posted Date: 2022-08-11

Last Posted Date: 2024-05-08

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 50

Registration Number: NCT05498116

Locations: 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

Active, not recruiting

Conditions: Asthma

Interventions: Drug: Montelukast
Drug: Fluticasone

First Posted Date: 2022-07-14

Last Posted Date: 2023-07-19

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 75678

Registration Number: NCT05457855

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Montelukast Use in Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Montelukast
Drug: Conventional DMARDs

First Posted Date: 2022-07-07

Last Posted Date: 2024-02-13

Lead Sponsor: Noha Mansour

Target Recruit Count: 92

Registration Number: NCT05447520

Locations: 🇪🇬
Mansoura University, Mansoura, Egypt

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Phase 3

Active, not recruiting

Conditions: Plasma Cell Myeloma Recurrent

Interventions: Drug: Isatuximab SC
Drug: Isatuximab IV
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Montelukast
Drug: Paracetamol / Acetaminophen
Drug: Diphenhydramine
Drug: Methylprednisolone

First Posted Date: 2022-06-06

Last Posted Date: 2024-11-14

Lead Sponsor: Sanofi

Target Recruit Count: 531

Registration Number: NCT05405166

Locations: 🇺🇸
Arizona Oncology Associates, PC - HAL- Site Number : 8400015, Prescott Valley, Arizona, United States
🇺🇸
Rocky Mountain Cancer Centers, LLP- Site Number : 8400021, Aurora, Colorado, United States
🇺🇸
Mayo Clinic- Site Number : 8400008, Jacksonville, Florida, United States

and more 143 locations

Targeting Leukotrienes in Kidney Disease

Phase 3

Terminated

Conditions: Diabetic Kidney Disease

Interventions: Drug: Montelukast

First Posted Date: 2022-05-05

Last Posted Date: 2024-04-02

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 5

Registration Number: NCT05362474

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States

Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

Phase 1

Conditions: Montelukast
Chronic Rhinosinusitis With Nasal Polyps

Interventions: Drug: Montelukast
Drug: Prednisolone
Drug: Fluticasone Furoate

First Posted Date: 2021-12-03

Last Posted Date: 2022-03-18

Lead Sponsor: Assiut University

Target Recruit Count: 60

Registration Number: NCT05143502

Locations: 🇪🇬
Assiut University Hospital, Assiut, Egypt

ACTIV-6: COVID-19 Study of Repurposed Medications

Phase 3

Completed

Conditions: Covid19

Interventions: Other: Placebo
Drug: Metformin
Drug: Ivermectin
Drug: Fluvoxamine
Drug: Fluticasone
Drug: Montelukast

First Posted Date: 2021-05-13

Last Posted Date: 2024-11-13

Lead Sponsor: Susanna Naggie, MD

Target Recruit Count: 10956

Registration Number: NCT04885530

Locations: 🇺🇸
Emory Healthcare, Atlanta, Georgia, United States
🇺🇸
Northwestern Univesity, Chicago, Illinois, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 106 locations

Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Not Applicable

Completed

Conditions: Nephrotic Syndrome

Interventions: Drug: Montelukast

First Posted Date: 2021-03-26

Last Posted Date: 2021-03-26

Lead Sponsor: Nishtar Medical University

Target Recruit Count: 106

Registration Number: NCT04818723

Locations: 🇵🇰
Department of Pediatric Nephrology, The Children's Hospital and Institute of Child Health, Multan, PPunjab, Pakistan

Drug Development Updates

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