CLINICAL TRIALS PROFILE FOR DENUFOSOL

Clinical Trials for Denufosol

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00034515 ↗	A Study in Adult and Pediatric Patients With Cystic Fibrosis	Completed	Merck Sharp & Dohme Corp.	Phase 1/Phase 2	The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis
NCT00056147 ↗	Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease	Completed	Cystic Fibrosis Foundation	Phase 2	The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
NCT00056147 ↗	Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease	Completed	Cystic Fibrosis Foundation Therapeutics	Phase 2	The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
NCT00056147 ↗	Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease	Completed	Merck Sharp & Dohme Corp.	Phase 2	The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
NCT00083967 ↗	Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment	Terminated	Merck Sharp & Dohme Corp.	Phase 2	The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.
NCT00103714 ↗	Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease	Completed	Merck Sharp & Dohme Corp.	Phase 2	The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
NCT00114062 ↗	Study to Treat Uveitis Associated Macular Edema	Terminated	Merck Sharp & Dohme Corp.	Phase 2	The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.

Clinical Trial Conditions for Denufosol

Condition Name

Condition Name for
Intervention	Trials
Cystic Fibrosis	9
Retinal Detachment	2
Healthy	2
Macular Edema, Cystoid	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Fibrosis	9
Cystic Fibrosis	9
Lung Diseases	6
Pulmonary Fibrosis	5

Clinical Trial Locations for Denufosol

Trials by Country

Trials by Country for
Location	Trials
United States	60
Australia	6
Canada	6
New Zealand	1

Trials by US State

Trials by US State for
Location	Trials
Texas	2
Indiana	2
Virginia	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for Denufosol

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	8
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	10
Terminated	4
Withdrawn	1

Clinical Trial Sponsors for Denufosol

Sponsor Name

Sponsor Name for
Sponsor	Trials
Merck Sharp & Dohme Corp.	15
Cystic Fibrosis Foundation	1
Cystic Fibrosis Foundation Therapeutics	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	15
Other	2