Drugs / denufosol
last change Feb 2011 re-read 3 minutes ago

denufosol

also known as denufosol tetrasodium · INS37217

Other / unclassified

Developed for
cystic fibrosis · cystoid macular edema · retinal detachment · uveitis
Investigated by
Merck Sharp & Dohme LLC · Cystic Fibrosis Foundation

Trials 15

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT00210093 Apr → May 2003 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00210054 Nov → Dec 2002 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00210067 May 2001 → Jun 2002 retinal detachment Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00034515 Jun 2001 → Aug 2002 cystic fibrosis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 28 trials
Phase 2 NCT01181622 Aug → Oct 2010 cystic fibrosis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00425165 Aug 2007 → May 2008 cystic fibrosis Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 2 NCT00114062 Sep 2005 → Dec 2006 cystoid macular edema, uveitis Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 2 NCT00130182 Aug 2005 → Sep 2006 cystic fibrosis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00135655 Aug 2005 → ? cystoid macular edema Merck Sharp & Dohme LLC Withdrawn No outcome recorded
Phase 2 NCT00103714 Jan → Aug 2005 cystic fibrosis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00083967 Jun 2004 → Apr 2006 retinal detachment Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 2 NCT00056147 Apr 2003 → Feb 2004 cystic fibrosis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 33 trials · 1 met primary · 1 missed
Phase 3 NCT00846781 Feb 2009 → Feb 2011 cystic fibrosis Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT00625612 Feb 2008 → Oct 2010 cystic fibrosis Merck Sharp & Dohme LLC Completed Missed primary
Phase 3 NCT00357279 Jul 2006 → Sep 2008 cystic fibrosis Merck Sharp & Dohme LLC Completed Met primary

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as denufosol ClinicalTrials.gov intervention name — accepted as the source's own label NCT00103714 ↗
14

NCT00846781 ↗

NCT00425165 ↗

NCT00135655 ↗

NCT00210093 ↗

NCT00210054 ↗

NCT00625612 ↗

NCT00034515 ↗

NCT00083967 ↗

NCT00210067 ↗

NCT00357279 ↗

Show 4 more sources

Known as denufosol tetrasodium “Denufosol tetrasodium (INS37217) is a selective P2Y(2) agonist that stimulates ciliary beat frequency and Cl(-) secretion in normal and cystic fibrosis (CF) airway epithelia,...” PMID 15704203 ↗ Apr 2005
13

“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...” NCT00103714 ↗

“Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.” NCT00625612 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00114062 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00210067 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00083967 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00135655 ↗

“denufosol tetrasodium (INS37217) Inhalation Solution” NCT00357279 ↗

“denufosol tetrasodium (INS37217) Inhalation Solution” NCT00425165 ↗

“denufosol tetrasodium Inhalation Solution” NCT01181622 ↗

“denufosol tetrasodium (INS37217)” NCT00210093 ↗

Show 3 more sources

Known as INS37217 “Denufosol tetrasodium (INS37217) is a selective P2Y(2) agonist that stimulates ciliary beat frequency and Cl(-) secretion in normal and cystic fibrosis (CF) airway epithelia,...” PMID 15704203 ↗ Apr 2005
12

“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...” NCT00103714 ↗

“Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.” NCT00625612 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00210067 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00114062 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00135655 ↗

“denufosol tetrasodium (INS37217) Intravitreal Injection” NCT00083967 ↗

“denufosol tetrasodium (INS37217) Inhalation Solution” NCT00425165 ↗

“denufosol tetrasodium (INS37217) Inhalation Solution” NCT00357279 ↗

“denufosol tetrasodium (INS37217)” NCT00130182 ↗

“denufosol tetrasodium (INS37217)” NCT00056147 ↗

Show 2 more sources

Action Activate “Denufosol tetrasodium is a selective P2Y(2) agonist” PMID 17446337 ↗ Apr 2007
Modality Other / unclassified “Denufosol is a novel ion channel regulator” PMID 21169471 ↗ Dec 2010
Route Other “administered by inhalation via the Pari LC Star nebulizer” NCT00034515 ↗