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denufosol

Small moleculeexperimental

Denufosol (INN) is an inhaled drug for the treatment of cystic fibrosis, being developed by Inspire Pharmaceuticals and sponsored by the Cystic Fibrosis Foundation. It was tested in two Phase III clinical trials, TIGER-1 and TIGER-2. Initially, in the first Phase III trial, TIGER-1, the compound showed significant results as compared with placebo. In the second Phase III trial, TIGER-2, the compound did not meet the primary endpoint, a significant change in baseline FEV1 at the week 48 endpoint as compared to placebo. As of 2011, no additional clinical studies are being conducted with the compound. — Wikipedia

Clinical trial activity

20 trials · 5 clinical orgs · 0 marketing orgs

Phase 1
4
Phase 2
13
Phase 3
3
Phase 4
0

Earliest trial started May 1, 2001 (NCT00210067)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

Indications

Studied for

Mechanism of action

Chemistry & pharmacology

Loading structure…

SMILES

Nc1ccn([C@H]2C[C@H](O)[C@@H](COP(=O)(O)OP(=O)(O)OP(=O)(O)OP(=O)(O)OC[C@H]3O[C@@H](n4ccc(=O)[nH]c4=O)[C@H](O)[C@@H]3O)O2)c(=O)n1
Mol. weight
773.32 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • denufosol
  • denufosol
  • denufosol
  • denufosol tetrasodium
  • denufosol tetrasodium
  • denufosol tetrasodium
  • denufosol tetrasodium
  • ins37217
  • ins37217
  • ins37217
  • ins 37217
  • ins-37217
  • ins-37217
  • p(1)-(uridine 5')-p(4)- (2'-deoxycytidine 5')tetraphosphate, tetrasodium salt

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06537349N/AAug 15, 2024He Eye Hospital
NCT05682547N/ANov 1, 2023He Eye Hospital, He Eye Hospital, Shenyang, China
NCT05193331N/AApr 1, 2023He Eye Hospital, He Eye Hospital, Shenyang, China, Santen Inc.
NCT04980144N/AAug 1, 2021He Eye Hospital, He Eye Hospital, Shenyang, China
NCT01181622Phase 2Aug 1, 2010Merck
NCT00846781Phase 3Feb 1, 2009Merck
NCT00625612Phase 3Feb 1, 2008Merck
NCT00425165Phase 2Aug 1, 2007Merck
NCT00357279Phase 3Jul 1, 2006Merck
NCT00114062Phase 2Sep 1, 2005Merck
NCT00135655Phase 2Aug 1, 2005Merck
NCT00130182Phase 2Aug 1, 2005Merck
NCT00103714Phase 2Jan 1, 2005Merck
NCT00083967Phase 2Jun 1, 2004Merck
NCT00210093Phase 1Apr 1, 2003Merck
NCT00056147Phase 2Apr 1, 2003Cystic Fibrosis Foundation Therapeutics, Merck
NCT00210015Phase 2Dec 1, 2002Merck
NCT00210054Phase 1Nov 1, 2002Merck
NCT00034515Phase 1/Phase 2 (Phase 2)Jun 1, 2001Merck
NCT00210067Phase 1May 1, 2001Merck
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit161632001
He Eye HospitalAcademic/Hospital4412021
He Eye Hospital, Shenyang, ChinaAcademic/Hospital3012021
Cystic Fibrosis Foundation TherapeuticsAcademic/Hospital1012003
Santen Inc.For profit1012023
5 organizations
Page 1 / 1