fenoldopam

Trade name: corlopam

Small moleculeapproved

Approved

Sep 23, 1997

Fenoldopam (marketed under the brand name Corlopam) is a drug and synthetic benzazepine derivative which acts as a selective D1 receptor partial agonist. Fenoldopam is a rapid-acting vasodilator. It is an agonist for D1-like dopamine receptors and binds with moderate affinity to α2-adrenoceptors. It has no significant affinity for D2-like receptors, α1 and β adrenoceptors, 5HT1 and 5HT2 receptors, or muscarinic receptors. Fenoldopam is a racemic mixture with the R-isomer responsible for the biological activity. The R-isomer has approximately 250-fold higher affinity for D1-like receptors than does the S-isomer. Fenoldopam Mesylate Injection, USP is indicated for the in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. — NCATS

Clinical trial activity

13 trials · 18 clinical orgs · 8 marketing orgs

Phase 1
1
Phase 2
5
Phase 3
5
Phase 4
3

Earliest trial started May 1, 2002 (NCT00122018)

Timeline

1990s

  1. Sep 23, 1997

    Hospira — Earliest FDA Approval

  2. Sep 23, 1997

    Hospira — NDA Secondary Org

  3. Sep 23, 1997

    Hospira — NDA Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Dec 1, 2003

    Lutipold — Marketing Organization

  3. Dec 1, 2003

    Sankyo — Marketing Organization

  4. Oct 12, 2004

    West-Ward Pharmaceutical — Marketing Organization

  5. Oct 12, 2004

    Hikma — Marketing Organization

  6. Feb 15, 2005

    Sandoz — Marketing Organization

  7. Feb 15, 2005

    Novartis — Marketing Organization

  8. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  9. Mar 7, 2007

    Teva — Marketing Organization

  10. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedSep 23, 1997

Chemistry & pharmacology

Loading structure…

SMILES

Oc1ccc(C2CNCCc3c2cc(O)c(O)c3Cl)cc1
Mol. weight
305.76 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • corlopam
  • corlopam
  • corlopam
  • corlopam
  • fenoldopam
  • fenoldopam
  • fenoldopam
  • fenoldopam
  • fenoldopam
  • fenoldopam
  • fenoldopam
  • fenoldopam
  • fénoldopam
  • fénoldopam
  • fenoldopam hydrobromide
  • fenoldopam hydrobromide
  • fenoldopam hydrobromide
  • fenoldopam hydrobromide
  • fenoldopam hydrobromide
  • fenoldopam hydrobromide
  • fenoldopam mesilate
  • fenoldopam mesylate
  • fenoldopam mesylate
  • fenoldopam mesylate
  • fenoldopam mesylate
  • fenoldopamum
  • fenoldopamum
  • sk-82526
  • sk-82526
  • sk-82526-j
  • sk-82526-j
  • sk&f-82526
  • sk&f-82526
  • sk&f-82526j
  • sk&f-82526j

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02620761Phase 2/Phase 3 (Phase 3)Dec 1, 2017Medical College of Wisconsin, University of Iowa
NCT01690832Phase 4Sep 1, 2012University of Roma La Sapienza
NCT01073189Phase 4Apr 1, 2010Southeast Renal Research Institute
NCT00982527Phase 3Sep 1, 2009Bambino Gesù Hospital and Research Institute
NCT00747331Phase 4Sep 1, 2008University of Milan
NCT00286403Phase 2/Phase 3 (Phase 3)Aug 1, 2008Dialysis Clinic, Inc., Emory University, Southeast Renal Research Institute
NCT00557219Phase 3Apr 1, 2008Medical University of Gdansk
NCT00621790Phase 3Feb 1, 2008Vita-Salute University of Milano. Italy
NCT00592150Phase 1Jun 1, 2007National Institutes of Health (NIH), University of Virginia
NCT00467181Phase 2Jan 1, 2005Summa Health System
NCT01324245N/ANov 1, 2002Georgetown University, University of Virginia
NCT00743106N/ASep 1, 2002University of Rochester
NCT00122018Phase 2May 1, 2002Abbott, Pulmonary and Critical Care Assoc. of Baltimore, Pulmonary Critical Care Associates of Baltimore
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Southeast Renal Research InstituteAcademic/Hospital2222008
University of VirginiaAcademic/Hospital2122002
AbbottFor profit1012002
Bambino Gesù Hospital and Research InstituteAcademic/Hospital1112009
Dialysis Clinic, Inc.Academic/Hospital1012008
Emory UniversityAcademic/Hospital1012008
Georgetown UniversityAcademic/Hospital1112002
Medical College of WisconsinAcademic/Hospital1112017
Medical University of GdanskAcademic/Hospital1112008
National Institutes of Health (NIH)Government1012007
Pulmonary and Critical Care Assoc. of BaltimoreAcademic/Hospital1012002
Pulmonary Critical Care Associates of BaltimoreAcademic/Hospital1112002
Summa Health SystemAcademic/Hospital1112005
University of IowaAcademic/Hospital1012017
University of MilanAcademic/Hospital1112008
University of RochesterAcademic/Hospital1112002
University of Roma La SapienzaAcademic/Hospital1112012
Vita-Salute University of Milano. ItalyAcademic/Hospital1112008
18 organizations
Page 1 / 1

Marketing (11)

OrganizationOrg typeRelationshipDate
HikmaFor profitSYNOct 12, 2004
HikmaFor profitMKTGOct 12, 2004
HospiraFor profitNDA2Sep 23, 1997
HospiraFor profitNDASep 23, 1997
LutipoldFor profitMKTGDec 1, 2003
NovartisFor profitMKTGFeb 15, 2005
SandozFor profitMKTGFeb 15, 2005
SandozFor profitSYNFeb 15, 2005
SankyoFor profitMKTGDec 1, 2003
TevaFor profitMKTGMar 7, 2007
West-Ward PharmaceuticalFor profitMKTGOct 12, 2004