hemin

Trade name: Panhematin

Biologicalapproved

Approved

Jul 20, 1983

Hemin (trade name Panhematin) is a protoporphyrin IX containing a ferric iron ion (heme B) with a chloride ligand, which is is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women. Manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with this disorder. the therapy for the acute porphyrias is not curative. Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of δ-aminolevulinic acid synthetase, the enzyme which limits the rate of the porphyrin/heme biosynthetic pathway. The exact mechanism by which hematin produces symptomatic improvement in patients with acute episodes of the hepatic porphyrias has not been elucidated. — NCATS

Clinical trial activity

18 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
13
Phase 3
2
Phase 4
1

Earliest trial started Jul 1, 1993 (NCT00004789)

Timeline

1980s

  1. Jul 20, 1983

    Recordati — Earliest FDA Approval

  2. Jul 20, 1983

    Recordati — NDA Secondary Org

  3. Jul 20, 1983

    Recordati — NDA Organization

1990s

  1. Jan 1, 1993

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedJul 20, 1983

Chemistry & pharmacology

Loading structure…

SMILES

[Cl-].[Fe+3].Cc1c(CCC(O)=O)c2cc3[n-]c(cc4nc(cc5[n-]c(cc1n2)c(C=C)c5C)c(C=C)c4C)c(C)c3CCC(O)=O
Mol. weight
651.94 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • chloro(protoporphyrinato)iron(iii)
  • haem arginate
  • hämin
  • hämin
  • hemearginat
  • heme arginate
  • heme arginate
  • heme arginate
  • heme arginate complex
  • hemin
  • hemin
  • hemin
  • hemin
  • hemin
  • hemin
  • hemin
  • hemin
  • hémine
  • hémine
  • hemin for injection
  • normosang
  • normosang
  • panhematin
  • panhematin
  • panhematin
  • panhematin
  • protohemin
  • protohemin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03646344Phase 3Sep 30, 2018Kidney Research UK, University of Edinburgh
NCT02922413Phase 2Aug 1, 2015University of Texas, Galveston
NCT02314780Phase 2Jan 1, 2015Medical University of Vienna, University of Vienna
NCT02142699Phase 2Jul 1, 2014Medical Research Council, NHS Lothian, University of Edinburgh
NCT02180412Phase 2Apr 1, 2014University of Texas, Galveston
NCT01855841Phase 2Apr 1, 2012Erasmus University Rotterdam
NCT01430156Phase 3Jan 1, 2012NHS Lothian, University of Edinburgh
NCT01206582Phase 2May 1, 2010Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Recordati
NCT00856817Phase 4Mar 1, 2009Dutch Diabetes Research Foundation, Radboud University
NCT00882804Phase 1Feb 1, 2009Mayo Clinic
NCT01461512Phase 2Jan 1, 2009University of Vienna
NCT00682370Phase 1Oct 1, 2007Medical University of Vienna, University of Vienna
NCT00483587Phase 1/Phase 2 (Phase 2)Jul 1, 2007University of Groningen
NCT00467610Phase 2May 1, 2007Lundbeck, Rush University
NCT00004398Phase 1Jan 1, 1998National Center for Research Resources (NCRR), The University of Texas, Dallas
NCT00004397Phase 1Jan 1, 1998National Center for Research Resources (NCRR), The University of Texas, Dallas
NCT00004396Phase 2Sep 1, 1997National Center for Research Resources (NCRR), The University of Texas, Dallas
NCT00004789Phase 1/Phase 2 (Phase 2)Jul 1, 1993National Center for Research Resources (NCRR), The University of Texas, Dallas
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Center for Research Resources (NCRR)Government4421993
The University of Texas, DallasAcademic/Hospital4021993
University of EdinburghAcademic/Hospital3322012
University of ViennaAcademic/Hospital3122007
Mayo ClinicAcademic/Hospital2222009
Medical University of ViennaAcademic/Hospital2222007
NHS LothianAcademic/Hospital2022012
University of Texas, GalvestonAcademic/Hospital2212014
Dutch Diabetes Research FoundationAcademic/Hospital1012009
Erasmus University RotterdamAcademic/Hospital1112012
Kidney Research UKAcademic/Hospital1012018
LundbeckFor profit1012007
Medical Research CouncilGovernment1012014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1012010
Radboud UniversityAcademic/Hospital1112009
RecordatiFor profit1012010
Rush UniversityAcademic/Hospital1112007
University of GroningenAcademic/Hospital1112007
18 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
RecordatiFor profitNDA2Jul 20, 1983
RecordatiFor profitNDAJul 20, 1983