ferumoxytol

Trade name: feraheme

Small moleculeapproved

Approved

Jun 30, 2009

Iron(II,III) oxide, or black iron oxide, is the chemical compound with formula Fe3O4. It occurs in nature as the mineral magnetite. It is one of a number of iron oxides, the others being iron(II) oxide (FeO), which is rare, and iron(III) oxide (Fe2O3) which also occurs naturally as the mineral hematite. It contains both Fe2+ and Fe3+ ions and is sometimes formulated as FeO ∙ Fe2O3. This iron oxide is encountered in the laboratory as a black powder. It exhibits permanent magnetism and is ferrimagnetic, but is sometimes incorrectly described as ferromagnetic. Its most extensive use is as a black pigment (see: Mars Black). For this purpose, it is synthesized rather than being extracted from the naturally occurring mineral as the particle size and shape can be varied by the method of production. — Wikipedia

Clinical trial activity

83 trials · 50 clinical orgs · 5 marketing orgs

Phase 1
23
Phase 2
34
Phase 3
18
Phase 4
10

Earliest trial started Feb 1, 2004 (NCT00103038)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    AMAG Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    AMAG Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  4. Jun 30, 2009

    AMAG Pharmaceuticals, Inc. — Earliest FDA Approval

  5. Jun 30, 2009

    AMAG Pharmaceuticals, Inc. — NDA Secondary Org

  6. Jun 30, 2009

    Covis — Marketing Organization

  7. Jun 30, 2009

    AMAG Pharmaceuticals, Inc. — NDA Organization

  8. Jun 30, 2009

    Covis — NDA Secondary Org

  9. Jun 30, 2009

    Azurity — Marketing Organization

2020s

  1. Jan 15, 2021

    Sandoz — Marketing Organization

  2. Jan 15, 2021

    Novartis — Marketing Organization

Indications

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedJun 30, 2009

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • ami-7228
  • code 7228
  • feraheme
  • feraheme
  • feraheme
  • ferumoxytol
  • ferumoxytol
  • ferumoxytol
  • ferumoxytol
  • ferumoxytol
  • ferumoxytol
  • ferumoxytol
  • rienso
  • rienso

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07313020Early Phase 1 (Phase 1)Dec 16, 2025Soochow University
NCT06483061Phase 2Dec 31, 2024Canadian Institutes of Health Research (CIHR), University of Alberta
NCT06440408Phase 1Sep 30, 2024University of Pennsylvania
NCT06348524Phase 3Aug 3, 2024Transmed Solutions
NCT05811377Early Phase 1 (Phase 1)Mar 29, 2023Lipella Pharmaceuticals, Inc., National Institutes of Health (NIH), University of Pittsburgh
NCT05340465Phase 2Oct 10, 2022National Institutes of Health (NIH), University of Washington
NCT05357833Early Phase 1 (Phase 1)Jun 1, 2022University of Utah
NCT04900792Phase 1Dec 31, 2021University of Iowa
NCT05515874Phase 4Aug 16, 2021Northwestern University, University of Chicago
NCT04839185Early Phase 1 (Phase 1)Apr 15, 2021National Institutes of Health (NIH), University of Wisconsin
NCT06110494Phase 4Jul 13, 2020University of Pennsylvania
NCT04369560Early Phase 1 (Phase 1)Jun 15, 2020National Cancer Institute (NCI), University of Pittsburgh
NCT04278651Phase 4Mar 1, 2020Auerbach Hematology and Oncology, Thomas Jefferson University
NCT04268849Phase 3Feb 17, 2020AMAG Pharmaceuticals, Inc., Auerbach Hematology and Oncology
NCT04205266Phase 4Jan 31, 2020AMAG Pharmaceuticals, Inc., Thomas Jefferson University
NCT04080908Phase 4Oct 31, 2019New York University
NCT03777514N/AAug 31, 2019AMAG Pharmaceuticals, Inc., Johns Hopkins University
NCT03893045Phase 3Jun 30, 2019AMAG Pharmaceuticals, Inc.
NCT03657433Phase 3Sep 1, 2018AMAG Pharmaceuticals, Inc., University of Arizona
NCT03619850Phase 3Aug 13, 2018AMAG Pharmaceuticals, Inc.
Showing 20 of 83 trials
Page 1 / 5

Organizations

Research & Development (50)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AMAG Pharmaceuticals, Inc.For profit281752004
Oregon Health and Science UniversityAcademic/Hospital15832004
National Cancer Institute (NCI)Government14332004
National Institutes of Health (NIH)Government6132014
OHSU Knight Cancer InstituteAcademic/Hospital6622014
Harvard UniversityAcademic/Hospital5542012
Stanford UniversityAcademic/Hospital5532011
Auerbach Hematology and OncologyAcademic/Hospital4342011
National Institute of Neurological Disorders and Stroke (NINDS)Government3022004
University of PennsylvaniaAcademic/Hospital3322018
Thomas Jefferson UniversityAcademic/Hospital2212020
University of EdinburghAcademic/Hospital2222010
University of HawaiiAcademic/Hospital2222011
University of PittsburghAcademic/Hospital2212020
University of Texas at HoustonAcademic/Hospital2222013
University of UtahAcademic/Hospital2212017
American Epilepsy SocietyAcademic/Hospital1012014
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012024
CelgeneFor profit1012017
Dartmouth UniversityAcademic/Hospital1112014
50 organizations
Page 1 / 3

Marketing (8)

OrganizationOrg typeRelationshipDate
AMAG Pharmaceuticals, Inc.For profitNDA2Jun 30, 2009
AMAG Pharmaceuticals, Inc.For profitNDAJun 30, 2009
AzurityFor profitMKTGJun 30, 2009
CovisFor profitMKTGJun 30, 2009
CovisFor profitNDA2Jun 30, 2009
NovartisFor profitMKTGJan 15, 2021
SandozFor profitMKTGJan 15, 2021
SandozFor profitSYNJan 15, 2021