peginesatide

Trade name: Omontys

Peptideapproved

Approved

Mar 27, 2012

Peginesatide, developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. — Wikipedia

Clinical trial activity

19 trials · 3 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
16
Phase 3
5
Phase 4
1

Earliest trial started Aug 1, 2004 (NCT00097747)

Timeline

2000s

  1. Jan 1, 2004

    Affymax — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2005

    Affymax — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2007

    Affymax — Earliest Phase 3 Sponsor(trial)

2010s

  1. Mar 27, 2012

    Affymax — Earliest FDA Approval

  2. Mar 27, 2012

    Affymax — NDA Organization

  3. Mar 27, 2012

    Takeda — Marketing Organization

  4. Mar 27, 2012

    Takeda — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedMar 27, 2012

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • af37702
  • af-37702
  • erythropoiesis-stimulating agent (esa)
  • hematide
  • hematide
  • hematide
  • hematide
  • omontys
  • omontys
  • omontys
  • peginesatide
  • peginesatide
  • peginesatide
  • peginesatide
  • peginesatide
  • peginesatide
  • peginesatide acetate
  • peginesatide acetate
  • peginesatide acetate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01737879Phase 4Oct 1, 2012Amgen
NCT01478971Phase 3Oct 1, 2011Affymax, Takeda
NCT00752791Phase 2Oct 1, 2008Affymax, Takeda
NCT00752609Phase 2Sep 1, 2008Affymax, Takeda
NCT00680043Phase 2Jun 1, 2008Affymax, Takeda
NCT00629876Phase 1Jan 1, 2008Affymax, Takeda
NCT00598442Phase 3Nov 1, 2007Affymax, Takeda
NCT00597584Phase 3Oct 1, 2007Affymax, Takeda
NCT00598273Phase 3Oct 1, 2007Affymax, Takeda
NCT00597753Phase 3Sep 1, 2007Affymax, Takeda
NCT00434330Phase 2Dec 1, 2006Affymax
NCT00453973Phase 2Nov 1, 2006Affymax
NCT00372489Phase 2Sep 1, 2006Affymax
NCT00314795Phase 2Apr 1, 2006Takeda
NCT00272662Phase 2Jan 1, 2006Affymax
NCT00228436Phase 2Sep 1, 2005Affymax
NCT00228449Phase 2Jul 1, 2005Affymax
NCT00109291Phase 2Mar 1, 2005Affymax
NCT00097747Phase 1Aug 1, 2004Affymax
Showing 19 of 19 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AffymaxFor profit171332004
TakedaFor profit10532006
AmgenFor profit1112012
3 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
AffymaxFor profitNDAMar 27, 2012
TakedaFor profitMKTGMar 27, 2012
TakedaFor profitNDA2Mar 27, 2012