Drugs / peginesatide
peginesatide
also known as
AF 37702 ACETATE · AF-37702 · hematide · Hematide acetate · Omontys · Omontys preservative free · Peginesatida · PEGINESATIDE ACETATE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | OMONTYS | — | 2012-03-27 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00629876 | Jan → Jun 2008 | anemia | Takeda | Terminated | No outcome recorded |
| Phase 1 | NCT00097747 | Aug 2004 → Jan 2005 | anemia, cancer, chronic renal failure syndrome | Affymax | Completed | No outcome recorded |
| Phase 211 trials · 1 missed | ||||||
| Phase 2 | NCT00752791 | Oct 2008 → May 2010 | anemia | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00752609 | Sep 2008 → Dec 2009 | anemia | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00680043 | Jun 2008 → Aug 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | Missed primary |
| Phase 2 | NCT00434330 | Dec 2006 → Apr 2008 | anemia, chronic renal failure syndrome | Affymax | Completed | No outcome recorded |
| Phase 2 | NCT00453973 | Nov 2006 → Sep 2009 | anemia, chronic renal failure syndrome | Affymax | Terminated | No outcome recorded |
| Phase 2 | NCT00372489 | Sep 2006 → Nov 2009 | anemia, chronic renal failure syndrome | Affymax | Terminated | No outcome recorded |
| Phase 2 | NCT00314795 | Apr 2006 → Oct 2016 | chronic renal failure syndrome, pure red-cell aplasia | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00272662 | Jan 2006 → Jun 2007 | cancer, chemotherapy-induced toxicity | Affymax | Completed | No outcome recorded |
| Phase 2 | NCT00228436 | Sep 2005 → Nov 2007 | anemia, chronic renal failure syndrome | Affymax | Completed | No outcome recorded |
| Phase 2 | NCT00228449 | Jul 2005 → May 2007 | anemia, chronic renal failure syndrome | Affymax | Completed | No outcome recorded |
| Phase 2 | NCT00109291 | Mar 2005 → Feb 2006 | anemia, chronic renal failure syndrome | Affymax | Terminated | No outcome recorded Stop: Enrollment |
| Phase 35 trials · 4 met primary | ||||||
| Phase 3 | NCT01478971 | Oct 2011 → Feb 2013 | anemia, chronic kidney disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00598442 | Nov 2007 → Jul 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | Met primary |
| Phase 3 | NCT00597584 | Oct 2007 → Jul 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | Met primary |
| Phase 3 | NCT00598273 | Oct 2007 → Mar 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | Met primary |
| Phase 3 | NCT00597753 | Sep 2007 → Jul 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT01737879 | Oct 2012 → Mar 2013 | anemia | Amgen | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2014-06-16 | Takeda | Regulatory Affymax and Takeda Announce Termination of Omontys ® (peginesatide) Product Collaboration and License Agreement takeda.com ↗
Takeda will work with the U.S. Food and Drug Administration to withdraw the Omontys NDA. |
All press releases naming this drug 2 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | peginesatide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00597753 ↗ |
| Known as | AF 37702 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Known as | AF-37702 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Known as | hematide | “Peginesatide (hematide) is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure” NCT00752609 ↗ |
| Known as | Hematide acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Known as | Omontys | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Known as | Omontys preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Known as | Peginesatida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Known as | PEGINESATIDE ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107866 ↗ |
| Action | Activate | “designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis” PMID 22935486 ↗ Aug 20121“Erythropoietin receptor agonist” CHEMBL2107866 ↗ |
| Modality | Peptide | “Peginesatide is a synthetic, PEGylated, investigational, peptide-based erythropoiesis-stimulating agent.” PMID 21940838 ↗ Sep 2011 |
| Route | Intravenous | “administered as an intravenous infusion” NCT00097747 ↗ |
| Target | EPOR | “Erythropoietin receptor agonist” CHEMBL2107866 ↗ |