drugset
Drugs / Epoetin delta
last change Mar 2009 re-read 3 minutes ago

Epoetin delta

also known as Dynepo · Epoetina delta · Epoetine delta · GA-EPO · HMR-4396

Protein / enzyme biologic targets EPOR via activation

Developed for
anemia · chronic renal failure syndrome · kidney failure
Investigated by
Shire

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Dynepo — 2009-03-17 europa.eu ↗
Refused (EMA) EU (EMA) Dynepo — 2008-03-12 europa.eu ↗
Approved EU (EMA) Dynepo — 2002-03-18 europa.eu ↗

Trials 1

today
EU approved 2002
NCT00514813 · Ph 4
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 41 trial
Phase 4 NCT00514813 Jun 2007 → Jul 2008 anemia, chronic renal failure syndrome Shire Terminated No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT00450333 Comparator Oct 2006 → Jul 2008 anemia, kidney failure Shire Terminated No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as Epoetin delta “Drug: Dynepo (Epoetin delta)” NCT00450333 ↗
Known as Dynepo ClinicalTrials.gov intervention name — accepted as the source's own label NCT00450333 ↗
1

NCT00514813 ↗
Known as Epoetina delta ChEMBL registry synonym — accepted as the source's own label CHEMBL2109093 ↗
Known as Epoetine delta ChEMBL registry synonym — accepted as the source's own label CHEMBL2109093 ↗
Known as GA-EPO ChEMBL registry synonym — accepted as the source's own label CHEMBL2109093 ↗
Known as HMR-4396 ChEMBL registry synonym — accepted as the source's own label CHEMBL2109093 ↗
Action Activate “Erythropoietin receptor agonist” CHEMBL2109093 ↗
Modality Protein / enzyme biologic — CHEMBL2109093 ↗
Route Subcutaneous “Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject” NCT00514813 ↗
Target EPOR “Erythropoietin receptor agonist” CHEMBL2109093 ↗