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Drug

Epoetin zeta

Approved · EMA
Late-stage development
Also known as Epoetina dseta, Erythropoetin zeta, Epoetina zeta, Epoetinum zeta+1 more

Epoetina dseta, Erythropoetin zeta, Epoetina zeta, Epoetinum zeta, Epoétine zêta.

1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Epoetin zeta
Aliases & brands
Epoetina dsetaErythropoetin zetaEpoetina zetaEpoetinum zetaEpoétine zêta
RxNorm CUI
758494
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-12-18
Latest approval
2007-12-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-12-18Approval
Approval: Retacrit (EMA)
Indication: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in adultShow full indication

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood-saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (four or more units of blood for females or five or more units for males). Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

1 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
1
registered trials across all phases
LATEST COMPLETION 2018
1
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 1
Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Biological Predictive Factors of Response to Erythropoiesis Stimulating Agent (ESA) in Low Risk Myelodysplastic Syndromes (MDS) Patients

CompletedPH IVAssociation pour la recherche sur les Affections Malignes en Immunologie Sanguinen=702018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Biological Predictive Factors of Response to Erythropoiesis Stimulating Agent (ESA) in Low Risk Myelodysplastic Syndromes (MDS) Patients

CompletedPH IVAssociation pour la recherche sur les Affections Malignes en Immunologie Sanguinen=702018
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.