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Epoetin-alpha (Procrit)
Epoetin-alpha (Procrit) is a Erythropoiesis-stimulating agent (ESA) Small molecule drug developed by Virginia Commonwealth University. It is currently in Phase 3 development for Anemia associated with chronic kidney disease, Anemia in patients with cancer receiving chemotherapy, Anemia in HIV-infected patients receiving antiretroviral therapy.
Epoetin-alpha is a recombinant erythropoietin that stimulates red blood cell production by binding to erythropoietin receptors on bone marrow progenitor cells.
Epoetin-alpha is a recombinant erythropoietin that stimulates red blood cell production by binding to erythropoietin receptors on bone marrow progenitor cells. Used for Anemia associated with chronic kidney disease, Anemia in patients with cancer receiving chemotherapy, Anemia in HIV-infected patients receiving antiretroviral therapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Epoetin-alpha (Procrit) |
|---|---|
| Sponsor | Virginia Commonwealth University |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor (EPOR) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Epoetin-alpha is a glycoprotein that mimics endogenous erythropoietin, a hormone that regulates red blood cell production. By binding to erythropoietin receptors on erythroid progenitor cells in the bone marrow, it promotes their proliferation, differentiation, and maturation into mature red blood cells. This increases hemoglobin levels and oxygen-carrying capacity of the blood.
Approved indications
- Anemia associated with chronic kidney disease
- Anemia in patients with cancer receiving chemotherapy
- Anemia in HIV-infected patients receiving antiretroviral therapy
Common side effects
- Hypertension
- Headache
- Arthralgia
- Fatigue
- Thrombotic events (stroke, MI, DVT)
- Pure red cell aplasia
Key clinical trials
- High Dose of Erythropoietin Analogue After Cardiac Arrest (PHASE3)
- Long Term Beta Thalassemia Treatment: Findings From The Extension Period (PHASE2)
- Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes (PHASE3)
- Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child (NA)
- A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome (PHASE2)
- A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve (PHASE3)
- The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy (PHASE2)
- Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Epoetin-alpha (Procrit) CI brief — competitive landscape report
- Epoetin-alpha (Procrit) updates RSS · CI watch RSS
- Virginia Commonwealth University portfolio CI
Frequently asked questions about Epoetin-alpha (Procrit)
What is Epoetin-alpha (Procrit)?
How does Epoetin-alpha (Procrit) work?
What is Epoetin-alpha (Procrit) used for?
Who makes Epoetin-alpha (Procrit)?
What drug class is Epoetin-alpha (Procrit) in?
What development phase is Epoetin-alpha (Procrit) in?
What are the side effects of Epoetin-alpha (Procrit)?
What does Epoetin-alpha (Procrit) target?
Related
- Drug class: All Erythropoiesis-stimulating agent (ESA) drugs
- Target: All drugs targeting Erythropoietin receptor (EPOR)
- Manufacturer: Virginia Commonwealth University — full pipeline
- Therapeutic area: All drugs in Hematology/Oncology
- Indication: Drugs for Anemia associated with chronic kidney disease
- Indication: Drugs for Anemia in patients with cancer receiving chemotherapy
- Indication: Drugs for Anemia in HIV-infected patients receiving antiretroviral therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing