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Epoetin beta pegol
Epoetin beta pegol is a Erythropoiesis-stimulating agent (ESA) Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Anemia in patients with chronic kidney disease, Anemia in patients with cancer receiving chemotherapy.
Epoetin beta pegol is a pegylated erythropoietin analog that stimulates erythropoiesis by binding to and activating the erythropoietin receptor on bone marrow progenitor cells.
Epoetin beta pegol is a pegylated erythropoietin analog that stimulates erythropoiesis by binding to and activating the erythropoietin receptor on bone marrow progenitor cells. Used for Anemia in patients with chronic kidney disease, Anemia in patients with cancer receiving chemotherapy.
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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. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 beta pegol |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor (EPOR) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
This drug is a long-acting formulation of erythropoietin created by attaching polyethylene glycol (PEG) chains to epoetin beta, which extends its half-life and reduces dosing frequency. It mimics the natural hormone erythropoietin to promote red blood cell production in patients with anemia, particularly those with chronic kidney disease or cancer-related anemia. The pegylation allows for less frequent subcutaneous or intravenous administration compared to conventional epoetin formulations.
Approved indications
- Anemia in patients with chronic kidney disease
- Anemia in patients with cancer receiving chemotherapy
Common side effects
- Hypertension
- Thrombotic events (venous thromboembolism)
- Headache
- Injection site reactions
- Pure red cell aplasia
Key clinical trials
- Vafseo Outcomes In-Center Experience (PHASE3)
- A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA. (PHASE3)
- A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. (PHASE3)
- A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
- Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (PHASE3)
- Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects (PHASE3)
- A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia (PHASE3)
- A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (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 beta pegol CI brief — competitive landscape report
- Epoetin beta pegol updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Epoetin beta pegol
What is Epoetin beta pegol?
How does Epoetin beta pegol work?
What is Epoetin beta pegol used for?
Who makes Epoetin beta pegol?
What drug class is Epoetin beta pegol in?
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What does Epoetin beta pegol target?
Related
- Drug class: All Erythropoiesis-stimulating agent (ESA) drugs
- Target: All drugs targeting Erythropoietin receptor (EPOR)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Hematology/Oncology
- Indication: Drugs for Anemia in patients with chronic kidney disease
- Indication: Drugs for Anemia in patients with cancer receiving chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing