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empegfilrastim
empegfilrastim is a Biologic drug developed by Biocad. It is currently in Phase 2 development. Also known as: Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim.
Empegfilrastim is a medication being studied for the prevention of neutropenia in patients with breast cancer, as well as other conditions such as chemotherapy-induced neutropenia and solid tumors. It is a form of filgrastim, a granulocyte colony-stimulating factor used to stimulate the production of white blood cells.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | empegfilrastim |
|---|---|
| Also known as | Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim, peg-GCSF |
| Sponsor | Biocad |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
- DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs
- Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer (PHASE2)
- Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients (PHASE3)
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:
- empegfilrastim CI brief — competitive landscape report
- empegfilrastim updates RSS · CI watch RSS
- Biocad portfolio CI
Frequently asked questions about empegfilrastim
What is empegfilrastim?
Who makes empegfilrastim?
Is empegfilrastim also known as anything else?
What development phase is empegfilrastim in?
Related
- Manufacturer: Biocad — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim, peg-GCSF
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing