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Drug

Efbemalenograstim alfa

Approved · EMA
Early-to-mid development

Also known as Benegrastim, Ryzneuta.

RxNorm2670630UNII5UPW5HJW3O
3
Active clinical trials
1
Regulatory events
Latest activity
beta

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

A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Multi-cohort, Open-label, Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count (ANC) Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen.

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

A Multicenter, Exploratory Clinical Study of Efbemalenograstim Alfa-vuxw Injection for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN

Clinical trial2025-09-23Results expected Q4 2026 · ClinicalTrials.gov

Approval: Ryzneuta (EMA)

Regulatory2024-03-21EMA

Profile

Identifiers & mechanism

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

Canonical name
Efbemalenograstim alfa
Aliases & brands
BenegrastimRyzneuta
RxNorm CUI
2670630
UNII
5UPW5HJW3O
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
2024-03-21
Latest approval
2024-03-21
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-03-21Approval
Approval: Ryzneuta (EMA)
Indication: Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… Show full indication

Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Evidence ↗

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

Clinical trials

3 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
3
registered trials across all phases
3
Active studies
3
Recruiting
1
Late-stage (III+)
PHASE DISTRIBUTIONn = 3
Phase 22Phase N / A1
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.