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Drug

Romiplostim

Approved · EMA
Late-stage development

Also known as Nplate, Romiplostim (E. Coli).

RxNorm805452UNIIGN5XU2DXKV
10
Active clinical trials
1
Regulatory events
Latest activity
beta

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

Approval: Nplate (EMA)

Regulatory2009-02-04EMA

Profile

Identifiers & mechanism

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

Canonical name
Romiplostim
Aliases & brands
NplateRomiplostim (E. Coli)
RxNorm CUI
805452
UNII
GN5XU2DXKV
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
2009-02-04
Latest approval
2009-02-04
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2009-02-04Approval
Approval: Nplate (EMA)
Indication: Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia  (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids,Show full indication

Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia  (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Evidence ↗

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

Clinical trials

56 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
56
registered trials across all phases
LATEST COMPLETION 2026
10
Active studies
8
Recruiting
24
Late-stage (III+)
31
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 56
Early Phase 12Phase 12Phase 1 / 23Phase 225Phase 2 / 33Phase 313Phase 46Phase N / A2

Late-stage studies

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

Recent completions

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

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.