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Drug

Reteplase

Regulatory activity · EMA
Late-stage development
Also known as Human t-PA (residues 1-3 and 176-527), Retavase, Reteplasa, RETEPLASE,RECOMBINANT+2 more

Human t-PA (residues 1-3 and 176-527), Retavase, Reteplasa, RETEPLASE,RECOMBINANT, Reteplase (Recombinant), Reteplase, recombinant.

RxNorm76895UNIIDQA630RIE9
1
Regulatory events
Latest activity
beta

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

Profile

Identifiers & mechanism

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

Canonical name
Reteplase
Aliases & brands
Human t-PA (residues 1-3 and 176-527)RetavaseReteplasaRETEPLASE,RECOMBINANTReteplase (Recombinant)Reteplase, recombinant
RxNorm CUI
76895
UNII
DQA630RIE9
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.

Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-01-26Market withdrawalMarket
Market withdrawal: Rapilysin (EMA)
Indication: Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the… Show full indication

Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.

Evidence ↗

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

Clinical trials

2 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
2
registered trials across all phases
1
Late-stage (III+)
2
Discontinued
PHASE DISTRIBUTIONn = 2
Phase 21Phase 31

Late-stage studies

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

Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction

TerminatedPH IIIGe Junbon=362023
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.