ML-SYS / 2026.07NON-CLINICAL RESEARCH MATERIALSORIGIN DECLARED BY LOT

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RM-CVS / Coagulation and vascular signalling

Bivalirudin

Also known as: Angiomax ยท Hirulog-1

Approved comparator existsEvidence grade A: Approved comparator exists

Grade describes the published research on the molecule. It is not a quality score, a safety score, or a release state.

What this is

Bivalirudin is a synthetic peptide that directly inhibits thrombin.

Evidence position

The regulated injection record supports Grade A for the named finished product.

What the record does not establish

Approval does not transfer manufacturing, sterility, fill or formulation controls to another sample.

Sources

  • 01
    Angiomax RTU prescribing informationDailyMed / U.S. National Library of Medicine
    Shows
    U.S. label for a defined ready-to-use bivalirudin injection
    Does not show
    Does not qualify a different presentation, strength or source

External database index

LIVE DATABASE INDEX / SEPARATE FROM CURATED EVIDENCE

Records below come directly from public scientific databases. They help find relevant material, but do not affect the evidence grade until they are matched to the molecule and added to the curated source list.

PUBMED / FOUND RECORDS

  1. Bivalirudin.Thrombosis and haemostasis / 2008 MayPMID 18449412 / DOI 10.1160/TH07-10-0644
  2. Bivalirudin. / 2026 JanPMID 32491755
  3. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies / 2025 Jan 1PMID 39585174 / DOI 10.1097/PCC.0000000000003642
  4. Bivalirudin in Extracorporeal Membrane Oxygenation.Journal of cardiovascular pharmacology / 2024 Dec 1PMID 39259286 / DOI 10.1097/FJC.0000000000001633
  5. Assays to Monitor Bivalirudin.Methods in molecular biology (Clifton, N.J.) / 2023PMID 37204724 / DOI 10.1007/978-1-0716-3175-1_24

CLINICALTRIALS.GOV / FOUND RECORDS

  1. Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMOCOMPLETED / PHASE4 / University of Texas Southwestern Medical CenterNCT03318393 / DIRECT intervention MATCH: Bivalirudin
  2. Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMIUNKNOWN / PHASE4 / I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioNCT01158846 / DIRECT intervention MATCH: Bivalirudin
  3. Antithrombotic Effects of Ticagrelor Versus ClopidogrelCOMPLETED / PHASE4 / Juan J BadimonNCT01642238 / DIRECT intervention MATCH: Bivalirudin
  4. Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial InfarctionCOMPLETED / PHASE3 / Cardiovascular Research Foundation, New YorkNCT00433966 / DIRECT intervention MATCH: Bivalirudin
  5. Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus BivalirudinUNKNOWN / PHASE4 / LifeBridge HealthNCT00370045 / DIRECT intervention MATCH: Bivalirudin

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