fibrinolysin, human

Biologicalapproved

Approved

Apr 1, 1964

Clinical trial activity

6 trials · 7 clinical orgs · 2 marketing orgs

Phase 1
3
Phase 2
5
Phase 3
1
Phase 4
0

Earliest trial started Apr 1, 2006 (NCT00348439)

Timeline

1960s

  1. Apr 1, 1964

    Pfizer — Earliest FDA Approval

  2. Apr 1, 1964

    Parke-Davis — NDA Secondary Org

  3. Apr 1, 1964

    Pfizer — NDA Secondary Org

  4. Apr 1, 1964

    Pfizer — NDA Organization

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • approvedApr 1, 1964

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Discontinued

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • actase
  • fibrinolysin
  • fibrinolysin
  • fibrinolysin
  • fibrinolysin (human)
  • fibrinolysin (human)
  • fibrinolysin, human
  • fibrinolysin, human
  • plasmin
  • plasmin
  • plasmin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04236739Phase 3Jul 23, 2019Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development
NCT01222117Phase 2Dec 1, 2010Grifols
NCT01014975Phase 1/Phase 2 (Phase 2)Nov 1, 2009Grifols, Melbourne Health, University of California, Los Angeles
NCT00418483Phase 1Mar 1, 2007Grifols, Jobst Vascular Center
NCT00347646Phase 1/Phase 2 (Phase 2)Sep 1, 2006Bausch & Lomb
NCT00348439Phase 2Apr 1, 2006Bausch & Lomb
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GrifolsFor profit3322007
Bausch & LombFor profit2212006
Jobst Vascular CenterAcademic/Hospital1012007
Melbourne HealthAcademic/Hospital1012009
University of California, Los AngelesAcademic/Hospital1012009
Utrecht UniversityAcademic/Hospital1112019
ZonMw: The Netherlands Organisation for Health Research and DevelopmentAcademic/Hospital1012019
7 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Parke-DavisFor profitNDA2Apr 1, 1964
PfizerFor profitNDA2Apr 1, 1964
PfizerFor profitNDAApr 1, 1964