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alteplase

Trade name: Activase

Recombinant proteinapproved

Approved

Nov 13, 1987

Alteplase, sold under the brand name Activase among others, is a biosynthetic form of human tissue-type plasminogen activator (t-PA). It is a thrombolytic medication used to treat acute ischemic stroke, acute ST-elevation myocardial infarction, pulmonary embolism associated with low blood pressure, and blocked central venous catheter. Alteplase is given by injection into a vein or artery. Alteplase is the same as the normal human plasminogen activator produced in vascular endothelial cells and is synthesized via recombinant DNA technology in Chinese hamster ovary cells (CHO). Alteplase causes the breakdown of a clot by inducing fibrinolysis. — Wikipedia

Clinical trial activity

223 trials · 298 clinical orgs · 1 marketing orgs

Phase 1
20
Phase 2
119
Phase 3
78
Phase 4
39

Earliest trial started Apr 1, 1983 (NCT00000505)

Timeline

1980s

  1. Jan 1, 1983

    Earliest Phase 3 Sponsor(trial)

  2. Nov 13, 1987

    Genentech — Earliest FDA Approval

  3. Nov 13, 1987

    Genentech — Marketing Organization

  4. Nov 13, 1987

    Genentech — NDA Secondary Org

  5. Nov 13, 1987

    Genentech — NDA Organization

1990s

  1. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 13, 1987

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • actilyse
  • actilyse
  • actilyse
  • actilyse cathflo
  • activase
  • activase
  • activase
  • activase
  • activase
  • altelplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase
  • alteplase (genetical recombination)
  • alteplase (genetical recombination)
  • alteplase,recombinant
  • alteplase, recombinant
  • cathflo activase
  • human tissue plasminogen activator
  • plasminogen activator (human tissue-type protein moiety)
  • prourokinase
  • recombinant human plasminogen activator
  • recombinant human prourokinase
  • rh-prouk
  • rt-pa
  • rt-pa
  • rt-pa
  • thrombolysin
  • tissue plasminogen activator
  • tissue plasminogen activator
  • tissue plasminogen activator
  • tissue-plasminogen activator
  • tissue-plasminogen activator
  • tissue plasminogen activator alteplase
  • tissue plasminogen activator, recombinant
  • tnkase
  • tnkase
  • tpa
  • tpa
  • t-pa
  • t-pa
  • t-plasminogen activator
  • t-plasminogen activator

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07111559Phase 4Aug 1, 2025Japan Research Foundation for Clinical Pharmacology, Nippon Medical School
NCT06768138Phase 3Jun 1, 2025University of Lorraine
NCT06841965Phase 3Mar 1, 2025Zhejiang University
NCT06841978Phase 3Mar 1, 2025Zhejiang University
NCT06760195Early Phase 1 (Phase 1)Jan 10, 2025Capital Medical University
NCT06749834Phase 3Dec 20, 2024Zhejiang University
NCT06658197Phase 3Dec 1, 2024Capital Medical University
NCT06663631Phase 1Nov 30, 2024Capital Medical University, Linyi People's Hospital
NCT06571149Phase 4Oct 31, 2024University of Bern
NCT06559436N/AOct 2, 2024University of Science and Technology of China
NCT06433011N/AJun 25, 2024Thrombolex, Inc.
NCT06241677N/AApr 15, 2024Chinese University of Hong Kong, The University of Hong Kong, Tuen Mun Hospital, Hong Kong, University of Adelaide, University of Toronto
NCT06196320Phase 3Feb 1, 2024Capital Medical University, University of Melbourne
NCT05766124Phase 2/Phase 3 (Phase 3)Jan 1, 2024Chinese University of Hong Kong
NCT06115070Phase 4Dec 1, 2023Zhejiang University
NCT05965193Phase 3Aug 17, 2023Anhui Medical University, Capital Medical University, Changsha Central Hospital, Government of China, Guizhou Medical University, Jining NO.1 People 's Hospital, Linyi People's Hospital, Nanchang University, Nantong University, Nanyang Central Hospital, People's Hospital of Rizhao, Shandong Provincial Hospital, Soochow University, Tianjin Huanhu Hospital, Xuzhou Medical University, Zhengzhou University, Zhumadian Central Hospital
NCT06184321Early Phase 1 (Phase 1)Aug 17, 2023University of Texas at Houston
NCT05965687Phase 3Aug 17, 2023Anhui Medical University, Capital Medical University, Changsha Central Hospital, Government of China, Guizhou Medical University, Jiangxi Provincial People's Hospital, Jining NO.1 People 's Hospital, Jiujiang University, Liaocheng People's Hospital, Linyi People's Hospital, Nanchang University, Nantong University, Nanyang Central Hospital, People's Hospital of Rizhao, Shandong Provincial Hospital, Soochow University, Tianjin Huanhu Hospital, Xuzhou Medical University, Zhengzhou University, Zhumadian Central Hospital
NCT05897554N/AAug 11, 2023Capital Medical University
NCT05856851Phase 3Aug 1, 2023Southern Medical University, Sun Yat-Sen University
Showing 20 of 223 trials
Page 1 / 12

Organizations

Research & Development (298)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenentechFor profit20252002
Capital Medical UniversityAcademic/Hospital151352002
National Institute of Neurological Disorders and Stroke (NINDS)Government13032003
Boehringer IngelheimFor profit10832000
Zhejiang UniversityAcademic/Hospital8732021
People's Liberation Army of ChinaGovernment7732015
University of CincinnatiAcademic/Hospital7432003
Government of ChinaGovernment6032009
Johns Hopkins UniversityAcademic/Hospital6622001
National Heart, Lung, and Blood Institute (NHLBI)Government6221983
University of TorontoAcademic/Hospital6442005
Harvard UniversityAcademic/Hospital5121983
University of GlasgowAcademic/Hospital5432011
McMaster UniversityAcademic/Hospital4122009
MedtronicFor profit4122009
Neuroscience Trials AustraliaAcademic/Hospital4422010
University of CalgaryAcademic/Hospital4232006
University of Texas at HoustonAcademic/Hospital4232010
University of WashingtonAcademic/Hospital4331983
Angde Biotech Pharmaceutical Co., Ltd.Government3322019
298 organizations
Page 1 / 15

Marketing (3)

OrganizationOrg typeRelationshipDate
GenentechFor profitMKTGNov 13, 1987
GenentechFor profitNDA2Nov 13, 1987
GenentechFor profitNDANov 13, 1987