dalteparin

Trade name: fragmin

Small moleculeapproved

Approved

Dec 22, 1994

Dalteparin is a low molecular weight heparin. It is marketed as Fragmin. Like other low molecular weight heparins, dalteparin is used for prophylaxis or treatment of deep vein thrombosis and pulmonary embolism and to reduce the risk of a stroke or heart attack. Dalteparin acts by potentiating the activity of antithrombin III, inhibiting formation of both Factor Xa and thrombin. It is normally administered by self-injection. — Wikipedia

Clinical trial activity

62 trials · 63 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
34
Phase 3
23
Phase 4
18

Earliest trial started Dec 1, 1998 (NCT00003674)

Timeline

1990s

  1. Dec 22, 1994

    Pharmacia — Earliest FDA Approval

  2. Dec 22, 1994

    Pfizer — NDA Secondary Org

  3. Dec 22, 1994

    Pharmacia — NDA Organization

  4. Dec 22, 1994

    Pfizer — Marketing Organization

  5. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

Indications

Studied for

Mechanism of action

Approval history

  • approvedDec 22, 1994

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • alpha-heparin
  • alpha-heparin
  • dalteparin
  • dalteparin
  • dalteparin
  • dalteparin
  • dalteparin
  • dalteparin sodium
  • dalteparin sodium
  • dalteparin sodium
  • dalteparin sodium
  • dalteparin sodium
  • dalteparin sodium
  • dalteparin sodium
  • fragmin
  • fragmin
  • fragmin
  • heparin fragment kabi 2165
  • low liquemine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06628778Phase 3Jul 1, 2025Johns Hopkins University, University of California, San Diego
NCT06370273Phase 3Nov 12, 2024University of London
NCT06583330N/AOct 31, 2024Capital Medical University
NCT06153394Phase 3Feb 1, 2024University of Western Ontario
NCT06020560Phase 4Mar 23, 2023University of Copenhagen
NCT05171075Phase 3Sep 27, 2022Anthos Therapeutics, Inc., Itreas
NCT05255003Phase 4Aug 29, 2022University of Ottawa
NCT05245877Phase 4Aug 17, 2022University of Helsinki
NCT05067153Phase 4May 1, 2021Aarhus University
NCT04850378Phase 1/Phase 2 (Phase 2)Mar 25, 2021Aarhus University
NCT04731558Phase 4Feb 10, 2021Government of Finland, The Finnish Medical Association, University of Helsinki
NCT05189002Phase 2May 31, 2019I.M. Sechenov First Moscow State Medical University, PharmaDiall Ltd.
NCT03559114Phase 3Sep 30, 2018Canadian Institutes of Health Research (CIHR), University of Toronto
NCT03671174N/ASep 30, 2018Anhui Medical University, Central South University, Jiao Tong University, Jilin University, Wuxi People's Hospital
NCT03297359Phase 2Mar 21, 2018University of Ottawa
NCT03139487Phase 2May 1, 2017University of Ulsan
NCT03045406Phase 3Apr 13, 2017Federation of Associations of Hospital Doctors on Internal Medicine (FADOI) Foundation, University of Perugia
NCT02744092N/ADec 1, 2016Alliance Foundation Trials, Cancer Research Network
NCT02607111Phase 4Aug 1, 2016University of Western Ontario
NCT02585713Phase 3Nov 1, 2015Academic and Community Cancer Research United, National Cancer Institute (NCI)
Showing 20 of 62 trials
Page 1 / 4

Organizations

Research & Development (63)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit17852002
National Cancer Institute (NCI)Government7131998
University of OttawaAcademic/Hospital6532000
Canadian Institutes of Health Research (CIHR)Academic/Hospital5012000
EisaiFor profit5042009
University of Western OntarioAcademic/Hospital4432002
Aarhus UniversityAcademic/Hospital3322013
McMaster UniversityAcademic/Hospital3222002
University of Texas at HoustonAcademic/Hospital3332000
Duke UniversityAcademic/Hospital2222009
National Heart, Lung, and Blood Institute (NHLBI)Government2012009
University of HelsinkiAcademic/Hospital2212021
University of OklahomaAcademic/Hospital2212002
University of RochesterAcademic/Hospital2212002
University of Southern CaliforniaAcademic/Hospital2212006
University of TorontoAcademic/Hospital2112002
Academic and Community Cancer Research UnitedAcademic/Hospital1112015
Alliance Foundation TrialsAcademic/Hospital1112016
Anhui Medical UniversityAcademic/Hospital1012018
Anthos Therapeutics, Inc.For profit1112022
63 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
PfizerFor profitNDA2Dec 22, 1994
PfizerFor profitMKTGDec 22, 1994
PharmaciaFor profitNDADec 22, 1994