enoxaparin

Trade name: lovenox

Small moleculeapproved

Approved

Mar 29, 1993

Enoxaparin is a low molecular weight heparin used as anticoagulant medication to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. Enoxaparin is a depolymerized derivative of Unfractionated heparin produced by controlled depolymerization using alkaline hydrolysis of the heparin benzylic ester. Like Unfractionated heparin, its major anticoagulant effect is mediated by interaction with antithrombin III, which in turn inactivates serine proteases like factors IIa (thrombin), IXa and Xa. Therefore, enoxaparin indirectly inhibits the conversion of prothrombin to thrombin and reduces the thrombin-mediated conversion of fibrinogen to fibrin, thus preventing clot formation. Among parenteral anticoagulants, enoxaparin stands out for certain major advantages: rapid onset of action, higher bioavailability, once- or twice-daily dosing that can be administered by patients at home without any need for monitoring, and no reported association with catheter thrombosis. Enoxaparin has been shown to be a safe and effective drug in a wide variety of thromboembolic conditions, and two decades of available data have undoubtedly inspired significant confidence. Although these properties make it a preferred option in a wide range of clinical disorders, lack of reliable antidote and accumulation in renal dysfunction are major concerns associated with its use, which are shared, apart from Unfractionated heparin, by most other available anticoagulants. — NCATS

Clinical trial activity

420 trials · 446 clinical orgs · 12 marketing orgs

Phase 1
33
Phase 2
205
Phase 3
143
Phase 4
108

Earliest trial started Sep 1, 1998 (NCT00182403)

Timeline

1990s

  1. Mar 29, 1993

    Sanofi-Aventis — Earliest FDA Approval

  2. Mar 29, 1993

    Sanofi-Aventis — NDA Organization

  3. Mar 29, 1993

    Sanofi-Aventis — NDA Secondary Org

  4. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 23, 2010

    Sandoz — Marketing Organization

  2. Jul 23, 2010

    Novartis — Marketing Organization

  3. Sep 19, 2011

    Amphastar Pharmaceuticals — Marketing Organization

  4. Jun 23, 2014

    Teva — Marketing Organization

  5. Jun 23, 2014

    Zydus Discovery DMCC — Marketing Organization

  6. Sep 28, 2018

    Apotex — Marketing Organization

  7. Sep 28, 2018

    Gland Pharma Ltd — Marketing Organization

  8. Sep 28, 2018

    Fosun — Marketing Organization

  9. Nov 29, 2019

    Nanjing King-Friend — Marketing Organization

2020s

  1. Mar 15, 2023

    Shenzhen Techdow — Marketing Organization

  2. Jun 6, 2023

    BE Pharmaceuticals — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 29, 1993

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

  • cb-01-05-mmx
  • clexane
  • clexane
  • clexane
  • clivarin
  • clivarine
  • clivarine
  • cy-216
  • enoxaparin
  • enoxaparin
  • enoxaparin
  • enoxaparin
  • enoxaparin
  • enoxaparin
  • enoxaparin
  • enoxaparine
  • enoxaparine
  • enoxaparine
  • enoxaparin sodium
  • enoxaparin sodium
  • enoxaparin sodium
  • enoxaparin sodium
  • enoxaparin sodium
  • enoxaparin sodium
  • enoxaparin sodium
  • eparina
  • exoxaparin
  • lmwh
  • lmwh
  • lmw heparin
  • lmw heparin
  • lovenox
  • lovenox
  • lovenox
  • lovenox
  • lovenox
  • low molecular weight heparin
  • low molecular weight heparin
  • low-molecular weight heparin
  • low-molecular weight heparin
  • low-molecular-weight heparin
  • low-molecular-weight heparin
  • lu 47311
  • lu-47311
  • pk-10169
  • pk-10169
  • reviparin
  • reviparin
  • reviparin
  • reviparin
  • reviparine
  • reviparin sodium
  • reviparin sodium
  • reviparin sodium
  • reviparin sodium
  • reviparin-sodium
  • rp-54563
  • rp-54563
  • sodium enoxaparin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07312851Phase 1Jan 12, 2026AstraZeneca, Parexel
NCT07228663Phase 3Dec 1, 2025Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, McMaster University
NCT07189897Phase 4Oct 31, 2025State University of New York, Syracuse
NCT07243080Phase 4Oct 10, 2025King Edward Medical University, Mayo Clinic
NCT07116239N/ASep 30, 2025Chinese Academy of Medical Sciences, Peking University
NCT07140523Phase 2Aug 15, 2025Sirius Medicine
NCT07015905Phase 3Jun 25, 2025Regeneron
NCT06845423Phase 4Apr 30, 2025University of Western Brittany
NCT06825416Phase 3Mar 14, 2025Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT06818279Phase 2/Phase 3 (Phase 3)Jan 31, 2025Institute of Liver and Biliary Sciences, India
NCT06963320Phase 2Jan 20, 2025Livzon Pharmaceutical Group Inc.
NCT07270263N/ANov 22, 2024Medical University of Gdansk
NCT06370273Phase 3Nov 12, 2024University of London
NCT06583330N/AOct 31, 2024Capital Medical University
NCT06689241N/AOct 1, 2024Alexandria University
NCT06494878Phase 3Sep 30, 2024Canadian Institutes of Health Research (CIHR), McGill University, University of Calgary
NCT06517563Phase 1Aug 14, 2024VarmX B.V.
NCT06531525Phase 2Aug 1, 2024Capital Medical University, Central South University, Chinese Academy of Medical Sciences, Peking University, People's Liberation Army of China, Sichuan University
NCT06442267Phase 4Jul 30, 2024Medical University of Vienna
NCT07124819Phase 3Jul 22, 2024Government of Russia
Showing 20 of 420 trials
Page 1 / 21

Organizations

Research & Development (446)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit382251999
BayerFor profit191622002
McMaster UniversityAcademic/Hospital15851998
Boehringer IngelheimFor profit10932000
Bristol-Myers SquibbFor profit10822004
University of BarcelonaAcademic/Hospital10342005
University of UtahAcademic/Hospital101042007
Harvard UniversityAcademic/Hospital9742006
Canadian Institutes of Health Research (CIHR)Academic/Hospital7032000
Daiichi SankyoFor profit7722008
Ain Shams UniversityAcademic/Hospital6522015
Capital Medical UniversityAcademic/Hospital6532009
Johnson and JohnsonFor profit6122004
University of ParisAcademic/Hospital6412007
Eli LillyFor profit5332002
PfizerFor profit5142000
Rovi Pharmaceuticals LaboratoriesFor profit5422001
University of HelsinkiAcademic/Hospital5322002
University of TorontoAcademic/Hospital5342000
AstellasFor profit4422006
446 organizations
Page 1 / 23

Marketing (15)

OrganizationOrg typeRelationshipDate
Amphastar PharmaceuticalsFor profitMKTGSep 19, 2011
Amphastar PharmaceuticalsFor profitSYNMar 14, 2019
ApotexFor profitMKTGSep 28, 2018
BE PharmaceuticalsFor profitMKTGJun 6, 2023
FosunFor profitMKTGSep 28, 2018
Gland Pharma LtdFor profitMKTGSep 28, 2018
Nanjing King-FriendFor profitMKTGNov 29, 2019
NovartisFor profitMKTGJul 23, 2010
SandozFor profitMKTGJul 23, 2010
SandozFor profitSYNNov 28, 2011
Sanofi-AventisFor profitNDAMar 29, 1993
Sanofi-AventisFor profitNDA2Mar 29, 1993
Shenzhen TechdowFor profitMKTGMar 15, 2023
TevaFor profitMKTGJun 23, 2014
Zydus Discovery DMCCFor profitMKTGJun 23, 2014