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prasugrel

Trade name: effient

Small moleculeapproved

Approved

Jul 10, 2009

Prasugrel, a thienopyridine derivative, is a platelet activation and aggregation inhibitor structurally and pharmacologically related to clopidogrel and ticlopidine. Similar to clopidogrel, prasugrel is a prodrug that requires enzymatic transformation in the liver to its active metabolite, R-138727. R-138727 irreversibly binds to P2Y12 type ADP receptors on platelets thus preventing activation of the GPIIb/IIIa receptor complex. As a result, inhibition of ADP-mediated platelet activation and aggregation occurs. Prasugrel was developed by Daiichi Sankyo Co. and is currently marketed under the brand name EFFIENT in the United States and Canada in cooperation with Eli Lilly and Company for acute coronary syndromes planned for percutaneous coronary intervention (PCI). FDA approved in 2009. — NCATS

Clinical trial activity

180 trials · 185 clinical orgs · 16 marketing orgs

Phase 1
13
Phase 2
50
Phase 3
38
Phase 4
99

Earliest trial started Apr 1, 2003 (NCT00059215)

Timeline

2000s

  1. Jan 1, 2003

    Eli Lilly — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    Eli Lilly — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2009

    Eli Lilly — Earliest Phase 1 Sponsor(trial)

  4. Jul 10, 2009

    Eli Lilly — Earliest FDA Approval

  5. Jul 10, 2009

    Cosette — Marketing Organization

  6. Jul 10, 2009

    Eli Lilly — NDA Organization

  7. Jul 10, 2009

    Daiichi Sankyo — Marketing Organization

  8. Jul 10, 2009

    Cosette — NDA Secondary Org

2010s

  1. Jul 12, 2017

    Mylan — Marketing Organization

  2. Oct 16, 2017

    Aurobindo Pharma — Marketing Organization

  3. Oct 16, 2017

    Panacea Biotec Ltd — Marketing Organization

  4. Oct 16, 2017

    US Pharma — Marketing Organization

  5. Oct 16, 2017

    Chartwell Pharmaceuticals — Marketing Organization

  6. Oct 16, 2017

    ANDA Repository — Marketing Organization

  7. Feb 2, 2018

    Accord Research — Marketing Organization

  8. Jun 19, 2018

    Amneal Pharmaceuticals — Marketing Organization

  9. Jan 16, 2019

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

2020s

  1. Jul 7, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  2. Jul 7, 2020

    Senores Pharms — Marketing Organization

  3. Jan 9, 2023

    Lupin — Marketing Organization

  4. Aug 28, 2023

    Unichem — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJul 10, 2009

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Mol. weight
373.45 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • cs-747
  • effient
  • effient
  • effient
  • effient
  • efient
  • efient
  • efient
  • efient
  • ly640315
  • prasugel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel
  • prasugrel hcl
  • prasugrel hcl
  • prasugrel hcl
  • prasugrel hydrochloride
  • prasugrel hydrochloride
  • prasugrel hydrochloride
  • prasugrel hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07195812Phase 4Oct 31, 2025Nanchang University, Wenzhou Medical University, Zhejiang University
NCT07195149Phase 3Oct 31, 2025Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o., Government of Poland
NCT07025148Phase 4Oct 1, 2025University of Florida
NCT06916520Phase 4Sep 30, 2025University of Amsterdam
NCT06821191Phase 4Feb 17, 2025University of Florida
NCT06702657N/AFeb 15, 2025Changhai Hospital, The First People's Hospital of Changzhou
NCT06691191Phase 4Jan 1, 2025University of Florida
NCT06718179Phase 4Dec 31, 2024Aalborg University, Aarhus University, University of Southern Denmark
NCT06588595Phase 4Nov 1, 2024University of Florida
NCT06535568N/AOct 10, 2024Fondazione Ricerca e Innovazione Cardiovascolare ETS, University of Cantabria
NCT06613191Phase 4Oct 1, 2024Ochsner Health System
NCT05995600Phase 4Dec 31, 2023Samjin Pharmaceutical Co., Ltd., Seoul National University
NCT06400940Phase 4Aug 17, 2023Government of Russia
NCT05952206Phase 3Jul 31, 2023iVascular S.L.U., University of Barcelona
NCT05779059Phase 3Apr 1, 2023Nicolaus Copernicus University
NCT05709626Phase 4Feb 28, 2023Boston Scientific Corporation, Kindai University
NCT05681702Phase 4Feb 15, 2023University of Florida
NCT05767723Phase 4Feb 6, 2023Albert Einstein Israelite Hospital
NCT05611242Phase 3Nov 1, 2022Mercy Health Partners, Cincinnati
NCT05491200Phase 4Jul 22, 2022Abbott, Research Maatschap Cardiologen Rotterdam Zuid
Showing 20 of 180 trials
Page 1 / 9

Organizations

Research & Development (185)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Daiichi SankyoFor profit28542004
Eli LillyFor profit262142003
University of FloridaAcademic/Hospital151522010
University of PatrasAcademic/Hospital121222010
Boston Scientific CorporationFor profit8232009
Dong-A UniversityAcademic/Hospital5512011
University of Roma La SapienzaAcademic/Hospital5522011
Erasmus University RotterdamAcademic/Hospital4112011
Harvard UniversityAcademic/Hospital4222009
Seoul National UniversityAcademic/Hospital4412014
University of AmsterdamAcademic/Hospital4422015
University of ParisAcademic/Hospital4322009
AbbottFor profit3112009
AstraZenecaFor profit3022014
Bristol-Myers SquibbFor profit3012009
CordisFor profit3112009
Duke UniversityAcademic/Hospital3032008
Ludwig Maximilians UniversityAcademic/Hospital3312013
MedtronicFor profit3012009
Technical University of MunichAcademic/Hospital3312009
185 organizations
Page 1 / 10

Marketing (22)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGOct 16, 2017
Accord ResearchFor profitMKTGFeb 2, 2018
Amneal PharmaceuticalsFor profitMKTGJun 19, 2018
Aurobindo PharmaFor profitMKTGOct 16, 2017
Aurobindo PharmaFor profitSYNOct 16, 2017
Chartwell PharmaceuticalsFor profitMKTGOct 16, 2017
CosetteFor profitMKTGJul 10, 2009
CosetteFor profitNDA2Jul 10, 2009
Daiichi SankyoFor profitMKTGJul 10, 2009
Dr. Reddy's LaboratoriesFor profitSYNJul 7, 2020
Dr. Reddy's LaboratoriesFor profitMKTGJul 7, 2020
Eli LillyFor profitNDAJul 10, 2009
LupinFor profitMKTGJan 9, 2023
LupinFor profitSYNJan 9, 2023
MylanFor profitMKTGJul 12, 2017
MylanFor profitSYNJul 12, 2017
Panacea Biotec LtdFor profitMKTGOct 16, 2017
Panacea Biotec LtdFor profitMKTGOct 16, 2017
Senores PharmsFor profitMKTGJul 7, 2020
Sunshine Lake Pharma Co., Ltd.For profitMKTGJan 16, 2019
US PharmaFor profitMKTGOct 16, 2017
UnichemFor profitMKTGAug 28, 2023