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daptomycin

Trade name: cubicin

Small moleculeapproved

Approved

Sep 12, 2003

Daptomycin is a lipopeptide antibiotic used in the treatment of systemic and life-threatening infections caused by Gram-positive organisms. Daptomycin has a distinct mechanism of action, disrupting multiple aspects of bacterial cell membrane function. It inserts into the cell membrane in a phosphatidylglycerol-dependent fashion, where it then aggregates. The aggregation of daptomycin alters the curvature of the membrane, which creates holes that leak ions. This causes rapid depolarization, resulting in a loss of membrane potential leading to inhibition of protein, DNA, and RNA synthesis, which results in bacterial cell death. Daptomycin is bactericidal against Gram-positive bacteria only. It has proven in vitro activity against enterococci (including glycopeptide-resistant enterococci (GRE)), staphylococci (including methicillin-resistant Staphylococcus aureus), streptococci, corynebacteria and stationary-phase Borrelia burgdorferi persisters. — NCATS

Clinical trial activity

83 trials · 71 clinical orgs · 28 marketing orgs

Phase 1
10
Phase 2
37
Phase 3
19
Phase 4
28

Earliest trial started Oct 1, 2000 (NCT00538694)

Timeline

2000s

  1. Jan 1, 2000

    Cubist — Earliest Phase 3 Sponsor(trial)

  2. Sep 12, 2003

    Cubist — Earliest FDA Approval

  3. Sep 12, 2003

    Cubist — NDA Organization

  4. Jan 1, 2005

    Cubist — Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Mar 15, 2013

    Hospira — NDA Secondary Org

  2. Sep 12, 2014

    Hospira — Marketing Organization

  3. Mar 25, 2016

    Teva — Marketing Organization

  4. Jun 15, 2016

    Cr Double Crane — Marketing Organization

  5. Jun 15, 2016

    Novo Nordisk — Marketing Organization

  6. Sep 12, 2017

    Sagent Pharmaceuticals, Inc. — NDA Secondary Org

  7. Sep 12, 2017

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  8. Sep 12, 2017

    Nichi-Iko Pharmaceutical Co., Ltd. — NDA Secondary Org

  9. Oct 20, 2017

    Xellia Pharmaceuticals — NDA Secondary Org

  10. Oct 20, 2017

    Novo Nordisk — NDA Secondary Org

  11. Oct 20, 2017

    Hikma — Marketing Organization

  12. Apr 11, 2018

    Fresenius — Marketing Organization

  13. Jun 5, 2018

    Mylan — Marketing Organization

  14. May 1, 2019

    Dr. Reddy's Laboratories — Marketing Organization

  15. Jun 24, 2019

    Accord Research — Marketing Organization

  16. Jun 26, 2019

    BE Pharmaceuticals — Marketing Organization

  17. Aug 22, 2019

    Hengrui Therapeutics, Inc. — Marketing Organization

  18. Aug 22, 2019

    Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. — Marketing Organization

  19. Nov 15, 2019

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

2020s

  1. Apr 21, 2021

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  2. Jun 21, 2021

    Pfizer — NDA Secondary Org

  3. Jun 29, 2021

    Meitheal — Marketing Organization

  4. Aug 24, 2021

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  5. Sep 2, 2021

    Eugia Pharma — Marketing Organization

  6. Nov 26, 2021

    Hangzhou Zhongmei — Marketing Organization

  7. Jan 25, 2022

    Baxalta — Marketing Organization

  8. Jan 25, 2022

    Takeda — NDA Secondary Org

  9. Aug 18, 2022

    Hainan Poly Pharm — Marketing Organization

  10. Sep 23, 2022

    Aspiro — Marketing Organization

  11. Aug 29, 2024

    Biocon Limited — Marketing Organization

  12. Nov 21, 2024

    Maia Pharms Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Cell membraneINHIBITOR

    Cell membrane inhibitor

    It binds to bacterial membranes and causes a rapid depolarization of membrane potential

Approval history

  • approvedPriority reviewSep 12, 2003

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCCCC(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@H](CC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@H]3[C@@H](C)OC(=O)[C@H](CC(=O)C4=C(N)C=CC=C4)NC(=O)[C@@H](NC(=O)[C@@H](CO)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCN)NC(=O)CNC3=O)[C@H](C)CC(O)=O
Mol. weight
1620.6706 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • cidecin
  • cubicin
  • cubicin
  • cubicin
  • cubicin
  • cubicin
  • dapcin
  • daptomicina
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycin
  • daptomycine
  • daptomycinum
  • deptomycin
  • ly146032
  • ly-146032

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06637332Phase 4Nov 14, 2024McGill University, The Peter Doherty Institute, University of Melbourne
NCT06189885N/AAug 1, 2024Chang Gung University
NCT05156437Phase 4Dec 20, 2021West Virginia University
NCT04983901Phase 2Sep 14, 2021University of Texas at Houston
NCT04775953Phase 2Apr 22, 2021National Institute of Allergy and Infectious Diseases (NIAID)
NCT04434300Phase 1Jun 30, 2020University of Caen-Normandie
NCT04141787Phase 4Jul 11, 2019Vancouver Island Health Authority
NCT03643952Phase 2Dec 12, 2018Merck
NCT03480191Phase 2Jun 7, 2018University of Burgundy
NCT03138733Phase 3Jun 1, 2017Basilea Pharmaceutica, Department of Health and Human Services
NCT02972983Phase 4Nov 1, 2016McGill University
NCT02660346Phase 4Nov 1, 2015Sharp HealthCare
NCT02508350N/AJan 1, 2015Southeast University
NCT02208063Phase 3Dec 1, 2014Theravance
NCT02241941Phase 4Sep 1, 2014University of Zurich
NCT02168816Phase 2Jun 1, 2014Loyola University
NCT02097953Early Phase 1 (Phase 1)May 1, 2014Cubist, University of Utah
NCT02142075Phase 3Mar 1, 2014University of Poitiers
NCT02052388Phase 2Feb 1, 2014Innovation Pharmaceuticals
NCT01975662Phase 2Jan 1, 2014Singapore Clinical Research Institute, Singapore General Hospital
Showing 20 of 83 trials
Page 1 / 5

Organizations

Research & Development (71)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CubistFor profit352252000
NovartisFor profit5322006
MerckFor profit4232008
University of Texas at HoustonAcademic/Hospital3312006
University of ZurichAcademic/Hospital3322009
AstraZenecaFor profit2222008
Duke UniversityAcademic/Hospital2222008
Henry Ford Health SystemAcademic/Hospital2112011
McGill UniversityAcademic/Hospital2212016
University of Caen-NormandieAcademic/Hospital2222013
West Virginia UniversityAcademic/Hospital2112007
Basilea PharmaceuticaFor profit1112017
CAMC Health SystemAcademic/Hospital1112007
Cempra IncFor profit1112012
Centre Hospitalier Universitaire VaudoisAcademic/Hospital1112012
Chang Gung UniversityAcademic/Hospital1112024
Clinical Alliance for Research & Education - Infectious Diseases, LLC.Academic/Hospital1112010
Clinica Universidad de NavarraAcademic/Hospital1112012
Cornell UniversityAcademic/Hospital1112006
Department of Health and Human ServicesGovernment1012017
71 organizations
Page 1 / 4

Marketing (35)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGJun 24, 2019
AspiroFor profitMKTGSep 23, 2022
BE PharmaceuticalsFor profitMKTGJun 26, 2019
BaxaltaFor profitMKTGJan 25, 2022
Biocon LimitedFor profitMKTGAug 29, 2024
Cr Double CraneFor profitMKTGJun 15, 2016
CubistFor profitNDASep 12, 2003
Dr. Reddy's LaboratoriesFor profitMKTGMay 1, 2019
Eugia PharmaFor profitMKTGSep 2, 2021
FreseniusFor profitMKTGApr 11, 2018
Hainan Poly PharmFor profitMKTGAug 18, 2022
Hangzhou ZhongmeiFor profitMKTGNov 26, 2021
Hengrui Therapeutics, Inc.For profitMKTGAug 22, 2019
Hengrui Therapeutics, Inc.For profitSYNAug 22, 2019
HikmaFor profitMKTGOct 20, 2017
HospiraFor profitNDA2Mar 15, 2013
HospiraFor profitMKTGSep 12, 2014
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.For profitMKTGAug 22, 2019
Maia Pharms IncFor profitMKTGNov 21, 2024
MeithealFor profitMKTGJun 29, 2021
MylanFor profitMKTGJun 5, 2018
MylanFor profitSYNAug 7, 2023
Nichi-Iko Pharmaceutical Co., Ltd.For profitNDA2Sep 12, 2017
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGNov 15, 2019
Novo NordiskFor profitNDA2Oct 20, 2017
Novo NordiskFor profitMKTGJun 15, 2016
PfizerFor profitNDA2Jun 21, 2021
Qilu Pharmaceutical Co., Ltd.For profitMKTGAug 24, 2021
Qilu Pharmaceutical Co., Ltd.For profitMKTGAug 24, 2021
Sagent Pharmaceuticals, Inc.For profitNDA2Sep 12, 2017
Sagent Pharmaceuticals, Inc.For profitMKTGSep 12, 2017
TakedaFor profitNDA2Jan 25, 2022
TevaFor profitMKTGMar 25, 2016
Xellia PharmaceuticalsFor profitNDA2Oct 20, 2017
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGApr 21, 2021