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colistin

Small moleculeapproved

Approved

May 17, 1962

Colistimethate is a methanesulfonate of polymyxin antibacterial colistin. Colistimethate is a nonactive prodrug. In aqueous solutions, colistimethate is hydrolyzed and forms a complex mixture of partially sulfomethylated derivatives and colistin. The antimicrobial activity of colistin is similar to that of polymyxin B and is restricted to gram-negative bacteria, including P aeruginosa, Acinetobacter species, Enterobacter-Klebsiella tribe, Escherichia coli, Salmonella and Shigella species, Citrobacter species, Yersinia pseudotuberculosis, Morganella morganii and Haemophilus influenzae. Colistin has also been shown to possess considerable in vitro activity against Stenotrophomonas maltophilia. Colistin and polymyxin B, however, do not have activity against Proteus, Providencia, Serratia species, Pseudomonas mallei, Burkholderia cepacia, Brucella species, most gram-positive bacteria, gram-negative cocci, anaerobes, fungi and parasites. Parenteral or nebulized colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. — NCATS

Clinical trial activity

75 trials · 84 clinical orgs · 14 marketing orgs

Phase 1
7
Phase 2
31
Phase 3
33
Phase 4
23

Earliest trial started Aug 1, 2001 (NCT01400750)

Timeline

1960s

  1. May 17, 1962

    Earliest FDA Approval

  2. May 17, 1962

    Endo Pharmaceuticals — Marketing Organization

  3. May 17, 1962

    Endo Pharmaceuticals — NDA Secondary Org

  4. May 17, 1962

    PH HEALTH — NDA Secondary Org

1970s

  1. Jun 4, 1970

    Par Pharmaceuticals — NDA Secondary Org

1990s

  1. Feb 26, 1999

    X Gen Pharmaceuticals — Marketing Organization

  2. Feb 26, 1999

    PHARMOBEDIENT — Marketing Organization

2000s

  1. Mar 19, 2004

    Nexus Pharmaceuticals — Marketing Organization

  2. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

  3. Apr 17, 2008

    Fresenius — Marketing Organization

  4. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Sep 28, 2012

    Emcure — Marketing Organization

  2. Sep 28, 2012

    Avet Lifesciences — Marketing Organization

  3. Feb 19, 2014

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  4. May 29, 2015

    Xellia Pharmaceuticals — Marketing Organization

  5. May 29, 2015

    Novo Nordisk — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMay 17, 1962

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)CCCCC(=O)N[C@@H](CCN)C(=O)N[C@@H](CN[C@@H](CCN)C(=O)N[C@H]1CCNC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CCN)NC1=O)[C@@H](C)O.CCC(C)CCCCC(=O)N[C@@H](CCN)C(=O)N[C@@H](CN[C@@H](CCN)C(=O)N[C@H]1CCNC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CCN)NC1=O)[C@@H](C)O
Mol. weight
2296.97 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • colifin 1 miu
  • colifin 2 miu
  • colimycin
  • colimycin
  • colimycin
  • colimycin m
  • colimycin sodium methanesulfonate
  • colistimethate
  • colistimethate
  • colistimethate
  • colistimethate
  • colistimethate
  • colistimethate
  • colistimethate
  • colistimethate
  • colistimethate, disodium salt
  • colistimethate sodium
  • colistimethate sodium
  • colistimethate sodium
  • colistimethate sodium
  • colistimethate sodium
  • colistimethate sodium
  • colistimethate sodium
  • colistin
  • colistin
  • colistin
  • colistin
  • colistin
  • colistin
  • colistin
  • colistin
  • colistin
  • colistina
  • colistina
  • colistin (colistimethate)
  • colistine
  • colistine
  • colistin methanesulfonate sodium
  • colistin methanesulfonic acid
  • colistin methanesulfonic acid
  • colistinmethanesulfonic acid
  • colistinmethanesulfonic acid
  • colistinmethanesulfonic acid
  • colistinmethanesulfonic acid
  • colistin sodium methanesulfonate
  • colistin sodium methanesulfonate
  • colistins sulfate
  • colistin sulfate
  • colistin sulfate
  • colistin sulfate
  • colistin sulfate
  • colistin sulfomethate
  • colistin sulfomethate
  • colistin sulfomethate
  • colistin sulphate
  • colistin sulphate
  • colistin sulphomethate
  • colistinum
  • colistinum
  • colobreathe
  • colobreathe
  • colomycin
  • colomycin
  • coly-mycin
  • coly-mycin
  • coly-mycin
  • coly-mycin m
  • coly-mycin m
  • coly-mycin s
  • pentasodium colistinmethanesulfonate
  • polymyxin e
  • polymyxin e
  • polymyxin e
  • polymyxin e
  • polymyxin e
  • promixin
  • w-1929
  • w-1929

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07089186Phase 3Apr 12, 2025Qilu Pharmaceutical Co., Ltd.
NCT06907069Phase 4Jan 1, 2025Ningbo University
NCT06893835Phase 4Dec 1, 2024Beni Suef University
NCT06650384Phase 2/Phase 3 (Phase 3)Nov 1, 2024Ain Shams University
NCT06488794Phase 2/Phase 3 (Phase 3)Oct 1, 2024University of Monastir
NCT06087536Phase 2Jan 31, 2024Omnix Medical
NCT05922124Phase 4Jan 31, 2024Hebrew University, Monaldi Hospital, Rutgers University, Technion University, Tel Aviv University
NCT06843668Phase 2/Phase 3 (Phase 3)Dec 25, 2023Mansoura University
NCT06051513N/AOct 30, 2023Southeast University
NCT06570850Phase 4Apr 1, 2023Chiangmai University
NCT05586815Phase 4Nov 30, 2022Mahidol University
NCT05613361Phase 3Nov 1, 2022Cairo University, October 6 University
NCT05542446Phase 4Sep 30, 2022Masaryk University, Palacky University, University Hospital Brno
NCT05258851Phase 3Jun 1, 2022King Faisal University
NCT05279586Early Phase 1 (Phase 1)Mar 31, 2022Tanta University
NCT05586438Phase 4Oct 18, 2021Mahidol University, Monash University
NCT05689229Phase 3Aug 3, 2021Beni Suef University
NCT04995133Phase 4Jul 14, 2021Universita' Cattolica del Sacro Cuore
NCT06827756Phase 4Mar 1, 2021Tanta University
NCT04208945N/ADec 31, 2019University of Thessaly
Showing 20 of 75 trials
Page 1 / 4

Organizations

Research & Development (84)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mahidol UniversityAcademic/Hospital8822006
Siriraj HospitalAcademic/Hospital5012006
European CommissionGovernment4032012
Technion UniversityAcademic/Hospital4332009
Ain Shams UniversityAcademic/Hospital2212016
Beni Suef UniversityAcademic/Hospital2222021
Department of Health and Human ServicesGovernment2012014
Fundación Pública AndaluzaAcademic/Hospital2222011
NovartisFor profit2112013
Tanta UniversityAcademic/Hospital2222021
Tel Aviv UniversityAcademic/Hospital2012013
University of PoitiersAcademic/Hospital2212009
University of SevilleAcademic/Hospital2122008
University of ThessalyAcademic/Hospital2212009
ZambonFor profit2212017
Achaogen, Inc.For profit1112014
Al Azhar UniversityAcademic/Hospital1112019
Andaluz Health ServiceAcademic/Hospital1012012
Belarusian State Medical UniversityAcademic/Hospital1012017
Ben Gurion UniversityAcademic/Hospital1112008
84 organizations
Page 1 / 5

Marketing (18)

OrganizationOrg typeRelationshipDate
American Home ProductsFor profitNDA—
Avet LifesciencesFor profitMKTGSep 28, 2012
EmcureFor profitMKTGSep 28, 2012
Endo PharmaceuticalsFor profitMKTGMay 17, 1962
Endo PharmaceuticalsFor profitNDA2May 17, 1962
FreseniusFor profitMKTGApr 17, 2008
Nexus PharmaceuticalsFor profitMKTGMar 19, 2004
Nexus PharmaceuticalsFor profitSYNMar 19, 2004
Novo NordiskFor profitMKTGMay 29, 2015
PH HEALTHFor profitNDA2May 17, 1962
PHARMOBEDIENTFor profitMKTGFeb 26, 1999
Par PharmaceuticalsFor profitNDA2Jun 4, 1970
Parke-DavisFor profitNDA2—
Sagent Pharmaceuticals, Inc.For profitMKTGFeb 19, 2014
Sagent Pharmaceuticals, Inc.For profitSYNFeb 19, 2014
X Gen PharmaceuticalsFor profitMKTGFeb 26, 1999
X Gen PharmaceuticalsFor profitSYNFeb 26, 1999
Xellia PharmaceuticalsFor profitMKTGMay 29, 2015