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polymyxin b sulfate

Trade name: poly-rx

Small moleculeapproved

Approved

Apr 19, 1954

Polymyxin B is a lipopeptide antibiotic isolated from Bacillus polymyxa. Its basic structure consists of a polycationic peptide ring and a tripeptide side chain with a fatty acid tail. Polymyxin B is a mixture of at least four closely related components, polymyxin B1 to B4, with polymyxin B1 and B2 being the two major components. Polymyxin B acts on Gram-negative bacteria by interacting with lipopolysaccharide (LPS) of the outer membrane and destabilizing it. Polymyxin B is indicated for the treatment of many bacterial diseases such as meningeal infections, urinary tract infections and bacteremia. — NCATS

Clinical trial activity

36 trials · 54 clinical orgs · 49 marketing orgs

Phase 1
6
Phase 2
12
Phase 3
11
Phase 4
5

Earliest trial started Nov 2, 1999 (NCT00000635)

Timeline

1950s

  1. Apr 19, 1954

    Earliest FDA Approval

  2. Apr 19, 1954

    Dow Pharmaceutical Sciences — Marketing Organization

  3. Mar 26, 1957

    Monarch Pharmaceuticals — Marketing Organization

  4. Mar 26, 1957

    Monarch Pharmaceuticals — NDA Secondary Org

  5. Jun 25, 1958

    Parke-Davis — Marketing Organization

  6. Jun 25, 1958

    Parke-Davis — NDA Secondary Org

1960s

  1. May 10, 1963

    Allergan — Marketing Organization

  2. May 10, 1963

    Allergan — NDA Secondary Org

  3. Jun 6, 1963

    Harrow Health — NDA Secondary Org

  4. Jul 19, 1963

    Novartis — NDA Secondary Org

  5. Jun 29, 1964

    West-Ward Pharmaceutical — Marketing Organization

  6. Jun 29, 1964

    Hikma — Marketing Organization

  7. Jul 8, 1965

    Casper Pharma LLC — Marketing Organization

  8. Jul 8, 1965

    Casper Pharma LLC — NDA Secondary Org

1970s

  1. Jan 5, 1972

    X Gen Pharmaceuticals — First NDA Organization

  2. Jan 5, 1972

    X Gen Pharmaceuticals — NDA Organization

  3. Jan 5, 1972

    X Gen Pharmaceuticals — Marketing Organization

  4. Oct 11, 1972

    Forest Laboratories — Marketing Organization

  5. Mar 12, 1974

    Alcon — Marketing Organization

  6. Mar 12, 1974

    Alcon — NDA Secondary Org

1980s

  1. Nov 13, 1980

    GlaxoSmithKline — Marketing Organization

  2. Jan 22, 1981

    Perrigo — Marketing Organization

  3. Jan 22, 1981

    Padagis Us — Marketing Organization

  4. Dec 1, 1981

    Schering — Marketing Organization

  5. Dec 1, 1981

    Schering-Plough — Marketing Organization

  6. Aug 25, 1983

    Sandoz — Marketing Organization

  7. Oct 29, 1984

    Novartis — Marketing Organization

  8. Nov 30, 1984

    Nestle — Marketing Organization

  9. Apr 8, 1986

    Watson Pharmaceuticals — Marketing Organization

  10. Oct 20, 1988

    SmithKline Beckman — NDA Secondary Org

1990s

  1. Jul 25, 1994

    Bausch & Lomb — Marketing Organization

  2. Sep 30, 1994

    BEOWULF ASSET — Marketing Organization

  3. Sep 30, 1994

    PHARMOBEDIENT — Marketing Organization

  4. Jan 30, 1995

    Akorn, Inc. — Marketing Organization

  5. Jan 30, 1995

    Sciegen Pharmaceticals — Marketing Organization

  6. Dec 17, 1998

    Epic Pharma Llc — Marketing Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Oct 28, 2005

    Amring Pharmaceticals — Marketing Organization

  3. Oct 31, 2005

    Saptalis Pharmaceuticals — Marketing Organization

  4. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

  5. Jan 10, 2008

    Fresenius — Marketing Organization

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Jun 29, 2011

    Mylan — Marketing Organization

  3. Jun 29, 2011

    Rising Pharmaceuticals — Marketing Organization

  4. Jan 15, 2014

    Xellia Pharmaceuticals — Marketing Organization

  5. Jan 15, 2014

    Novo Nordisk — Marketing Organization

  6. Apr 4, 2016

    Aurobindo Pharma — Marketing Organization

  7. Apr 4, 2016

    Eugia Pharma — Marketing Organization

  8. Apr 14, 2016

    Gland Pharma Ltd — Marketing Organization

2020s

  1. Aug 5, 2024

    Somerset Pharmaceuticals — Marketing Organization

  2. Sep 30, 2025

    Amneal Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedApr 19, 1954

Chemistry & pharmacology

Loading structure…

SMILES

CCC(C)CCCCC(=O)N[C@@H](CCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCN)C(=O)N[C@H]1CCNC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](Cc2ccccc2)NC(=O)[C@@H](CCN)NC1=O)[C@@H](C)O.OS(=O)(=O)O
Mol. weight
1301.58 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • aerosporin
  • aerosporin
  • aerosporin
  • aerosporin
  • bacitracin - polymyxin b
  • bacitracin, polymyxin b drug combination
  • duobiotic
  • gppe pdr ster
  • mastimyxin
  • neosporin
  • neosporin
  • neosporin
  • polimixina b
  • polimixina b
  • polyfax
  • polyfax
  • polyfax
  • polymycin b sulfate
  • polymyxin
  • polymyxin
  • polymyxin b
  • polymyxin b
  • polymyxin b
  • polymyxin b
  • polymyxin b
  • polymyxin b
  • polymyxin b(1)
  • polymyxin-b-sulfat
  • polymyxin-b-sulfat
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulfate
  • polymyxin b sulphate
  • polymyxin b sulphate
  • polymyxin b sulphate
  • polymyxine b
  • polymyxine b
  • polymyxine b (sulfate de)
  • polymyxine b (sulfate de)
  • polymyxini b sulfas
  • polymyxini b sulfas
  • polymyxinum b
  • polymyxinum b
  • poly-rx
  • poly-rx
  • polysporin
  • polysporin
  • polysporin
  • polytrim
  • polytrim
  • thiosporin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05685615Phase 2Apr 20, 2023BioVersys SAS
NCT05359627Phase 1May 31, 2022TTY Biopharm
NCT05063422Phase 1Jan 18, 2021Altamash Institute of Dental Medicine
NCT06739382Phase 3Jan 1, 2021Beni Suef University, Cairo University
NCT05234086Phase 2Jan 2, 2020Government of Chile, Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
NCT03920007Phase 1/Phase 2 (Phase 2)Jul 9, 2019Sanofi
NCT03950544Early Phase 1 (Phase 1)Jan 1, 2019Huazhong University of Science and Technology
NCT03715387Phase 2/Phase 3 (Phase 3)Oct 10, 2018University of British Columbia
NCT03159078Phase 3May 25, 2017University of Puerto Rico
NCT02792036Phase 1Nov 1, 2016St. Jude Children's Hospital
NCT03099863Phase 4Apr 1, 2016Case Western Reserve University
NCT02809131Phase 3Apr 1, 2016Medtronic, Rowan University, Thomas Jefferson University, Valley Health System, Vanderbilt University
NCT02641236Phase 2Mar 1, 2016Harvard University
NCT02515656Phase 3Sep 1, 2015Fournier Labs, International Clinical Trials Association, Laboratoire Innotech International, Venn Life Sciences
NCT02497326N/AApr 1, 2015King Edward Medical University
NCT02320695N/AMar 1, 2015Johnson and Johnson
NCT02134106Phase 2/Phase 3 (Phase 3)Jan 1, 2015Changi General Hospital, Nanyang Technological University, National University of Singapore, Singapore General Hospital
NCT02328183Phase 4Dec 1, 2014Mahidol University, Siriraj Hospital
NCT02186457N/ANov 1, 2014Indiana University
NCT02138994N/AJul 1, 2014Jacksonville Center for Clinical Research, Mayo Clinic, Next Science
Showing 20 of 36 trials
Page 1 / 2

Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Fournier LabsFor profit2022009
Laboratoire Innotech InternationalFor profit2222009
University of British ColumbiaAcademic/Hospital2222012
Altamash Institute of Dental MedicineAcademic/Hospital1112021
AzidusFor profit1112011
Bausch & LombFor profit1012011
Beni Suef UniversityAcademic/Hospital1112021
BioVersys SASFor profit1112023
Cairo UniversityAcademic/Hospital1012021
Case Western Reserve UniversityAcademic/Hospital1112016
Changi General HospitalAcademic/Hospital1012015
Chulalongkorn UniversityAcademic/Hospital1112007
EMS S/AFor profit1112012
Faculdade de Medicina do ABCAcademic/Hospital1012009
Fraser HealthAcademic/Hospital1112009
Glaxo WellcomeFor profit1011999
Government of ChileGovernment1012020
Harvard UniversityAcademic/Hospital1112016
Huazhong University of Science and TechnologyAcademic/Hospital1112019
Indiana UniversityAcademic/Hospital1112014
54 organizations
Page 1 / 3

Marketing (65)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTG—
Akorn, Inc.For profitMKTGJan 30, 1995
Akorn, Inc.For profitSYNDec 17, 1998
AlconFor profitMKTGMar 12, 1974
AlconFor profitSYNNov 17, 1986
AlconFor profitNDA2Mar 12, 1974
AllerganFor profitMKTGMay 10, 1963
AllerganFor profitNDA2May 10, 1963
AltanaFor profitMKTG—
Amneal PharmaceuticalsFor profitMKTGSep 30, 2025
Amring PharmaceticalsFor profitMKTGOct 28, 2005
Aurobindo PharmaFor profitMKTGApr 4, 2016
BEOWULF ASSETFor profitMKTGSep 30, 1994
Bausch & LombFor profitMKTGJul 25, 1994
Bristol-Myers SquibbFor profitNDA2—
Bristol-Myers SquibbFor profitMKTG—
Casper Pharma LLCFor profitMKTGJul 8, 1965
Casper Pharma LLCFor profitNDA2Jul 8, 1965
Dow Pharmaceutical SciencesFor profitMKTGApr 19, 1954
Epic Pharma LlcFor profitMKTGDec 17, 1998
Eugia PharmaFor profitMKTGApr 4, 2016
Forest LaboratoriesFor profitMKTGOct 11, 1972
FreseniusFor profitMKTGJan 10, 2008
Gland Pharma LtdFor profitMKTGApr 14, 2016
Gland Pharma LtdFor profitSYNApr 14, 2016
GlaxoSmithKlineFor profitMKTGNov 13, 1980
GlaxoSmithKlineFor profitNDA2—
Harrow HealthFor profitNDA2Jun 6, 1963
HikmaFor profitMKTGJun 29, 1964
Monarch PharmaceuticalsFor profitMKTGMar 26, 1957
Monarch PharmaceuticalsFor profitNDA2Mar 26, 1957
MylanFor profitMKTGJun 29, 2011
Naska PharmacalFor profitMKTG—
NestleFor profitMKTGNov 30, 1984
NovartisFor profitMKTGOct 29, 1984
NovartisFor profitSYNJun 6, 1963
NovartisFor profitNDA2Jul 19, 1963
Novo NordiskFor profitMKTGJan 15, 2014
PHARMOBEDIENTFor profitMKTGSep 30, 1994
Padagis UsFor profitMKTGJan 22, 1981
Paddock LaboratoriesFor profitMKTG—
Parke-DavisFor profitMKTGJun 25, 1958
Parke-DavisFor profitNDA2Jun 25, 1958
PerrigoFor profitMKTGJan 22, 1981
PfizerFor profitMKTG—
Pharmacia & UpjohnFor profitMKTG—
PharmadermFor profitMKTG—
PharmafairFor profitMKTG—
Rising PharmaceuticalsFor profitMKTGJun 29, 2011
Rising PharmaceuticalsFor profitSYNJun 29, 2011
SandozFor profitMKTGAug 25, 1983
SandozFor profitSYNAug 25, 1983
Saptalis PharmaceuticalsFor profitMKTGOct 31, 2005
ScheringFor profitMKTGDec 1, 1981
Schering-PloughFor profitMKTGDec 1, 1981
Sciegen PharmaceticalsFor profitMKTGJan 30, 1995
SmithKline BeckmanFor profitNDA2Oct 20, 1988
Somerset PharmaceuticalsFor profitMKTGAug 5, 2024
Watson PharmaceuticalsFor profitMKTGApr 8, 1986
West-Ward PharmaceuticalFor profitMKTGJun 29, 1964
X Gen PharmaceuticalsFor profitNDAJan 5, 1972
X Gen PharmaceuticalsFor profitMKTGJan 5, 1972
X Gen PharmaceuticalsFor profitSYNSep 30, 1994
Xellia PharmaceuticalsFor profitMKTGJan 15, 2014
iPharmaFor profitMKTG—