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bacitracin

Trade name: polysporin

Small moleculeapproved

Approved

Jul 29, 1948

Bacitracin is a polypeptide antibiotic produced by Bacillus subtilis and Bacillus licheniformis. Bacitracin in combination with neomycin and polymyxin B is indicated for the treatment of many bacterial diseases. The antibacterial properties of bacitracin are mediated by its binding to C55-isoprenyl pyrophosphate, resulting in inhibition of cell wall biosynthesis. — NCATS

Clinical trial activity

32 trials · 35 clinical orgs · 27 marketing orgs

Phase 1
2
Phase 2
4
Phase 3
4
Phase 4
13

Earliest trial started Nov 2, 1999 (NCT00000635)

Timeline

1940s

  1. Jul 29, 1948

    Burroughs Wellcome — Earliest FDA Approval

  2. Jul 29, 1948

    Pharmacia & Upjohn — Marketing Organization

  3. Jul 29, 1948

    Burroughs Wellcome — NDA Organization

1950s

  1. Sep 6, 1950

    Pfizer — Marketing Organization

  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

1970s

  1. May 10, 1971

    Casper Pharma LLC — Marketing Organization

  2. May 10, 1971

    Casper Pharma LLC — NDA Secondary Org

  3. Nov 9, 1971

    Perrigo — Marketing Organization

  4. Nov 9, 1971

    Padagis Us — Marketing Organization

  5. Jan 6, 1972

    X Gen Pharmaceuticals — Marketing Organization

  6. Dec 21, 1972

    Apothekernes — Marketing Organization

1990s

  1. Jan 26, 1995

    Bausch & Lomb — Marketing Organization

  2. Jan 30, 1995

    Saptalis Pharmaceuticals — Marketing Organization

  3. Jan 30, 1995

    Sciegen Pharmaceticals — Marketing Organization

2000s

  1. Dec 3, 2002

    Fresenius — Marketing Organization

  2. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. May 11, 2010

    Mylan — Marketing Organization

  2. Aug 25, 2014

    Xellia Pharmaceuticals — Marketing Organization

  3. Aug 25, 2014

    Novo Nordisk — Marketing Organization

  4. Oct 20, 2017

    Akorn, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 29, 1948

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H](C)[C@H](N)C1=N[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](CCC(=O)O)C(=O)N[C@H](C(=O)N[C@H]2CCCCNC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](CC(=O)O)NC(=O)[C@H](Cc3cnc[nH]3)NC(=O)[C@@H](Cc3ccccc3)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@@H](CCCN)NC2=O)[C@@H](C)CC)CS1
Mol. weight
1422.72 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

  • albac 50
  • baciferm 50
  • baciguent
  • baciguent
  • baciguent
  • baciim
  • baciim
  • bacillichin
  • bacilliquin
  • baci-rx
  • baci-rx
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin
  • bacitracin f, 1-(n-((2-(1-amino-2-methylbutyl)-4,5-dihydro-4-thiazolyl)carbonyl)-l-leucine)-
  • bacitracin f, 1-(n-((2-(1-amino-2-methylbutyl)-4,5-dihydro-4-thiazolyl)carbonyl)-l-leucine)-
  • bacitracin zinc
  • bacitracin zinc
  • bacitracin zinc
  • bacitracin zinc
  • e700
  • e700

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05874219Phase 2/Phase 3 (Phase 3)Apr 10, 2023Future University in Egypt
NCT04438655N/AMay 1, 2019University of Turin
NCT03929224Phase 4Oct 25, 2018Ascension Health, Michigan Ear Institute
NCT03715387Phase 2/Phase 3 (Phase 3)Oct 10, 2018University of British Columbia
NCT03483363Phase 4Mar 31, 2018University of Texas at Houston
NCT03199911Phase 4Oct 2, 2017University of California, San Francisco
NCT03213249Phase 1Jul 25, 2017The Plastic Surgery Foundation, Washington University in St. Louis
NCT03099863Phase 4Apr 1, 2016Case Western Reserve University
NCT02395614N/ADec 1, 2015Vanderbilt University
NCT02497326N/AApr 1, 2015King Edward Medical University
NCT02320695N/AMar 1, 2015Johnson and Johnson
NCT02138994N/AJul 1, 2014Jacksonville Center for Clinical Research, Mayo Clinic, Next Science
NCT02106962Phase 4Apr 1, 2014California Institute of Renal Research, Inc., Harrow Health
NCT02673229Phase 4Jan 1, 2014Healthpoint, University of Kansas
NCT01608880N/AAug 1, 2012University of British Columbia
NCT01668030Phase 4Apr 1, 2012Healthpoint, University of Louisville
NCT01516463Phase 4Mar 1, 2012Healthpoint, University of Kansas
NCT01350102Phase 4Feb 1, 2012Milton S. Hershey Medical Center, Pennsylvania State University
NCT01359735Phase 2May 1, 2011Healthpoint
NCT01222832Phase 2Jul 1, 2010Tufts University
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (35)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
HealthpointFor profit4222011
Tufts UniversityAcademic/Hospital3332006
University of British ColumbiaAcademic/Hospital3222009
Case Western Reserve UniversityAcademic/Hospital2222006
University of KansasAcademic/Hospital2112012
Ascension HealthAcademic/Hospital1112018
California Institute of Renal Research, Inc.For profit1112014
Fraser HealthAcademic/Hospital1112009
Future University in EgyptAcademic/Hospital1112023
Glaxo WellcomeFor profit1011999
Harrow HealthFor profit1012014
Jacksonville Center for Clinical ResearchFor profit1012014
Johnson and JohnsonFor profit1112015
King Edward Medical UniversityAcademic/Hospital1112015
Mayo ClinicAcademic/Hospital1012014
McMaster UniversityAcademic/Hospital1112009
Michigan Ear InstituteAcademic/Hospital1012018
Milton S. Hershey Medical CenterAcademic/Hospital1112012
MylanFor profit1112007
National Institute of Allergy and Infectious Diseases (NIAID)Government1111999
35 organizations
Page 1 / 2

Marketing (30)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGOct 20, 2017
AltanaFor profitMKTG—
ApothekernesFor profitMKTGDec 21, 1972
Athenex, Inc.For profitMKTG—
Bausch & LombFor profitMKTGJan 26, 1995
Bristol-Myers SquibbFor profitNDA2—
Bristol-Myers SquibbFor profitMKTG—
Burroughs WellcomeFor profitNDAJul 29, 1948
Casper Pharma LLCFor profitMKTGMay 10, 1971
Casper Pharma LLCFor profitNDA2May 10, 1971
Dow Pharmaceutical SciencesFor profitMKTGApr 19, 1954
Eli LillyFor profitMKTG—
FreseniusFor profitMKTGDec 3, 2002
GlaxoSmithKlineFor profitNDA2—
Monarch PharmaceuticalsFor profitMKTGMar 26, 1957
Monarch PharmaceuticalsFor profitNDA2Mar 26, 1957
MylanFor profitMKTGMay 11, 2010
Naska PharmacalFor profitMKTG—
Novo NordiskFor profitMKTGAug 25, 2014
Padagis UsFor profitMKTGNov 9, 1971
Paddock LaboratoriesFor profitMKTG—
PerrigoFor profitMKTGNov 9, 1971
PfizerFor profitMKTGSep 6, 1950
Pharmacia & UpjohnFor profitMKTGJul 29, 1948
PharmadermFor profitMKTG—
PharmafairFor profitMKTG—
Saptalis PharmaceuticalsFor profitMKTGJan 30, 1995
Sciegen PharmaceticalsFor profitMKTGJan 30, 1995
X Gen PharmaceuticalsFor profitMKTGJan 6, 1972
Xellia PharmaceuticalsFor profitMKTGAug 25, 2014