neomycin

Small moleculeapproved

Approved

Apr 19, 1954

Neomycin is an aminoglycoside antibiotic found in many topical medications such as creams, ointments, and eye drops. In vitro tests have demonstrated that neomycin is bactericidal and acts by inhibiting the synthesis of protein in susceptible bacterial cells. It is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. Neomycin is active in vitro against Escherichia coli and the Klebsiella-Entero. Topical uses include treatment for superficial eye infections caused by susceptible bacteria (used in combination with other anti-infective), treatment of otitis externa caused by susceptible bacteria, treatment or prevention of bacterial infections in skin lesions, and use as a continuous short-term irrigant or rinse to prevent bacteriuria and gram negative rod bacteremia in bacteriuria patients with indwelling catheters. May be used orally to treat hepatic encephalopathy, as a perioperative prophylactic agent, and as an adjunct to fluid and electrolyte replacement in the treatment of diarrhea caused to enter pathogenic E. coli (EPEC). Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Oral Solution and other antibacterial drugs, susceptible bacteria should use Neomycin Sulfate Oral Solution only to treat or prevent infections that are proven or strongly suspected to be caused. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Neomycin binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site near nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes — NCATS

Clinical trial activity

46 trials · 66 clinical orgs · 41 marketing orgs

Phase 1
8
Phase 2
12
Phase 3
8
Phase 4
10

Earliest trial started Dec 1, 2003 (NCT00166868)

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

1960s

  1. May 17, 1962

    Endo Pharmaceuticals — Marketing Organization

  2. May 17, 1962

    Endo Pharmaceuticals — NDA Secondary Org

  3. May 10, 1963

    Allergan — Marketing Organization

  4. May 10, 1963

    Allergan — NDA Secondary Org

  5. Jun 6, 1963

    Alcon — NDA Secondary Org

  6. Jun 6, 1963

    Harrow Health — NDA Secondary Org

  7. Jun 11, 1963

    Medimetriks — Marketing Organization

  8. Jul 19, 1963

    Novartis — NDA Secondary Org

  9. Sep 2, 1964

    Teva — Marketing Organization

  10. Oct 19, 1964

    Bayer — Marketing Organization

  11. Oct 19, 1964

    Bayer — NDA Secondary Org

  12. Dec 7, 1964

    Pharmacia & Upjohn — NDA Secondary Org

  13. Dec 7, 1964

    Pharmacia & Upjohn — Marketing Organization

  14. Oct 26, 1966

    Lannett Company, Inc. — Marketing Organization

  15. Oct 26, 1968

    Akorn, Inc. — Marketing Organization

  16. Oct 26, 1968

    Epic Pharma Llc — Marketing Organization

  17. Jul 2, 1969

    Merck — Marketing Organization

  18. Jul 2, 1969

    Merck — NDA Secondary Org

1970s

  1. May 10, 1971

    Casper Pharma LLC — Marketing Organization

  2. May 10, 1971

    Casper Pharma LLC — NDA Secondary Org

  3. Jan 5, 1972

    X Gen Pharmaceuticals — Marketing Organization

  4. Mar 12, 1974

    Alcon — Marketing Organization

1980s

  1. Jan 22, 1981

    Perrigo — Marketing Organization

  2. Jan 22, 1981

    Padagis Us — Marketing Organization

  3. Aug 25, 1983

    Sandoz — Marketing Organization

  4. Oct 29, 1984

    Novartis — Marketing Organization

  5. Nov 30, 1984

    Nestle — Marketing Organization

  6. Apr 8, 1986

    Watson Pharmaceuticals — Marketing Organization

1990s

  1. Jul 25, 1994

    Bausch & Lomb — Marketing Organization

2000s

  1. Oct 28, 2005

    Amring Pharmaceticals — Marketing Organization

  2. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

  3. Mar 13, 2009

    Pfizer — NDA Secondary Org

2010s

  1. Mar 29, 2010

    Esteve Labs — Marketing Organization

  2. Mar 29, 2010

    Nostrum Laboratories — Marketing Organization

  3. Jan 1, 2013

    Bayer — Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2013

    Earliest Phase 2 Sponsor(trial)

  5. Jun 10, 2016

    Chartwell Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedApr 19, 1954

Chemistry & pharmacology

Loading structure…

SMILES

NC[C@@H]1O[C@H](O[C@H]2[C@@H](O)[C@H](O[C@@H]3[C@@H](O)[C@H](N)C[C@H](N)[C@H]3O[C@H]4O[C@H](CN)[C@@H](O)[C@H](O)[C@H]4N)O[C@@H]2CO)[C@H](N)[C@@H](O)[C@@H]1O.OS(=O)(=O)O
Mol. weight
712.73 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Black box warning

Sources

Also known as

  • bykomycin
  • cicatrene
  • cicatrin
  • cicatrin
  • cicatrin
  • endomixin
  • fradiomycin sulfate
  • fradiomycin sulfate
  • fradiomycin sulfate
  • framycetin
  • framycetin
  • gppe nsl gel
  • graneodin
  • mycerin sulfate
  • mycifradin
  • mycifradin
  • mycifradin
  • myciguent
  • myciguent
  • naseptin
  • neobacrin
  • neomycin
  • neomycin
  • neomycin
  • neomycin
  • neomycin
  • neomycin
  • neomycin
  • neomycin b
  • neomycin b sulfate
  • neomycin b sulfate
  • neomycin b sulfate
  • neomycin b sulfate
  • neomycin b sulfate
  • neomycin b sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulfate
  • neomycin sulphate
  • neo-rx
  • neo-rx
  • nivemycin
  • nivemycin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07032506N/AOct 31, 2025Cornell University
NCT06889701Phase 1/Phase 2 (Phase 2)Apr 3, 2025TenNor Therapeutics Ltd, Xinjiang Medical University
NCT06747611Early Phase 1 (Phase 1)Jan 15, 2025University of Minnesota
NCT06080698N/AJan 1, 2024Johns Hopkins University, Patient-Centered Outcomes Research Institute
NCT06148025Phase 4Nov 30, 2023Flinders University, South Australian Health and Medical Research Institute, Telethon Kids Institute, University of Adelaide, University of Sydney
NCT06093191Phase 4Sep 25, 2023Huazhong University of Science and Technology
NCT05874219Phase 2/Phase 3 (Phase 3)Apr 10, 2023Future University in Egypt
NCT05999955N/ADec 29, 2022Huro Biotech Joint Stock Company, Thai Binh University of Medicine and Pharmacy, Vietstar Biomedical Research
NCT05593601Phase 4Nov 24, 2022Mahidol University
NCT05449392Phase 1Sep 1, 2022Bill and Melinda Gates Foundation, Yale University
NCT04729322Early Phase 1 (Phase 1)Feb 22, 2021National Cancer Institute (NCI), University of Texas at Houston
NCT04281667Phase 4Feb 29, 2020University of Helsinki
NCT03856671N/AMay 17, 2019Sun Yat-Sen University
NCT04438655N/AMay 1, 2019University of Turin
NCT03663504Phase 4Oct 1, 2018University of Ottawa
NCT03476317Phase 2Jul 12, 2018National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania
NCT03557008Phase 4Jul 5, 2018Emory University
NCT03006809Phase 1Jun 15, 2017University of California, San Francisco
NCT02973880Phase 3Feb 1, 2017Catholic University of Sacred Heart, Rome, SIFI SpA, Sintesi Research Srl
NCT02682485Phase 2Jan 1, 2017University of Chicago
Showing 20 of 46 trials
Page 1 / 3

Organizations

Research & Development (66)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AzidusFor profit2212011
Cedars-Sinai Medical CenterAcademic/Hospital2212009
Emory UniversityAcademic/Hospital2222015
Fournier LabsFor profit2022009
Laboratoire Innotech InternationalFor profit2222009
University of HelsinkiAcademic/Hospital2212016
University of MinnesotaAcademic/Hospital2222016
University of PennsylvaniaAcademic/Hospital2212016
American Diabetes AssociationAcademic/Hospital1012012
Bausch Health CompaniesFor profit1012009
BayerFor profit1112013
Bill and Melinda Gates FoundationAcademic/Hospital1012022
Case Western Reserve UniversityAcademic/Hospital1112016
Catholic University of Sacred Heart, RomeAcademic/Hospital1012017
Chulalongkorn UniversityAcademic/Hospital1112007
Conselho Nacional de Desenvolvimento Científico e TecnológicoGovernment1012008
Consumer Product Testing CorporationAcademic/Hospital1012014
Cornell UniversityAcademic/Hospital1112025
Crohn's and Colitis FoundationAcademic/Hospital1012016
European CommissionGovernment1012016
66 organizations
Page 1 / 4

Marketing (59)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTG
Akorn, Inc.For profitMKTGOct 26, 1968
AlconFor profitMKTGMar 12, 1974
AlconFor profitNDA2Jun 6, 1963
AlconFor profitSYNJul 21, 1986
AlconFor profitNDA
AllerganFor profitMKTGMay 10, 1963
AllerganFor profitNDA2May 10, 1963
AltanaFor profitMKTG
Amring PharmaceticalsFor profitMKTGOct 28, 2005
Bausch & LombFor profitMKTGJul 25, 1994
BayerFor profitMKTGOct 19, 1964
BayerFor profitNDA2Oct 19, 1964
Bristol-Myers SquibbFor profitMKTG
Casper Pharma LLCFor profitMKTGMay 10, 1971
Casper Pharma LLCFor profitNDA2May 10, 1971
Chartwell PharmaceuticalsFor profitMKTGJun 10, 2016
Dow Pharmaceutical SciencesFor profitMKTGApr 19, 1954
Eli LillyFor profitNDA2
Eli LillyFor profitMKTG
Endo PharmaceuticalsFor profitMKTGMay 17, 1962
Endo PharmaceuticalsFor profitNDA2May 17, 1962
Epic Pharma LlcFor profitMKTGOct 26, 1968
Esteve LabsFor profitMKTGMar 29, 2010
Esteve LabsFor profitSYNMar 29, 2010
FougeraFor profitMKTG
GlaxoSmithKlineFor profitNDA2
Harrow HealthFor profitNDA2Jun 6, 1963
Lannett Company, Inc.For profitMKTGOct 26, 1966
Lannett Company, Inc.For profitSYNJun 10, 2016
MedimetriksFor profitMKTGJun 11, 1963
MerckFor profitMKTGJul 2, 1969
MerckFor profitNDA2Jul 2, 1969
Monarch PharmaceuticalsFor profitMKTGMar 26, 1957
Monarch PharmaceuticalsFor profitNDA2Mar 26, 1957
Naska PharmacalFor profitMKTG
NestleFor profitMKTGNov 30, 1984
Nostrum LaboratoriesFor profitMKTGMar 29, 2010
NovartisFor profitMKTGOct 29, 1984
NovartisFor profitSYNJun 6, 1963
NovartisFor profitNDA2Jul 19, 1963
Padagis UsFor profitMKTGJan 22, 1981
PerrigoFor profitMKTGJan 22, 1981
PfizerFor profitNDA2Mar 13, 2009
PfizerFor profitMKTG
Pharmacia & UpjohnFor profitNDA2Dec 7, 1964
Pharmacia & UpjohnFor profitMKTGDec 7, 1964
PharmadermFor profitMKTG
PharmafairFor profitMKTG
Roxane LaboratoriesFor profitMKTG
SandozFor profitMKTGAug 25, 1983
SandozFor profitSYNAug 25, 1983
Savage LabsFor profitMKTG
ScheringFor profitMKTG
TevaFor profitMKTGSep 2, 1964
Watson PharmaceuticalsFor profitMKTGApr 8, 1986
X Gen PharmaceuticalsFor profitSYNJan 31, 2006
X Gen PharmaceuticalsFor profitMKTGJan 5, 1972
iPharmaFor profitMKTG