CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

tobramycin

Trade name: nebcin

Small moleculeapproved

Approved

Jun 11, 1975

Tobramycin, an aminoglycoside antibiotic obtained from cultures of Streptomyces tenebrarius, it is effective against gram-negative bacteria, especially the pseudomonas species. Tobramycin is used in combination with other antibiotics to treat urinary tract infections, gynecologic infections, peritonitis, endocarditis, pneumonia, bacteremia and sepsis, respiratory infections including those associated with cystic fibrosis, osteomyelitis, and diabetic foot and other soft-tissue infections. It acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death. Tobramycin has in vitro activity against a wide range of gram-negative organisms including Pseudomonas aeruginosa. Tobramycin binds irreversibly to one of two aminoglycoside binding sites on the 30 S ribosomal subunit, inhibiting bacterial protein synthesis. Tobramycin may also destabilize bacterial memebrane by binding to 16 S 16 S r-RNA. An active transport mechanism for aminoglycoside uptake is necessary in the bacteria in order to attain a significant intracellular concentration of tobramycin. KITABIS PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. — NCATS

Clinical trial activity

120 trials · 142 clinical orgs · 48 marketing orgs

Phase 1
20
Phase 2
57
Phase 3
43
Phase 4
32

Earliest trial started Jun 1, 1995 (NCT00004829)

Timeline

1970s

  1. Jun 11, 1975

    Eli Lilly — Earliest FDA Approval

  2. Jun 11, 1975

    Eli Lilly — NDA Organization

  3. Oct 1, 1976

    Eli Lilly — Marketing Organization

1980s

  1. Dec 12, 1980

    Novartis — NDA Secondary Org

  2. Dec 13, 1984

    Sandoz — Marketing Organization

  3. Jul 21, 1989

    Eyevance — Marketing Organization

  4. Jul 21, 1989

    Eyevance — NDA Secondary Org

  5. Jul 21, 1989

    Harrow Health — NDA Secondary Org

  6. Aug 9, 1989

    Watson Pharmaceuticals — Marketing Organization

1990s

  1. Jul 31, 1990

    Hospira — Marketing Organization

  2. Apr 26, 1991

    Hikma — Marketing Organization

  3. Apr 26, 1991

    West-Ward Pharmaceutical — Marketing Organization

  4. Jan 30, 1992

    Teva — Marketing Organization

  5. Nov 29, 1993

    Bausch & Lomb — Marketing Organization

  6. May 25, 1994

    Alcon — Marketing Organization

  7. May 25, 1994

    Nestle — Marketing Organization

  8. May 31, 1994

    Apothecon — Marketing Organization

  9. Oct 31, 1994

    Teligent Pharmaceuticals — Marketing Organization

  10. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  11. Jan 31, 1996

    Akorn, Inc. — Marketing Organization

  12. Jan 31, 1996

    Epic Pharma Llc — Marketing Organization

  13. Dec 22, 1997

    Mylan — NDA Secondary Org

  14. Dec 22, 1997

    Viatris — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Aug 17, 2001

    X Gen Pharmaceuticals — Marketing Organization

  3. Sep 11, 2001

    Fera Development, LLC — Marketing Organization

  4. Sep 11, 2001

    Chartwell Pharmaceuticals — Marketing Organization

  5. Feb 25, 2002

    Apotex — Marketing Organization

  6. Nov 29, 2002

    Fresenius — NDA Secondary Org

  7. Nov 29, 2002

    Fresenius — Marketing Organization

  8. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  9. Dec 14, 2004

    Bausch & Lomb — NDA Secondary Org

  10. Mar 11, 2008

    Mylan — Marketing Organization

2010s

  1. Oct 12, 2012

    Chiesi — NDA Secondary Org

  2. Oct 12, 2012

    Chiesi — Marketing Organization

  3. Sep 16, 2014

    Xellia Pharmaceuticals — Marketing Organization

  4. Sep 16, 2014

    Novo Nordisk — Marketing Organization

  5. Dec 2, 2014

    Pulmoflow Inc — NDA Secondary Org

  6. Jul 13, 2015

    Amneal Pharmaceuticals — Marketing Organization

  7. Jul 1, 2016

    Baxalta — Marketing Organization

  8. Jul 1, 2016

    Shire — Marketing Organization

  9. Mar 22, 2017

    Lupin — Marketing Organization

  10. Jun 28, 2017

    Somerset Pharmaceuticals — Marketing Organization

  11. Oct 13, 2017

    PHARMOBEDIENT — Marketing Organization

  12. Jul 9, 2018

    Dr. Reddy's Laboratories — Marketing Organization

  13. Apr 19, 2019

    Alembic — Marketing Organization

  14. Dec 26, 2019

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Jan 22, 2021

    Aurobindo Pharma — Marketing Organization

  2. Jan 22, 2021

    Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. — Marketing Organization

  3. Feb 9, 2021

    Gland Pharma Ltd — Marketing Organization

  4. Feb 9, 2021

    Fosun — Marketing Organization

  5. Apr 1, 2021

    Alkem Labs Ltd — Marketing Organization

  6. Feb 11, 2022

    Padagis Us — Marketing Organization

  7. Sep 22, 2022

    Mankind Pharma — Marketing Organization

  8. Feb 1, 2023

    Hainan Poly Pharm — Marketing Organization

  9. Feb 1, 2023

    SLATE RUN PHARMA — Marketing Organization

  10. Jun 21, 2023

    Eugia Pharma — Marketing Organization

  11. Jul 27, 2023

    Micro Labs Ltd India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJun 11, 1975

Chemistry & pharmacology

Loading structure…

SMILES

NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O.NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O.O=S(=O)(O)O.O=S(=O)(O)O.O=S(=O)(O)O.O=S(=O)(O)O.O=S(=O)(O)O
Mol. weight
1425.44 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 3'-deoxykanamycin b
  • 3'-deoxykanamycin b
  • 47663
  • aktob
  • aktob
  • bethkis
  • bethkis
  • bethkis
  • bramitob
  • bramitob
  • dexamethasone mixture with tobramycin
  • nebcin
  • nebcin
  • nebcin
  • nebcin
  • nebcin
  • nebicin
  • nebicin
  • nebramycin
  • nebramycin
  • nebramycin 6
  • nebramycin 6
  • nebramycin 6
  • nebramycin factir 6
  • nebramycin factir 6
  • nebramycin factor 6
  • nebramycin factor 6
  • nebramycin-faktor 6
  • nebramycin-faktor 6
  • nebramycin vi
  • nebris
  • o-3-amino-3-deoxy-alpha-d-glucopyranosyl-(1-4)-o-(2,6-diamino-2,3,6-trideoxy-alpha-d-ribohexopyranosyl-(1-4))-2-deoxy-d-streptamine
  • o-3-amino-3-deoxy-alpha-d-glucopyranosyl-(1-4)-o-(2,6-diamino-2,3,6-trideoxy-alpha-d-ribohexopyranosyl-(1-4))-2-deoxy-d-streptamine
  • obramycin
  • obramycin
  • tobi
  • tobi
  • tobi podhaler
  • tobracin
  • tobracin (tn)
  • tobracin (tn)
  • tobradex
  • tobradex
  • tobradex
  • tobradex st
  • tobradistin
  • tobralex
  • tobralex
  • tobralex
  • tobramaxin
  • tobramaxin
  • tobramicin
  • tobramicina
  • tobramicina
  • tobramycetin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycin
  • tobramycine
  • tobramycine
  • tobramycin sulfate
  • tobramycin sulfate
  • tobramycin sulfate
  • tobramycin sulfate
  • tobramycin sulfate (pharmacy bulk)
  • tobramycinum
  • tobramycinum
  • tobravisc
  • tobrex
  • tobrex
  • tobrex (tn)
  • tobrex (tn)
  • tymbrineb
  • vantobra
  • vantobra
  • vantobra
  • vantobra
  • vantobra
  • vantobra

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06404541Phase 4Jan 10, 2024Cairo University
NCT06016088Phase 1/Phase 2 (Phase 2)Oct 31, 2023Respirion Pharmaceuticals Pty Ltd
NCT05865743Phase 3Sep 30, 2023Katholieke Universiteit Leuven, Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development
NCT06093191Phase 4Sep 25, 2023Huazhong University of Science and Technology
NCT05849090Early Phase 1 (Phase 1)Mar 27, 2023University of Utah
NCT05429671Phase 3Jun 20, 2022Thomas Jefferson University
NCT05169229Phase 2/Phase 3 (Phase 3)Apr 1, 2022Linkoping University, Region Östergötland, The Swedish Research Council
NCT04964947Phase 3Dec 31, 2021Department of Defense, University of Kentucky
NCT04872400Phase 4Jun 14, 2021University of Colorado, University of Colorado, Denver
NCT04678154Phase 3May 7, 2021Atrium Medical Center, Johns Hopkins University, Major Extremity Trauma Research Consortium, University of North Carolina at Chapel Hill
NCT05076955Early Phase 1 (Phase 1)Mar 31, 2021Keystone Pharmacy, University of Mississippi
NCT04560179Phase 1Nov 30, 2020Children's Hospital of Philadelphia, University of Pennsylvania
NCT05353101Phase 1Jul 1, 2020Nanchang University
NCT04297631Phase 4Feb 14, 2020Washington University in St. Louis
NCT03975374Early Phase 1 (Phase 1)Jun 15, 2019Sutphin Drugs Inc.
NCT03875963N/AApr 30, 2019Biocomposites, Ltd., University of Western Ontario
NCT03904836Phase 1Jan 31, 2019University of Montreal
NCT03928522Phase 4Jan 28, 2019Washington University in St. Louis
NCT03715322Phase 3Dec 31, 2018Guangzhou Medical University
NCT03721328Phase 2Oct 26, 2018Joint Purification Systems, Ortho Carolina Research Institute
Showing 20 of 120 trials
Page 1 / 6

Organizations

Research & Development (142)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit181742003
Bausch & LombFor profit9832005
AlconFor profit6622006
ChiesiFor profit5332009
University of WashingtonAcademic/Hospital5442004
Cystic Fibrosis Foundation TherapeuticsAcademic/Hospital4042004
University of North Carolina at Chapel HillAcademic/Hospital4132000
Gilead SciencesFor profit3322008
ISTA PharmaceuticalsFor profit3022005
Katholieke Universiteit LeuvenAcademic/Hospital3132001
National Heart, Lung, and Blood Institute (NHLBI)Government3032004
University of Colorado, DenverAcademic/Hospital3212016
University of TorontoAcademic/Hospital3132014
Case Western Reserve UniversityAcademic/Hospital2022000
CF Therapeutics Development Network Coordinating CenterAcademic/Hospital2022004
Clininfo S.A.For profit2022011
Erasmus University RotterdamAcademic/Hospital2122015
ErempharmaFor profit2222010
Johns Hopkins UniversityAcademic/Hospital2022000
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce ZdrojAcademic/Hospital2012009
142 organizations
Page 1 / 8

Marketing (65)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGJan 31, 1996
Akorn, Inc.For profitSYNMay 28, 2014
AlconFor profitSYNJul 21, 1989
AlconFor profitMKTGMay 25, 1994
AlembicFor profitMKTGApr 19, 2019
AlembicFor profitSYNApr 19, 2019
Alkem Labs LtdFor profitMKTGApr 1, 2021
Amneal PharmaceuticalsFor profitMKTGJul 13, 2015
Amneal PharmaceuticalsFor profitMKTGJul 15, 2021
ApotexFor profitMKTGFeb 25, 2002
ApotheconFor profitMKTGMay 31, 1994
Aurobindo PharmaFor profitMKTGJan 22, 2021
Bausch & LombFor profitMKTGNov 29, 1993
Bausch & LombFor profitNDA2Dec 14, 2004
Bausch & LombFor profitSYNNov 29, 1993
BaxaltaFor profitMKTGJul 1, 2016
Chartwell PharmaceuticalsFor profitMKTGSep 11, 2001
ChiesiFor profitNDA2Oct 12, 2012
ChiesiFor profitMKTGOct 12, 2012
Dr. Reddy's LaboratoriesFor profitMKTGJul 9, 2018
Eli LillyFor profitNDAJun 11, 1975
Eli LillyFor profitMKTGOct 1, 1976
Epic Pharma LlcFor profitMKTGJan 31, 1996
Eugia PharmaFor profitMKTGJun 21, 2023
EyevanceFor profitMKTGJul 21, 1989
EyevanceFor profitNDA2Jul 21, 1989
Fera Development, LLCFor profitMKTGSep 11, 2001
FosunFor profitMKTGFeb 9, 2021
FreseniusFor profitNDA2Nov 29, 2002
FreseniusFor profitMKTGNov 29, 2002
Gland Pharma LtdFor profitMKTGFeb 9, 2021
Gland Pharma LtdFor profitSYNFeb 9, 2021
Hainan Poly PharmFor profitMKTGFeb 1, 2023
Harrow HealthFor profitNDA2Jul 21, 1989
HikmaFor profitMKTGApr 26, 1991
HospiraFor profitMKTGJul 31, 1990
LupinFor profitMKTGMar 22, 2017
Mankind PharmaFor profitMKTGSep 22, 2022
Micro Labs Ltd IndiaFor profitMKTGJul 27, 2023
MylanFor profitNDA2Dec 22, 1997
MylanFor profitMKTGMar 11, 2008
MylanFor profitSYNOct 13, 2017
MylanFor profitSYNOct 13, 2017
NestleFor profitMKTGMay 25, 1994
NovartisFor profitNDA2Dec 12, 1980
NovartisFor profitSYNDec 12, 1980
Novo NordiskFor profitMKTGSep 16, 2014
PHARMOBEDIENTFor profitMKTGOct 13, 2017
Padagis UsFor profitMKTGFeb 11, 2022
Pulmoflow IncFor profitNDA2Dec 2, 2014
SLATE RUN PHARMAFor profitMKTGFeb 1, 2023
SandozFor profitMKTGDec 13, 1984
SandozFor profitSYNDec 13, 1984
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.For profitMKTGJan 22, 2021
ShireFor profitMKTGJul 1, 2016
Somerset PharmaceuticalsFor profitMKTGJun 28, 2017
Sun PharmaceuticalsFor profitMKTGDec 26, 2019
Teligent PharmaceuticalsFor profitMKTGOct 31, 1994
TevaFor profitMKTGJan 30, 1992
ViatrisFor profitMKTGDec 22, 1997
Watson PharmaceuticalsFor profitMKTGAug 9, 1989
West-Ward PharmaceuticalFor profitMKTGApr 26, 1991
X Gen PharmaceuticalsFor profitMKTGAug 17, 2001
X Gen PharmaceuticalsFor profitSYNAug 17, 2001
Xellia PharmaceuticalsFor profitMKTGSep 16, 2014