CDEK
← All drugs Report issue

gentamicin

Trade name: garamycin

Small moleculeapproved

Approved

Mar 15, 1966

Gentamicin C2 together with epimer C2a is a part of the antibiotic of the aminoglycoside group, gentamicin. Gentamicin C2 has a methyl group in the 6′ position. Gentamicin is a broad-spectrum antibiotic that binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. Gentamicin is bactericidal in vitro against Gram-positive and Gram-negative bacteria. — NCATS

Clinical trial activity

168 trials · 215 clinical orgs · 48 marketing orgs

Phase 1
18
Phase 2
66
Phase 3
45
Phase 4
41

Earliest trial started Feb 1, 2000 (NCT00005574)

Timeline

1960s

  1. Mar 15, 1966

    Schering — Earliest FDA Approval

  2. Mar 15, 1966

    Schering — NDA Organization

  3. Mar 15, 1966

    Schering — Marketing Organization

1970s

  1. May 3, 1973

    Schering-Plough — Marketing Organization

  2. Oct 1, 1979

    Schering-Plough — NDA Secondary Org

1980s

  1. May 2, 1980

    Pharmacia & Upjohn — Marketing Organization

  2. Jun 5, 1980

    Hikma — Marketing Organization

  3. Jun 5, 1980

    West-Ward Pharmaceutical — Marketing Organization

  4. Jul 2, 1980

    Sandoz — Marketing Organization

  5. May 15, 1981

    Padagis Us — Marketing Organization

  6. Aug 20, 1981

    Watson Pharmaceuticals — Marketing Organization

  7. Mar 4, 1982

    Fresenius — Marketing Organization

  8. Apr 5, 1982

    Kala Pharmaceuticals — Marketing Organization

  9. Sep 7, 1982

    Baxalta — Marketing Organization

  10. Sep 7, 1982

    Baxter — Marketing Organization

  11. Mar 28, 1983

    Pharm Spec — Marketing Organization

  12. May 26, 1983

    Taro Pharmaceuticals — Marketing Organization

  13. Aug 11, 1983

    Abbott — Marketing Organization

  14. Aug 15, 1983

    Hospira — Marketing Organization

  15. Mar 30, 1984

    Novartis — Marketing Organization

  16. Jul 5, 1984

    Fougera — Marketing Organization

  17. Oct 10, 1984

    Allergan — Marketing Organization

  18. Oct 10, 1984

    SmithKline Beckman — Marketing Organization

  19. Nov 25, 1985

    Alcon — Marketing Organization

  20. Nov 25, 1985

    Nestle — Marketing Organization

  21. Jan 8, 1987

    Akorn, Inc. — Marketing Organization

  22. Jan 8, 1987

    Epic Pharma Llc — Marketing Organization

  23. Aug 28, 1987

    B. Braun — Marketing Organization

  24. Jun 10, 1988

    SmithKline Beckman — NDA Secondary Org

  25. Dec 1, 1989

    SmithKline Beecham — NDA Secondary Org

1990s

  1. Nov 21, 1991

    Teva — Marketing Organization

  2. Apr 29, 1994

    Cosette — Marketing Organization

  3. Apr 29, 1994

    ACP Nimble — Marketing Organization

  4. Apr 29, 1994

    G & W Laboratories Inc. — Marketing Organization

  5. May 11, 1994

    Bausch & Lomb — Marketing Organization

  6. Aug 31, 1995

    Sciegen Pharmaceticals — Marketing Organization

  7. Aug 31, 1995

    Saptalis Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  4. Jan 30, 2004

    Perrigo — Marketing Organization

  5. Jul 30, 2004

    Fera Development, LLC — Marketing Organization

2010s

  1. Dec 31, 2018

    Pharmaceutical Associates — Marketing Organization

  2. Dec 31, 2018

    Teligent Pharmaceuticals — Marketing Organization

  3. Dec 31, 2018

    Encube Ethicals Pvt. Ltd. — Marketing Organization

2020s

  1. Jan 8, 2024

    Eugia Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMar 15, 1966

Chemistry & pharmacology

Loading structure…

SMILES

CNC(C)[C@@H]1CC[C@@H](N)[C@@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3OC[C@](C)(O)[C@H](NC)[C@H]3O)[C@H](N)C[C@@H]2N)O1.CN[C@@H]1[C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3O[C@H](C(C)N)CC[C@H]3N)[C@@H](N)C[C@H]2N)OC[C@]1(C)O.CN[C@@H]1[C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3O[C@H](CN)CC[C@H]3N)[C@@H](N)C[C@H]2N)OC[C@]1(C)O
Mol. weight
1390.73 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

  • alcomicin
  • aminoglycoside
  • aminoglycoside
  • apogen
  • apogen
  • cidomycin
  • cidomycin
  • cidomycin intrathecal
  • garamycin
  • garamycin
  • garamycin
  • garamycin
  • genoptic
  • genoptic
  • gentacin
  • gentak
  • gentak
  • gentamicin
  • gentamicin
  • gentamicin
  • gentamicin
  • gentamicin
  • gentamicin
  • gentamicin
  • gentamicin
  • gentamicine sulfate
  • gentamicin pmma
  • gentamicin-polymethylmethacrylate bead
  • gentamicin-polymethyl-methacrylate chain
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate
  • gentamicin sulfate mixture with paromomycin sulfate
  • gentamicin sulphate
  • gentamycin
  • gentamycin
  • genticin
  • genticin
  • genticin intrathecal
  • g-pmma
  • lugacin
  • refobacin
  • refobacin-palacos r
  • sch-9724
  • sch-9724
  • septopal
  • septopal
  • uromycine
  • uromycine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07300553Phase 2Dec 31, 2025Assistance Publique - Hôpitaux de Paris
NCT07311395N/ADec 8, 2025Western Galilee Hospital
NCT07220967Phase 4Oct 21, 2025Memorial Sloan-Kettering Cancer Center
NCT06712641Phase 4Jun 30, 2025Oslo Metropolitan University, University of Oslo
NCT06841003Phase 3Feb 28, 2025Spaarne Gasthuis, ZonMw: The Netherlands Organisation for Health Research and Development
NCT06585020Phase 2Oct 31, 2024Central Hospital Saint Quentin, Centre Hospitalier COMPIEGNE, Centre Hospitalier de Cannes, Centre hospitalier de Mulhouse, Centre hospitalier de Perpignan, Centre Hospitalier le Mans, CH PERPIGNAN, Croix-Rousse Hospital, Lyon, Hospital Avicenne, Rouen Normandy University, University Hospital, Tours, University of Angers, University of Bordeaux, University of Burgundy, University of Grenoble, University of Paris, University of Picardie Jules Verne, University of Poitiers, University of Reims, University of Rennes, University of Strasbourg, University of Western Brittany
NCT06814223Phase 4Oct 28, 2024Western Galilee Hospital
NCT06362447Phase 2Sep 30, 2024University of Toulouse
NCT06387147Phase 3Sep 1, 2024Assistance Publique - Hôpitaux de Paris, University of Paris
NCT06332781Phase 4Aug 1, 2024Brown University
NCT05977400Phase 3Apr 30, 2024New York Presbyterian Hospital, Pennsylvania State University, Sharp HealthCare, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, State University of New York, Brooklyn, Thomas Jefferson University, University of Louisville, University of Pennsylvania, University of Pittsburgh, University of South Florida, University of Texas, San Antonio, University of Toronto, Westchester Medical Center, Yale University
NCT05766670Phase 3Feb 29, 2024Wake Forest University
NCT06007352Phase 2Jan 31, 2024Yale University
NCT06209047Phase 4Jan 25, 2024Assiut University
NCT06168708N/ADec 7, 2023Tanta University
NCT06489431Phase 3Dec 4, 2023Rush University
NCT06332040Phase 4Oct 9, 2023University of Arizona
NCT05750966N/AJul 19, 2023University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
NCT05548283Phase 4Feb 1, 2023Cystic Fibrosis Foundation, Medical University of South Carolina, University of Washington
NCT05594472Phase 3Nov 1, 2022Ain Shams University, Cairo University
Showing 20 of 168 trials
Page 1 / 9

Organizations

Research & Development (215)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
InnocollFor profit7722007
Assistance Publique - Hôpitaux de ParisAcademic/Hospital5522018
Premier Research GroupFor profit5022007
University of Southern CaliforniaAcademic/Hospital5522016
Duke UniversityAcademic/Hospital4122007
Miguel Hernández UniversityAcademic/Hospital4412011
University of AmsterdamAcademic/Hospital4132012
University of LondonAcademic/Hospital4112009
University of ParisAcademic/Hospital4132003
University of ToulouseAcademic/Hospital4422016
Hebrew UniversityAcademic/Hospital3322014
Johns Hopkins UniversityAcademic/Hospital3222003
United States ArmyGovernment3312004
University of California, San DiegoAcademic/Hospital3232015
University of LouisvilleAcademic/Hospital3232014
University of OxfordAcademic/Hospital3222017
Western Galilee HospitalAcademic/Hospital3322022
ZonMw: The Netherlands Organisation for Health Research and DevelopmentAcademic/Hospital3032016
Aga Khan UniversityAcademic/Hospital2212003
Ain Shams UniversityAcademic/Hospital2112016
215 organizations
Page 1 / 11

Marketing (55)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGApr 29, 1994
AbbottFor profitMKTGAug 11, 1983
Akorn, Inc.For profitMKTGJan 8, 1987
AlconFor profitMKTGNov 25, 1985
AllerganFor profitMKTGOct 10, 1984
AlpharmaFor profitMKTG—
American Home ProductsFor profitMKTG—
B. BraunFor profitMKTGAug 28, 1987
Bausch & LombFor profitMKTGMay 11, 1994
BaxaltaFor profitMKTGSep 7, 1982
BaxterFor profitMKTGSep 7, 1982
Bristol-MyersFor profitMKTG—
CosetteFor profitMKTGApr 29, 1994
Encube Ethicals Pvt. Ltd.For profitMKTGDec 31, 2018
Epic Pharma LlcFor profitMKTGJan 8, 1987
Eugia PharmaFor profitMKTGJan 8, 2024
Fera Development, LLCFor profitMKTGJul 30, 2004
FougeraFor profitMKTGJul 5, 1984
FreseniusFor profitMKTGMar 4, 1982
G & W Laboratories Inc.For profitMKTGApr 29, 1994
HikmaFor profitMKTGJun 5, 1980
HikmaFor profitMKTGJun 5, 1980
HospiraFor profitMKTGAug 15, 1983
International MedicationFor profitMKTG—
Kala PharmaceuticalsFor profitMKTGApr 5, 1982
King PharmaceuticalsFor profitMKTG—
NestleFor profitMKTGNov 25, 1985
NovartisFor profitMKTGMar 30, 1984
PacoFor profitMKTG—
Padagis UsFor profitMKTGMay 15, 1981
PerrigoFor profitMKTGJan 30, 2004
PerrigoFor profitSYNMay 15, 1981
Pharm SpecFor profitMKTGMar 28, 1983
Pharmaceutical AssociatesFor profitMKTGDec 31, 2018
Pharmacia & UpjohnFor profitMKTGMay 2, 1980
PharmadermFor profitMKTG—
PharmafairFor profitMKTG—
SOLOPAKFor profitMKTG—
SandozFor profitSYNJul 2, 1980
SandozFor profitMKTGJul 2, 1980
Saptalis PharmaceuticalsFor profitMKTGAug 31, 1995
ScheringFor profitNDAMar 15, 1966
ScheringFor profitMKTGMar 15, 1966
Schering-PloughFor profitNDA2Oct 1, 1979
Schering-PloughFor profitMKTGMay 3, 1973
Sciegen PharmaceticalsFor profitMKTGAug 31, 1995
SmithKline BeckmanFor profitNDA2Jun 10, 1988
SmithKline BeckmanFor profitMKTGOct 10, 1984
SmithKline BeechamFor profitNDA2Dec 1, 1989
Taro PharmaceuticalsFor profitMKTGMay 26, 1983
Teligent PharmaceuticalsFor profitSYNDec 31, 2018
Teligent PharmaceuticalsFor profitMKTGDec 31, 2018
TevaFor profitMKTGNov 21, 1991
Watson PharmaceuticalsFor profitMKTGAug 20, 1981
West-Ward PharmaceuticalFor profitMKTGJun 5, 1980