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Garamycin

(Gentamicin)

ApprovedSmall molecule

SSchering-Plough

Gentamicin is an antibiotic used to treat serious bacterial infections, including those affecting the blood, heart, lungs, and urinary tract. It works by killing bacteria that cause infections.[2] Garamycin is currently approved and in use across 35 indications[4].[1]

Garamycin is one of 465 small molecule programs targeting Premature Birth. It is currently in Approved.

35

Indications

49

Total Trials

10

Active Trials

464

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Premature BirthApproved

Bacterial DiseaseActive, not recruiting

ChorioamnionitisApproved

GonorrheaCompleted

CholangitisActive, not recruiting

LeishmaniasisApproved

Atopic EczemaApproved

IschemiaRecruiting

Cutaneous LeishmaniasisApproved

Vestibular SchwannomaApproved

Premature BirthApproved

Approved

Bacterial DiseaseApproved

Active, not recruiting

ChorioamnionitisApproved

Approved

GonorrheaApproved

Completed

CholangitisPreclinical

Active, not recruiting

LeishmaniasisApproved

Approved

Atopic EczemaApproved

Approved

IschemiaPhase 3

Recruiting

Cutaneous LeishmaniasisApproved

Approved

Vestibular SchwannomaApproved

Approved

Showing 10 of 34 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Garamycin

SSchering-Plough

Zolymbus

Blenoxane

Bristol-Myers Squibb

MS Contin

HHikma Pharmaceuticals LLC

Spravato

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Acupan

YYonsei University

Chantix

PPrism Pharmaceuticals

Nubain

AAultman Health Foundation

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

PreclinicalRecruiting

Surgical Site Infection

NCT07311395

Q2 2027

Phase 2Not yet recruiting

Ichthyosis

NCT06362447

Q3 2027

Phase 1Not yet recruiting

Spinal Cord Injury

NCT07643974

Q4 2027

Phase 3Recruiting

Ischemia

NCT06387147

Phase 3Active, not recruiting

Erectile Dysfunction

NCT06489431

Clinical

Trials by Indication[1]

Peritoneal Dialysis2 trials

Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis

Unknown status·KKwong Wah Hospital·Phase 4·NCT00751374·500 enrolled

Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection

Unknown status·PPhramongkutklao College of Medicine and Hospital·N/A·NCT05251584·60 enrolled

Recessive Dystrophic Epidermolysis Bullosa2 trials

Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Unknown status·UUniversity of Southern California·Phase 1/2·NCT03392909·9 enrolled

Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Nonsense Mutation Patients

Completed·UUniversity of Southern California·Phase 1/2·NCT02698735·5 enrolled

Antibiotics2 trials

INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI

Withdrawn·MMayo Clinic·Phase 4·NCT03299387

NICU Antibiotics and Outcomes (NANO) Follow-up Study

Not yet recruiting·SSharp HealthCare·Phase 3·NCT05977400·802 enrolled

Malnutrition2 trials

First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

Unknown status·UUniversity of Oxford·Phase 3·NCT03174236·2,000 enrolled

Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition

Unknown status·MMakerere University·Phase 2/3·NCT05051163·300 enrolled

Antibiotic2 trials

Antibiotic Loaded Cement After TKA

Completed·RRothman Institute Orthopaedics·Phase 3·NCT05429671·50 enrolled

The Effect of Antibiotic Eye Drops on the Nasal Microbiome in Healthy Subjects

Completed·MMedical University of Vienna·Phase 2·NCT05287425·20 enrolled

38 more indications

Vestibular schwannoma1 trial

Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma

Completed·—·N/A·NCT02963896·20 enrolled

Atopic Dermatitis1 trial

Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis

Completed·HHoth Therapeutics, Inc.·Phase 1·NCT04544943·31 enrolled

Pneumonia1 trial

Innovative Treatments in Pneumonia (ITIP) 3

Completed·SSave the Children··NCT02960919·1,001 enrolled

Refractory1 trial

Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

Completed·IImperial College London·Phase 2/3·NCT00802529·60 enrolled

Lymphadenitis1 trial

Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis

Completed·UUniversity Hospital, Toulouse·Phase 3·NCT03132116·75 enrolled

Ischemia1 trial

ORal Antibiotics in Acute Mesenteric Ischemia

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06387147·196 enrolled

Rehabilitation1 trial

Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

Unknown status·—·N/A·NCT05355610·93 enrolled

Complication1 trial

The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.

Unknown status·TTanta University·N/A·NCT06168708·220 enrolled

Cholangitis1 trial

Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting

Completed·TTehran University of Medical Sciences·N/A·NCT01148693·114 enrolled

Bronchiectasis1 trial

Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Completed·UUniversity of Edinburgh·Phase 4·NCT00749866·60 enrolled

Gonorrhea1 trial

Efficacy of Combination Therapies for Gonorrhea Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00926796·614 enrolled

Mastectomy1 trial

Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Completed·WWashington University School of Medicine·Phase 1·NCT03213249·19 enrolled

Dialysis Patients1 trial

Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients.

Terminated·UUniversity Hospital, Limoges·Phase 4·NCT01982864·24 enrolled

Treatment1 trial

Treatment and Diagnosis of Plague

Completed·CCenters for Disease Control and Prevention·Phase 2/3·NCT00128466·114 enrolled

Cystitis1 trial

Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting

Unknown status·MMercy Health Ohio·Phase 2·NCT05702762·160 enrolled

Ventilator-Associated Pneumonia1 trial

A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia

Completed·PPoitiers University Hospital·Phase 1·NCT02515448·12 enrolled

Chorioamnionitis1 trial

Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

Completed·SStanford University·N/A·NCT00185991·126 enrolled

Trial1 trial

Gentamicin Bladder Instillation Trial

Unknown status·GGillette Children's Specialty Healthcare·Phase 4·NCT01884467·24 enrolled

Pregnancy1 trial

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Completed·UUniversity of Wisconsin, Madison··NCT00214331·150 enrolled

Inguinal hernia1 trial

Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Completed·—·Phase 4·NCT01273818·276 enrolled

Prophylaxis1 trial

Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Unknown status·HHaEmek Medical Center, Israel·Phase 4·NCT00480376·160 enrolled

Muscular Dystrophy1 trial

Gentamicin Treatment of Muscular Dystrophy

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00005574·4 enrolled

Schwannoma1 trial

Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Withdrawn·LLund University·Phase 4·NCT02415257

Antibiotic Prophylaxis1 trial

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Completed·NNorthwestern University·Phase 4·NCT01659866·563 enrolled

Urolithiasis1 trial

Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

Withdrawn·YYale University·Phase 2·NCT06007352

Ciprofloxacin1 trial

Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague

Completed·UUniversity of Oxford·Phase 3·NCT04110340·222 enrolled

Kidney Stone1 trial

A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])

Completed·UUniversity of California, San Diego·Phase 4·NCT02384200·86 enrolled

Ampicillin1 trial

Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients

Completed·SStanford University··NCT02427932·45 enrolled

Diabetic Foot1 trial

Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers

Terminated·RRoyer Biomedical, Inc.·Phase 1/2·NCT02036528·9 enrolled

Ichthyosis1 trial

Efficacy of Injectable Gentamicin in Hereditary Ichthyosis

Not yet recruiting·UUniversity Hospital, Toulouse·Phase 2·NCT06362447·26 enrolled

Recurrent Uti1 trial

Intravesical Gentamicin to Prevent Recurrent UTI

Recruiting·WWomen and Infants Hospital of Rhode Island·Phase 4·NCT06332781·30 enrolled

Cystic Fibrosis1 trial

Interest of Gentamicin-induced Readthrough in Cystic Fibrosis Patients

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT00376428·20 enrolled

Fracture1 trial

Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial

Recruiting·WWake Forest University Health Sciences·Phase 3·NCT05766670·242 enrolled

Fracture Open Tibia1 trial

A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures

Recruiting·UUniversity of California, San Francisco·Approved·NCT05157126·890 enrolled

Spinal Cord Injury1 trial

Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI/D and NLUTD

Not yet recruiting·MMedstar Health Research Institute·Phase 1·NCT07643974·48 enrolled

Erectile Dysfunction1 trial

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial

Active, not recruiting·RRush University Medical Center·Phase 3·NCT06489431·200 enrolled

Surgical Site Infection1 trial

Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.

Recruiting·WWestern Galilee Hospital-Nahariya·Preclinical·NCT07311395·100 enrolled

Unspecified2 trials

The Immunostimulatory Effects of Gentamicin

Terminated·SSingapore General Hospital·Phase 2·NCT05303909·33 enrolled

Gentamicin Bladder Instillation on CAUTI

Recruiting·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 4·NCT06332040·400 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

GARAMYCIN

NDA NDA050505

Jan 1, 1982

GARAMYCIN

NDA NDA050425

Jan 1, 1982

GARAMYCIN

NDA NDA050039

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Gentamicin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Garamycin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Gentamicin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Gentamicin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050505). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Schering-Plough company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSchering-Plough

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