Garamycin

(Gentamicin Sulfate)

Phase 2Small molecule

SSchering-Plough

Garamycin is one of 12 small molecule programs targeting Epidermolysis Bullosa. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Epidermolysis BullosaRecruiting

Epidermolysis BullosaPhase 2

Recruiting

Competition

Competitive Landscape

11 competitors in Epidermolysis Bullosa

#DrugCompanyPhaseTrials

Fludara

Busulfex

1 3

Cytoxan

BBaxter Healthcare Corporation

Approved

1 4

Accutane

CConrado Roberto Hoffmann Filho

Approved

—5

E-Mycin

AAzurity Pharmaceuticals

Approved

—6

Oleogel-S10

Chiesi Farmaceutici S.p.A.

Phase 3

2 7

Allo-APZ2-OTS

RRHEACELL GmbH & Co. KG

Phase 3

2 8

Fludara

Sanofi

Preclinical

1 9

Garamycin

SSchering-Plough

Phase 2

1 10

Naropin

FFresenius Kabi USA, LLC

Preclinical

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

Clinical

Trials by Indication[1]

Urinary Tract Infection2 trials

Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

Completed·UUniversity of Louisville·Phase 2·NCT03931408·6 enrolled

Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

Completed·UUniversity of Michigan·Phase 2/3·NCT03503513·23 enrolled

Epidermolysis Bullosa1 trial

Gentamicin for Junctional Epidermolysis Bullosa

Recruiting·UUniversity of Southern California·Phase 1/2·NCT03526159·6 enrolled

ESS1 trial

Topical Gentamicin Nonsense Suppression Therapy of EB

Completed·OOslo University Hospital·Phase 1/2·NCT04644627·4 enrolled

Pneumonia1 trial

A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

Completed·UUniversity of Oxford·Phase 3·NCT04041791·4,392 enrolled

RDEB1 trial

Gentamicin for RDEB

Completed·UUniversity of Southern California·Phase 1/2·NCT03012191·6 enrolled

5 more indications

Antibiotic1 trial

New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

Completed·PPublic Health Service of Amsterdam·Phase 3·NCT03294395·346 enrolled

Peritoneal Dialysis1 trial

Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Active, not recruiting·SSingapore General Hospital·N/A·NCT05143164·60 enrolled

Hypotrichosis Simplex1 trial

Efficacy of Topical Gentamycin for Hereditary Hypotrichosis Simplex Caused by Nonsense Mutations in CDSN

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 2·NCT03492866·8 enrolled

Infection1 trial

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Completed·KKaiser Permanente·Phase 2·NCT04246996·370 enrolled

Unspecified1 trial

Optimizing IV Gentamicin in JEB

Unknown status·UUniversity of Southern California·Phase 1/2·NCT04140786·6 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

GARAMYCIN

NDA NDA050505

Jan 1, 1982

GARAMYCIN

NDA NDA050425

Jan 1, 1982

GARAMYCIN

NDA NDA050039

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Gentamicin Sulfate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gentamicin Sulfate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gentamicin Sulfate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050505). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Schering-Plough company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSchering-Plough

Garamycin

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Urinary Tract Infection2 trials

Epidermolysis Bullosa1 trial

ESS1 trial

Pneumonia1 trial

RDEB1 trial

Antibiotic1 trial

Peritoneal Dialysis1 trial

Hypotrichosis Simplex1 trial

Infection1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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