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Tobrex

(Tobramycin)

ApprovedSmall molecule

VViatris Specialty LLC

Tobramycin is an antibiotic used to treat serious bacterial infections, including infections of the lungs (especially in cystic fibrosis patients), eyes, and other parts of the body caused by susceptible bacteria.[2] Tobrex is currently approved and in use across 22 indications[4].[1]

Tobrex is one of 466 small molecule programs targeting Bacterial Disease. It is currently in Approved.

22

Indications

33

Total Trials

1

Active Trials

465

Competitors

9

FDA Applications

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

Respiratory Tract InfectionActive, not recruiting

Bronchopulmonary DysplasiaApproved

SinusitisApproved

Allergic ConjunctivitisActive, not recruiting

BronchiectasisApproved

Anterior UveitisActive, not recruiting

GlaucomaActive, not recruiting

ConjunctivitisActive, not recruiting

Bacterial ConjunctivitisActive, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Respiratory Tract InfectionApproved

Active, not recruiting

Bronchopulmonary DysplasiaApproved

Approved

SinusitisApproved

Approved

Allergic ConjunctivitisApproved

Active, not recruiting

BronchiectasisApproved

Approved

Anterior UveitisApproved

Active, not recruiting

GlaucomaApproved

Active, not recruiting

ConjunctivitisApproved

Active, not recruiting

Bacterial ConjunctivitisPhase 3

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

Tobrex

VViatris Specialty LLC

Prevacid

Innohep

Alnylam Pharmaceuticals

Jakafi

Primaquine

Neutrexin

WWest Japan Thoracic Oncology Group

Virazole

CConrado Roberto Hoffmann Filho

Primsol

CConrado Roberto Hoffmann Filho

Mucinex

AAultman Health Foundation

Cancidas

FFresenius Kabi Oncology Ltd.

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

Clinical

Trials by Indication[1]

Cystic Fibrosis9 trials

Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Unknown status·IImperial College London·Phase 4·NCT01044719·240 enrolled

Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

Completed·FFDA Office of Orphan Products Development·Phase 3·NCT00004829·200 enrolled

Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified

Completed·UUniversity College Cork·N/A·NCT02526004·223 enrolled

Show 6 more trials

Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis

Unknown status·TThe Leeds Teaching Hospitals NHS Trust·N/A·NCT02489955

DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis

Unknown status·UUniversity Medical Center Groningen·Phase 1/2·NCT03485456·10 enrolled

Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis

Completed·UUniversity Medical Center Groningen·Phase 1/2·NCT02035488·8 enrolled

Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis

Completed·UUniversity of Milan·Phase 4·NCT01608555·10 enrolled

Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis

Unknown status·EErempharma·Phase 1/2·NCT01337219·36 enrolled

Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

Completed·UUniversity of Jena·Phase 2·NCT00774072·9 enrolled

Open Fracture3 trials

Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Terminated·UUniversity of Virginia·Phase 3·NCT03705962·11 enrolled

Acute Application of Antibiotic Powder in Open Fracture Wounds

Completed·UUniversity of Colorado, Denver·Phase 4·NCT04872400·20 enrolled

Tobramycin Injection to Prevent Infection in Open Fractures

Active, not recruiting·MMassachusetts General Hospital·Phase 3·NCT04964947·600 enrolled

Treatment2 trials

Effect of Various Treatment Modalities on Dendritic Vial Ulcer

Unknown status·SSohag University··NCT05313828·40 enrolled

Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

Completed· Novartis logo

Novartis·Phase 3·NCT00634192·50 enrolled

Bacterial Conjunctivitis2 trials

Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00105469·743 enrolled

Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

Completed·LLaboratoires Thea·Phase 3·NCT01155999·286 enrolled

Bronchiectasis2 trials

Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection

Unknown status·RRabin Medical Center·N/A·NCT02102152·40 enrolled

A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis

Unknown status·SShandong University·Phase 4·NCT01677403·120 enrolled

13 more indications

Glaucoma1 trial

Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

Completed·GGlaukos Corporation·Phase 4·NCT02873806·53 enrolled

Prospective1 trial

Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study

Completed·SSandra Walker·Phase 1/2·NCT02269969·10 enrolled

Surgical Site Infection1 trial

Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection

Unknown status·MMcMaster University·Phase 4·NCT03308253·60 enrolled

Dialysis1 trial

Tobramycin Administered at the Beginning of Dialysis

Completed·MMaisonneuve-Rosemont Hospital·Phase 1·NCT03904836·11 enrolled

Efficacy1 trial

A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT01111383·209 enrolled

Antibiotic1 trial

Antibiotic Loaded Cement After TKA

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

Conjunctivitis1 trial

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 4·NCT00705159·137 enrolled

MPA1 trial

Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™

Completed·PPharmaero ApS·Phase 1·NCT02207426·12 enrolled

Bone Graft1 trial

Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

Completed·UUniversity of Lausanne Hospitals··NCT01938417·12 enrolled

Safety and Efficacy1 trial

IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy

Completed·NNational Jewish Health·Phase 4·NCT02918409·51 enrolled

Chronic Rhinosinusitis1 trial

Topical Antibiotics in Chronic Rhinosinusitis

Completed·MMayo Clinic·Phase 1/2·NCT03673956·19 enrolled

Intraarticular1 trial

Intraarticular Antibiotic in TKA

Completed·WWashington University School of Medicine·Phase 4·NCT04297631·20 enrolled

Unspecified3 trials

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Completed· Novartis logo

Novartis·Phase 1·NCT00420836·20 enrolled

Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study

Completed· Novartis logo

Novartis·Phase 1·NCT00399945·12 enrolled

Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

Completed·UUniversity Hospital Tuebingen·Phase 3·NCT03341741·26 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

TOBREX

NDA NDA050541

Jan 1, 1982

TOBREX

NDA NDA050555

Jan 1, 1982

NEBCIN

NDA NDA050477

Jan 1, 1982

NEBCIN

NDA NDA050519

Dec 22, 1997

TOBI

NDA NDA050753

Jul 13, 2004

TOBRAMYCIN SULFATE

NDA NDA050789

Oct 12, 2012

BETHKIS

NDA NDA201820

Mar 22, 2013

TOBI PODHALER

NDA NDA201688

Dec 2, 2014

KITABIS PAK

NDA NDA205433

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Tobramycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tobrex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tobramycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tobramycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205433). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tobrex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Patent Landscape[6]

Patent Cliff

Sep 12, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8869794Sep 12, 2028

10207066Nov 4, 2030

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