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Drug

Tobramycin

Approved · FDA / EMA
Emerging researchLate-stage development
Also known as 3'-Deoxykanamycin B, Bethkis, Kitabis, Loteprednol Etabonate-Tobramycin Ophthalmic+15 more

3'-Deoxykanamycin B, Bethkis, Kitabis, Loteprednol Etabonate-Tobramycin Ophthalmic, Nebcin, Nebcin Pediatric, Nebramycin 6, Tobi, Tobradex, Tobramycin Ophthalmic, Tobrex, Tomycine, Zylet, Dexamethasone-Tobramycin, Tobramicina, Tobramycine, 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, Tobramycin Sulfate, Tobramycinum.

RxNorm10627ChEMBLCHEMBL1747UNIIVZ8RRZ51VK
1
Research papers
1
Active clinical trials
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy

Clinical trial2026-04-28Results posted · ClinicalTrials.gov

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

Clinical trial2026-03-06Results posted · ClinicalTrials.gov

Label change: TOBRAMYCIN (ANDA201422)

Regulatory2024-09-30FDA

Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty

Clinical trial2023-11-30Completed · ClinicalTrials.gov

Topical Antibiotics in Chronic Rhinosinusitis

Clinical trial2022-04-20Results posted · ClinicalTrials.gov

Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin Via the Cyclops® in Children With Cystic Fibrosis

Clinical trial2020-11-13Primary completion · ClinicalTrials.gov

Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

Clinical trial2020-11-04Results posted · ClinicalTrials.gov

Label change: TOBRAMYCIN (ANDA201422)

Regulatory2020-01-21FDA

Label change: TOBRAMYCIN (ANDA201422)

Regulatory2020-01-21FDA

Label change: TOBRAMYCIN (ANDA201422)

Regulatory2020-01-21FDA

Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection.

Research2017-03-03Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tobramycin
Aliases & brands
3'-Deoxykanamycin BBethkisKitabisLoteprednol Etabonate-Tobramycin OphthalmicNebcinNebcin PediatricNebramycin 6TobiTobradexTobramycin OphthalmicTobrexTomycineZyletDexamethasone-TobramycinTobramicinaTobramycineO-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-streptamineTobramycin SulfateTobramycinum
RxNorm CUI
10627
ChEMBL ID
CHEMBL1747
UNII
VZ8RRZ51VK
Regulatory jurisdictions
fdaema

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-07-20
Latest approval
2019-02-18
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 5 events
2024-09-30Label change
Label change: TOBRAMYCIN (ANDA201422)
Evidence ↗
2020-01-21Label change
Label change: TOBRAMYCIN (ANDA201422)
Evidence ↗
2020-01-21Label change
Label change: TOBRAMYCIN (ANDA201422)
Evidence ↗
emaEuropean Medicines Agency· 2 events
2019-02-18Approval
Approval: Vantobra (previously Tobramycin PARI) (EMA)
Indication: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).… Show full indication

Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗
2011-07-20Approval
Approval: Tobi Podhaler (EMA)
Indication: Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic… Show full indication

Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
34
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
22
Late-stage (III+)
25
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 34
Phase 16Phase 1 / 25Phase 21Phase 39Phase 49Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

CompletedPH IVUniversity of Colorado, Denvern=202023

IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy

CompletedPH IVNational Jewish Healthn=512021

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

CompletedPH IVGlaukos Corporationn=532019

Pilot Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection in Vascular Surgery Patients

Unknown statusPH IVMcMaster Universityn=602019

A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis

Unknown statusPH IVShandong Universityn=1202014

Recent completions

Trials that read out recently, adding to the completed evidence base.

Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty

CompletedPH IIIRothman Institute Orthopaedicsn=502023

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

CompletedPH IVUniversity of Colorado, Denvern=202023

IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy

CompletedPH IVNational Jewish Healthn=512021

Topical Antibiotics in Chronic Rhinosinusitis

CompletedPH I/IIMayo Clinicn=192021

Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session

CompletedPH IMaisonneuve-Rosemont Hospitaln=112019

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

CompletedPH IVGlaukos Corporationn=532019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2017 · 12 cites
Recent papers

Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2017 · 12 cites
Major research themes4
Burkholderia cepacia complex1Burkholderia Infections1Cystic Fibrosis1Respiratory Tract Infections1
Journals, researchers & institutions
Top journals
  • Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society1
Leading researchers
  • Beaudoin T1
  • Klingel M1
  • McDonald N1
  • Ratjen F1
  • Rizvi L1
  • Tom SK1
  • Tullis E1
  • Waters V1
Leading institutions
free-text, unnormalised
  • Department of Pediatric Laboratory Medicine1
  • Division of Respirology and Keenan Research Centre of Li Ka Shing Knowledge Institute1
  • Hospital for Sick Children1
  • The Hospital for Sick Children1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.