Drugs / Tobramycin
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Tobramycin

Developed for
cystic fibrosis · periprosthetic joint infection · Pseudomonas aeruginosa infectious disease · chronic rhinosinusitis · bronchiectasis · respiratory tract infectious disorder · bacterial infectious disease · cataract
+28 more · Pseudomonas infection · skin infection · acute apical periodontitis · bacterial conjunctivitis · bacterial infectious disease with sepsis · bacterial pneumonia · blepharitis · bronchopulmonary dysplasia · burkholderia infectious disease · cancer · chalazion · chronic bronchitis · colorectal cancer · critical illness polyneuropathy · dry eye syndrome · furunculosis · infectious disease · infectious disease with sepsis · neutropenia · pneumonia caused by pseudomonas aeruginosa infection · pulpitis · ulcer of lower limbs · vernal keratoconjunctivitis · bacterial urinary tract infection · conjunctivitis · keratitis · osteomyelitis · urinary tract infection
Investigated by
Novartis Pharmaceuticals · Novartis · Chiesi Farmaceutici S.p.A. · Osteal Therapeutics, Inc. · United States Department of Defense · Bausch & Lomb Incorporated
+102 more · Erasmus Medical Center · Major Extremity Trauma Research Consortium · McMaster University · Second Affiliated Hospital of Nanchang University · University Medical Center Groningen · University of Florida · University of Milan · Washington University School of Medicine · Alcon Research · Azidus Brasil · Centre Hospitalier Universitaire de Besancon · Cystic Fibrosis Foundation · Denver Health and Hospital Authority · Dutch Digestive Diseases Foundation · Eastern Virginia Medical School · Erik Allen Jensen · FDA Office of Orphan Products Development · First Affiliated Hospital of Zhejiang University · French Society for Intensive Care · Fundacion Clinic per a la Recerca Biomédica · Gilead Sciences · GlaxoSmithKline · Guangzhou Institute of Respiratory Disease · H. Jaap Bonjer, PhD · Henri Mondor University Hospital · Huang Shan People's Hospital · Imperial College London · Innlandet Hospital Trust · Jinhua Central Hospital · Jinhua People's Hospital · Keystone Pharmacy · Lishui Country People's Hospital · MJM Bonten · Maisonneuve-Rosemont Hospital · Massachusetts General Hospital · Mayo Clinic · Naryx Pharma · National Center for Research Resources (NCRR) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Ningbo Medical Center Lihuili Hospital · Oslo University Hospital · Papworth Hospital NHS Foundation Trust · Paris 12 Val de Marne University · Peking University Third Hospital · People's Hospital of Quzhou · Pharmaero ApS · Qilu Hospital of Shandong University · Queen's University, Belfast · Radboud University Medical Center · Region Östergötland · RenJi Hospital · Respirion Pharmaceuticals Pty Ltd · Royal Brompton & Harefield NHS Foundation Trust · Sandra Walker · Seattle Children's Hospital · Second Affiliated Hospital of Wenzhou Medical University · Second Affiliated Hospital, Zhejiang University, School of Medicine · Sentralsjukehuset i Hedemark · Sentralsjukehuset i Rogaland · Shanghai Tongji Hospital, Tongji University School of Medicine · Sir Run Run Shaw Hospital · SmithKline Beecham · Solsys Medical LLC · Sorlandet Hospital HF · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sunnybrook Health Sciences Centre · Sykehuset Asker og Baerum · Sykehuset Buskerud · Taizhou Hospital · The First People's Hospital of Huzhou · The Fourth Affiliated Hospital of Zhejiang University School of Medicine · The George Institute · The Hospital of Vestfold · The National Institute of Health, Oslo · all 108 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Tobi Podhaler — 2011-07-20 europa.eu ↗
Label expansions (2) US (FDA) NEBCIN — 1975-09-03 – 1997-10-01 fda.gov ↗
Approved US (FDA) NEBCIN — 1975-06-11 fda.gov ↗

Trials 73 · started per year

today
US approved 1975
EU approved 2011
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT05849090 Mar 2023 → Dec 2024 infectious disease University of Utah Completed No outcome recorded
Phase 0 NCT05076955 Mar 2021 → Aug 2022 ulcer of lower limbs University of Mississippi Medical Center Unknown No outcome recorded
Phase 17 trials
Phase 1 NCT04560179 Mar 2022 → Dec 2023 bronchopulmonary dysplasia Erik Allen Jensen Completed No outcome recorded
Phase 1 NCT05353101 Jul 2020 → Jun 2021 vernal keratoconjunctivitis Second Affiliated Hospital of Nanchang University Completed No outcome recorded
Phase 1 NCT03904836 Jan → Dec 2019 end stage renal failure Maisonneuve-Rosemont Hospital Completed No outcome recorded
Phase 1 NCT02212587 Sep 2014 → May 2016 burkholderia infectious disease, cystic fibrosis Unity Health Toronto Completed No outcome recorded
Phase 1 NCT02207426 Jul → Aug 2014 — Pharmaero ApS Completed No outcome recorded
Phase 1 NCT00399945 May 2006 → ? cystic fibrosis Novartis Completed No outcome recorded
Phase 1 NCT00420836 Apr 2006 → ? cystic fibrosis Novartis Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT06016088 Apr 2024 → Apr 2026 Pseudomonas aeruginosa infectious disease, cystic fibrosis, respiratory tract infectious disorder Respirion Pharmaceuticals Pty Ltd Completed No outcome recorded
Phase 1/2 NCT03485456 May 2019 → Nov 2020 cystic fibrosis University Medical Center Groningen Unknown No outcome recorded
Phase 1/2 NCT03673956 Sep 2018 → Feb 2021 chronic rhinosinusitis Mayo Clinic Completed No outcome recorded
Phase 1/2 NCT02334384 Apr 2016 → Aug 2017 furunculosis Eastern Virginia Medical School Completed No outcome recorded
Phase 1/2 NCT02269969 Mar → Dec 2015 bacterial infectious disease Sandra Walker Completed No outcome recorded
Phase 1/2 NCT02035488 Oct 2013 → Dec 2014 bronchiectasis University Medical Center Groningen Completed No outcome recorded
Phase 212 trials · 1 met primary
Phase 2 NCT07463339 May 2026 → Apr 2027 expected — University of Calgary Not yet recruiting No outcome recorded
Phase 2 NCT05607030 Jan 2023 → May 2024 periprosthetic joint infection Osteal Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT05169229 Apr 2022 → Dec 2028 expected osteoarthritis, hip, periprosthetic joint infection University Hospital, Linkoeping Recruiting No outcome recorded
Phase 2 NCT04662632 Nov 2021 → Mar 2023 periprosthetic joint infection Osteal Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03935828 Jun 2019 → Dec 2020 chronic rhinosinusitis, poisoning United States Naval Medical Center, San Diego Withdrawn No outcome recorded
Phase 2 NCT03721328 Oct 2018 → Aug 2020 periprosthetic joint infection Osteal Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT02712983 Feb 2017 → Mar 2019 bronchiectasis Novartis Pharmaceuticals Completed Met primary
Phase 2 NCT01570192 Sep 2010 → Apr 2015 bacterial pneumonia University of Florida Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00794586 Nov 2008 → Feb 2010 cystic fibrosis Gilead Sciences Completed No outcome recorded
Phase 2 NCT00699803 May → Aug 2008 cataract Bausch & Lomb Incorporated Completed No outcome recorded
Phase 326 trials · 4 met primary · 2 missed
Phase 3 NCT05865743 Oct 2024 → Dec 2027 expected carcinoma of esophagus Radboud University Medical Center Recruiting No outcome recorded
Phase 3 NCT05615844 Nov 2023 → Mar 2027 expected — University of Maryland, Baltimore Recruiting No outcome recorded
Phase 3 NCT04964947 Jan 2022 → Jul 2026 skin infection Massachusetts General Hospital Completed No outcome recorded
Phase 3 NCT04597008 May 2021 → Jul 2025 — Major Extremity Trauma Research Consortium Completed No outcome recorded
Phase 3 NCT04678154 May 2021 → Sep 2026 overdue — Major Extremity Trauma Research Consortium Recruiting No outcome recorded
Phase 3 NCT03715322 Oct 2018 → Apr 2021 Pseudomonas infection, bronchiectasis Guangzhou Institute of Respiratory Disease Unknown Met primary
Phase 3 NCT03066453 Jun 2017 → Jan 2020 cystic fibrosis University Hospital, Lille Terminated No outcome recorded
Phase 3 NCT02389036 May 2017 → Apr 2023 critical illness polyneuropathy, infectious disease with sepsis The George Institute Completed No outcome recorded
Phase 3 NCT02888730 Feb → May 2017 chronic rhinosinusitis, cystic fibrosis, lung disorder Virginie ESCABASSE Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT03705962 Jul 2015 → Mar 2019 — University of Virginia Terminated No outcome recorded Stop: Business
Phase 416 trials · 1 met primary · 1 missed
Phase 4 NCT07856355 Oct 2026 → Oct 2028 expected — Second Affiliated Hospital, Zhejiang University, School of Medicine Not yet recruiting No outcome recorded
Phase 4 NCT04872400 Jun 2021 → Sep 2023 disease of bone structure, skin infection University of Colorado, Denver Completed No outcome recorded
Phase 4 NCT04297631 Feb → Aug 2020 — Washington University School of Medicine Completed No outcome recorded
Phase 4 NCT03928522 Jan → Sep 2019 — Washington University School of Medicine Completed No outcome recorded
Phase 4 NCT03308253 Jul 2018 → Jun 2019 — McMaster University Unknown No outcome recorded
Phase 4 NCT02478710 Jun 2015 → Feb 2017 — Wright State University Terminated No outcome recorded
Phase 4 NCT02440828 Mar 2015 → Mar 2020 — Erasmus Medical Center Completed No outcome recorded
Phase 4 NCT02248922 Jan 2015 → Apr 2017 pneumonia caused by pseudomonas aeruginosa infection Novartis Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT02015663 Jan → Dec 2014 cystic fibrosis Novartis Pharmaceuticals Terminated No outcome recorded
Phase 4 NCT01775137 Feb 2013 → Nov 2014 — Novartis Pharmaceuticals Completed No outcome recorded
Phase not applicable3 trials
— NCT07332936 Jul 2023 → Jun 2024 acute apical periodontitis, pulpitis Umm Al-Qura University Completed No outcome recorded
— NCT02958514 Nov 2016 → Feb 2017 dry eye syndrome Peking University Third Hospital Completed No outcome recorded
— NCT00153634 Mar 2004 → Nov 2007 chronic bronchitis, cystic fibrosis Seattle Children's Hospital Completed No outcome recorded
Phase not stated1 trial
— NCT06383611 — periprosthetic joint infection Osteal Therapeutics, Inc. Temporarily not available No outcome recorded
Comparator or background therapy48 trials
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT06175676 Comparator Dec 2021 → Jun 2023 chronic dacryocystitis Tianjin Medical University Eye Hospital Completed No outcome recorded
Phase 1 NCT00695435 Comparator Jun 2008 dry eye syndrome Alcon Research Completed No outcome recorded
Phase 1 NCT00823238 Comparator Jul 2004 → May 2008 cystic fibrosis University of North Carolina, Chapel Hill Completed No outcome recorded
Phase 2 NCT07308938 Background Oct 2026 → Dec 2029 expected corneal ulcer Vishal Jhanji Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2019-04-01 Alembic Pharmaceuticals Ltd. Regulatory 22nd April, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tobramycin Ophthalmic Solution USP, 0.3%.
2010-10-21 Gilead Sciences Results Gilead's Cayston(R) Superior to Tobramycin Inhalation Solution in Six-Month Head-to-Head Cystic Fibrosis Study gilead.com ↗
Patients receiving Cayston had an adjusted mean actual increase in FEV 1 percent predicted from baseline over six months of 2.05 percent compared to a 0.66 percent decrease for patients receiving TIS.
2010-06-18 Gilead Sciences Results Gilead's Head-to-Head Study of Cayston(R) Versus Tobramycin Inhalation Solution in Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint of Non-Inferiority gilead.com ↗
Patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to Day 28 of 8.35 percent compared to 0.55 percent for patients receiving TIS, which meets the statistical definition of superiority.

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 130 sources stand behind the page.

FieldValueCited text
Known as Tobramycin “Gilead is developing a broad spectrum combination antibiotic (FTI) consisting of fosfomycin (an antibiotic with activity against gram-positive and gram-negative bacteria) and...” NCT00794586 ↗
121

“Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin,...” NCT07072923 ↗

“In the intervention arm, participants with airway microbiome positive for VAP pathogens will receive inhaled tobramycin, participants with airway S. aureus will receive inhaled...” NCT07463339 ↗

“This was a pilot, open-label clinical trial of tobramycin inhalation powder (TIP) delivered via Podhaler twice daily for 28days in adults and children with CF and chronic B....” PMID 28262569 ↗ Mar 2017

“A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in...” NCT00447837 ↗

“Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of...” NCT04597008 ↗

“Protocol for Expanded Access to Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Exchange Arthroplasty for Periprosthetic Joint...” NCT06383611 ↗

“The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and...” NCT05615844 ↗

“The SDD treatment comprises two oral liquids: an oral suspension containing amphotericin B and an oral solution containing both colistin sulfate and tobramycin.” PMID 41345690 ↗ Dec 2025

“A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx” NCT02389036 ↗

“Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.” NCT02334384 ↗

Show 111 more sources

Known as Bethkis “inhaled tobramycin nebulization solution 300 mg/4 ml (TNS4, Bramitob(®)/Bethkis(®)) was assessed over 56 weeks in CF patients” PMID 24464974 ↗ Jan 2014
Known as Gernebcin “Tobramycin (Gernebcin®)” NCT00774072 ↗
Known as Nebcin “Tobramycin, (Tobi, Tobrex, Nebcin)” NCT05849090 ↗
Known as SPRC-AB01 “A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in...” NCT00447837 ↗
Known as TIP “This was a pilot, open-label clinical trial of tobramycin inhalation powder (TIP) delivered via Podhaler twice daily for 28days in adults and children with CF and chronic B....” PMID 28262569 ↗ Mar 2017
7

“This is an integrated analysis of data from patients with cystic fibrosis (CF) aged 6-21 years who were treated with up to seven cycles of tobramycin powder for inhalation...” PMID 26709158 ↗ Dec 2015

“300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)” NCT02248922 ↗

“The ETOILES study (Clinicaltrials.gov identifier: NCT01519661) evaluated the safety of tobramycin inhalation powder (TIP) for 1 year.” PMID 27435882 ↗ Sep 2016

“Tobramycin inhalation powder (TIP), approved for treatment of Pa infection in cystic fibrosis, could be a promising candidate.” PMID 31433997 ↗ Aug 2019

“Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP.” NCT00918957 ↗

“Tobramycin Inhalation Powder (TIP) capsules for inhalation.” NCT00388505 ↗

“Tobramycin inhalation powder (TIP) 112mg/b.i.d” NCT01775137 ↗

Known as TIP(TM) “This is an integrated analysis of data from patients with cystic fibrosis (CF) aged 6-21 years who were treated with up to seven cycles of tobramycin powder for inhalation...” PMID 26709158 ↗ Dec 2015
Known as TIS “300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)” NCT02248922 ↗
6

“Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor” NCT01641822 ↗

“amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID).” PMID 31451351 ↗ Aug 2019

“maintenance tobramycin inhalation solution (TIS) in bronchiectasis patients without cystic fibrosis” PMID 36531900 ↗ Dec 2022

“of tobramycin inhalation solution (TIS) 300 mg/5 ml twice daily” PMID 19996339 ↗ Dec 2009

“nebulized tobramycin inhalation solution (TIS)” PMID 35863486 ↗ Jul 2022

“TIS (Tobramycin Inhalation Solution)” NCT01270347 ↗

Known as TNS4 “inhaled tobramycin nebulization solution 300 mg/4 ml (TNS4, Bramitob(®)/Bethkis(®)) was assessed over 56 weeks in CF patients” PMID 24464974 ↗ Jan 2014
Known as TNS5 “tobramycin 300 mg/5 ml (TNS5, TOBI(®))” PMID 24464974 ↗ Jan 2014
Known as TOBI “The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.” NCT01315678 ↗
6

“Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs” NCT00125346 ↗

“Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer” NCT00388505 ↗

“administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels.” NCT02212587 ↗

“tobramycin 300 mg/5 ml (TNS5, TOBI(®))” PMID 24464974 ↗ Jan 2014

“Tobramycin, (Tobi, Tobrex, Nebcin)” NCT05849090 ↗

“TOBI (tobramycin inhaled solution)” NCT01082367 ↗

Known as TOBI - tobramycin inhalation solution (TIS) “TOBI® - tobramycin inhalation solution (TIS)” NCT01400750 ↗
Known as TOBI Podhaler “300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)” NCT02248922 ↗
Known as TOBIr “This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age.” NCT00006280 ↗
Known as Tobramycin inhalation powder “Tobramycin inhalation powder (TIP), approved for treatment of Pa infection in cystic fibrosis, could be a promising candidate.” PMID 31433997 ↗ Aug 2019
5

“Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm” NCT02015663 ↗

“Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.” NCT00982930 ↗

“Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP.” NCT00918957 ↗

“Tobramycin Inhalation Powder (TIP) capsules for inhalation.” NCT00388505 ↗

“Drug: Tobramycin inhalation powder” NCT01069705 ↗

Known as Tobramycin inhalation powder (TIP) “Tobramycin inhalation powder (TIP) 112mg/b.i.d” NCT01775137 ↗
Known as Tobramycin inhalation solution “TOBI® is tobramycin inhalation solution” NCT01315678 ↗
Known as tobramycin powder for inhalation “This is an integrated analysis of data from patients with cystic fibrosis (CF) aged 6-21 years who were treated with up to seven cycles of tobramycin powder for inhalation...” PMID 26709158 ↗ Dec 2015
Known as Tobramycin Solution for Inhalation “Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer” NCT00388505 ↗
Known as Tobramycin Sulfate “Protocol for Expanded Access to Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Exchange Arthroplasty for Periprosthetic Joint...” NCT06383611 ↗
Known as Tobrex “PURPOSE: To assess the within-treatment efficacy of hot compresses (HC), HC plus tobramycin (Tobrex) and HC plus tobramycin/dexamethasone (Tobradex) for chalazia treatment.” PMID 29338124 ↗ Jan 2018
2

“Tobramycin, (Tobi, Tobrex, Nebcin)” NCT05849090 ↗

NCT00695435 ↗

Route Inhaled “by inhalation” NCT00004829 ↗