Last update 12 Dec 2024

Tobramycin

Last update 12 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Concentrated Divitamins and Sodium, Concentrated Divitamins and Sodium Phoshate Syrup, Concentrated Divitamins and Sodium Phosp

+ [25]

Target

30S subunit

Mechanism

30S subunit inhibitors(30S ribosomal subunit inhibitors)

Therapeutic Areas

Infectious DiseasesCongenital DisordersDigestive System Disorders+ [5]

Active Indication

BronchiectasisCystic FibrosisInfectious Lung Disorder+ [17]

Inactive Indication

CataractChronic sinusitisLower Respiratory Tract Infections+ [2]

Originator Organization

Eli Lilly & Co.

Active Organization

Nitto Medic Co., Ltd.Viatris Healthcare (Pty) Ltd.

Towa Pharmaceutical Co., Ltd.

+ [11]

Inactive Organization

CHIESI Farmaceutici SpA

Novartis AG

Novartis Pharmaceuticals Canada, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1974),

Bacterial Infections

RegulationOrphan Drug (US)

Structure

Molecular FormulaC18H37N5O9

InChIKeyNLVFBUXFDBBNBW-PBSUHMDJSA-N

CAS Registry32986-56-4

119

Clinical Trials associated with Tobramycin

NCT05865743 / Not yet recruitingPhase 3IIT

PERi-operative Selective Decontamination of the Digestive Tract to Prevent Severe Infectious Complications After Esophagectomy: a Randomized Multicenter Clinical Trial in Patients With Primary Resectable Esophageal Carcinoma (cT1-4, N0-3, M0)

The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Start Date01 Jun 2024

Sponsor / Collaborator

Radboud University Medical Center

[+2]

ChiCTR2400081616 / SuspendedPhase 4IIT

Microbiological efficacy of tobramycin inhalation solution with acute exacerbation of bronchiectasis with pseudomonas aeruginosa infection: a single-center, randomized clinical trial

Start Date22 Mar 2024

Sponsor / Collaborator-

CTRI/2024/02/062498 / Not yet recruitingPhase 2/3IIT

RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF MATRU STANYA AASCHOTANA WITH TOBRAMYCIN EYE DROP IN KUKUNAKA (OPTHALMIA NEONATARUM) IN NEONATES - Nil

Start Date14 Feb 2024

Sponsor / Collaborator-

100 Clinical Results associated with Tobramycin

100 Translational Medicine associated with Tobramycin

100 Patents (Medical) associated with Tobramycin

7,804

Literatures (Medical) associated with Tobramycin

31 Dec 2024·Virulence

Tobramycin-resistant small colony variant mutant of Salmonella enterica serovar Typhimurium shows collateral sensitivity to nitrofurantoin

Article

Author: Xu, Jin-Peng ; Zhang, Yue-Jun ; Sun, Jian ; Wang, Chang-Zhen ; Long, Teng-Fei ; Fang, Liang-Xing ; Zhou, Yu-Feng ; Chu, Yue-Fei ; Liao, Xiao-Ping ; Zhong, Long-Gen ; Liang, Liu-Yan

The increasing antibiotic resistance poses a significant global health challenge, threatening our ability to combat infectious diseases. The phenomenon of collateral sensitivity, whereby resistance to one antibiotic is accompanied by increased sensitivity to another, offers potential avenues for novel therapeutic interventions against infections unresponsive to classical treatments. In this study, we elucidate the emergence of tobramycin (TOB)-resistant small colony variants (SCVs) due to mutations in the hemL gene, which render S. Typhimurium more susceptible to nitrofurantoin (NIT). Mechanistic studies demonstrate that the collateral sensitivity in TOB-resistant S. Typhimurium SCVs primarily stems from disruptions in haem biosynthesis. This leads to dysfunction in the electron transport chain (ETC) and redox imbalance, ultimately inducing lethal accumulation of reactive oxygen species (ROS). Additionally, the upregulation of nfsA/B expressions facilitates the conversion of NIT prodrug into its active form, promoting ROS-mediated bacterial killing and contributing to this collateral sensitivity pattern. Importantly, alternative NIT therapy demonstrates a significant reduction of bacterial load by more than 2.24-log₁₀ cfu/g in the murine thigh infection and colitis models. Our findings corroborate the collateral sensitivity of S. Typhimurium to nitrofurans as a consequence of evolving resistance to aminoglycosides. This provides a promising approach for treating infections due to aminoglycoside-resistant strains.

31 Dec 2024·Gut Microbes

Comparison of Crohn’s disease-associated adherent-invasive Escherichia coli (AIEC) from France and Hong Kong: results from the Pacific study

Article

Author: Xu, Zhilu ; Bonnet, Richard ; Beyrouthy, Racha ; Sulakvelidze, Alexander ; Chevarin, Caroline ; Colombel, Jean-Frédéric ; Barnich, Nicolas ; Robin, Frederic ; Ng, Siew C ; Buisson, Anthony ; Martin, Lucas

Association between ileal colonization by Adherent-Invasive Escherichia coli (AIEC) and Crohn's disease (CD) has been widely described in high-incidence Western countries but remains unexplored in Asian countries with a fast increase in CD incidence. In the PACIFIC study, we compared the characteristics of AIEC pathobionts retrieved from ileal biopsies of CD patients enrolled in France (FR) and Hong Kong (HK). The prevalence of AIEC was similar in France (24.5%, 25/102) and Hong Kong (30.0%, 18/60) (p = 0.44). No difference was observed between the two populations of AIEC regarding adhesion and invasion levels. When tested for antibiotic resistance, the proportion of AIEC strains resistant to ampicillin, piperacillin, tobramycin, and gentamicin was significantly higher in HK AIEC strains compared to French strains. AIEC strains from FR or HK population were both able to persist in the mice intestine (DSS-treated CEABAC10 mice model). Moreover, genomic analysis of 25 FR and 17 hK AIEC strains using next-generation sequencing revealed the co-existence of several virulence factors associated with enteric E. coli pathotypes, although no single virulence factor was significantly associated with either country of origin or AIEC status. In vitro, all AIEC strains (FR and HK) were sensitive to the EcoActive™ phage cocktail, suggesting that it could be a promising option to target AIEC in CD across the world.

05 Dec 2024·Microbiology Spectrum

Bone allograft impregnated with tobramycin and vancomycin delivers antibiotics in high concentrations for prophylaxis against bacteria commonly associated with prosthetic joint infections

Article

Author: Schilcher, Jörg ; Nilsson, Lennart E. ; Berglund, Björn ; Wezenberg, Daphne ; Söderquist, Bo ; Nilsson, Maud

ABSTRACT:

Local delivery of antibiotics as prophylaxis for prosthetic joint infections (PJIs) is frequently used during total hip replacement surgery. Morselized bone allograft impregnated with vancomycin and tobramycin ( TobraVanc ) could provide effective prophylaxis against bacteria commonly associated with PJIs. In this study, the concentrations of antibiotics released by bone allograft impregnated with TobraVanc were determined by using an in vitro bioassay system entailing measuring inhibition zone diameters caused by antibiotic-impregnated bone chips cast in agar against standard curves. The concentrations were determined in samples of TobraVanc -impregnated bone graft taken before and after the application of the bone graft in the patients undergoing acetabular revision surgery. Antibiotic-impregnated bone grafts, sampled prior to application in the patient, delivered antibiotics in the concentration ranges of 730–9,800 mg/L for tobramycin and 1,300–11,000 mg/L for vancomycin. Samples taken after application in the patient released lower concentrations of tobramycin (490–1,900 mg/L; P < 0.01) and vancomycin (3,000–5,100 mg/L; P < 0.05); however, these concentrations remained well above the tobramycin minimum inhibitory concentrations (MICs) for investigated, highly tobramycin-resistant Staphylococcus epidermidis strains (MICs > 256 mg/L). At the tested concentrations, bone graft material mixed with TobraVanc delivered antibiotics in potent concentrations above the MICs for bacteria causing PJIs. Clinical trials are needed to evaluate the efficacy and risk of TobraVanc -impregnated bone graft as a prophylactic agent for patients undergoing hip replacement surgery.

IMPORTANCE:

Antibiotic prophylaxis is the cornerstone of successful joint replacement surgery, reducing the risk for the dreaded complication of prosthetic joint infection (PJI) to roughly 0.5%–2% in standard total hip replacement (THR). In addition to systemic antibiotics, antibiotics added locally have the potential to reduce the PJI risk even further, because of the high concentrations that can be achieved in the joint with limited risk for systemic toxicity. The results in the current study show that bone chips impregnated with a combination of tobramycin and vancomycin ( TobraVanc ) release antibiotics in concentrations that are potent against common bacteria causing PJIs. Especially in high-risk patients, our results support the prophylactic use of TobraVanc in hip replacement surgery requiring the use of a bone graft. A clinical study testing the efficacy of TobraVanc -impregnated bone graft in reducing the incidence of PJI in hip replacement surgery is currently ongoing (EudraCT: 2021-001708-14).

News (Medical) associated with Tobramycin

10 Dec 2024

·www.businesswire.com

Sound Pharma Announces Positive Phase 3 Results for the Treatment of Meniere’s Disease with SPI-1005

SEATTLE--( BUSINESS WIRE )--Sound Pharmaceuticals is pleased to announce that the pivotal Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Meniere’s Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination. Meniere’s disease (MD) is an inner ear disorder that involves fluctuating hearing loss and tinnitus, and episodic vertigo and/or dizziness. There are no FDA-approved medical treatments for MD, nor for the treatment of hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 is an oral capsule containing 200 mg ebselen that has shown safety and efficacy in several Phase 2 clinical trials involving multiple hearing loss and tinnitus indications including MD. STOPMD-3 enrolled adult subjects (N=221) with a history of definite MD and active symptoms into a randomized double-blind placebo-controlled trial (RCT) in which subjects received 28 days of either SPI-1005 (400 mg twice daily) or placebo treatment with monthly follow-up assessments of auditory and vestibular function through 84 days. Compliant patients could immediately enter an open label extension (OLE) of SPI-1005 treatment for up to 12 months. During OLE, subjects continued to receive SPI-1005 and had their auditory and vestibular function reassessed every 3 months. In both the intent-to-treat and per-protocol RCT analysis, the SPI-1005 group showed higher rates of improvement in low frequency hearing loss (≥10 dB gain at one low frequency from baseline) using pure-tone audiometry (LFPTA) and speech discrimination (≥4-word increase from baseline) using the words-in-noise (WIN) test than the placebo group at day 28, 56, and 84 of follow-up. On day 84, the SPI-1005 group showed a significant rate of LFPTA improvement over placebo (57.9% vs 36.5%, an increase of 58.6% over placebo, p-value=0.0037). When LFPTA criteria were increased to require a ≥10 dB gain at two adjacent low frequencies from baseline, the SPI-1005 group showed a significant rate of improvement of 204.4% over placebo (41.1% vs 13.5%, p-value <0.0001). On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs. 27.1%, p=0.0336). During OLE, responder rates involving LFPTA and WIN continued to improve, and patient reported outcome measures for tinnitus, vertigo, aural fullness, and dizziness severity all improved significantly from baseline (≥30% on average, p-value <0.001). “We would like to thank all of our investigators and study participants for contributing to this pivotal Phase 3 trial success involving SPI-1005,” said Dr. Jonathan Kil, MD, CEO of Sound Pharmaceuticals. A presentation of the full RCT/OLE data analysis as well as additional post-hoc analysis will occur at the Association for Research in Otolaryngology Midwinter Meeting in Orlando FL, February 22-26. About Meniere’s Disease (MD) MD is diagnosed by episodic vertigo or dizziness, fluctuating low frequency hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling of the inner ear involving the endolymphatic duct. Patients are typically diagnosed between 40-65 years of age, and the auditory symptoms of hearing loss and tinnitus often involve only one ear. Some patients experience aural fullness or pressure in the affected ear that can also contribute to dizziness. As patients age, the hearing loss and tinnitus become worse resulting in severe to profound hearing loss and intractable tinnitus. For the definite diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of low frequency hearing loss (i.e., ≥30 dB) in at least one ear using pure tone audiometry. Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not proven effective and is not FDA-approved for the treatment of MD. About the STOPMD-3 trial STOPMD-3 screened 254 participants for eligibility at 11 sites, including some of the leading academic centers in the US. Eligible participants (221) were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed up to day 84. 201 participants continued on to SPI-1005 OLE for 1-6-months (153 completed) and 107 participants continued on to 7-12-months (82 completed). To our knowledge, STOPMD-3 is the longest continuous treatment trial involving an investigational new drug ever completed for a hearing loss or tinnitus indication including MD. STOPMD-3 was led by Dr. Paul Lambert, Distinguished University Professor and Chair Emeritus of the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and the past President of the American Neurotologic Society. Dr. Lambert, Dr. Shaun Nguyen, director of clinical trial research in the Dept. of Otolaryngology-HNS at MUSC, and their colleagues also led the successful Phase 2b RCT involving SPI-1005 and MD patients. About SPI-1005 SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity and is effective in reducing neuroinflammation across the central and peripheral nervous system. GPx activity is critical to several cell types and tissues in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during exposures to environmental insults or aging. Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside antibiotics (such as tobramycin or amikacin) or platinum-based chemotherapy (such as cisplatin or carboplatin). To date, no significant drug-drug interactions have been observed across multiple study populations including bipolar mania and treatment-resistant depression. About Sound Pharmaceuticals A privately-held biotechnology company is testing SPI-1005 under five other active Investigational New Drug Applications involving several neurotologic indications including the prevention and treatment of aminoglycoside-induced ototoxicity co-funded by the CF Foundation and hearing preservation in cochlear implant patients co-funded by MED-EL. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or www.soundpharma.com . Please contact info@soundpharma.com for further information.

Clinical ResultPhase 2Phase 3

10 Dec 2024

·www.globenewswire.com

Microbix Assisting EMQN with Novel Genetic-Test EQA Program

For Rapid Identification of Patients Susceptible to Antibiotic-Induced Hearing LossMISSISSAUGA, Ontario and MANCHESTER, United Kingdom, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and EMQN CIC (EMQN), a global supplier of laboratory external quality assessment (“EQA”) schemes for human genomic testing, announce the go-live of a program to support the accurate identification of patients who carry a gene-variant associated with increased susceptibility to hearing loss following treatment with a widely-used class of antibiotics. This first-of-its kind EQA program is intended to help ensure the proficiency of Point-of-Care Testing (“POCT”) and acute-care labs that are assessing whether patients carry the MT-RNR1 m.1555A>G gene variant. It is estimated that one in 500 persons carry this variant that can lead to profound and irreversible hearing loss upon exposure to aminoglycoside antibiotics. This class of antibiotics include Gentamycin, Kanamycin, Streptomycin, and Tobramycin, which are used to treat a wide range of “gram negative” bacterial infections. Of particular concern are newborn babies who are suspected to be at risk of bacterial sepsis – a life-threatening condition that can lead to death from multi-organ failure if not treated promptly with appropriate antibiotic drugs and other acute medical care. Microbix-produced quality assessment products (“QAPs™”), formatted onto Copan® FLOQSwabs®, are being used in this EMQN EQA program to help assess the proficiency and accuracy of such acute care genetic testing. The QAPs provide samples that participants can process like cheek or buccal swabs, enabling them to verify the accuracy of MT-RNR1 assays in their POCT. With a subscription to this EMQN program, participants will receive three samples every two months (18 per year), helping them to ensure the accuracy of their testing on an ongoing basis and thereby make the most reliable diagnoses possible. Sean Sales, Operations Director at EMQN, commented, “It has been a pleasure to have Microbix’s assistance in making the QAPs for this groundbreaking and important new EQA program. Acute care physicians need the information to be able to evaluate the risk-benefit of antibiotic treatments and no patient should have to face a lifetime of hearing loss when tests to identify this risk are available.” Cameron Groome, CEO and President at Microbix also commented, “We’re pleased to help enable the creation of EQA for this clinically-important decision-making. Our expertise was joined to that of EMQN and Copan to ensure that accurate testing and properly-directed treatment is available for patients worldwide. This QAP marks Microbix’s entry into supporting the accuracy of genetic tests, adding to our established presence in infectious diseases and emerging role in oncology.” UK and international labs can enroll in this EQA program (code POCT MT-RNR1 25) via EMQN CIC at https://www.emqn.org/our-eqa-schemes/ and enquiries about Microbix QAPs can be directed to customer.service@microbix.com. About EMQN CICEMQN is a Manchester, UK based company that provides quality assurance tools and specialized knowledge to the human genomic testing community through External Quality Assessment (EQA) schemes. Its work helps guarantee the best possible molecular diagnostic procedure, analytical performance, and clinical interpretation. EMQN’s highly qualified peer group of assessors take pride in their thought leadership position and are committed to regularly publishing best practice guidelines and other information for the molecular diagnostics field. EMQN is accredited by the United Kingdom Accreditation Service (UKAS) to the international standard for EQA scheme providers, ISO 17043. About Microbix Biosystems Inc.Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and sales now targeting C$ 2.0 million or more per month. It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR compliant CE marked products across the EU. Forward-Looking InformationThis news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the tests, the EQA program, EMQN, Copan, or their relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain, and actual performance may be affected by a number of material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information. Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings. For further information, please contact Microbix at: Cameron Groome, CEO(905) 361-8910Jim Currie, CFO(905) 361-8910Deborah Honig, Investor RelationsAdelaide Capital Markets(647) 203-8793 ir@microbix.com Copyright © 2024 Microbix Biosystems Inc. Microbix®, DxTM™, Kinlytic®, and QAPs™ are trademarks of Microbix Biosystems Inc.Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.

14 Nov 2024

·www.globenewswire.com

Osteal Therapeutics Announces Positive 12-Month Results from the APEX Clinical Trial Program at the 2024 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting

Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty and highlight a 71% reduction in PJI burdenDALLAS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. The two prospective, randomized, comparative studies evaluated the efficacy of a rapid (7-day) exchange arthroplasty with intra-articular antibiotic irrigation versus the current standard of care, two-stage exchange arthroplasty. Results were featured at the 2024 American Association of Hip and Knee Surgeons (AAHKS) annual meeting and were presented by Dr. Nicolas S. Piuzzi, MD, of the Cleveland Clinic Foundation in Cleveland, Ohio. The APEX clinical program enrolled 152 patients across 23 centers in the U.S., with 76 patients treated in each study arm. Results demonstrated a statistically significant net treatment effect at 12-months of 19% (MSIS Tier 1, VT-X7: 71% vs. Control: 52%). Additionally, the median time to revision arthroplasty was significantly shorter at 7 days in VT-X7 patients compared to 98 days in patients with standard two-stage exchange. Of those patients completing revision arthroplasty (VT-X7: 100% vs. Control: 82%), patients treated with VT-X7 had a shorter overall procedure time by 62 minutes compared to patients treated with two-stage exchange. When considering the overall burden of PJI to the patients during the study follow-up period (i.e. time spent without a permanent implant and/or time spent as a failure), VT-X7 reduced PJI burden by 71% compared to standard two-stage exchange. Overall, the 12-month results demonstrated both a statistically significant and clinically meaningful treatment effect with VT-X7 compared to standard two-stage exchange. “A periprosthetic joint infection presents a significant challenge, with treatment often requiring multiple surgeries and prolonged rounds of antibiotics, which can profoundly disrupt a patient’s life. The APEX clinical program results are impressive, demonstrating a clinical advantage of rapid exchange arthroplasty with target site irrigation and providing surgeons with a promising, transformative approach to treating PJI, one that addresses the need to expedite infection eradication and allow patients to reclaim their lives.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study. About Periprosthetic Joint Infection (PJI) Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. About VT-X7 KIT VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, two well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need in PJI. About Osteal Therapeutics, Inc. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com Corporate Contact: Todd SaundersVice President of MarketingOsteal Therapeutics, Inc.Phone: 469-809-2630Email: info@ostealtx.com

Clinical ResultFast TrackOrphan DrugBreakthrough TherapyQualified Infectious Disease Product

100 Deals associated with Tobramycin

External Link

KEGG	Wiki	ATC	Drug Bank
D00063	Tobramycin	S01AA12 J01GB01	DB00684

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bronchiectasis	CN	Joincare Pharmaceutical Group Industry Co., Ltd.	11 Oct 2022
Cystic Fibrosis	JP	Viatris Healthcare GK	28 Sep 2012
Cystic Fibrosis	JP	Viatris Pharmaceutical GK	28 Sep 2012
Infectious Lung Disorder	EU	Viatris Healthcare (Pty) Ltd.	20 Jul 2011
Infectious Lung Disorder	IS	Viatris Healthcare (Pty) Ltd.	20 Jul 2011
Infectious Lung Disorder	LI	Viatris Healthcare (Pty) Ltd.	20 Jul 2011
Infectious Lung Disorder	NO	Viatris Healthcare (Pty) Ltd.	20 Jul 2011
Pseudomonas Infections	US	Mylan Specialty LP	22 Dec 1997
Acute Bronchitis	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Cystitis	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Hemorrhagic Septicemia	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Peritonitis	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Pneumonia	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Pyelonephritis	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Pyoderma	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Secondary infection	JP	Towa Pharmaceutical Co., Ltd.	01 Mar 1986
Blepharitis	JP	Nitto Medic Co., Ltd.	07 Dec 1981
Conjunctivitis	JP	Nitto Medic Co., Ltd.	07 Dec 1981
Corneal Ulcer	JP	Nitto Medic Co., Ltd.	07 Dec 1981
Dacryocystitis	JP	Nitto Medic Co., Ltd.	07 Dec 1981

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pseudomonas aeruginosa infection	Phase 3	CA	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	EG	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	FR	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	DE	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	GR	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	HU	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	IT	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	RO	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	RU	Novartis Pharmaceuticals Corp.	01 Apr 2010
Pseudomonas aeruginosa infection	Phase 3	CH	Novartis Pharmaceuticals Corp.	01 Apr 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02528123 (CTgov)	Not Applicable	Myopia	114	Small incision lenticule extraction+Tobramycin+Proxymetacaine 0.5%+Oxybuprocaine 0.4%+dexamethasone+Ofloxacin	yybtlspcdn(xnbglajifj) = wgiamxqxgm ncmkiyqsoj (sihloosogr, gusnvlphru - iqoaqtteru) View more	-	23 Apr 2024
NCT03705962 (CTgov)	Phase 3	Fractures, Open \| Infectious Diseases	11	Tobramycin (Antibiotic)	rkdlaosmyo(uvdmvkpmxu) = jeijwhkcng nfmwrycnmf (qavkwtmrlm, ysnayteobp - adpesynyek) View more	-	15 Jun 2023
				Placebo: normal saline (Normal Saline)	rkdlaosmyo(uvdmvkpmxu) = topynpjpgv nfmwrycnmf (qavkwtmrlm, esalfyffhs - jaygusfqjd) View more
NCT02478710 (AAINTVAP, CTgov)	Phase 4	Pneumonia, Ventilator-Associated	16	Aerosolized Placebo (Aerosolized Placebo)	bdgobrfkgq(rvxzzzeltg) = qryjoyhxdn ncjmqrbrem (zaxdqbchbd, ffhrcqidse - xaqruduyzj) View more	-	22 May 2023
				Tobramycin+Vancomycin (Aerosolized Tobramycin or Vancomycin)	bdgobrfkgq(rvxzzzeltg) = pdjibbtboj ncjmqrbrem (zaxdqbchbd, uzcctcbvdo - evqmffzwwl) View more
NCT02657473 (The BATTLE study, Pubmed \| Respir Res)	Phase 2/3	Non-cystic fibrosis bronchiectasis Maintenance	58	Tobramycin inhalation solution (TIS)	vdlnfulbmh(vvzllxmrrl): RR = 0.74 (95% CI, 0.49 - 1.14), P-Value = 0.15	-	03 Dec 2022
				Placebo
NCT02918409 (CTgov)	Phase 4	Cystic Fibrosis	51	Colistin (Standard Colistin Arm)	tjfpknebfs(hxzqfuqpqy) = cfnszyzoix gmpwuqahdm (qnticzjsbw, nhccodnpkt - xaumbtxmkd) View more	-	06 Oct 2022
				Colistin (Modified Colistin Arm)	tjfpknebfs(hxzqfuqpqy) = gphlmtaybi gmpwuqahdm (qnticzjsbw, edkhsxvnoi - iivympalpl) View more
NCT03673956 (CTgov)	Phase 1/2	Chronic sinusitis	19	Tobramycin (Tobramycin Topical Antibiotic Nasal Saline Rinse)	fregazcsit(qiteslfans) = nkkyfmssom robksvyagh (fsrfmfvgdf, nrarylmnaf - lhvdvyxppn) View more	-	20 Apr 2022
				Levofloxacin (Levofloxacin Topical Antibiotic Nasal Saline Rinse)	fregazcsit(qiteslfans) = hhcxrvoavn robksvyagh (fsrfmfvgdf, safpbzvhuf - hyychqtswe) View more
NCT01069705 (CTgov)	Phase 3	Pseudomonas Infections \| Cystic Fibrosis \| Infectious Lung Disorder	49	Tobramycin inhalation powder	xiukitomsy(uqxlhtetsb) = kyjmmbanuq rfnttmhvoj (yqrtrjxiow, qedqgkkgiz - tbqpxwtehe) View more	-	02 Jun 2021
MO294 (ERA2021)	Not Applicable	Glomerulosclerosis, Focal Segmental	200	TIP (Cellular variant of primary FSGS)	ayjzixjubs(llcakvupsw) = qiblfngahh hmrauaffin (rlfjjeeyzi )	Positive	29 May 2021
NCT02677701 (TEACH, CTgov)	Phase 4	Cystic Fibrosis	119	inhaled tobramycin+azithromycin (Azithromycin)	yrquinolak(jkwkucpwmm) = licazqjhtv vovyszjugy (bnpznhkrmo, vtvjviczjx - ofjzhbdkvh) View more	-	01 Mar 2021
				placebo (for azithromycin)+inhaled tobramycin (Placebo)	yrquinolak(jkwkucpwmm) = epopzzfbpo vovyszjugy (bnpznhkrmo, szrvbvgtlh - nnialebikq) View more

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