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62 News |  |
- | Xtoro (finafloxacin) / Amgen
Preclinical, Journal: Layering vaccination with antibiotic therapy results in protection and clearance of Burkholderia pseudomallei in Balb/c mice. (Pubmed Central) - Jan 30, 2024
Vaccination was also shown to improve the outcome, in a composite measure of survival and clearance. In summary, layering a subunit vaccine with the antibiotic finafloxacin is a promising therapeutic alternative for use in the treatment of B. pseudomallei infections.
- | Baxdela (delafloxacin) / Menarini, Melinta Therap, Xtoro (finafloxacin) / Amgen, Gracevit (sitafloxacin) / Daiichi Sankyo
Preclinical, Journal: Comparison of the in vitro antibacterial activity of ofloxacin, levofloxacin, moxifloxacin, sitafloxacin, finafloxacin, and delafloxacin against Mycobacterium tuberculosis strains isolated in China. (Pubmed Central) - Nov 13, 2023
In summary, layering a subunit vaccine with the antibiotic finafloxacin is a promising therapeutic alternative for use in the treatment of B. pseudomallei infections. SFX exhibits the highest inhibitory activity against Mtb in vitro and THP-1
- | Xtoro (finafloxacin) / Horizon Therapeutics
Preclinical, Journal: In Vitro Activity of Finafloxacin against Panels of Respiratory Pathogens. (Pubmed Central) - Jul 29, 2023
Broth microdilution assays were performed at neutral and acidic pH, to determine antimicrobial activity. Finafloxacin demonstrated superior activity at reduced pH for all of the bacterial species investigated, highlighting the requirement to determine the activity of antimicrobials in host-relevant conditions.
- || Retrospective data, Review, Journal: Clinical efficacy and safety of novel antibiotics for complicated urinary tract infection: A systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) - Jun 19, 2023
While showing similar safety, the investigated novel antibiotics may be more effective than the conventional antibiotics for patients with cUTIs. However, as the pooled evidence relating to CCR remained inconclusive, further studies are required to address this issue.
- | Xtoro (finafloxacin) / Horizon Therapeutics, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Preclinical, Journal: Antibiotic discovery against Piscirickettsia salmonis using a combined in silico and in vitro approach. (Pubmed Central) - May 7, 2023
However, as the pooled evidence relating to CCR remained inconclusive, further studies are required to address this issue. The in silico results of this work showed that flumequine (-6.6
- | Xtoro (finafloxacin) / Horizon Therapeutics
Preclinical, Journal: Efficacy of finafloxacin in a murine model of inhalational glanders. (Pubmed Central) - Dec 13, 2022
However, finafloxacin was more effective than co-trimoxazole in controlling bacterial load within tissues and demonstrating clearance in the liver, lung and spleen following 14 days of therapy. In summary, finafloxacin should be considered as a promising alternative treatment following exposure to B. mallei.
- | Xtoro (finafloxacin) / Horizon Therapeutics
Preclinical, Journal: An Investigation into the Re-Emergence of Disease Following Cessation of Antibiotic Treatment in Balb/c Mice Infected with Inhalational Burkholderia pseudomallei. (Pubmed Central) - Oct 29, 2022
Following cessation of treatment, the infection re-established in some animals. Finafloxacin prevented the re-establishment of the infection for longer than co-trimoxazole, and it is apparent based on the protection offered, the development of clinical signs of disease, bodyweight loss and bacterial load, that finafloxacin was more effective at controlling infection when compared to co-trimoxazole.
- || Review, Journal: Potential new fluoroquinolone treatments for suspected bacterial keratitis. (Pubmed Central) - Sep 29, 2022
Notably, we found significant variation in the reported corneal and aqueous FQ concentrations so that reliance on the reported mean concentration may not be appropriate, and the first quartile concentration may be more clinically relevant. The provision of the MIC for the microorganism together with the achieved lower (first) quartile concentration of a FQ in the cornea could inform management decisions such as whether to continue with the prescribed antimicrobial, increase the frequency of application, use a combination of antimicrobials or change treatment.
- | Xtoro (finafloxacin) / Horizon Therapeutics
Journal, Combination therapy: Investigation of a combination therapy approach for the treatment of melioidosis. (Pubmed Central) - Sep 3, 2022
Doxycycline was also unable to control the levels of bacteria within tissues to the extent that doxycycline and finafloxacin used in combination or finafloxacin (as a sole therapy) could. In summary, finafloxacin is a promising therapy for use in the event of exposure to B. pseudomallei.
- | Baxdela (delafloxacin) / Menarini, Melinta Therap, Xtoro (finafloxacin) / Horizon Therapeutics
Preclinical, Journal: In Vitro Activity of Delafloxacin and Finafloxacin against Mycoplasma hominis and Ureaplasma Species. (Pubmed Central) - Jul 2, 2022
Finafloxacin displayed activity similar to moxifloxacin but superior to levofloxacin against M. hominis and Ureaplasma spp. Our findings demonstrate that delafloxacin is a promising fluoroquinolone with outstanding activity against fluoroquinolone-resistant M. hominis and Ureaplasma spp.
- | Journal: Discovery and Development of Antibacterial Agents: Fortuitous and Designed. (Pubmed Central) - May 26, 2022
This article aims to review the investigational and recently approved antibacterials with a focus on their structure, mechanisms of action/resistance, and spectrum of activity. Delving deep, their success or otherwise in various phases of clinical trials is also discussed while attributing the same to various causal factors.
- || Zabolante (zabofloxacin) / Dong Wha, Baxdela (delafloxacin) / Menarini, Melinta Therap, Xtoro (finafloxacin) / Horizon Therapeutics
Review, Journal: Delafloxacin, Finafloxacin, and Zabofloxacin: Novel Fluoroquinolones in the Antibiotic Pipeline. (Pubmed Central) - Dec 27, 2021
The introduction of these novel fluoroquinolones into daily practice extends the possible indications of antibiotics into different bacterial infections, and provides treatment options in difficult-to-treat infections. However, some reports of delafloxacin resistance have already appeared, thus underlining the importance of the prudent use of antibiotics.
- | Xtoro (finafloxacin) / Horizon Therapeutics
Preclinical, Journal: Finafloxacin, a Novel Fluoroquinolone, Reduces the Clinical Signs of Infection and Pathology in a Mouse Model of Q Fever. (Pubmed Central) - Dec 20, 2021
However, histopathological analysis suggested that treatment with finafloxacin reduced tissue damage associated with C. burnetii infection. In addition, we report for the first time, the use of viable counts on axenic media to evaluate antibiotic efficacy in vivo.
- | Xtoro (finafloxacin) / Horizon Therapeutics
Journal: Intracellular activity of antibiotics against Coxiella burnetii in a model of activated human THP-1 cells. (Pubmed Central) - Dec 16, 2021
Acidification of the culture media reduced antibiotic activity with the exceptions of doxycycline (no change) and finafloxacin (slight improvement). This model may be used to select antibiotics to be evaluated in-vivo.
- | ampicillin / Generic mfg.
Preclinical, Journal, Heterogeneity: Uropathogenic Escherichia coli shows antibiotic tolerance and growth heterogeneity in an in-vitro model of intracellular infection. (Pubmed Central) - Dec 16, 2021
Intracellularly, kill curves showed biphasic kinetics for both fluoroquinolones, suggesting the presence of drug-tolerant subpopulations. Flow cytometry analysis of TIMERbac fluorescence revealed a marked heterogeneity in intracellular growth of individual bacteria, suggesting that the presence of subpopulations reaching a state of metabolic dormancy was the main reason for increased antibiotic tolerance of intracellular UPEC.
- || Review, Journal: Structural Characterization of the Millennial Antibacterial (Fluoro)Quinolones-Shaping the Fifth Generation. (Pubmed Central) - Aug 29, 2021
Antibacterial quinolones class continues to acquire new compounds with antibacterial potential, among other effects. Numerous derivatives, hybrids or conjugates are currently in various stages of research.
- || Xtoro (finafloxacin) / Horizon Therapeutics
PK/PD data, Journal: Influence of pH on the activity of finafloxacin against extracellular and intracellular Burkholderia thailandensis, Yersinia pseudotuberculosis, and Francisella philomiragia and on its cellular pharmacokinetics in THP-1 monocytes. (Pubmed Central) - Jul 4, 2021
Numerous derivatives, hybrids or conjugates are currently in various stages of research. Fluoroquinolones have proven to be effective in reducing the intracellular reservoirs of B. thailandensis, Y. pseudotuberculosis and F. philomiragia, with finafloxacin demonstrating an additional advantage in acidic environments.
- | Xtoro (finafloxacin) / Horizon Therapeutics
Preclinical, Journal: Finafloxacin is an effective treatment for inhalational tularemia and plague in mouse models of infection. (Pubmed Central) - Jun 22, 2021
A benefit was demonstrated with finafloxacin, when compared to ciprofloxacin in both models, when therapy was delivered later in the infection. These studies suggest that finafloxacin is an effective alternative therapeutic for the prophylaxis and treatment of inhalational infections with F. tularensis or Y. pestis.
- | Journal: Treatment of multidrug-resistant Gram-negative skin and soft tissue infections. (Pubmed Central) - May 1, 2021
Novel antibiotics are currently under development. It is hoped that future clinical trials will be designed to address MDR-GNB SSTIs.
- | ciprofloxacin / Generic mfg., Avelox (moxifloxacin) / Bayer
Review, Journal: Fluoroquinolones structural and medicinal developments (2013-2018): Where are we now? (Pubmed Central) - Sep 10, 2020
Fluoroquinolones are considered one of the widely utilized antibiotics, specifically, with the recent development of newer generations such as moxifloxacin, delafloxacin and finafloxacin which possess a wider spectrum of activity and improved bioavailability...At present, quinolone scaffold diverse biological activities prompted the fortuitous discovery of novel antimicrobial and anticancer derivatives. Herein, the opponent arguments (2013-2015) regarding the structure activity relationships of fluoroquinolones' antibacterial, anticancer, antifungal activities are inscribed.
- | ciprofloxacin / Generic mfg.
Journal: Treatment of urinary tract infections in the era of antimicrobial resistance and new antimicrobial agents. (Pubmed Central) - Jun 18, 2020
Ceftazidime-avibactam, meropenem/vaborbactam, imipenem/cilastatin-relebactam, colistin, fosfomycin, aztreonam and ceftazidime-avibactam, aztreonam and amoxicillin-clavulanate, aminoglycosides including plazomicin, cefiderocol, tigecycline are treatment options for UTIs caused by carbapenem-resistant Enterobacteriales (CRE)...include fluoroquinolones, ceftazidime, cefepime, piperacillin-tazobactam, carbapenems including imipenem-cilastatin/relebactam, meropenem and fosfomycin, ceftolozane-tazobactam, ceftazidime-avibactam, aminoglycosides including plazomicin, aztreonam and ceftazidime-avibactam, cefiderocol, and colistin. It is important to use the new antimicrobials wisely for treatment of UTIs caused by MDR- organisms to avoid resistance development.
- | Journal: Developments on antibiotics for multidrug resistant bacterial Gram-negative infections. (Pubmed Central) - Mar 14, 2020
Recently approved antibiotic formulations; and agents in advanced stages of development, including combinations of β-lactam/β-lactamase inhibitor, novel cephalosporins (cefiderocol), tetracyclines (eravacycline), aminoglycosides (plazomicin), quinolones (delafloxacin and finafloxacin) and pleuromutilins (lefamulin) are discussed in this review...However, most of the new compounds are based on modifications of traditional antibiotic structures challenging their longevity as therapeutic options. More investment is needed for the discovery and clinical development of truly innovative and effective antibiotics without cross resistance to currently used antibiotics.
- | Xtoro (finafloxacin) / Aravis
Preclinical, Journal: Demonstration of the broad spectrum in vitro activity of finafloxacin against pathogens of biodefence interest. (Pubmed Central) - Oct 3, 2019
In all instances, finafloxacin demonstrated superior activity at low pH. These results highlight the importance of evaluating antimicrobial efficacy in conditions relevant to those encountered in vivo.
- | finafloxacin / Aravis
Preclinical, Journal: The Fluoroquinolone Finafloxacin Protects BALB/c Mice Against an Intranasal Infection With Francisella tularensis Strain SchuS4. (Pubmed Central) - May 25, 2019
In summary, finafloxacin may be a promising therapy for use in the event of exposure to F. tularensis, perhaps enabling the treatment regimen to be shortened or if therapy is delayed. The efficacy of finafloxacin against other biological threat agents also warrants investigation.
- | ciprofloxacin / generics
Clinical, Journal: Early clinical assessment of the antimicrobial activity of finafloxacin compared to ciprofloxacin in sub-sets of microbiologically characterized isolates. (Pubmed Central) - Apr 21, 2019
P2
The efficacy of finafloxacin against other biological threat agents also warrants investigation. Finafloxacin demonstrated an early and rapid activity against uropathogens including fluoroquinolone- and/or multi-resistant or ESBL-producers while ciprofloxacin was less active against this subset of resistant pathogens.
- | finafloxacin / Aravis
Clinical, PK/PD data, Journal: Population pharmacokinetics of finafloxacin in healthy volunteers and patients with complicated urinary tract infections. (Pubmed Central) - Apr 21, 2019
P2
Despite the inter-individual variability, the present dataset does not support covariate-based dose adjustments. Based on the favorable safety and efficacy data, the clinical relevance of the observed variability appears to be limited.
- | ciprofloxacin / generics
Clinical, P2 data, Journal: Efficacy and Safety of Finafloxacin versus Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections: An Explorative Randomized Phase II Clinical Study. (Pubmed Central) - Apr 21, 2019
P2
A short course regimen of five days with finafloxacin resulted in higher eradication and improved clinical outcome rates than treatment with ciprofloxacin for 10 days. In contrast to ciprofloxacin, the clinical effects of finafloxacin were not reduced by acidic urine pH.
- ciprofloxacin / Generic mfg., Xtoro (finafloxacin) / Horizon Therapeutics, Garamycin (gentamicin sulfate) / Generic mfg.
Activity of finafloxacin, ciprofloxacin, and imipenem against intracellular Burkholderia thailandensis, Yersinia pseudotuberculosis, and Francisella philomirargia in media at neutral or acidic pH () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_2216;
For intracellular infection, human THP-1 monocytes were incubated with bacteria opsonized by human serum, after which non-phagocytosed bacteria were eliminated by incubation with gentamicin (10-100 X its MIC) during 1h. This work highlights the interest of fluoroquinolones for markedly reducing the intracellular reservoirs of B. thailandensis, Y. pseudotuberculosis, and F. philomirargia, with finafloxacin showing additional advantage in acidic environments that are prevalent in infected tissues.
- |||| Xtoro (finafloxacin) / Amgen
Trial completion: Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis (clinicaltrials.gov) - Mar 2, 2016
P2, N=225, Completed, Sponsor: MerLion Pharmaceuticals GmbH
This work highlights the interest of fluoroquinolones for markedly reducing the intracellular reservoirs of B. thailandensis, Y. pseudotuberculosis, and F. philomirargia, with finafloxacin showing additional advantage in acidic environments that are prevalent in infected tissues. Active, not recruiting --> Completed
- ||| Xtoro (finafloxacin) / Amgen
Enrollment closed, Trial primary completion date: Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis (clinicaltrials.gov) - Apr 9, 2015
P2, N=258, Active, not recruiting, Sponsor: MerLion Pharmaceuticals GmbH
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2014 --> Jun 2014
- Xtoro (finafloxacin) / Amgen
Enrollment change, Trial withdrawal, Surgery: Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery (clinicaltrials.gov) - Oct 15, 2014
P1, N=0, Withdrawn, Sponsor: Alcon Research
Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2014 --> Jun 2014 N=30 --> 0 | Not yet recruiting --> Withdrawn
- Xtoro (finafloxacin) / Amgen
Trial initiation date, Trial primary completion date, Surgery: Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery (clinicaltrials.gov) - Sep 19, 2014
P1, N=30, Not yet recruiting, Sponsor: Alcon Research
N=30 --> 0 | Not yet recruiting --> Withdrawn Initiation date: Aug 2014 --> Nov 2014 | Trial primary completion date: Oct 2014 --> Jan 2015
- | Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) / Novartis, Xtoro (finafloxacin) / Amgen
Trial termination: Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes (clinicaltrials.gov) - Aug 29, 2014
P2, N=83, Terminated, Sponsor: Alcon Research
Initiation date: Aug 2014 --> Nov 2014 | Trial primary completion date: Oct 2014 --> Jan 2015 N=140 --> 83 | Recruiting --> Terminated | Trial primary completion date: Jun 2015 --> Aug 2014 | Recruiting --> Terminated; Management decision
- Xtoro (finafloxacin) / Amgen
Trial initiation date, Surgery: Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery (clinicaltrials.gov) - Apr 27, 2014
P1, N=30, Not yet recruiting, Sponsor: Alcon Research
N=140 --> 83 | Recruiting --> Terminated | Trial primary completion date: Jun 2015 --> Aug 2014 | Recruiting --> Terminated; Management decision Initiation date: Apr 2014 --> Jun 2014
- |||| Xtoro (finafloxacin) / Amgen
Enrollment open: Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis (clinicaltrials.gov) - Aug 19, 2013
P2, N=258, Recruiting, Sponsor: MerLion Pharmaceuticals GmbH
Initiation date: Apr 2014 --> Jun 2014 Not yet recruiting --> Recruiting
- ||| Xtoro (finafloxacin) / Amgen
New P1 trial: Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects (clinicaltrials.gov) - Jul 28, 2013
P1, N=58, Completed, Sponsor: MerLion Pharmaceuticals GmbH
- ||||| Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) / Novartis, Xtoro (finafloxacin) / Amgen
New P2 trial: Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes (clinicaltrials.gov) - Jul 24, 2013
P2, N=140, Recruiting, Sponsor: Alcon Research
- | Xtoro (finafloxacin) / Amgen
New P1 trial, Surgery: Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery (clinicaltrials.gov) - Jul 24, 2013
P1, N=30, Not yet recruiting, Sponsor: Alcon Research
- | Xtoro (finafloxacin) / Amgen
New P1 trial: Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin (clinicaltrials.gov) - Jul 23, 2013
P1, N=18, Completed, Sponsor: MerLion Pharmaceuticals GmbH
- | Xtoro (finafloxacin) / Amgen
Trial completion: Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin (clinicaltrials.gov) - Jul 21, 2013
P1, N=18, Completed, Sponsor: MerLion Pharmaceuticals GmbH
Not yet recruiting --> Recruiting Not yet recruiting --> Completed
- | Xtoro (finafloxacin) / Amgen
New P1 trial: Effect of Age and Gender on the PK and Tolerability of Finafloxacin (clinicaltrials.gov) - Jul 18, 2013
P1, N=40, Completed, Sponsor: MerLion Pharmaceuticals GmbH
- ||||| Xtoro (finafloxacin) / Amgen
New P2 trial: Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis (clinicaltrials.gov) - Jul 16, 2013
P2, N=258, Recruiting, Sponsor: MerLion Pharmaceuticals GmbH
- ||||| Xtoro (finafloxacin) / Amgen
Enrollment change: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (clinicaltrials.gov) - Jun 20, 2013
P3, N=693, Completed, Sponsor: Alcon Research
Not yet recruiting --> Completed N=500 --> 693
- ||||||| Xtoro (finafloxacin) / Amgen
Trial completion: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (clinicaltrials.gov) - Jun 20, 2013
P3, N=693, Completed, Sponsor: Alcon Research
N=500 --> 693 Recruiting --> Completed
- ||||||| Xtoro (finafloxacin) / Amgen
Trial completion: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (clinicaltrials.gov) - Jan 16, 2013
P3, N=589, Completed, Sponsor: Alcon Research
Recruiting --> Completed Recruiting --> Completed
- |||||||||| Xtoro (finafloxacin) / Amgen
New P3 trial: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (clinicaltrials.gov) - Feb 16, 2012
P3, N=693, Completed, Sponsor: Alcon Research
- |||||||||| Xtoro (finafloxacin) / Amgen
New P3 trial: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa (clinicaltrials.gov) - Feb 15, 2012
P3, N=589, Completed, Sponsor: Alcon Research