zoliflodacin (ETX0914) / Global Antibiotic Research and Development Partnership, Innoviva 
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  • ||||||||||  zoliflodacin (ETX0914) / Global Antibiotic Research and Development Partnership, Innoviva
    Trial completion date, Trial primary completion date, Head-to-Head:  Zoliflodacin in Uncomplicated Gonorrhoea (clinicaltrials.gov) -  Sep 21, 2021   
    P3,  N=1092, Recruiting, 
    These findings suggest zoliflodacin is not proarrhythmic and contribute to the favorable assessment of cardiac safety for a single oral dose of zoliflodacin. Trial completion date: Aug 2021 --> Jul 2023 | Trial primary completion date: May 2021 --> Jun 2023
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Clinical, Journal:  Susceptibility trends of zoliflodacin against multidrug-resistant Neisseria gonorrhoeae clinical isolates in Nanjing, China (2014-2018). (Pubmed Central) -  Jun 22, 2021   
    Among 202 isolates tested, all were quinolone resistant with double or triple mutations in gyrA; One hundred ninety three (193/202; 95.5%) also had mutations in parC There were no D429N/A and/or K450T mutations in GyrB identified in the 143 isolates with higher zoliflodacin MICs; a S467N mutation in GyrB was identified in one isolate. We report that zoliflodacin continues to have excellent in vitro activity against clinical gonococcal isolates, including those with high-level resistance to ciprofloxacin, azithromycin and extended spectrum cephalosporins.
  • ||||||||||  Review, Journal:  Multidrug-resistant gram-negative organisms: a review of recently approved antibiotics and novel pipeline agents. (Pubmed Central) -  Jun 16, 2021   
    From ClinicalTrials.gov a total of 4 citations were identified (Ftortiazinon n = 1, Zoliflodacin n = 1, Gepotidacin n = 1, ETX2514 + sulbactam n = 1)...There are limited novel drug classes targeting gram-negative infections in the pipeline. Providers must be vigilant with the use of current antibiotics, especially until research and development (R&D) advancements are made.
  • ||||||||||  solithromycin (CEM-101) / Melinta Therap, Fujifilm Holdings, gepotidacin (GSK2140944) / GSK, zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Review, Journal:  Neisseria gonorrhoeae Antimicrobial Resistance: Past to Present to Future. (Pubmed Central) -  May 15, 2021   
    Thus, this review focuses on the mechanisms of resistance to recommended antimicrobials in the past and present time. The approaches by the scientific community in the development of novel technologies such as whole-genome sequencing to predict antimicrobial resistance, track gonococcal transmission, as well as, introduce new therapeutics like Solithromycin, Zoliflodacin, and Gepotidacin were also discussed.
  • ||||||||||  ceftriaxone / Generic mfg.
    Journal:  New treatment options for Neisseria gonorrhoeae in the era of emerging antimicrobial resistance. (Pubmed Central) -  Sep 25, 2020   
    At present, zoliflodacin and gepotidacin appear to be the most promising antimicrobial agents in clinical development...Given this observation, it is unlikely that either of these new agents could be promoted for monotherapy of gonorrhoea. The pre-clinical pipeline remains relatively empty of agents likely to progress to clinical development for gonorrhoea treatment and increased investment into gonorrhoea-specific drug discovery is recommended.
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap
    Journal:  Determination of MIC Quality Control Ranges for the Novel Gyrase Inhibitor, Zoliflodacin. (Pubmed Central) -  Jul 8, 2020   
    In a separate study, broth microdilution MIC quality control ranges for zoliflodacin against the following additional QC strains were determined to be: 0.12 - 0.5 μg/mL for Staphylococcus aureus ATCC 29213, 0.25 - 2 μg/mL for Enterococcus faecalis ATCC 29212, 1 - 4 μg/mL for Escherichia coli ATCC 25922, 0.12 - 0.5 μg/mL for Streptococcus pneumoniae ATCC 49619 and 0.12 - 1 μg/mL for Haemophilus influenzae ATCC 49247. These MIC QC ranges were also approved by CLSI for use in future in vitro susceptibility testing studies against organisms other than N. gonorrhoeae.
  • ||||||||||  ceftriaxone / Generic mfg.
    Journal:  Antimicrobial Resistance in Neisseria gonorrhoeae and Treatment of Gonorrhea. (Pubmed Central) -  Mar 2, 2020   
    Holistic actions are imperative. These include an enhanced advocacy; prevention, early diagnosis, contact tracing, treatment, test-of-cure, and additional measures for effective management of anogenital and pharyngeal gonorrhea; antimicrobial stewardship; surveillance of infection, AMR and treatment failures; and intensified research, for example, regarding rapid molecular point-of-care detection of gonococci and AMR, novel AMR determinants, new antimicrobials, and an effective gonococcal vaccine, which is the only sustainable solution for management and control of gonorrhea.
  • ||||||||||  zoliflodacin (ETX0914) / Global Antibiotic Research and Development Partnership, Innoviva
    Trial completion date, Head-to-Head:  Zoliflodacin in Uncomplicated Gonorrhoea (clinicaltrials.gov) -  Dec 12, 2019   
    P3,  N=1092, Recruiting, 
    Along with the results from these studies and based upon the safety, PK, and the PK/PD targets, a dosage regimen was selected for evaluation in a Phase 2 study in urogenital gonorrhea. Trial completion date: Feb 2021 --> Aug 2021
  • ||||||||||  zoliflodacin (ETX0914) / Global Antibiotic Research and Development Partnership, Innoviva
    Enrollment open, Head-to-Head:  Zoliflodacin in Uncomplicated Gonorrhoea (clinicaltrials.gov) -  Oct 7, 2019   
    P3,  N=1092, Recruiting, 
    Trial completion date: Feb 2021 --> Aug 2021 Not yet recruiting --> Recruiting
  • ||||||||||  zoliflodacin (ETX0914) / Global Antibiotic Research and Development Partnership, Innoviva
    New P3 trial, Head-to-Head:  Zoliflodacin in Uncomplicated Gonorrhoea (clinicaltrials.gov) -  May 21, 2019   
    P3,  N=1092, Not yet recruiting, 
  • ||||||||||  meropenem / generics, ceftazidime / generics
    Journal:  New antibiotics in infection treatment (Pubmed Central) -  Mar 28, 2019   
    The new MRX-1 preapplate, alongside tedizolid and cadazolid, are further oxazolidinones that show significant activity against multi-resistant Gram-positive pathogens. The presented palette of new molecules with antimicrobial activity will certainly significantly improve the effectiveness of antibiotic therapy.
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Trial completion:  Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea (clinicaltrials.gov) -  Apr 25, 2016   
    P2,  N=180, Completed, 
    Initiation date: Jan 2018 --> Feb 2018 Active, not recruiting --> Completed
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Enrollment closed, Trial primary completion date:  Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea (clinicaltrials.gov) -  Dec 29, 2015   
    P2,  N=180, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2015 --> Jan 2016
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Trial primary completion date:  Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea (clinicaltrials.gov) -  Jun 11, 2015   
    P2,  N=180, Recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2015 --> Jan 2016 Trial primary completion date: May 2015 --> Sep 2015
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Trial completion:  AZD0914 Phase 1 ADME Study in Healthy Volunteers (clinicaltrials.gov) -  May 12, 2015   
    P1,  N=6, Completed, 
    Trial primary completion date: May 2015 --> Sep 2015 Active, not recruiting --> Completed
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Enrollment closed:  AZD0914 Phase 1 ADME Study in Healthy Volunteers (clinicaltrials.gov) -  Feb 3, 2015   
    P1,  N=6, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Enrollment open:  AZD0914 Phase 1 ADME Study in Healthy Volunteers (clinicaltrials.gov) -  Jan 15, 2015   
    P1,  N=6, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    Enrollment open:  Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea (clinicaltrials.gov) -  Dec 5, 2014   
    P2,  N=180, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  zoliflodacin (ETX0914) / Entasis Therap, Global Antibiotic Research and Development Partnership
    New P1 trial:  AZD0914 Phase 1 ADME Study in Healthy Volunteers (clinicaltrials.gov) -  Nov 24, 2014   
    P1,  N=6, Not yet recruiting,