Levovir (clevudine) / Bukwang Pharma, Eisai 
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  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Aug 14, 2023   
    P=N/A,  N=12, Terminated, 
    N=25 --> 12 | Trial completion date: Nov 2024 --> Nov 2022 | Recruiting --> Terminated | Trial primary completion date: Nov 2023 --> Nov 2022; Insufficient accrual
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai, Vemlidy (tenofovir alafenamide) / Gilead, ATI-2173 / Antios Therap
    Review, Journal:  Active site polymerase inhibitor nucleotides (ASPINs): Potential agents for chronic HBV cure regimens. (Pubmed Central) -  Nov 25, 2022   
    Thus, ATI-2173 is currently in clinical development as an agent for HBV cure. Here, we review the mechanism of action and preclinical and clinical profiles of clevudine and ATI-2173 to support the role of ASPINs as part of curative regimens for chronic HBV infection.
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Enrollment open, Trial completion date, Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Aug 9, 2022   
    P=N/A,  N=25, Recruiting, 
    These results support evaluation of ATI-2173 with tenofovir disoproxil fumarate in phase 2 studies. Trial completion date: Nov 2022 --> Nov 2024 | Trial primary completion date: Nov 2021 --> Nov 2023 | Suspended --> Recruiting
  • ||||||||||  ATI-2173 / Antios Therap
    Journal:  ATI-2173, A Novel Liver-Targeted Non-Chain Terminating Nucleotide for HBV Cure Regimens. (Pubmed Central) -  Jun 22, 2021   
    ATI-2173 activity was decreased by viral polymerase mutations associated with entecavir, lamivudine, and adefovir resistance, but not capsid inhibitor resistance mutations...Despite reduced plasma clevudine exposure, liver concentrations of the 5'-triphosphate were equivalent following ATI-2173 versus clevudine administration. By selectively delivering the 5'-monophosphate to the liver, while retaining the unique anti-HBV activity of the 5'-triphosphate, ATI-2173 may provide an improved pharmacokinetic profile for clinical use, reducing systemic exposure of clevudine and potentially eliminating skeletal myopathy.
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial completion date, Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Apr 22, 2021   
    P=N/A,  N=25, Suspended, 
    By selectively delivering the 5'-monophosphate to the liver, while retaining the unique anti-HBV activity of the 5'-triphosphate, ATI-2173 may provide an improved pharmacokinetic profile for clinical use, reducing systemic exposure of clevudine and potentially eliminating skeletal myopathy. Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2020 --> Nov 2021
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial completion date, Trial primary completion date:  The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 (clinicaltrials.gov) -  Jan 27, 2021   
    P2,  N=60, Recruiting, 
    The 25 and 50 mg doses of ATI-2173 have been advanced into a phase 2a study in combination with tenofovir in both HBV mono-infected and HBV/ HDV co-infected populations. Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Sep 2020 --> Jan 2021
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Journal:  Biogenesis and molecular characteristics of serum hepatitis B virus RNA. (Pubmed Central) -  Jan 8, 2021   
    In summary, serum HBV RNA is secreted in noninfectious virion-like particle as spliced and poly(A)-free pgRNA. Our study will shed light on the molecular biology of serum HBV RNA in HBV life cycle, and aid the development of serum HBV RNA as a novel biomarker for CHB diagnosis and treatment prognosis.
  • ||||||||||  lamivudine / Generic mfg., ATI-2173 / Antios Therap
    [VIRTUAL] ATI-2173, a novel phosphoramidate nucleoside prodrug for HBV cure regimens (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1825;    
    ATI-2173 is a potent liver-targeted molecule that delivers the 5’-monophosphate of clevudine, enhancing the anti-HBV activity while significantly reducing systemic exposure to clevudine in the rat and monkey. ATI-2173 combined with TDF, ETV or other direct acting antivirals, could become an integral part of combination HBV cure regimens.
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial completion date, Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Mar 27, 2020   
    P=N/A,  N=25, Suspended, 
    Not yet recruiting --> Recruiting Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2019 --> Nov 2020
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial completion date, Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Jan 25, 2019   
    P=N/A,  N=25, Suspended, 
    Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2019 --> Nov 2020 Trial completion date: Nov 2019 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2019
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Dec 20, 2017   
    P=N/A,  N=25, Suspended, 
    Trial completion date: Nov 2019 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2019 Trial primary completion date: Nov 2017 --> Nov 2018
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial initiation date, Trial primary completion date:  PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) -  Apr 11, 2017   
    P=N/A,  N=25, Suspended, 
    Trial primary completion date: Nov 2017 --> Nov 2018 Initiation date: Oct 2012 --> Nov 2013 | Trial primary completion date: Oct 2016 --> Nov 2017
  • ||||||||||  Levovir (clevudine) / Bukwang Pharma, Eisai
    Trial completion:  Long-term Study With Clevudine (clinicaltrials.gov) -  Jul 23, 2012   
    P4,  N=150, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed