izencitinib (TD-1473) / Theravance Biopharma 
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 0 Diseases   2 Trials   2 Trials   11 News 
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Izencitinib induction treatment in patients with moderately-to-severely-active Crohn's Disease: A phase 2 double-blind, randomized, placebo-controlled study (Poster exhibition) -  Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_1174;    
    No clinically important changes in laboratory values, electrocardiography parameters, or vital signs were noted in patients treated with izencitinib compared with placebo, and no drug-related AEs of special interest were observed.ConclusionIn patients with moderately-to-severely active Crohn's Disease, izencitinib treatment for 12 weeks did not demonstrate a statistically significant reduction in CDAI or endoscopic severity. Izencitinib at both doses was well tolerated without a new safety signal.
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Journal:  Gut-Selective Design of Orally-Administered Izencitinib (TD-1473) Limits Systemic Exposure and Effects of Janus Kinase Inhibition in Nonclinical Species. (Pubmed Central) -  May 6, 2022   
    Izencitinib did not affect embryonic development in rats and rabbits as commonly reported with systemic JAK inhibition, consistent with low maternal systemic concentrations (2-6X plasma Cave: JAK IC50 ratio, 10-33X nonclinical: clinical AUC margin) and negligible fetal exposures. In conclusion, the izencitinib gut-selective approach resulted in minimal systemic findings in nonclinical species at pharmacologic, clinically-relevant systemic exposures, highlighting the impact of organ-selectivity in reducing systemic safety findings.
  • ||||||||||  Journal:  JAK inhibitors in crohn's disease: ready to go? (Pubmed Central) -  Feb 26, 2022   
    JAK-inhibitors are a promising class of oral compounds in moderate-severe CD. Further clinical trials are necessary in order to implement the available knowledge, especially on their long-term safety issues.
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion date, Trial termination:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Jan 27, 2022   
    P2,  N=167, Terminated, 
    Further clinical trials are necessary in order to implement the available knowledge, especially on their long-term safety issues. Trial completion date: Jan 2023 --> Dec 2021 | Active, not recruiting --> Terminated; The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion date, Trial termination, Trial primary completion date:  TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) -  Nov 26, 2021   
    P2/3,  N=46, Terminated, 
    Trial completion date: Sep 2028 --> Oct 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2028 --> Oct 2021; Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion date, Trial termination, Trial primary completion date:  RHEA: Efficacy & Safety of TD-1473 in Ulcerative Colitis (clinicaltrials.gov) -  Nov 26, 2021   
    P2b,  N=243, Terminated, 
    Trial completion date: Jul 2025 --> Oct 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Oct 2021; Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment closed:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Oct 28, 2021   
    P2,  N=167, Active, not recruiting, 
    Company decision based on interim analysis results in TD-1473-0157. Recruiting --> Active, not recruiting
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment closed, Enrollment change:  RHEA: Efficacy & Safety of TD-1473 in Ulcerative Colitis (clinicaltrials.gov) -  Oct 1, 2021   
    P2b,  N=243, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=880 --> 243
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment closed, Enrollment change:  TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) -  Oct 1, 2021   
    P2/3,  N=46, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=880 --> 243 Recruiting --> Active, not recruiting | N=500 --> 46
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion date, Trial primary completion date:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Aug 18, 2021   
    P2,  N=160, Recruiting, 
    Recruiting --> Active, not recruiting | N=500 --> 46 Trial completion date: Aug 2022 --> Jan 2023 | Trial primary completion date: Aug 2021 --> Jan 2022
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion, Trial completion date, Trial primary completion date:  Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects (clinicaltrials.gov) -  Apr 9, 2021   
    P1,  N=58, Completed, 
    [Clinicaltrials.gov NCT02657122, NCT02818686]. Recruiting --> Completed | Trial completion date: Apr 2021 --> Dec 2020 | Trial primary completion date: Apr 2021 --> Dec 2020
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion date, Trial primary completion date:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Jan 20, 2021   
    P2,  N=160, Recruiting, 
    Recruiting --> Completed | Trial completion date: Apr 2021 --> Dec 2020 | Trial primary completion date: Apr 2021 --> Dec 2020 Trial completion date: Dec 2021 --> Aug 2022 | Trial primary completion date: Nov 2020 --> Aug 2021
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment open:  Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects (clinicaltrials.gov) -  Nov 17, 2020   
    P1,  N=82, Recruiting, 
    Trial completion date: Dec 2021 --> Aug 2022 | Trial primary completion date: Nov 2020 --> Aug 2021 Not yet recruiting --> Recruiting
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment open:  TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) -  Sep 2, 2020   
    P2/3,  N=500, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  TD-1473 / J&J
    Journal:  A pleiotropic role of FlaG in regulating the cell morphogenesis and flagellar homeostasis at the cell poles of Treponema denticola. (Pubmed Central) -  Mar 20, 2020   
    Cryo-electron tomography analysis reveal that the wild-type cells have 2-3 PFs with nearly homogenous lengths (ranging from 3 to 6 μm), whereas the mutant cells have less intact PFs with disparate lengths (ranging from 0.1 to 9 μm). The phenotype of T. denticola TDE1473 mutant reported here is different from its counterparts in other bacteria, which provides insight into further understanding the role of FlaG in the regulation of bacterial cell morphogenesis and flagellation.
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial initiation date:  TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) -  Dec 10, 2019   
    P2/3,  N=500, Not yet recruiting, 
    The phenotype of T. denticola TDE1473 mutant reported here is different from its counterparts in other bacteria, which provides insight into further understanding the role of FlaG in the regulation of bacterial cell morphogenesis and flagellation. Initiation date: Nov 2019 --> Feb 2020
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion date, Trial primary completion date:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Nov 27, 2019   
    P2,  N=160, Recruiting, 
    Initiation date: Nov 2019 --> Feb 2020 Trial completion date: Sep 2020 --> Dec 2021 | Trial primary completion date: Feb 2020 --> Nov 2020
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion:  Multiple Dose Ethnobridging PK Study in Healthy Subjects (clinicaltrials.gov) -  Mar 12, 2019   
    P1,  N=60, Completed, 
    Trial completion date: Sep 2020 --> Dec 2021 | Trial primary completion date: Feb 2020 --> Nov 2020 Recruiting --> Completed
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment open:  RHEA: Efficacy & Safety of TD-1473 in Ulcerative Colitis (clinicaltrials.gov) -  Jan 8, 2019   
    P2b,  N=880, Recruiting, 
    Recruiting --> Completed Not yet recruiting --> Recruiting
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial initiation date:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Dec 4, 2018   
    P2,  N=160, Recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Aug 2018 --> Nov 2018
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment open:  DIONE: Efficacy and Safety of TD-1473 in Crohn's Disease (clinicaltrials.gov) -  Sep 11, 2018   
    P2,  N=160, Recruiting, 
    Initiation date: Aug 2018 --> Nov 2018 Not yet recruiting --> Recruiting
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Trial completion, Trial completion date, Trial primary completion date:  TD-1473 for Active Ulcerative Colitis (UC) (clinicaltrials.gov) -  Aug 3, 2018   
    P1b,  N=40, Completed, 
    Not yet recruiting --> Completed Recruiting --> Completed | Trial completion date: Oct 2017 --> Mar 2018 | Trial primary completion date: Oct 2017 --> Mar 2018
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    Enrollment open:  TD-1473 for Active Ulcerative Colitis (UC) (clinicaltrials.gov) -  Aug 19, 2016   
    P1b,  N=40, Recruiting, 
    Recruiting --> Completed Not yet recruiting --> Recruiting
  • ||||||||||  izencitinib (TD-1473) / Theravance Biopharma
    New P1 trial:  TD-1473 for Active Ulcerative Colitis (UC) (clinicaltrials.gov) -  Jun 30, 2016   
    P1b,  N=40, Not yet recruiting,