zatolmilast (BPN14770) / Shionogi 
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 0 Diseases   2 Trials   2 Trials   43 News 


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  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion date, Trial primary completion date:  A Study of BPN14770 in Male Adults (Aged 18 to 45) With Fragile X Syndrome (clinicaltrials.gov) -  Oct 31, 2024   
    P3,  N=150, Recruiting, 
    Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Feb 2024 --> Sep 2025 Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Feb 2024 --> Jun 2025
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion date, Trial primary completion date:  An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Oct 31, 2024   
    P3,  N=300, Enrolling by invitation, 
    Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Feb 2024 --> Jun 2025 Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Feb 2024 --> Sep 2027
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Clinical Trials in Fragile X Syndrome (Oceans 10/11; IN-PERSON) -  Jul 4, 2024 - Abstract #NFXFFXC2024NFXF_FXC_144;    
    A basic explanation of how each medication works and the results in trials previously conducted will be discussed. For each trial currently recruiting, requirements for participation, sites where patients can participate, and logistical information will be given, and presenters will answer any questions about trials.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Auditory N1 event-related potential amplitude is predictive of bioavailability of BPN14770 in fragile x syndrome (Crystal D & E; IN-PERSON) -  Jul 4, 2024 - Abstract #NFXFFXC2024NFXF_FXC_67;    
    A recent phase 2 clinical trial assessing BPN14770, a first-in-class phosphodiesterase 4D inhibitor, in 30 adult males with FXS demonstrated cognitive improvements including language and daily functioning and marginal decreases in N1 auditory event-related potential (ERP) amplitude from an auditory habituation task. Reductions in N1 ERP amplitude were associated with bioavailability of BPN14770 (via pharmacokinetic sampling), raising confidence in the validity of the original results, in favor of neural processing improvements with BPN14770.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion date:  An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Dec 18, 2023   
    P3,  N=300, Enrolling by invitation, 
    This study provides initial evidence that inhibiting PDE4B or PDE4D holds promise for mitigating memory deficits due to SD. Trial completion date: Dec 2024 --> Dec 2025
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment status, Trial completion date, Trial initiation date:  A Study of BPN14770 in Male Adults (Aged 18 to 45) With Fragile X Syndrome (clinicaltrials.gov) -  Feb 21, 2023   
    P3,  N=150, Recruiting, 
    Improvements in PAF with BPN14770 treatment for those with FXS suggests BPN14770 may enhance processing speed within the alpha range, a frequency band often reported to have low power in individuals with FXS. Enrolling by invitation --> Recruiting | Trial completion date: Oct 2024 --> Jul 2024 | Initiation date: Mar 2022 --> Nov 2022
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment open, Trial primary completion date:  An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Feb 17, 2023   
    P3,  N=300, Enrolling by invitation, 
    Enrolling by invitation --> Recruiting Not yet recruiting --> Enrolling by invitation | Trial primary completion date: Dec 2024 --> Feb 2024
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  A Study of BPN14770 in Male Adults (Aged 18 to 45) With Fragile X Syndrome (clinicaltrials.gov) -  Feb 17, 2023   
    P3,  N=150, Enrolling by invitation, 
    Not yet recruiting --> Enrolling by invitation | Trial primary completion date: Dec 2024 --> Feb 2024 Not yet recruiting --> Enrolling by invitation | Trial completion date: Oct 2023 --> Oct 2024 | Initiation date: Jun 2022 --> Mar 2022 | Trial primary completion date: Aug 2023 --> Feb 2024
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment status, Trial completion date, Trial primary completion date:  A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome (clinicaltrials.gov) -  Feb 16, 2023   
    P2/3,  N=150, Enrolling by invitation, 
    Not yet recruiting --> Enrolling by invitation | Trial completion date: Oct 2023 --> Oct 2024 | Initiation date: Jun 2022 --> Mar 2022 | Trial primary completion date: Aug 2023 --> Feb 2024 Recruiting --> Enrolling by invitation | Trial completion date: Nov 2023 --> Jul 2024 | Trial primary completion date: Aug 2023 --> Feb 2024
  • ||||||||||  Keynote — Clinical Trials in Fragile X Syndrome (Town & Country - A) -  Aug 7, 2022 - Abstract #NFXFFXC2022NFXF_FXC_3;    
    A basic explanation of how each medication works and results in trials previously conducted will be discussed. For each trial currently recruiting, requirements for participation, sites where patients can participate, and logistical information will be given, and presenters will answer any questions about trials.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Journal:  PDE4D inhibitor: a novel weapon against mild cognitive impairment and Alzheimer's disease? (Pubmed Central) -  May 14, 2022   
    Further chromatin co-immunoprecipitation assays showed cAMP-dependent CREB directly increased ADAM10 and IDE expression, and inhibited BACE-1 expression through NF-κB, resulting in reduction of Aβ production and increase in Aβ degradation. These findings reveal a causal relationship between PDE4D signaling and the progress of AD and demonstrate the clinical potential of BPN14770 in the treatment of AD.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment open, Trial initiation date, Trial primary completion date:  A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome (clinicaltrials.gov) -  May 4, 2022   
    P2/3,  N=150, Recruiting, 
    These findings reveal a causal relationship between PDE4D signaling and the progress of AD and demonstrate the clinical potential of BPN14770 in the treatment of AD. Not yet recruiting --> Recruiting | Initiation date: Dec 2021 --> Mar 2022 | Trial primary completion date: Apr 2023 --> Aug 2023
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial withdrawal:  A Phase 1, Open-Label, PET Study of T2310 & BPN14770 (clinicaltrials.gov) -  Jan 9, 2022   
    P1,  N=0, Withdrawn, 
    The most potent inhibitor was successfully labeled with carbon-11 and will be evaluated in monkey with PET imaging soon. Recruiting --> Withdrawn
  • ||||||||||  BPN14770 / Shionogi
    Clinical, P2 data, Journal:  Inhibition of phosphodiesterase-4D in adults with fragile X syndrome: a randomized, placebo-controlled, phase 2 clinical trial. (Pubmed Central) -  Jun 24, 2021   
    P2
    The goal of this study was to determine whether a phosphodiesterase-4D (PDE4D) allosteric inhibitor (BPN14770) would improve cognitive function and behavioral outcomes in patients with fragile X syndrome (FXS)...Benefit as assessed by visual analog caregiver rating scales was judged to be clinically meaningful for language (+14.04, P = 0.0051) and daily functioning (+14.53, P = 0.0017). Results from this study using direct, computer-based assessment of cognitive performance by adult males with FXS indicate significant cognitive improvement in domains related to language with corresponding improvement in caregiver scales rating language and daily functioning.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Phase classification:  Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D) (clinicaltrials.gov) -  Feb 12, 2021   
    P1/2,  N=3, Completed, 
    Overall, these results show that imaging of PDE4D in primate brain is feasible, but that further radioligand refinement is needed, most likely to avoid problematic radiometabolites. Phase classification: P1 --> P1/2
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion:  A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome (clinicaltrials.gov) -  Dec 3, 2020   
    P2,  N=30, Completed, 
    These findings suggest that inhibition of PDE4D enhances signaling through the cAMP-PKA-SIRT1-Akt -Bcl-2/Bax pathway and thereby may provide therapeutic benefit in neurocognitive disorders. Active, not recruiting --> Completed
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment closed:  A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome (clinicaltrials.gov) -  Mar 11, 2020   
    P2,  N=30, Active, not recruiting, 
    The study provides useful insight into the potential role of compensatory mechanisms in Alzheimer's disease in a model of oligomeric Aβ 1-42 neurotoxicity. Recruiting --> Active, not recruiting
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion date, Trial primary completion date:  A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome (clinicaltrials.gov) -  Mar 10, 2020   
    P2,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D) (clinicaltrials.gov) -  Feb 21, 2020   
    P1,  N=3, Completed, 
    Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020 Recruiting --> Completed | N=40 --> 3 | Trial completion date: Dec 2022 --> Feb 2020 | Trial primary completion date: Mar 2022 --> Feb 2020
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  A Phase 1, Open-Label, PET Study of T2310 & BPN14770 (clinicaltrials.gov) -  Feb 19, 2020   
    P1,  N=9, Recruiting, 
    Recruiting --> Completed | N=40 --> 3 | Trial completion date: Dec 2022 --> Feb 2020 | Trial primary completion date: Mar 2022 --> Feb 2020 Not yet recruiting --> Recruiting | Trial completion date: Jan 2020 --> May 2020 | Initiation date: Oct 2019 --> Jan 2020 | Trial primary completion date: Dec 2019 --> Apr 2020
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment closed, Trial completion date, Trial primary completion date:  Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects (clinicaltrials.gov) -  Oct 31, 2019   
    P2,  N=255, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Jan 2020 --> May 2020 | Initiation date: Oct 2019 --> Jan 2020 | Trial primary completion date: Dec 2019 --> Apr 2020 Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Feb 2020 | Trial primary completion date: Jun 2020 --> Feb 2020
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion date, Trial primary completion date:  A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome (clinicaltrials.gov) -  Sep 11, 2019   
    P2,  N=30, Recruiting, 
    These findings provide support for the utility of allosteric PDE4D inhibitors in mediation of memory and identify biomarkers related to treatment of memory deficits associated with AD. Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Aug 2019 --> Dec 2019
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial primary completion date:  Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D) (clinicaltrials.gov) -  May 8, 2019   
    P1,  N=40, Recruiting, 
    Thus, BPN14770 may be useful for the treatment of fragile-X syndrome and other disorders with decreased cAMP signaling. Trial primary completion date: Dec 2022 --> Mar 2022