zatolmilast (BPN14770) / Shionogi 
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 0 Diseases   2 Trials   2 Trials   101 News 


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  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    From Bench to Clinic: Zatolmilast and the Translation of Neurobiology Research into a Targeted Therapy for Fragile X Syndrome (Plenary Hall: Lomond Auditorium) -  Jun 26, 2026 - Abstract #CINP2026CINP_257;    
    This session will provide a comprehensive overview of the translational, preclinical, and early clinical research, including key methodological considerations, that has helped to propel zatolmilast into a registrational, Phase 2/3 clinical development program in FXS. By sharing both the experience and learnings from this foundational work, we aspire to inform future interventional clinical trials in FXS.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    SCNP-Selected Symposium 5: Translational Therapeutic Discovery in Autism and Fragile X Syndrome (Plenary Hall: Lomond Auditorium) -  Jun 26, 2026 - Abstract #CINP2026CINP_255;    
    Their mechanistic studies have implicated the ERK/MAPK and mTOR pathways, which control mRNA translation, and are overactivated in several brain areas of these mouse models.Together, these talks integrate molecular, circuit-level, and pharmacological perspectives to identify new entry points for therapeutic development in autism and FXS. By linking mechanistic research with translational innovation, this symposium will highlight promising pathways for intervention and promote cross-disciplinary collaboration between basic scientists and clinical investigators.
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Trial completion date, Trial primary completion date:  Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS]) (clinicaltrials.gov) -  Jun 9, 2026   
    P2,  N=30, Active, not recruiting, 
    By linking mechanistic research with translational innovation, this symposium will highlight promising pathways for intervention and promote cross-disciplinary collaboration between basic scientists and clinical investigators. Trial completion date: Jan 2030 --> Dec 2027 | Trial primary completion date: Jan 2030 --> Dec 2027
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    Enrollment open:  Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls (clinicaltrials.gov) -  Aug 21, 2025   
    P1,  N=16, Recruiting, 
    Work to improve trials for targeted treatment development in FXS has helped circumvent previous trial design issues and appears to have been critical for more successful trials.GS, ND, RCT Not yet recruiting --> Recruiting
  • ||||||||||  zatolmilast (BPN14770) / Shionogi
    [11C]ZTP-1, an Effective Shorter-lived Radioligand for PET Imaging of Brain Phosphodiesterase-4B (SS_2) -  May 10, 2025 - Abstract #SNMMI2025SNMMI_774;    
    PET imaging with [11C]ZTP-1 of rhesus monkey and rat brain was performed at baseline and after administration of selective inhibitors (pan-PDE4 inhibitor: rolipram; PDE4B preferring inhibitor: PF-06445974; and PDE4D selective inhibitor: BPN14770)... [11C]ZTP-1 was obtained in ~10% decay-corrected yield (2.0
  • ||||||||||  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, First-in-human:  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