XEN1101 / Xenon 
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 0 Diseases   2 Trials   2 Trials   3 News 


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  • ||||||||||  XEN1101 / Xenon
    Trial completion date:  X-TOLE: A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy (clinicaltrials.gov) -  Apr 18, 2024   
    P2,  N=325, Active, not recruiting, 
    For the other compounds, adequately powered placebo-controlled efficacy trials have not been completed to date. Trial completion date: Oct 2026 --> Oct 2028
  • ||||||||||  XEN1101 / Xenon
    Review, Journal:  A profile of azetukalner for the treatment of epilepsy: from pharmacology to potential for therapy. (Pubmed Central) -  Apr 4, 2024   
    A literature review on the pharmacology, efficacy, tolerability, and safety of azetukalner (XEN1101), a second-generation opener of neuronal potassium channels currently in Phase 3 development as ASM...The upcoming Phase 3 clinical trials are expected to provide further insight into the efficacy, tolerability, and safety of azetukalner in treating focal-onset and primary generalized tonic-clonic seizures. Structurally distinct from currently marketed ASMs, azetukalner has the potential to be the only-in-class Kv7.2/7.3 opener on the market upon regulatory approval.
  • ||||||||||  XEN1101 / Xenon
    Trial completion date, Trial primary completion date:  X-TOLE4: An Open-label Study of XEN1101 in Epilepsy (clinicaltrials.gov) -  Mar 2, 2024   
    P3,  N=880, Enrolling by invitation, 
    XEN1101 may be appropriate for patients with focal epilepsy across the spectrum of disease severity. Trial completion date: Jun 2027 --> Sep 2028 | Trial primary completion date: Jun 2026 --> Jul 2028
  • ||||||||||  XEN1101 / Xenon
    Enrollment open:  A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) (clinicaltrials.gov) -  Jul 31, 2023   
    P3,  N=360, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: May 2023 --> Sep 2023 Not yet recruiting --> Recruiting
  • ||||||||||  XEN1101 / Xenon
    Enrollment open:  X-TOLE4: An Open-label Study of XEN1101 in Epilepsy (clinicaltrials.gov) -  May 3, 2023   
    P3,  N=880, Enrolling by invitation, 
    Unknown status --> Completed | N=64 --> 130 Not yet recruiting --> Enrolling by invitation
  • ||||||||||  Journal:  Current and future pharmacotherapy options for drug-resistant epilepsy. (Pubmed Central) -  Sep 30, 2022   
    For specific epilepsy syndromes, XEN 496 is under Phase III development for potassium voltage-gated channel subfamily Q member 2 developmental and epileptic encephalopathy (KCNQ2-DEE), carisbamate is under Phase III development for LGS and Ganaxolone under Phase III development for TSC. Finally, in preclinical models several molecular targets including inhibition of glycolysis, neuroinflammation and sodium channel inhibition have been identified in animal models although further data in animal and later human studies are needed.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    P2/3 data, Clinical Trial,Phase III, Journal:  Epilepsy: Expert opinion on emerging drugs in phase 2/3 clinical trials. (Pubmed Central) -  Apr 6, 2022   
    Novel mechanisms of action involve cholesterol degradation, mitochondrial pathways, anti-inflammation and neuro-regeneration. Earlier identification of genetic conditions through genetic testing will allow for earlier use of disease specific and disease-modifying therapies.
  • ||||||||||  XEN1101 / Xenon
    Biomarker, Journal:  Spontaneous and TMS-related EEG changes as new biomarkers to measure anti-epileptic drug effects. (Pubmed Central) -  Mar 11, 2022   
    Spontaneous and TMS-related cortical oscillations represent a powerful tool to characterize the effect of AEDs on in vivo brain activity. Spectral fingerprints of specific AEDs should be further investigated to provide robust and objective biomarkers of biological effect in human clinical trials.
  • ||||||||||  XEN1101 / Xenon
    XEN1101, a Differentiated KV7 Potassium Channel Modulator, Impacts Depression and Anhedonia () -  Dec 12, 2021 - Abstract #AES2021AES_1105;    
    Further, XEN1101 significantly increased the number of lever presses at the same doses (n=439 ± 40 at 3 mg/kg, n=480 ± 57 at 8 mg/kg, compared to n=334 ± 38 for vehicle; p< 0.05 and p< 0.001, respectively). In the sub-group analysis, the XEN1101 effect on breakpoint and total lever presses was only significant in the low performing sub-group.
  • ||||||||||  XEN1101 / Xenon
    Enrollment open, Trial initiation date:  XEN1101 for Major Depressive Disorder (clinicaltrials.gov) -  Nov 4, 2021   
    P2,  N=60, Recruiting, 
    In the sub-group analysis, the XEN1101 effect on breakpoint and total lever presses was only significant in the low performing sub-group. Not yet recruiting --> Recruiting | Initiation date: Jun 2021 --> Oct 2021
  • ||||||||||  XEN1101 / Xenon
    Enrollment closed, Trial completion date, Trial primary completion date:  X-TOLE: A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy (clinicaltrials.gov) -  Nov 1, 2021   
    P2,  N=300, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Jun 2021 --> Oct 2021 Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Oct 2024 | Trial primary completion date: Jun 2021 --> Sep 2021
  • ||||||||||  XEN1101 / Xenon
    New P2 trial:  XEN1101 for Major Depressive Disorder (clinicaltrials.gov) -  Mar 31, 2021   
    P2,  N=60, Not yet recruiting, 
  • ||||||||||  XEN1101 / Xenon, lamotrigine liquid oral suspension / OWP Pharma
    [VIRTUAL] Cortical oscillations to measure anti-epileptic drug activity in clinical trials () -  Nov 28, 2020 - Abstract #AES2020AES_680;    
    Spectral fingerprints should be further investigated to provide robust and objective biomarkers of target engagement in human clinical trials. Funding: This study represents an independent research supported by the National Institute for Health Research (NIHR)-Well come King’s Clinical Research Facility and the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.
  • ||||||||||  XEN1101 / Xenon
    Trial completion date, Trial primary completion date:  X-TOLE: A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy (clinicaltrials.gov) -  Aug 20, 2020   
    P2,  N=300, Recruiting, 
    These results support the implementation of TMS as a tool to inform early-stage clinical trials. Trial completion date: Jul 2020 --> Jun 2022 | Trial primary completion date: Jul 2020 --> Jun 2021
  • ||||||||||  XEN1101 / Xenon
    Enrollment closed, Trial completion date, Trial primary completion date:  Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101. (clinicaltrials.gov) -  Jul 22, 2019   
    P1,  N=64, Active, not recruiting, 
    Incorporating TMS evidence of CNS activity in Phase 1 studies may be a useful adjunct in refining dose selection for Phase 2 epilepsy studies. Recruiting --> Active, not recruiting | Trial completion date: Sep 2018 --> Dec 2019 | Trial primary completion date: Aug 2018 --> Dec 2019
  • ||||||||||  XEN1101 / Xenon
    Enrollment open:  X-TOLE: A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy (clinicaltrials.gov) -  Feb 8, 2019   
    P2,  N=300, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Sep 2018 --> Dec 2019 | Trial primary completion date: Aug 2018 --> Dec 2019 Not yet recruiting --> Recruiting