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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.
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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
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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
- |||||||||| XEN1101 / Xenon
Rapid Onset of Efficacy of XEN1101, a Novel Potassium Channel Opener, in Adults with Focal Epilepsy: Results from a Phase 2b Study (X-TOLE) (Hall B, Level 3) - Nov 29, 2022 - Abstract #AES2022AES_1777; At week 1, XEN1101 demonstrated a reduction of 39.1% (p=0.002), 41.5% (p=0.039) and 55.4% (p< 0.001) in the 10, 20, and 25 mg groups, respectively, from baseline in median weekly FOS compared to placebo (20.2%). At week 1, RR50 was 43.5% (p=0.034), 47.1% (p=0.015) and 53.6% (p< 0.001) for 10, 20 and 25 mg, respectively, compared to placebo (28.1%).
- |||||||||| 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.
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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.
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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
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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, 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
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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
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