A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures - XPF-010-302

Start Date13 Oct 2023

Sponsor / Collaborator

Xenon Pharmaceuticals, Inc.

NCT05716100 / RecruitingPhase 3

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Start Date09 May 2023

Sponsor / Collaborator

Xenon Pharmaceuticals, Inc.

[+1]

NCT05718817 / Enrolling by invitationPhase 3

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy

This study will evaluate the long term safety, tolerability, PK, and efficacy of XEN1101 25 mg QD taken orally in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 3 years.

Start Date25 Apr 2023

Sponsor / Collaborator

Xenon Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Azetukalner

100 Translational Medicine associated with Azetukalner

100 Patents (Medical) associated with Azetukalner

Literatures (Medical) associated with Azetukalner

01 Oct 2024·EPILEPSIA

Progress report on new medications for seizures and epilepsy: A summary of the 17th Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVII). II. Drugs in more advanced clinical development

Article

Author: White, H. Steve ; Johannessen, Svein I. ; Perucca, Emilio ; Tomson, Torbjörn ; Koepp, Matthias J. ; Bialer, Meir ; Perucca, Piero

Abstract:

The 17th Eilat Conference on New Antiepileptic Drugs and Devices took place in Madrid, Spain on May 5–8, 2024. As usual, the core part of the conference consisted of presentations on investigational drugs at various stages of development for epilepsy‐related indications. Summaries of information on compounds in preclinical or early clinical development are included in an accompanying publication (Part I). In this article, we provide summaries for five compounds in more advanced clinical development, i.e. compounds for which some information on antiseizure activity in individuals with epilepsy is available. These investigational treatments include azetukalner (XEN1101), a potent, KV7.2/7.3‐specific potassium channel opener in development for the treatment of focal seizures, generalized tonic–clonic seizures, and major depressive disorder; bexicaserin (LP352), a selective 5‐HT2C receptor superagonist in development for the treatment of seizures associated with developmental and epileptic encephalopathies; radiprodil, a selective negative allosteric modulator of NR2B subunit‐containing N‐methyl‐D‐aspartate glutamate receptors, in development for the treatment of seizures and behavior manifestations associated with disorders caused by gain‐of‐function mutations in the GRIN1, −2A, ‐2B, or ‐2D genes; soticlestat (TAK‐935), a selective inhibitor of cholesterol 24‐hydroxylase in development for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome; and STK‐001, an antisense oligonucleotide designed to upregulate Nav1.1 protein expression and improve outcomes in individuals with Dravet syndrome. The diversity in mechanisms of action of these agents illustrates different approaches being pursued in the discovery of novel treatments for seizures and epilepsy. For two of the compounds discussed in this report (azetukalner and soticlestat), clinical evidence of efficacy has already been obtained in a randomized placebo‐controlled adjunctive‐therapy trial. For the other compounds, adequately powered placebo‐controlled efficacy trials have not been completed to date.

01 Nov 2023·JAMA neurology

Efficacy and Safety of XEN1101, a Novel Potassium Channel Opener, in Adults With Focal Epilepsy

Article

Importance:

Many patients with focal epilepsy experience seizures despite treatment with currently available antiseizure medications (ASMs) and may benefit from novel therapeutics.

Objective:

To evaluate the efficacy and safety of XEN1101, a novel small-molecule selective Kv7.2/Kv7.3 potassium channel opener, in the treatment of focal-onset seizures (FOSs).

Design, Setting, and Participants:

This phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging adjunctive trial investigated XEN1101 over an 8-week treatment period from January 30, 2019, to September 2, 2021, and included a 6-week safety follow-up. Adults experiencing 4 or more monthly FOSs while receiving stable treatment (1-3 ASMs) were enrolled at 97 sites in North America and Europe.

Interventions:

Patients were randomized 2:1:1:2 to receive XEN1101, 25, 20, or 10 mg, or placebo with food once daily for 8 weeks. Dosage titration was not used. On completion of the double-blind phase, patients were offered the option of entering an open-label extension (OLE). Patients not participating in the OLE had follow-up safety visits (1 and 6 weeks after the final dose).

Main Outcomes and Measures:

The primary efficacy end point was the median percent change from baseline in monthly FOS frequency. Treatment-emergent adverse events (TEAEs) were recorded and comprehensive laboratory assessments were made. Modified intention-to-treat analysis was conducted.

Results:

A total of 325 patients who were randomized and treated were included in the safety analysis; 285 completed the 8-week double-blind phase. In the 325 patients included, mean (SD) age was 40.8 (13.3) years, 168 (51.7%) were female, and 298 (91.7%) identified their race as White. Treatment with XEN1101 was associated with seizure reduction in a robust dose-response manner. The median (IQR) percent reduction from baseline in monthly FOS frequency was 52.8% (P &lt; .001 vs placebo; IQR, −80.4% to −16.9%) for 25 mg, 46.4% (P &lt; .001 vs placebo; IQR, −76.7% to −14.0%) for 20 mg, and 33.2% (P = .04 vs placebo; IQR, −61.8% to 0.0%) for 10 mg, compared with 18.2% (IQR, −37.3% to 7.0%) for placebo. XEN1101 was generally well tolerated and TEAEs were similar to those of commonly prescribed ASMs, and no TEAEs leading to death were reported.

Conclusions and Relevance:

The efficacy and safety findings of this clinical trial support the further clinical development of XEN1101 for the treatment of FOSs.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03796962

01 Aug 2023·Acta pharmacologica Sinica

Functional characterization and in vitro pharmacological rescue of KCNQ2 pore mutations associated with epileptic encephalopathy.

Article

Author: Tian, Fu-Yun ; Li, Ping ; Yang, Chuan-Yan ; Shen, Yan-Wen ; Yang, Gui-Mei ; Gao, Zhao-Bing ; Yuan, Hui

Mutations in the KCNQ2 gene encoding K_V7.2 subunit that mediates neuronal M-current cause a severe form of developmental and epileptic encephalopathy (DEE). Electrophysiological evaluation of KCNQ2 mutations has been proved clinically useful in improving outcome prediction and choosing rational anti-seizure medications (ASMs). In this study we described the clinical characteristics, electrophysiological phenotypes and the in vitro response to KCNQ openers of five KCNQ2 pore mutations (V250A, N258Y, H260P, A265T and G290S) from seven patients diagnosed with KCNQ2-DEE. The KCNQ2 variants were transfected into Chinese hamster ovary (CHO) cells alone, in combination with KCNQ3 (1:1) or with wild-type KCNQ2 (KCNQ2-WT) and KCNQ3 in a ratio of 1:1:2, respectively. Their expression and electrophysiological function were assessed. When transfected alone or in combination with KCNQ3, none of these mutations affected the membrane expression of KCNQ2, but most failed to induce a potassium current except A265T, in which trace currents were observed when co-transfected with KCNQ3. When co-expressed with KCNQ2-WT and KCNQ3 (1:1:2), the currents at 0 mV of these mutations were decreased by 30%-70% compared to the KCNQ2/3 channel, which could be significantly rescued by applying KCNQ openers including the approved antiepileptic drug retigabine (RTG, 10 μM), as well as two candidates subjected to clinical trials, pynegabine (HN37, 1 μM) and XEN1101 (1 μM). These newly identified pathologic variants enrich the KCNQ2-DEE mutation hotspots in the pore-forming domain. This electrophysiological study provides a rational basis for personalized therapy with KCNQ openers in DEE patients carrying loss-of-function (LOF) mutations in KCNQ2.

News (Medical) associated with Azetukalner

02 Oct 2024

·www.biospace.com

Xenon to Present at BofA Securities 2024 CNS Therapeutics Virtual Conference

VANCOUVER, British Columbia and BOSTON, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced its participation in the upcoming BofA Securities 2024 CNS Therapeutics Virtual Conference taking place October 7, 2024. Fireside Chat Presentation Details: Date: Monday, October 7, 2024 Time: 11:40 am Eastern Time Webcast: Register here A live webcast of the company presentation will be available on the “ Investors ” section of Xenon’s website and posted for replay following the event. The above listed dates and times are subject to change. About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (Nasdaq:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are advancing a novel product pipeline to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, our lead Kv7 channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit . “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Contacts: For Investors: Chad Fugere Vice President, Investor Relations (857) 675-7275 investors@xenon-pharma.com For Media: Colleen Alabiso Senior Vice President, Corporate Affairs (617) 671-9238 media@xenon-pharma.com

09 Sep 2024

·www.globenewswire.com

Xenon Showcases Azetukalner Data at 15th European Epilepsy Congress

Three presentations highlighting long-term data and improved quality of life outcomes in adults with focal onset seizures VANCOUVER, British Columbia and BOSTON, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced three poster presentations at the 15th European Epilepsy Congress (EEC) taking place in Rome, Italy. Azetukalner, a novel, potent Kv7 channel opener, is the most advanced, clinically validated potassium channel modulator in late-stage development for multiple indications, including focal onset seizures (FOS), primary generalized tonic-clonic seizures (PGTCS) and major depressive disorder (MDD). “We are excited for this opportunity to engage with leading epileptologists at EEC in Rome and share long-term azetukalner data from our ongoing X-TOLE open-label extension study. Azetukalner represents the only Kv7 potassium channel opener in clinical development that is supported by Phase 2b data as well as long-term efficacy and safety data in epilepsy patients,” stated Dr. Christopher Kenney, Chief Medical Officer of Xenon. “These data are particularly impressive given the baseline disease severity, with patients who are out to 30 months in the open-label extension study showing a greater than 90% reduction in median monthly seizure frequency, while approximately one in four patients on azetukalner for at least two years in the OLE have experienced a period of seizure freedom of a year or longer.” Dr. Kenney continued, “We are also presenting patient-reported survey data illustrating the substantial burden of illness for people living with epilepsy, with reduced quality of life, high seizure frequency and fatigue, as well as other comorbidities such as anxiety and depression, further underscoring the need for new medications to help people living with epilepsy.” Presentations at EEC: Poster #P282: Azetukalner (XEN1101), a Novel, Potent Kv7 Potassium Channel Opener: Interim Data From an Ongoing, Long‑Term, Open‑Label Extension of a Phase 2b Study (X‑TOLE) in Adults With Focal Onset SeizuresPresenter: Jacqueline A. French, New York University Grossman School of Medicine and NYU Langone Health, New York, NYSession Times: Daily from 1:30-3:00 pm CEST Poster #P281: Long-term, Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Improvements in Adults With Focal Onset Seizures Treated With Azetukalner (XEN1101) in an Ongoing, Open-Label Extension of a Phase 2b study (X-TOLE)Presenter: Christian Brandt, Bethel Epilepsy Centre, Mara Hospital, University Hospital for Epileptology, Bielefeld, GermanySession Times: Daily from 1:30-3:00 pm CESTPoster Tour: S2 Clinical Neurophysiology/Drug Therapy Poster #P406: Non-seizure Symptoms, Mental Health Comorbidities, and Quality of Life in Patients Reporting Focal Onset SeizuresPresenter: Cynthia Harden, Xenon Pharmaceuticals Inc. Session Times: Daily from 1:30-3:00 pm CEST Posters will be available for viewing at the conference from Sunday, September 8 until Tuesday, September 10 at 4:00 pm CEST and will be added to the Xenon website consistent with conference guidelines. Xenon is also hosting a Scientific Exhibit at location SE1 and Booth #346. About Xenon Pharmaceuticals Inc.Xenon Pharmaceuticals (Nasdaq:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are advancing a novel product pipeline to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, our lead Kv7 channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit www.xenon-pharma.com. About the Azetukalner Phase 3 Epilepsy ProgramXenon’s Phase 3 epilepsy program includes three ongoing Phase 3 clinical trials in focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS). Designed closely after the Phase 2b X-TOLE clinical trial, the Phase 3 X-TOLE clinical trials are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered with food as adjunctive treatment in approximately 360 patients with FOS per study. The primary efficacy endpoint is the median percent change (MPC) in monthly seizure frequency from baseline through the double-blind period (DBP) of azetukalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study evaluating the clinical efficacy, safety, and tolerability of 25 mg of azetukalner administered with food as adjunctive treatment in approximately 160 patients with PGTCS. The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the DBP of azetukalner compared to placebo. Safe Harbor StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and potential results from clinical trials; the potential efficacy, safety profile, future development plans in current and anticipated indications, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our azetukalner and other pipeline and development programs; and our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including azetukalner, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of market, industry, and regulatory conditions on clinical trial enrollment; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Contacts: For Investors:Chad FugereVice President, Investor Relations(857) 675-7275investors@xenon-pharma.com For Media:Colleen AlabisoSenior Vice President, Corporate Affairs(617) 671-9238media@xenon-pharma.com

Phase 2Phase 3

12 Aug 2024

·www.globenewswire.com

Xenon Expands Leadership Team with Matthew D. Ronsheim, Ph.D. as Chief Operating Officer

VANCOUVER, British Columbia and BOSTON, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced the appointment of Matthew D. Ronsheim, Ph.D. as Chief Operating Officer and a member of the Xenon senior executive team. In this new role, Dr. Ronsheim will lead Chemistry, Manufacturing and Controls (CMC), Program Management and Quality Assurance and as a member of the senior executive team will be responsible for providing strategic and operational leadership for the Company’s pipeline of small molecule programs with a focus on preparation for the commercial launch of azetukalner. “Matt joins Xenon at an exciting time of growth where his extensive operational, pharmaceutical development and manufacturing expertise will help support the advancement of our Phase 3 epilepsy and MDD programs, planning for regulatory submissions and commercialization, while also progressing our broad portfolio of pre-clinical assets that will fuel future growth,” stated Ian Mortimer, President and Chief Executive Officer of Xenon. Dr. Ronsheim has 25 years of experience bringing important medicines from discovery through clinical development, global regulatory filings and approvals, and commercial launch and supply. Before joining Xenon, Dr. Ronsheim was President of Innoviva Specialty Therapeutics, having previously served as their Chief Technical Officer. Prior to this, Dr. Ronsheim was President of Entasis Therapeutics, which was acquired by Innoviva, Inc. in 2022. Throughout his career, he has held leadership roles overseeing research, CMC, pharmaceutical development, and commercialization at companies including Merck/Cubist Pharmaceuticals, Enanta Pharmaceuticals, and Forest Laboratories. Dr. Ronsheim’s industry contributions and leadership have contributed to delivering important therapies across several disease areas including central nervous system disorders. Dr. Ronsheim holds a B.S. in Chemistry from Southern Connecticut State University and a Ph.D. in Synthetic Organic Chemistry from the University of New Hampshire. “I am thrilled to join Xenon to support the future development and commercialization of azetukalner given its compelling profile in both epilepsy and depression with a broad Phase 3 program underway,” said Dr. Matt Ronsheim, Chief Operating Officer of Xenon. “I am also excited about the opportunity to deliver on Xenon’s promise of a next-generation ion channel modulators with the advancement of multiple Kv7, Nav1.7 and Nav1.1 molecules creating opportunities for development across a broad range of CNS indications.” About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (Nasdaq:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are advancing a novel product pipeline to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, our lead Kv7 channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit www.xenon-pharma.com. Safe Harbor Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and potential results from clinical trials; the potential efficacy, safety profile, future development plans in current and anticipated indications, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our azetukalner and other pipeline and development programs; our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including azetukalner, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of market, industry, and regulatory conditions on clinical trial enrollment; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Contacts: For Investors:Chad FugereVice President, Investor Relations(857) 675-7275investors@xenon-pharma.com For Media:Colleen AlabisoSenior Vice President, Corporate Affairs(617) 671-9238media@xenon-pharma.com

Executive ChangeAcquisitionPhase 3

100 Deals associated with Azetukalner

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Indication	Highest Phase	Country/Location	Organization	Date
Epilepsy, Tonic-Clonic	Phase 3	US	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	AR	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	AU	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	AT	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	BG	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	CA	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	HR	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	CZ	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	IL	Xenon Pharmaceuticals, Inc.	14 Feb 2023
Epilepsy, Tonic-Clonic	Phase 3	IT	Xenon Pharmaceuticals, Inc.	14 Feb 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03796962 (X-TOLE, CTgov)	Phase 2	Epilepsies, Partial \| Seizures	325	XEN1101 (25 mg XEN1101)	phkjehrhih(nhmkfdhokv) = mzxikheczv fwjuwnmwkg (pjccorinzq, fpgubfxkzo - apczhcnrti) View more	-	24 Sep 2024
				XEN1101 (20 mg XEN1101)	phkjehrhih(nhmkfdhokv) = iqzxjarixs fwjuwnmwkg (pjccorinzq, townudfrmo - debpsngjxy) View more
NCT05376150 (X-NOVA, Company_Website) Manual	Phase 2	Depressive Disorder, Major	168	Azetukalner 10mg	kjeistjglo(jgtvawijcw) = liwxwdtxte lwngbztzuu (paabxedaiv )	Positive	28 May 2024
				Azetukalner 20mg	kjeistjglo(jgtvawijcw) = ckyrogpmmz lwngbztzuu (paabxedaiv ) View more
NCT03796962 (X-TOLE, AES2023) Manual	Phase 2	Epilepsies, Partial	170	XEN1101 (overall)	pblkfwnmyr(tqyhjjazlu) = tvhgihvjqu acblrkeshx (fcsagcwqjx ) View more	Positive	03 Dec 2023
				XEN1101 (seizure-free group)	pblkfwnmyr(tqyhjjazlu) = mjcjudxjfa acblrkeshx (fcsagcwqjx ) View more
NCT03796962 (X-TOLE, AES2023) Manual	Phase 2	Epilepsies, Partial	325	XEN1101	jkrgqyccgn(iyzpfyhjwe) = pwpcgtvgbt nsofmalpqd (jakulgcbjs )	Positive	03 Dec 2023
				Placebo	jkrgqyccgn(iyzpfyhjwe) = zfeayppwvx nsofmalpqd (jakulgcbjs )
NCT03796962 (X-TOLE, AES2023) Manual	Phase 2	Epilepsies, Partial	275	XEN1101	ubvteqgzhp(pvllqvnijq) = The most common reasons for discontinuation were lack of efficacy (13.1%), adverse events (12.0%), and study withdrawal by patient (11.3%). hwnhzohksw (vnntfyackg ) View more	Positive	02 Dec 2023
NCT05376150 (X-NOVA, Corporate Publications) Manual	Phase 2	Depressive Disorder, Major	168	XEN1101 10 mg	ttsvkwrele(qiazrwgtev) = hzjmzyjvib yeazaziabn (kimpbgwfyu )	Positive	27 Nov 2023
				XEN1101 20 mg	ttsvkwrele(qiazrwgtev) = ofiayfinue yeazaziabn (kimpbgwfyu ) View more
NCT03796962 (X-TOLE, Pubmed) Manual	Phase 2	Epilepsies, Partial	325	XEN1101 25 mg	uqhzsqxkcp(lrhtqobenz) = qgrqgklcpi psyzcqwluz (rducqjcakh, -80.4 to -16.9)	Positive	09 Oct 2023
				XEN1101 20 mg	uqhzsqxkcp(lrhtqobenz) = qknibxitql psyzcqwluz (rducqjcakh, -76.7 to -14.0)
IEC2023	Phase 2	Epilepsies, Partial	275	XEN1101 20 mg QD	uhtbxkndmh(qzjfhefvcm) = 11.6% opufqugzfv (topvtnqijm ) View more	Positive	04 Sep 2023
				Placebo
X-TOLE (AAN2023)	Phase 2	Epilepsies, Partial	285	XEN1101 20 mg	gupsvfsyvi(ruhfyichsv) = The most common TEAEs were dizziness, headache, somnolence, weight increased, fall, gait disturbance, fatigue, confusional state, aphasia, and memory impairment. No TEAEs of pigmentary abnormalities were reported. Two patients experienced TEAEs of urinary retention (1 mild, 1 moderate, possibly drug related, but both patients continued the medication) dktwwdlpnk (rbcqnmpblv ) View more	-	25 Apr 2023
X-TOLE (AAN2022)	Phase 2	Epilepsies, Partial	325	XEN1101 10mg	dkpwpcvpux(jyfflxmndb) = vzipdwrjzh mkzobldjhm (xtudmvncmj ) View more	Positive	03 May 2022
				XEN1101 20mg	xkstmplcbg(xpldgckfzt) = rwmkowbrrb iibldypnpu (mtuqqruoos )

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