Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

Start Date14 Oct 2024

Sponsor / Collaborator

SK Life Science, Inc.

NCT06352723 / Not yet recruitingEarly Phase 1IIT

Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.
Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

Start Date01 Apr 2024

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

CTIS2023-506841-52-00 / Recruiting

Open-Label Safety and Efficacy Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial-onset (Focal) Seizures - YKP3089C040

Start Date19 Apr 2023

Sponsor / Collaborator

SK Life Science, Inc.

100 Clinical Results associated with Cenobamate

100 Translational Medicine associated with Cenobamate

100 Patents (Medical) associated with Cenobamate

161

Literatures (Medical) associated with Cenobamate

01 Dec 2024·PEDIATRIC NEUROLOGY

Cenobamate's Efficacy for Seizure Treatment in Tuberous Sclerosis Complex

Article

Author: Horn, Paul ; Aungaroon, Gewalin ; Franz, David N. ; Krueger, Darcy ; Cooke, Alexander ; Ritter, David ; Franz, David N ; Horn, Porn

BACKGROUND:

Epilepsy is prevalent, and seizure control is challenging in patients with tuberous sclerosis complex (TSC). Cenobamate (CBM) has proven efficacy in several studies; however, its benefit in the TSC population is not known.

METHODS:

We performed a retrospective review of patients with TSC who received adjunctive CBM for seizure treatments. We assessed treatment efficacy by comparing seizure frequencies three months before CBM (baseline) and those at 3-, 6-, 12-, and 18- month follow-ups.

RESULTS:

We identified 70 patients with TSC receiving CBM and excluded 16 with insufficient data. Fifty-four patients aged 2 to 39 years, with an average baseline seizure of 66.1 ± 88.9 per month, were analyzed. Treatment retention rates at 3, 6, 12, and 18 months were 94.4%, 79.6%, 66.7%, 44.4%, and responder rates (proportions of patients who remained on treatment and had ≥50% seizure reduction) were 38.1%, 51.7%, 53.1%, and 59.1%, respectively. Seizure-free rates at these respective follow-ups were 7.1%, 13.8%, 6.3%, and 9.1%. For patients experiencing reduced seizures, the mean percentage of change ranged from 61.5% to 74.6%. Side effects were common (64.8%), particularly sedation (42.6%), behavioral disturbance (24.1%), and gastrointestinal disturbance (22.2%).

CONCLUSIONS:

Most patients in this study showed seizure reduction; however, the overall responder and seizure-free rates were lower than the literature, likely due to the unique underlying epileptogenesis in TSC and the challenges of tolerating CBM. The lower treatment retention rates signal areas for improvement in concurrent medication adjustment practices.

01 Dec 2024·PEDIATRIC NEUROLOGY

Mammalian Target of Rapamycin Inhibitor Levels Decrease Under Cenobamate Treatment

Article

Author: Krueger, Darcy A. ; Becker, Lena-Luise ; Ritter, David M. ; Ritter, David M ; Agricola, Karen ; Krueger, Darcy A ; Franz, David Neal

BACKGROUND:

Everolimus therapy has been approved in Tuberous Sclerosis Complex (TSC), for drug-resistant epilepsy as adjunctive therapy. A novel anti-seizure medication is cenobamate, which was approved for adults as adjunctive treatment for focal-onset seizures in drug-resistant epilepsy and is now commonly used in patients with TSC. Drug-drug interactions between cenobamate and mammalian target of rapamycin (mTORi) have not been prospectively evaluated, even though these agents are frequently administered together.

METHODS:

We performed a retrospective analysis of patients with TSC and compared mTORi drug levels before and after treatment initiation with cenobamate.

RESULTS:

We evaluated 20 patients with clinically diagnosed TSC (male: 55%, female: 45%) with a median current age at last visit of 17.0 years (range: 4-41 years, interquartile range [IQR]: 12.5 years). All patients received mTORi treatment of either everolimus (N = 12, 60%) or sirolimus (N = 8, 40%). Cenobamate treatment led to seizure freedom in 2 patients (10%), reduction of seizures in 9 patients (45%) and no change in seizure frequency in 9 patients (45%). Median maximal cenobamate dose was 200 mg (range: 100-500 mg, IQR: 262.5 mg), for example, 3.2 mg/kg/day (range: 0.8-9.5 mg/kg/day, IQR: 3.2 mg/kg/day). Median everolimus levels decreased significantly after cenobamate initiation from 5.1 ng/ml (range: 1.9-11.6 ng/ml, IQR: 3.8 ng/ml) to 3.4 ng/ml (range: 1-7.9 ng/ml, IQR: 1.7 ng/ml, P = 0.01221). The median sirolimus level did not decrease significantly (P = 0.3828).

CONCLUSION:

Everolimus levels decreased following cenobamate initiation. This is likely due to CYP3A4 induction of cenobamate. We recommend monitoring of serum plasma levels of mTORi co-administered with cenobamate and adjustment of mTORi doses accordingly.

02 Oct 2024·CURRENT MEDICAL RESEARCH AND OPINION

Seizure burden and healthcare resource utilization among people living with drug-resistant focal epilepsy in the United States

Article

Author: Boca, Andra ; Dandurand, Ann ; Mao, Jianbin ; Xu, Churong ; Song, Yan ; Cheng, Mu ; Takahashi, Koji

OBJECTIVE:

This study investigated clinical characteristics, burden of uncontrolled seizures, and seizure-related healthcare resource utilization (HRU) among individuals living with drug-resistant focal epilepsy (FE) in the United States (US).

METHODS:

Medical charts of adults with drug-resistant FE who initiated third-line (3 L) anti-seizure medication were extracted from clinical practices in the US (1/1/2013-1/31/2020). The index date, defined as the date of 3 L initiation, was used to indicate the emergence of drug resistance. Individuals on cenobamate were followed for any length of time from the index date. Demographic and clinical characteristics were analyzed descriptively. Primary clinical outcomes included seizure burden (i.e. change in seizure frequency and time to the first and second seizure events) and epilepsy-related HRU.

RESULTS:

Overall, 189 neurologists/epileptologists contributed 345 charts of individuals living with drug-resistant FE (66% male; average age 24 years at diagnosis and 32 years at index date). 66% had ≥1 neurologic/neuropsychiatric comorbidity at baseline. Average monthly seizure rate decreased from 6.1 at baseline to 3.8 at follow-up; however, nearly half of individuals experienced worse/no change or only some improvement (<50% reduction) in seizure frequency. Most individuals (91%) had ≥1 epilepsy-related outpatient visit during follow-up. Unplanned HRU included emergency department visits (43%) and hospitalizations (24%), primarily due to breakthrough seizure events.

CONCLUSION:

Despite the availability of many anti-seizure medications in the US, people living with drug-resistant FE continue to experience multiple seizures per month and incur substantial healthcare resources. Novel pharmacotherapies may help individuals living with drug-resistant epilepsy achieve seizure freedom.

News (Medical) associated with Cenobamate

17 Jul 2024

·www.fiercebiotech.com

SK inks $572M deal for Full-Life prospect, advancing push to become Asia’s radiopharma leader

The deal is part of a broader expansion into radiopharmaceuticals. SK Biopharmaceuticals has followed through on its promise to place big bets in a bid to become Asia’s radiopharma leader. The Korean biotech got the ball rolling by striking a $571.5 million biobucks deal to license a drug candidate in development at Full-Life Technologies. Today, SK’s pipeline and portfolio is focused on central nervous system disorders, with the epilepsy drug Xcopri leading the charge. But the biotech is making a concerted effort to branch out. One year ago, SK outlined plans to expand in oncology and identified radiopharmaceuticals as one of the modalities at the heart of the push. SK is joining a who’s who of Big Pharma companies on the hunt for radiopharma deals. The expansion plan led SK to Full-Life, a radiotherapeutics biotech with operations in Belgium, Germany and China. Specifically, SK has plucked the NTSR1-directed radionuclide drug conjugate program FL-091 from Full-Life’s pipeline. NTSR1 is overexpressed in tumors including colorectal, breast, pancreatic, and head and neck cancers, leading Full-Life to identify the neurotensin receptor as a potential target for a radioligand. The biotech recently published preclinical data on FL-091. The public pipeline of Full-Life, which has a PSMA program in human testing, puts FL-091 on the cusp of clinical development. SK has secured global rights to take FL-091 forward through a deal worth up to $571.5 million in upfront and milestone payments. Neither party has disclosed the size of the upfront payment. The deal gives SK the right of first negotiation to license other pre-selected Full-Life programs. The deal is part of a broader expansion into radiopharmaceuticals. SK CEO Donghoon Lee used the press release about the deal to tease the unveiling and implementation of radiopharmaceutical business plans later this year. The company put another piece of its oncology strategy in place in 2023 when it bought a 60% stake in Proteovant Therapeutics to add protein degradation capabilities and a cancer R&D center.

AcquisitionPROTACsLicense out/in

17 Jul 2024

·www.prnewswire.com

Full-Life Technologies, SK Biopharmaceuticals Enter Licensing Agreement for Novel Therapeutic Targeting Multiple Solid Tumors

Full-Life Technologies seal s $571.5 million agreement with SK Biopharmaceuticals to license and further develop Full-Life's 'FL-091' radiopharmaceutical compound into an innovative anti-cancer treatment for worldwide markets HEIDELBERG, Germany and SEOUL, South Korea, July 16, 2024 /PRNewswire/ -- Full-Life Technologies ("Full-Life"), a fully integrated global radiotherapeutics company, announced today that it has entered into a license agreement with SK Biopharmaceuticals, a global biotech company, for exclusive worldwide clinical research, development, manufacturing, and commercialization rights to Full-Life's "FL-091" radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) positive cancers. This licensing deal worth $571.5 million includes an upfront payment, and development and commercial milestones, separate from royalties. Under the terms of the agreement, SK Biopharmaceuticals will in-license the NTSR1-targeting Radionuclide Drug Conjugate (RDC) program FL-091 – as well as its back-up compounds – aimed at developing and commercializing it as an innovative anti-cancer drug. FL-091 is a small-molecule radioligand vector designed to deliver targeted radiation therapy to cancer cells by binding specifically to NTSR1, a receptor protein, which is selectively overexpressed in various types of solid tumors, including colorectal cancer, prostate cancer, and pancreatic cancer. SK Biopharmaceuticals also has a right of first negotiation to license other pre-selected RDC programs of Full-Life. Lanny Sun, Chief Executive Officer of Full-Life, said, "This agreement with SK Biopharmaceuticals highlights the potential of FL-091 in advancing cancer treatment and demonstrates SK Biopharmaceuticals' unwavering commitment to building an oncology business around medical innovation. We look forward to future collaborations with SK Biopharmaceuticals, and to leveraging its expertise and resources to advance radiopharmaceutical therapy. The agreement is aligned with our strategic vision of fostering global partnerships and making a meaningful impact on patients worldwide." Donghoon Lee, Chief Executive Officer and President of SK Biopharmaceuticals, said, "The licensing agreement with Full-Life not only brings the two companies closer together for future collaborations in the fastest rising biotech sector, but also most importantly, pushes SK Biopharmaceuticals forward to become a 'Big Biotech'. Since the introduction of the company's strategy roadmap to venture into radiopharmaceuticals last year, we have been on track toward our envisioned goal. We expect to further unveil and implement business plans for RPT (radiopharmaceutical therapy) this year, and actively pursue clinical development and commercialization in the near future to provide treatment options and create new value worldwide." About FL-091 FL-091 is a novel small-molecule radioligand vector targeting NTSR1 positive solid tumors. Overexpression of NTSR1 has been associated with disease progression of multiple types of cancers, including colorectal, breast, pancreatic, and head and neck cancers. FL-091 radioligands have demonstrated favorable biodistribution profiles and enhanced binding affinity to NTSR1, as well as encouraging anti-tumor activities in preclinical studies. The development of the alpha-emitter therapy candidate 225Ac-FL-091 targeting NTSR1-positive tumors is currently in progress. About Full-Life Technologies Full-Life Technologies ("Full-Life") is a fully integrated global radiotherapeutics company with operations in Belgium, Germany, and China. We aim to own the entire value chain for radiopharmaceutical research & development, production & commercialization to deliver clinical impact for patients. The Company endeavors to tackle fundamental challenges affecting radiopharmaceuticals today by pioneering innovative research that will shape the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and seasoned scientists with a proven history of success in the life sciences, alongside radioisotope research and clinical development. For more information, visit Full-Life's website at . About SK Biopharmaceuticals SK Biopharmaceuticals focuses on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts. SK Biopharmaceuticals is the first and only Korean company to independently develop and commercialize an antiseizure medication, cenobamate (brand name: XCOPRI®) in the U.S. More than 100,000 patients have been treated globally with cenobamate, developed by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, Inc., since its launch in the U.S. in 2020. Cenobamate has successfully entered five major regions: North America, Europe, Asia, Central and South America, and the Middle East and North Africa. The company also has a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, SK Biopharmaceuticals is focused on the discovery of new treatments in oncology. For more information, visit SK Biopharmaceuticals' website at , and SK Life Science's website at . SOURCE Full-Life Technologies

License out/inDrug Approval

12 Apr 2024

·www.pharmaceutical-technology.com

FDA approves new administration routes for Xcopri

Partial-onset seizure epilepsy is where seizures originate in one area of the brain, causing symptoms such as muscle jerking and altered consciousness. Credit: peterschreiber.media via Shutterstock. South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, says Louis Ferrari, SK Life Sciences vice president of medical affairs. “In some patients, crushing tablets offer an additional option for dosing and administration by nasogastric tube. This label update addresses an unmet need for this patient population and offers administration alternatives to the healthcare providers managing their care,” says Ferrari. See Also: Candel wins FDA orphan drug designation for pancreatic cancer drug FDA approves AstraZeneca’s FASENRA for asthma in children Xcopri was first approved by the FDA in November 2019 for partial-onset seizures in adults, followed by a European approval of the drug in 2021 under the name Ontozry. The treatment is commercialised by Angelini Pharma, following the acquisition of Arvelle Therapeutics, who signed an exclusive licensing agreement with SK Biopharmaceuticals worth $430m in February 2019. Angelini acquired Arvelle in a $960m deal in 2021. According to GlobalData’s Pharma Intelligence Center, Xcopri/Ontozry is forecast to generate $1.5bn in sales in 2027. GlobalData is the parent company of Pharmaceutical Technology. Partial-onset seizure epilepsy is a type of epilepsy where seizures originate in one area of the brain. Seizures can cause a variety of symptoms depending on the part of the brain affected such as muscle jerking, sensory disturbances, or altered consciousness.

Drug ApprovalOrphan DrugAcquisitionLicense out/in

100 Deals associated with Cenobamate

External Link

KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	EU	Angelini Pharma, Inc.	26 Mar 2021
Epilepsy	IS	Angelini Pharma, Inc.	26 Mar 2021
Epilepsy	LI	Angelini Pharma, Inc.	26 Mar 2021
Epilepsy	NO	Angelini Pharma, Inc.	26 Mar 2021
Seizures	EU	Angelini Pharma, Inc.	26 Mar 2021
Seizures	IS	Angelini Pharma, Inc.	26 Mar 2021
Seizures	LI	Angelini Pharma, Inc.	26 Mar 2021
Seizures	NO	Angelini Pharma, Inc.	26 Mar 2021
Epilepsies, Partial	US	SK Life Science, Inc.	21 Nov 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Epilepsy, Generalized	Phase 3	JP	Ono Pharmaceutical Co., Ltd.	12 Jul 2022
HIV Seropositivity	Phase 3	CN	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	JP	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	KR	SK Life Science, Inc.	08 Mar 2021
Epilepsy, Tonic-Clonic	Phase 3	US	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	BG	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	CZ	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	HU	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	PL	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	SK	SK Life Science, Inc.	13 Aug 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04690751 (CTgov)	Phase 1	Epilepsies, Partial	28	Cenobamate 200Mg Tab Fasted (Treatment A)	vgrnhvuhbn(ryjtoqipxx) = inncfycbmk afrqveshlj (hmocktszoo, viclzgwzsl - webnyqlrgu) View more	-	12 Aug 2024
NCT04690751 (CTgov)	Phase 1	Epilepsies, Partial	28	Cenobomate Oral Suspension Fasted (Treatment B)	vgrnhvuhbn(ryjtoqipxx) = onbntwpbio afrqveshlj (hmocktszoo, srbtccjehn - pyoznivsrh) View more	-	12 Aug 2024
NCT03678753 (Pubmed)	Phase 3	Drug Resistant Epilepsy Add-on	659	Cenobamate add-on therapy	ekagtlxoyc(eauxakpsxk) = aijxifclyi qxifhwbdjr (rpqejsmqrb, 1.02 - 1.27) View more	Positive	01 Aug 2024
NCT03678753 (Pubmed)	Phase 3	Drug Resistant Epilepsy Add-on	659	Placebo	ekagtlxoyc(eauxakpsxk) = gvceydgnoh qxifhwbdjr (rpqejsmqrb, 1.02 - 1.27) View more	Positive	01 Aug 2024
C017 (IEC2023)	Not Applicable	-	354	Cenobamate	mzftzsweil(ujwhwuupbt) = uqvrgszsxj qnsbgunmae (unwnhblyib ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Medication interactions	34	Cenobamate	uglgbswcaq(awakvpfnvs) = effects were frequent initially (35.3% ataxia, 52.9% dizziness and 64.7% drowsiness) but were drastically reduced at 12 months (3.8% ataxia, no dizziness and 33.3% drowsiness at 12 months). No skin rash was detected. aacdqkgmko (iyffmmikag )	Positive	04 Sep 2023
YKP3089-C017, YKP3089-C021 (IEC2023)	Not Applicable	Seizures	61	Cenobamate (CNB)	wpimarmuwz(qzmxjsbvde) = jfghmliinj jqeizqvkld (ixjiskhzdv ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Epilepsies, Partial Adjuvant	43	Cenobamate	zogulhlzsc(roqiraiwjf) = tsismxenlo ronwbjxyjd (sxkaiewiuu ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Drug Resistant Epilepsy	34	Cenobamate 200mg/day	pcysykguye(wqmxwfvfaa) = dqtcrkgvin vdlchtdsgd (czcmrvkzmn ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	-	-	Cenobamate	azuyhfiefr(oulwaacyfy) = judgewojhv aierhpspfd (lnvcgoqjno ) View more	-	04 Sep 2023
IEC2023	Not Applicable	Seizures	231	Cenobamate (CNB)	fpdmxuiaqq(ogzlslntqr) = wijdtrwvkq rkyxdfppgv (mecnyjiqtg ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Seizures	231	Valproate (VPA)	fpdmxuiaqq(ogzlslntqr) = avpiqcpkev rkyxdfppgv (mecnyjiqtg ) View more	Positive	04 Sep 2023
NCT01866111 (C017, IEC2023)	Phase 2	Seizures	206	Cenobamate	kyufrvavlv(djczkrqekv) = rhiqamvadr kkwykszreq (akwdkreuaw )	Positive	04 Sep 2023
NCT01866111 (C017, IEC2023)	Phase 2	Seizures	206	Placebo	kyufrvavlv(djczkrqekv) = bdaihmtbmm kkwykszreq (akwdkreuaw )	Positive	04 Sep 2023

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