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 Date26 Aug 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

122

Literatures (Medical) associated with Cenobamate

01 Mar 2024·Epilepsy & behavior : E&B

Efficacy and safety of six new antiseizure medications for adjunctive treatment of focal epilepsy and epileptic syndrome: A systematic review and network meta-analysis

Review

Author: Li, Qifu ; Liu, Jiaqi ; Li, Zongjun ; Tong, Jingyi ; Chen, Yibin ; Lu, Na ; Ji, Tingting ; Liu, Ting

OBJECTIVE:

This study aimed to evaluate the efficacy and safety of six new antiseizure medications (ASMs) for adjunctive treatment in adult patients with focal epilepsy and adolescents with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), or tuberous sclerosis complex (TSC).

METHODS:

A comprehensive literature search was performed using PubMed, Medline, Embase, and Cochrane library databases from inception to October 13, 2023. We included published studies for a systematic review and a network meta-analysis (NMA). The efficacy and safety were reported in terms of a 50% response rate and dropout rate along with serious adverse events (SAEs). The outcomes were ranked with the surface under the cumulative ranking curve (SUCRA).

RESULTS:

Twenty eligible trials with 5516 patients and 21 interventions, including placebo, contributed to the analysis. Included ASMs were brivaracetam (BRV), cenobamate (CBM), cannabidiol (CBD), fenfluramine (FFM), everolimus (ELM), and soticlestat (SLT). The six new ASMs were compared in four different epilepsy subtypes. In focal epilepsy treatment, BRV seemed to be safe [vs placebo, risk ratio (RR) = 0.69, 95 % confidence interval (CI): 0.25-1.91] and effective (vs placebo, RR = 2.18, 95 % CI: 1.25-3.81). In treating focal epilepsy, CBM 300 mg was more effective at a 50 % response rate (SUCRA 91.8 %) compared with BRV and CBD. However, with the increase in dosage, more SAEs (SUCRA 85.6 %) appeared compared with other ASMs. CBD had good efficacy on LGS (SUCRA 88.4) and DS (SUCRA 66.2), but the effect on adult focal epilepsy was not better than that of placebo [vs placebo, RR = 0.83 (0.36-1.93)]. The NMA indicated that the likelihood of the most appropriate intervention (SUCRA 91.2 %) with minimum side effects（SUCRA 12.5 %）for the DS was FFM. Compared with CBD, high exposure to ELM demonstrated a more effective treatment of TSC (SUCRA 89.7 %). More high-quality SLT studies are needed to further evaluate the efficacy and safety. The comparison-adjusted funnel plots of annualized relapse rate and side effects in the included studies revealed no significant funnel plot asymmetry.

CONCLUSIONS:

This NMA indicated that the most effective treatment strategy for focal epilepsy, DS, Lennox-Gastaut syndrome, and TSC, respectively, included CBM 300 mg, FFM, CBD, and ELM. However, the aforementioned findings need further confirmation.

01 Feb 2024·Epilepsy & behavior : E&B

Cognitive and psychiatric adverse events during adjunctive cenobamate treatment in phase 2 and phase 3 clinical studies

Article

Author: Chung, Steve S ; Ferrari, Louis ; Krauss, Gregory L ; Rosenfeld, William E ; Stern, Sean

OBJECTIVE:

Cognitive and psychiatric adverse events in patients with epilepsy are important determinants of therapeutic outcomes and patient quality of life. We assessed the relationship between adjunctive cenobamate treatment and selected cognitive and psychiatric treatment-emergent adverse events (TEAEs) in adults with uncontrolled focal epilepsy.

METHODS:

This was a retrospective analysis of pooled populations of patients with focal epilepsy from two phase 2, randomized, double-blind clinical trials; two open-label extensions (OLEs) of those trials; and a long-term, open-label, phase 3 safety study. Occurrence of cognitive and psychiatric TEAEs in patients treated with adjunctive cenobamate or placebo during double-blind treatment were evaluated. Exposure-adjusted incidence rates of the cognitive and psychiatric TEAEs, defined as the number of TEAEs per patient-year of treatment, during up to 7 years of long-term adjunctive cenobamate treatment, were determined in the pooled OLE and phase 3 patient populations.

RESULTS:

The pooled randomized trials resulted in a population of 442 patients treated with cenobamate (100 mg/day: n = 108; 200 mg/day: n = 223; 400 mg/day: n = 111) and 216 placebo-treated patients. The combined open-label studies resulted in pooled populations of cenobamate-treated patients ranging from n = 1690 during Year 1 to n = 103 during Year 7. Among cenobamate-treated (all doses) and placebo-treated patients during double-blind treatment, cognitive TEAEs were reported by ≤ 1.9 % (range, 0 %-1.9 %) and ≤ 0.5 % (range, 0 %-0.5 %), respectively, and psychiatric TEAEs by ≤ 3.6 % (range, 0 %-3.6 %) and ≤ 3.2 % (range, 0 %-3.2 %), respectively. During up to 7 years of open-label adjunctive cenobamate treatment, exposure-adjusted incidence rates of cognitive and psychiatric TEAEs were < 0.018 and < 0.038 events per patient-year, respectively. Discontinuation of adjunctive cenobamate due to cognitive or psychiatric TEAEs assessed in this study during double-blind or open-label treatment occurred in ≤ 0.3 % and ≤ 1.7 % of patients, respectively.

CONCLUSIONS:

Cognitive and psychiatric TEAEs were reported by similar numbers of cenobamate- and placebo-treated patients during double-blind adjunctive cenobamate treatment (< 4 % of patients), and exposure-adjusted incidence rates of these TEAEs remained low during open-label cenobamate treatment for up to 7 years. Treatment discontinuations due to these TEAEs were rare. The results of this post-hoc analysis indicate that adjunctive cenobamate treatment exhibits a low incidence of cognitive or psychiatric TEAEs in patients with uncontrolled focal seizures.

01 Jan 2024·European journal of pharmacology

Cenobamate enhances the anticonvulsant effect of other antiseizure medications in the DBA/2 mouse model of reflex epilepsy

Article

Author: Leo, Antonio ; Gallelli, Luca ; Bosco, Francesca ; Citraro, Rita ; Guarnieri, Lorenza ; Rania, Vincenzo ; De Sarro, Giovambattista ; De Sarro, Caterina

Clinical studies documented that cenobamate (CNB) has a marked efficacy compared to other antiseizure medications (ASMs) in reducing focal seizures. To date, different aspects of CNB need to be clarified, including its efficacy against generalized seizures. Similarly, the pattern of drug-drug interactions between CNB and other ASMs also compels further investigation. This study aimed to detect the role of CNB on generalized seizures using the DBA/2 mouse model. We have also studied the effects of an adjunctive CNB treatment on the antiseizure properties of some ASMs against reflex seizures. The effects of this adjunctive treatment on motor performance, body temperature, and brain levels of ASMs were also evaluated. ^CNB was able to antagonize seizures in DBA/2 mice. CNB, at 5 mg/kg, enhanced the antiseizure activity of ASMs, such as diazepam, clobazam, levetiracetam, perampanel, phenobarbital, topiramate, and valproate. No synergistic effects were observed when CNB was co-administered with some Na⁺ channel blockers. The increase in antiseizure activity was associated with a comparable intensification in motor impairment; however, the therapeutic index of combined treatment of ASMs with CNB was more favorable than the combination with vehicle except for carbamazepine, phenytoin, and oxcarbazepine. Since CNB did not significantly influence the brain levels of the ASMs studied, we suggest that pharmacokinetic interactions seem not probable. Overall, this study shows the ability of CNB to counteract generalized reflex seizures in mice. Moreover, our data documented an evident synergistic antiseizure effect for the combination of CNB with ASMs including phenobarbital, benzodiazepines, valproate, perampanel, topiramate, and levetiracetam.

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.

to view more data

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.

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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	-	28	Cenobamate 200Mg Tab Fasted (Treatment A)	falcrdrekm(jxsjgydleq) = jmihbvqypq qikbiotuee (fchvnnncgr, firfdqcugz - xkxzflppra) View more	-	12 Aug 2024
NCT04690751 (CTgov)	Phase 1	-	28	Cenobomate Oral Suspension Fasted (Treatment B)	falcrdrekm(jxsjgydleq) = dvqzedriwu qikbiotuee (fchvnnncgr, wydsrzdtvd - jveefhfkdv) View more	-	12 Aug 2024
NCT03678753 (Pubmed)	Phase 3	Drug Resistant Epilepsy Add-on	659	Cenobamate add-on therapy	vhiqvpjkvx(unyzjsmzqu) = cjmrygsfxp tfaqdsemoo (nwnznjrldf, 1.02 - 1.27) View more	Positive	01 Aug 2024
NCT03678753 (Pubmed)	Phase 3	Drug Resistant Epilepsy Add-on	659	Placebo	vhiqvpjkvx(unyzjsmzqu) = msmerqbdgf tfaqdsemoo (nwnznjrldf, 1.02 - 1.27) View more	Positive	01 Aug 2024
C017 (IEC2023)	Not Applicable	-	354	Cenobamate	kznmqunegh(lxtongtfhj) = cexnxtimks rjnhrfydme (khevuyknty ) View more	Positive	04 Sep 2023
NCT01866111 (C017, IEC2023)	Phase 2	Seizures	206	Cenobamate	ytltqvquoz(mcatdgpxja) = xqjovyjanp exjkjhmuma (gmdnswrrhr )	Positive	04 Sep 2023
NCT01866111 (C017, IEC2023)	Phase 2	Seizures	206	Placebo	ytltqvquoz(mcatdgpxja) = kegxebepmq exjkjhmuma (gmdnswrrhr )	Positive	04 Sep 2023
IEC2023	Not Applicable	Epilepsies, Myoclonic Add-on pathogenic variants in the α subunit of the voltage-gated sodium channel gene SCN1A	4	Cenobamate	mbdwannfsc(rfsilyfysn) = No severe adverse events occurred baziflavto (prdmmvsvjf ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Seizures	-	Cenobamate 300 mg/d	ydkvdyzwwb(gtkfozbpgl) = lobwgxgdvj jinvrjuccp (dxgyuatktd ) View more	-	04 Sep 2023
IEC2023	Not Applicable	-	64	Cenobamate	gklpjzmfcq(ngnkgpnncq) = akeycocxko ojgmvkybir (cyooapbozt ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Epilepsies, Partial Adjuvant	43	Cenobamate	flberjvndj(mzgdomstsc) = tdgunxrxbw hsuuanitmh (cruhtkbjcs ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	-	-	Cenobamate	ryjnjojywm(zoearnpoqb) = syxkibqbyy mduityfswx (vnpgsxomsj ) View more	-	04 Sep 2023
IEC2023	Not Applicable	-	-	Cenobamate	epsrrhxwxz(ubgcfjcpax) = gaanxwufdm chcowzuzjm (dfjojnmtyh ) View more	-	04 Sep 2023

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