单次给药主要研究目的：考察中国健康受试者在空腹条件下，单次口服不同剂量水平的醋酸艾司利卡西平片的药代动力学（Pharmacokinetics, PK）特征和PK种族敏感性。多次给药主要研究目的：考察中国健康受试者在空腹条件下，多次口服同一剂量的醋酸艾司利卡西平片的药代动力学（Pharmacokinetics, PK）特征。

[Translation]

The main purpose of single-dose administration is to investigate the pharmacokinetic (PK) characteristics and PK ethnic sensitivity of eslicarbazepine acetate tablets at different dose levels in Chinese healthy subjects under fasting conditions. The main purpose of multiple-dose administration is to investigate the pharmacokinetic (PK) characteristics of eslicarbazepine acetate tablets at the same dose in Chinese healthy subjects under fasting conditions.

Start Date24 Sep 2024

Sponsor / Collaborator

Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd

[+1]

CTR20220017

/ CompletedPhase 3

一项多中心、随机、双盲、安慰剂对照短期研究及为期一年的开放性、非对照安全扩展研究，评价醋酸艾司利卡西平片用于成人局灶起源癫痫伴有或不伴有局灶进展为双侧强直阵挛发作添加治疗的有效性和安全性以及长期疗效和安全性

[Translation] A multicenter, randomized, double-blind, placebo-controlled short-term study and a one-year open-label, non-controlled safety extension study to evaluate the efficacy and safety of eslicarbazepine acetate tablets as add-on treatment for adults with focal epilepsy with or without focal progression to bilateral tonic-clonic seizures, as well as long-term efficacy and safety

评价醋酸艾司利卡西平片用于成人局灶起源癫痫伴有或不伴有局灶进展为双侧强直阵挛发作添加治疗的疗效。

[Translation]

To evaluate the efficacy of eslicarbazepine acetate tablets as add-on treatment for adults with epilepsy of focal origin with or without focal progression to bilateral tonic-clonic seizures.

Start Date28 Jul 2022

Sponsor / Collaborator

Shanghai ZhongXi Pharmaceutical Co. Ltd.

[+1]

CTR20201102

/ CompletedNot Applicable

醋酸艾司利卡西平片在健康受试者中随机、开放、两周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of eslicarbazepine acetate tablets in healthy subjects under fasting and fed conditions

研究空腹或餐后状态下，单次口服醋酸艾司利卡西平片受试制剂(规格：400mg，生产商：扬子江药业集团有限公司，提供商：扬子江药业集团北京海燕药业有限公司）与参比制剂（Aptiom®，规格：400mg，持证商：Sunovion Pharmaceuticals Inc. ）在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To study the pharmacokinetic behavior of the test preparation of eslicarbazepine acetate tablets (specification: 400 mg, manufacturer: Yangtze River Pharmaceutical Group Co., Ltd., provider: Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.) and the reference preparation (Aptiom®, specification: 400 mg, licensee: Sunovion Pharmaceuticals Inc.) in healthy subjects after a single oral administration in the fasting or postprandial state, and to evaluate the bioequivalence of the two preparations. To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date08 Jun 2020

Sponsor / Collaborator

Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Eslicarbazepine Acetate

100 Translational Medicine associated with Eslicarbazepine Acetate

100 Patents (Medical) associated with Eslicarbazepine Acetate

743

Literatures (Medical) associated with Eslicarbazepine Acetate

01 Apr 2025·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

Sodium channel blockers for the treatment of focal epilepsy: A Chinese expert consensus

Review

Author: Zhou, Jian ; Liao, Weiping ; Yan, Raowei ; Wu, Xintong ; Zhu, Guoxing ; Wang, Xiaoshan ; Ding, Meiping ; Wang, Yuping ; Liang, Shuli ; Xiao, Bo ; Zhang, Kai ; Zhou, Dong ; Zhu, Suiqiang ; Wang, Tiancheng ; Lin, Weihong ; Liu, Xiaorong ; Zhou, Shuizhen ; Liu, Xuewu ; Zhou, Liemin ; Wang, Xin ; Wang, Xiangqing ; Yu, Peimin ; Hong, Zhen ; Han, Xiong ; Deng, Yanchun ; Wang, Xuefeng ; Zhang, Hesheng

PURPOSE:

To provide consensus-based recommendations for the use of sodium channel blockers (SCBs) in the management of focal epilepsy.

METHODS:

A three-round modified Delphi procedure was conducted among a Delphi panel of 24 Chinese experts to build a consensus. A steering committee developed 9 statements related to SCBs for the treatment of focal epilepsy, and these statements were evaluated and voted upon by the expert panel.

RESULTS:

The expert panel achieved consensus on nine statements regarding the treatment recommendations for oxcarbazepine, lamotrigine, lacosamide, eslicarbazepine, topiramate, zonisamide and cenobamate in focal epilepsy patients and treatment adjustments for SCBs.

CONCLUSION:

This is a Chinese expert consensus on the use of SCBs in focal epilepsy developed using the modified Delphi method. These recommendations can help clinicians in their practice and guide future research.

01 Apr 2025·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Adjunctive treatment for pediatric focal epilepsy: a systematic review

Review

Author: Zhang, Xiaolu ; Wang, Zhaoxuan ; Wang, Siru ; Sun, Chunxiao ; Sun, Hu ; Liu, Chang

PURPOSE:

We aim to use a network meta-analysis to evaluate the efficacy and safety of antiseizure medications and provide a theoretical basis for rational drug use for children and adolescents in adjunctive treatment.

METHODS:

The databases of PubMed, Embase, Cochrane Library, and Web of Science were systematically searched for random clinical trials about perampanel, valproic acid, carbamazepine, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, topiramate, zonisamide, brivaracetam, cenobamate, eslicarbazepine acetate, and pregabalin from their inception until December 10, 2023. The included studies' risk of bias was evaluated by the Cochrane Collaboration's tool (RoB2). The network meta-analysis was performed using Stata 15 on the included studies.

RESULTS:

Seventeen studies were identified and of these 19 randomized controlled trials evaluating 9 different antiepileptic drugs were included. In total, 2959 patients were covered in the analysis of the outcomes. For efficacy, lacosamide (OR = 1.91, 95%CI 1.14-3.20), lamotrigine (OR = 3.82, 95%CI 1.86-7.83), levetiracetam (OR = 3.01, 95%CI 1.89-4.80), oxcarbazepine (OR = 2.75, 95%CI 1.52-4.96), perampanel (OR = 2.05, 95%CI 1.15-3.65), and zonisamide (OR = 2.27, 95%CI 1.21-4.24) were more effective than placebo in the 50% responder rate. Lamotrigine ranked first on the cumulative probability curve, followed by levetiracetam. Eslicarbazepine acetate (OR = 6.44, 95%CI 1.43-29.00) and levetiracetam (OR = 5.75, 95%CI 2.45-13.50) were better than placebo in seizure freedom. For safety, topiramate (OR = 4.11, 95%CI 1.43-11.76) and oxcarbazepine (OR = 2.72, 1.28-5.76) were more likely to cause adverse effects in children or adolescents compared to placebo.

CONCLUSION:

In terms of efficacy and safety, lamotrigine and levetiracetam may be selected preferentially for the adjunctive treatment of focal epilepsy in children and adolescents. However, owing to the limited random clinical trials, our results need to be verified by further studies.

01 Mar 2025·CNS DRUGS

Comment on: “A Prospective Longitudinal Study of the Effects of Eslicarbazepine Acetate Treatment on Bone Density and Metabolism in Patients with Focal‑Onset Epilepsy”

Letter

Author: Liu, Zhongxing ; Duan, Lincheng ; Tian, Mengzhe

News (Medical) associated with Eslicarbazepine Acetate

10 Jul 2023

·www.biospace.com

Sumitomo Pharma America Launches as New Combined Organization with Expanded Scale, Resources & Capabilities

CAMBRIDGE, Mass., July 10, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets, with topline data for two of its Phase 3 candidates in the fields of psychiatry and urology expected this quarter. The company will apply its proprietary advanced analytics and computational technology platforms to support and accelerate its diverse pipeline and commercial programs as well as needed innovations in priority areas of discovery, science, research and development. SMPA's President and Chief Executive Officer, Myrtle Potter, Chief Executive Officer of Biopharma, Adele Gulfo, and Chief Medical Officer, Armin Szegedi, were appointed as Executive Officers of Sumitomo Pharma Co., Ltd. effective July 1, 2023. Innovation Growth Engine "We are pleased to have successfully completed the combination of Sumitomo Pharma's U.S. subsidiaries to form SMPA," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Pharma. "As a Sumitomo Pharma Group growth engine, SMPA will focus on maximizing the value of the three key products early, namely, ORGOVYX®, MYFEMBREE®, and GEMTESA®. SMPA will propel scientific and therapeutic innovations to meaningfully impact the evolving health needs of patients in North America and promote development to meet the needs of patients worldwide while also delivering long-term value to society as a stronger, more profitable enterprise." "SMPA comprises some of the brightest talent in drug development, business, science, and technology, operating as one global team to push beyond industry norms and reimagine what's possible," said Myrtle Potter, President and Chief Executive Officer, Sumitomo Pharma America. "Our goal is to realize new treatments with greater benefit to patients while maximizing the potential of our key marketed and development assets to better support areas of critical need and provide potential treatment options where solutions are lacking or do not exist." Commercial Biopharma Business Adele Gulfo, Chief Executive Officer of Biopharma Commercial of Sumitomo Pharma America, said, "SMPA is poised to help solve health challenges in critical disease areas through the exceptional talents and dedication of our highly experienced cross-functional team. SMPA's broad product portfolio, including key brands, ORGOVYX®, MYFEMBREE® and GEMTESA®, will drive the growth of our business and fuel future potential investments. We are deeply committed to the patients we serve in oncology, women's health, urology, rare disease, psychiatry, and neurology, as well as our additional products APTIOM®, RETHYMIC®, and LATUDA®, which healthcare providers and patients continue to rely on." R&D & Pipeline Armin Szegedi, Chief Medical Officer of Sumitomo Pharma America, said, "SMPA has a robust and balanced pipeline, with more than 30 assets and dozens of clinical trials currently underway, to address areas of significant need in psychiatry, neurology, oncology, urology, and regenerative medicine. I am excited about the opportunities we have at SMPA to develop innovative treatments across multiple therapeutic indications, including our lead pipeline candidate, ulotaront, which is being studied in individuals living with schizophrenia, generalized anxiety disorder and the adjunctive treatment of major depressive disorder." Jatin Shah, Chief Oncology Development Officer of Sumitomo Pharma America, added, "SMPA is uniquely positioned with a strong internal discovery and translational research engine committed to the identification and development of innovative, best-in-class, oncology therapies. We are also looking forward to quickly advancing our oncology programs including, TP-3654, an investigational selective oral PIM1 kinase inhibitor, being studied for patients with myelofibrosis (MF) and DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, being evaluated for the treatment of acute myeloid leukemia (AML)." SMPA's leadership team comprises industry-leading experts with deep life sciences expertise across the business and drug development spectrum, as well as quality & manufacturing, commercialization, and data & analytics. We invite you to learn about SMPA's full leadership team and capabilities on our new website: . About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 6,000 employees worldwide. Sumitomo Pharma defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma is available through its corporate website at . Forward-Looking Statements This press release contains forward-looking statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and Sumitomo Pharma America, Inc. may make related oral, forward-looking statements on or following the date hereof. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma America, Inc. and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma America, Inc. as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma America, Inc. does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein. Sumitomo Pharma America, Inc. is a registered trademark of Sumitomo Pharma Co., Ltd. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. © 2023 Sumitomo Pharma America, Inc. All rights reserved. SMPA IR / Media Contact: Maya Frutiger VP, Head of Corporate Communications Sumitomo Pharma America, Inc. CorpComms@us.sumitomo-pharma.com View original content to download multimedia: SOURCE Sumitomo Pharma America, Inc.

Executive ChangePhase 3

20 Feb 2009

·www.pharmatimes.com

EMEA calls for Raptiva suspension, issues latest recommendations

On a busy day for the regulator, the European Medicines Agency has recommended that marketing authorisation be suspended for Merck KGaA/Genentech's psoriasis drug Raptiva over possible links between the drug and a rare but deadly brain infection. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said the benefits of Raptiva (efalizumab) no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The CHMP noted three confirmed cases of PML in patients who had taken Raptiva for more than three years, two of resulted in the patient’s death, and the agency has received an additional report of a suspected case of PML, “which could not be confirmed”. Nevertheless, following a review, the CHMP has concluded that “Raptiva’s benefits are modest”. In addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barre and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections,” the EMEA noted. It added that “there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks”. The EMEA’s call for suspension came as its counterpart in the USA, the Food and Drug Administration, issued a public health advisory about the three confirmed reports of PML and the possible fourth case. The FDA stated that it will “take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits”. Merck, which markets Raptiva in Europe, said it would work with health authorities across the continent "to undertake all necessary measures to comply with the EMEA recommendations." Earlier this week, the Darmstadt-based group noted that it had written off 195 million euros due to “sharply lower sales expectations” for the drug. Staying with the EMEA, the agency has issued the latest list of positive opinions from the CHMP. The drugs recommended for approval include Wyeth’s Conbriza (bazedoxifene) for postmenopausal osteoporosis, Bial’s anti-epileptic Zebinix (eslicarbazepine; see story on today’s elert) and Fresenius’ Removab (catumaxomab) for the removal of cancerous fluid from the abdomen. The CHMP is also recommending approval for Nycomed’s over-the-counter versions of its own heartburn drug Pantozol (pantoprazole) and Teva’s generic version of Novartis’ anti-dementia drug Exelon (rivastigmine). However, it adopted a negative opinion for Biferonex (interferon-beta-1a), from Switzerland’s BioPartners, for multiple sclerosis. BioPartners is appealing the decsion, claiming that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market".

100 Deals associated with Eslicarbazepine Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D09612	Eslicarbazepine Acetate	N03AF04	DB09119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	South Korea	Whan In Pharmaceutical Co., Ltd.	10 Nov 2020
Epilepsies, Partial	European Union	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	Iceland	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	Liechtenstein	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	Norway	BIAL-Portela & Cia SA	21 Apr 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	Phase 3	Portugal	BIAL-Portela & Cia SA	01 Nov 2010
Neuralgia, Postherpetic	Phase 3	Germany	BIAL-Portela & Cia SA	01 Sep 2010
Seizures	Phase 3	Portugal	BIAL-Portela & Cia SA	01 Jul 2004
Stroke	Phase 2	Austria	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	France	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	Germany	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	Israel	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	Italy	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	Portugal	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	Spain	BIAL-Portela & Cia SA	29 May 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IEC2023	Not Applicable	Behavioural disorders	849	Eslicarbazepine Acetate	lcahiejbpr(upvoawgbtr) = 43 reports zzebkwexee (nutrfcmhfs ) View more	-	04 Sep 2023
P14-1.003 (AAN2023)	Phase 3	Seizures	1,447	Eslicarbazepine Acetate 800mg	tzjqcdnydo(mpbeuivhmb) = Incidence of AEs and AEs leading to discontinuation increased with ESL dose wrhanflseg (ctbtingxgk ) View more	Positive	25 Apr 2023
				Eslicarbazepine Acetate 1200mg
P4-1.010 (AAN2023)	Not Applicable	Seizures	-	Eslicarbazepine Acetate 400mg/day	vibzuqupht(rnyvqejfiy) = ppttxcrzzx htsspwbboq (qqwozrcjqo, 8.6)	Positive	25 Apr 2023
				Eslicarbazepine Acetate 800mg/day	vibzuqupht(rnyvqejfiy) = cxvghajacv htsspwbboq (qqwozrcjqo, 6.2)
NCT02484001 (NCT01162460/NCT02484001; EudraCT 2009-011135-13/2015-001243-36, Pubmed \| Ther Adv Neurol Disord)	Phase 3	Seizures plasma lipid levels \| total cholesterol \| low-density lipoprotein (LDL) cholesterol	184	Eslicarbazepine acetate (ESL)	yueexoqudw(zwbggreoqe) = elcljwwrdp xehnikfncj (kerobbnlfj ) View more	Positive	01 Jan 2023
				Controlled-release carbamazepine (CBZ-CR)	yueexoqudw(zwbggreoqe) = zdihuurhgg xehnikfncj (kerobbnlfj ) View more
BIA-2093-208 \| BIA-2093-305 (EAN2022)	Phase 2/3	Seizures	-	Eslicarbazepine acetate	auckhwqqmc(kdujulmooy) = qogzgdnhba zcfmdcszlp (ogeeuuonsg ) View more	Positive	24 Jun 2022
				Placebo	auckhwqqmc(kdujulmooy) = wgzpwyiegw zcfmdcszlp (ogeeuuonsg ) View more
BIA-2093-304 (EAN2021)	Not Applicable	-	496	Eslicarbazepine acetate 800mg/day	ccuhqfqmhp(ivvlskpobq) = 7.5% in Part II and not reported in Part III ggjopmwrir (bjkeeewcno ) View more	Positive	18 Jun 2021
				Eslicarbazepine acetate 400-1600mg/day
EAN2021	Not Applicable	Pregnancy	3,986	Eslicarbazepine acetate	ptiumwwumv(ksryyeosjy) = sciektgimd mnyffootyq (kvjdnqlzmv ) View more	Positive	18 Jun 2021
EAN2021	Not Applicable	Paediatric infections	-	Perampanel 8mg/d	vdhsyeosdk(txbeegwbmm): RR = 0.97 (95% CI, 0.75 - 1.28) View more	-	18 Jun 2021
				Brivaracetam 100mg/d
NCT00957047 \| NCT00957684 \| NCT00988429 (Pubmed \| Epilepsy Res)	Phase 3	Epilepsies, Partial \| Seizures	-	eslicarbazepine acetate (Older adults (≥60 years))	upnmdlbcdr(iadrexnxxn) = yqqfxbgyfz eplrjgagew (dlcmootspx ) View more	-	01 Jan 2021
				eslicarbazepine acetate (Younger adults (18-59 years))	upnmdlbcdr(iadrexnxxn) = sumsrdcpxt eplrjgagew (dlcmootspx ) View more
NCT02484001 (Pubmed) Manual	Phase 3	Epilepsies, Partial	184	eslicarbazepine acetate (ESL/ESL)	epwbkgsava(htyngmzcyj) = vlrrieshcx hydaqypwlm (dsrqhtgglg, 0.0292 - 0.1366) View more	Positive	01 Oct 2020
				controlled-release carbamazepine+eslicarbazepine acetate (CBZ-CR/ESL)	epwbkgsava(htyngmzcyj) = rmaqoxzslm hydaqypwlm (dsrqhtgglg, 0.0180 - 0.1210) View more

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