A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults with Developmental and Epileptic Encephalopathies

This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

Start Date11 Nov 2024

Sponsor / Collaborator

Longboard Pharmaceuticals, Inc.

NCT06660394

/ RecruitingPhase 3

This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Start Date02 Oct 2024

Sponsor / Collaborator

Longboard Pharmaceuticals, Inc.

NCT05626634

/ CompletedPhase 2

A Phase 2, Multicenter, Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Who Completed Study LP352-201 and Are Candidates for Continuous Treatment for Up to 52 Weeks

The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.

Start Date08 Nov 2022

Sponsor / Collaborator

Longboard Pharmaceuticals, Inc.

100 Clinical Results associated with Bexicaserin

100 Translational Medicine associated with Bexicaserin

100 Patents (Medical) associated with Bexicaserin

Literatures (Medical) associated with Bexicaserin

01 Feb 2025·BIOMEDICAL CHROMATOGRAPHY

A Highly Sensitive Triple Quad LC–MS/MS Method Development and Validation for the Determination of Bexicaserin (LP352) in Human Plasma and Urine Matrices

Article

Author: Neal, Katie ; Yeager, Maisy ; Chan, Rosa ; Fletcher, Katharine ; Srinivas, Nuggehally R. ; Kallem, Raja Reddy

ABSTRACT:

Bexicaserin is a highly selective agonist at the 5‐HT2c receptor in clinical development for the treatment of seizures associated with developmental and epileptic encephalopathies (DEEs). We report an LC–MS/MS method for the quantitative estimation of bexicaserin in human plasma and urine. The sample preparation involves the extraction of bexicaserin and internal standard (13CD2‐bexicaserin; IS) from 150 μL plasma and 50 μL urine using a solid phase extraction method. The chromatographic separation of bexicaserin and IS was achieved on a Poroshell EC‐C18 column using 5 min gradient program. The calibration curve ranged from 0.1 to 100 ng/mL in plasma and 1.0 to 1000 ng/mL in urine. Intraday and interday precision and accuracy, linearity, matrix effect, extraction recovery, carry‐over, dilution integrity, a battery of stability studies, and incurred sample reanalysis were performed for bexicaserin in both plasma and urine. The intraday and interday accuracy and precision were well within the acceptable limits in both plasma and urine matrices. Stability studies in plasma and urine showed that bexicaserin was stable on bench for 24 h, in autosampler over 54 h, five freeze–thaw cycles, and long‐term storage at −20°C and −80°C for > 368 days. The validated methods were successfully applied in clinical study.

01 Jan 2025·JOURNAL OF THE INDIAN CHEMICAL SOCIETY

Synthesis of magnesium oxide nanoparticles via hydrothermal and sol-gel methods: Charaterization and their application for H2S and NO2 gas sensing

Author: Shinde, Vrushali Shyamrao ; Gurule, Akanksha Changdeo ; Gaikwad, Sharad Shankar ; Jadhav, Ghanshyam Ratan ; Gaikwad, Vishwasrao Bhaskarrao ; Kajale, Dynaneshwar Dattu

Magnesium oxide nanoparticles (MgO NPs) are particularly appealing for scientific investigation due to their numerous uses in optical devices, catalysis, and gas sensing.This study describes the synthesis of pure MgO NPs using two active methods: hydrothermal and sol-gel.The work analyzes different synthesis methods, emphasizing such critical factors as reaction time, mole ratio, calcination temperature, synthesis temperature, and solvent selection for the hydrothermal process.Variations in these parameters have a major impact on MgO NPs' sensing capabilities.The constructed MgO NPs were characterized by XRD, UV-visible spectroscopy, FTIR, SEM-EDAX.The synthesis approach was convenient and effective, producing particles with average crystallite sizes ranging from 10 nm to 25 nm.The MgO band gap was optimized between 3 and 4 eV.A gas sensing unit was used to investigate the sensing properties of several gases, including ammonia, CO2, LPG, NO2, SO2, and H2S.Hydrothermally produced MgO NPs were very sensitive to H₂S gas, with the most significant reaction revealed when propanol was used as the solvent.MgO NPs produced by the sol-gel technique, on the other hand, displayed improved NO₂ gas sensitivity.

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.

News (Medical) associated with Bexicaserin

11 Mar 2025

·www.prnewswire.com

Apnimed Appoints Kevin R. Lind as Non-Executive Chairman of the Board of Directors

– Larry Miller, CEO, to Continue Serving as Non-Independent Board Director – Phase 3 SynAIRgy and LunAIRo Clinical Trials on Track for Topline Results in 2Q2025 and 3Q2025, Respectively CAMBRIDGE, Mass., March 11, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovering, developing, and commercializing first-in-class oral therapies for the neuromuscular dysfunction associated with obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced the expansion of its Board of Directors with the appointment of Kevin R. Lind as non-executive Chairman of the Board. Mr. Lind brings decades of experience from the biotech and financial sectors. "We are thrilled to welcome Kevin to Apnimed's Board," said Larry Miller, MD, Chief Executive Officer of Apnimed. "His proven leadership in biotechnology and corporate strategy will provide invaluable insights as we approach Phase 3 clinical trial results for AD109 and prepare for its potential commercial launch as a once-nightly oral therapy for OSA. Our team has been executing to our stated milestones and, most importantly, our ongoing Phase 3 trials are on track to report top-line results in 2Q2025 and 3Q2025, respectively." "Apnimed is well-positioned for growth with both its promising late-stage asset, AD109, and its synergistic partnership with Shionogi to drive long-term value," said Mr. Lind. "I am excited to join Apnimed at this pivotal time and look forward to contributing to the company's continued clinical and future commercial successes." About Kevin Lind Kevin Lind recently served as Longboard Pharmaceuticals' President and Chief Executive Officer and as a member of its board from the company's inception in 2020 until Longboard was acquired by H. Lundbeck A/S in December 2024. Prior to co-founding Longboard Pharmaceuticals, Mr. Lind served as EVP and Chief Financial Officer during the turnaround of Arena Pharmaceuticals (acquired by Pfizer) from 2016 to 2020. As an executive leader at these organizations, he successfully raised over $1.1B in equity capital (including Longboard's IPO), secured valuable business development partnerships (including ~$1B in upfront payments), spun out two organizations, and was instrumental in activities resulting in the successful acquisitions of both companies for a cumulative value of ~$9.3B. At Longboard, Mr. Lind also led the initiation of a global Phase 3 program for a neurological drug candidate, bexicaserin, and innovative drug development strategies resulting in the conceptualization of a novel medical indication and securing of Breakthrough Therapy designation from the U.S. FDA. Prior to Longboard, Mr. Lind focused on healthcare investing at TPG Special Situations Partners from 2009 to 2016 and at TPG-Axon from 2006 to 2008. He served in various capacities as a healthcare investment banker at Lehman Brothers, Inc., a former global financial services firm, from 1998 to 2002 and 2004 to 2006. Mr. Lind received a B.S. from Stanford University in Biological Sciences and an MBA from UCLA Anderson School of Management. About AD109 AD109 is a once-nightly oral pill that could be the first pharmacological treatment to improve oxygenation during sleep by directly targeting the underlying neuromuscular dysfunction that causes the upper airway to collapse in people with obstructive sleep apnea (OSA). It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. In a disease characterized by complex and invasive treatment options, AD109 may offer a simple solution to help improve oxygenation and overall health for people living with OSA. AD109 has successfully completed multiple Phase 1 and Phase 2 trials in OSA. The Phase 3 program is fully enrolled with topline results expected in mid-2025. About Obstructive Sleep Apnea Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. It has been demonstrated that OSA affects people of all body types, ages and genders —there is no single "face" of the disease. An estimated 80 million people in the United States and 1 billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, such as high blood pressure, cardiovascular disease and type 2 diabetes, along with impacts on quality of life, including daytime fatigue and impaired judgement. Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in all people with OSA. About Apnimed Apnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. This includes AD109, which is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA, as well as several therapies being developed as part of our joint venture with Shionogi & Co., Ltd, through Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Ramzi Benamar [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Executive ChangePhase 3IPO

18 Feb 2025

·endpts.com

After research pivot, Biogen beefs up pipeline with Stoke's late-stage Dravet candidate

A month after Biogen signaled plans to shift its attention to “ external opportunities ,” it delivered on that ambition. The drugmaker said Tuesday it’s paying $165 million upfront for the ex-North America rights to Stoke Therapeutics’ experimental Dravet syndrome drug. The antisense oligonucleotide (ASO), called zorevunersen, is slated to enter Phase 3 in the second quarter, with data from the pivotal program expected to land in the second half of 2027. The upfront payment extends Stoke’s runway to mid-2028, and it will help fuel the company’s launch plans in the US, Canada and Mexico, where it retains commercial rights. “This has been a longstanding process and it was very competitive,” Stoke CEO Ed Kaye said Tuesday in an interview. “When we did the assessment, the investment in rest-of-world for all of commercial and regulatory and med affairs — it was quite costly. What we had hoped for is to get a very strong partner like Biogen, who had an enormous experience in the rest of the world [and] who could guarantee a successful launch for this product.” Kaye declined to comment whether Biogen made an outright acquisition offer. “We had multiple companies that were very interested in what we were doing,” he said. He pointed to Biogen’s experience in neurology and rare diseases, citing the drugmaker’s experience with another ASO called Spinraza, which is now one of its top-selling drugs. The treatment is approved for spinal muscular atrophy and generated $1.57 billion in revenue last year. The FDA lifted a partial clinical hold on zorevunersen in August, potentially opening the door to more fruitful conversations with potential partners amid a hit-or-miss moment for the Dravet field. Back in June, Takeda and Ovid said their enzyme therapy “ narrowly missed ” the bar in a Phase 3 trial. Then, in November, Eisai axed a Phase 3 study for its Dravet candidate. At the same time, Lundbeck ponied up $2.6 billion in October to snag Longboard Pharmaceuticals and its late-stage Dravet candidate, a 5-HT2C superagonist known as bexicaserin . Compared to those therapies, Stoke’s ASO takes a different approach. It targets the SCN1A gene, which is thought to be an underlying cause of most cases of the genetic condition. Dravet syndrome is a severe form of epilepsy that can cause other developmental delays in patients, most of whom are diagnosed as infants. “Our approach is so different than everybody else,” Kaye said. “We’re not just focusing on seizure. We’re really trying to change the underlying genetic cause of the disease.” Biogen recently terminated a partnership for a different kind of epilepsy medicine. It then tried to buy that partner, Sage Therapeutics, but was rebuffed . “I think what Biogen got excited about is our approach is really the next generation of what is going to happen for the treatment of genetic epilepsy,” Kaye said. “They’re looking to fill their late-stage pipeline.” In a statement, Biogen’s head of development Priya Singhal said Stoke’s drug could be the “first disease-modifying medicine” for Dravet.

AcquisitionPhase 3OligonucleotideDrug Approval

15 Jan 2025

·www.echemi.com

Johnson & Johnson Acquires Neuropharmaceutical Company for $14.6 Billion

On January 13, Johnson & Johnson announced that it has reached a final agreement with biopharmaceutical company Intra-Cellular Therapies, which focuses on the development and commercialization of drugs for central nervous system (CNS) diseases. Under the agreement, Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies at a price of $132 per share, totaling approximately $14.6 billion. The core asset of Intra-Cellular Therapies includes the orally administered antipsychotic product Caplyta (lumateperone). This drug is a 5-HT2A receptor antagonist and D2 dopamine receptor modulator, originally developed by Bristol-Myers Squibb (BMS) and licensed to Intra-Cellular Therapies for global development in 2015. In December 2019, Caplyta was approved by the FDA for the treatment of schizophrenia in adults. In December 2021, the drug was also approved for the adjunctive treatment of depressive episodes associated with bipolar I or II disorder. Furthermore, Intra-Cellular Therapies submitted a new indication application for Caplyta to the FDA in December 2024 for the adjunctive treatment of major depressive disorder (MDD) and is exploring its use in pediatric indications and long-acting formulations. Through this acquisition, Johnson & Johnson will also gain access to several pipeline candidates, including ITI-1284, lenrispodun, ITI-1020, ITI-333, and ITI-1549, further strengthening its pipeline in neuroscience. With the surge in mental health crises and the aging global population, over 1 billion people worldwide (or 1 in every 8 individuals) suffer from neuropsychiatric or neurodegenerative diseases. This substantial patient market has attracted numerous pharmaceutical companies. For instance, in December 2023, Bristol-Myers Squibb acquired Karuna Therapeutics for $14 billion, gaining the potential new schizophrenia drug Cobenfy (formerly KarXT), which was approved by the FDA in 2024. In the same month, AbbVie purchased Cerevel for $8.7 billion, obtaining several promising candidates for diseases such as schizophrenia, Parkinson's disease, and mood disorders. However, AbbVie's flagship project emraclidine failed to meet its expected endpoints in two Phase II studies targeting schizophrenia, reflecting the high-risk nature of new drug development in the neuroscience field. In October 2024, AbbVie acquired Aliada for $1.4 billion, securing its main project for Alzheimer's disease treatment ALIA-1758 to bolster its neuroscience pipeline. Similarly, in October 2024, Langbo Pharmaceuticals acquired Longboard Pharmaceuticals for $2.6 billion, obtaining a new epilepsy drug Bexicaserin. Johnson & Johnson's $14.6 billion acquisition of Intra-Cellular Therapies will undoubtedly inject new vitality into the neuroscience field. In 2024, there was only one merger in the pharmaceutical industry exceeding $10 billion, but at the start of 2025, Johnson & Johnson has made the first significant acquisition. With the JPM conference underway, more merger transactions are expected to occur in the pharmaceutical industry in the coming days.

Drug ApprovalCell TherapyAcquisitionPhase 2Immunotherapy

100 Deals associated with Bexicaserin

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Indication	Highest Phase	Country/Location	Organization	Date
Seizures	Phase 3	US	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	CN	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	AU	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	BE	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	BR	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	CA	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	FR	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	DE	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	IT	Longboard Pharmaceuticals, Inc.	02 Oct 2024
Seizures	Phase 3	LV	Longboard Pharmaceuticals, Inc.	02 Oct 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05364021 (PACIFIC, NEWS) Manual	Not Applicable	Seizures	40	Bexicaserin	pxffgsszea(vkulshwxct) = yjquierxzs abinoozeaf (cecpjjouml ) View more	Positive	17 Jun 2024
NCT05364021 (PACIFIC, Corporate Publications) Manual	Phase 1/2	Infantile Epileptic-Dyskinetic Encephalopathy	52	LP352	qnosthwnyi(wupclrobsf) = onoxnxwjnj hxiygwlnzh (uenzzewliw ) View more	Positive	02 Jan 2024
				Placebo	qnosthwnyi(wupclrobsf) = tzsotadzyi hxiygwlnzh (uenzzewliw )
IEC2023	Not Applicable	-	-	LP352 6 mg TID	zdpjbiggdg(gdratunysz) = wzygohyiyz nehopofwet (lotcioakjd ) View more	-	04 Sep 2023
				LP352 12 mg TID	zdpjbiggdg(gdratunysz) = dduugwcuaa nehopofwet (lotcioakjd ) View more
102 (Corporate Publications) Manual	Phase 1	Epileptic encephalopathy	20	LP-352 (Cohort 1 = 6 mg)	gvrxavatwf(iufndohbiq) = Favorable safety and tolerability results were observed in this study, with adverse events (AEs) generally consistent with previous clinical studies qujxnhqnqa (gjglaqxbfi )	Positive	05 Dec 2022
				LP-352 (Cohort 2 = 12 mg)
AAN2022	Not Applicable	-	-	LP352	gaawioniwd(efgxvefuap) = mild to moderate in severity mgserzhdsl (muqdvnpvsd ) View more	Positive	03 May 2022

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