A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

开始日期2024-07-25

申办/合作机构

Janssen Research & Development LLC

NCT05307692 / Completed临床2期

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, and Clinical Efficacy of Seltorexant (JNJ-42847922) on Behavioral and Psychological Symptoms of Dementia in Patients With Probable Alzheimer's Disease

The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression.

开始日期2022-05-19

申办/合作机构

Janssen Research & Development LLC

NCT05236868 / Completed临床1期

An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants

The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.

开始日期2022-02-03

申办/合作机构

Janssen Research & Development LLC

100 项与 Seltorexant 相关的临床结果

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100 项与 Seltorexant 相关的转化医学

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100 项与 Seltorexant 相关的专利（医药）

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项与 Seltorexant 相关的文献（医药）

2023-04-19·Molecules (Basel, Switzerland)

Characteristics of Seltorexant-Innovative Agent Targeting Orexin System for the Treatment of Depression and Anxiety.

Review

作者: Biala, Grazyna ; Grabowska, Karolina ; Kurowska, Antonina ; Kurowska, Michalina ; Ziemichod, Wojciech

Twenty-five years have passed since the discovery of the orexin system, during which time we have learned more and more about it. A number of studies have been conducted showing the role of the orexin system in insomnia, as well as its potential use in the treatment of obesity and depression. In this review, we present the role of the orexin system in the development of depressive illness and show the characteristics of seltorexant, a potential drug for the treatment of depression. This review describes the structure and synthesis of the compound as well as its pharmacodynamics and pharmacokinetics. Pre-clinical and clinical studies are also described, including side effects. There is evidence that the use of seltorexant is considered safe, with no clear or major clinically significant side effects, which makes it a promising candidate for the treatment of depression and anxiety disorders.

2023-01-01·Noro psikiyatri arsivi

Orexin Receptor Antagonists as an Adjunct for the Treatment of Depression: A mini meta-analysis

Review

作者: Uğurlu, Mustafa

Introduction:

There is growing interest in the efficacy of orexin receptor antagonists (ORA), one of the new psychopharmacological agents used in the treatment of insomnia, in other psychiatric disorders such as depression.

Methods:

This meta-analysis was conducted in accordance with PRISMA requirements. Literature searches were conducted using PubMed, Scopus and EBSCO (Medline) databases. Search words were (depression OR mood disorder OR affective disorder) AND (orexin OR orx OR hypocretin OR orx1 OR orx2 OR orexin receptor antagonist OR almorexant OR suvorexant OR lemborexant OR daridorexant OR seltorexant OR vornorexant OR filorexant). No date restrictions were used. The random effects model was used for analyses with I² values above 50% and fixed effects model was used for analyses with I² values below 50%.

Results:

In the acute phase, ORAs had no significant effect on core, sleep-adjusted and total symptoms of depression respectively; Standardized Mean Difference (SMD) for random effect -0.422, 95% CI [-0.90; 0.06], p=0.089, I²=62.4%; SMD for random effect -0.375, 95% CI [-1.24; 0.49], p=0.400; I²=66.6% and SMD for random effect -0.477, 95% CI [-0.97; 0.01], p=0.059; I²=83.1%). However, they had a significant effect on core and total symptoms of depression in the early period respectively; SMD for fixed effect=-0.228, 95% CI [-0.44; -0.01], p=0.036, I²=9.1%; and SMD for fixed effect=-0.186, 95% CI [-0.37; -0.001], p=0.048, I²=0.0%, respectively).

Conclusion:

The results of this meta-analysis suggest that ORAs may provide direct antidepressant efficacy when added to existing antidepressant treatment and may also have indirect antidepressant effects through improvement in sleep symptoms. Considering the physiological effects of orexin on behaviors, ORAs may be promising new treatment modalities in the treatment of many psychiatric disorders other than insomnia. However, these results are preliminary and further studies with different ORAs at different doses and with different samples are needed.

2023-01-01·CNS drugs

Orexin Receptor Antagonists in the Treatment of Depression: A Leading Article Summarising Pre-clinical and Clinical Studies

Article

作者: Jones, Edward ; Fagan, Harry ; Baldwin, David S

The orexin (hypocretin) system comprises two neuropeptides (orexin-A and orexin-B) and two G-protein coupled receptors (the orexin type 1 and the orexin type 2 receptor). The system regulates several biological functions including appetite, the sleep-wake cycle, the stress response, and motivation and reward processing. Dysfunction of the orexin system has been implicated in the pathophysiology of depression in human and animal studies, although the exact nature of this dysfunction remains unclear. Orexin receptor antagonists (ORAs) are a class of compounds developed for the treatment of insomnia and have demonstrated efficacy in this area. Three dual orexin receptor antagonists (DORAs) have received licences for treatment of primary insomnia and some ORAs have since been investigated as potential treatments for major depressive disorder (MDD). In this leading article, we summarise the existing literature on use of ORAs in depression, in pre-clinical and clinical studies. In rodent models of depression, investigated ORAs have included the DORA almorexant and TCS1102, the selective orexin 1 receptor antagonists SB334867 and SB674042 and the selective orexin 2 receptor antagonists LSN2424100, MK-1064 and TCS-OX2-29. These pre-clinical studies suggest a possible antidepressant effect of systemic DORA treatment, however the evidence from selective ORAs is conflicting. To date, four published RCTs (one with the DORA filorexant and three with the selective orexin 2 receptor antagonist seltorexant), have compared an ORA with placebo in the treatment of MDD. Only one of these demonstrated a statistically significant difference relative to placebo.

项与 Seltorexant 相关的新闻（医药）

2024-11-25

·PRNewswire

Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline | DelveInsight

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期临床结果快速通道突破性疗法

2024-11-04

·药时代

有增有减！跨国药企2024年第三季度新药管线调整总结

正文共：2434字 1图预计阅读时间： 6分钟在2024年第三季度，跨国药企对其新药管线进行了一系列的增加和删除调整，以适应不断变化的市场需求和科研进展。以下是对这些调整的详细总结。 Novartis（诺华） 2023年，诺华成功剥离山德士之后，完成了向“纯药企”定位的转型。诺华明确聚焦心血管-肾脏-代谢、免疫、神经科学和肿瘤业务四大核心治疗领域。诺华在第三季度的管线调整中，增加了几个新药项目，包括FXX489和177Lu-NNS309 Radioligand therapy用于实体瘤治疗，GIZ943针对FOLR1的放射性配体疗法，ITU512作为HbF诱导剂（WIZ降解剂）用于镰状细胞病，以及VHB937作为TREM2稳定剂和激活剂（单克隆抗体）用于肌萎缩侧索硬化症治疗。同时，诺华也从管线中删除了QGE031（ligelizumab），一种IgE抑制剂，用于食物过敏；PHE885（durcabtagene autoleucel），BCMA细胞疗法，用于4线多发性骨髓瘤；以及CMK389，IL-18抑制剂，用于肺结节病。 BMS（百时美施贵宝）百时美施贵宝在第三季度增加了BMS-986460针对去势抵抗前列腺癌的治疗，BMS-986484针对实体瘤，以及RYZ801，GPC3-225Ac。公司删除了MAGEA4/8 TCER (IMA401)，IMA401原研为Immatics，今年9月份Immatics在ESMO会议刚公布IMA401的初步临床验证数据，便遭退货。此外，还有一款TIGIT双特异性抗体以及抗IL8抗体BMS-986253均遭删除。 Roche（罗氏）罗氏在第三季度的管线调整中增加了RG6434针对神经退行性疾病，LTBR激动剂针对实体瘤，以及CDK4/2i (RGT419B)针对HR+乳腺癌。与此同时，罗氏从管线中删除了多个项目，包括tobemstomig PD1/LAG3双抗针对实体瘤，forimtamig GPRC5D/CD3双抗用于多发性骨髓瘤，RG6341 TRPA1拮抗剂用于慢性咳嗽，bepranemab抗Tau单抗用于阿尔茨海默病，ruzotolimod TLR7激动剂用于乙型肝炎病毒（HBV），xalnesiran RNAi用于HBV，PDL1 LNA用于HBV，以及HBsAg Mab用于慢性乙型肝炎。 Pfizer（辉瑞）辉瑞在第三季度，宣布自愿从目前所有获批的市场中撤回所有批次的镰状细胞病（SCD）治疗药物Oxbryta，并停止所有正在进行的临床试验和全球扩展访问计划。同时，公司还从管线中剔除了一种早期阶段的RSV和流感的组合疫苗PF-07941314；目前处在临床二期的CDK2抑制剂Tagtociclib ；下一代CDK4抑制剂PF-07220060联合内分泌治疗。 GSK（葛兰素史克）葛兰素史克在第三季度将GSK4527363，一种B细胞调节剂，用于系统性红斑狼疮，新加入到I期临床研究。公司从管线中删除了GSK5101956（肺炎球菌24价疫苗）用于成人肺炎球菌病；淋病疫苗GSK4348413，其疫苗类型显示为膜抗原（GMMA）；首款单纯疱疹病毒（HSV）疫苗GSK3943104；以及GSK3858279（抗CCL17单抗）用于骨关节炎疼痛。 Sanofi（赛诺菲）赛诺菲在第三季度移除了三项研究，包括losmapimod（p38α/β MAPK抑制剂）用于治疗面肩肱型肌营养不良（FSHD）的III期临床研究，以及oditrasertib（RIPK1抑制剂）用于多发性硬化症（MS）的II期研究。 Merck（默沙东）默克在第三季度从管线中删除了MK-8189，一种PDE10A抑制剂，用于精神分裂症，以及MK-7264（gefapixant），一种P2X3受体拮抗剂，用于咳嗽（美国）。 J&J（强生）强生在第三季度管线中删除了一款IL-17抑制剂JNJ-1459，以及三款神经科学领域的临床研究项目：包括：seltorexant治疗阿尔兹海默病的II期临床研究、P2X7拮抗剂治疗双相障碍（Bipolar Depression）的II期临床研究，以及另一项JNJ-0376治疗帕金森病的I期临床研究。其中，seltorexant是强生在研的OX2R拮抗剂，其在重度抑郁症和失眠症领域的开发已进入III期临床阶段。 Eli Lilly（礼来）礼来在第三季度从管线中删除了APOC3 siRNA，用于心血管疾病的I期研究，DC-806，一种用于银屑病的IL-17A/IL-17F蛋白-蛋白相互作用抑制剂，以及PERESOLIMAB，一种用于类风湿性关节炎的抗PD1单抗。小结对于市场而言，管线的剔除多被市场认定为“失败”，多会影响投资界与研发界的判断。当然，"砍管线”对于企业本身并非坏事，反映了药企在新药研发领域的动态变化，旨在优化管线，集中资源于最有前景的项目，并及时淘汰那些不符合预期的项目。随着临床试验的进展和市场需求的变化，我们可以预期这些药企将继续调整其管线，以保持竞争力和创新能力。封面图来源：123rf 欢迎参加进博会自身免疫、炎症和癌症首届创新药研发峰会暨JAK-STAT信号通路发现30周年庆典！ 2024-11-03 转机！FDA高级官员发话，CAR-T有望摘下 “黑框警告” 2024-11-02 复宏汉霖「地舒单抗」上市申请获FDA受理！ 2024-11-01 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩！

临床1期临床2期疫苗放射疗法

2024-11-04

·BioSpace

7 Alzheimer’s and Parkinson’s Programs Discarded in 2024

iStock/ bawanch This year has seen several biopharma companies drop Alzheimer’s and Parkinson’s disease programs, but experts say plenty are still chasing these multi-billion-dollar markets. There’s no question that the approvals of Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla generated momentum in the Alzheimer’s disease treatment space. However, this year has seen attrition in the pipelines for both Alzheimer’s and Parkinson’s disease. Roche in particular has parted with several assets for Alzheimer’s disease, recently terminating a partnership with UCB. This is the second Alzheimer’s cut this year for the Swiss pharma, which in January returned two failed assets to AC Immune. Several other companies, including Johnson & Johnson, Sage Therapeutics and Otsuka Pharmaceuticals, have also dropped programs targeting Alzheimer’s and/or Parkinson’s. But Graig Suvannevejh, senior biopharmaceuticals and biotechnology equity research analyst at Mizuho Americas, said this is not an indication of any major shifts in the R&D landscape but rather a “coincidence.” These decisions are “really dependent on data,” he told BioSpace . Several discarded Alzheimer’s and Parkinson’s programs, including AC Immune’s crenezumab, failed to produce positive data in clinical trials. “Maybe it’s also a reflection, sometimes, of what’s happening on the competitive landscape.” In terms of anti-amyloid antibody programs, such as crenezumab, Suvannevejh noted that despite the approvals of Leqembi and Kisunla, as well as Eisai and Biogen’s Aduhelm, this class has struggled to gain traction in the market. So companies may “have an evolving view of the commercial opportunity in Alzheimer’s disease,” he said. Overall, Suvannevejh said the pipelines of companies focused on Alzheimer’s disease are “okay.” While acknowledging that large pharmaceutical companies in this space do not have the “very rich, late-stage” pipelines they had three to five years ago, he said “there’s still a presence, because it is one of the few areas that could represent easily for any drug that gets approved, at least on paper, a multi-billion-dollar annual sales potential type of product.” The Alzheimer’s treatment space is projected to be worth $15.5 billion by 2031, according to iHealthcareAnalyst. As for Parkinson’s, Suvannevejh said there are around 20 therapies on the market that address the symptoms of the disease. There currently are none, however, that are disease-modifying because the underlying cause the disease is still unclear. While alpha-synuclein is the current candidate du jour , “we don’t have data yet,” he said. The global market for Parkinson’s disease drugs is currently valued at $5.56 billion and is expected to reach $6.63 billion by 2029. Parkinson’s is “still viewed as a very big commercial opportunity,” Suvannevejh said, “but so far, it’s been equally a difficult market to tap into.” Here, BioSpace takes a closer look at four companies that have recently discontinued programs for these two intractable neurodegenerative diseases. Roche Indication: Alzheimer’s disease Assets: Bepranemab, crenezumab, semorinemab In July 2020, Roche’s Genentech inked a collaboration with UCB to develop an anti-tau antibody treatment, bepranemab (UCB0107) for Alzheimer’s disease. Roche handed over $120 million upfront to UCB, with the Belgian company eligible for $2 billion based on certain regulatory approvals and other milestones. Four years later, that partnership is over. UCB revealed Roche’s decision while announcing the acceptance of an abstract for a Phase IIa study of bepranemab at the 2024 Clinical Trials on Alzheimer’s Disease conference, saying that the rights to the program had been handed back. No further details were provided. UCB isn’t the first company to receive a return from Roche this year. In January, the pharma ended its long-term collaboration with AC Immune, handing back two Alzheimer’s assets—anti-amyloid beta antibody crenezumab and anti-tau antibody semorinemab. In 2020, topline results from a Phase II trial of semorinemab showed the candidate failed to hit its primary endpoint, as well as two secondary endpoints, while crenezumab failed Phase II and III clinical trials in 2019 and 2022, respectively, according to Fierce Biotech . Long devoted to Alzheimer’s, Roche has struggled to gain a foothold in the space. A particular blow fell when gantenerumab, an investigational antibody, failed two Phase III studies in November 2022. This was the company’s second setback that year, following crenezumab’s failure to hit its co-primary endpoints in a Phase III for people with a specific gene mutation that causes early-onset Alzheimer’s. Despite all the bumps, Roche isn’t backing away from Alzheimer’s. Two other assets, RG6289 and trontinemab, are in Phase II studies. Roche touted positive data in March 2024 from a small Phase Ib/IIa study of trontinemab, reporting “rapid and robust” amyloid plaque reduction. Johnson & Johnson Indication: Alzheimer’s disease and Parkinson’s disease Assets: Seltorexant and JNJ-0376 A week before Roche parted ways with UCB, Johnson & Johnson slashed several pipeline programs in the neurology and psychiatry spaces, including seltorexant for Alzheimer’s disease and JNJ-0376 for Parkinson’s disease. Seltorexant, a human orexin-2 receptor blocker intended for the treatment of agitation or aggression in Alzheimer’s, was being studied in a Phase II trial. While a pipeline document on J&J’s website indicates it will no longer develop the drug for this indication, it will continue to evaluate seltorexant as a treatment for major depressive disorder with insomnia symptoms. Also on the chopping block was JNJ-0376, a Phase I Parkinson’s candidate the company had previously touted in a 2023 business overview presentation as having “novel mechanisms to modify, treat and/or prevent neurodegenerative disorders.” J&J did not provide further details on this program. Sage Therapeutics Indication: Alzheimer’s disease and Parkinson’s disease Asset: Dalzanemdor It hasn’t been a good year for Sage Therapeutics’ dalzanemdor. In April, the Cambridge, Mass.–based biopharma announced it would discontinue development of dalzanemdor in Parkinson’s disease after the oral drug candidate, which is intended to treat cognitive disorders associated with NMDA receptor dysfunction, failed a mid-stage trial. In the Phase II PRECEDENT study, which included 86 patients with Parkinson’s, dalzanemdor was found to be safe, but did not show any meaningful differences over placebo in any of the exploratory endpoints, including a cognition test. Six months later, dalzanemdor suffered another defeat, missing the primary endpoint in the Phase II LIGHTWAVE study in Alzheimer’s disease. According to Sage, trial data “did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo” on the same cognition test. Sage will halt further development of the asset in Alzheimer’s, according to an Oct. 8 press release . Sage has one remaining shot on goal with dalzanemdor. A Phase II study of the embattled candidate is ongoing in Huntington’s disease, with early data expected later this year. Otsuka Pharmaceutical Indication: Alzheimer’s-related agitation Asset: AVP-786 The pipeline of Japanese neuro player Otsuka Pharmaceutical is one candidate lighter after AVP-786 failed to improve agitation associated with dementia due to Alzheimer’s disease in a Phase III trial. Topline Phase III results in February 2024 showed the asset, which came to Otsuka in late 2014 in the $3.5 billion acquisition of Avanir Pharmaceuticals, did not show improvement over placebo in patients’ condition. The company announced in May it would end development of AVP-786. Otsuka is still developing brexpiprazole for agitation associated with dementia due to Alzheimer’s, which has been filed with regulatory authorities in Japan, according to the company’s pipeline document . Otsuka’s current pipeline includes candidates for schizophrenia, major depressive disorder and generalized anxiety disorder, among other psychiatric diseases, but does not list any other programs for Alzheimer’s.

临床2期并购临床3期临床结果

100 项与 Seltorexant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11269	Seltorexant	-	DB14961

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
重度抑郁症	临床3期	美国	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	阿根廷	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	比利时	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	保加利亚	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	加拿大	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	智利	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	捷克	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	丹麦	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	芬兰	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	拉脱维亚	Janssen Research & Development LLC	2020-09-15

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04533529 (ASCP2024) 人工标引	临床3期	重度抑郁症	588	Seltorexant	簾壓繭糧襯蓋淵鏇網壓(廠製範築蓋醖醖鑰鑰網): Difference = -2.6 (95% CI, -4.53 ~ -0.74), P-Value = 0.007 更多	积极	2024-05-29
				Placebo
NCT03321526 (CTgov)	临床2期	重度抑郁症	107	serotonin-norepinephrine reuptake+seltorexant (Seltorexant)	憲廠範窪窪壓憲膚鬱觸(醖製夢壓選選窪壓壓鏇) = 襯製鏇蓋築製鏇憲襯鏇網餘艱選餘糧網獵顧選 (醖淵淵網網觸齋築繭鑰, 夢衊鹽繭積襯艱遞網憲 ~ 襯鹽積願鏇鑰簾鹽憲鹽) 更多	-	2022-08-16
				Quetiapine XR (Quetiapine XR)	憲廠範窪窪壓憲膚鬱觸(醖製夢壓選選窪壓壓鏇) = 膚鬱製壓網壓網襯糧觸網餘艱選餘糧網獵顧選 (醖淵淵網網觸齋築繭鑰, 餘構選範艱襯艱觸築壓 ~ 遞壓積鹽淵製網淵廠願) 更多
NCT03375203 (CTgov)	临床2期	入睡和睡眠障碍	365	Placebo	築壓廠繭襯淵艱襯夢糧(衊蓋顧積鹽壓憲繭膚選) = 遞簾壓簾衊壓顧鑰顧壓齋餘壓餘鹽糧蓋醖衊積 (襯鹽簾鑰鹽廠顧憲範築, 蓋選襯艱積簾鹹衊築淵 ~ 顧醖醖鏇構醖願鹹襯選) 更多	-	2022-05-23
NCT03227224 (Pubmed \| Int J Neuropsychopharmacol)	临床2期	重度抑郁症	287	Seltorexant 20 mg	簾夢鑰範齋鬱顧醖鏇餘(選衊窪構獵廠鹹衊範網): LSM difference = -4.5 (90% CI, -6.96 ~ -2.07)	积极	2021-07-29
				Placebo