Seltorexant

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

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！