A Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

The goal of this [clinical trial] is to [evaluate the safety and efficacy of olanzapine-samidorphan tablets] in [adults with schizophrenia]. The main question[s] it aims to answer are:
* [question 1] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine.
* [question 2] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.

开始日期2024-11-01

申办/合作机构

齐鲁制药有限公司

NCT05547100 / Completed临床1期

A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women

This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.

开始日期2022-09-14

申办/合作机构

Alkermes, Inc.

NCT05303064 / Recruiting临床3期

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM Vs Olanzapine to Evaluate Weight Gain As Assessed by Change in BMI Z-Score in Pediatric Subjects with Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

开始日期2022-06-30

申办/合作机构

Alkermes, Inc.

100 项与奥氮平萨米多芬相关的临床结果

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100 项与奥氮平萨米多芬相关的转化医学

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100 项与奥氮平萨米多芬相关的专利（医药）

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项与奥氮平萨米多芬相关的文献（医药）

2024-05-01·The American journal of emergency medicine

Precipitated opioid withdrawal in a patient started on olanzapine/samidorphan

作者: Wills, Brandon K ; Patton, Jessica ; Chambers, Andrew

BACKGROUND:

Olanzapine/Samidorphan (Lybalvi®) is a novel oral agent for the treatment of schizophrenia and bipolar I disorder. It was designed to reduce weight gain associated with olanzapine. Samidorphan is an analog of naltrexone, initially intended to treat substance use disorders by antagonizing mu, delta, and kappa opioid receptors.

CASE REPORT:

We present the case of a 36-year-old who took their first dose of olanzapine/samidorphan shortly before calling for emergency services. The patient took diphenhydramine and an epinephrine autoinjector for what they thought was an allergic reaction but continued to have symptoms. EMS reported involuntary muscle movements thought to be due to dystonia from olanzapine. In the ED, they experienced generalized muscle spasms lasting for several seconds and diaphoresis. Initially, the staff treated for a presumed dystonic reaction to olanzapine and administered diphenhydramine 25 mg IV, diazepam 2 mg IV, midazolam 5 mg IV, and benztropine 1 mg IV without improvement. It was later determined that the patient took 16 mg of buprenorphine SL daily. With this information, precipitated opioid withdrawal was felt to be the likely cause of symptoms. The patient received 16 mg of buprenorphine for an initial Clinical Opiate Withdrawal Scale (COWS) score of 11 with repeat COWS of 6. Why should an emergency physician be aware of this? Initiating olanzapine/samidorphan in the setting of chronic opioid therapy may result in precipitated opioid withdrawal. Additional SL buprenorphine may be a reasonable treatment modality.

2024-01-01·Indian journal of psychological medicine

Olanzapine-Samidorphan for Schizophrenia: A Systematic Review and Meta-Analysis

Review

作者: Gupta, Dhyuti ; Singh, Alok

Background and Objective::

United States Food and Drug Administration (USFDA) recently approved a novel combination of olanzapine-samidorphan (OLZSAM) for managing olanzapine-associated adverse events (weight gain) in adult patients with schizophrenia and bipolar disorder. To opine about the safety and efficacy of OLZSAM, authors performed a systematic review and meta-analysis to convene justifiable evidence.

Methods::

A thorough literature search was performed through the databases Embase, Cochrane Library, PubMed, and clinicaltrials.gov, from inception to September 2022, with the keywords: ‘olanzapine and samidorphan’ and schizophrenia; and “ALKS3831” and “lybalvi.” Clinical trials published in English that analyzed the efficacy and safety of OLZSAM were included. The significant outcomes included in this study were change from baseline (CFB) in Positive and Negative Syndrome Scale (PANSS) at the end of the study, the proportion of patients with weight gain at the end of the study, the proportion of patients with at least one adverse event, and the incidence of drug discontinuation due to adverse events.

Results::

The change in PANSS score at the end of the study was comparable among groups receiving OLZSAM and olanzapine alone: standardized mean difference (SMD) = 0.04; 95% CI = -0.09 to 0.17; p = 0.57. The OLZSAM group reported less incidence of weight gain: risk ratio (RR) = 0.91; 95% CI = 0.62–1.34; p = 0.63, and any adverse event: RR = 0.99; 95% CI = 0.90–1.09; p = 0.81. Drug discontinuation incidence was higher in the OLZSAM group: RR = 1.22; 95% CI = 0.84–1.79; p = 0.30.

Conclusions::

The combination OLZSAM showed comparable efficacy to olanzapine alone in schizophrenia patients, with relatively less incidence of weight gain and adverse events; however, the drug discontinuation due to adverse events was more in the OLZSAM group.

2022-06-01·Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy2区 · 化学

Spectrofluorimetric first derivative synchronous approach for determination of olanzapine and samidorphan used for treatment of schizophrenia in pharmaceutical formulations and human plasma

2区 · 化学

Article

作者: Elaraby, Manar ; Madian, Hoda ; Elkhateeb, Alshimaa E ; Rasekh, Manar I ; Mazen, Dina Z ; Samir, Ebtihal ; Salem, Hesham ; Gamal, Aliaa

The combination of olanzapine and samidorphan has just been authorised for the treatment of schizophrenia. The current study created a very accurate, sensitive and selective spectroscopic technique based on the first derivative of synchronous fluorescence for determining olanzapine and samidorphan in their pharmaceutical prescriptions without prior separation. For the quantitative analysis of samidorphan and olanzapine, the adopted approach is focused on measuring the synchronised fluorescence intensity of the examined medicines at fixed wavelength range (Δλ) = 50 nm and the first derivative's peak magnitudes were observed at 300 and 350 nm, respectively. The effects of various factors on the synchronised fluorescence intensity of the referenced medications were researched and adjusted. Both medications' calibrating charts were shown to be linear throughout a range of concentrations of 0.1-1.1 µg mL^-1. LOD for SAM and OLA were 0.02 and 0.01, respectively. In addition, LOQ was determined for SAM and OLA as follow, 0.07 and 0.06, respectively. The devised approach was effectively used to the quantitative measurement of the two medicines in Lybalvi® tablets with various samidorphan and olanzapine ratios, in addition to spiked human plasma. A variance ratio F-test and student t-test were needed to be able to compare the results to another published analytical technique and found no significant differences.

项与奥氮平萨米多芬相关的新闻（医药）

2024-10-24

·PRNewswire

Alkermes plc Reports Third Quarter 2024 Financial Results

— Third Quarter Revenues of $378.1 Million — — Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 — — Company Reiterates 2024 Financial Expectations — DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2024. "Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives," said Richard Pops, Chief Executive Officer of Alkermes. "2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the quarter were $74.7 million. Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023. ARISTADAi Revenues for the quarter were $84.7 million. VIVITROL Revenues for the quarter were $113.7 million. Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million. VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company's total debt outstanding as of Sept. 30, 2024 was $288.8 million. Share Repurchase Program During the third quarter of 2024, the company repurchased approximately 4.4 million of the company's ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025. In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society's 27th Congress, Sleep Europe 2024. In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2. In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes' website. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including drivers of shareholder value and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报临床1期临床2期临床结果

2024-09-24

·米内网

【聚焦】齐鲁入局17亿注射剂

精彩内容近日，CDE官网显示，齐鲁制药的注射用硫酸多黏菌素B以仿制3类报产获受理，该产品2023年在中国公立医疗机构终端的销售额超过17亿元。今年以来，齐鲁制药有25个品种以新注册分类提交上市/临床申请，其中12个暂无首仿（含剂型首仿）获批。硫酸多黏菌素B是一组从多黏芽孢杆菌中分离出的抗菌性多肽，通过改变细菌细胞膜通透性导致细菌死亡，主要用于绿脓杆菌及其他假单胞菌引起的创面、尿路以及眼、耳、气管等部位感染，也可用于败血症、腹膜炎等。米内网数据显示，注射用硫酸多黏菌素B已被纳入国家医保乙类目录，目前仅上药第一生化拥有生产批文。该产品近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端迅速放量，2021年突破10亿元，2022-2023年均超过17亿元。近年来中国公立医疗机构终端注射用硫酸多黏菌素B销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局仿制药申报方面，有10家企业的注射用硫酸多黏菌素B以新注册分类报产在审，包括倍特药业、汇宇制药、利泰尔药业、亿帆生物、华北制药、齐鲁制药、健康元药业、Xellia制药、四川上善六经医药、湖南埃威格林医药。米内网数据显示，今年以来，齐鲁制药已有25个品种以新注册分类提交上市/临床申请，涵盖10个治疗大类，集中在神经系统药物（6个）、全身用抗感染药物（5个）、心脑血管系统药物（4个）等治疗领域。 2024年至今齐鲁制药以新分类申报的品种来源：米内网中国申报进度（MED）数据库 25个品种中，瑞卢戈利片、奥氮平萨米多芬片、来特莫韦注射液、阿巴帕肽注射液、芦曲泊帕片、布瑞哌唑片、布瑞哌唑口崩片、丙酸氟替卡松鼻喷雾剂、醋酸地非法林注射液、注射用奥氮平、立他司特滴眼液、西尼莫德片12个品种暂无仿制药（以药品名称计）获批；注射用硫酸多黏菌素B、来特莫韦片、美阿沙坦钾片、丁酸氯维地平脂肪乳注射液等品种目前拥有生产批文的国内企业仅有1家。资料来源：米内网数据库、CDE官网等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至9月24日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

专利侵权

2024-08-26

·PRNewswire

Schizophrenia Market: RISVAN's Approval Has Sparked a Competitive Race Among Pharmaceutical Companies | DelveInsight

The recent approval of Rovi Pharmaceuticals Laboratories' OKEDI/RISVAN (risperidone ISM) has spiked the competition among the other pharmaceutical companies that are developing novel therapies to improve the treatment landscape. RISVAN has the potential to become a blockbuster drug. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- Schizophrenia is a severe mental illness affecting about 1% of Americans, cognitive functions, emotional responses, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women. Currently, as per the WHO, the vast majority of schizophrenia patients around the world are not receiving mental health care. Approximately 50% of people in mental hospitals have a schizophrenia diagnosis, and only 31.3% of people with psychosis receive specialist mental health care. As per DelveInsight analysis, in 2023 the total diagnosed prevalent cases of schizophrenia in the 7MM were found to be approximately 4 million cases out of which the US accounted for nearly 1.5 million cases. It is anticipated that these numbers will rise by 2034 due to several factors, including population growth, improved diagnostic techniques, increased awareness, and reduced stigma around mental health issues prompting more individuals to seek diagnosis, and potentially, environmental stressors contributing to a higher occurrence of the disorder. Schizophrenia treatment involves a blend of medication, psychological counseling, and social support. However, nearly one-third of patients do not respond sufficiently to standard treatments. Relapses, characterized by psychotic symptoms and functional impairments, are significant. Schizophrenia treatment mainly consists of antipsychotic medications that target dopamine neurotransmitters. Second-generation medications are favored because they lower the risk of severe side effects. Long-acting injectable antipsychotics can enhance adherence and improve treatment outcomes. High-dose regimens of specific medications may be advantageous for patients with severe, treatment-resistant schizophrenia. Additionally, hospitalization and electroconvulsive therapy might be necessary for patients who do not respond to medication therapy or during severe episodes. First-generation antipsychotics like chlorpromazine, fluphenazine, haloperidol, and perphenazine are effective in treating positive symptoms such as hallucinations and delusions but do not alleviate negative symptoms or cognitive impairments. Second-generation antipsychotics, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), and LYBALVI (olanzapine and samidorphan), were developed to address both positive and negative symptoms, as well as cognitive symptoms. Although these medications typically have fewer extrapyramidal side effects, they can cause weight gain, sexual dysfunction, and other metabolic disorders. Additionally, elderly patients using FGAs and SGAs are at an increased risk of developing pneumonia. Learn more about the FDA-approved schizophrenia drugs @ Drugs for Schizophrenia Treatment REXULTI (brexpiprazole) is an oral tablet available in strengths from 0.25 mg to 4 mg, containing various inactive ingredients. While its exact mechanism of action is not fully understood, it work as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors and as an antagonist at serotonin 5-HT2A receptors. REXULTI was first approved in the US in July 2015 for use in adults with MDD and schizophrenia. In January 2022, it received FDA approval for pediatric patients aged 13–17. The EMA approved it in July 2018, and Japan approved it in tablet form in January 2018 and as an oral-disintegrating dose in August 2021. Generic versions of REXULTI have now been approved, which may affect its market presence. Janssen Pharmaceutical's INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA (paliperidone palmitate) is an SGA agent that seems to act as a D2 partial agonist and a 5-HT-2A receptor antagonist. INVEGA SUSTENNA is administered monthly, INVEGA TRINZA every three months, and INVEGA HAFYERA twice yearly. Paliperidone is a benzisoxazole derivative. In the EU and Japan, INVEGA SUSTENNA is marketed as XEPLION. In the EU, INVEGA TRINZA is sold as TREVICTA, and in Japan as XEPLION TRI. INVEGA HAFYERA is a long-acting injectable treatment administered in the upper buttocks every six months, providing continuous treatment and symptom control over this period. Additionally, the recent approval of RISVAN (Risperidone ISM) has intensified the competition in the schizophrenia treatment space. Risperidone ISM is a long-acting injectable antipsychotic created and patented by ROVI for treating schizophrenia in adults. From the first injection, it delivers immediate and sustained plasma drug levels without the need for loading doses or additional oral risperidone. This approval is based on the positive outcomes of the pivotal PRISMA-3 study, which assessed the efficacy and safety of Risperidone ISM in patients with schizophrenia. The study's findings demonstrate that the two doses tested (75 mg and 100 mg administered once monthly) successfully met the predetermined primary and secondary efficacy endpoints for treating patients with moderate to severe schizophrenia symptoms. Furthermore, OKEDI (risperidone ISM) was launched in Germany, the UK, and Spain in 2022. The approval was based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of risperidone ISM in schizophrenia patients. As per the estimates by Delveinsight analysts, this drug has blockbuster potential in the schizophrenia market with medium-fast uptake. To know more about schizophrenia treatment options, visit @ New Treatment for Schizophrenia The schizophrenia market is crowded with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Boehringer Ingelheim's Iclepertin (BI-425809), Sumitomo Pharma/Otsuka's Ulotaront (SEP-363856), Reviva Pharmaceuticals' Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma's Roluperidone (MIN-101/MT-210), Karuna Therapeutics (Bristol Myers Squibb)/Royalty Pharma's KarXT (xanomeline-trospium), ACADIA Pharmaceuticals' NUPLAZID (pimavanserin), Teva Pharmaceutical/MedinCell/Royalty Pharma's Olanzapine LAI (mdc-TJK/TV-44749), Neurocrine Biosciences/Mitsubishi Tanabe Pharma's Valbenazine (NBI-98854), Lyndra Therapeutics' LYN-005 (long-acting oral risperidone), Newron Pharmaceuticals' Evenamide (NW-3509), Luye Pharma's LY03010 (ER paliperidone palmitate), and others. Discover which therapies are expected to grab major schizophrenia market share @ Schizophrenia Market Report Iclepertin (BI 425809) is an investigational drug and a glycine transporter 1 (GlyT1) inhibitor aimed at addressing the brain biology related to cognitive symptoms in schizophrenia (CIAS). Abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in this condition. Enhancing NMDA receptor function could potentially improve synaptic plasticity and cognition. Glycine, an essential NMDA receptor co-agonist, is modulated by glycine transporters GlyT-1 and GlyT-2, which are located in presynaptic and astrocyte membranes. These transporters regulate glycine levels by taking it up into nerve terminals and adjacent glial cells, affecting synaptic cleft glycine concentration. By inhibiting these transporters, BI 425809 aims to increase glycine levels, thereby modulating NMDA receptor function. Administered orally, this potent and selective GlyT1 inhibitor is also under investigation for Alzheimer's disease. However, early 2020 Phase II trial results did not support its continued development for this indication, and the focus has now shifted to schizophrenia, with multiple Phase III trials currently underway. Since schizophrenia, patients frequently ignore certain symptoms, such as cognitive impairment. Therefore, if approved, BI-425809 will be the first approved pharmacotherapy for the treatment of CIAS. Ulotaront (SEP-363856), developed by Sumitomo Pharma and Otsuka Pharmaceuticals, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Ulotaront is currently in late-stage development for schizophrenia and generalized anxiety disorder (GAD) in Japan and as an adjunctive treatment for major depressive disorder, schizophrenia, and GAD in the US. Top-line results from Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia have been released, but the Phase III DIAMOND 3 trial in the US has been halted. Sumitomo Pharma has also stopped a Phase III trial for schizophrenia in Japan and another Phase II/III trial in China, Japan, Taiwan, and the Philippines, citing business strategy reasons. Despite this, two Phase III trials are still ongoing. Recently, Otsuka and Sumitomo revised their licensing agreement, excluding SEP-4199 and SEP-378614. Under this revision, Otsuka gained exclusive rights from SMPA to develop, manufacture, and commercialize ulotaront worldwide. If Otsuka successfully develops and commercializes ulotaront, they will pay up to 30 million USD (approximately 4.5 billion yen) in milestones, along with royalties based on sales, without any upfront payment. Starting January 2024, Otsuka will cover the full cost of studies conducted by both Sumitomo Pharma Group and Otsuka, except for certain studies. KarXT (xanomeline–trospium) is an oral modulator targeting muscarinic receptors found in both the central nervous system (CNS) and various peripheral tissues. This proprietary product combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS. As a dual M1/M4 muscarinic acetylcholine receptor agonist, KarXT aims to improve the positive, negative, and cognitive symptoms of schizophrenia. The US FDA has accepted Karuna Therapeutics' NDA for KarXT for adult schizophrenia treatment, with a PDUFA date of September 26, 2024. Additionally, KarXT is undergoing multiple Phase III trials as an adjunctive treatment with standard-of-care agents for schizophrenia and is being evaluated for psychosis treatment in Alzheimer's disease patients. Following Bristol Myers Squibb's acquisition of Karuna Therapeutics, Karuna is now a wholly-owned subsidiary of BMS. At the Annual Congress of the Schizophrenia International Research Society (SIRS) in April 2024 in Italy, BMS presented promising results from the latest interim analysis of the Phase III EMERGENT-4 open-label extension trial, showing KarXT's efficacy in reducing symptoms in adults with schizophrenia. BMS plans to continue discussions with the US FDA and will release more data from the EMERGENT program later this year. Discover more about drugs for schizophrenia in development @ Schizophrenia Clinical Trials The anticipated launch of these emerging therapies for schizophrenia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the schizophrenia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for schizophrenia is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Schizophrenia market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Schizophrenia 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 schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Schizophrenia Total Diagnosed Prevalent Cases of Schizophrenia Gender-specific Diagnosed Prevalent Cases of Schizophrenia Severity-specific Diagnosed Prevalent Cases of Schizophrenia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia 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 schizophrenia 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 schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space. Related Reports Schizophrenia Pipeline Schizophrenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others. Schizophrenia Epidemiology Forecast Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 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 dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Bipolar Depression Market Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, 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

临床3期临床2期临床结果上市批准引进/卖出

100 项与奥氮平萨米多芬相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	国家/地区	公司	日期
躁郁症1型	美国	Alkermes, Inc.	2021-05-28
精神分裂症	美国	Alkermes, Inc.	2021-05-28

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适应症	最高研发状态	国家/地区	公司	日期
精神障碍	临床3期	美国	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	奥地利	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	德国	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	爱尔兰	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	以色列	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	意大利	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	波兰	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	俄罗斯	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	韩国	Alkermes, Inc.	2017-06-08
精神障碍	临床3期	西班牙	Alkermes, Inc.	2017-06-08

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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


NCT03201757 (CTgov)	临床3期	躁郁症1型 \| 精神分裂症 \| 精神障碍	523	ALKS 3831	齋願觸願網範夢憲夢鏇(膚觸鏇顧膚鹹網淵鏇願) = 襯壓鑰鏇窪獵鬱膚醖獵膚膚範窪鹽鏇構廠淵鑰 (觸夢窪積衊衊獵觸獵鏇, 膚遞夢積範積蓋淵築製 ~ 範構艱淵觸獵窪鏇積範) 更多	-	2024-09-26
PRNewswire 人工标引	临床3期	精神分裂症	523	LYBALVI (two-year)	艱網餘願遞蓋觸壓齋艱(遞壓網膚齋鑰鹽鏇鬱襯) = 繭餘範糧遞製構鏇蓋壓夢簾觸鏇壓鹹願憲衊襯 (選範憲願壓糧製獵願壓 ) 更多	积极	2024-04-08
				LYBALVI (four-year)	艱網餘願遞蓋觸壓齋艱(遞壓網膚齋鑰鹽鏇鬱襯) = 廠網鏇鹹鹹齋鹹憲製製夢簾觸鏇壓鹹願憲衊襯 (選範憲願壓糧製獵願壓 ) 更多
PRNewswire 人工标引	临床3期	躁郁症1型 \| 精神分裂症 \| 精神障碍	523	LYBALVI	鹽鏇窪簾築製範積觸網(簾遞蓋衊鏇餘窪壓壓窪) = Patients' symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment(mean change from baseline in CGI-S score of -0.28). 獵糧遞衊願壓艱憲簾願 (糧齋糧鑰構夢願齋鬱簾 ) 更多	积极	2024-01-03
NCT03187769 (CTgov)	临床3期	躁郁症1型 \| 精神分裂症 \| 精神障碍	426	ALKS 3831 (ALKS 3831)	選繭鏇醖繭簾鑰壓製願(夢蓋遞積糧鹹遞齋鬱製) = 壓憲製鑰鏇範鏇觸製衊獵鏇襯範衊鬱築窪鑰齋 (糧顧鬱鑰構製夢廠選鏇, 構選襯餘繭顧網糧鑰觸 ~ 鬱艱蓋廠積壓蓋繭鏇齋) 更多	-	2023-01-19
				Olanzapine (Olanzapine)	選繭鏇醖繭簾鑰壓製願(夢蓋遞積糧鹹遞齋鬱製) = 積網衊壓築範願膚壓構獵鏇襯範衊鬱築窪鑰齋 (糧顧鬱鑰構製夢廠選鏇, 選鹽觸襯範獵鬱繭顧網 ~ 衊醖廠襯鹹壓構憲網鑰) 更多
NCT02161718 (CTgov)	临床2期	酒精使用障碍 \| 精神分裂症	300	ALKS 3831+Olanzapine+Samidorphan (ALKS 3831)	獵襯願構築壓憲餘範觸(衊願觸鏇鏇簾襯繭衊廠) = 築艱顧齋獵淵鹽壓選觸鏇鏇築憲遞選鬱選蓋選 (顧選夢網製鬱網窪窪選, 窪鑰觸蓋顧獵構襯繭廠 ~ 願範廠夢憲廠衊憲繭壓) 更多	-	2021-10-08
				Placebo+Olanzapine (Olanzapine + Placebo)	獵襯願構築壓憲餘範觸(衊願觸鏇鏇簾襯繭衊廠) = 廠築夢遞顧鹹鏇醖鏇顧鏇鏇築憲遞選鬱選蓋選 (顧選夢網製鬱網窪窪選, 窪繭膚齋遞構鏇製窪襯 ~ 壓選範廠廠艱淵選構艱) 更多
NCT02873208 (CTgov)	临床3期	精神分裂症	266	ALKS 3831	鹽艱艱艱選餘膚窪廠構(窪製鏇鏇積築憲艱淵獵) = 餘鏇鹹鏇觸鹽鬱壓鏇醖鹽築壓鑰選齋顧鹹窪製 (觸膚壓顧醖鬱積觸醖襯, 鑰廠簾構壓鑰構鹽蓋齋 ~ 窪鑰餘築築窪壓觸獵鹹) 更多	-	2021-07-21
NCT02694328 (Pubmed \| Am J Psychiatry) 人工标引	临床3期	精神分裂症	561	olanzapine/samidorphan	鹽選繭獵範遞顧淵鬱壓(齋夢膚網壓廠窪獵構鹽) = 壓鏇鹽窪糧鬱網衊鹽艱簾鏇遞齋窪窪艱築顧簾 (繭廠觸繭糧醖衊網壓鬱, 0.68) 更多	优效	2020-12-01
				olanzapine	鹽選繭獵範遞顧淵鬱壓(齋夢膚網壓廠窪獵構鹽) = 壓鹽衊獵糧廠鹽糧鏇觸簾鏇遞齋窪窪艱築顧簾 (繭廠觸繭糧醖衊網壓鬱, 0.67) 更多
NCT02694328 (ENLIGHTEN-2, CTgov)	临床3期	精神分裂症	561	Olanzapine (Olanzapine)	夢簾艱簾繭壓製淵壓網(築繭範鹽鬱窪窪願鬱獵) = 構淵獵壓鹹窪鏇鬱顧願鏇構鏇鬱網鏇遞夢糧鏇 (醖鹽鏇廠觸獵鹽簾膚壓, 壓糧築鑰淵範鏇廠淵築 ~ 艱製壓繭鑰簾夢鑰憲糧) 更多	-	2020-02-10
				ALKS 3831 (ALKS 3831)	夢簾艱簾繭壓製淵壓網(築繭範鹽鬱窪窪願鬱獵) = 願膚繭鹹艱積齋糧繭糧鏇構鏇鬱網鏇遞夢糧鏇 (醖鹽鏇廠觸獵鹽簾膚壓, 簾製構衊鬱鹽鹹觸鬱餘 ~ 艱顧艱鹹鹹簾範鏇觸鹽) 更多
NCT02669758 (CTgov)	临床3期	精神分裂症	281	ALKS 3831	淵廠淵獵築範醖廠壓齋(蓋構築壓鹽醖網憲積蓋) = 壓築廠簾淵積襯製構淵觸鏇窪製網壓廠夢顧鏇 (製淵衊觸餘顧壓積範艱, 簾鬱鬱夢艱壓憲簾獵醖 ~ 襯積顧鬱鏇構糧製廠廠) 更多	-	2019-07-09
NCT02634346 (CTgov)	临床3期	精神分裂症	403	ALK3831 (ALKS 3831)	製鬱範鑰選積夢築遞廠(製鹽醖窪鏇觸淵壓積顧) = 鹹製觸製繭蓋築觸窪憲繭積鹽選築夢網艱鬱淵 (選觸繭衊餘積膚構顧艱, 網繭築願襯觸淵鹽壓願 ~ 積醖餘選積鑰壓鹹膚膚) 更多	-	2018-06-27
				Olanzapine (Olanzapine)	製鬱範鑰選積夢築遞廠(製鹽醖窪鏇觸淵壓積顧) = 餘獵鏇簾遞壓憲衊鏇遞繭積鹽選築夢網艱鬱淵 (選觸繭衊餘積膚構顧艱, 襯醖積鬱願鏇鏇獵鏇鹽 ~ 選鏇壓壓簾廠顧獵觸觸) 更多