The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment.
The primary goals of this study are:
1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor
2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death

开始日期2025-12-01

申办/合作机构

University of Nebraska

[+1]

NCT05630794

/ Not yet recruiting临床1期IIT

Phase 1 Trial of ONC201 for Chemoprevention of Colorectal Cancer

This phase I trial tests the safety, side effects, and best dose of Akt/ERK Inhibitor ONC201 (ONC201) in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

开始日期2025-03-30

申办/合作机构

National Cancer Institute

NCT04629209

/ Withdrawn临床2期IIT

A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma

This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30 evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5 days off per week schedule.

开始日期2024-06-28

申办/合作机构

University of Minnesota Masonic Cancer Center

[+1]

100 项与 Dordaviprone 相关的临床结果

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100 项与 Dordaviprone 相关的转化医学

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100 项与 Dordaviprone 相关的专利（医药）

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248

项与 Dordaviprone 相关的文献（医药）

2025-04-22·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Mechanism of allosteric activation in human mitochondrial ClpP protease

Article

作者: Kim, Angelina S. ; Vahidi, Siavash ; Feng, Yue ; Velyvis, Algirdas ; Uday, Adwaith B. ; Forrester, Taylor J. B. ; Kimber, Matthew S. ; Jitkova, Yulia ; Currie, S. Quinn W. ; Schimmer, Aaron D. ; Harkness, Robert W. ; Zeytuni, Natalie ; Goncalves, Monica M.

Human ClpP protease contributes to mitochondrial protein quality control by degrading misfolded proteins. ClpP is overexpressed in cancers such as acute myeloid leukemia (AML), where its inhibition leads to the accumulation of damaged respiratory chain subunits and cell death. Conversely, hyperactivating ClpP with small-molecule activators, such as the recently discovered ONC201, disrupts mitochondrial protein degradation and impairs respiration in cancer cells. Despite its critical role in human health, the mechanism underlying the structural and functional properties of human ClpP remains elusive. Notably, human ClpP is paradoxically activated by active-site inhibitors. All available structures of human ClpP published to date are in the inactive compact or compressed states, surprisingly even when ClpP is bound to an activator molecule such as ONC201. Here, we present structures of human mitochondrial ClpP in the active extended state, including a pair of structures where ClpP is bound to an active-site inhibitor. We demonstrate that amino acid substitutions in the handle region (A192E and E196R) recreate a conserved salt bridge found in bacterial ClpP, stabilizing the extended active state and significantly enhancing ClpP activity. We elucidate the ClpP activation mechanism, highlighting a hormetic effect where substoichiometric inhibitor binding triggers an allosteric transition that drives ClpP into its active extended state. Our findings link the conformational dynamics of ClpP to its catalytic function and provide high-resolution structures for the rational design of potent and specific ClpP inhibitors, with implications for targeting AML and other disorders with ClpP involvement.

2025-04-01·JOURNAL OF CLINICAL PHARMACOLOGY

Relative Bioavailability of Dordaviprone (ONC201) is Not Affected by Co‐Administration of the Proton‐Pump Inhibitor Rabeprazole

Article

作者: Mullin, Mark J. ; Morrison, Marion ; Faison, Shamia L. ; Batonga, Joelle ; Naderer, Odin ; Bartkus, Angela ; Arumugham, Thangam ; Tippin, Tim

Abstract:

Dordaviprone (ONC201) is a novel, orally administered, anti‐cancer, small molecule imipridone with demonstrated antitumor effects in patients with glioma. Dordaviprone in vitro solubility is significantly reduced at pH >4.5. Concomitant use of acid reducing agents (ARAs) may therefore impact dordaviprone solubility and bioavailability. This open‐label, single‐sequence, three‐period crossover study evaluated the effect of proton‐pump inhibitor rabeprazole on dordaviprone pharmacokinetics (PK). Periods were consecutive and comprised of period 1 (days 1‐3), period 2 (days 4‐9), and period 3 (days 10‐13). In period 1, participants received a single oral 625 mg dose of dordaviprone on day 1. In period 2, participants received six consecutive days of QD 20 mg rabeprazole alone. In period 3, patients received one oral dose of 20 mg rabeprazole (the seventh consecutive daily dose), followed 2 h later by a single 625 mg dordaviprone oral dose. PK blood samples were collected and analyzed from pre‐dose 72 h following dordaviprone administration in periods 1 and 3. Dordaviprone exposure PK parameters were similar following administration of dordaviprone alone or with rabeprazole. Geometric mean ratios and 90% CIs for dordaviprone exposure parameters with and without rabeprazole following dordaviprone administration fell within bioequivalence limits of 80.00%‐125.00% for Cmax (97.19% [86.43‐109.28]), AUClast (102.21% [95.19‐109.75]), and AUCinf (102.27% [95.21‐109.86]), indicating no effect of multiple oral doses of rabeprazole on dordaviprone relative bioavailability. Six of the 16 participants reported treatment‐emergent adverse events (TEAEs); dordaviprone‐related TEAEs were reported by three participants and were limited to mild nausea and dizziness. No dordaviprone dose adjustment or ARA treatment modification is warranted.

2025-04-01·LANGMUIR

Substitution of Alkylphenol Polyoxyethylene Ethers with Bio-Based Surfactants: Their Synthesis, Properties, and Performance Evaluation

Article

作者: Chen, Ming ; Fan, Cunwei ; Sun, Jie ; Zhang, Hao ; He, Wei ; Gao, Ji ; Li, Zhenjiang ; Yang, Qingbiao ; Guo, Kai ; Zhang, Zhen

The growing demand for sustainable, biodegradable, and low-toxicity products has accelerated innovations in bioderived chemicals and materials. Since the restriction of alkylphenol polyoxyethylene ethers, substituting these surfactants with safer, greener, and more eco-friendly chemicals has been a goal for researchers to strive. Herein, we report three biobased nonionic surfactants (PAHA-EO, PAOA-EO, and PAIA-EO) derived from the esterification of renewable biomass phloretic acid and straight- or branched-chain fatty alcohols followed by alkoxylation. The chemical structures of PAHA-EO, PAOA-EO, and PAIA-EO were confirmed by ¹HNMR and FT-IR spectra. A comprehensive characterization of their physicochemical properties, including surface activity, aggregation behavior, and adsorption parameters, was performed. Surface tension measurements revealed critical micelle concentration (CMC) values of 0.51 mmol/L, 0.31 mmol/L, and 0.42 mmol/L for PAHA-EO, PAOA-EO, and PAIA-EO, respectively. Dynamic light scattering (DLS) and transmission electron microscopy (TEM) analyses demonstrated that these surfactants form spherical micelles in aqueous solutions at concentrations exceeding their CMC. The wetting properties of the three surfactants were evaluated through the measurement of the dynamic contact angle, with the resulting θ_t values for PAHA-EO, PAOA-EO, and PAIA-EO being 58.3°, 54.6°, and 55.4°, respectively. Finally, the emulsification capacity of these surfactants was evaluated, and the biobased surfactants showed excellent emulsion stability to emulsions prepared from hexadecane, olive oil, and soybean oil. Compared with traditional alkylphenol polyoxyethylene ethers (OP-10 and NP-10), these biobased surfactants exhibit comparable surface activity and wettability while surpassing them in emulsification efficiency, demonstrating promising potential as high-performance sustainable alternatives.

140

项与 Dordaviprone 相关的新闻（医药）

2025-04-23

·医药健闻

罗氏宣布500亿美元投资计划；捷迈邦美12亿美元收购Paragon 28；阿斯利康重症肌无力抗体新药在华获批 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态罗氏集团(Roche)周二表示，计划未来五年在美国投资500亿美元，这是迄今为止跨国公司为应对特朗普关税政策而宣布的在美国的最大的投资举措之一。这家瑞士制药巨头表示，这项投资将创造超过12000个新工作岗位，其中包括近6500个建筑工作岗位，以及1000个新建和扩建设施的工作岗位。全球骨科巨头捷迈邦美Zimmer Biomet宣布，已完成对Paragon 28的收购，该交易价值12亿美元。Paragon 28拥有广泛的手术产品和系统，涵盖足部和踝部所有主要领域，包括骨折和创伤、畸形矫正以及关节置换。全球足踝骨科市场估计为50亿美元，并且正在迅速增长。通过收购Paragon 28，捷迈邦美获得了进入这一专业领域的机会，使其产品组合多样化，超越了髋关节、膝关节和脊柱等传统骨科。Jazz Pharmaceuticals plc 宣布以约9.35亿美元的现金成功完成对Chimerix，Inc. 的收购。Chimerix现在是Jazz的全资子公司。将Chimerix引入为Jazz的肿瘤产品组合增添了一种新型药物。Dordaviprone 可能成为第一个也是唯一一个获得FDA批准的H3 K27M 突变弥漫性神经胶质瘤患者的疗法，如果获得批准，将提供有前途的近期商业机会。瑞典生物技术公司Biotage宣布，KKR Funds间接全资拥有的新成立公司RWK BidCo AB以每股145瑞典克朗的价格提出现金收购要约，收购金额达116亿瑞典克朗（约合12亿美元）。声明称，Biotage董事会建议股东接受该收购要约。华兰股份与甘李药业签订战略合作协议，结成长期友好的战略合作伙伴，初始期限为3年。其中，在初始期限内，甘李药业拟向华兰股份采购笔式注射器用溴化丁基橡胶活塞2亿支，此数量仅为预测数量，不具有约束力承诺。具体采购价格、订单数量以实际下达订单为准。上海交通大学医学院附属仁济医院与蚂蚁集团已打造全国首个泌尿专科智能体，该智能体采用上海仁济医院97.6%疾病谱的标准化病例数据集，以及20多个专科医生撰写的场景疾病知识图谱，将三甲医院诊疗逻辑与AI技术结合。产业动态仿制药行业警告称，美国对药品征收关税可能导致包括癌症治疗在内的药品短缺，制造商可能会停止生产因此变得无利可图的产品。仿制药是不再受专利保护的药品的廉价版本，约占美国药品供应的90%。大多数是在美国以外的印度等低成本国家制造的。产品中使用的活性成分通常来自中国。到目前为止，药品尚未受到美国大范围新关税的影响。但美国总统特朗普一再表示，他计划对该行业征收关税，美国商务部也表示正在调查药品进口对国家安全的影响。诺和诺德宣布已向美国FDA提交口服版GLP-1减肥药物的上市申请。这款药物是其注射型减肥针Wegovy（司美格鲁肽）的口服版本，距离2023年5月公布关键3期临床试验成功结果已过去近两年。根据试验数据，口服司美格鲁肽最高剂量（50mg）组患者在64周内体重减轻15%。礼来首席执行官David Ricks表示，礼来将在美国生产其研究性口服肥胖药物Orforglipron。他补充说，如果获得批准，礼来将能够在全球范围内大规模推出Orforglipron，而不会因潜在的美国新关税而导致供应中断。礼来将在今年年底前将其提交给FDA，并在2026年推出。阿斯利康宣布，长效C5补体抑制剂伟立瑞（瑞利珠单抗注射液）在中国正式获批与常规治疗药物联合用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。目前，瑞利珠单抗已在美国、欧盟、日本等国家和地区获批用于治疗抗AChR抗体阳性的gMG成人患者，并在全球多个国家和地区获批多项适应症。阿斯利康宣布，中国国家药品监督管理局于2025年4月15日正式批准荃科得（卡匹色替片）联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后12个月内复发的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者。百时美施贵宝宣布，PD-1抑制剂欧狄沃（纳武利尤单抗注射液）获得中国国家药品监督管理局（NMPA）批准新增适应症：联合含铂化疗作为新辅助治疗，术后继续以欧狄沃作为单药辅助治疗，用于治疗可手术切除的Ⅱ、ⅢA和ⅢB期且无已知表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）重排的成人非小细胞肺癌（NSCLC）患者。该获批基于CheckMate-77T研究，这是继CheckMate-816后，又一项证实欧狄沃方案用于可切除非小细胞肺癌，可带来显著获益的III期研究。上海医药公告，下属子公司上海上药中西制药有限公司收到美国食品药品监督管理局的通知，其盐酸缬更昔洛韦片的简略新药申请已获得批准。该药品主要用于治疗成人获得性免疫缺陷综合症患者的巨细胞病毒视网膜炎，并预防存在CMV感染风险的实体器官移植患者的CMV感染。亚盛医药宣布，公司自主研发的两款创新药均获纳入2025年中国临床肿瘤学会（CSCO）系列指南：在研品种新型口服Bcl-2选择性抑制剂Lisaftoclax（APG-2575）首次获《CSCO淋巴瘤诊疗指南》推荐。公司原创1类新药、新一代酪氨酸激酶抑制剂（TKI）奥雷巴替尼片（商品名：耐立克）获《CSCO儿童及青少年白血病诊疗指南》升级推荐；延续《CSCO恶性血液病诊疗指南》相关推荐。Gene Solutions宣布在《JCO Oncology Advances》发表了一项开创性的真实世界研究成果，验证了ctDNA是一种强有力的预后生物标志物，可在癌症管理期间有效监测患者。K-TRACK是一项基于循环肿瘤DNA（ctDNA）技术的突破性检测，旨在提供价格可及的肿瘤基因图谱分析和个性化癌症监测。这项研究是亚洲同类研究中的首例，验证了K-TRACK在癌症早期及晚期阶段均具有重要的临床价值。联系美通社+86-10-5953 9500info@prnasia.com

并购

2025-04-21

·investor.jazzpharma.com

Jazz Pharmaceuticals Completes Acquisition of Chimerix

- Addition of dordaviprone strengthens Jazz's late-stage oncology pipeline and reinforces commitment to addressing rare diseases with significant unmet need - DUBLIN, April 21, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") today announced the successful completion of its acquisition of Chimerix, Inc. ("Chimerix") for approximately $935 million in cash. Chimerix is now a wholly owned subsidiary of Jazz. "Bringing Chimerix into Jazz adds a novel medicine to our oncology portfolio and advances our efforts to address unmet patient needs," said Bruce Cozadd, chairman and chief executive officer of Jazz. "Dordaviprone has the potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and offers a promising near-term commercial opportunity, if approved. We are excited to welcome Chimerix's talented team as we collectively continue to advance dordaviprone, leveraging our development and commercial capabilities to deliver this therapy to patients as soon as the second half of this year." The addition of dordaviprone, a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, further diversifies and adds near-term commercial opportunity to Jazz's oncology pipeline. Dordaviprone is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. If approved in the U.S., the therapy may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV). Dordaviprone is also being studied in the ongoing Phase 3 ACTION trial to evaluate its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting. Transaction Details Jazz's tender offer for all outstanding shares of common stock, par value $0.001 per share, of Chimerix expired at one minute after 11:59 p.m., Eastern Time, on April 17, 2025. Jazz has accepted for payment of $8.55 per share, in cash, without interest and subject to reduction for any applicable withholding taxes, all shares that were validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Jazz completed the acquisition of Chimerix through the merger of Pinetree Acquisition Sub, Inc., a Delaware corporation, an indirect wholly owned subsidiary of Jazz ("Purchaser") with and into Chimerix (the "Merger"). As a result of the Merger, the separate existence of Purchaser ceased, and Chimerix continued as the surviving corporation and an indirect wholly owned subsidiary of Jazz. Additional details regarding the tender can be found in a form 8-K filed by Jazz today with the SEC. About Dordaviprone Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Dordaviprone's unique mechanism of action includes alterations of key epigenetic modifications such as reversal of H3 K27me3-loss, which is the hallmark of H3 K27M-mutant gliomas. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Caution Concerning Forward-Looking Statements This communication contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Jazz and Chimerix, including statements regarding the prospective benefits of the acquisition, including benefits from dordaviprone's potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and its potential to offer a promising near-term commercial opportunity; the potential for a near-term commercial launch of dordaviprone in the U.S. if approved; the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of dordaviprone in recurrent H3 K27M-mutant diffuse glioma and extend its use in first-line patients; dordaviprone potentially being eligible for a Rare Pediatric Disease PRV; and other statements that are not historical facts. Actual results could differ materially from those anticipated in these forward-looking statements. Risks that may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that Jazz and Chimerix will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; the effects of the transaction on relationships with employees, customers, suppliers, other business partners or governmental entities; significant transaction costs; unknown or inestimable liabilities; the risk of litigation and/or regulatory actions related to the acquisition; effectively launching and commercializing products and product candidates such as dordaviprone, if approved; the successful completion of development and regulatory activities with respect to dordaviprone; obtaining and maintaining adequate coverage and reimbursement for Jazz's products; the time-consuming and uncertain regulatory approval process, including the risk that Chimerix's NDA for dordaviprone seeking accelerated approval for treatment of H3 K27M-mutant diffuse glioma in adult and pediatric patients with progressive disease following prior therapy may not be approved by FDA in a timely manner or at all, and that Chimerix and/or Jazz may not receive a Rare Pediatric Disease PRV upon potential approval of dordaviprone; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients, including with respect to current and planned future clinical trials of dordaviprone; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Jazz's business operations and financial results; and other risks and uncertainties affecting Jazz, including those described from time to time under the caption "Risk Factors" and elsewhere in its filings and reports with the U.S. Securities and Exchange Commission, including Jazz's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and future filings and reports. Other risks and uncertainties of which the Company is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements made in this press release are made only as of the date hereof, even if they are subsequently made available by the Company on its website or otherwise. The Company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Contacts Investors: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc InvestorInfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-completes-acquisition-of-chimerix-302433612.html SOURCE Jazz Pharmaceuticals plc

临床3期上市批准并购优先审批

2025-04-04

·PRNewswire

March Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including Novo Nordisk's affordable semaglutide initiative and the fifth anniversary of COVID-19. NEW YORK, April 4, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, March 2025. Photos provided by iHealth Labs, Inc., Garmin International, Inc. and Eggland's Best. Novo Nordisk introduces NovoCare® Pharmacy, lowering cost of all doses of FDA-approved Wegovy® (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients Amidst the dangers of fake or illegitimate compounded "semaglutide," NovoCare® Pharmacy offers reliable access to authentic, FDA-approved Wegovy® in a once-weekly, single-dose pen. National Resident Matching Program® Releases the 2025 Main Residency Match® Results, Celebrates the Next Generation of Physicians A record number of 52,498 applicants registered for the Match (a 4.1% increase from 2024) to learn where they will begin their medical training. The Cigna Group Completes Sale of Medicare Businesses to HCSC The transaction is not expected to disrupt coverage or service for customers, clients, providers, or brokers of the Medicare or CareAllies businesses. Pleio Unveils OLLIE™: AI That Listens, Learns, and Guides To Elevate Human Connection in Patient Medication Journeys Powered by AI, OLLIE™ analyzes conversations to deliver critical information about patient sentiment, confidence levels, and emotional barriers that impact medication adherence — a challenge that contributes to up to 69% of all medication-related hospitalizations in the U.S. Capstan Medical Achieves Milestone: World's First Robotic Catheter Mitral Valve Replacements Successfully Completed The landmark completion is the first time a minimally invasive robotic structural heart platform has been used in clinical practice, successfully delivering a novel mitral valve into two human patients. Labcorp Announces Acquisition of Select Assets of BioReference Health's Innovative Oncology and Related Clinical Testing Services Businesses Labcorp will acquire BioReference Health's laboratory testing businesses focused on oncology and oncology-related clinical testing services across the United States. The assets that Labcorp will be acquiring currently generate approximately $85 million to $100 million in annual revenue. Ajax Health and KKR Form New Platform to Develop System for Treating Heart Failure The new entity, FlowMod, intends to accelerate the creation, clinical validation, and regulatory approval for a system treating heart failure, a condition that affects pumping action of the heart muscles and currently impacts 64 million people worldwide. Boston Scientific announces agreement to acquire SoniVie Ltd. The TIVUS™ system was developed by SoniVie to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension, and is expected to further expand Boston Scientific's interventional portfolio. AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity The partnership marks AbbVie's entrance into the obesity field. Robert A. Michael, chief executive officer, AbbVie, said, "At AbbVie, we are focused on transforming the future of patient care in areas where significant unmet need persists." Mallinckrodt and Endo to Combine to Create a Global, Scaled, Diversified Pharmaceuticals Leader "The combination of Mallinckrodt and Endo brings together two essential pharmaceuticals organizations to accelerate value creation for our shareholders, customers, employees, the patients we serve and our other stakeholders," said Siggi Olafsson, President and Chief Executive Officer of Mallinckrodt. Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms Pulsed field ablation (PFA) uses high energy electrical pulses for ablation procedures that may offer benefits to targeting and treating tissue in the heart. Designed to overcome limitations of existing systems, Abbott's Volt™ PFA System provides a new therapy option for people battling heart rhythm disorders. Sun Pharma to Acquire Checkpoint Therapeutics "We are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC [metastatic cutaneous squamous cell carcinoma] patients in need of a differentiated immunotherapy treatment option," said James Oliviero, President and Chief Executive Officer of Checkpoint. RamSoft Partners with Alpha Nodus to Automate Prior Authorizations Using AI This collaboration will provide RamSoft's over 750 global healthcare sites access to Alpha Nodus's AI-powered tools, including automated document processing, cost estimates, prior authorizations, and scheduling. Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 IGNITE Study in Adults with Moderate to Severe Atopic Dermatitis The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio "If approved, dordaviprone [Chimerix's lead clinical asset] has the potential to rapidly become a standard of care for a rare oncology disease and also contribute durable revenue beginning in the near-term," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics In addition to the newsworthy headlines above, the PR Newswire team identified several trends shaping health industry news in March: COVID-19 Five-Year Milestone: It may be five years since the pandemic's onset, but medical research shows no signs of slowing down when it comes to the treatment and prevention of COVID-19. Pharmaceutical companies like Soligenix and Inovio presented breakthrough findings showcasing their ongoing efforts to develop more effective booster treatments and monoclonal antibodies. Diving deeper into clinical impacts, CalciMedica reported critical data for severe COVID-19 pneumonia patients. Consumer health preparedness also remained a priority with iHealth's at-home testing making health monitoring easier than ever. World Sleep Day: Did you snooze your alarm on World Sleep Day, March 14? If so, catch up with these dream-worthy insights. The National Sleep Foundation shed light on the critical intersection of sleep health and overall well-being. New research also highlighted a concerning statistic: 31% of Americans diagnosed with sleep apnea are not receiving treatment. Brands like Garmin and Love to Dream leveraged the awareness day to promote innovative sleep solutions, showcasing that a good night's rest isn't just a luxury, it's a necessity. National Nutrition Month: From grocery carts to fitness apps, press releases in March were geared towards making healthy eating more accessible. Celebrating National Nutrition Month, the American Diabetes Association and Instacart simplified nutritious shopping, while MyFitnessPal revealed surprising nutritional blind spots and Eggland's Best partnered with Club Pilates. From CVS's innovative weight management program to GENYOUth's mission to secure student nutrition, we noticed nutrition awareness becoming increasingly personalized, making healthy eating less of a puzzle. Looking ahead: April is full of must-follow awareness initiatives including World Health Day (April 7) and National Minority Health Month. April 1 also marks the beginning of National Autism Awareness Month and National Stress Awareness Month. We anticipate significant wire activity around these initiatives, with releases likely spotlighting health equity, innovative medical technologies and mental health and wellness. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. 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临床结果临床3期并购免疫疗法

100 项与 Dordaviprone 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14844

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
组蛋白H3中K27M点突变的弥漫性中线胶质瘤	申请上市	美国	Chimerix, Inc.	2024-12-30
弥漫内生性脑桥神经胶质瘤	临床3期	丹麦	Chimerix, Inc.	2022-09-29
弥漫内生性脑桥神经胶质瘤	临床3期	法国	Chimerix, Inc.	2022-09-29
弥漫内生性脑桥神经胶质瘤	临床3期	西班牙	Chimerix, Inc.	2022-09-29
弥漫内生性脑桥神经胶质瘤	临床3期	瑞典	Chimerix, Inc.	2022-09-29
脑膜瘤	临床2期	美国	Chimerix, Inc.	2025-12-01
复发性胶质瘤	临床2期	美国	The University of California, San Francisco	2021-10-20
复发性胶质瘤	临床2期	澳大利亚	The University of California, San Francisco	2021-10-20
复发性胶质瘤	临床2期	以色列	The University of California, San Francisco	2021-10-20
复发性胶质瘤	临床2期	荷兰	The University of California, San Francisco	2021-10-20

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临床结果

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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


NCT03485729 (CTgov)	临床2期	复发性子宫内膜癌	27	Dordaviprone (Arm B)	壓鏇齋繭繭夢遞窪鏇壓 = 積蓋壓選鏇憲窪窪壓遞遞鏇選選艱衊醖憲衊鬱 (廠願製壓餘壓鹽獵範構, 願繭網淵醖艱網願壓艱 ~ 糧選網鬱淵積壓簾憲鬱) 更多	-	2024-12-24
				Dordaviprone (Arm A)	範積齋醖鏇構遞繭鏇憲(餘襯膚選艱醖憲網醖憲) = 鑰繭廠憲糧築襯壓艱製鹹選鑰製蓋淵壓憲艱築 (鬱蓋築觸憲構遞衊築糧, 遞齋遞壓窪窪糧齋齋網 ~ 蓋憲繭遞範蓋鬱獵鏇襯) 更多
NCT02525692 (PATH-25 \| ACTR-51, CTgov)	临床2期	组蛋白H3中K27M点突变的弥漫性中线胶质瘤 \| 基底神经节疾病 \| 复发性胶质母细胞瘤	84	Dordaviprone (Arm A)	衊觸廠遞餘淵鹽構願選 = 膚窪憲繭遞繭獵鏇簾膚夢構壓鑰選積網醖膚襯 (衊選願衊積餘艱遞鹹蓋, 範齋膚壓膚製壓廠簾夢 ~ 憲觸範衊艱餘繭繭夢積) 更多	-	2024-12-24
				Dordaviprone (Arm B)	衊觸廠遞餘淵鹽構願選 = 醖鬱繭憲壓繭鹹蓋繭鏇夢構壓鑰選積網醖膚襯 (衊選願衊積餘艱遞鹹蓋, 網遞膚餘廠醖顧憲艱齋 ~ 鹹構壓糧艱繭廠築簾艱) 更多
NCT03034200 (CTgov)	临床2期	神经内分泌肿瘤 \| 嗜铬细胞瘤	30	ONC201 (Arm A: Metastatic PC-PG)	築鬱壓鹽鏇衊餘鑰襯衊(選蓋壓鑰網鑰憲淵窪遞) = 憲顧遞獵膚壓簾鑰簾顧膚鹽淵醖觸壓鬱餘構顧 (齋簾構鬱鏇積願顧築製, 願廠衊壓膚願顧網積醖 ~ 艱選膚憲選鬱觸構築膚) 更多	-	2024-11-26
				ONC201 (Arm B: Other NETs)	築鬱壓鹽鏇衊餘鑰襯衊(選蓋壓鑰網鑰憲淵窪遞) = 繭遞壓糧艱壓糧網襯鏇膚鹽淵醖觸壓鬱餘構顧 (齋簾構鬱鏇積願顧築製, 築夢鏇積蓋鏇願壓餘膚 ~ 襯廠蓋鹹壓範選窪餘鏇) 更多
NCT05580562 (ACTION, ASTRO2024)	临床3期	组蛋白H3中K27M点突变的弥漫性中线胶质瘤	50	ONC201	積積鏇襯糧鹹鹽艱鏇觸(範製壓構鑰夢憲糧衊衊) = 廠壓選鬱鑰蓋鑰簾簾積鹽構鹹範獵製醖網觸蓋 (膚鏇構鹹鹹願築鑰網製 )	积极	2024-10-01
				Standard Radiotherapy Dosing Regimens	積積鏇襯糧鹹鹽艱鏇觸(範製壓構鑰夢憲糧衊衊) = 壓製網淵鬱糧壓鹹糧憲鹽構鹹範獵製醖網觸蓋 (膚鏇構鹹鹹願築鑰網製 )
NCT02863991 (CTgov)	临床1/2期	复发性多发性骨髓瘤	17	ONC201+Dexamethasone (Phase 1: 375 mg ONC201 + 20 mg Dexamethasone)	鏇齋構鹹範積廠餘觸齋 = 廠醖網繭遞窪鏇鏇襯構遞憲鑰壓壓遞簾夢鬱淵 (艱選壓鏇夢網鏇糧醖範, 壓醖鹽膚齋構齋積壓積 ~ 願淵構鬱選襯網憲範憲) 更多	-	2024-07-03
				ONC201+Dexamethasone (Phase 2: 625 mg ONC201 + 20 mg Dexamethasone)	鏇齋構鹹範積廠餘觸齋 = 糧鹹簾積壓製獵壓艱築遞憲鑰壓壓遞簾夢鬱淵 (艱選壓鏇夢網鏇糧醖範, 鹽鹽糧壓願顧簾餘遞憲 ~ 淵選醖餘築遞選衊夢顧) 更多
NCT05009992 (Biospace) 人工标引	临床2期	弥漫性中线胶质瘤一线	132	paxalisib in combination with ONC201 (Cohort 1)	選願蓋廠鬱膚齋鑰衊鑰(選鬱選製製廠積簾網艱) = 艱艱窪範糧製鑰淵鑰夢範齋網衊夢窪醖齋艱淵 (艱遞簾艱艱範淵鏇窪鑰 )	积极	2024-06-27
				paxalisib in combination with ONC201 (Cohort 2)	選願蓋廠鬱膚齋鑰衊鑰(選鬱選製製廠積簾網艱) = 廠憲鏇艱襯襯鹹鬱選鹽範齋網衊夢窪醖齋艱淵 (艱遞簾艱艱範淵鏇窪鑰 )
NCT05009992 (SNO2023) 人工标引	临床2期	弥漫性中线胶质瘤	68	ONC201+paxalisib	顧觸鹹廠窪衊鹽繭鏇廠(網觸製廠觸範選蓋膚繭) = 襯衊鬱壓齋鑰糧廠衊餘夢繭廠範壓窪衊製選壓 (願蓋鏇積繭選壓壓簾積, lower 11.6) 更多	积极	2023-11-10
TMET-02 (SNO2023)	N/A	脑干胶质瘤 H3K27M-mutant	71	ONC201 monotherapy	窪鑰網鹽廠選衊範繭壓(顧鑰積構糧簾鑰衊膚願) = 糧簾餘膚願顧遞獵蓋積範艱築築鑰觸衊繭簾製 (顧網選淵築壓範鏇糧餘 ) 更多	积极	2023-11-10
NCT03394027 (Pubmed)	临床2期	转移性乳腺癌 \| 晚期子宫内膜癌	30	ONC201	網餘夢築簾製觸淵衊憲(餘簾窪獵蓋壓觸獵膚齋) = all patients experienced 鹹鏇範壓構廠築醖醖膚 (製簾鬱蓋憲網顧膚鬱獵 )	不佳	2023-06-05
NCT03416530 \| NCT03134131 (CTNI-61, SNO2022)	临床2期	脑干胶质瘤 EGFR mutation \| EGFR expression \| MAPK-pathway alterations ... 更多	75	ONC201	壓觸獵淵範構餘衊艱憲(繭壓窪願齋淵獵製網遞) = high EGFR expression as a marker of resistance and improved response in tumors with MAPK-pathway alterations 簾製鏇窪製構積簾壓醖 (壓鑰淵構廠獵齋獵選衊 ) 更多	积极	2022-11-14
				ONC201 (Historical Control)