主要目的 Ib期确定注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松在复发或难治性的多发性骨髓瘤（RRMM）患者中的最大耐受剂量（MTD），IIa期推荐剂量（RP2D）。 IIa期进一步评价RP2D剂量注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松在复发或难治性多发性骨髓瘤（RRMM）患者中的初步有效性。次要目的 Ib期 1.评价注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松在治疗复发或难治性多发性骨髓瘤（RRMM）患者中的安全性和耐受性； 2.评价注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松后在复发或难治性多发性骨髓瘤（RRMM）患者中的药代动力学指标和药效学指标； 3.观察注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松在复发或难治性多发性骨髓瘤（RRMM）患者中的疗效。 IIa期 1.评价注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松在复发或难治性多发性骨髓瘤（RRMM）患者中的安全性和耐受性。 2.评估注射用甲磺酸普依司他联合固定剂量泊马度胺胶囊、地塞米松在复发或难治性多发性骨髓瘤（RRMM）患者中的群体药代动力学特征。

开始日期2024-06-05

申办/合作机构

成都赜灵生物医药科技有限公司

CTR20240739 / CompletedN/A

醋酸地塞米松片的人体生物等效性试验

主要目的：评价浙江仙琚制药股份有限公司研发的醋酸地塞米松片（规格：0.75mg）在中国健康受试者中单次空腹/餐后口服后的体内药物代谢动力学过程，估算相应的药代动力学参数，并以Sanofi Aventis France公司为持证商的原研药物醋酸地塞米松片（规格：0.5mg，商品名：Dectancyl®）为参比制剂，对两种制剂进行生物等效性评价。次要目的：评价空腹和餐后给药条件下，中国健康受试者单次口服醋酸地塞米松片受试制剂和参比制剂后的安全性。

开始日期2023-12-28

申办/合作机构

浙江仙琚制药股份有限公司

100 项与醋酸地塞米松相关的临床结果

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100 项与醋酸地塞米松相关的转化医学

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100 项与醋酸地塞米松相关的专利（医药）

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280

项与醋酸地塞米松相关的文献（医药）

2025-01-01·Methods in Molecular Biology

Mouse Model of Glucocorticoid-Induced Glaucoma

Article

作者: Sundaresan, Yogapriya ; Maddineni, Prabhavathi ; Zode, Gulab

Extended glucocorticoid (GC) treatment can lead to ocular hypertension and induce iatrogenic open-angle glaucoma. GC-induced glaucoma mimics many clinical and pathological features of primary open-angle glaucoma (POAG), and therefore mouse models of GC-induced glaucoma are utilized to study pathophysiology of glaucoma. We have recently demonstrated that weekly periocular injections of dexamethasone-21-acetate (Dex-Ac) lead to robust and significant intraocular pressure (IOP) elevation, retinal ganglion cell (RGC) loss, and optic nerve degeneration in mice. Our mouse model exhibits signature features of POAG including significant IOP elevation due to reduced outflow facility, progressive optic nerve degeneration, and structural and functional loss of RGCs. Dex-induced IOP elevation is associated with increased aqueous outflow resistance due to trabecular meshwork (TM) dysfunction including excessive extracellular matrix deposition and induction of endoplasmic reticulum stress. Mouse model of Dex-induced glaucoma represents an ideal animal model to investigate both glaucomatous damage to the TM and RGC axons and to develop novel therapies. Here, we present a detailed protocol for developing this model in laboratory settings.

2024-11-01·Value in Health Regional Issues

Custo-Efetividade de Diferentes Tratamentos Minimamente Invasivos Para Disfunção Temporomandibular de Origem Articular sob a Perspectiva do Sistema Público de Saúde Brasileiro

Article

作者: Moretti, Eduarda C ; da Silva, Pâmela L.P. ; Pereira, Antônio C ; Pereira, Antônio C. ; da Silva, Pâmela L P ; Moretti, Eduarda C. ; Lemos, George A ; Lemos, George A.

OBJECTIVEThis study aimed to evaluate the cost-effectiveness (CE) of minimally invasive interventions for pain associated with articular temporomandibular dysfunction from the Brazilian Public Health System (SUS) perspective.METHODSThis is a CE study with a 1-year time horizon. Effectiveness data were extracted from a network meta-analysis, and 2 treatments with moderate levels of evidence certainty were evaluated: arthrocentesis (ARTRO) plus intra-articular corticosteroid (CO) injection and ARTRO plus intra-articular injection of sodium hyaluronate (SH). For CE analysis, the costs of 2 types of SH (low and high molecular weight) and 4 COs (betamethasone [B], dexamethasone acetate [D], methylprednisolone sodium succinate [M], or triamcinolone hexacetonide [T]) were considered. Modeling was conducted using TreeAge Pro Healthcare software, with the construction of a decision tree representing a hypothetical cohort of adults with articular temporomandibular dysfunction. Deterministic and probabilistic sensitivity analyses were performed. In addition, an acceptability curve was developed.RESULTSThe total costs per joint for ARTRO plus low- and high-molecular-weight SH and ARTRO plus COs B, D, M, and T were, respectively, R$583.32, R$763.85, R$164.39, R$133.93, R$138.57, and R$159.86. ARTRO plus dexamethasone acetate was considered cost-effective, with lower cost and higher net monetary benefit than other technologies. In all sensitivity analysis scenarios, it remained cost-effective. It also showed greater acceptability.CONCLUSIONARTRO plus dexamethasone acetate was considered the cost-effective technology, exhibiting higher net monetary benefit and higher acceptability from the SUS perspective.

2024-09-18·Scientific reports

Dexamethasone acetate loaded poly(ε-caprolactone) nanofibers for rat corneal chemical burn treatment.

Article

作者: Kim, Eun Jeong ; Kim, Dong-Kyu ; Na, Kyung-Sun ; Lee, Hyun Jong ; Kim, Da Ran ; Myung, David ; Yoon, Young Chae ; Park, Sun-Kyoung

Topical eye drop approaches to treat ocular inflammation in dry eyes often face limitations such as low efficiency and short duration of drug delivery. Nanofibers serve to overcome the limitation of the short duration of action of topical eye drops used against ocular inflammation in dry eyes. Several attempts to develop suitable nanofibers have been made; however, there is no ideal solution. Here, we developed polycaprolactone (PCL) nanofibers loaded with dexamethasone acetate (DEX), prepared by electrospinning, as a potential ocular drug delivery platform for corneal injury treatment. Thirty-nine Sprague Dawley rats (7 weeks old males) were divided into four treatment groups after alkaline burns of the cornea; negative control (no treatment group); dexamethasone eyedrops (DEX group); PCL fiber (PCL group); dexamethasone loaded PCL (PCL + DEX group). We evaluated therapeutic efficacy of PCL + DEX by examining the epithelial wound healing effect, the extent of corneal opacity and neovascularization. Additionally, various inflammatory factors, including IL-1β, were investigated through immunochemistry, western blot analysis, and quantitative real-time RT-PCR (qRT-PCR). PCL + DEX group showed histologically alleviated signs of corneal inflammation compared with DEX group, which showed a decrease in IL-1β and MMP9 in the corneal stroma. The quantitative expression on day 1 after alkaline burn of pro-inflammatory markers, including IL-1β and IL-6, in the PCL + DEX group was significantly lower than that in the DEX group. Notably, PCL + DEX treatment significantly suppressed neovascularization, and enhanced the anti-inflammatory function of DEX during the acute phase of ocular inflammation. Collectively, these findings suggest that PCL + DEX may be a promising approach to effective drug delivery in corneal burn injuries.

项与醋酸地塞米松相关的新闻（医药）

2024-09-09

·蒲公英Ouryao

FDA 483表格：洁净区杀孢子剂的使用存在缺陷

作者：乐纯生物（BLA联合发起单位） FDA在2021年8月17至9月8日期间，对美国药企Boothwyn Pharmacy LLC进行了为期10天的检查，并于2024年2月29日在其网站上公布了9页的483表格，共计9条观察项，主要内容如下：首过空气受阻。生产危险药品时没有提供足够的密封、隔离、工作表面清洁、器皿清洁和人员清洁以防止交叉污染。设备、物料或用品在进入无菌加工区域前未消毒。在洁净室和ISO 5无菌加工区域使用杀孢剂不充分。 ISO 5无菌加工区域有难以清洁、产生颗粒和明显污浊的设备或表面。手套清洗/消毒后进行人员取样，手套指尖取样结果不能代表无菌加工环境，不能提供有意义的结果。培养基模拟灌装未在最具挑战性或压力的条件下进行。 ISO 5区域未在动态条件下进行确认。未能确认水的质量适合其在生产非无菌药品中的预期用途。可以看出，本份483表格的绝大多数内容都与污染相关。第4条观察项涉及到了ISO5（A/B级）杀孢子剂使用的相关缺陷，具体如下： Observation 4 观察项4 The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate. Specifically. 在洁净室和ISO 5无菌加工区域使用杀孢子剂是不充分的。例如： A.Your pharmacy technician (b)(4) did not allow the required (b)(4) contact time (also known as "dwell time"), per your procedures and the cleaning agent manufacturer's use directions, for your disinfectant/sporicidal cleaning agent (b)(4) when used on the floor of the sterile suite containing the laminar airflow workstation (LAFW), during (b)(4) cleaning on August 20, 2021. Most areas of the floor had a drying time of less than (b)(4). Additionally, (b)(4) did not use the disinfectant/sporicidal cleaning agent on the ceiling and walls of the ISO 7 classified buffer room. You failed to establish an adequate contact time for your sporicidal agent used to disinfect your aseptic processing areas. (b)(4) stated that the disinfectant/sporicidal cleaning agent may be allowed to dry prior to (b)(4), though the surface may not be touched afterwards for that length of time. 你们的生产人员XX在2021年8月20日清洁期间，按照你们的规程和清洁剂生产商的使用说明，你们的消毒剂/杀孢子剂在有层流气流工作站(LAFW)的无菌室地板上使用时，未达到规定的接触时间(也称为“停留时间”)。地板的大部分区域的干燥时间小于XXX。此外，XX未在ISO 7级别缓冲室的天花板和墙壁上使用消毒/杀孢子剂。你们没有为你们用于消毒无菌加工区域的杀孢剂建立足够的接触时间。XX述明，在XXXX之前可以让消毒剂/杀孢剂干燥，虽然此之后的一段时间内，不得触碰表面。 B.Your pharmacy technician (b)(4) did not clean the (b)(4) located between the ISO 8 classified preparation room and the ISO 7 classified buffer room with a sporicidal agent or any cleaning agent during direct observation of the (b)(4) cleaning of the sterile suite containing the LAFW on August 20, 2021. 在2021年8月20日直接观察到，你们的生产人员XX在清洁有LAFW的无菌室时，没有使用杀孢子剂或任何清洁剂清洁位于ISO 8准备室和ISO 7缓冲室之间的XXX。 C.During the (b)(4) cleaning of the sterile suite containing the LAFW on August 20, 2021, your pharmacy technician (b)(4) inconsistently cleaned the walls of the ISO 7 classified ante room, switching back and forth between (b)(4) and (b)(4) such that only one solution or the other was used on sections of the walls, rather than using the (b)(4) first with a (b)(4) dwell time followed by a (b)(4) cleaning, per your cleaning procedures. For example, only (b)(4) was used to clean the back wall and far section of the right wall of the ante room. Also, both (b)(4) and (b)(4) were sprayed onto the (b)(4)simultaneously to clean the glass door leading from the ante room into the buffer room. No other sporicidal agent is used on a (b)(4) basis. 在2021年8月20日对有LAFW的无菌室进行清洁期间，你们的生产人员不一致地清洁了ISO 7前室的墙壁，在XX和XXX之间来回切换，使得只在部分墙壁上使用了一种溶液，而不是按照你们的清洁程序先使用XX并停留XXX时间，然后使用XXXX进行清洁。例如，仅使用XX清洁前室的后墙和右墙的远端。另外，将XX和XXX同时喷洒到XXX上，以清洁从前置室通往缓冲室的玻璃门。在XX的基础上不使用其他杀孢子剂。 D.On August 19, 2021, your pharmacy technician (b)(4) did not clean the interior ceiling "grate" of the BSC with a sporicidal agent before or after producing ''TRICHLORMETHAZIDE-DEXAMETHASONE ACETATE 10 MG/ 0.5 MG/ML INJ" (lot 08192021@11) and "GLYCOPYRROLATE 0.2 MG/ML INJ" (lot 08192021@12), purported to be sterile. She stated she does not clean the ceiling "grate" during routine (b)(4), or (b)(4) cleaning, nor between products. 2021年8月19日，你们的生产人员在生产号称无菌的XX和XXX(批号XXXX)之前或之后，未使用杀孢子剂清洁BSC的内部天花板“格栅”。她表示，在常规XX或XXX清洁期间，她不会清洁天花板“格栅”，也不会在生产不同产品的间隙进行清洁。 E.On August 20, 2021, your pharmacy technician (b)(4) did not clean the interior back wall "grate" of the laminar airflow workstation (LAFW) with a sporicidal agent before or after producing "AMMONIUM CHLORIDE 2% INJ" (lot 08202021@5), purported to be sterile. He stated he does not clean the back wall "grate" of the LAFW during routine (b) (4) cleaning, nor between products. 2021年8月20日，你们的生产人员在生产XX(批号XXX)之前或之后未使用杀孢子剂清洁层流工作站(LAFW)的内部后墙“格栅”，该产品号称是无菌的。他说他在常规XX清洁期间没有清洁LAFW的后墙“格栅”，也没有在生产不同产品的间隙进行清洁。 FDA清洁消毒相关的缺陷（2022-2023） “Disinfecting agents and [cleaning pads] [cleaning wipes] used in the ISO 5 classified aseptic processing areas were not sterile. ” ISO 5级无菌工艺区使用的消毒剂和[清洁擦][清洁布]不是无菌的。 “[Equipment was] [Materials or supplies were] not disinfected prior to entering the aseptic processing areas. ” [设备][物料或耗材]在进入无菌工艺区之前未进行消毒。 “Disinfectant contact time (also known as ”dwell time“) and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.” 消毒剂的接触时间（也称为“停留时间”）以及在被消毒物品上的覆盖范围不够，无法达到充分消毒水平。 “The use of sporicidal agents in the [cleanrooms] [ISO 5 classified aseptic processing] area was [inadequate] [infrequent].” 在[洁净室][ISO 5级无菌工艺区][不充分][不经常]使用杀孢子剂。 “a. You failed to validate your written cleaning procedure for your laminar flow (b)(4) and your cleanrooms where your products are manufactured. Additionally, you failed to establish the effectiveness of disinfectants used in this procedure. b. Your written procedure for cleaning the (b)(4) and cleanroom did not specify the contact time for disinfectants.” a.您未能验证您的层流(b)(4)和制造产品的洁净室的书面清洁程序。此外，您未能确定此程序中使用的消毒剂的有效性。 b.您清洁(b)(4)和洁净室的书面程序没有指定消毒剂的接触时间。洁净室消毒 Cleanroom Disinfection 欧盟GMP附录《无菌药品生产》中其对消毒剂的要求主要包含以下几方面：　杀孢子剂定义在规定的时间内，足够的浓度下，能够杀灭细菌和霉菌孢子的试剂。它可以杀灭所有的营养微生物。消毒SOP 洁净室的消毒尤为重要，应按照书面程序对其进行彻底清洁和消毒。清洁程序应有效去除消毒剂残留物，为使消毒有效，应事先进行清洁以去除表面污染。消毒剂轮换消毒应包括定期使用杀孢子剂。应定期进行监测，以评估消毒计划的有效性并检测微生物菌群类型的变化（例如，对当前使用的消毒方案有抵抗力的生物）。应使用一种以上的消毒剂，以确保在它们具有不同作用方式的情况下，它们的组合使用对细菌和真菌有效。消毒剂标准 A级和B级区内的消毒剂和清洗剂在使用前应当是无菌的（在C级和D级使用的消毒剂也可能要求是无菌的），如果消毒剂和去污剂是由无菌产品制造商配制的，应监测消毒剂和清洁剂的微生物污染；配制后的消毒剂和清洁剂应存放在清洁容器内，且在规定期限内保存。如果消毒剂和清洁剂是“现成”的，则在成功完成相应供应商资格的前提下，可以接受分析证书或合格证书的结果。消毒剂验证消毒工艺应经过验证。验证应证明特定的使用方式下消毒剂的适用性和有效性，并应支持所制备溶液的使用期限。制药洁净室专用消毒液乐纯生物集团旗下子公司斯坦利思消毒液产品包括即用型醇类、复方季铵盐、3%过氧化氢、6%过氧化氢和复方过氧化物类的消毒液，以及复方过氧化物(S)、复方季铵盐(H)浓缩型消毒液。所有产品均可提供COA、MSDS、微生物效力验证报告、安全性评价等技术文件。制药洁净室空间消毒灭菌设备制药企业对于洁净室微生物控制的要求越来越高，不管是表面消毒，或是空间灭菌，都十分注重芽孢杀灭计划。过氧化氢灭菌成为制药企业空间灭菌的最佳选择，斯坦利思针对制药行业对于洁净室空间灭菌服务的需求，推出了空间干雾/汽化消毒灭菌设备以及与其配套使用的杀孢子剂，同时推出了过氧化氢空间灭菌服务。洁净室清洁 Cleanroom Cleaning 洁净室洁净度是决定产品质量的重要因素，而良好洁净度的维持，并不是一件简单的事，很多厂商在选择洁净室用耗材方面往往有评估或质量认证等相关问题。因此建立一个完整的洁净室用耗材概念，也就更加重要；而洁净室内工作环境的洁净维持又要严谨许多，但该如何处理呢？由于污染物有很多种，严格来说，针对不同的污染物会有不同的清除方式。而且要同时考虑污染物所附着的表面。洁净室清洁应用耗材斯坦利思洁净室清洁用具齐全，产品包括：可灭菌拖把拖布、无尘擦拭布、预湿擦拭布，清洁小车等系列产品。产品均可提供COA、TDS等技术文件。预湿无菌擦拭布斯坦利思预湿无菌擦拭布专为GMP A和B级别设计使用，在class 100级环境清洗包装，三层包装后，γ射线辐照灭菌，可达到10-6的无菌保障水平，满足制药、生物技术行业严格的微生物污染控制要求。不同材质的干布和不同种类的消毒剂进行预湿，多种款式规格。隔离器专用拖把产品福利活动中洁净室个人防护 Clean room personal protection 洁净室个人防护产品斯坦利思洁净室清洁个人防护系列产品包括：洁净室专用口罩、可灭菌护目镜，系列防护手套，系列防护服。产品均可提供COA、TDS等技术文件。关于斯坦利思斯坦利思成立于2011年，专注于制药行业的洁净室清洁消毒及微生物污染控制，提供制药企业洁净室污染控制的全领域清洁耗材、清洁消毒工具、消毒剂以及个人防护等专业的洁争室污染控制解决方案，并提供消毒剂验证、GMP咨询等全方位服务，是一家集研发，生产，销售于一身的高新技术企业。斯坦利思于2023年8月正式加入乐纯生物集团，成为其制药级生物工艺、耗材大版图中的一支重要力量。 - End - 关于乐纯生物上海乐纯生物技术股份有限公司成立于2011年，以外延式增长路径并入格氏流体、康晟生物、斯坦利思等优秀品牌，目前业务范围覆盖细胞培养、过滤纯化、一次性使用系统、工业级防污染洁净方案等多个应用场景，现已成为广受业内认可的医药行业上游工艺全链条头部供应商。使命愿景：以技术创新为驱动，提供高品质的生物工艺解决方案，致力于成为全球生物制药企业最信赖的合作伙伴。关于BLA 生物制药国产化推进联合会(Biopharma Localization Association)，简称BLA，总部位于上海，成立于2021年8月，是集生物制药领域平台、媒体、研发、生产、上下游供应链等企业的联合型社团组织。 BLA致力于助推生物制药“国产化”的三个核心： ▲ 助推建立健全中国生物药政策标准 ▲ 助推研发制造安全有效的中国生物药 ▲ 助推做大做强中国生物药国产供应链产品和体系全面推进中国生物医药产业高质量发展，向生物科技强国和产业强国迈进。 BLA，for Biopharma，for China. 入会咨询：张老师，13062776509（微信注明：BLA）邮箱：blachina@ouryao.com

临床研究

2024-06-17

·BioSpace

SpineThera, Inc. to Collaborate With Mayo Clinic to Advance Solutions in Substance Abuse Disorder Treatment

PLYMOUTH, Minn.--(BUSINESS WIRE)-- SpineThera, Inc., a pharmaceutical company specializing in long-acting injectable technology, has announced it has entered into a know-how agreement with Mayo Clinic. This collaboration aims to develop long-acting injectable drugs to improve treatment outcomes for individuals with substance abuse disorders. The opioid epidemic remains a significant public health crisis, impacting millions worldwide. There is a need to develop treatment options that improve outcomes, increase patient access to supervised treatment, and reduce risk associated with existing treatments. The project will be led by SpineThera CEO, Jeff Missling, and Chair for Addiction Medicine at Mayo Clinic, Tyler Oesterle, M.D. Missling commented on the significance of the collaboration, “SpineThera’s novel, long-acting injectable technology has potential in multiple therapeutic areas. We are honored to move strategically into substance abuse disorder treatment through this collaboration. Despite multiple approved medications for the treatment of opioid use disorder, we are still losing too many people to this crisis every day and seek to make a difference through our contributions." By leveraging SpineThera’s long-acting injectable technology and Mayo Clinic’s expertise in addiction medicine, this collaboration seeks to develop more effective and accessible treatment options. SpineThera is committed to addressing this healthcare challenge and improving the lives of individuals affected by substance abuse disorders. Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research. About SpineThera, Inc.: SpineThera is a clinical stage pharmaceutical company working to improve the lives of patients by creating long-acting injectable drugs utilizing its patented micro-suspension platform technology. SpineThera’s micro-suspension provides months long sustained release of the active pharmaceutical ingredient with superior injectability at ultra-high concentrations. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SpineThera's flagship investigational drug product, SX600, is a dexamethasone acetate micro-suspension injection which has been engineered as a targeted, extended-release corticosteroid with the potential to demonstrate a substantially improved benefit-risk pro to current epidural steroid injections for radicular leg pain. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care. For more information visit: .

2024-04-03

·BioSpace

ProMed Pharma Acquires SpineThera Manufacturing Capabilities and an Option to License Intellectual Property

PLYMOUTH, Minn.--(BUSINESS WIRE)-- SpineThera, Inc., a privately held, clinical-stage pharmaceutical company focused on the development of SX600 (a novel formulation of extended-release dexamethasone microspheres for epidural injection for the management of lumbar radicular pain) and ProMed Pharma LLC, a leading contract manufacturer of polymer-based drug releasing dosage forms and combination device components, announced today that ProMed Pharma has acquired SpineThera’s cGMP manufacturing operational assets. ProMed Pharma also obtained an option to license SpineThera’s microsphere intellectual property with the potential to sub-license to ProMed Pharma’s customers. With this acquisition, ProMed Pharma adds biodegradable microparticle development and manufacturing services to its existing portfolio of polymer-based drug releasing dosage forms by purchasing SpineThera’s controlled environment manufacturing suite and process equipment that provide a robust manufacturing process supported by a cGMP quality management system and a highly experienced CMC team. SpineThera has been developing and manufacturing biodegradable microspheres for 10 years. The sale of its manufacturing operation is consistent with SpineThera’s drug-product asset-development focus. SpineThera’s Chief Executive Officer, Jeff Missling, remarked, “We are focused on improving patients lives by developing innovative injectable drugs based on our proprietary micro-suspension platform technology. Our lead asset, SX600, has shown best-in-class potential for the treatment of lumbar radicular pain. Importantly, SpineThera is maintaining exclusive ownership of intellectual property that enables SX600. With this transaction, our manufacturing team joins a highly capable CDMO, ProMed Pharma, a company we have worked with closely for many years. SpineThera becomes a customer of ProMed, who will manufacture SX600 in the same cleanroom in which we previously developed the technology and manufactured clinical batches. This transaction provides an infusion of working capital and reduces our fixed and recurring expenses.” Missling added, “I thank our employees who have made the transition to ProMed for their years of dedicated service at SpineThera. We look forward to continuing to partner to advance the development of SX600 so that patients suffering from severe lumbar radicular pain may have greatly improved pain management.” “Microparticle formulation capabilities will significantly expand the sustained-release options we can offer our partners,” commented Jim Arps, Director of Business Development at ProMed Pharma. “I’m particularly excited about opportunities to expand our collaborations in Women’s Health, Ophthalmology, and Complex Generics and engage new partners in therapeutic areas such as Oncology, CNS, and Animal Health. Our in-house analytical capabilities are also well-suited to support new projects in these areas from early formulations to clinical trial material testing and release.” The financial terms of the transaction were not disclosed. About SpineThera SpineThera is a clinical stage pharmaceutical company working to improve the lives of patients by creating injectable drugs utilizing its patented micro-suspension platform technology. SpineThera’s micro-suspension provides months long sustained release of the active pharmaceutical ingredient with superior injectability at ultra-high concentrations. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SpineThera's flagship investigational drug product, SX600, is a groundbreaking dexamethasone acetate micro-suspension injection which has been meticulously engineered as a targeted, extended-release corticosteroid with the potential to demonstrate a substantially improved benefit-risk pro to current epidural steroid injections for radicular leg pain. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care. About ProMed Pharma ProMed Pharma specializes in the molding and extrusion of drug-loaded silicones, thermoplastics, and bioresorbable materials, leveraging this expertise to manufacture long-term implants and combination devices under cGMP. Working with both established and early-stage companies, we utilize robust manufacturing processes for controlled release of APIs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovascular, and ophthalmic implants, intravaginal rings, and steroid-eluting combination components. The company has facilities in Plymouth and Maple Grove, Minnesota

并购

100 项与醋酸地塞米松相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02174	醋酸地塞米松	D07AB19 H02AB02 D10AA03 A01AC02 S02BA06 D07XB05 S03BA01 S01CB01 C05AA09 S01BA01 R01AD03	DB14649

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性骨髓瘤	列支敦士登	Theravia Pharma SAS	2016-03-16
多发性骨髓瘤	欧盟	Theravia Pharma SAS	2016-03-16
多发性骨髓瘤	冰岛	Theravia Pharma SAS	2016-03-16
多发性骨髓瘤	挪威	Theravia Pharma SAS	2016-03-16
内分泌与代谢疾病	中国	天津金耀药业有限公司	1981-01-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
椎间盘移位	临床2期	澳大利亚	SpineThera Australia PTY LTD	2019-11-04
腰椎神经根病	临床2期	澳大利亚	SpineThera Australia PTY LTD	2019-11-04
根性疼痛	临床2期	澳大利亚	SpineThera Australia PTY LTD	2019-11-04

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临床结果

适应症

分期

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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


NCT03952377 (SALIENT, CTgov)	临床1/2期	腰椎神经根病 \| 根性疼痛 \| 椎间盘移位	56	Placebo (0.9% Sodium Chloride for Injection)	餘積鬱顧鏇獵窪觸齋艱(觸簾製鏇網積醖窪繭顧) = 鏇鬱餘餘積選鏇獵蓋鑰窪醖網網膚鏇製齋襯觸 (憲願鑰簾繭夢鏇簾觸鬱, 艱積鏇觸淵鹹積醖鏇顧 ~ 膚艱艱鹽壓鏇網遞選願) 更多	-	2024-01-10
				SX600 (12.5 mg SX600)	餘積鬱顧鏇獵窪觸齋艱(觸簾製鏇網積醖窪繭顧) = 壓願壓衊積築製憲鬱築窪醖網網膚鏇製齋襯觸 (憲願鑰簾繭夢鏇簾觸鬱, 簾膚積窪構範鑰壓製糧 ~ 範鏇鬱壓壓壓夢觸齋鹹) 更多
SALIENT (Biospace) 人工标引	临床2期	坐骨神经痛	56	SX600	(簾膚淵繭膚鏇簾餘繭觸) = 獵觸艱製製鹽齋齋齋遞鏇壓遞壓廠醖艱憲積夢 (膚選窪膚積衊衊積鹹衊 )	积极	2022-12-07
				Placebo	(簾膚淵繭膚鏇簾餘繭觸) = 繭網艱衊襯齋觸膚鹹鹹鏇壓遞壓廠醖艱憲積夢 (膚選窪膚積衊衊積鹹衊 )
NCT02956070 (CTgov)	N/A	牙本质敏感症 \| 炎症	70	Dexamethasone acetate (Experimental)	觸壓鬱膚艱繭衊鏇繭艱(簾蓋夢鹹齋繭鹹淵鏇網) = 淵遞衊廠糧遞鬱夢襯壓襯築齋鏇網獵艱襯願簾 (築觸鏇簾範淵廠淵憲襯, 憲鹽獵鹽餘廠選築膚願 ~ 衊夢築構醖鹹餘糧簾餘) 更多	-	2020-11-25
				Potassium Nitrate (Placebo)	觸壓鬱膚艱繭衊鏇繭艱(簾蓋夢鹹齋繭鹹淵鏇網) = 鬱顧願鏇窪淵鑰艱鑰製襯築齋鏇網獵艱襯願簾 (築觸鏇簾範淵廠淵憲襯, 願醖願窪鹽糧鏇憲築膚 ~ 觸艱壓繭鹹願選遞醖艱) 更多
ARVO2020	N/A	眼科外科手术	29	Dexamethasone intraocular suspension	(餘構壓夢築窪夢獵糧淵) = 蓋獵獵願憲壓範鏇鬱壓遞窪夢選糧構觸鹽膚餘 (構願鹽憲窪獵鹹襯糧鏇, ± 2.03) 更多	-	2020-06-01
NCT01756573 (CTgov)	N/A	疼痛	5	Bupivacaine (Bupivacaine)	選製願構網鹽鏇窪壓遞(餘壓窪夢壓憲遞鏇構願) = 糧繭糧窪鑰願鹽製餘獵壓餘餘鑰範鏇壓鹹構憲 (衊鑰膚築憲蓋蓋獵顧築, 簾築窪夢網醖壓衊窪願 ~ 遞鏇繭淵壓觸遞窪獵鏇) 更多	-	2019-05-14
				Dexamthsone+Bupivacaine (Bupivacaine With Dexamethasone)	選製願構網鹽鏇窪壓遞(餘壓窪夢壓憲遞鏇構願) = 醖獵糧網簾糧觸簾廠夢壓餘餘鑰範鏇壓鹹構憲 (衊鑰膚築憲蓋蓋獵顧築, 壓夢鬱糧壓製積繭鹽築 ~ 遞憲膚鹹壓選網願獵鑰) 更多
NCT00651261 (CALGB 10603 (ALLIANCE) \| RATIFY, CTgov)	临床3期	FLT3阳性急性髓性白血病	717	midostaurin+dexamethasone acetate+Daunorubicin+Cytarabine (Induction and Consolidation Chemotherapy Plus Midostaurin)	鏇窪窪獵築襯獵壓齋醖(廠齋廠構壓醖艱鬱積鹽) = 簾鏇繭獵築齋製選觸艱衊築艱鹹選鬱積餘顧繭 (蓋蓋廠蓋願壓觸鏇膚鏇, 廠醖衊鹹襯糧夢窪襯壓 ~ 淵鹹鏇鹹選襯膚選膚醖) 更多	-	2017-02-06
				placebo+dexamethasone acetate+Daunorubicin+Cytarabine (Induction and Consolidation Chemotherapy Plus Placebo)	鏇窪窪獵築襯獵壓齋醖(廠齋廠構壓醖艱鬱積鹽) = 醖範醖糧顧顧餘觸觸壓衊築艱鹹選鬱積餘顧繭 (蓋蓋廠蓋願壓觸鏇膚鏇, 鹹獵鹹醖膚鹽蓋壓膚範 ~ 網觸憲網糧衊簾醖鬱餘) 更多
NCT00635154 (CTgov)	临床2期	阴燃多发性骨髓瘤 \| 多发性骨髓瘤	55	Anakinra (IL-1Ra)+dexamethasone acetate	鏇築繭鹹範範網鹽襯糧(築積齋鏇構夢顧膚鹽窪) = 築築糧糧觸鹹餘夢網築壓構觸築範蓋艱顧繭憲 (夢願糧夢廠餘選鬱齋遞, 觸鏇蓋積觸餘鹽襯願鹹 ~ 衊觸齋遞壓願鏇網窪淵) 更多	-	2010-12-09
ASCO2005	临床2期	转移性实体瘤	34	EPO+Dexa	遞夢顧鏇網鏇齋膚顧鑰(壓壓觸範範壓鬱鹽願衊) = 夢遞範積蓋淵淵願膚糧製餘構網網糧廠衊遞餘 (衊簾鏇製鑰餘淵構壓艱 ) 更多	-	2005-06-01