更新于：2023-05-28

Dexamethasone

地塞米松

更新于：2023-05-28

概要

概要

基本信息

简介地塞米松是一种具有糖皮质激素受体 (GR) 激动作用的小分子药物。 GR 广泛分布于各种细胞类型，负责无数生理反应，包括免疫和炎症反应。地塞米松与 GR 结合，通过基因表达和蛋白质合成发挥激动作用，从而降低机体炎症反应，降低免疫系统活动。地塞米松已证明可以治疗多种疾病，包括但不限于光化性唇炎、轻链 (AL) 淀粉样变性、眼部炎症、黄斑水肿和过敏反应。早在 1958 年 10 月 30 日，FDA 就批准了地塞米松。此外，英国国家卫生服务局和美国国立卫生研究院推荐地塞米松用于需要机械通气或补充氧气（无通气）的COVID-19患者。

药物类型

小分子化药

别名

Dexamethasone Intravitreal Implant、Dexamethasone Acetata Cream、Dexamethasone Acetale Cream

+ [41]

靶点

GR(糖皮质激素受体)

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

肿瘤、免疫系统疾病、感染+ [13]

在研适应症

轻链 (AL) 淀粉样变性、眼部炎症、眼科外科手术+ [50]

非在研适应症

胃肠道疾病

原研机构

Merck & Co., Inc.

在研机构

Santen Pharmaceutical Co., Ltd.

Nichi-Iko Pharmaceutical Co., Ltd.

University of Oxford

+ [14]

非在研机构

Merck & Co., Inc.

最高研发状态(全球)批准上市

首次获批日期(全球)

美国 (1958-10),

内分泌系统疾病、眼部疾病、胃肠道疾病+ [7]

最高研发状态(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)

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结构

分子式C22H29FO5

InChIKeyUREBDLICKHMUKA-CXSFZGCWSA-N

CAS号50-02-2

关联

2,988

项与地塞米松相关的临床试验

NCT05334316 / Not yet recruiting临床2期

Individualizing Corticosteroid Use in Pneumonia

In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in pneumonia.

开始日期2024-07-01

申办/合作机构

Mayo Clinic

NCT05521087 / Not yet recruiting临床1期

A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

开始日期2024-02-07

申办/合作机构

Janssen Research & Development LLC

NCT05745714 / Not yet recruiting临床1/2期

International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol C Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol C is a phase I/II trial evaluating the safety and efficacy of ruxolitinib and venetoclax in combination with dexamethasone, cyclophosphamide and cytarabine in children and AYA with R/R ped ALL/LBL whose tumor present with alterations in the IL7R/JAK-STAT pathway.

开始日期2023-10-01

申办/合作机构

Princess Maxima Centre For Pediatric Oncology

100 项与地塞米松相关的专利（医药）

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57,189

项与地塞米松相关的文献（医药）

2023-12-01·The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

European guidelines on perinatal care: corticosteroids for women at risk of preterm birth.

Article

作者: George Daskalakis ; Vasilios Pergialiotis ; Magnus Domellöf ; Harald Ehrhardt ; Gian Carlo Di Renzo ; Esin Koç ; Ariadne Malamitsi-Puchner ; Marian Kacerovsky ; Neena Modi ; Andrew Shennan ; Diogo Ayres-de-Campos ; Elko Gliozheni ; Kristiina Rull ; Thorsten Braun ; Artur Beke ; Katarzyna Kosińska-Kaczyńska ; Ana Luisa Areia ; Simona Vladareanu ; Tanja Premru Sršen ; Thomas Schmitz ; Bo Jacobsson

of recommendationsCorticosteroids should be administered to women at a gestational age between 24⁺⁰ and 33⁺⁶weeks, when preterm birth is anticipated in the next seven days, as these have been consistently shown to reduce neonatal mortality and morbidity. (Strong-quality evidence; strong recommendation). In selected cases, extension of this period up to 34⁺⁶weeks may be considered (Expert opinion). Optimal benefits are found in infants delivered within 7 days of corticosteroid administration. Even a single-dose administration should be given to women with imminent preterm birth, as this is likely to improve neurodevelopmental outcome (Moderate-quality evidence; conditional recommendation).Either betamethasone (12 mg administered intramuscularly twice, 24-hours apart) or dexamethasone (6 mg administered intramuscularly in four doses, 12-hours apart, or 12 mg administered intramuscularly twice, 24-hours apart), may be used (Moderate-quality evidence; Strong recommendation). Administration of two "all" doses is named a "course of corticosteroids".Administration between 22⁺⁰ and 23⁺⁶weeks should be considered when preterm birth is anticipated in the next seven days and active newborn life-support is indicated, taking into account parental wishes. Clear survival benefit has been observed in these cases, but the impact on short-term neurological and respiratory function, as well as long-term neurodevelopmental outcome is still unclear (Low/moderate-quality evidence; Weak recommendation).Administration between 34 + 0 and 34 + 6 weeks should only be offered to a few selected cases (Expert opinion). Administration between 35⁺⁰ and 36⁺⁶weeks should be restricted to prospective randomized trials. Current evidence suggests that although corticosteroids reduce the incidence of transient tachypnea of the newborn, they do not affect the incidence of respiratory distress syndrome, and they increase neonatal hypoglycemia. Long-term safety data are lacking (Moderate quality evidence; Conditional recommendation).Administration in pregnancies beyond 37⁺⁰weeks is not indicated, even for scheduled cesarean delivery, as current evidence does not suggest benefit and the long-term effects remain unknown (Low-quality evidence; Conditional recommendation).Administration should be given in twin pregnancies, with the same indication and doses as for singletons. However, existing evidence suggests that it should be reserved for pregnancies at high-risk of delivering within a 7-day interval (Low-quality evidence; Conditional recommendation). Maternal diabetes mellitus is not a contraindication to the use of antenatal corticosteroids (Moderate quality evidence; Strong recommendation).A single repeat course of corticosteroids can be considered in pregnancies at less than 34⁺⁰weeks gestation, if the previous course was completed more than seven days earlier, and there is a renewed risk of imminent delivery (Low-quality evidence; Conditional recommendation).

2023-12-01·Blood pressure

A novel homozygous CYP17A1 mutation causes partial 17 α-hydroxylase/17,20-lyase deficiency in 46,XX: a case report and literature review.

Review

作者: Heye Chen ; Yingting Chen ; Hongxian Mao ; Huaying Huang ; Xueyong Lou

Aim: 17 α-hydroxylase/17,20-lyase deficiency (17-OHD) is an extremely rare autosomal recessive disorder that typically causes hypertension, hypokalaemia, primary amenorrhoea, and the absence of secondary sex characteristics in 46,XX individuals. Partial 17-OHD is even rarer than complete 17-OHD and is prone to missed diagnosis due to its subtler symptoms. The aim of this study was to help early detection and diagnosis of partial 17-OHD.Methods: We present a case of a 41-year-old female (46,XX) patient with partial 17-OHD caused by a novel missense CYP17A1 mutation, c.391 A > C (p.T131P). This patient experienced hypertension, hypokalaemia and adrenal hyperplasia, but did not present with primary amenorrhoea or absence of secondary sex characteristics. Initially, she was misdiagnosed and underwent right and left adrenalectomy, but the procedures were ineffective. Afterward, she received a one-month treatment of 0.5 mg dexamethasone, which greatly relieved her symptoms. Additionally, we reviewed reports of thirteen other patients with partial 17-OHD in 46,XX individuals from the literature, totalling fourteen probands.Results: We found that primary amenorrhoea, hypertension, hypokalaemia, and ovarian cysts accounted for 15.4%, 42.9%, 38.5%, and 72.7% of these patients, respectively. In contrast, elevated serum progesterone was present in all patients.Conclusion: Based on our literature review, the absence of primary amenorrhoea, hypertension or hypokalaemia cannot rule out suspicion for 17-OHD in 46,XX individuals. However, an elevation in serum progesterone levels is a highly sensitive indicator for diagnosing 17-OHD.

The association between bronchopulmonary dysplasia grade and risks of adverse neurodevelopmental outcomes among preterm infants born at less than 30 weeks of gestation.

Article

作者: Izabela Oluwole ; John B C Tan ; Shirin DeSouza ; Matthew Hutchinson ; Rebekah M Leigh ; Minha Cha ; Abigail Rodriguez ; Gina Hou ; Srinandini S Rao ; Arvind Narang ; Fu-Sheng Chou

BACKGROUND:

Bronchopulmonary dysplasia (BPD) is a multifactorial disease with neurodevelopmental implications. This study aims to quantify the risks of adverse neurodevelopmental outcomes for each BPD grade among preterm infants born at less than 30 weeks' gestation.

METHODS:

We retrospectively studied infants who received care in our institution until at least 36 weeks postmenstrual age and had a formal neurodevelopmental assessment in our infant follow-up clinic using the Bayley Scales for Infant and Toddler Development (BSID). We assessed the association between BPD grade and adverse neurodevelopmental outcomes using descriptive statistics and regression models.

RESULTS:

Two hundred and fifty infants, including 89 (35.6%), 87 (34.8%), 65 (20.6%), and 9 (3.6%) with No BPD, Grade 1, Grade 2, and Grade 3 BPD, were included in the study. Small for gestational age, late pulmonary hypertension, dexamethasone administration, and adverse neurodevelopmental outcomes were more common as BPD grade increased. In a logistic regression analysis, Grades 2 and 3, but not Grade 1, BPD were associated with increased odds of a composite adverse neurodevelopmental outcome by 2.7 and 7.2 folds, respectively. A BSID domain-specific analysis showed that higher grades were associated with lower scores in the cognitive, gross motor, and fine motor domains.

CONCLUSIONS:

Grades 2 and 3 BPD, but not Grade 1, correlate with risks of adverse neurodevelopmental outcomes at a grade-dependent manner in our single-center cohort retrospective study. Further validation using a multi-center large cohort is warranted.

741

项与地塞米松相关的新闻（医药）

2023-05-22

·美通社

Oculis宣布了OCS-01滴眼液治疗糖尿病黄斑水肿的三期临床试验DIAMOND第1阶段的积极顶线结果

2023年5月22日，美国东部时间上午10：30 OCS-01 滴眼液治疗糖尿病黄斑水肿（DME）的DIAMOND试验达到了其第1 阶段目标，即验证旨在优化OCS-01疗效潜力的荷载和维持给药方案，具有显著的统计学意义第6周时最佳矫正视力（BCVA）与基线相比的主要疗效终点显示，OCS-01组与对照组相比，视力的增加有统计学意义次要终点结果同样具有统计学意义，与对照组相比，OCS-01组在BCVA中获得≥15个字母改善的患者比例更高，视网膜厚度的改善也更高 OCS-01耐受性良好，未观察到预料之外的不良事件如果获得批准，OCS-01有可能成为DME的第一个使用滴眼方式的非侵入性治疗方法瑞士楚格和波士顿 2023年5月23日 /美通社/ -- Oculis 公司（纳斯达克：OCS）（"Oculis"），一家致力于改善视力和保护眼睛的国际生物制药公司，今天宣布OCS-01滴眼液治疗糖尿病黄斑水肿（DME）的三期临床试验DIAMOND第1阶段取得积极顶线结果。DME是导致糖尿病患者视力丧失和失明的主要原因，影响了全球约3700万人，由于缺乏方便的治疗方案，大量患者未得到治疗。 OCS-01 三期临床第 1阶段积极顶线结果意味着DME 治疗模式可能面临改变 DIAMOND是一项双盲、随机、多中心、分两个阶段进行的三期临床试验，旨在评估OCS-01滴眼液在DME患者中的有效性和安全性。第一阶段的主要目的是选择最佳的给药方案。第一阶段在美国和欧洲的39个临床中心进行，148名患者按2：1随机接受OCS-01（=100）或安慰剂（=48），先是每天滴眼6次为期6周的荷载期，随后进入每天滴眼3次为期6周的维持期。第1阶段达到了主要疗效终点，从基线到第6周，治疗组与安慰剂组相比，运用"早期治疗糖尿病视网膜病变研究"图表（BCVA ETDRS）的平均BCVA评分有统计学上的显著改善（OCS-01：7.2个字母，安慰剂： 3.1个字母，p=0.007），显示治疗组视力增加显著。持续到第12周的疗效同样具有统计学意义（OCS-01： 7.6个字母，安慰剂：3.7个字母，p= 0.016）。此外，在第6周，OCS-01组中BCVA改善达到≥15个字母的患者比例更高（OCS-01： 25.3%，安慰剂： 9.8%，p=0.015），并持续到第12周（OCS-01： 27.4%，安慰剂：7.5%，p=0.009）。在这项为期3个月的试验中，OCS-01达到了全部两个临床疗效终点（BCVA评分改善，和获得3行视力提升的患者比例）。药物批准将要求这些指标在为期12个月的治疗中可以实现。在OCS-01治疗组中，视网膜中心凹厚度（CST）在第6周时有统计学意义的显著下降（OCS-01： -63.6µm，安慰剂： +5.5µm，p<0.0001）。视网膜厚度的下降持续到第12周（-61.6µm 对 - 16µm，p=0.004）。 OCS-01耐受性良好，未观察到预料之外的不良事件。 OCS-01开发项目将按计划继续进入第2阶段，包括两项全球试验，每个试验招募约350-450名患者。Oculis预计将在今年下半年开始DIAMOND试验的第2阶段。 Oculis的首席执行官，医学博士，Riad Sherif说： "我很高兴，非常受鼓舞，在这个试验的第一阶段，OCS-01以显著的方式达到了主要和次要终点。在 OCS-01之前，从来没有滴眼液治疗DME 的积极结果。现在，OCS-01已经在两项不同的研究中得到验证，具有一致和重复的积极结果。我们仍将专注于高度优先地推进三期临床 DIAMOND 试验的第2阶段。这一重要的里程碑有可能让我们离首次应用滴眼液治疗 DME 这种严重和致盲的疾病更近一步。" 内华达州里诺Sierra Eye Associates临床研究主任，医学博士，DIAMOND临床试验主要研究者Arshad M. Khanani评论道： "作为三期临床 DIAMOND 试验的主要研究者，看到第1阶段试验的积极结果令人非常兴奋。DME患者在开始使用OCS-01 滴眼液治疗6周后，BCVA改善7.2个字母，CST减少63.6µm，这对治疗医生和患者具有临床意义。OCS-01作为一种已显示出这些积极结果的非侵入性治疗方法，如果获得批准，有可能使大量DME患者受益。我期待着将患者纳入这个试验的第2阶段。 " 南加州大学凯克医学院眼科临床教授，医学博士，DIAMOND临床试验主要研究者David S.Boyer教授说：： "DME 与渗透性增加和炎症都相关。目前抗 VEGF 作为有效的抗渗透性药物，但对炎症无影响。因此，相当大比例的患者单独使用抗 VEGF 治疗效果不佳。如果获得批准，OCS-01有潜力补充目前的治疗，和用于治疗顽固性患者。此外，由于它是一种外用药物，如果获得批准，它也有潜力成为 DME 的一线治疗药物。简而言之，我相信OCS-01在DME中的影响可能使其成为真正的游戏规则改变者。" 关于OCS-01 滴眼液及 Optireach ®技术利用Oculis公司的Optireach®专利技术，OCS-01是一种新型的高浓度（15 mg\/ml）地塞米松局部制剂。它通过滴眼液到达视网膜，是DME治疗新的给药途径，与目前治疗方法不同，目前的治疗都需要使用更有侵入性的方法，如眼部植入物或玻璃体内注射将药物输送到视网膜。Optireach®增溶配方技术，通过提高亲脂性药物的溶解度，增加药物在眼表的停留时间，使药物通过眼表到达眼后段，从而解决了传统滴眼液的局限性。关于糖尿病黄斑水肿（DME） DME是导致糖尿病患者视力丧失和失明的主要原因。目前据估计，它将影响全球约3700万人，随着糖尿病的增加，其患病率预计到2040年将增加到5300万人1,2. DME是糖尿病视网膜病变的一种不可逆的进行性并发症，与持续的高血糖水平损害黄斑中的神经和血管有关，黄斑是视网膜负责清晰视力的区域。视网膜内的血管膨胀，进而渗漏，导致视网膜内的液体积聚（水肿），从而发生DME。对于DME患者，仍然迫切需要更安全、更有效、更持久、负担更少的治疗方法。关于Oculis Oculis（Nasdaq： OCS）是一家致力于改善视力和保护眼睛的国际生物制药公司。Oculis的高度差异化管线由多个在开发的创新候选药物组成，应对未满足的眼科临床需求。它包括，OCS-01滴眼液，处于三期临床阶段用于治疗糖尿病性黄斑水肿（DME）和眼部手术后炎症和疼痛的外用候选药物；OCS-02滴眼液，处于临床二期用于治疗干眼病（DED）和葡萄膜炎的外用生物候选药物；以及OCS-05，用于治疗急性视神经炎（AON）和其他神经眼科疾病，如青光眼、糖尿病视网膜病变、地理萎缩和神经营养性角膜炎，改变疾病进程的候选药物。OCS-05首个用于患者的概念验证试验目前正在法国进行。Oculis的总部设在瑞士，业务遍及欧洲、美国和中国，致力于为世界各地的患者提供改变生活的治疗方法，由经验丰富的管理团队领导，并得到领先的国际医疗投资者的支持。详情请浏览： www.oculis.com 1） Yau 等. 糖尿病视网膜病变的全球患病率和主要危险因素，Diabetes Care 2012 Mar; 35(3): 556-564. 2）国际糖尿病联合会-diabetesatlas.org 估计，全球糖尿病患者 2021 年 5.37 亿 , 到 2045 年达到 7.83 亿关于前瞻性声明的警示性声明本新闻稿包含了前瞻性的声明和信息。例如，关于OCS-01潜在益处的声明，包括患者影响和市场机会；DIAMOND试验第2阶段的预期；OCS-01成为DME第一个局部和非侵入性治疗的潜力；OCS-01补充抗VEGF治疗的潜力；预期未来的里程碑和催化剂；Oculis临床和临床前研究的启动、时间、进展和结果；Oculis的研发项目、注册和商业战略、未来发展计划和管理；Oculis推进候选产品并成功完成临床试验的能力；注册申请和批准的时间或可能性是前瞻性的。所有前瞻性陈述都是基于估计和假设，虽然Oculis及其管理层认为这是合理的，但本身是不确定的，本身受到风险、可变性和意外事件的影响，其中许多是Oculis无法控制的。这些前瞻性陈述仅供说明目的，无意也不能被投资者作为对事实或可能性的担保、保证、预测或最终陈述。实际的事件和情况很难或不可能预测到，并将不同于假设。本文所提供的临床资料是初步的，随着分析的正在进行，可能会发生变化。这些结果可能不会在随后的患者和临床试验中重现。所有的前瞻性陈述都受到风险、不确定性和其他因素的影响，这些因素可能导致实际结果与我们的预期和\/或这些前瞻性陈述所表达或暗示的结果有重大差异。前瞻性声明受到许多条件的影响，其中许多条件是Oculis无法控制的，包括Oculis提交给美国证券交易委员会（"SEC"）材料的风险因素部分中提到的。这些文件的副本可以在SEC的网站www.sec.gov上找到。除法律要求外，Oculis没有义务在本声明发布日期之后更新这些声明以进行修改或更改。

临床3期临床结果临床2期临床成功

2023-05-22

·GlobeNewswire-Health Care

Scilex Holding Company Added to the Preliminary List of the Russell 3000® Index and the Small-Cap Russell 2000® Index as part of the 2023 Russell Indexes Annual Reconstitution in June 2023

PALO ALTO, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced today that it has been added to the preliminary list of the Russell 3000® Index and the Small-Cap Russell 2000® Index as part of the 35th Russell indexes annual reconstitution. Preliminary membership lists (reflecting any updates) will be posted to the FTSE Russell website from May 26 – June 16, 2023. The annual reconstitution will be final after the close of market on Friday, June 23, 2023 and will become effective Monday, June 26th 2023 at the open of the equity markets. This rebalancing process is designed to capture market shifts from the previous year to ensure the Russell U.S. Indexes continue to accurately reflect the US equity market. Annual reconstitution of Russell's U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. The Russell 3000® Index serves as the U.S. component to the Russell Global Index. Membership in the Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. The largest 1,000 stocks indexed in the Russell 3000® Index constitute the Russell 1000® Index, while the Russell 2000® Index is a subset of the smallest 2,000 components of the Russell 3000® Index. As of April 2023, the market capitalization of the Russell 3000® Index stock holdings was nearly $500 billion. FTSE Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes. “We are pleased to be included in the Russell 3000® Index. This milestone highlights our growth as a public company and the inclusion in the index signals the importance of our market position as a global leader in non-opioid pain management and we will continue to execute our strategy to deliver value for our stakeholders,” said Henry Ji, Ph.D., Executive Chairperson of Scilex Holding Company. "We are very pleased to join the Russell 3000® Index and see this as an opportunity for Scilex to gain broader visibility among investors who use the Russell indexes to benchmark their portfolios,” said Jaisim Shah, President and Chief Executive Officer of Scilex Holding Company. “As we continue to advance commercialization of our revenue generating opioid sparing pain management assets and further clinical development of our 3 non-opioid pipeline programs, we believe our addition to the Russell indexes will broaden awareness of the innovative advantages of Scilex opioid sparing therapies. We remain committed to leading the next evolution of opioid sparing therapies for the treatment of acute and chronic pain using our proprietary and innovative technology platforms.” Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $12 trillion in assets are benchmarked against Russell’s U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website (https://www.ftserussell.com/resources/russell-reconstitution). About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex intends to submit a request to the FDA for a type D meeting for purposes of pre-NDA discussion with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido® in October 2018, in-licensed a commercial product Gloperba® in June 2022, and launched its third FDA-approved product Elyxyb™ in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize Elyxyb™ (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched Elyxyb™ in April 2023 and is planning to commercialize Gloperba® in the fourth quarter of 2023 and is well-positioned to market and distribute those products. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2 study, triple-strength formulation of ZTlido®, for the treatment of acute low back pain, with FDA Fast Track status; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2023. For further information regarding the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161 – Corticosteroid Lumbar Epidural Analgesia for Radiculopathy – Full Text View – ClinicalTrials.gov. Scilex Holding Company is headquartered in Palo Alto, California. About FTSE Russell FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s anticipated inclusion in the Russell 3000® Index and the Small-Cap Russell 2000® Index and its expectations regarding the potential benefits of such inclusion, Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies, Scilex’s current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido®, Gloperba®, ELYXYB™, SP-102 (SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s development and commercialization plans; and Scilex’s products, technologies and prospects. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: the risk that Scilex is not included, or does not remain, in the Russell 3000® Index and the Small-Cap Russell 2000® Index; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to the ongoing COVID-19 pandemic; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the results of the Phase 2 trial for SP-103 or Phase 1 trials for SP-104 may not be successful; risks that the prior results of the clinical trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB™ is the subject of an exclusive, transferable license to use the trademark by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2023 Scilex Holding Company All Rights Reserved.

临床3期临床2期临床1期快速通道上市批准

2023-05-22

·GlobeNewswire-Health Care

Revolo Biotherapeutics Presents New Preclinical Data for ‘1104 in Acute Respiratory Distress Syndrome Associated With Influenza Infection at the ATS 2023 International Conference

Data continues to demonstrate the broader potential of ‘1104 to avoid and reduce inflammation in multiple models of disease, including allergy and beyond NEW ORLEANS and CAMBRIDGE, UK,, May 22, 2023 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced new preclinical data discussed in a poster presentation at the American Thoracic Society (ATS) 2023 International Conference. The poster showcases the ability of its immune-resetting drug candidate ‘1104 to inhibit and reduce lung inflammation without immunosuppression in a new model of acute respiratory distress syndrome (ARDS) associated with influenza infection. “We are pleased with these new results which showcase the potential of ‘1104 to modulate the inflammatory response in the lung in models beyond our lead allergic disease indications,” said Jonathan Rigby, Chief Executive Officer of Revolo. “The data continues to highlight the unique mechanism of action (MOA) of ‘1104, acting ahead of the inflammatory cascade to reset the immune system. As we build on the positive Phase 2a trial data of ‘1104 in eosinophilic esophagitis (EoE) and prepare to release data from our second Phase 2a study of ‘1104 in allergic disease, we continue to evaluate additional potential indications that could benefit from ‘1104’s unique MOA.” In this model, Mice treated with ‘1104 had significantly reduced inflammatory infiltration in the lung by neutrophils, macrophages, and lymphocytes compared to those treated with dexamethasone.Prophylactic and therapeutic dosing of ‘1104 resulted in a dose-dependent suppression of relevant pro-inflammatory cytokines and chemokines (TNF-a, interleukin 1β (IL-1β), IL-6, IL-17, MCP-1, and MIP-1a), usually elevated in ARDS-associated viral infection.Neither ‘1104 nor the positive control had a significant effect on viral load in lung tissue, indicating that ‘1104 can modulate the immune inflammatory response without causing immunosuppression. As part of the study, mice were infected with influenza A virus (IAV). Three days after infection, animals received either PBS (negative control) or 30µg of polyinosinic-polycytidylic acid (poly I:C) to exacerbate influenza-induced lung inflammation. Mice were treated with ‘1104 (80 or 800 µg/Kg) or PBS 15 minutes before and 24 hours after poly I:C or with dexamethasone at 10mg/kg (treatment control), 1 hour before and 24 hours after the poly I:C challenge. At 48 hours after the poly I:C challenge, bronchoalveolar lavage fluid was collected to conduct differential cell counts and to measure cytokines. Lung tissue was also collected to determine the viral load. About ‘1104‘1104 is a first-in-class peptide derived from a natural immune-regulatory protein, mTB Chaperonin 60.1 that is involved in resetting the immune system. Revolo Bio has recently advanced ‘1104 through two Phase 2a trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity, while exploring its potential for other allergic diseases. Revolo BiotherapeuticsRevolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1805 is a modified analogue of a key protein in immune function nearing initiation of a second Phase 2b clinical trial for moderate-to-severe rheumatoid arthritis and a Phase 2a clinical trial for an additional autoimmune indication. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases. For further information, please visit www.revolobio.com. Company ContactMarylyn Rigby, VP Investor Relations & Marketing mrigby@revolobio.com Media Contact Monica Rouco Molina, Ph.D.LifeSci Communications+1-929-469-3850mroucomolina@lifescicomms.com

临床2期临床结果

外链

KEGG	Wiki	ATC	Drug Bank
D00292	地塞米松	C05AA09 A01AC02 H02AB02 S01BA01 D10AA03 S02BA06 D07XB05 S01CB01 S03BA01 R01AD03 D07AB19	DB01234

研发状态

适应症	最高研发状态	国家/地区	公司
眼科外科手术	批准上市	美国更多	Ocular Therapeutix, Inc. 更多
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