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更新于：2025-01-23

Hydrocortisone

氢化可的松

更新于：2025-01-23

概要

基本信息

简介氢化可的松是一种小而强大的分子，以其作为糖皮质激素受体 (GR) 激动剂的能力而闻名，从而刺激 GR。该药物具有广泛的临床应用，通常用于治疗与肾上腺功能不全密切相关的多种疾病，包括但不限于先天性肾上腺增生、肾上腺增生、艾迪生病和孤立性促肾上腺皮质激素缺乏症。此外，它已被证明可有效治疗亚急性甲状腺炎、溃疡性结肠炎、直肠结肠炎和溃疡性直肠炎等炎症。值得注意的是，FDA 最初于 1952 年 8 月 5 日批准了氢化可的松。氢化可的松的开发归功于该药物的先驱 Merck Sharp & Dohme Corp。由于其非凡的抗炎和免疫抑制特性，氢化可的松已成为许多慢性炎症性疾病的最终药物。

药物类型

小分子化药

别名

(11β)-11,17,21-trihydroxypregn-4-ene-3,20-dione、11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione、11beta-hydrocortisone

+ [58]

靶点

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+ [10]

在研适应症

先天性肾上腺增生孤立性ACTH缺乏症肾上腺皮质功能不全+ [19]

非在研适应症

淋巴母细胞淋巴瘤21-羟化酶缺乏症引起的先天性肾上腺皮质增生非霍奇金淋巴瘤+ [3]

原研机构

Merck Sharp & Dohme Corp.

在研机构

ANI Pharmaceuticals, Inc.

Neurocrine Biosciences, Inc.Pharmacia & Upjohn, Inc.

+ [4]

非在研机构

Merck & Co., Inc.

Takeda Pharmaceutical Co., Ltd.

Shire Plc

最高研发阶段批准上市

首次获批日期

美国 (1952-08-05),

内分泌系统疾病超敏反应免疫系统疾病+ [1]

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)

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结构/序列

分子式C21H30O5

InChIKeyJYGXADMDTFJGBT-VWUMJDOOSA-N

CAS号50-23-7

关联

465

项与氢化可的松相关的临床试验

NCT06381661

/ Not yet recruiting临床3期IIT

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

开始日期2026-04-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT04231708

/ Not yet recruiting临床2期IIT

Effects of Pharmacological Stress and Repetitive Transcranial Magnetic Stimulation Interventions on Executive Function in Opioid Use Disorder

This preliminary study is designed to evaluate mechanisms by which excitatory dorsolateral prefrontal cortex (dlPFC) repetitive transcranial magnetic stimulation (rTMS) (vs. sham) and pharmacological stress (vs. placebo) alter behavior in non-treatment seeking individuals with opioid use disorder (OUD). Specific Aims are to (1) Evaluate how stress impacts domains of behavior including (1a) executive function and (1b) opioid-seeking behavior; and (2) Determine whether rTMS stimulation attenuates (2a) executive dysfunction, (2b) stress-reactivity, and (2c) opioid-seeking in individuals with OUD not receiving treatment.

开始日期2025-06-01

申办/合作机构

Wayne State University (Michigan)

NCT06317662

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

开始日期2025-01-26

申办/合作机构

National Cancer Institute

100 项与氢化可的松相关的临床结果

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100 项与氢化可的松相关的转化医学

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100 项与氢化可的松相关的专利（医药）

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37,944

项与氢化可的松相关的文献（医药）

2025-04-01·WATER RESEARCH

A feasibility study on cortisol and cortisone as biomarkers for psychological stress in wastewater-based epidemiology

Article

作者: Gong, Zhen-Fang ; Shao, Xue-Ting ; Lin, Jian-Guo ; Li, Yan-Ying ; Wang, Yan-Song ; Wang, De-Gao

Psychological stress has a significant impact on individuals' quality of life and health. Traditionally, psychological stress assessment relies on self-reported tools such as the Perceived Stress Scale (PSS), which are inherently subjective. This study aims to evaluate the feasibility of using wastewater-based epidemiology (WBE) to assess cortisol and cortisone as biomarkers for psychological stress. We conducted sampling and monitoring of cortisol and cortisone concentrations at both a small-scale campus setting (five weeks) and a large-scale municipal wastewater treatment plant (12 months), calculating the mass loads of these hormones. At the campus level, while the mass load of cortisone was higher during exam weeks compared to regular class weeks, and higher in females than in males, no significant differences were observed in the mass load of cortisol. The mass load results of cortisone were consistent with the findings of the PSS-14 questionnaire. These results suggest that cortisone is a more suitable biomarker for psychological stress assessment. In the large-scale municipal wastewater samples, seasonal variations were observed, with higher levels of cortisol and cortisone in winter compared to summer, likely due to the COVID-19 outbreak in winter and the presence of external pharmaceutical sources. The results indicate that cortisone is more suitable for small-scale stress assessments, as larger-scale evaluations may be more significantly influenced by wastewater transport or sampling methodologies.

2025-03-01·BIOSENSORS & BIOELECTRONICS

Light source-free smartphone detection of salivary cortisol via colorimetric lateral flow immunoassay using a photoluminescent film

Article

作者: Hong, Donggu ; Choi, Chang Woon ; Kim, Min-Gon

An accurate assay was developed by integrating a novel lateral flow immunoassay (LFIA) design, smartphone-based photoluminescence detection, and computer-aided analysis using machine learning algorithms for the quantitative measurement of cortisol levels in human saliva samples. The unique LFIA strip incorporates a photoluminescent film, which enables photoluminescence detection without an external light source, beneath a nitrocellulose membrane. A smartphone is used to capture images of the LFIA test strips, and specific regions in the captured images are analyzed. The digitized data are then processed using a computer. Machine learning algorithms were employed to interpret the data and quantify cortisol levels in saliva samples obtained from 14 volunteers. The developed assay was shown to be highly accurate, and a low average difference of 18.12% was observed between the predicted cortisol levels and those measured using an established enzyme-linked immunosorbent assay (ELISA) in real saliva samples. The assay has a calculated limit of detection of approximately 139 pg/mL. Furthermore, the strong correlation (r = 0.935) between the results of the developed assay and the ELISA results supports its validity.

2025-03-01·JOURNAL OF HAZARDOUS MATERIALS

Neurotoxic effects of citronellol induced by the conversion of kynurenine to 3-hydroxykynurenine

Article

作者: Son, Yuji ; Ha, Youngran ; Kim, Ki-Tae ; Kim, Suhyun ; Lee, Hyojin ; Cho, Sung-Hee ; Kim, Ki Young ; Park, Hae-Chul ; Yang, Jung Yoon ; Lee, Han-Seul ; Im, Hyunji ; Hwang, Kyu-Seok ; Bae, Myung Ae ; Kim, Seong Soon ; Kim, Yeonhwa ; Shin, Dae-Seop ; Park, Sung Bum

Citronellol is widely utilized in consumer products, including cosmetics, fragrances, and household items. However, despite being considered a relatively safe chemical, the health effects and toxicity mechanisms associated with exposure to high concentrations of citronellol, based on product content, remain inadequately understood. Here, we aimed to analyze the neurological effects of citronellol in zebrafish larvae using behavioral and histological analyses and elucidate the mechanisms underlying its neurotoxicity in vivo. Exposure to citronellol (2, 4 and 8 mg/L) in zebrafish larvae induced a range of neurotoxic effects, including locomotor impairments, anxiety-like behaviors, oxidative stress, an inflammatory response, and apoptosis in the brain. Additionally, citronellol exposure compromised the blood-brain barrier (BBB) integrity, permitting the infiltration of inflammatory cell into the brain. Neurotoxic effects were further sustained by increased kynurenine (KYN) metabolism to the neurotoxic metabolite 3-hydroxykynurenine (3-HK), accompanied by altered neurosteroid levels, including reduced progesterone and allopregnanolone, and elevated cortisol. Similar metabolic dysregulation was observed in mouse models following oral administration (345, 690 and 3450 mg/kg) and in human brain organoids exposed to citronellol (1, 10 and 100 μM), suggesting conserved mechanisms across species. Notably, experiments using zebrafish, mice and brain-chip systems confirmed that citronellol crosses the BBB and accumulates in the brain. Overall, we identified a novel neurotoxic pathway involving the KYN to 3-HK metabolic pathway, oxidative stress, and neuroinflammation, underscoring the potential risks of prolonged citronellol exposure.

149

项与氢化可的松相关的新闻（医药）

2025-01-06

·CPHI制药在线

FDA 2025年第一季度审批全览

关注并星标CPHI制药在线 01 Ozempic (semaglutide) ● 开发商：诺和诺德 ● 模态：多肽 ● PDUFA日期：2025年1月 ● 适应症类型/说明：代谢、肾脏/每周一次皮下注射semaglutide的新适应症，用于治疗患有 2 型糖尿病和慢性肾脏病 (CKD) 的成年人，包括延缓 CKD 进展并降低肾脏和心血管死亡风险。 ● 审评类型：标准审评 ● 申请递交时间：2024年3月 ● 审评情况：FDA于2024年6月24日接受申请 02 Subvenite (lamotrigine oral liquid) ● 开发商：OWP Pharmaceuticals ● 模态：小分子 ● PDUFA日期：2025年1月3日 ● 适应症类型/说明：中枢神经系统疾病/用于治疗癫痫和躁郁症的抗癫痫药物的新型口服液制剂 ● 审评类型：505(b)(2) NDA标准审评 ● 申请递交时间：2024年3月 ● 审评情况：FDA于2024年5月20日接受申请 03 TX05 (trastuzumab 生物类似药) ● 开发商：Tanvex ● 模态：单抗 ● PDUFA日期：不晚于2025年1月6日 ● 适应症类型/说明：癌症/Genetech的 HER2 靶向抗体Herceptin的生物类似药 ● 审评类型：351(k) BLA标准审评 ● 申请递交时间：2024年7月6日（重新递交） ● 审评情况：FDA之前于2022年8月签发了完整回复函 04 Ryoncil (remestemcel-L-rknd，新生物制品) ● 开发商：Mesoblast ● 模态：细胞疗法 ● PDUFA日期：2025年1月7日 ● 适应症类型/说明：免疫学/同种异体扩增间充质基质细胞 (MSC) 干细胞疗法，用于治疗类固醇难治性急性移植物抗宿主病 (SR-aGVHD) 的儿科患者 ● 审评类型：优先审评 ● 申请递交时间：2024年7月8日（重新递交） ● 审评情况：FDA之前于2022年8月3日签发了第二封完整回复函（第一封签发于2020年10月1日） 05 Tabelecleucel （新生物制品） ● 开发商：Atara Biotherapeutics/Pierre Fabre ● 模态：细胞疗法 ● PDUFA日期：2025年1月15日 ● 适应症类型/说明：免疫学、支持性治疗/同种异体、Epstein-Barr 病毒 (EBV) 特异性 T 细胞免疫疗法，用于单药治疗 2 岁及以上患有 EBV 阳性移植后淋巴增生性疾病 (EBV+ PTLD) 的成人和儿童患者，这些患者至少接受过一次先前治疗 ● 审评类型：优先审评 ● 申请递交时间：2024年5月20日 ● 审评情况：突破性疗法认定 06 Lumakras (sotorasib) ● 开发商：安进 ● 模态：小分子 ● PDUFA日期：2025年1月17日 ● 适应症类型/说明：癌症 /新适应症，与panitumumab (Vectibix) 组成联合疗法，用于治疗 KRAS G12C 突变转移性结直肠癌 (CRC) 。 ● 审评类型：优先审评 ● 申请递交时间：2024年4月 ● 审评情况：延期，原PDUFA日期为2024年10月17日 07 Leqembi (lecanemab-irmb) ● 开发商：卫材/渤健 ● 模态：抗体 ● PDUFA日期：2025年1月25日 ● 适应症类型/说明：中枢神经系统疾病/新的维持给药方案，为已完成每两周一次的阿尔茨海默病治疗初始阶段的患者提供每月一次的Leqembi静脉注射 ● 审评类型：标准审评 ● 申请递交时间：2024年4月1日 ● 审评情况：FDA于2024年6月9日接受申请 08 CT-P47 (tocilizumab生物类似药) ● 开发商：Celltrion ● 模态：单抗 ● PDUFA日期：不晚于2025年1月28日 ● 适应症类型/说明：免疫学/抗白细胞介素 6 (IL-6) 抗体Actemra生物类似药，针对类风湿关节炎和幼年特发性关节炎等适应症 ● 审评类型：351(k) BLA标准审评 ● 申请递交时间：2024年1月28日 09 Elamipretide （新分子实体） ● 开发商：Stealth BioTherapeutics ● 模态：多肽 ● PDUFA日期：2025年1月29日 ● 适应症类型/说明：心血管先天性疾病/与磷脂心磷脂结合的线粒体保护肽，用于治疗巴特综合征 ● 审评类型：优先审评（最初为标准审评，但在Stealth Bio的要求下更改为优先审评） ● 申请递交时间：2024年1月 ● 审评情况：最初申请递交时间为2021年8月，FDA 2021年10月签署拒绝备案(RTF)信函；重新递交后，FDA于2024年4月8日接受申请；罕见儿科疾病认定。 10 Suzetrigine (VX-548，新分子实体) ● 开发商：Vertex ● 模态：小分子 ● PDUFA日期：2025年1月30日 ● 适应症类型/说明：中枢神经系统疾病/选择性 NaV1.8 疼痛信号抑制剂，口服、非阿片类药物，治疗中度至重度急性疼痛 ● 审评类型：优先审评 ● 申请递交时间：2024年5月30日 ● 审评情况：FDA 2024年7月30日接受申请；突破性疗法认定 11 Treosulfan (新药) ● 开发商：medac GmbH/Medexus ● 模态：小分子 ● PDUFA日期：2025年1月30日 ● 适应症类型/说明：癌症、血液疾病/双功能烷化剂，与氟达拉滨联合使用，作为接受异基因造血干细胞移植 (allo-HSCT) 的成人和儿科患者的减毒预处理方案 ● 审评类型：标准审评 ● 申请递交时间：2024年4月 ● 审评情况：FDA 2021年8月3日签署完整回复函；重新提交申请后FDA于2024年6月6日接受申请；PDUFA日期由最初的2024年10月30日推迟。 12 AXS-07 (meloxicam/rizatriptan) ● 开发商：Axsome Therapeutics ● 模态：小分子 ● PDUFA日期：2025年1月31日 ● 适应症类型/说明：中枢神经系统疾病/偏头痛的急性治疗 ● 审评类型：505(b)(2) NDA标准审评 ● 申请递交时间：2024年7月 ● 审评情况：2021 年 7 月首次提交申请，FDA 于 2022 年 5 月 2 日签署完整回复函；2024 年 9 月 4 日FDA接受重新提交审查。 13 Translarna (ataluren，新分子实体) ● 开发商：PTC Therapeutics ● 模态：小分子 ● PDUFA日期：2025年2月或3月 ● 适应症类型/说明：中枢神经系统疾病/治疗无义突变杜氏肌营养不良症 (nmDMD) ● 审评类型：优先审评 ● 申请递交时间：2024年8至9月 14 Omvoh (mirikizumab-mrkz) ● 开发商：礼来 ● 模态：单抗 ● PDUFA日期：不迟于2025年2月 ● 适应症类型/说明：胃肠道疾病/ Omvoh的新适应症，治疗患有中度至重度活动性克罗恩病的成年人 ● 审评类型：标准审评 ● 申请递交时间：2024年3至4月 15 Enhertu (fam-trastuzumab deruxtecan-nxki) ● 开发商：第一三共/阿斯利康 ● 模态：ADC ● PDUFA日期：2025年2月1日 ● 适应症类型/说明：癌症/Enhertu新适应症，治疗不可切除或转移性 HER2 低或 HER2 超低乳腺癌的成年人 ● 审评类型：优先审评 ● 申请递交时间：2024年8月1日 ● 审评情况： FDA 于 2024年10月1日接受申请；突破性疗法认定 16 SPN-830 (apomorphine infusion pump) ● 开发商：Supernus/US WorldMeds/Brittania ● 模态：小分子 ● PDUFA日期：2025年2月1日 ● 适应症类型/说明：中枢神经系统疾病/多巴胺激动剂apomorphine的持续皮下输注制剂，用于治疗帕金森病成人的运动波动（OFF 发作） ● 审评类型：标准审评 ● 申请递交时间：2024年8月1日 ● 审评情况：经历一次RTF（Refuse to File）和两次完整回复函。 17 Bentracimab （新生物制品） ● 开发商：SFJ Pharmaceuticals/SERB Pharmaceuticals ● 模态：抗体 ● PDUFA日期：不晚于2025年2月2日 ● 适应症类型/说明：心血管疾病/针对因使用替格瑞洛而引起的紧急出血事件，或在紧急手术情况下需要逆转替格瑞洛的抗血小板效果 ● 审评类型：优先审评 ● 申请递交时间：2024年5至6月 ● 审评情况：FDA 2024年8月2日接受BLA申请；突破性疗法认定 18 Datopotamab deruxtecan (Dato-DXd，新生物制品) ● 开发商：第一三共/阿斯利康 ● 模态：ADC ● PDUFA日期：不晚于2025年2月2日 ● 适应症类型/说明：癌症/转移性激素受体 (HR) 阳性、HER2 阴性（IHC 0、IHC 1+ 或 IHC 2+/ISH-）乳腺癌成人患者 ● 审评类型：标准审评 ● 申请递交时间：2024年1至2月 ● 审评情况：FDA 2024年4月2日接受BLA申请 19 Sublocade (buprenorphine depot injection) ● 开发商：Indivior ● 模态：小分子 ● PDUFA日期：2025年2月7日 ● 适应症类型/说明：中枢神经系统疾病/皮下注射阿片类激动剂，用于治疗中度至重度阿片类药物使用障碍 (OUD) ● 审评类型：优先审评 ● 申请递交时间：2024年8月 ● 审评情况：FDA 2024年10月7日接受申请 20 Rexulti (brexpiprazole) ● 开发商：Otsuka/Lundbeck ● 模态：小分子 ● PDUFA日期：2025年2月8日 ● 适应症类型/说明：中枢神经系统疾病/血清素-多巴胺活性调节剂 (SDAM) 非典型抗精神病药，新适应症，与舍曲林联合使用，用于治疗成人创伤后应激障碍 (PTSD) ● 审评类型：标准审评 ● 申请递交时间：2024年4月10日 ● 审评情况：FDA 2024年6月25日接受申请 21 CHIKV VLP (chikungunya vaccine, 此前称作PXVX0317，新生物制品) ● 开发商：Bavarian Nordic ● 模态：疫苗 ● PDUFA日期：2025年2月14日 ● 适应症类型/说明：传染病/用于成人和 12 岁及以上的儿童，预防基孔肯雅病毒感染 ● 审评类型：优先审评 ● 申请递交时间：2024年6月17日 ● 审评情况：突破性疗法认定 22 MenABCWY (meningococcal group A,B,C,Y/W-135 vaccine，新生物制品) ● 开发商：GSK ● 模态：疫苗 ● PDUFA日期：2025年2月14日 ● 适应症类型/说明：传染病/预防侵袭性脑膜炎球菌病 ● 审评类型：标准审评 ● 申请递交时间：2024年2月 ● 审评情况：FDA 2024年4月16日接受申请 23 Vimseltinib （新分子实体） ● 开发商：Deciphera (Ono Pharmaceutical) ● 模态：小分子 ● PDUFA日期：2025年2月17日 ● 适应症类型/说明：癌症/治疗腱鞘巨细胞瘤 (TGCT) 患者 ● 审评类型：优先审评 ● 申请递交时间：2024年6月 ● 审评情况：FDA 2024年8月15日接受申请 24 Mirdametinib （新分子实体） ● 开发商：SpringWorks Therapeutics ● 模态：小分子 ● PDUFA日期：2025年2月18日 ● 适应症类型/说明：癌症/治疗患有 1 型神经纤维瘤病相关丛状神经纤维瘤 (NF1-PN) 的儿童和成人患者 ● 审评类型：优先审评 ● 申请递交时间：2024年6月 ● 审评情况：FDA 2024年8月15日接受申请 25 ET-400 (hydrocortisone oral solution) ● 开发商：Eton Pharmaceuticals ● 模态：小分子 ● PDUFA日期：2025年2月28日 ● 适应症类型/说明：内分泌、免疫学/氢化皮质酮(又称氢化可的松)，新型糖皮质激素口服溶液剂型，在室温下稳定，适用于婴儿和儿科患者 ● 审评类型：505(b)(2) NDA标准审评 ● 申请递交时间：2024年4月30日 ● 审评情况：FDA 2024年7月15日接受申请 26 Adcetris (brentuximab vedotin) ● 开发商：辉瑞 ● 模态：ADC ● PDUFA日期：2025年3月 ● 适应症类型/说明：癌症/CD30 靶向 ADC brentuximab vedotin 的新适应症，用于与来那度胺和利妥昔单抗联合治疗复发或难治性大 B 细胞淋巴瘤 (LBCL) ● 审评类型：标准审评 ● 申请递交时间：2024年5月 ● 审评情况：FDA 2024年7月30日接受申请 27 Susvimo (眼部植入物玻璃体注射 ranibizumab) ● 开发商：罗氏 ● 模态：单抗 ● PDUFA日期：不晚于2025年3月 ● 适应症类型/说明：眼科/ranibizumab的新适应症，该植入物可提供定制配方的 VEGF 抑制剂（不同于 Lucentis 玻璃体内注射），最长可使用六个月，用于治疗糖尿病性黄斑水肿和糖尿病性视网膜病变 ● 审评类型：标准审评 ● 申请递交时间：2024年5月 ● 审评情况：FDA 2024年7月18日接受申请 28 neffy (肾上腺素 1mg 鼻喷雾剂) ● 开发商：ARS Pharmaceuticals ● 模态：小分子 ● PDUFA日期：2025年3月6日 ● 适应症类型/说明：免疫学/1mg 新浓度和扩大的儿科适应症，适用于体重 15-30 公斤儿童的 I 型过敏反应（包括过敏性休克）的鼻内紧急治疗 ● 审评类型：优先审评；505(b)(2) NDA ● 申请递交时间：2024年9月9日 29 Furoscix (furosemide, 皮下制剂) ● 开发商：scPharmaceuticals ● 模态：小分子 ● PDUFA日期：2025年3月6日 ● 适应症类型/说明：心血管疾病/新适应症，皮下注射，治疗慢性肾病 (CKD) 患者因液体超负荷引起的水肿 ● 审评类型：标准审评 ● 申请递交时间：2024年5月 ● 审评情况：FDA 2024年7月25日接受申请 30 CT-P39 (omalizumab生物类似药) ● 开发商：Celltrion ● 模态：单抗 ● PDUFA日期：不晚于2025年3月11日 ● 适应症类型/说明：免疫学/Genetech的Xolair 的可互换生物类似药，用于治疗严重持续性过敏性哮喘、鼻息肉、荨麻疹和免疫球蛋白 E 介导的食物过敏等。 ● 审评类型：标准审评；351(k) BLA ● 申请递交时间：2024年3月11日 31 Condoliase (SI-6603，新生物制品) ● 开发商：Seikagaku/Ferring Pharmaceutical ● 模态：蛋白质 ● PDUFA日期：不晚于2025年3月14日 ● 适应症类型/说明：中枢神经系统疾病/成人腰椎间盘突出症 (LDH) 相关的根性腿痛 ● 审评类型：标准审评 ● 申请递交时间：2024年3月 ● 审评情况：FDA 2024年5月14日接受申请，2025年1月1日FDA顾问委员会会议 32 Revakinagene taroretcel (NT-501，新生物制品) ● 开发商：Neurotech Pharmaceuticals ● 模态：基因疗法 ● PDUFA日期：2025年3月18日 ● 适应症类型/说明：眼科/治疗 2 型黄斑毛细血管扩张症（MacTel，即特发性近焦点黄斑毛细血管扩张症） ● 审评类型：优先审评 ● 申请递交时间：2024年4月 ● 审评情况：FDA 2024年6月20日接受申请，PDUFA日期从最初的2024年12月17日延期 33 Camrelizumab (SHR-1210，新生物制品) ● 开发商：江苏恒瑞 (2023年10月授权Elevar) ● 模态：单抗 ● PDUFA日期：2025年3月20日 ● 适应症类型/说明：癌症/PD-1 抑制剂，与 Elevar 的 VEGFR-2 激酶抑制剂rivoceranib联合用于不可切除或转移性肝细胞癌 (uHCC) 的一线全身治疗 ● 审评类型：标准审评 ● 申请递交时间：2024年9月23日 ● 审评情况：首次BLA申请2023年5月17日，FDA 2024年5月27日签发完全回复函；再次申请获得接受。 34 Amvuttra (vutrisiran) ● 开发商：Alnylam ● 模态：寡核苷酸 ● PDUFA日期：2025年3月23日 ● 适应症类型/说明：心血管疾病、中枢神经系统疾病/ vutrisiran 新适应症，治疗伴有心肌病的转甲状腺素蛋白淀粉样变性 (ATTR-CM) ● 审评类型：使用一张优先审评券PRV ● 申请递交时间：2024年10月9日 ● 审评情况：FDA 2024年11月25日接受申请。 35 Rivoceranib （新分子实体） ● 开发商：Elevar Therapeutics (HLB LifeScience) ● 模态：小分子 ● PDUFA日期：不晚于2025年3月23日 ● 适应症类型/说明：癌症/与恒瑞医药的 PD-1 抑制剂Camrelizumab联合用于不可切除的肝细胞癌 (uHCC) 的一线治疗 ● 审评类型：标准审评 ● 申请递交时间：2024年9月23日 ● 审评情况：2023年5月17日递交的NDA申请被拒，再申请获得接受。 36 TLX007-CDx ● 开发商：Telix ● 模态：放射性示踪剂 ● PDUFA日期：2025年3月24日 ● 适应症类型/说明：癌症成像剂/前列腺癌诊断 ● 审评类型：标准审评 ● 申请递交时间：2024年5月27日 ● 审评情况：FDA 2024年7月24日接受申请。 37 Gepotidacin （新分子实体） ● 开发商：GSK ● 模态：小分子 ● PDUFA日期：2025年3月26日 ● 适应症类型/说明：传染病/口服治疗患有无并发症尿路感染 (uUTI) 的成年女性（≥40 公斤）和青少年（≥12 岁，≥40 公斤） ● 审评类型：优先审评 ● 申请递交时间：2024年7月 ● 审评情况：FDA 2024年10月16日接受申请。 38 Cardamyst (etripamil，新分子实体) ● 开发商：Milestone Pharmaceuticals ● 模态：小分子 ● PDUFA日期：2025年3月26日 ● 适应症类型/说明：心血管疾病/鼻腔喷雾剂，治疗阵发性室上性心动过速 (PSVT) ● 审评类型：标准审评 ● 申请递交时间：2024年3月28日 ● 审评情况：FDA 2023年12月签发RTF信函，之后重新递交申请，FDA 2024年5月26日接受申请。 39 Egrifta MDV (tesamorelin F8 formulation) ● 开发商：Theratechnologies ● 模态：多肽 ● PDUFA日期：不晚于2025年3月26日 ● 适应症类型/说明：代谢疾病/用于治疗 HIV 相关脂肪营养障碍 ● 审评类型：标准审评 ● 申请递交时间：2024年11月26日 ● 审评情况：FDA接受之前遭受一份完整回复函。 40 DCCR (diazoxide choline) ● 开发商：Soleno Therapeutics ● 模态：小分子 ● PDUFA日期：2025年3月27日 ● 适应症类型/说明：内分泌疾病/治疗 4 岁及以上患有贪食症的普拉德-威利综合征 (PWS) 患者 ● 审评类型：优先审评 ● 申请递交时间：2024年6月27日 ● 审评情况：最初PDUFA日期为2024年12月27日，延期。 41 Fitusiran （新分子实体） ● 开发商：赛诺菲 ● 模态：寡核苷酸 ● PDUFA日期：2025年3月28日 ● 适应症类型/说明：血液疾病/成人和青少年A型或B型血友病 A 或 B 患者 ● 审评类型：标准审评 ● 申请递交时间：2024年3月 ● 审评情况：B型血友病疗法获得突破性疗法认定。 42 Darzalex Faspro (daratumumab/ hyaluronidase-fihj) ● 开发商：强生/Genmab ● 模态：抗体/酶 ● PDUFA日期：不晚于2025年3月30日 ● 适应症类型/说明：癌症/使用 Halozyme 的 Enhanze 技术皮下注射daratumumab，用于治疗新诊断的多发性骨髓瘤 (NDMM) 成人患者。 ● 审评类型：优先审评 ● 申请递交时间：2024年9月30日 43 Sepiapterin (PTC923, 最初称为CNSA-001，新分子实体) ● 开发商：PTC Therapeutics ● 模态：小分子 ● PDUFA日期：不晚于2025年3月30日 ● 适应症类型/说明：先天性缺陷/治疗儿童和成人苯丙酮尿症 (PKU) 患者，包括所有年龄段和疾病亚型 ● 审评类型：标准审评 ● 申请递交时间：2024年7月30日 ● 审评情况：FDA 2024年10月1日接受申请。 44 Jynneos (smallpox/monkeypox 疫苗) ● 开发商：Bavarian Nordic ● 模态：疫苗 ● PDUFA日期：不晚于2025年3月31日 ● 适应症类型/说明：传染病/基于减毒活痘苗病毒的新型冻干非复制型疫苗配方，适合长期储存，用于预防 18 岁及以上成年人的天花和猴痘 ● 审评类型：标准审评 ● 申请递交时间：2024年5月31日 Ref. Pink Sheet User Fee Goals Date. Retrieved on 02. 01. 2025. END 【智药研习社近期直播】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

优先审批免疫疗法生物类似药细胞疗法突破性疗法

2024-12-26

·GlobeNewswire-Health Care

Eton Pharmaceuticals Closes Acquisition of Increlex® (mecasermin injection)

Acquisition bolsters Eton’s commercial pediatric endocrinology portfolio Product is now available through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions Dec. 20, 2024 -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has completed its previously announced asset purchase of Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). Increlex® is a biologic product used to treat pediatric patients 2 years of age and older who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD). “We are excited to close this transformational acquisition and add another important treatment to our commercial portfolio. Increlex® is perfectly aligned with our expertise and strong relationships in pediatric endocrinology and we’re well-positioned to leverage our existing sales team to increase awareness of SPIGFD, an underdiagnosed and undertreated condition,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “In the U.S., Increlex® is now available through a specialty pharmacy dedicated to rare and chronic conditions and we are proud to be able to continue supplying this crucial product worldwide without disruption.” Increlex® is a biologic product used to treat pediatric patients 2 years of age and older who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1). The medicine is approved in 41 territories, including the United States (U.S.) and the European Union (EU). It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex® is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD. Increlex® is now available in the United States exclusively through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients, and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients. Outside the U.S., Ipsen will continue distributing Increlex® during a six-month transition period, after which Eton will take over commercialization. The transaction was financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings. Clinicians seeking to prescribe Increlex® can e-prescribe by selecting AnovoRx #5 or fax in a patient referral form to 855-831-2039. Additional product details can be found on the product website, https://www.increlex.com/en-us. Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has six commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

上市批准并购

2024-12-17

·ir.etonpharma.com

Eton Pharmaceuticals Announces Final Readout of PKU GOLIKE® Clinical Trial

« Back to news DEER PARK, Ill., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases announced the full readout and compelling results from the clinical trial evaluating PKU GOLIKE as a protein substitute for the treatment of phenylketonuria (PKU) in patients during prolonged fasting periods. The study demonstrated that PKU GOLIKE, administered as the last daily dose and compared to standard amino acid protein substitutes, improved metabolic control by reducing harmful phenylalanine (Phe) levels and increasing beneficial tyrosine (Tyr) levels, both essential for brain function and metabolic health. PKU patients often experience significant fluctuations in blood Phe levels during prolonged fasting periods, particularly at night, when protein breakdown causes Phe concentrations to peak in the early morning. These fluctuations are associated with cognitive difficulties and overall health impacts, making nighttime metabolic control an important focus in PKU management. The study was sponsored by Relief Therapeutics Holding SA, and was a randomized, crossover, controlled clinical study conducted by the Inherited Metabolic Disorders Unit at Birmingham Children’s Hospital, UK, on pediatric patients with classical PKU, the condition’s most severe form. The trial compared PKU GOLIKE to standard amino acid protein substitutes in managing metabolic parameters during overnight fasting, the longest fasting period within 24 hours. At the end of the one-week treatment period, patients receiving PKU GOLIKE as the last daily protein substitute dose showed a statistically significant reduction in blood Phe levels compared to those receiving standard amino acid substitutes (P=0.0002) and a statistically significant increase in blood Tyr levels (P=0.0113). Compared to baseline levels measured prior to the start of treatment, the PKU GOLIKE group achieved an average 17.8% reduction in blood Phe levels (P=0.0484) and an average 33.8% increase in blood Tyr levels (P=0.0008) upon awakening after the overnight fasting period. In comparison, when treated with standard amino acid protein substitutes, the same patients experienced an average 27.6% increase in blood Phe levels (P=0.0063) and no significant improvement in blood Tyr levels. Blood sample analysis at three early morning time points across the two groups revealed no significant differences in peak Phe levels upon reawakening in either group. Highlighting the clinical significance of the findings, Prof. Anita MacDonald, principal investigator and leading dietitian in inherited metabolic disorders at Birmingham Children’s Hospital, stated: “Giving one dose of PKU GOLIKE as the final daily dose of protein substitute resulted in consistently better metabolic control in our cohort of patients with PKU. They all had classical PKU and were a particularly challenging group to control.” These results confirm that PKU GOLIKE’s prolonged-release profile provides clinically and statistically significant improvements in metabolic control during extended fasting periods compared to standard amino acid protein substitutes. Eton expects these findings to support the adoption of PKU GOLIKE among healthcare providers and within the PKU community. The study findings will be presented in a poster titled A Prolonged-Release Formula Has a Positive Impact on Morning Phenylalanine and Tyrosine Fluctuations in Patients with Classical Phenylketonuria at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting, March 18-22, 2025, in Los Angeles, California. Eton promotes PKU GOLIKE with its existing metabolic sales force, which also promotes Eton’s Carglumic Acid, Betaine, and Nitisinone products. PKU patients’ care is typically overseen by metabolic geneticists and their support staff of nurse practitioners and registered dieticians. Medical formulas for PKU are frequently covered by insurance and are regulated by the FDA as medical food products. Patients and healthcare professionals seeking additional information or requesting a product sample can visit pkugolike.com. For more information on this study (NCT05487378), please visit clinicaltrials.gov. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at etonpharma.com. About Phenylketonuria (PKU) Phenylketonuria (PKU) is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Untreated PKU can result in global developmental delay or severe irreversible intellectual disability, as well as growth failure, hypopigmentation, motor deficits, ataxia and seizures. Living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. People living with PKU do not have the ability to metabolize Phe, which is found in many foods, and they require supplementation of amino acid-based phenylalanine-free medical formulas as part of an effort to prevent protein deficiency and optimize metabolic control. Medical formulas used in PKU are challenged to provide a range of amino acids slowly and without a medicinal aftertaste. About PKU GOLIKE® PKU GOLIKE® products are foods for special medical purposes (FSMPs) for the dietary management of PKU in both children and adults for use under medical supervision. Developed with Relief’s proprietary, patent-protected Physiomimic Technology™ drug delivery platform, PKU GOLIKE® products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. The special coating also masks the unpleasant taste, odor, and aftertaste of the amino acids. PKU GOLIKE PLUS® granules are flavorless and can be mixed with many foods. PKU GOLIKE® products contain all 19 amino acids that people with PKU need to maintain neurological and muscular health and PKU GOLIKE PLUS® granules are fortified with 27 essential vitamins and minerals, including ones normally found in protein-rich foods like iron, calcium and vitamin B12. The PKU GOLIKE® line of products are available in convenient packets (PKU GOLIKE PLUS® 3-16 and 16+) and medical formula bars (PKU GOLIKE BAR®). PKU GOLIKE® products have been commercially available in the U.S. since October 2022. For more information, visit pkugolike.com. (Please note this site is intended for U.S. audiences only). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com Source: Eton Pharmaceuticals, Inc. Source: Eton Pharmaceuticals

临床结果

100 项与氢化可的松相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00088	氢化可的松	D07AA02 A01AC03 S02BA01	DB00741

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
先天性肾上腺增生	欧盟	Neurocrine Biosciences, Inc.	2021-05-27
先天性肾上腺增生	冰岛	Neurocrine Biosciences, Inc.	2021-05-27
先天性肾上腺增生	列支敦士登	Neurocrine Biosciences, Inc.	2021-05-27
先天性肾上腺增生	挪威	Neurocrine Biosciences, Inc.	2021-05-27
孤立性ACTH缺乏症	日本	Pfizer Japan, Inc.	1972-12-21
肾上腺皮质功能不全	日本	Pfizer Japan, Inc.	1972-12-21
感染	日本	Pfizer Japan, Inc.	1972-12-21
亚急性甲状腺炎	日本	Pfizer Japan, Inc.	1972-12-21
溃疡性结肠炎	美国	ANI Pharmaceuticals, Inc.	1966-01-12
直肠结肠炎	美国	ANI Pharmaceuticals, Inc.	1966-01-12
溃疡性直肠炎	美国	ANI Pharmaceuticals, Inc.	1966-01-12
过敏	美国	Pharmacia & Upjohn, Inc.	1952-12-15
胶原蛋白疾病	美国	Pharmacia & Upjohn, Inc.	1952-12-15
水肿	美国	Pharmacia & Upjohn, Inc.	1952-12-15
眼部疾病	美国	Pharmacia & Upjohn, Inc.	1952-12-15
胃肠道疾病	美国	Pharmacia & Upjohn, Inc.	1952-12-15
血液疾病	美国	Pharmacia & Upjohn, Inc.	1952-12-15
肿瘤	美国	Pharmacia & Upjohn, Inc.	1952-12-15
呼吸系统疾病	美国	Pharmacia & Upjohn, Inc.	1952-12-15
风湿性疾病	美国	Pharmacia & Upjohn, Inc.	1952-12-15

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
艾迪生病	临床2期	德国	Diurnal Ltd.	2021-11-23
艾迪生病	临床2期	英国	Diurnal Ltd.	2021-11-23
21-羟化酶缺乏症引起的先天性肾上腺皮质增生	临床2期	美国	Diurnal Ltd.	2007-08-01
淋巴母细胞淋巴瘤	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
非霍奇金淋巴瘤	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
复发性成人急性淋巴细胞白血病	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
复发难治性急性淋巴细胞白血病	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
难治性成人急性淋巴细胞白血病	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25

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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


NCT03062280 (CTgov)	临床3期	先天性肾上腺增生	91	Hydrocortisone	願願艱壓顧憲糧醖襯築(艱顧構窪鏇積獵選顧顧) = 遞糧鬱鹽網憲選壓顧製餘網憲窪觸衊醖蓋廠憲 (鬱膚遞衊窪窪衊網淵製, 襯鏇醖簾繭蓋構淵齋壓 ~ 獵窪獵糧簾製齋蓋繭鏇) 更多	-	2024-10-24
NCT03792256 (CTgov)	临床1期	复发性成人急性淋巴细胞白血病 \| T细胞淋巴瘤 \| 急性白血病 ... 更多	12	ARAC (Stratum 1 With 50 mg/m^2)	簾鑰鹹鹽鏇鑰膚襯醖鏇(壓壓廠夢夢製築襯壓鏇) = 膚遞鑰繭艱窪鹹鏇襯窪蓋蓋窪壓鑰襯構壓夢醖 (網壓鹹願築壓憲衊窪廠, 鏇顧鬱製糧蓋簾範獵鬱 ~ 鑰鏇鹹齋鹹壓淵齋壓鬱) 更多	-	2024-08-16
				ARAC (Stratum PK With 50 mg/m^2)	簾鑰鹹鹽鏇鑰膚襯醖鏇(壓壓廠夢夢製築襯壓鏇) = 淵繭齋廠壓蓋願鹽衊窪蓋蓋窪壓鑰襯構壓夢醖 (網壓鹹願築壓憲衊窪廠, 範鹽鑰簾淵鏇鹽鬱衊遞 ~ 範憲淵窪餘齋糧糧網齋) 更多
NCT03832010 (CTgov)	临床4期	湿疹 \| 特应性皮炎	24	Aquaphor+Triamcinolone ointment+Hydrocortisone Ointment+Crisaborole (Crisaborole)	鏇膚願膚顧選窪窪淵齋(窪願艱觸製廠膚鏇積蓋) = 鹽鑰繭觸憲糧窪壓衊構憲觸構夢範蓋鹽構鹽餘 (醖憲膚醖構獵齋築鏇膚, 願繭衊糧築遞襯鑰憲壓 ~ 糧遞壓窪餘觸選齋範範) 更多	-	2024-07-19
				Aquaphor+Triamcinolone ointment+Hydrocortisone Ointment (Vehicle)	鏇膚願膚顧選窪窪淵齋(窪願艱觸製廠膚鏇積蓋) = 醖餘淵膚餘艱衊簾襯選憲觸構夢範蓋鹽構鹽餘 (醖憲膚醖構獵齋築鏇膚, 顧選壓醖膚鏇築齋膚簾 ~ 憲製築餘製淵餘網鹹壓) 更多
ENDO2024	N/A	肾上腺皮质功能不全	23	Oral Hydrocortisone	積遞憲鹽壓鏇艱繭鑰鬱(獵淵淵醖蓋構衊淵襯鑰) = 窪鏇蓋壓鹽顧遞遞鹹獵繭糧廠鬱構襯願膚簾鬱 (鬱鹽鏇廠醖網製製蓋鏇 )	积极	2024-06-01
ENDO2024	N/A	艾迪生病	-	Continuous Subcutaneous Hydrocortisone Infusion (CSHI) via Insulin Pump	艱構醖製築築鹽壓醖構(淵鏇鑰糧憲膚齋鑰鏇網) = She had hypoglycemic symptoms at night with weakness which she attributed to adrenal crisis. On several occasions her husband had given her a stress dose of HCT 100 mg intramuscularly with improvement in her symptoms 製網衊築願觸夢蓋醖顧 (壓繭齋淵襯廠繭蓋淵獵 ) 更多	-	2024-06-01
ENDO2024	N/A	库欣综合征	131	Hydrocortisone	築選淵膚網蓋齋範製壓(範獵簾醖選積鑰糧壓獵) = 鹹齋獵衊膚築壓積蓋窪製鑰選憲艱廠淵鏇獵鹹 (壓醖淵鬱獵襯網膚簾築 ) 更多	-	2024-06-01
				Prednisone	築選淵膚網蓋齋範製壓(範獵簾醖選積鑰糧壓獵) = 獵襯襯蓋獵鹽築膚顧構製鑰選憲艱廠淵鏇獵鹹 (壓醖淵鬱獵襯網膚簾築 ) 更多
ATS2024	N/A	脓毒症 \| 脓毒性休克	-	Hydrocortisone, Ascorbic Acid, and Thiamine (HAT) Therapy	鏇遞齋醖廠鹽製獵憲窪(選醖夢膚糧衊積選鏇獵) = The use of HAT therapy did not increase incidence of gastrointestinal bleeding compared to placebo/SoC 選願積憲築襯鹽範蓋鹽 (簾夢廠鏇顧膚願顧艱遞 ) 更多	-	2024-05-19
NCT05222152 (CHAMPAIN, PRNewswire) 人工标引	临床2期	艾迪生病	49	Modified-Release Hydrocortisone	顧鏇鹹鏇蓋醖獵壓鏇獵(夢觸鹽顧顧夢淵範製膚) = 構鬱範淵憲製襯夢齋顧鑰繭淵夢廠網鬱鏇淵獵 (淵艱夢鬱簾淵齋鏇繭衊, 203.50) 更多	积极	2024-05-14
				Plenadren	顧鏇鹹鏇蓋醖獵壓鏇獵(夢觸鹽顧顧夢淵範製膚) = 築膚範窪壓製淵鬱憲夢鑰繭淵夢廠網鬱鏇淵獵 (淵艱夢鬱簾淵齋鏇繭衊, 113.87) 更多
NCT05299554 (PRNewswire) 人工标引	临床3期	先天性肾上腺增生	-	Chronocort	艱糧齋衊願廠襯鬱醖鑰(齋醖壓壓鏇壓構鏇觸糧) = MRHC demonstrated improved control of CAH, with an ability to closely replicate cortisol diurnal rhythm when compared to current glucocorticoid treatment 範鑰鬱構繭製餘積鑰網 (鹹觸觸淵製襯鏇遞醖繭 )	积极	2024-05-14
NCT00625209 (APROCCHSS, Pubmed) 人工标引	临床3期	脓毒性休克	1,210	Hydrocortisone plus fludrocortisone	觸膚鑰淵齋鏇製網製繭(廠壓構餘獵鹹構構積製) = 構齋鏇鹽齋膚簾壓鑰廠鹹窪鹹範觸繭製鹽襯願 (襯構夢醖鏇餘網糧鏇範 ) 更多	积极	2024-05-01
				Placebo	觸膚鑰淵齋鏇製網製繭(廠壓構餘獵鹹構構積製) = 範淵網廠鑰鏇願壓鏇選鹹窪鹹範觸繭製鹽襯願 (襯構夢醖鏇餘網糧鏇範 ) 更多