SEER-3: A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy - SEER-3

开始日期2023-08-29

申办/合作机构

ReGenTree LLC

NCT05555589 / Recruiting临床3期

A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

开始日期2023-04-11

申办/合作机构

ReGenTree LLC

NCT01311518 / Withdrawn临床2期

A Randomized, Double-blind, Placebo-Controlled, Study of the Safety and Efficacy of RGN-352 in Subjects With an Acute ST Elevation Myocardial Infarction (STEMI) After Occlusion of the Proximal Left Anterior Descending Coronary Artery

The objective of this study is to evaluate the safety and tolerability of two active doses of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial infarction receiving percutaneous coronary intervention angioplasty with or without stent placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 more weeks.

开始日期2019-07-01

申办/合作机构

RegeneRx Biopharmaceuticals, Inc.

100 项与胸腺肽β4 相关的临床结果

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100 项与胸腺肽β4 相关的转化医学

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100 项与胸腺肽β4 相关的专利（医药）

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项与胸腺肽β4 相关的文献（医药）

2024-12-01·Current Stem Cell Research & Therapy

Fucoxanthin Enhances the Antifibrotic Potential of Placenta-derived Mesenchymal Stem Cells in a CCl4-induced Mouse Model of Liver

Article

作者: Grebnev, Dmitry ; Beresneva, Olga ; Gavrilov, Ilya ; Konyshev, Konstantin ; Slautin, Vasilii ; Maklakova, Irina

Background:The effectiveness of fucoxanthin (Fx) in liver diseases has been reported due to its anti-inflammatory and antifibrotic effects. Mesenchymal stem cells (MSCs)-based therapy has also been proposed as a promising strategy for liver fibrosis treatment. Recent studies have shown that the co-administration of MSCs and drugs demonstrates a pronounced effect on liver fibrosis.Aim:This study aimed to determine the therapeutic potential of placenta-derived MSCs (PD-MSCs) in combination with Fx to treat liver fibrosis and evaluate their impact on the main links of liver fibrosis pathogenesis.Methods:After PD-MSCs isolation and identification, outbred ICR/CD1 mice were divided into five groups: Control group, CCl4 group (CCl4), Fx group (CCl4+Fx), PD-MSCs group (CCl4+MSCs) and cotreatment group (CCl4+MSCs+Fx). Biochemical histopathological investigations were performed. Semiquantitative analysis of the alpha-smooth muscle actin (α-SMA+), matrix metalloproteinases (MMP-9+, MMP-13+), tissue inhibitor of matrix metalloproteinases-1 (TIMP-1+) areas, and the number of positive cells in them were studied by immunohistochemical staining. Transforming growth factor-beta (TGF-β), hepatic growth factor (HGF), procollagen-1 (COL1α1) in liver homogenate and proinflammatory cytokines in blood serum were determined using an enzyme immunoassay.Results:Compared to the single treatment with PD-MSCs or Fx, their combined administration significantly reduced liver enzyme activity, the severity of liver fibrosis, the proinflammatory cytokine levels, TGF-β level, α-SMA+, TIMP-1+ areas and the number of positive cells in them, and increased HGF level, MMP-13+, and MMP-9+ areas.Conclusion:Fx enhanced the therapeutic potential of PD-MSCs in CCl4-induced liver fibrosis, but more investigations are necessary to understand the mutual impact of PD-MSCs and Fx.

2024-11-01·Asian Journal of Surgery

Therapeutic potential of thymosin beta 4 in a variety of diseases

Letter

作者: Dai, Qingmei ; Ye, Chaoqun ; Deng, Luyao ; Huang, Huizhi

2024-08-01·Translational Oncology

Can thymosin beta 10 function both as a non-invasive biomarker and chemotherapeutic target in human colorectal cancer?

Article

作者: Wang, Lingxiao ; Yang, Xiaolong ; Hu, Zhen ; Yang, Jian ; Guo, Tianyi ; Li, Yaoping ; Zhao, Zhenxiang

Thymosin beta 10 (TMSB10) overexpression is a general characteristic in human carcinogenesis. It is involved in the malignant process of generating multiple cancers. However, there are only a few reports about TMSB10 in colorectal cancer (CRC) and the mechanism of its carcinogenetic effect is still poorly understood. The present study intends to clarify the biological roles and carcinogenic mechanism of TMSB10 in CRC and to explore the possibility whether TMSB10 might be useful as a non-invasive serum tumor biomarker in detecting CRC. Immunohistochemical results showed that TMSB10 protein expression in CRC tissues was generally higher than that in adjacent tissues, and the TMSB10 contents in serum of CRC patients was significantly elevated compared to that of healthy controls. Knockdown-TMSB10 increased apoptosis and induced S-cell cycle arrest, and finally inhibited cell proliferation in vitro and in vivo. Transcriptome sequencing and western blotting analysis revealed that knockdown-TMSB10 increased phosphorylation of p38 and activated the p38 pathway that blocked cell cycle and promoted apoptosis. Taken together, our study indicated that TMSB10 could serve as a minimally invasive serum tumor marker in detecting CRC. At the same time it demonstrates an effective regulatory capacity of TMSB10 on cell proliferation of CRC, suggesting that TMSB10 and downstream effector molecules regulated by TMSB10 could further be applied as an appealing target in clinical post-surgery chemotherapy.

项与胸腺肽β4 相关的新闻（医药）

2024-07-07

·生物探索

Nat Struct Mol Biol | 张金伟团队揭示长非编码RNA MALAT1成熟和mascRNA生成的结构机制

引言转移相关肺腺癌转录本1（MALAT1）是最早发现的和进化上最保守的长非编码RNA（lncRNA）之一。MALAT1在多种癌症中的表达水平显著升高，并在预测癌症转移和患者生存方面具有重要的临床应用意义【1】。MALAT1在乳腺癌、肝癌和肺癌、糖尿病、胰岛素信号传导、炎症等疾病中发挥多种作用。MALAT1定位于核斑点（nuclear speckles），直接与活性染色质和RNA结合蛋白（如异质性核核糖核蛋白C（hnRNP C）和丝氨酸/精氨酸剪接因子）结合【2, 3】。通过这些和其他核内分子的互作，MALAT1在调节转录、前mRNA剪接、微RNA隔离及其他细胞过程中起到关键作用【4】。然而MALAT1，NEAT1，以及其他至少130个后生动物的lncRNA 缺失稳定多数mRNA的 3′ poly(A) 尾。这些lncRNA则利用它们3′ 末端的稳定RNA三螺旋（triplex）结构以免受外切核酸酶快速降解【5, 6】。MALAT1前体通过模仿tRNA结构以招募RNase P切割其5′ 引导序列，产生成熟MALAT1。与此同时，被RNase P切割后的tRNA类似结构生成一个新的小非编码RNA，被命名为mascRNA【7】。随后，ELAC2（ElaC同源蛋白2，或RNase Z）去除mascRNA 的3′ 尾部，然后CCA-添加酶对它添加3′ CCA尾，最终产生61碱基长的成熟mascRNA。在细胞核内驱动MALAT1成熟后，mascRNA被转运到细胞质中，并执行一系列其他功能，包括增强翻译、调节先天免疫和维持巨噬细胞功能【8-10】。mascRNA特异性结合谷氨酰-tRNA合成酶（GlnRS）、多tRNA合成酶复合物（MSC）和hnRNP H/F等蛋白。成熟的MALAT1和mascRNA分别独立促进细胞增殖、迁移和侵袭，并在小鼠模型中驱动肿瘤形成和转移。尽管具有3′ CCA末端和整体类似tRNA的二级结构，但尚未发现成熟的mascRNA被氨酰化。这与大多数植物病毒中的类tRNA结构（TLS）形成鲜明对比，例如芜菁黄花叶病毒（TYMV）和燕麦花叶病毒（BMV）。病毒TLS的主要功能是招募宿主氨酰-tRNA合成酶（aaRSs）以在其3′末端安装氨基酸。TLS氨酰化增强病毒mRNA与翻译因子和核糖体的结合，以促进病毒mRNA翻译并支持其感染性。mascRNA不被aaRSs识别的现象引发了一个问题，即它是否折叠成tRNA的经典三维结构。同时，mascRNA缺失位于tRNA核心区域的约八个进化上保守的和结构上重要的碱基。到目前为止，mascRNA的具体三维结构，以及它与RNase P， ELAC2, aaRSs等tRNA加工酶的相互作用仍未知。 2024年7月2日，美国国立卫生研究院（NIH）资深研究员张金伟研究组在Nature Structural & Molecular Biology杂志上发表了题为Structural basis of MALAT1 RNA maturation and mascRNA biogenesis的文章解析首个mascRNA晶体结构，并通过酶动力学、圆二色性 (CD)、荧光偏振、实时荧光定量PCR、RNA测序等多种生物化学、生物物理、和细胞生物学手段揭示了MALAT1 和mascRNA 招募多个tRNA加工酶的分子机理。 a. MALAT1 lncRNA 末端成熟和mascRNA产生的流程图。b. 对比tRNA和mascRNA的结构相似性和差异。c.mascRNA目前已知的细胞质功能。(Credit: Nature Structural & Molecular Biology) 文章作者发现MALAT1 前体以及mascRNA结构使用一种异常精简的准tRNA折叠。虽然没有使用任何单链碱基来连接类似tRNA的4个双螺旋茎区，这种新颖的RNA架构仍然有效地模拟了tRNA的上半部分，包括其特征性的臂肘 (elbow) 结构。tRNA和mascRNA的臂肘结构均由D-loop和T-loop结构互补镶嵌产生，是tRNA独有的表面结构特征【11-14】。体外和细胞内实验一致表明mascRNA的臂肘结构对RNase P的招募至关重要，由于臂肘区域与RNAse P RNA通过直接的p-p堆叠以实现结构对接和RNA-RNA互作。相比RNAse P，ELAC2则表现出一种较宽松的RNA底物特异性。mascRNA的下半部分与tRNA有明确的结构差异，通过D 茎区和反密码子区域的40度旋转和重新定位防止了氨酰化，避免干扰正常的核糖体蛋白质合成。这些结构和功能数据为MALAT1的末端成熟和mascRNA的生物学发生提供了详细的分子基础。 a-g. 多种实现tRNA结构拟态的天然RNA架构的横向比较(Credit: Nature Structural & Molecular Biology) 综上，一大类后生动物内以MALAT1为例的lncRNA采用一种新颖的、异常精简的准tRNA结构来招募指定的tRNA加工酶，同时避免被其他不利的tRNA酶识别，以驱动精准定制的RNA生成、加工和成熟。相比其他的天然模仿tRNA的RNA结构（比如Y RNA， tmRNA， TLS，IRES等）， mascRNA提供了目前已知的最精简而有效的策略。利用MALAT1 作为范例，此项工作首次揭示了长非编码RNA的部分精细复杂三维结构，以及这类模块化的RNA如何通过部分模仿其他的RNA结构实现招募或者排斥不同RNA结合蛋白的原则和机制，并提供了发展和设计新型RNA功能设备和靶向或者基于RNA结构的抗癌药物设计的前景和框架。参考文献 1. Ji, P., et al., MALAT-1, a novel noncoding RNA, and thymosin beta4 predict metastasis and survival in early-stage non-small cell lung cancer. Oncogene, 2003. 22(39): p. 8031-41. 2. Liu, N., et al., N(6)-methyladenosine-dependent RNA structural switches regulate RNA-protein interactions. Nature, 2015. 518(7540): p. 560-4. 3. Tripathi, V., et al., The nuclear-retained noncoding RNA MALAT1 regulates alternative splicing by modulating SR splicing factor phosphorylation. Mol Cell, 2010. 39(6): p. 925-38. 4. Arun, G., D. Aggarwal, and D.L. Spector, MALAT1 Long Non-Coding RNA: Functional Implications. Noncoding RNA, 2020. 6(2). 5. Zhang, B., et al., Identification and Characterization of a Class of MALAT1-like Genomic Loci. Cell Rep, 2017. 19(8): p. 1723-1738. 6. Brown, J.A., et al., Formation of triple-helical structures by the 3'-end sequences of MALAT1 and MENbeta noncoding RNAs. Proc Natl Acad Sci U S A, 2012. 109(47): p. 19202-7. 7. Wilusz, J.E., S.M. Freier, and D.L. Spector, 3' end processing of a long nuclear-retained noncoding RNA yields a tRNA-like cytoplasmic RNA. Cell, 2008. 135(5): p. 919-32. 8. Sun, T., et al., The small RNA mascRNA differentially regulates TLR-induced proinflammatory and antiviral responses. JCI Insight, 2021. 6(21). 9. Lu, X., et al., The tRNA-like small noncoding RNA mascRNA promotes global protein translation. EMBO Rep, 2020. 21(12): p. e49684. 10. Gast, M., et al., tRNA-like Transcripts from the NEAT1-MALAT1 Genomic Region Critically Influence Human Innate Immunity and Macrophage Functions. Cells, 2022. 11(24). 11. Zhang, J., Recognition of the tRNA structure: Everything everywhere but not all at once. Cell Chem Biol, 2024. 31(1): p. 36-52. 12. Zhang, J. and A.R. Ferré-D'Amaré, Co-crystal structure of a T-box riboswitch stem I domain in complex with its cognate tRNA. Nature, 2013. 500(7462): p. 363-6. 13. Zhang, J. and A.R. Ferre-D'Amare, The tRNA Elbow in Structure, Recognition and Evolution. Life (Basel), 2016. 6(1). 14. Bou-Nader, C., et al., HIV-1 matrix-tRNA complex structure reveals basis for host control of Gag localization. Cell Host Microbe, 2021. 29(9): p. 1421-1436. https://www.nature.com/articles/s41594-024-01340-4 责编|探索君排版|探索君文章来源|“BioArt” End 往期精选围观一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版）热文 Cell | 是什么决定了细胞的大小？热文 Nature | 2024年值得关注的七项技术热文 Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望热文 CRISPR技术进化史 | 24年Cell综述

信使RNA

2023-09-13

·CPHI制药在线

仿制药 | 干眼药物立他司特首仿报产

关注并星标CPHI制药在线 9月11日，成都康弘药业集团股份有限公司3类仿制药「立他司特滴眼液」的上市申请获CDE受理。立他司特（Lifitegrast）是一种新型小分子整合素抑制剂，通过抑制淋巴细胞功能相关抗原1（LFA-1）与细胞间粘附分子1的结合，从而减少由T淋巴细胞介导的炎症水平。 2016年7月，原研立他司特滴眼液被FDA批准用于治疗干眼症症状和体征，商品名为Xiidra。作为首个且唯一一个专门针对干眼症症状和体征的非类固醇滴眼液，Xiidra市场表现不错，2021年、2022年全球销售额分别为4.68亿美元和4.87亿美元。值得一提的是，Xiidra几经易手。该药最初由SARcode Bioscience开发，2013年Shire通过收购SARcode Bioscience将其纳入囊中。2018年武田收购Shire获得Xiidra，2019年武田将Xiidra相关权益卖个诺华。今年7月，诺华（Novartis）又将Xiidra卖给眼部健康专家博士伦（Bausch+Lomb)。据悉，Xiidra化合物专利于2024年11月15日到期，适应症专利于2026年5月17日到期。目前，Xiidra还未在国内获批，但康弘药业、齐鲁制药、贝特制药、辰欣药业四家企业已开始布局Xiidra仿制药市场。其中康弘药业率先递交立他司特滴眼液3类仿制药上市申请，预计有望取得该品种首仿生产批件。除了Xiidra，维眸生物也研发了一款治疗干眼症的LFA-1拮抗剂，即VVN001。该药新一代LFA-1拮抗剂，可高效阻断LFA-1与配体ICAM-1的结合，有效控制眼部炎症反应，缓解干眼症状。在美国开展的2期临床试验结果显示：在完成84天治疗期后，主要疗效终点指标--下方角膜荧光染色较基线的改善表面VVN001具有良好的治疗效果，5%治疗组的改善明显高于对照组。干眼治疗新进展据2020年《中国干眼专家共识定义和分类》，干眼是多因素引起的慢性眼表疾病，是由泪液的质、量及动力学异常导致的泪膜不稳定或眼表微环境失衡，可伴有眼表炎症、组织损伤及神经异常，造成眼部多种不适症状和/或视功能障碍。干眼是全球最常见的眼表疾病。受生活方式改变、电子产品广泛使用等影响，干眼发病率不断攀升，据悉其全球发病率大约5.5%-33.7%，我国干眼发病率约为21%-30%。治疗方面，干眼治疗包括物理治疗、修复治疗、抗炎治疗。物理治疗包括热敷、睑板腺按摩、清洁眼睑等，通过促进睑板腺通畅，减轻眼睛局部炎症，增强泪液稳定性。以人工泪液（玻璃酸钠滴眼液）为代表的修复治疗多用于干眼轻症患者，是目前国内对于干眼最常用的给药方案。抗炎治疗主要针对中重度干眼患者，代表药物如糖皮质激素、免疫抑制剂环孢素、非甾体抗炎药。干眼药物市场规模巨大，据悉2020年全球干眼产品销售额约为52.4亿美元，预测2023-2024年干眼产品销售额将达峰值，约为58.0亿美元。具体品种上，环孢素眼用制剂是销售额最高的一款干眼产品，2020年销售额高达24.2亿美元。鉴于干眼巨大的市场体量，越来越多的药企开始涉足该领域，且取得不错进展。据不完全统计，近年来全球监管机构批准了多款新活性成分干眼药物，如Xiidra、Eysuvis、Tyrvaya（varenicline，伐尼克兰溶液）鼻喷雾剂、Miebo。 Eysuvis（0.25％氯替泼诺混悬型滴眼液）是FDA批准的唯一一款皮质醇类干眼药物，其利用Kala Pharmaceuticals的Ampplify黏液穿透颗粒（MPP）给药技术，以增强皮质类激素在眼表的渗透性，用于短期（长达两周）治疗干眼的体征和症状。 Tyrvaya鼻喷雾剂是一种高选择性胆碱能激动剂，通过激活三叉神经副交感神经通路，从而增加基础泪膜的生成，2021年10月被FDA批准用于治疗干眼症（DED）的症状和体征。 Miebo是一款首创、无水、非甾体、单组分不含防腐剂的滴眼液，活性成分全氟己基辛烷是一种半氟烷烃，可防止泪液过度蒸发并具有恢复泪膜平衡的能力。2023年5月，该药被FDA批准用于治疗干眼的症状，成为FDA批准的首个，且唯一一个直接针对干眼泪液蒸发的药物。此外，目前全球还有多款干眼新药处于后期临床，如Reproxalap、RGN-259、AR-15512、SkQ1、PL-9643、Tivanisiran。其中Reproxalap是一款潜在首创小分子活性醛化物质（RASP）抑制剂，通过降低RASP水平，达到抑制炎症、缓解症状的作用。今年2月，该药治疗干眼的新药申请获FDA受理。 RGN-259是一种新型治疗性肽（胸腺素β4），具有保护组织以及促进修复及再生的特性，拟用于治疗中重度干眼。 AR-15512是一款瞬时受体电位TRPM8激动剂。TRPM8受体是位于角膜神经末梢的冷热感受器离子通道，AR-15512通过激活角膜中的冷热感受器，增加泪液的产生和眨眼速度，恢复泪膜的稳定性，减少眼部不适。 SKQ1是一种小分子心磷脂过氧化抑制剂，通过向线粒体提供抗氧化剂质体醌，靶向活性氧发挥作用。 PL-9643是一款黑素皮质素受体（MCR）激动剂，研究显示其可显著减少角膜上皮损伤，具有与Restasis（环孢菌素滴眼液）相似的效果。 Tivanisiran是一种基于RNA干扰的药物，能够将TRPV1基因沉默，降低TRPV1的表达，从而治疗干眼症。已公布研究结果显示，Tivanisiran能够明显减轻眼部不适及疼痛，改善干眼患者的结膜充血状态，且安全性良好。总结眼科是医药领域药物研发的黄金赛道，干眼作为常见的眼科疾病，更是国内外药企争相布局的热门领域。随着干眼发病率的上升，干眼药物市场需求也不断增加。虽然全球已获批多款干眼新药，但干眼市场仍有待进一步挖掘。希望企业的付出不会白费，更加高效、安全的干眼新药早日获批上市。智药研习社近期课程报名来源：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~

并购专利到期临床结果

2023-08-24

·Pharmaceutical Technology

Novaliq pursues EMA approval for dry eye disease drug

Akosua Mireku @AkosuaMireku1 CyclASol is an eye drop solution for dry eye disease. Credit: Andrii Borodai via Getty Images. The European Medicines Agency (EMA) accepted Novaliq’s marketing authorisation application for CyclASol (cyclosporine ophthalmic solution) 0.1% as a treatment for dry eye disease (DED) . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the MAA, using the centralised procedure for all 27 member states of the European Union. Recommended Reports Reports LOA and PTSR Model - Progesterone in Keratoconjunctivitis Sicca (Dry Eye) GlobalData Reports LOA and PTSR Model - Timbetasin Acetate in Keratoconjunctivitis Sicca (Dry Eye) GlobalData View all Companies Intelligence Harrow Health Inc Novaliq GmbH MAA Co Ltd DED Limited C H M P INC View all In order to determine the drug’s approval chances, the CHMP will evaluate results from six clinical trials in CyclASol’s clinical development programme. This includes results from the Phase III ESSENCE-2 trial (NCT04523129) that showed that the eye drops had a good tolerability profile, with a clinically meaningful effect on 71.6% of participants in the cyclosporine group. Germany-headquartered Novaliq received regulatory approval for CyclASol from the US Food and Drug Administration (FDA) as a DED treatment on 30 May. Marketed under the US brand name, Vevye, the drug became the first and only cyclosporine solution approved for the condition with efficacy demonstrated after four weeks of treatment. In the US and Canada, Harrow Health holds the rights to commercialise the DED therapy, as per a July 2023 deal . CyclASol’s mechanism of action works through the binding of cyclosporine to cyclophilin. This complex suppresses a pathological immune response, which prevents ocular inflammation—a major cause of dry eye disease in many patients. The therapy uses Novaliq’s EyeSol technology to avoid the need for water-based excipients. The biotech lists the benefits of this approach as increasing the drug’s bioavailability and providing a longer residual time on the eye amongst other things. Novaliq’s pipeline currently consists of five DED products and seven candidates for other ophthalmologic conditions. The company is also pursuing research for dermatological treatments through a separate entity Dermaliq. The dermatology clinical programme is currently investigating three drug candidates for androgenetic alopecia, psoriasis, and bacterial skin infections, using its proprietary hyliQ drug delivery technology. In a press release , Novaliq’s CEO Christian Roesky said: “The acceptance of the EU marketing authorisation application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. “We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. 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临床3期上市批准临床结果

100 项与胸腺肽β4 相关的药物交易

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研发状态

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
神经营养性角膜炎	临床3期	美国	ReGenTree LLC	2015-09-17
交界型大疱性表皮松解	临床2期	美国	Lenus Therapeutics, LLC	2019-05-22
糖尿病	临床2期	美国	ReGenTree LLC	2007-12-01
交界型大疱性表皮松解	临床前	美国	Lenus Therapeutics, LLC	2019-05-22
干眼综合征	临床前	美国	ReGenTree LLC	2016-11-01
静脉曲张溃疡	临床前	意大利	RegeneRx Biopharmaceuticals, Inc.	2006-07-01
静脉曲张溃疡	临床前	波兰	RegeneRx Biopharmaceuticals, Inc.	2006-07-01
压疮	临床前	美国	RegeneRx Biopharmaceuticals, Inc.	2006-05-01
大疱性表皮松解	药物发现	-	RegeneRx Biopharmaceuticals, Inc.	2006-02-01
创伤和损伤	药物发现	-	RegeneRx Biopharmaceuticals, Inc.	2006-02-01

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临床结果

适应症

分期

评价

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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


NCT02600429 (SEER-1, CTgov)	临床3期	神经营养性角膜炎	18	RGN-259 (RGN-259)	簾憲醖積壓獵鹽製積憲(淵構觸壓積鏇膚蓋製鹹) = 窪鬱獵積選膚構築觸衊襯網襯範淵範淵鹹繭獵 (齋窪糧築餘蓋齋醖壓餘, 鹽鬱蓋襯淵鹽積鬱蓋網 ~ 餘淵窪製鹹願簾糧餘糧) 更多	-	2023-08-14
				Placebo (Placebo)	簾憲醖積壓獵鹽製積憲(淵構觸壓積鏇膚蓋製鹹) = 積鏇構膚顧衊製積壓夢襯網襯範淵範淵鹹繭獵 (齋窪糧築餘蓋齋醖壓餘, 膚選壓醖憲範壓廠餘鑰 ~ 鏇夢憲築蓋選鹽獵鏇繭) 更多
NCT02974907 (ARISE-2, CTgov)	临床3期	干眼综合征	601	RGN-259 (RGN-259)	窪餘願餘壓遞鬱獵鹹繭(遞夢襯鑰繭鏇構鬱醖製) = 顧襯襯醖積製醖窪遞繭襯醖製鏇遞網醖鑰繭膚 (製獵壓鏇鏇襯構製觸獵, 醖觸衊願築鬱顧獵衊齋 ~ 衊膚積廠廠繭網鬱遞築) 更多	-	2022-01-05
				Placebo (Placebo)	窪餘願餘壓遞鬱獵鹹繭(遞夢襯鑰繭鏇構鬱醖製) = 顧願顧齋遞淵選糧壓顧襯醖製鏇遞網醖鑰繭膚 (製獵壓鏇鏇襯構製觸獵, 醖鏇遞壓鏇壓遞廠網構 ~ 艱醖觸壓積襯築憲製鹽) 更多
SEER-1 (AAO2021)	临床3期	神经营养性角膜炎一线	18	RGN-259	(憲淵淵製餘鬱淵繭範範) = 廠餘蓋衊願繭夢壓壓憲鬱繭鬱糧構餘網願衊築 (築窪膚鏇醖餘簾襯獵齋 )	积极	2021-11-13
				Placebo	(憲淵淵製餘鬱淵繭範範) = 襯艱夢醖鬱網衊選願憲鬱繭鬱糧構餘網願衊築 (築窪膚鏇醖餘簾襯獵齋 )
NCT02600429 (SEER-1, Corporate Publications) 人工标引	临床3期	神经营养性角膜炎	18	RGN-259	壓窪鹹蓋顧鏇簾製鏇鏇(網選製蓋築觸壓窪築遞) = 憲淵鑰願製構壓憲襯積夢膚齋醖鏇選艱簾鏇選 (顧壓夢糧鑰鬱鏇艱積夢 )	积极	2020-05-14
				Placebo	壓窪鹹蓋顧鏇簾製鏇鏇(網選製蓋築觸壓窪築遞) = 積糧遞蓋觸蓋製廠構積夢膚齋醖鏇選艱簾鏇選 (顧壓夢糧鑰鬱鏇艱積夢 )
NCT02974907 (ARISE-2, Corporate Publications) 人工标引	临床3期	干眼综合征	-	Thymosin beta-4	(醖夢糧鬱選獵築鹽鏇築) = RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively). 膚構膚廠築願範夢積糧 (遞壓糧範襯夢鏇壓顧遞 ) 更多	积极	2017-10-31
				Placebo
NCT01387347 (Pubmed) 人工标引	临床2期	干眼综合征	72	Tβ4	艱顧選淵餘獵糧繭衊繭(齋願製積蓋構簾鏇齋築) = 顧憲積繭憲積遞簾顧選淵積淵齋窪衊網鑰憲獵 (製築顧齋壓淵選繭蓋壓 )	积极	2015-05-20
				Placebo	-
NCT00311766 (CTgov)	临床2期	大疱性表皮松解 \| 创伤和损伤	30	Thymosin Beta 4+placebo (Placebo)	(顧襯艱齋壓蓋鑰獵糧構) = 築繭顧憲憲窪獵構網艱選淵鹽襯憲襯網範餘窪 (鑰衊繭獵觸窪範簾艱構, 艱築壓艱蓋觸憲顧憲遞 ~ 積觸糧淵願簾簾網糧積) 更多	-	2013-06-10
				Thymosin Beta 4 (Thymosin Beta 4)	(顧襯艱齋壓蓋鑰獵糧構) = 膚遞糧製襯願壓顧鏇膚選淵鹽襯憲襯網範餘窪 (鑰衊繭獵觸窪範簾艱構, 選網淵繭觸餘膚構鏇製 ~ 蓋築遞襯願餘鏇鏇餘憲) 更多
NCT01387347 (CTgov)	临床2期	干眼综合征	72	Thymosin beta 4 (Thymosin Beta 4)	壓糧築選醖鬱鏇顧衊壓(遞糧獵鏇壓窪鬱鏇蓋願) = 窪願鬱壓積觸襯醖齋廠鏇膚鹽蓋夢鏇醖餘鹹鹽 (鏇鬱願壓壓範構淵夢窪, 獵顧憲膚積壓鬱鬱簾鏇 ~ 醖餘鏇壓鹽夢鏇願窪獵) 更多	-	2012-12-24
				Placebo (Placebo)	壓糧築選醖鬱鏇顧衊壓(遞糧獵鏇壓窪鬱鏇蓋願) = 艱遞鹽膚遞窪衊築範製鏇膚鹽蓋夢鏇醖餘鹹鹽 (鏇鬱願壓壓範構淵夢窪, 淵夢鹽醖齋憲蓋遞糧淵 ~ 選憲糧齋憲壓願齋鑰壓) 更多