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更新于：2025-12-04

Levothyroxine Sodium

左甲状腺素钠

更新于：2025-12-04

概要

基本信息

简介左旋甲状腺素钠是一种小分子药物，作用于甲状腺激素受体，是甲状腺激素受体的激动剂。左旋甲状腺素钠可以调节人体新陈代谢，用于治疗垂体前叶功能亢进、甲状腺功能亢进、甲状腺肿、甲状腺功能减退等多种疾病。其作用机制是增加甲状腺激素的水平，从而调节人体的新陈代谢、心血管系统、中枢神经系统等方面的功能。左旋甲状腺素钠是由AbbVie公司开发的，并于1964年8月7日首次获得批准。

药物类型

小分子化药

别名

Levothyroxine Sodium Hydrate、LT4、Sustained-release levothyroxine sodium

+ [32]

靶点

THR

作用方式

激动剂

作用机制

THR激动剂(甲状腺激素受体激动剂)

治疗领域

肿瘤神经系统疾病遗传病与畸形+ [3]

在研适应症

分化型甲状腺癌粘液性水肿昏迷垂体功能亢进+ [6]

非在研适应症-

原研机构

AbbVie, Inc.

在研机构

深圳市中联股份合作公司

BioSyent, Inc.

Bukwang Pharmaceutical Co., Ltd.

+ [16]

非在研机构

Eton Pharmaceuticals, Inc.BERLIN-CHEMIE AG

权益机构

Oliva Therapeutics LLC

IBSA Institut Biochimique SA

Lannett Co., Inc.

+ [4]

最高研发阶段批准上市

首次获批日期

日本 (1964-08-07),

甲状腺功能减退症

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C15H13I4NNaO5

InChIKeyVSGRWOHSMUGJIF-LTCKWSDVSA-N

CAS号6106-07-6

关联

325

项与左甲状腺素钠相关的临床试验

NCT06790589

/ Not yet recruiting临床2期IIT

COmparison of Two Alternative Thyrotropin Suppression Strategies Among Patients With Advanced Differentiated Cancer of the tHyroid

Most thyroid cancers can be cured with surgery, sometimes with radioactive iodine therapy. However, some patients have cancer that has spread, and some have cancer that comes back after treatment. For those with remaining cancer, lowering TSH levels is recommended. This is because thyroid cancer growth can depend on TSH, so reducing TSH can lower the risk of cancer returning and slow its growth in patients with cancer that can't be surgically removed.
International guidelines recommend keeping TSH levels as low as <0.1 mU/L for patients with advanced thyroid cancer. This advice is based on past studies, but it hasn't been tested in a controlled way. One old study suggested that not lowering TSH enough could lead to more cancer relapses. Another study suggested that lowering TSH more could help prevent cancer from getting worse in high-risk patients. However, a recent study found no link between TSH levels and better outcomes, and the researchers suggested doing a new study to confirm if this practice is truly beneficial.
Lowering TSH levels to <0.1 mU/L using levothyroxine has been the standard of care for treating advanced thyroid cancer for a long time. The researchers would like to investigate whether using levothyroxine to keep TSH levels between 0.1 and 0.5 mU/L is just as safe and effective for cancer treatment as the current recommendation of keeping it below 0.1 mU/L. The researchers also believe this study can help set TSH suppression targets based on cancer type, reducing unnecessary side effects from too much TSH suppression while still achieving the same cancer treatment results.
If the researchers can prove that keeping TSH levels between 0.1 and 0.5 mU/L is just as safe and effective as the standard of care practice, we can change our standard treatment approach. This would help reduce symptoms for our patients.

开始日期2025-12-01

申办/合作机构

AHS Cancer Control Alberta

NCT07239674

/ Not yet recruiting临床3期IIT

Desiccated Thyroid Extract Combined With Levothyroxine for TSH Suppression Therapy in Intermediate-to-High Risk Differentiated Thyroid Cancer After Surgery: A National Multicenter, Open-Label, Randomized Controlled Trial

The global incidence of Differentiated Thyroid Cancer (DTC) is rising. While surgery followed by TSH suppression is the standard of care, achieving target TSH levels with levothyroxine (L-T4) monotherapy remains challenging, with only 25-70% of intermediate/high-risk patients attaining it within 6-8 months. This therapeutic dilemma stems from three key issues: impaired T4-to-T3 conversion due to DIO2 polymorphisms, the non-physiological hormone ratio of T4 monotherapy, and L-T4's narrow therapeutic window. This often results in an "under- versus over-suppression" paradox, increasing risks of recurrence, atrial fibrillation, and osteoporosis. Combining L-T4 with desiccated thyroid extract (DTE; T4:T3 ≈ 4:1) may overcome these limitations by bypassing DIO2 defects and providing a more physiological hormone profile, thereby potentially improving TSH control while mitigating side effects. Supported by the 2023 Chinese guidelines and our promising pilot data (82% cumulative target attainment at a median of 1.4 months), we propose a two-stage national study: a multicenter cohort study followed by a randomized trial, to generate high-level evidence for this combination therapy in high-risk DTC.

开始日期2025-11-30

申办/合作机构

四川大学华西医院（四川省国际医院）

[+10]

ChiCTR2500111859

/ Not yet recruitingN/AIIT

Study on the Efficacy of Thyroxine Supplementation Therapy in Sinus Bradycardia

开始日期2025-11-11

申办/合作机构

北京大学航天临床医学院

100 项与左甲状腺素钠相关的临床结果

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100 项与左甲状腺素钠相关的转化医学

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100 项与左甲状腺素钠相关的专利（医药）

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42,209

项与左甲状腺素钠相关的文献（医药）

2026-02-01·JOURNAL OF NUTRITIONAL BIOCHEMISTRY

Vitamin A acts as a potent suppressor of selenoprotein P with potential relevance for multivitamin supplementation

Article

作者: Karmeli, Sophia ; Sane, Rajas ; Schwarz, Maria ; Schomburg, Lutz ; Gröber, Uwe ; Hackler, Julian ; Kipp, Anna P ; Chillon, Thilo Samson

Multivitamin supplementation is a widely used strategy to prevent disease, slow the ageing process, improve quality of life and extend life span, although recent clinical findings do not support these claims. Since selenium (Se) deficiency is associated with morbidity and mortality risk, we tested the hypothesis that certain vitamins interfere with the regular biosynthesis of the Se transporter selenoprotein P (SELENOP). Human liver cancer cells (HepG2) were treated with different concentrations of folic acid, nicotinamide, nicotinic acid, pyridoxal phosphate, thiamine, vitamin A, vitamin C, vitamin D2, vitamin D3, vitamin E, vitamin K and vitamin B12. Secreted SELENOP was quantified by ELISA and characterized by Western blot analysis. SELENOP transcript levels and promoter activity were determined, and resveratrol as a negative and thyroid hormone as a positive modulator were included for comparison. The concentration of extracellular SELENOP decreased twofold in response to micromolar concentrations of vitamin A. The SELENOP transcript concentration decreased to 70% after incubation with 1 µM vitamin A, and a moderate concomitant decrease in SELENOP core promoter activity was observed. Co-incubation experiments of vitamin A with the active thyroid hormone T3 revealed dose-dependent effects and suggested competitive activities of these two modifiers of SELENOP expression in opposite directions. We conclude that vitamin A is able to suppress hepatic SELENOP biosynthesis and secretion, which may confer health risks in self-administered or clinically indicated supplementation with retinoids, especially in individuals with marginal Se intake and status.

2026-01-01·MOLECULAR AND CELLULAR ENDOCRINOLOGY

Raman spectroscopic characterization of liver steatosis and fibrosis in a 2D and 3D in vitro thyroxine-treated hypothyroid cellular model

Article

作者: Scopacasa, B ; Scionti, F ; Mare, R ; Geirola, N ; Mirarchi, A ; Pujia, A ; Frosina, M ; Candeloro, P ; Maurotti, S ; Tirinato, L ; Pujia, R ; Montalcini, T

Primary hypothyroidism has been associated with metabolic dysfunction-associated steatotic liver disease and, potentially, increased liver fibrosis risk. Although T4-analog drug is one of the standard treatments, its molecular effects on the liver are not fully understood. To elucidate drug-induced hepatic metabolic changes, chronic human 2D and 3D hypothyroid models were developed. The effects of T4 were assessed by Raman spectroscopy and complementary biological techniques to observe lipid and fibrotic changes. In vitro chronic hypothyroidism caused lipid droplet (LDs) accumulation in liver cells which was unaffected by T4 therapy. Notably, TSH and T4 influenced TG fatty acid saturation in different ways: T4-exposed cells accumulated monounsaturated fatty acids at the expense of saturated fatty acids. In the case of liver fibrosis, TSH treatment activated hepatic stellate cells as evidenced by increased collagen secretion and decreased LD content, regardless of T4 co-treatment. Data confirmed that TSH induced pro-inflammatory changes leading to higher inflammasome levels in a 3D liver model. These findings indicate the detrimental effects of elevated TSH levels, and it is worth noting that T4 administration does not reverse the excess of hepatic lipid overload but has the ability to alter its lipid composition. Furthermore, T4 administration did not reverse TSH-induced hepatic fibrogenesis in the hypothyroid cell models. Because micro-Raman spectroscopy is currently restricted to 2D/3D in-vitro systems, further validation in intact tissue and in vivo is warranted. In conclusion, our results highlight the importance of further research into the molecular pathways associated with chronic liver injury in patients with chronic hypothyroidism.

2026-01-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

A method for simultaneous determination of triiodothyronine and thyroxine in fingernail clippings by LC/ESI-MS/MS

Article

作者: Wada, Norio ; Miyoshi, Arina ; Tanaka, Sakurako ; Higashi, Tatsuya ; Baba, Shuhei ; Shibata, Kenjiro

A fingernail clipping is a promising specimen for evaluating the medium-to-long term status of low-molecular weight hormones. However, the nail concentrations of thyroid hormones and their clinical significance remain poorly understood. In this study, a liquid chromatography/electrospray ionization-tandem mass spectrometry (LC/ESI-MS/MS) method was developed and validated for simultaneously quantifying triiodothyronine (T₃) and thyroxine (T₄) in the thumbnail clippings. The nail T₃ and T₄ were extracted with 50 % ethanol and purified using a Strata-X cartridge, then injected into the LC/ESI-MS/MS. ¹³C₆-T₄ was used as the internal standard for both T₃ and T₄. Validation results demonstrated that the method was precise (relative standard deviations in five repetitive measurements were ≤ 4.5 %) and accurate (analytical recovery rates were 98.3-103.3 %). The lower limits of quantification were 0.20 ng/g for both thyroid hormones. By using this method, we found that the nail concentrations of T₃ (0.74 ± 0.26 ng/g, mean ± standard deviation) were at the same level as those of T₄ (0.90 ± 0.27 ng/g) in euthyroid subjects (n = 40). This result might be caused due to the greater free and albumin-bound fractions of circulating T₃ compared to T₄. The patients with Graves' disease showed significantly higher nail T₃ and T₄ concentrations than the euthyroid subjects. The patients with hypothyroidism due to Hashimoto's thyroiditis tended to have lower nail T₃ and T₄ concentrations compared to the euthyroid subjects. Thus, the developed method would be useful for evaluating the medium-to-long term status of thyroid hormone production and has sufficient clinical applicability.

171

项与左甲状腺素钠相关的新闻（医药）

2025-12-02

·三弟药闻

20251202 中国国家药品监督管理局药品审评中心(CDE)受理信息--化药

1 甲苯磺酸妥舒沙星细粒剂受理号：JYHL2500002（进口化药临床申请）药品名称：甲苯磺酸妥舒沙星细粒剂企业名称：TOWA PHARMACEUTICAL CO., LTD. 靶点与机制：氟喹诺酮类抗生素，通过抑制细菌DNA旋转酶和拓扑异构酶IV，细粒剂型适合儿童，用于敏感菌感染注册分类：5.2类（进口药）2 曲伏前列素滴眼液受理号：CYHS2504140（国产化药仿制上市申请）药品名称：曲伏前列素滴眼液企业名称：南京海纳医药科技股份有限公司；广州大光制药有限公司靶点与机制：前列腺素类似物，通过增加葡萄膜巩膜途径房水外流，降低眼内压，用于青光眼注册分类：4类（仿制药）3 低钙腹膜透析液(乳酸盐-G2.5%) 受理号：CYHS2504139（国产化药仿制上市申请）药品名称：低钙腹膜透析液(乳酸盐-G2.5%）企业名称：广东科泓药业有限公司；广东科泓药业有限公司靶点与机制：腹膜透析液，低钙配方适合高钙血症患者，乳酸盐缓冲，用于终末期肾病腹膜透析注册分类：4类（仿制药）4 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 受理号：CYHS2504138（国产化药仿制上市申请）药品名称：中性低钙腹膜透析液(碳酸氢盐-G2.5%）企业名称：石家庄四药有限公司；石家庄四药有限公司靶点与机制：腹膜透析液，碳酸氢盐缓冲体系，更符合生理状态，用于终末期肾病注册分类：3类（仿制药）5 蔗糖羟基氧化铁咀嚼片受理号：CYHS2504137（国产化药仿制上市申请）药品名称：蔗糖羟基氧化铁咀嚼片企业名称：湖南埃威格林医药科技有限公司；山东丰金生物医药有限公司靶点与机制：磷结合剂，在肠道中与磷酸盐结合，咀嚼片剂型适合慢性肾病患者高磷血症注册分类：4类（仿制药）6 注射用甲磺酸萘莫司他受理号：CYHL2500211（国产化药临床申请）药品名称：注射用甲磺酸萘莫司他企业名称：天津红日药业股份有限公司靶点与机制：蛋白酶抑制剂，通过抑制胰蛋白酶等丝氨酸蛋白酶，用于急性胰腺炎注册分类：3类（仿制药）7 枸橼酸西地那非片受理号：CYHB2502460（国产化药补充申请）药品名称：枸橼酸西地那非片企业名称：吉林金恒制药股份有限公司；吉林金恒制药股份有限公司靶点与机制：PDE5抑制剂，通过抑制磷酸二酯酶5，增加cGMP浓度，用于勃起功能障碍注册分类：未标注（补充申请）8-9 左甲状腺素钠片（2个受理号）受理号：CYHB2502459、CYHB2502458（国产化药补充申请）药品名称：左甲状腺素钠片企业名称：默克制药(江苏)有限公司；默克制药(江苏)有限公司靶点与机制：甲状腺激素，补充外源性甲状腺素，用于甲状腺功能减退症注册分类：未标注（补充申请）10-14 哌柏西利胶囊受理号：JYHB2500657（进口化药补充申请）药品名称：哌柏西利胶囊企业名称：Pfizer Europe MA EEIG；Pfizer Manufacturing Deutschland GmbH 靶点与机制：CDK4/6抑制剂，通过抑制细胞周期蛋白依赖性激酶4/6，用于HR+、HER2-晚期乳腺癌注册分类：未标注（补充申请）15 水飞蓟素胶囊受理号：JYHB2500652（进口化药补充申请）药品名称：水飞蓟素胶囊企业名称：Viatris Healthcare GmbH；MADAUS GMBH 靶点与机制：肝细胞保护剂，通过抗氧化和稳定肝细胞膜，用于中毒性肝损伤注册分类：未标注（补充申请）16 拉米夫定多替拉韦片受理号：JYHB2500651（进口化药补充申请）药品名称：拉米夫定多替拉韦片企业名称：ViiV Healthcare BV；GlaxoSmithKline LLC；Glaxo Wellcome S.A. 靶点与机制：复方抗HIV药，拉米夫定抑制逆转录酶，多替拉韦抑制整合酶，用于HIV感染注册分类：未标注（补充申请）17-18 紫杉醇注射液受理号：JYHB2500650、JYHB2500649（进口化药补充申请）药品名称：紫杉醇注射液企业名称：Pfizer Australia Pty Ltd；Hospira Australia Pty Ltd 靶点与机制：微管稳定剂，通过促进微管蛋白聚合抑制解聚，用于卵巢癌、乳腺癌等注册分类：未标注（补充申请）19 Lazertinib片受理号：JXHB2500165（进口新药补充申请）药品名称：Lazertinib片企业名称：Janssen Research & Development, LLC；Janssen-Cilag SpA 靶点与机制：第三代EGFR-TKI，强生开发的2.4类改良型新药，用于EGFR突变非小细胞肺癌注册分类：2.4类（改良型新药）20 利托那韦片受理号：JTH2500187（进口化药申请）药品名称：利托那韦片企业名称：AbbVie Deutschland GmbH & Co. KG；上海迪赛诺医药集团股份有限公司靶点与机制：HIV蛋白酶抑制剂，通过抑制HIV蛋白酶，用于抗HIV治疗注册分类：未标注（进口申请）21 精氨酸培哚普利片受理号：JTH2500186（进口化药申请）药品名称：精氨酸培哚普利片企业名称：LES LABORATOIRES SERVIER INDUSTRIE；上海博志研新药物研究有限公司靶点与机制：ACE抑制剂，通过抑制血管紧张素转换酶，用于高血压和心力衰竭注册分类：未标注（进口申请）22 注射用甲泼尼龙琥珀酸钠受理号：JTH2500185（进口化药申请）药品名称：注射用甲泼尼龙琥珀酸钠企业名称：南光化学制药股份有限公司；海南贞元药业有限公司靶点与机制：糖皮质激素，具有强效抗炎和免疫抑制作用，用于严重炎症和自身免疫疾病注册分类：未标注（进口申请）23 瑞舒伐他汀依折麦布片(I) 受理号：CYHS2504136（国产化药仿制上市申请）药品名称：瑞舒伐他汀依折麦布片(I) 企业名称：江苏欧歌制药有限公司；江苏欧歌制药有限公司靶点与机制：复方降脂药，瑞舒伐他汀抑制HMG-CoA还原酶，依折麦布抑制胆固醇吸收注册分类：4类（仿制药）24-25 氢溴酸替格列汀片受理号：CYHS2504135、CYHS2504134（国产化药仿制上市申请）药品名称：氢溴酸替格列汀片企业名称：江西施美药业股份有限公司；江西施美药业股份有限公司靶点与机制：DPP-4抑制剂，通过抑制二肽基肽酶4，提高内源性GLP-1水平，用于2型糖尿病注册分类：4类（仿制药）26-30 达格列净二甲双胍缓释片受理号：CYHS2504133、CYHS2504132、CYHS2504131、CYHS2504130、CYHS2504129（国产化药仿制上市申请）药品名称：达格列净二甲双胍缓释片(I-IV) 企业名称：北京赛而生物药业有限公司；北京赛而生物药业有限公司靶点与机制：复方降糖药，达格列净抑制SGLT2促进尿糖排泄，二甲双胍改善胰岛素敏感性，缓释剂型注册分类：4类（仿制药）31 注射用磷酸特地唑胺受理号：CYHS2504128（国产化药仿制上市申请）药品名称：注射用磷酸特地唑胺企业名称：苏州东瑞制药有限公司；湖南赛隆药业（长沙）有限公司靶点与机制：恶唑烷酮类抗生素，通过抑制细菌蛋白质合成，用于复杂性皮肤和软组织感染注册分类：4类（仿制药）32-33 重酒石酸去甲肾上腺素注射液（2个受理号）受理号：CYHS2504126、CYHS2504125（国产化药仿制上市申请）药品名称：重酒石酸去甲肾上腺素注射液企业名称：山西阳和医药技术有限公司；山西普恒制药有限公司靶点与机制：α受体激动剂，通过强烈收缩血管升高血压，用于休克抢救注册分类：3类（仿制药）34 佩玛贝特片受理号：CYHS2504124（国产化药仿制上市申请）药品名称：佩玛贝特片企业名称：广州一品红制药有限公司；广州一品红制药有限公司靶点与机制：PPARα激动剂，通过激活过氧化物酶体增殖物激活受体α，用于高甘油三酯血症注册分类：4类（仿制药）35-36 硫酸氢氯吡格雷片受理号：CYHS2504123、CYHS2504122（国产化药仿制上市申请）药品名称：硫酸氢氯吡格雷片企业名称：浙江车头制药股份有限公司；杭州民生药业股份有限公司靶点与机制：P2Y12受体拮抗剂，通过抑制ADP诱导的血小板聚集，用于预防动脉粥样硬化血栓形成注册分类：4类（仿制药）37 复方聚乙二醇（3350）电解质口服溶液受理号：CYHS2504121（国产化药仿制上市申请）药品名称：复方聚乙二醇（3350）电解质口服溶液企业名称：杭州呋欧医药科技有限公司；浙江凯润药业股份有限公司靶点与机制：渗透性泻药，通过增加肠道内水分，用于便秘治疗和肠道清洁准备注册分类：3类（仿制药）38 注射用氟氧头孢钠受理号：CYHS2504120（国产化药仿制上市申请）药品名称：注射用氟氧头孢钠企业名称：海南倍特药业有限公司；海南倍特药业有限公司靶点与机制：氧头孢烯类抗生素，通过抑制细菌细胞壁合成，用于敏感菌引起的感染注册分类：4类（仿制药）39 莫匹罗星软膏受理号：CYHS2504119（国产化药仿制上市申请）药品名称：莫匹罗星软膏企业名称：福建太平洋制药有限公司；福建太平洋制药有限公司靶点与机制：局部抗生素，通过抑制细菌异亮氨酸tRNA合成酶，软膏剂型用于皮肤感染注册分类：4类（仿制药）40 布洛芬混悬液受理号：CYHS2504118（国产化药仿制上市申请）药品名称：布洛芬混悬液企业名称：健民药业集团股份有限公司；健民集团叶开泰国药（随州）有限公司靶点与机制：非甾体抗炎药，通过抑制环氧合酶，混悬液剂型适合儿童解热镇痛注册分类：4类（仿制药）41 依折麦布片受理号：CYHS2504117（国产化药仿制上市申请）药品名称：依折麦布片企业名称：海南赛立克药业有限公司；海南赛立克药业有限公司靶点与机制：胆固醇吸收抑制剂，通过抑制小肠胆固醇转运蛋白，用于高胆固醇血症注册分类：4类（仿制药）42 呋塞米注射液受理号：CYHB2550377（国产化药补充申请）药品名称：呋塞米注射液企业名称：山东益健药业有限公司；山东益健药业有限公司靶点与机制：袢利尿剂，通过抑制髓袢升支粗段Na+-K+-2Cl-共转运子，用于水肿性疾病注册分类：未标注（补充申请）43 注射用水溶性维生素受理号：CYHB2550376（国产化药补充申请）药品名称：注射用水溶性维生素企业名称：山东罗欣药业集团股份有限公司；山东罗欣药业集团股份有限公司靶点与机制：维生素补充剂，提供多种水溶性维生素，用于维生素缺乏的预防和治疗注册分类：未标注（补充申请）44 间苯三酚口崩片受理号：CYHB2502457（国产化药补充申请）药品名称：间苯三酚口崩片企业名称：武汉九珑人福药业有限责任公司；南京海纳制药有限公司靶点与机制：平滑肌松弛剂，通过直接作用于胃肠道和泌尿生殖道平滑肌，口崩片剂型提高用药便利性注册分类：3类（补充申请）45 舒林酸片受理号：CYHB2502456（国产化药补充申请）药品名称：舒林酸片企业名称：浙江皓格药业有限公司；成都通德药业有限公司靶点与机制：非甾体抗炎药，通过抑制环氧合酶，用于类风湿关节炎和骨关节炎注册分类：3类（补充申请）46 对乙酰氨基酚布洛芬片受理号：CYHB2502455（国产化药补充申请）药品名称：对乙酰氨基酚布洛芬片企业名称：北大医药股份有限公司；南京海纳制药有限公司靶点与机制：复方镇痛药，对乙酰氨基酚抑制中枢前列腺素合成，布洛芬抑制外周前列腺素合成，协同镇痛注册分类：3类（补充申请）47 来特莫韦注射液受理号：CYHB2502454（国产化药补充申请）药品名称：来特莫韦注射液企业名称：南京正大天晴制药有限公司；南京正大天晴制药有限公司靶点与机制：巨细胞病毒（CMV）终止酶复合物抑制剂，通过抑制病毒DNA加工和包装，用于CMV感染预防注册分类：4类（补充申请）48 克林霉素磷酸酯外用溶液受理号：CYHB2502453（国产化药补充申请）药品名称：克林霉素磷酸酯外用溶液企业名称：安徽四环科宝制药有限公司；安徽四环科宝制药有限公司靶点与机制：林可酰胺类抗生素，通过抑制细菌蛋白质合成，外用溶液剂型用于痤疮治疗注册分类：4类（补充申请）49 注射用醋酸卡泊芬净受理号：CYHB2502452（国产化药补充申请）药品名称：注射用醋酸卡泊芬净企业名称：辽宁海思科制药有限公司；辽宁海思科制药有限公司靶点与机制：棘白菌素类抗真菌药，通过抑制β-1,3-葡聚糖合成酶，用于侵袭性真菌感染注册分类：未标注（补充申请）50 注射用甲苯磺酸瑞马唑仑受理号：CXHS2500146（国产新药上市申请）药品名称：注射用甲苯磺酸瑞马唑仑企业名称：江苏恒瑞医药股份有限公司；江苏恒瑞医药股份有限公司靶点与机制：短效GABA_A受体激动剂，恒瑞医药开发的2.4类改良型镇静麻醉药，起效快、恢复快注册分类：2.4类（改良型新药）51-52 HRS-1780片（2个受理号）受理号：CXHL2501317、CXHL2501316（国产新药临床申请）药品名称：HRS-1780片企业名称：山东盛迪医药有限公司靶点与机制：MR拮抗剂(盐皮质激素受体拮抗剂) 注册分类：1类（创新药）53 HT-101注射液受理号：CXHL2501315（国产新药临床申请）药品名称：HT-101注射液企业名称：苏州星曜坤泽生物制药有限公司；安吉星曜坤泽生物制药有限公司靶点与机制：HT-101注射液为一款N-乙酰半乳糖胺（GalNAc）偶联的siRNA创新药物，是首个进入临床阶段的国产GalNAc偶联的siRNA乙肝产品。注册分类：1类（创新药）54-55 BGB-16673片受理号：CXHB2500319、CXHB2500318（国产新药补充申请）药品名称：BGB-16673片企业名称：百济神州（苏州）生物科技有限公司靶点与机制：BGB-16673是一种口服靶向布鲁顿氏酪氨酸激酶（BTK）的嵌合式降解激活化合物（CDAC）注册分类：1类（创新药）56-59 BGM0504注射液受理号：CXHB2500317、CXHB2500316、CXHB2500315、CXHB2500314（国产新药补充申请）药品名称：BGM0504注射液企业名称：博瑞制药（苏州）有限公司靶点与机制：BGM0504注射液是博瑞医药自主研发的GLP-1（胰高血糖素样肽1）和GIP（葡萄糖依赖性促胰岛素多肽）受体双重激动剂注册分类：1类（创新药）

申请上市

2025-12-01

·癌友交流圈

全国癌症病友群大集合：肠癌、肺癌、乳腺癌、胃癌、肝癌、宫颈癌、前列腺癌、甲癌、肾癌、胆管癌、淋巴瘤胶质瘤罕见病等病友家属均可加入

全国癌症病友群大集合：肠癌、肺癌、乳腺癌、胃癌、肝癌、宫颈癌、前列腺癌、甲癌、肾癌、胆管癌、淋巴瘤胶质瘤罕见病等病友家属均可加入！开头黄金3秒（灵魂提问+惊人数据）： “确诊那天，世界是安静的。医生的话在耳边嗡嗡作响，你却一个字也听不清。心里只有一个问题在疯狂盘旋：‘接下来，我该怎么办？’” 这不是你一个人的战斗。在中国，每分钟就有超过8个人被诊断为癌症。但同样在中国，有成千上万个“我们”，正汇聚在一个个温暖的网络社群中，用彼此的经验、鼓励和陪伴，将这条原本孤独的荆棘之路，走成一条充满希望与力量的征途。第一部分：为什么病友群是抗癌路上不可或缺的“战略资源”？在互联网医疗尚未如此发达的时代，患者和家属获取信息的渠道极其有限，往往只能被动听从医生的建议，内心充满了未知和恐惧。而今天，病友群已经演变成一个功能强大的“支持系统”，其价值远超简单的聊天解闷。信息共享的“实时百科”：从“上海哪家医院的乳腺外科最好？”到“靶向药奥希替尼的医保报销流程是怎样的？”，再到“化疗后白细胞低，吃什么升得快？”……这些琐碎、具体却又至关重要的问题，在病友群里总能得到最快、最接地气的回答。这是无数“前辈”用亲身经历换来的宝贵经验，能帮你少走无数弯路。情感共鸣的“安全港湾”：在这里，你可以毫无顾忌地诉说内心的恐惧、治疗的痛苦和经济的压力，因为所有人都“懂”。你不需要解释为什么因为掉光头发而哭泣，也不需要为一次CEA（癌胚抗原）指标的轻微波动而独自焦虑。一句“我懂”、“我也经历过”，具有无比强大的治愈力量。经验借鉴的“实战指南”：如何应对各种治疗的副作用？如何为病人准备既营养又开胃的饭菜？如何与医生进行有效沟通？这些在教科书上学不到的“实战技巧”，是病友群的核心价值之一。看到群里有病友成功度过了五年、十年，本身就是一剂最强的“心理良药”。最新资讯的“前沿哨所”：许多群友会第一时间分享国内外最新的临床试验、药物上市信息、权威专家讲座等。这为你和主治医生探讨后续治疗方案提供了更多可能性和参考依据。第二部分：精准对接！按癌种分类的病友群指南（文章核心）不同癌种的诊疗路径、治疗方案、康复重点千差万别。一个精准的病友群，意味着更高效的信息获取和更贴切的情感支持。以下是针对标题中列出癌种的简要分析和寻群指引： 1. 高发癌种群：群体庞大，经验丰富肺癌群：重点关注基因检测、靶向药（如EGFR、ALK、KRAS等靶点）、免疫治疗（PD-1/PD-L1抑制剂）的讨论。群内对耐药后的换药策略、药物副作用管理讨论非常深入。肠癌群：讨论核心常围绕手术方式（保肛与否）、辅助化疗（FOLFOX/FOLFIRI方案）、肝/肺转移的综合治疗、以及RAS/BRAF等基因状态。造口护理与生活质量的提升也是重要话题。乳腺癌群：内部常细分为Luminal型、HER2阳性型、三阴性等亚型群。话题涵盖保乳手术、内分泌治疗、靶向治疗（赫赛汀、CDK4/6抑制剂）及术后形体康复、心理重建。胃癌群：关注HER2、MSI-H、CLDN18.2等 biomarker的检测，以及化疗、靶向、免疫的联合应用。饮食营养是永恒的热点。肝癌群：多讨论介入治疗（TACE）、靶向药（仑伐替尼、索拉非尼）、免疫治疗的“T+A”等方案，以及抗病毒治疗（针对乙肝/丙肝背景）和定期复查（AFP、影像）的重要性。 2. 预后较好/特色鲜明的癌种群前列腺癌群：由于进展相对缓慢，病友们更关注主动监测的时机、内分泌治疗（去势治疗）的长期副作用管理、以及后续的化疗、新型内分泌治疗选择。甲状腺癌（甲癌）群：被誉为“幸福癌”的社群，氛围通常较为轻松。主要交流手术范围、碘131治疗、TSH抑制治疗及优甲乐服用技巧，以及对疤痕修复的美观需求。宫颈癌群：主要讨论HPV疫苗、手术与放化疗的选择、靶向/免疫治疗的应用，以及治疗后对生育功能、性生活质量的关注。 3. 难治性/罕见癌种群：抱团取暖，寻找希望肾癌群：肾癌对传统放化疗不敏感，群内核心是靶向治疗（舒尼替尼、帕唑帕尼等）和免疫治疗的序列选择、副作用应对和耐药后的方案探讨。胆管癌群：较为罕见，治疗棘手。病友群是获取FGFR2、IDH1等罕见靶点检测信息和对应靶向药的重要渠道，群友间“报团取暖”的情感支持尤为重要。淋巴瘤群：亚型极其复杂（霍奇金 vs 非霍奇金，B细胞 vs T细胞等）。群内对化疗方案（如CHOP）、靶向药（利妥昔单抗）、CAR-T细胞治疗、PD-1抑制剂等的讨论非常专业。胶质瘤群：作为最常见的脑瘤，关注点在于手术切除程度、放化疗（替莫唑胺）、电场治疗（TTF）、以及IDH、MGMT等基因标记的预后意义和其对认知功能的影响。各类罕见病群：患者分散，信息极度匮乏。一个高质量的罕见病群，往往是患者和家庭的生命线，是分享全球最新疗法、组织患者互助、甚至推动药物研发和引进的核心力量。第三部分：加入病友群，你必须知道的“道”与“术” 在拥抱病友群温暖的同时，也需要保持一份理性和警惕。如何找到一个靠谱的病友群？通过权威平台：关注“癌友社区”、“觅健”等垂直App或公众号，它们通常按癌种设有官方或认证社群。依托大型医院：许多顶尖肿瘤医院的专家或其医护团队，会牵头或认可一些病友群，质量较高。线下活动转化：参加医院或基金会组织的患教讲座、康复活动，现场就能加入相关的微信群。社交媒体搜索：在知乎、豆瓣、小红书等平台，用“癌种+病友群”等关键词搜索，但需仔细甄别。病友群“生存守则”：相信医生，相信科学：病友的经验是“参考”，绝不是“医嘱”。任何治疗决策，必须与你的主治医生共同商定。保持理性，屏蔽噪音：群里信息繁杂，避免被个别负面案例或偏激言论影响心态。吸收对你有用的，过滤掉让你焦虑的。保护隐私，谨防诈骗：切勿轻易透露身份证、银行卡等敏感信息。对群内主动私聊推销“神药”、“偏方”或“特效疗法”的人，保持高度警惕。乐于分享，传递正能量：在获取帮助的同时，也请积极分享你的成功经验和暖心鼓励。爱出者爱返，福往者福来。第四部分：致家属——你们是坚强的后盾，也需要被支撑家属，是患者最亲密的战友，也是最容易被忽略的群体。你们承受着经济、护理、情感的多重压力。为家属设立的群组或板块，是你们可以倾诉疲惫、交换护理心得、寻求心理慰藉的专属空间。请记住，照顾好自己，才能更好地照顾你所爱的人。抗癌，是一场没有硝烟的战争，但我们不是散兵游勇。病友群，就是我们集结的营地，是互相包扎伤口、分享情报、呐喊助威的阵地。在这里，我们交换勇气，共筑希望。你是否也曾从病友群中获得过温暖和力量？你对于选择一个靠谱的病友群，还有哪些疑问？或者，你想为自己或家人寻找一个特定的病友群？欢迎在评论区留下你的足迹，分享你的故事与困惑。你的每一次发声，都可能成为照亮他人前行路上的一盏灯。如果觉得这篇文章有用，请不吝【点赞】+【在看】，让它能帮助到更多正在迷茫中寻找组织的战友和家人！

2025-12-01

·xerispharma.com

Xeris Announces Notice of Allowance from U.S. Patent and Trademark Office for XP-8121 Patent Application

CHICAGO--(BUSINESS WIRE)--Dec. 1, 2025-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its subsidiary Xeris Pharmaceuticals Inc.’s U.S. patent application covering XP-8121, one of its novel product candidates. The Notice of Allowance indicates that the USPTO has determined the application meets the requirements for patentability and is expected to issue as a U.S. patent following standard administrative steps. The allowed claims in this application are specific to the XP-8121 formulation. In parallel, Xeris continues to pursue additional layers of U.S. and international IP protection in the levothyroxine (LT4) technology space. “We believe XP-8121 has tremendous potential to solve an unmet medical need for hypothyroidism, and this patent represents a key milestone in strengthening our intellectual property protection around this important pipeline program,” said John Shannon, Chief Executive Officer. “It further demonstrates the ability of our XeriSol® platform to enable the development of difficult-to-formulate drugs into subcutaneous injections.” About XP-8121 XP-8121 is an investigational, ready-to-use liquid formulation of levothyroxine sodium designed for once-weekly subcutaneous injection using Xeris’ proprietary XeriSol® technology. By avoiding the gastrointestinal tract, XP-8121 may address the well-documented limitations of oral levothyroxine, including variable absorption, drug and food interactions, and inconsistent therapeutic effect. About Xeris Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical Company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and a gastrointestinal motility inhibitor when used as a diagnostic aid; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram. Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans, opportunities, and prospects for Xeris Biopharma Holdings, Inc., including statements regarding the scope, timing and outcome of future regulatory actions, its pursuit of global protection of its intellectual property, the market and therapeutic potential of its products and product candidates, including XP-8121’s potential to solve an unmet medical need for hypothyroidism, the potential utility of its formulation platforms such as XeriSol®, the advancement of its pipeline, and other statements containing the words "achieve," "anticipate," "continue," “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results (including revenue and sales in the near- and long-term), performance or achievements, industry results, market opportunity and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, its and collaborators’ ability to protect its intellectual property and proprietary technology, the accuracy and completeness of its assumptions and its ability to accurately estimate future financial results and market opportunities, and general macroeconomic and geopolitical conditions, including the possibility of an economic downturn, changes in governmental priorities and resources, announced or implemented tariffs or export controls and market volatility. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Annual Report on Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. The risks described herein and in Xeris’ U.S. Securities and Exchange Commission filings are not the only risks the Company faces. Additional risks and uncertainties not currently known to it or that it currently deems immaterial may also impact its business operations or financial results. Forward-looking statements in this communication are based on information available to management, as of the date of this communication and, while the Company believes its assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, the Company does not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. View source version on businesswire.com: https://www.businesswire.com/news/home/20251201785819/en/ Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com Source: Xeris Biopharma Holdings, Inc.

临床3期

100 项与左甲状腺素钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01010	左甲状腺素钠	H03AA01	DB00451

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
分化型甲状腺癌	美国	Mylan Pharmaceuticals, Inc.	2022-04-29
粘液性水肿昏迷	美国	Fresenius Kabi USA LLC	2011-06-24
垂体功能亢进	美国	King Pharmaceuticals Research & Development LLC	2001-05-25
甲状腺功能亢进症	中国	深圳市中联股份合作公司	2000-01-01
甲状腺癌	中国	深圳市中联股份合作公司	2000-01-01
甲状腺肿	日本	ASKA Pharmaceutical Co., Ltd.	1998-02-12
先天性甲状腺功能减退症	韩国	Bukwang Pharmaceutical Co., Ltd.	1974-04-06
粘液水肿	韩国	Bukwang Pharmaceutical Co., Ltd.	1974-04-06
甲状腺功能减退症	日本	Takeda Pharmaceutical Co., Ltd.	1964-08-07

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
内分泌与代谢疾病	临床前	美国	Eton Pharmaceuticals, Inc.	2019-08-06

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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


NCT04288115 (Pubmed \| Endocrine)	临床2期	甲状腺功能减退症	45	Levothyroxine	鏇遞遞繭獵壓衊鑰窪糧(鑰蓋艱蓋繭蓋遞膚膚糧) = The only notable adverse event was rib fractures in a placebo group participant (TSH 3.04 mIU/L at 6 months). Two participants in the placebo group restarted levothyroxine (n = 1, TSH > 10 mIU/L; n = 1, fatigue). 選顧淵淵遞齋鬱遞糧淵 (蓋鬱憲製遞積積製觸簾 )	积极	2025-07-30
				Placebo
NCT05823012 (CTgov)	临床2期	甲状腺功能减退症	46	levothyroxine sodium	積廠觸製繭餘網顧衊鹽(獵鹹網夢淵膚鏇遞糧餘) = 襯壓積簾壓鹽齋網網蓋鹽觸觸壓願鹽艱淵艱壓 (壓憲觸齋顧衊網淵襯積, 網憲夢願膚夢窪網夢簾 ~ 簾壓獵顧餘鏇糧鬱蓋觸) 更多	-	2025-07-03
AHNS2025	N/A	瘘	203	IV levothyroxine	願壓鹽簾網襯簾願齋鬱(鑰鏇簾積鹽醖繭襯鬱淵) = 繭鏇餘窪簾襯膚觸蓋齋選選選餘鏇齋鹹襯簾艱 (憲簾觸鑰構範築選襯蓋 ) 更多	积极	2025-05-14
				Enteral levothyroxine	壓鬱憲餘窪壓構繭醖觸(構築齋積夢繭獵顧鬱觸) = 鑰蓋鹽餘顧齋餘顧繭遞觸夢艱鹽鬱範鹽範顧繭 (鏇鏇積廠壓鹽鏇築鹹壓 )
NCT00941551 (Twenty-year follow-up of a randomized clinical trial of unilateral thyroid lobectomy with or without postoperative levothyroxine treatment, Pubmed \| World J Surg)	N/A	iodine metabolism status assessed by urinary iodine excretion	150	Prophylactic LT4 treatment	衊選艱鑰積廠範鹽願夢(觸衊夢網襯鏇獵淵鹹鏇) = 鏇憲壓壓鹹獵餘願遞構憲窪壓餘選齋蓋鬱顧鏇 (網範蓋網範選夢積觸夢 )	积极	2025-01-01
				No LT4 treatment	衊選艱鑰積廠範鹽願夢(觸衊夢網襯鏇獵淵鹹鏇) = 顧選獵鹹觸築廠構憲鹽憲窪壓餘選齋蓋鬱顧鏇 (網範蓋網範選夢積觸夢 )
NCT04782856 (CTgov)	临床2期	甲状腺功能减退症 \| 甲状腺肿 \| 甲状腺癌	13	Placebo+Levothyroxine (Single Therapy)	淵繭蓋願醖繭獵齋壓廠(構憲觸糧餘膚廠遞選顧) = 夢艱餘糧觸衊夢願觸窪獵憲艱鑰壓糧艱齋繭範 (窪糧艱遞艱糧膚鑰廠餘, 3.9) 更多	-	2024-06-14
				Liothyronine+Levothyroxine (Combination Therapy)	淵繭蓋願醖繭獵齋壓廠(構憲觸糧餘膚廠遞選顧) = 醖選艱範獵廠窪醖網遞獵憲艱鑰壓糧艱齋繭範 (窪糧艱遞艱糧膚鑰廠餘, 2.1) 更多
NCT05823012 (Biospace) 人工标引	临床2期	甲状腺功能减退症	46	XP-8121	窪鏇繭窪窪糧夢觸鹽獵(鏇觸鏇選遞積觸構簾糧) = 憲鏇衊鹽廠觸糧簾鹽醖襯鏇鏇簾繭繭糧構壓鹽 (齋齋鬱願鹹範鬱夢網襯 )	积极	2024-05-30
NCT04415658 (CTgov)	临床3期	心脏衰竭 \| 脑死亡	838	Thyroxine (Thyroxine)	觸鏇壓顧淵廠窪構糧膚 = 醖簾築廠鹽簾築衊鹹鬱醖顧衊鏇憲製糧壓壓壓 (鏇餘獵遞獵憲衊鏇膚壓, 蓋襯壓積廠獵窪夢顧衊 ~ 鬱願壓選鹽衊顧顧衊衊) 更多	-	2024-01-10
				Saline (Saline Placebo)	觸鏇壓顧淵廠窪構糧膚 = 繭鹽餘積餘膚顧蓋願簾醖顧衊鏇憲製糧壓壓壓 (鏇餘獵遞獵憲衊鏇膚壓, 繭蓋醖廠選廠簾選願積 ~ 餘淵膚積鏇憲遞餘選壓) 更多
NCT03094416 (Pubmed \| Thyroid)	临床4期	serum thyrotropin (TSH) \| free thyroxine (fT4) \| total thyroxine (TT4) ... 更多	-	Levothyroxine Sodium Soft Gelatin Capsules (Tirosint)	製簾製鏇憲築積遞繭鑰(齋範顧築顧淵遞衊膚壓) = 築繭構觸簾襯壓顧廠蓋製窪鹹廠廠膚窪鬱鏇壓 (鏇鑰夢鹽範鏇製鹽積範 ) 更多	积极	2023-12-01
ESMO_GI2023	N/A	转移性结直肠癌一线 RAS wild type \| RAS mutated \| BRAF mutant	139	Levothyroxine	餘鏇構構構製糧艱醖顧(憲憲鏇襯願獵衊製觸選) = 範齋鏇獵鑰淵願膚鬱淵艱壓淵鏇顧鑰獵範夢淵 (餘鏇廠淵鏇網鑰夢鬱襯 ) 更多	不佳	2023-07-01
				No Levothyroxine	餘鏇構構構製糧艱醖顧(憲憲鏇襯願獵衊製觸選) = 壓襯鹹簾壓襯顧餘製餘艱壓淵鏇顧鑰獵範夢淵 (餘鏇廠淵鏇網鑰夢鬱襯 ) 更多
NCT04747275 (CTgov)	临床4期	甲状腺功能减退症 \| 唐氏综合征	6	Liquid stable levothyroxine (L-T4) Tirosint-SOL (Liquid Stable Levothyroxine (l-T4) TirosintSOL First, Then Oral Tablet Levothyroxine (L-T4))	齋襯襯獵觸簾遞淵鹹鹹(淵鏇蓋構衊鬱衊選齋鬱) = 築顧製觸壓構廠壓獵顧夢膚繭壓顧鹽鬱願鏇鏇 (鬱獵網壓夢淵餘遞築選, 餘襯衊襯製襯顧簾糧觸 ~ 築蓋淵鑰鹹淵製獵窪鑰) 更多	-	2023-04-10
				Liquid stable levothyroxine (L-T4) Tirosint-SOL (Oral Tablet Levothyroxine (L-T4) First, Then Liquid Stable Levothyroxine (L-T4) Tirosint-SOL)	齋襯襯獵觸簾遞淵鹹鹹(淵鏇蓋構衊鬱衊選齋鬱) = 糧鑰鹹鏇鏇網壓醖願醖夢膚繭壓顧鹽鬱願鏇鏇 (鬱獵網壓夢淵餘遞築選, 鑰壓鏇獵膚鑰鬱襯鏇遞 ~ 築鬱鑰構願衊襯餘積壓) 更多