醋酸亮丙瑞林(Leuprolide Acetate) - 药物靶点：GnRHR_在研适应症：脊髓延髓肌肉萎缩症，激素依赖性前列腺癌，晚期前列腺癌_专利_临床

概要

基本信息

药物类型

合成多肽

别名

DKF-MA102、Leuprolide acetate (USP)、Leuprorelin Acetate

+ [33]

靶点

GnRHR

作用方式

激动剂

作用机制

GnRHR激动剂(促性腺激素释放激素受体激动剂)

治疗领域

肿瘤神经系统疾病遗传病与畸形+ [4]

在研适应症

脊髓延髓肌肉萎缩症激素依赖性前列腺癌晚期前列腺癌+ [18]

非在研适应症

脉络丛乳头状瘤局部晚期前列腺癌绝经前乳腺癌+ [1]

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构

Janssen, Inc.

TOLMAR, Inc.

Takeda Pharmaceutical Co., Ltd.

+ [9]

非在研机构

GP Pharm SA

Ortho-McNeil Pharmaceutical LLC

最高研发阶段批准上市

首次获批日期

美国 (1985-04-09),

晚期前列腺癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C59H84N16O12.C2H4O2

InChIKeyRGLRXNKKBLIBQS-XNHQSDQCSA-N

CAS号74381-53-6

Sequence Code 20294387

关联

280

项与醋酸亮丙瑞林相关的临床试验

NCT05827081

/ Not yet recruiting临床3期

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

开始日期2025-04-20

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT06654336

/ Not yet recruiting临床2期IIT

Phase II Randomized Trial of Recurrence-directed Therapy (RDT) with or Without Androgen-Deprivation Therapy (ADT) in Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

开始日期2025-04-15

申办/合作机构

Ontario Clinical Oncology Group

[+2]

NCT06855589

/ Not yet recruiting临床3期IIT

Phase III Study of Hypofractionated, Dose Escalation Radiotherapy and Brachytherapy for Intermediate-risk Adenocarcinoma of the Prostate with 6 Versus 12 Months of Hormonal Manipulation

Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.

开始日期2025-03-01

申办/合作机构-

100 项与醋酸亮丙瑞林相关的临床结果

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100 项与醋酸亮丙瑞林相关的转化医学

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100 项与醋酸亮丙瑞林相关的专利（医药）

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3,900

项与醋酸亮丙瑞林相关的文献（医药）

2025-04-01·Gynecologic Oncology Reports

Case report of stage IIIC low-grade serous ovarian cancer in a 13-year-old female treated with novel therapy

Article

作者: Handagala, Ishara ; Anderson, Charles ; Gordon, Jennifer ; NewBill, Colin

Low-grade serous ovarian carcinoma (LGSOC) is a rare malignancy in pediatric populations, with most ovarian tumors in adolescents typically being of germ cell origin. LGSOC is a distinct subtype of serous ovarian carcinoma characterized by slow progression, frequent estrogen receptor (ER) positivity, and resistance to traditional chemotherapy. Despite its indolent nature, most patients ultimately experience disease recurrence, highlighting the need for alternative treatment approaches. This report presents the case of a 13-year-old female diagnosed with advanced-stage LGSOC following menarche. She initially presented with unintentional weight loss, constipation, and early satiety, and imaging revealed extensive pelvic disease. Given the tumor's limited sensitivity to chemotherapy, she was treated with neoadjuvant endocrine therapy (ET) using fulvestrant, palbociclib, and leuprolide. This regimen led to substantial tumor regression and normalization of CA-125 levels. Following 15 cycles, she underwent interval debulking surgery, achieving optimal cytoreduction while preserving the uterus. She continues adjuvant therapy with no signs of disease progression. Given the long-term effects of hormonal suppression in adolescents, careful monitoring is essential. Recent studies suggest that targeted therapies, including MEK and CDK4/6 inhibitors, may improve outcomes in LGSOC. Research has shown promising response rates and reduced toxicity compared to traditional chemotherapy. This case supports the potential role of endocrine-based targeted therapy in managing pediatric LGSOC, offering a viable alternative for patients with limited treatment options. Further research is needed to optimize treatment strategies and improve survival outcomes in this rare population.

2025-02-25·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Central precocious puberty in a toddler with hypothalamic hamartoma

Article

作者: Büyükyılmaz, Gönül ; Turhan, Banu ; Boyraz, Mehmet

Abstract:

Objectives:

Hypothalamic hamartoma (HH) is a rare condition that causes epilepsy and central precocious puberty (CPP) at an early age. In this report, we describe a child with CPP secondary to HH and discuss the current literature.

Case presentation:

A 26-month-old girl was brought to our hospital for evaluation of breast enlargement. Her parents were first-degree relatives. Her breast development was categorized as Tanner stage 3, and her bone age was 7 years/4 months. Laboratory investigations were consistent with CPP. Brain magnetic resonance imaging (MRI) revealed a smooth, spherical lesion in the hypothalamus, located in the tuber cinereum and measuring 11 × 9 × 10 mm. The lesion was identified as a HH. The patient was started on gonadotropin-releasing hormone analogue therapy, specifically 200 μg/kg/month of leuprolide acetate (3.75 mg depot) administered intramuscularly every 28 days. During the 2-year follow-up, her breast development remained at Tanner stage 3, and she did not develop axillary or pubic hair. Her bone age was 7 years/6 months (chronological age; 4 years/2 months). 2-year follow-up MRI showed no change in the size or contours of the HH compared with the initial diagnosis. No side effects from the medical treatment were observed during the follow-up period.

Conclusions:

In patients under the age of 4 years showing signs of CPP, HH should be considered as diagnosis. All patients receiving medical treatment should be closely monitored.

2025-02-19·Future Oncology

Plain language summary: does enzalutamide treatment with or without leuprolide improve outcomes and affect quality of life in patients with high-risk biochemical recurrence?

Article

作者: Freedland, Stephen J. ; De Giorgi, Ugo ; Woo, Henry H. ; Ganguli, Arijit ; Tutrone Jr., Ronald F. ; Gleave, Martin ; Pieczonka, Christopher M. ; Rannikko, Antti ; Shore, Neal D. ; Tarazi, Jamal ; Tang, Yiyun ; Haas, Gabriel P. ; Ramirez-Backhaus, Miguel ; Venugopal, Balaji

110

项与醋酸亮丙瑞林相关的新闻（医药）

2025-03-31

·药事纵横

复杂注射剂之原位凝胶

1、概述由于一些药物的口服生物利用度较低，为避免药物首过效应，同时解决频繁注射的潜在副作用，长效药物缓释递送系统得到迅速发展。可注射原位成型植入物（Injectable in-situ forming implants(ISFIs)）作为其中之一，具有稳定的血药浓度、缓释数周乃至数月以及提高患者依从性等优势。本文主要从原位成型植入物的分类、处方考量和开发要点出发进行总结概述。ISFI系统主要由可生物降解的聚合物组成，以液体形式注射给药，在注射后形成固体或半固体储库，根据固化机制的不同，又可分为以下几类：原位交联体系、原位固化有机凝胶体系和原位相分离体系。1.1 原位交联系统由于温度变化(热响应交联)、光子吸收(光响应交联)、阴离子聚合物与小阳离子之间的离子相互作用(离子响应交联)或酶的存在(酶响应交联)而形成聚合物交联，多用于递送不稳定的药物如蛋白质或多肽类。1.2 原位固化有机凝胶系统由不溶于水的两亲性脂质组成，这些脂质被加热并溶解在诸如乙醇的有机溶剂中，脂质在水中膨胀产生多种溶性晶体。形成的溶致晶体的特性取决于多种因素，包括所载药物的性质、脂质结构特征、水的体积和温度。该系统常用的两亲性脂质主要是甘油脂肪酸酯，如单油酸甘油酯(GMO)、单亚油酸甘油酯等。Camurus利用FluidCrystal技术开发了Brixadi/Buvidal，是一款可每周和每月用药的丁丙诺啡长效制剂，通过大豆磷脂胆碱和二油酸甘油酯包裹丁丙诺啡，注射后脂质基液体会转变为结晶凝胶，并通过缓慢降解释放丁丙诺啡。1.3 原位相分离系统1.3.1 pH响应系统此类系统由环境pH变化引起的溶胶到凝胶的转变，通常由含有酸性或碱性基团的聚合物组成，其可以根据环境pH值接受或提供质子。聚丙烯酸(PAA)及其衍生物都是pH敏感聚合物。1.3.2温度响应系统温度敏感型原位凝胶是一类对温度变化敏感的原位凝胶，即环境温度低于最低临界相变温度时呈现液体状态，进入给药部位后由于温度升高导致高分子聚合物发生相转变，常用的凝胶基质包括泊洛沙姆、壳聚糖、聚N-异丙基丙烯酰胺。1.3.3 光响应系统光响应聚合物含有至少一个水溶性和可生物降解的区域和至少两个自由基可聚合的区域。水溶性区域由聚乙二醇(PEG)、聚乙烯醇、PEO-PPO共聚物、多糖组成。可生物降解区域由聚乳酸(PLA)、聚乙醇酸、聚氨基酸和聚内酯组成的聚合物。自由基可聚合区域包括丙烯酸酯、二丙烯酸酯或其他生物上可接受的光聚合基团。1.3.4 溶剂交换系统制剂在注射后，溶剂随体液流走，可生物降解的聚合物沉淀固化在原位包裹药物缓慢释放。基质主要采用可生物降解的聚合物包括聚乳酸、聚乳酸羟基乙酸共聚物、聚己内酯等。采用PLA或PLGA作为高分子聚合物，以NMP作为生物相容性有机溶剂的Atrigel系统上市药物主要有盐酸多西环素(Atridox®)、醋酸亮丙瑞林(Eligard®)、丁丙诺啡(Sublocade®)和利培酮(Perseris®)。采用乙酸异丁酸蔗糖酯实现缓释并以苯甲醇作为溶剂为长效布比卡因制剂(Posimir®)。2、基于溶剂交换相分离系统的处方考量基于溶剂交换相分离系统处方通常由可生物降解的聚合物（常用的PLA/PLGA）、与水混溶的有机溶剂（常用的为NMP/DMSO）以及活性成分组成。该系统的形成、溶剂交换、药物释放的示意图见如图1，下文主要对处方中各组分影响药物释放的因素进行介绍。图1 植入物形成、溶剂交换、药物递送示意图[3]2.1溶剂用于该递送系统的的溶剂的性质需具备水和体液的混溶性、聚合物的良好溶解度、生物和化学相容性、无毒和无刺激性。溶剂的代谢产物不应有任何有害作用。溶剂粘度应适中且不应在注射时引起疼痛，例如高粘性的溶剂与约30%聚合物和药物制备的制剂会给注射带来困难。用于溶解聚合物的溶剂分为两类:高水溶性溶剂和低水溶性溶剂。2.1.1高水溶性溶剂常用的高水溶性溶剂通常包括N-甲基吡咯烷酮、二甲基亚砜、2-吡咯烷酮和低分子量PEG等。上述溶剂表现出快速的相反转，导致形成高度多孔的原位系统。此外高水溶性的溶剂黏度较低，制备的体系易于注射给药，其通过提供亲水性环境也可增强生物相容性。2.1.2 低水溶性溶剂低水溶性溶剂最大限度地降低聚合物溶液与水之间的亲和力，从而降低液-液相分离速率，表现为缓慢的形成相反转，这些溶剂包括苯甲酸乙酯、乙酸乙酯、三乙酸甘油酯、柠檬酸三乙酯和苯甲醇等，形成的原位系统孔隙较少，与高水溶性溶剂形成的体系相比突释降低，如三乙酸甘油酯水溶性有限仅为7%，以其作为溶剂制备制剂后其不仅会降低体系的初始释放甚至降低整体释放速率，同时溶剂的疏水性也使得原位系统的可注射性降低。将上述两种溶剂混合可能是实现合理粘度、适当的相转化和低突释的较好选择之一。2.2聚合物可降解聚合物包括PLGA/PLA是调控原位体系释放的关键组分，影响药物释放主要包括以下几点（1）PLGA链内丙交酯和乙交酯的比例和分布：其是调节系统疏水性和结晶度并影响溶剂-水交换速率和降解的基本参数，乙交酯比例的增加可以提高水解速率，从而加快药物释放。（2）分子量：PLGA聚合物的分子量是影响药物释放的另一个参数。它可以影响系统的物理化学和机械特性，如粘度、玻璃化转变温度、溶解度和扩散系数，通常分子量较高的PLGA降解速率和释放动力学较慢，但也有文献研究显示低分子量的PLGA具有更低的突释，主要归结于具有较低分子量PLGA制备的制剂在水中的溶解度增加，因此需要更多的时间来实现相转化并释放药物。（3）处方中聚合物的浓度：聚合物浓度的增加会导致植入物相转化速率变慢，从而导致药物释放速率的降低，植入物的孔隙形态从手指状的多孔结构转变为海绵状的致密结构，与增加聚合物分子量类似，增加聚合物浓度也会产生一系列影响，如改变粘度，性能，降低扩散系数，增加体系疏水性等。（4）PLGA端基：使用酯封端的 PLGA聚合物可以减慢药物的释放速率并延长药物的释放期，而酸封端的 PLGA则促进了更快的药物释放，酸封端聚合物还会催化酯键降解，同时还可能会与药物间发生相互作用。2.3 药物药物在体系中的溶解度、载药量和稳定性也是影响释放的重要因素，药物可以以溶解或分散的状态存在于原位系统中，形成均相或不均相溶液。高载药量的注射制剂的优点是施用的固定剂量时可以减少制剂注射体积，但药物不同载药量高低对释放的影响也不同，无特定规律。此外应关注某些药物与聚合物之间的化学相互作用，例如阿司匹林其高亲水性有助于与聚合物链形成氢键进而促进聚合物降解，综上该系统不适合于易被水解的药物，也不适合于聚合物降解后对酸性环境高度敏感的药物。在此前一个小分子药物制备成原位凝胶制剂研发过程中，在筛选活性物质不同盐型制备制剂以调节释放过程中发现，选用较强的有机酸与其成盐后制备制剂，制剂的分子量会随着时间的放置显著下降，导致释放变快，在选择药物时应注意此点。此外当药物以完全溶解的形式存在于制剂中，即整个体系为均相溶液状态，制剂初始突释及后期的释放均会高于混悬体系。2.4 添加剂添加剂可分为亲水性、疏水性和两亲性三种。使用亲水性添加剂如甘露醇和聚乙烯吡咯烷酮，有助于增强液液分离，并产生高突释制剂。疏水添加剂的加入可以降低药物突释，这些添加剂包括硬脂酸、单硬脂酸甘油、庚酸甲酯、庚酸乙酯和壬酸乙酯，这些添加剂可以产生更少的多孔海绵状基质，减少药物的初始突释并使后期释放减慢。使用两亲性添加剂，如Pluronic可以减少药物的突释，从而实现微小的形态变化。Pluronic浓度和链长的选择有助于实现亲水-亲脂平衡，这种平衡表现在亲水性PEO末端的高吸水性和亲脂性PPO链的扩散屏障之间，亲脂性PPO链嵌入到聚合物基质中，减少药物吸附，增强系统生物相容性。3、原位成型植入物优劣势原位成型植入物具有良好的缓控释效果，可提高患者顺应性，具有可注射性及良好的生物相容性，提供稳定的血药浓度，并可以通过液体给药实现精准定量，制备工艺及设备简单易于放大。但同时该系统也存在一定的局限性，以下是处方开发中需考量的几点：（1）原位成型系统在注射后存在形状、比表面积不一致导致的药物释放行为差异较大，例如快速注射形成棒状，缓慢注射则为球形，然而不规则的形状也使得这些系统适合于组织工程；（2）注射后的初始突释，其通常可通过处方调控得以解决和控制；（3）由于药物制剂与组织反应是复杂的，故原位成型植入物释放评价时体内外相关性较差。开发时尽量建立体内外相关模型，若不能也应建立具有区分度的体外释放质控方法；（4）原位成型植入物系统需使用大量有机溶剂，开发时应关注有机溶剂的安全性和刺激性，许多药物在有机溶剂中不稳定，此类问题在开发时可通过改变包装方式，通过两支注射器，临用前连接推注混合的方式解决（例如Eligard-一支装有聚合物溶液的注射器+一支活性药物粉末的注射器；Okedi-一支装有有机溶剂的注射器+一支装有活性药物粉末和聚合物粉末的注射器），此外还应关注包装系统密封性问题；（5）部分制剂粘度较大在注射过程中易引起疼痛，导致注射部位坏死或瘢痕结节生成，在开发过程中应关注注射剂黏度，保证通针性并考虑注射器残留问题；由于制剂黏度过大无法过滤除菌还应根据制剂的具体情况选择合适的灭菌方式，比如辐照灭菌等；(6)原位成型植入物在降解过程中会导致pH下降,在开发如蛋白质、多肽和对酸性pH敏感的药物应该此类问题。有研究表明在降解或释放研究过程中，使用聚己内酯等聚合物不会导致酸性环境的产生。通过使用各种新技术和新策略，原位成型植入物一定会有越来越多的药物上市。[1] P.D.D. Graham, K.J.J. Brodbeck, A.J.J. McHugh, Phase inversion dynamics of PLGA solutions related to drug delivery, J. Control. Release 58 (1999) 233–245.[2]田虹,樊瑜波.聚丙交酯-乙交酯降解研究进展[J].现代生物医学进展, 2011, 11(1):3.DOI:CNKI:SUN:SWCX.0.2011-01-049.[3]Thakur RR, McMillan HL, Jones DS. Solvent induced phase inversion-based in situ forming controlled release drug delivery implants. J Control Release. 2014 Feb 28;176:8-23. doi: 10.1016/j.jconrel.2013.12.020. Epub 2013 Dec 27. PMID: 24374003.[4] J.R. DesNoyer, A.J. McHugh, Role of crystallization in the phase inversion dynamics and protein release kinetics of injectable drug delivery systems, J. Control. Release 70 (2001) 285–294药事纵横投稿须知：稿费已上调，欢迎投稿

免疫疗法

2025-03-13

·Pharmaceutical Technology

Gedeon Richter’s once-daily endometriosis pill approved for NHS use

Endometriosis can cause severe pain, heavy periods, fatigue, and fertility issues. Credit: LaylaBird via Getty Images. The UK’s National Institute for Health and Care (NICE) has approved Gedeon Richter’s Ryeqo (relugolix–estradiol–norethisterone), a once-daily oral treatment for endometriosis, for use on the National Health Service (NHS). The drug works by blocking gonadotrophin releasing hormone (GnRH) that contributes to endometriosis while simultaneously providing necessary hormone replacement. Unlike traditional GnRH agonists – such as Takeda’s Prostap (leuprorelin) and AstraZeneca’s Zoladex (goserelin) – which are limited to six months of use, Ryeqo can be taken until menopause. NICE estimates that around 1,000 women per year could benefit from the treatment, which has a list price of £72 per 28-day pack. Helen Knight, director of medicines evaluation at NICE, highlighted the benefits of a pill-based treatment: “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.” Endometriosis, a condition where tissue similar to the womb lining grows outside the uterus, causes severe pain, heavy periods, fatigue and fertility issues. Current treatment options include pain relief, hormonal therapy, and surgery. Ryeqo is now an option for those who have previously undergone medical or surgical treatments but found alternatives like tranexamic acid, hormonal contraceptives, and intrauterine delivery systems ineffective or unsuitable. NICE’s final draft guidance emphasised the need for non-invasive, long-term treatment options for endometriosis symptoms, as there is no cure. Charities, including Endometriosis UK, welcomed the news, but noted that Ryeqo induces a state of “medical menopause” alongside hormone replacement therapy (HRT), meaning it may only be suitable for “a small proportion of the 1.5 million with the disease”. NICE reversed its previous negative stance on the drug after Gedeon Richter provided additional evidence on the drug’s effectiveness and cost-effectiveness. Ryeqo improved endometriosis-associated pain and was well tolerated compared to placebo in the Phase III SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331) clinical studies, which enrolled over 1,200 women. Beyond the approval of new treatments, Endometriosis UK has called for greater investment in research to find the root cause of the disease, improve management strategies, and to develop a cure. At the Royal Society of Medicine’s Innovation in Women’s Health and Femtech meeting on 3 March 2025, McKinsey partner Anouk Petersen pointed out that despite affecting a similar proportion of the population as diabetes (about 10%), endometriosis receives eight to ten times less funding. A report from McKinsey & Company and the World Economic Forum underscored the economic impact of conditions like endometriosis, finding that while women live longer than men, they spend 25% more of their lives in debilitating health conditions. This has direct productivity consequences, with 60% of the gender health gap occurring during prime working years, contributing to 80% of the economic burden on gross domestic product (GDP). According to GlobalData’s Pharma Intelligence Center, Ryeqo is forecast to generate up to $775m in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology.

临床结果上市批准临床3期

2025-03-12

·Pharma CMC

圣兆药物50亿大品种BE生物等效，将申报上市！

3月11日，浙江圣兆药物发布公告，公司已完成在研项目注射用醋酸亮丙瑞林微球（一月制剂）在前列腺癌受试者中的随机、开放、平行设计的生物等效性试验（临床试验登记号：【CTR20241720】）。据统计分析结果表明：圣兆药物的注射用醋酸亮丙瑞林微球（一月制剂）（规格：3.75mg）与参比制剂注射用醋酸亮丙瑞林微球（商品名：抑那通®，规格：3.75mg）在吸收速度、吸收程度上符合生物等效评价标准，两制剂生物等效。圣兆药物将在相关申报资料准备完成之后，按照化学药品新注册分类4类申报药品上市。注射用醋酸亮丙瑞林微球主要用于治疗子宫内膜异位症、子宫肌瘤、前列腺癌、绝经前乳腺癌和中枢性性早熟等疾病。亮丙瑞林通过与垂体促性腺激素释放激素（GnRH）受体结合竞争性抑制促性腺激素释放激素调节作用，从而导致垂体分泌的促性腺激素减少，进而发挥对性激素依赖疾病的治疗作用，如前列腺癌、乳腺癌与子宫内膜异位症等。亮丙瑞林是由9个氨基酸组成的肽类药物，必须注射使用，但其半衰期短、治疗周期长等缺点导致患者需要反复注射。因此，将微球作为亮丙瑞林的载体可延长亮丙瑞林的半衰期，大大降低注射次数并提高患者依从性。原研药品为武田与艾伯维合作开发的注射用醋酸亮丙瑞林微球Luprondepot（抑那通），于1989年被FDA批准。1992年，抑那通在中国获批上市，目前进入国家医保乙类。国内共有两款国产注射用醋酸亮丙瑞林微球（一月制剂）获批，其中博恩特（注射用醋酸亮丙瑞林缓释微球）于2009年7月获批，丽珠集团于2009年9月获批，目前仅丽珠集团通过了一致性评价。

上市批准一致性评价

100 项与醋酸亮丙瑞林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00989	醋酸亮丙瑞林	L02AE02	DBSALT000105

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
脊髓延髓肌肉萎缩症	日本	Takeda Pharmaceutical Co., Ltd.	2017-08-28
激素依赖性前列腺癌	澳大利亚	Mundipharma Pty Ltd.	2003-11-26
子宫癌	中国	Takeda Pharmaceutical Co., Ltd.	2000-03-15
乳腺癌	日本	Takeda Pharmaceutical Co., Ltd.	1996-10-09
子宫肌瘤	日本	Takeda Pharmaceutical Co., Ltd.	1996-10-09
性早熟	美国	AbbVie Endocrine, Inc.	1993-04-16
子宫内膜异位症	美国	AbbVie Endocrine, Inc.	1990-10-22
平滑肌瘤	美国	AbbVie Endocrine, Inc.	1990-10-22
前列腺癌	美国	AbbVie Endocrine, Inc.	1989-01-26
晚期前列腺癌	美国	AbbVie Endocrine, Inc.	1985-04-09

未上市

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适应症	最高研发状态	国家/地区	公司	日期
HER2 阴性乳腺癌	临床3期	美国	TOLMAR, Inc.	2022-12-28
HER2 阴性乳腺癌	临床3期	阿根廷	TOLMAR, Inc.	2022-12-28
HER2 阴性乳腺癌	临床3期	巴西	TOLMAR, Inc.	2022-12-28
HER2 阴性乳腺癌	临床3期	波多黎各	TOLMAR, Inc.	2022-12-28
HR阳性/HER2阴性乳腺癌	临床3期	美国	TOLMAR, Inc.	2021-07-01
HR阳性/HER2阴性乳腺癌	临床3期	阿根廷	TOLMAR, Inc.	2021-07-01
HR阳性/HER2阴性乳腺癌	临床3期	巴西	TOLMAR, Inc.	2021-07-01
HR阳性/HER2阴性乳腺癌	临床3期	加拿大	TOLMAR, Inc.	2021-07-01
HR阳性/HER2阴性乳腺癌	临床3期	印度	TOLMAR, Inc.	2021-07-01
HR阳性/HER2阴性乳腺癌	临床3期	墨西哥	TOLMAR, Inc.	2021-07-01

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临床结果

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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


AFU-GETUG-20 (ASCO_GU2025) 人工标引	临床3期	局限性前列腺癌辅助	322	Leuprorelin acetate	繭艱網淵繭網醖製鑰齋(鹹簾製壓鬱積範餘繭範) = Patients in the leuprorelin arm reported poorer HRQoD on EORTC QLQ-C30 global health scales, social function scale, and specific symptoms (fatigue, pain, dyspnoea, and insomnia). 襯顧選廠選壓襯範築簾 (積選積窪淵壓憲艱憲顧 )	不佳	2025-02-13
ENDO2024	N/A	LH concentrations	62	Subcutaneous Leuprolide Acetate 45 mg	顧繭蓋鹽淵淵鬱醖簾鹽(憲簾願繭鬱醖觸構窪衊) = 鑰艱簾醖鹽簾蓋壓選醖願蓋繭鏇鹽繭簾艱鹽積 (餘艱鏇遞築餘衊鏇衊鹽 )	积极	2024-06-01
AUA2024	N/A	晚期前列腺癌	-	Leuprolide	蓋壓淵餘願網構蓋範範(糧淵製繭衊觸窪糧選構) = 觸鹹壓製遞淵窪積顧遞壓鑰範網獵醖憲製淵構 (構獵膚願構選繭網壓憲 )	-	2024-05-01
				Relugolix	蓋壓淵餘願網構蓋範範(糧淵製繭衊觸窪糧選構) = 鏇餘選襯簾選艱鬱獵構壓鑰範網獵醖憲製淵構 (構獵膚願構選繭網壓憲 )
NCT03572387 (CTgov)	临床2期	去势抵抗性前列腺癌	14	ATRA+5-AZA ('Early' 5-AZA+ATRA)	築繭築衊鹽觸繭鏇觸積 = 糧鹹齋選鏇獵窪窪範齋餘壓獵糧範廠鹹觸壓餘 (齋獵網窪網簾遞憲襯齋, 構簾積蓋窪鹹遞築積遞 ~ 夢襯鬱鏇網積夢鬱夢獵) 更多	-	2024-04-30
				ATRA+5-AZA ('Delayed' 5-AZA+ATRA)	築繭築衊鹽觸繭鏇觸積 = 衊壓蓋遞顧範簾夢淵鬱餘壓獵糧範廠鹹觸壓餘 (齋獵網窪網簾遞憲襯齋, 蓋窪醖壓鑰醖選觸簾獵 ~ 蓋顧構艱衊構鹹夢齋鑰) 更多
Pubmed \| J Pediatr Endocrinol Metab	N/A	性早熟	28	3-month leuprorelin acetate (11.25 mg)	餘憲夢構憲廠憲衊糧顧(艱壓範憲醖鹹鏇顧顧憲) = 網廠簾餘淵夢繭鹽積鹹鏇獵醖蓋膚糧鹹壓窪觸 (齋網淵網廠遞壓夢顧簾 ) 更多	积极	2024-01-29
NCT03902951 (SATURN, ASCO_GU2024) 人工标引	临床2期	转移性前列腺癌	28	leuprolide+abiraterone acetate+ prednisone+ apalutamide+ SBRT	壓窪構簾壓襯襯構簾鹹(襯構壓淵鹽觸蓋簾遞膚) = 鹽製獵壓膚艱獵淵淵觸蓋構壓繭積鹹衊網簾積 (製鬱鹹製簾艱網製選衊, 32 ~ 67) 更多	积极	2024-01-25
NCT01674140 (S1207 \| SWOG S1207 \| e3, CTgov)	临床3期	HR阳性/HER2阴性乳腺癌	1,939	placebo+letrozole+tamoxifen citrate+exemestane+leuprolide acetate+goserelin acetate+anastrozole (Placebo)	鑰醖鏇膚鬱觸艱襯願築 = 觸鑰網鏇積積餘獵網齋壓願選鑰選選鹽憲艱顧 (淵艱選襯艱繭醖鑰願鑰, 構鑰齋積鑰廠夢積願選 ~ 齋淵壓網鹹壓築襯窪膚) 更多	-	2023-12-20
				Everolimus (Everolimus)	鑰醖鏇膚鬱觸艱襯願築 = 蓋衊衊壓膚齋觸蓋鬱艱壓願選鑰選選鹽憲艱顧 (淵艱選襯艱繭醖鑰願鑰, 簾膚遞蓋夢淵齋壓餘鬱 ~ 鏇淵窪網願憲醖願壓齋) 更多
THU195 (ENDO2023)	N/A	性早熟	62	Leuprolide Acetate (Non-overweight children)	範窪積願醖壓糧窪範糧(繭築憲製廠窪構構築壓) = 淵簾顧簾築廠觸窪壓壓襯襯蓋築製繭醖餘築範 (築築網壓艱壓築壓艱繭 ) 更多	积极	2023-10-05
				Leuprolide Acetate (Overweight children)	範窪積願醖壓糧窪範糧(繭築憲製廠窪構構築壓) = 範襯簾廠廠襯艱顧繭蓋襯襯蓋築製繭醖餘築範 (築築網壓艱壓築壓艱繭 ) 更多
ESPE2023	N/A	性早熟 \| 家族性低磷酸盐血症性佝偻病	-	Leuprolide acetate	築膚廠齋積顧範簾鹹構(繭壓憲鏇餘憲窪鹹齋憲) = 鹽夢築觸憲構廠構鹹醖醖醖網艱構衊襯構願網 (簾構襯製範齋鑰鬱壓觸 ) 更多	积极	2023-09-21
				Burosumab	築膚廠齋積顧範簾鹹構(繭壓憲鏇餘憲窪鹹齋憲) = 鑰壓餘糧獵衊鹽鏇膚願醖醖網艱構衊襯構願網 (簾構襯製範齋鑰鬱壓觸 ) 更多
ESPE2023	N/A	性早熟	582	Leuprolide acetate 11.25mg 3-month formulation	蓋鑰獵遞糧衊願簾獵願(製選憲膚淵製膚鑰醖獵) = 醖夢憲艱膚憲夢衊蓋築齋鹽餘選築夢鹽範衊襯 (醖夢築鹹齋鏇蓋鹽鹽選, 2.27–9.87) 更多	-	2023-09-21