阿帕他胺(Apalutamide) - 药物靶点：AR_在研适应症：转移性前列腺癌，转移性去势抵抗性前列腺癌，激素依赖性前列腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Apalutamide (JAN/INN)、阿帕鲁胺、ARN-509

+ [9]

靶点

AR

作用方式

拮抗剂

作用机制

AR拮抗剂(雄激素受体拮抗剂)

治疗领域

肿瘤泌尿生殖系统疾病口颌疾病

在研适应症

转移性前列腺癌转移性去势抵抗性前列腺癌激素依赖性前列腺癌+ [14]

非在研适应症

阿尔茨海默症神经内分泌前列腺癌前列腺小细胞癌

原研机构

Janssen Global Services LLC

在研机构

Aragon Pharmaceuticals, Inc.

Janssen Pharmaceutica NV

西安杨森制药有限公司

+ [9]

非在研机构

Janssen LPAzienda Ospedaliero-Universitaria CareggiJanssen-Cilag Ltd.

权益机构

Aragon Pharmaceuticals, Inc.Janssen Pharmaceutical KK

Nippon Shinyaku Co., Ltd.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2018-02-14),

去势抵抗性前列腺癌

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、临床急需境外新药 (中国)、优先审评 (澳大利亚)

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结构/序列

分子式C21H15F4N5O2S

InChIKeyHJBWBFZLDZWPHF-UHFFFAOYSA-N

CAS号956104-40-8

关联

159

项与阿帕他胺相关的临床试验

NCT05521698

/ Not yet recruiting临床1期IIT

A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer

This phase I trial evaluates the effects of apalutamide, compared to placebo, on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Previous studies have suggested that expression of a protein called EGFR on tumor cells is related to bladder cancer disease progression. This trial may help doctors evaluate if apalutamide has any effect on EGFR expression in patients with non-muscle invasive bladder cancer.

开始日期2025-11-01

申办/合作机构

National Cancer Institute

NCT06592924

/ Recruiting临床3期IIT

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

开始日期2025-05-28

申办/合作机构

Canadian Cancer Trials Group

[+4]

NCT06931340

/ Not yet recruiting临床3期IIT

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

开始日期2025-05-08

申办/合作机构

Alliance for Clinical Trials in Oncology

[+1]

100 项与阿帕他胺相关的临床结果

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100 项与阿帕他胺相关的转化医学

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100 项与阿帕他胺相关的专利（医药）

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840

项与阿帕他胺相关的文献（医药）

2025-08-01·Clinical Genitourinary Cancer

Do Older Patients With Metastatic Hormone-Sensitive Prostate Cancer Benefit From Triplet or Doublet Therapy? A Network Meta-Analysis

Article

作者: Kishi, Noriko ; Alerasool, Parissa ; Tsao, Che-Kai ; Zhou, Susu

INTRODUCTION:

With the expanded approval of androgen receptor axis-targeted (ARAT) agents, clinicians now have more treatment options to offer patients with metastatic hormone-sensitive prostate cancer (mHSPC). Uncertainty remains as to whether older population could benefit similarly from these intensification treatment options.

PATIENTS AND METHODS:

A systematic database search was performed for randomized controlled trials (RCTs) evaluating the efficacy of androgen deprivation therapy (ADT) in combination with ARAT agents and/or docetaxel in older patients (aged ≥ 70 or 75 years) with mHSPC. The primary endpoint was overall survival (OS). Indirect comparisons of available treatment options were estimated using a random-effects network meta-analysis.

RESULTS:

A total of 11 RCTs were eligible. In comparison with ADT alone or ADT + docetaxel doublet, darolutamide + ADT + docetaxel showed a significant OS benefit, with hazard ratios (HRs) of 0.47 (95% confidence interval [CI]: 0.28-0.77) and 0.61 (95% CI, 0.40-0.93), respectively. However, another triplet (abiraterone + ADT + docetaxel) failed to demonstrate a statistically significant OS benefit, with HRs of 0.61 (95% CI, 0.37-1.02) and 0.80 (95% CI, 0.52-1.24), respectively. Triplet therapies comprising darolutamide and abiraterone ranked first and second, with P score of .90 and .67, respectively, followed by darolutamide + ADT (0.61), apalutamide + ADT (0.60), enzalutamide + ADT (0.56), ADT + docetaxel (0.40), abiraterone + ADT (0.20) and ADT alone (0.06). Furthermore, our data suggest an additional benefit from adding docetaxel as a component of doublet and triplet therapies for older men with mHSPC.

CONCLUSION:

In older patients with mHSPC, triplet therapy comprising darolutamide, ADT, and docetaxel demonstrated the most pronounced OS benefit and ranked highest among currently available treatment options. Further studies are needed to explore the specific toxicities associated with the triplet regimen in this population to better balance oncologic benefits with treatment-related toxicities when making treatment decision.

2025-07-15·CANCER RESEARCH

A Cyanobacteria-Derived RNA Aptamer Resensitizes Prostate Cancer to Hormone Therapy

Article

作者: Bhowmick, Neil A. ; Lu, Shelly C. ; Seki, Ekihiro ; Smith, Bethany ; Thiruvalluvan, Manish ; Cruz-Hernández, Carlos D. ; Underhill, David M. ; Gonzales, Gabrielle ; Billet, Sandrine

Abstract:

Prostate adenocarcinoma resistance to androgen receptor (AR) signaling inhibitor therapy is associated with elevated glutamine (L-Gln). Glutamine sensors, present in conserved riboswitches (glnA), control nitrogen metabolism in many organisms, such as cyanobacteria. Iterative in silico modifications of glnA found in Synechococcus elongatus and thermodynamic analysis of a 56mer aptamer resulted in high L-Gln specificity and affinity. The optimized aptamer depleted L-Gln from prostate adenocarcinoma cells by both L-Gln sequestration and extracellular glutaminase activation, serving as an allosteric activator. Glutamine depletion reduced FOXM1 transcriptional occupancy on the promoter of FGF8, a known mediator of prostate adenocarcinoma castration resistance. A point mutation in the binding pocket of the 56mer rendered the aptamer ineffective in L-Gln binding and FGF8 regulation. Accordingly, the L-Gln–depleting aptamer, with demonstrated serum stability, limited the proliferation and promoted cell death of castration-resistant prostate adenocarcinoma alone and in combination therapy with AR antagonists, enzalutamide and apalutamide, in subcutaneous and orthotopic mouse models. Further selective tumor targeting was achieved by functionalizing gold nanoparticles with either the optimized L-Gln aptamer or the point-mutant aptamer. Castration sensitivity was restored by the L-Gln–depleting aptamer but not by the point-mutant aptamer. The functionalized nanoparticle demonstrated superior antitumor efficacy in an orthotopic prostate adenocarcinoma model compared with the untargeted aptamer. The antitumor activity of the aptamer helped support L-Gln as an oncometabolite in prostate adenocarcinoma that can be targeted to sensitize tumors to hormone therapy.

Significance::

Depletion of glutamine, which can mediate hormone therapy resistance in prostate cancer patients, with a cyanobacteria-derived catalytic aptamer blocks FGF8 expression and sensitizes hormone refractive prostate tumors to androgen receptor inhibitors.

2025-07-01·ANTICANCER RESEARCH

Low-dose Apalutamide in Non-metastatic Castration-resistant Prostate Cancer: A Case Series

Article

作者: Gorobets, Olena ; Modestine, Johan Rose Dite ; Vinh-Hung, Vincent ; Verschraegen, Claire F ; Nguyen, Minh Dung ; Djoua, Yannick

BACKGROUND/AIM:

Apalutamide is an androgen receptor (AR) inhibitor that has been approved for prostate cancer; however, its minimal effective dose remains unclear. This study aimed to evaluate the outcomes of low-dose apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

PATIENTS AND METHODS:

We conducted a retrospective chart review of patients with nmCRPC, who received ≤60 mg/day of apalutamide. Inclusion criteria were histologically confirmed prostate cancer, rising prostate-specific antigen (PSA) levels without distant metastasis at imaging, testosterone levels <0.50 mg/ml, and consent to data-sharing. The treatment start date was defined as the first dose of apalutamide treatment. PSA response was defined as a >50% decrease at week 12. Results were matched to data from a phase 1 dose-escalation study (ARN-509-001).

RESULTS:

Six patients were identified (mean age 81.1 years; range=69.6-95.0). Mean PSA level was 14.3 ng/ml (range=5.1-20.7) with a doubling time of 12.7 months (range=2.1-29.6). Disease was confined to prostate only (n=4) and prostate and pelvic nodes (n=2). ECOG performance statuses were 2 (n=2) and 0-1 (n=4). All patients showed a decrease in PSA levels at 12 weeks (binomial test, p=0.031). The time to 50% PSA decrease was 21.6 days (range=11.5-53.5). The median follow-up was 2.44 years. Five of the 6 patients were alive: 2 with undetectable PSA levels, 2 with stable disease, and 1 with an increasing PSA level that remained <2 ng/ml at 3.2 years. This data matched the dose-escalation data (ARN-509-001) that revealed 2/3 responses in patients receiving 60-90 mg/day of apalutamide.

CONCLUSION:

Low-dose apalutamide was effective in this 6-patient case series. While awaiting new dose-response studies, we propose an apalutamide dose prescription flowchart that can be adapted for individual patients to avoid exposure to higher doses of the drug.

341

项与阿帕他胺相关的新闻（医药）

2025-07-17

·医药经济报

诺华诺欣妥热卖46亿美元，强生CAR-T销量翻倍，MNC中报放榜！

跨国药企正进入中报季，集中展现其在全球市场的布局与战略调整。7月17日，诺华发布2025年半年报：创造净销售额为272.87亿美元，按固定汇率计算同比增长13%（下同）；实现净利润为76.33亿美元，同比增长31%。其中，诺华中国区销售额为22亿美元，同比增长8%。无独有偶，强生也在前一天发布2025年半年报：其创新制药和医疗科技两大核心业务板块共同创造了高达456.36亿美元的营收，同比增长4.1%。其中，创新制药板块为强生带来290.75亿美元的收入，同比增长3.6%。在日益复杂的国际医药环境中，跨国药企凭借强大的研发实力和多元化的产品线，持续推动创新药物的研发和市场拓展。同时，面对全球医药市场的变化，这些制药巨头也在不断优化业务结构，提升运营效率，以期在激烈的市场竞争中保持领先地位。MNC半年报的密集公布，为业界提供了一个宝贵的观察视角。诺华：肿瘤药创收超80亿美元作为一家纯粹的创新药物公司，诺华明确专注于心血管-肾脏-代谢、免疫学、神经科学和肿瘤学四大核心治疗领域。具体来看，在上半年，肿瘤学管线为诺华贡献了最多收入，高达81.99亿美元，同比增长22%。其中，凭借将适应症范围扩展至早期乳腺癌患者，诺华的明星抗癌药CDK4/6抑制剂Kisqali（瑞波西利）在上半年实现了强劲增长，创造了21.33亿美元，同比增长高达60%。Kisqali上半年居于诺华Top20畅销药榜单的第三位，增速仅次于心血管-肾脏-代谢管线的长效PCSK9产品Leqvio（英克司兰），全年销售额或将突破40亿美元。诺华两款核药Pluvicto（镥[177Lu]特昔维匹肽）和Lutathera（镥[177lu]氧奥曲肽）同样表现不俗，共同创造了12.25亿美元营收。其中，Pluvicto在2024年销售额首次突破10亿美元大关，成为诺华旗下又一款“重磅炸弹”药物，其针对前列腺癌的两项适应症已在国内提交上市申请。心血管-肾脏-代谢管线的贡献仅次于肿瘤学，上半年为诺华创造了51.73亿美元收入，同比增长26%。其中，兼具降压和抗心力衰竭作用的重磅药物Entresto（沙库巴曲缬沙坦）仍是诺华的支柱产品，46.18亿美元销售额和同比22%的强劲增长令其继续霸榜诺华全球最畅销产品。值得一提的是，Entresto尽管在第十一批国采中因存在专利侵权高风险而被豁免纳入，但已有南京一心和、科伦药业两家国内企业的同品种药物突破专利壁垒上市。不仅如此，Entresto在美国市场的独占期也正在受到来自MSN制药、瑞迪博士等公司的多款仿制药挑战。与此同时，该药在美国的Medicare谈判将在明年执行，为其市场表现再添变数。销售增速最高的Leqvio同样值得期待，其在上半年实现收入5.55亿美元，同比增加66%，加速向“重磅炸弹”药物行列迈进。未来若治疗青少年高胆固醇血症等适应症获批，Leqvio有望接棒Entresto，成为诺华的新支柱产品。在免疫学领域，诺华实现收入49.58亿美元，同比增长13%。其中，明星产品Cosentyx（司库奇尤单抗）增速有所放缓，上半年实现收入31.63亿美元，同比增长11%。在中国，Cosentyx的核心专利即将到期，百奥泰已在今年2月提交司库奇尤单抗生物类似药上市申请，市场竞争一触即发。在神经领域，诺华创造收入27.59亿美元，同比增长23%。Kesimpta（奥法妥木单抗）凭借居家注射的便利性，销售额同比增速已提至38%，迅速打开多发性硬化症市场，为诺华在报告期内创收19.76亿美元。基于目前的业绩表现，诺华展望，如果未发生不可预见事件，其全年净销售额将实现高个位数增长。强生：传奇CAR-T实现翻倍增长强生与诺华深耕的疾病领域部分重合，强生聚焦肿瘤、自身免疫、神经科学、感染、肺动脉高压、心血管及代谢等关键领域。其中，肿瘤板块仍是强生创新制药业务的重中之重。上半年，肿瘤板块为强生取得了119.90亿美元的营收，同比增长21.1%。具体来看，该板块主要增长依然来源于Darzalex（达雷妥尤单抗）、Carvykti（西达基奥仑赛）、Erleada（阿帕他胺）和Rybrevant/Lazcluze（埃万妥单抗/兰泽替尼）等拳头产品。作为全球首个获批上市的CD38单抗，Darzalex已成为全球多发性骨髓瘤临床治疗的核心产品，上半年创收67.76亿美元，同比增长21.7%，独自撑起了强生肿瘤板块销售额的“半壁江山”，再度超出业界预期。为了巩固自身在多发性骨髓瘤的霸主地位，强生推出更丰富的产品矩阵，其和传奇生物共同开发的CAR-T细胞疗法Carvykti尤为亮眼。上半年，Carvykti的销售额高达8.08亿美元，同比增长136%，朝着全球年销售额20亿美元的目标狂飙。但英雄迟暮，强生昔日的血液瘤重磅产品Imbruvica（伊布替尼）因同类药物竞争，销售额同比下降7.0%，仅剩14.44亿美元。不过，强生的双抗药物管线正加快显现在多发性骨髓瘤治疗领域的价值。全球首款CD3/BCMA双抗Tecvayli（特立妥单抗）上半年实现销售额3.17亿美元，同比增长18.2%；GPRC5D/CD3双抗Talvey（塔奎妥单抗）也加快放量，实现销售额1.92亿美元，同比增长52%。今年2月，Talvey已在中国获批，用于治疗复发或难治性多发性骨髓瘤。除了血液肿瘤，强生在实体瘤领域也逐步站稳脚跟。其中，雄激素受体抑制剂Erleada（阿帕他胺）是强生在前列腺癌领域的核心产品，上半年创收16.79亿美元，同比增长17.8%。不仅如此，非小细胞肺癌产品组合EGFR/c-Met双抗Rybrevant（埃万妥单抗）和EGFR T790M抑制剂Lazcluze（兰泽替尼）已成功进击一线治疗场景，上半年合计带来3.20亿美元的收入。在过去引以为傲的自免领域，强生正面临前所未有的挑战，该板块在报告期内实现77.00亿美元收入，同比下滑14.1%。具体来看，强生的核心自免产品IL-12p40单抗Stelara（乌司奴单抗）受到生物类似药的强烈冲击，收入仅为32.78亿美元，同比下降38.6%。在克罗恩病新适应症的加持下，强生的IL-23p19单抗Tremfya（古塞奇尤单抗）继续保持25%的高增长，上半年销售额为21.42亿美元。但独木难支，Tremfya的市场增量也难以抵消Stelara、Remicade（英夫利西单抗）和Simponi（戈利木单抗）等专利过期药的销售额下滑。为挽颓势，强生加快培育自免领域的“新接班人”。今年4月，强生65亿美元收购押注的FcRn阻断剂Imaavy（nipocalimab）获得FDA批准上市，用于治疗重症肌无力。此外，口服IL-23R拮抗剂icotrokinra的两项斑块状银屑病Ⅲ期研究已经取得成功，距离上市只差临门一脚。强生判断，当前的产品组合和研发管线使其有望在今年下半年实现高速增长，预计将在肺癌和膀胱癌、重度抑郁症、牛皮癣和心血管等领域获得突破性的批准和提交申请，将以变革性方式改善患者获益。编辑：范晓艳版式编辑：于成林审校：马飞、张松医保飞检来袭！医院、药店这些领域将被重点核查五年3次100亿美元大并购！默沙东将在何处培育“新药王”？第十一批国采正式启动！55个品种入围，涉及默沙东、AZ、诺华、正大天晴、齐鲁、石药www.yyjjb.com.cn洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

专利侵权财报免疫疗法细胞疗法

2025-07-17

·米内网

【重磅】苑东生物发威，首款抗肿瘤生物药1类新药来了

精彩内容7月17日，成都苑东生物制药提交了注射用YLSH003的临床申请获得承办，该新药是公司首款抗肿瘤生物药1类新药。2024年在中国三大终端六大市场（统计范围见文末），抗肿瘤和免疫调节剂（化+生）的市场规模超过2300亿元，苑东生物早前在该类药物市场已布局了3款化药1类新药。图1：苑东生物最新申报的新药来源：CDE官网据苑东生物2024年年报资料显示，注射用YLSH003是一款ADC药物，该新药采用自主研发的新型连接子，保持安全性的前提下增加药物释放效率，体内药效显示抗肿瘤效果得到提高，同时采取差异化的临床适应症选择方案，与已经上市的ADC拉开差距，具体应用前景为抗肿瘤。图2：抗肿瘤和免疫调节剂（化+生）的市场规模来源：米内网格局数据库在中国三大终端六大市场，抗肿瘤和免疫调节剂（化+生）的市场规模逐年攀升，2024年涨至2374.5亿元，2025年Q1再有6.84%的增长，市场空间巨大。米内网数据显示，截至目前，#苑东生物已上市的抗肿瘤和免疫调节剂均为化学药，包括了乌苯美司胶囊、卡培他滨片、磷酸芦可替尼片、达可替尼片、阿昔替尼片、阿帕他胺片6个产品，暂无生物药获批。表1：苑东生物已获批临床的抗肿瘤和免疫调节新药情况来源：米内网数据库、公司年报新药方面，苑东生物早前已有3款抗肿瘤和免疫调节1类新药获批临床，均为化学药，本次申报临床的注射用YLSH003是公司首款抗肿瘤和免疫调节生物药1类新药，意义重大。资料来源：CDE官网、米内网数据库、公司年报注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。统计截至7月17日，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

抗体药物偶联物上市批准免疫疗法

2025-07-17

·米内网

【火热】$30亿热销品种，华东医药入局抢食

精彩内容7月17日，华东医药旗下博华制药和中美华东联合提交了阿帕他胺片的4类仿制上市申请。阿帕他胺是强生的重磅内分泌治疗用药，2024年在全球的销售额接近30亿美元、在中国三大终端六大市场的销售额已达到了7亿元。图1：华东医药最新申报的产品来源：CDE官网图2：阿帕他胺的全球销售情况来源：米内网跨国上市公司数据库阿帕他胺作为新一代口服雄激素受体（AR）抑制剂，在治疗非转移性去势抵抗性前列腺癌方面展现出了显著疗效。米内网数据显示，近几年阿帕他胺在全球的销售额不断上涨，2024年达到了29.99亿美元。图3：阿帕他胺在中国三大终端六大市场的销售情况（单位：万元）来源：米内网格局数据库原研的阿帕他胺片在2019年进入中国市场，2021年通过谈判顺利进入国家医保目录，助力产品实现销售增长。在中国三大终端六大市场，强生的阿帕他胺片2023-2024年均达到了7亿元水平，2025年Q1增长率为2.78%。在内分泌治疗用药市场，阿帕他胺为TOP9品种。国产仿制药方面，齐鲁制药在2024年12月拿下了阿帕他胺片的国内首仿，2025年至今科伦药业和苑东生物也陆续获批了，华东医药将参与该产品国产第四家争夺。表1：华东医药（含子公司）今年以来获批的新产品来源：米内网中国申报进度（MED）数据库#华东医药（含子公司）积极拓宽产品线，今年以来已累计拿下了7个新品，抗肿瘤和免疫调节剂大类中的免疫刺激剂、免疫抑制剂、抗肿瘤药3个亚类市场均有斩获，阿帕他胺片将为公司的内分泌治疗用药产品线再添一员猛将。资料来源：CDE官网、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。统计截至7月17日，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准

100 项与阿帕他胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11040	阿帕他胺	L02BB05	DB11901

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
转移性前列腺癌	日本	Janssen Pharmaceutical KK	2020-05-29
转移性去势抵抗性前列腺癌	美国	Janssen Biotech, Inc.	2019-09-17
激素依赖性前列腺癌	欧盟	Janssen-Cilag International NV	2019-01-14
激素依赖性前列腺癌	冰岛	Janssen-Cilag International NV	2019-01-14
激素依赖性前列腺癌	列支敦士登	Janssen-Cilag International NV	2019-01-14
激素依赖性前列腺癌	挪威	Janssen-Cilag International NV	2019-01-14
前列腺癌	加拿大	Janssen Research & Development LLC	2018-07-27
去势敏感前列腺癌	澳大利亚	Janssen-Cilag Pty Ltd.	2018-07-05
去势抵抗性前列腺癌	美国	Janssen Biotech, Inc.	2018-02-14

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
前列腺腺癌	临床3期	中国香港	Janssen LP	2020-07-20
复发性前列腺癌	临床3期	中国香港	Janssen LP	2020-07-20
非转移性前列腺癌	临床3期	法国	Janssen Pharmaceutica NV	2020-01-09
阿尔茨海默症	临床3期	美国	西安杨森制药有限公司	2015-12-07
阿尔茨海默症	临床3期	美国	Janssen Research & Development LLC	2015-12-07
阿尔茨海默症	临床3期	美国	Aragon Pharmaceuticals, Inc.	2015-12-07
阿尔茨海默症	临床3期	日本	Aragon Pharmaceuticals, Inc.	2015-12-07
阿尔茨海默症	临床3期	日本	Janssen Research & Development LLC	2015-12-07
阿尔茨海默症	临床3期	日本	西安杨森制药有限公司	2015-12-07
阿尔茨海默症	临床3期	阿根廷	西安杨森制药有限公司	2015-12-07

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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


NCT03412396 (CTgov)	临床2期	前列腺腺癌	45	Apalutamide	鹹齋襯憲遞壓膚鹽夢鑰 = 構齋簾遞製築壓顧鬱鏇願顧築構構願餘簾齋襯 (觸糧鬱製鹹顧壓鬱廠窪, 窪構積鹹餘構築糧鹹構 ~ 鑰鹹範廠憲獵積蓋膚襯) 更多	-	2025-07-03
ASCO2025	N/A	激素依赖性前列腺癌 PSA kinetics	129	Apalutamide plus ADT	繭鏇夢襯築繭壓願願衊(鏇廠鏇觸糧糧願夢遞淵) = 積網積範顧艱艱範簾廠廠遞齋膚淵範窪餘淵鬱 (選衊鬱鹽蓋顧夢膚遞簾 ) 更多	积极	2025-05-30
NCT04926181 (CTgov)	临床2期	神经内分泌前列腺癌 \| 前列腺小细胞癌	2	Apalutamide+Cetrelimab	鑰鑰蓋願獵鹹膚廠齋繭 = 鹽構鏇築積構繭鏇廠選膚齋醖鏇範鏇繭襯選齋 (淵糧鹹衊齋鹹窪選衊繭, 蓋網繭簾製製鏇鹽築淵 ~ 鹽餘憲襯膚醖壓獵簾鏇) 更多	-	2025-05-15
NCT04108208 (CTgov)	临床4期	去势抵抗性前列腺癌	75	Placebo (Placebo Plus Androgen-deprivation Therapy (ADT))	網網壓膚鑰夢製衊獵構(製獵膚夢醖夢遞膚鹽範) = 齋壓襯願襯觸繭網窪鏇製餘壓願繭範鏇製願觸 (廠窪廠鑰夢觸鹽製製顧, 壓築艱鏇夢簾積艱繭製 ~ 鬱製築廠廠網襯繭衊憲) 更多	-	2025-03-28
				Apalutamide (Apalutamide 240 mg Plus ADT)	網網壓膚鑰夢製衊獵構(製獵膚夢醖夢遞膚鹽範) = 製糧餘鏇網鏇簾簾齋窪製餘壓願繭範鏇製願觸 (廠窪廠鑰夢觸鹽製製顧, 鬱淵願鬱壓膚繭衊壓膚 ~ 遞膚鹹鏇獵蓋醖餘觸築) 更多
NCT06013475 (DEAR-EXT, ASCO_GU2025) 人工标引	N/A	去势抵抗性前列腺癌	1,205	DarolutamideDarolutamide (DARO) (Black pts)	-	积极	2025-02-13
				DarolutamideDarolutamide (DARO) (White pts)
NCT05717660 (PERSIAN, ASCO_GU2025) 人工标引	临床2期	激素依赖性前列腺癌	174	Apalutamide+ADT (ARM A: Control)	網蓋廠夢餘窪範鑰網願(襯壓範壓顧獵鬱廠觸蓋) = 艱獵衊製積蓋築獵製製憲網繭選夢齋衊鹽獵觸 (繭觸築淵選廠遞鹽繭簾 )	积极	2025-02-13
				Apalutamide+ADT+SBRT (ARM B: Treatment)	網蓋廠夢餘窪範鑰網願(襯壓範壓顧獵鬱廠觸蓋) = 鹹網艱憲鏇積襯糧網鬱憲網繭選夢齋衊鹽獵觸 (繭觸築淵選廠遞鹽繭簾 )
NCT02489318 (TITAN, ASCO_GU2025) 人工标引	临床3期	去势敏感前列腺癌	524	Apalutamide + ADT (With CV/metabolic risk factors at baseline)	糧積鑰構蓋襯膚鑰窪獵(範鬱遞壓構壓構艱鬱鹹): HR = 0.49 (95% CI, 0.38 ~ 0.63), P-Value = <0.0001 更多	积极	2025-02-13
				Placebo + ADT (With CV/metabolic risk factors at baseline)
NCT04666129 (ASCO_GU2025) 人工标引	临床1期	晚期前列腺癌	24	Relugolix 120 mg + Abiraterone 1000 mg + prednisone 5 mg/methylprednisolone 4 mg (Part 1)	餘積製鏇繭憲壓憲遞範(膚襯構窪觸構鹹製選窪) = 鹽顧獵鬱窪襯顧構餘餘餘範壓觸築鹹鬱選範獵 (膚觸廠網範憲鹹艱選糧, 3.2) 更多	积极	2025-02-13
				Relugolix 240 mg + Apalutamide 240 mg	餘積製鏇繭憲壓憲遞範(膚襯構窪觸構鹹製選窪) = 願膚繭襯襯壓壓鹽構廠餘範壓觸築鹹鬱選範獵 (膚觸廠網範憲鹹艱選糧, 8.0) 更多
ASCO_GU2025 人工标引	N/A	去势敏感前列腺癌 Prostate specific antigen	363	Apalutamide (APA)	蓋獵構窪齋醖觸築觸鬱(鹽鏇鑰顧壓積憲齋遞窪) = 蓋鏇襯襯餘鏇鏇顧膚鹽遞淵網製襯艱選築憲願 (鏇醖獵獵顧繭鬱繭醖窪 ) 更多	积极	2025-02-13
				Abiraterone acetate (ABI)	蓋獵構窪齋醖觸築觸鬱(鹽鏇鑰顧壓積憲齋遞窪) = 鹽鬱網簾鑰鑰夢遞餘繭遞淵網製襯艱選築憲願 (鏇醖獵獵顧繭鬱繭醖窪 ) 更多
TITAN and SPARTAN (ASCO_GU2025)	N/A	晚期前列腺癌	2,190	Statin use	-	积极	2025-02-13
				Apalutamide + Statin	願憲觸鬱醖範鏇顧顧遞(選願衊範築築製壓淵衊) = 網遞觸糧遞憲鹽範繭構膚觸夢鹽鬱窪糧簾網鑰 (蓋遞蓋廠網簾積糧蓋選 )