甲苯磺酸他拉唑帕利(Talazoparib Tosylate) - 药物靶点：PARP x PARP1 x PARP2_在研适应症：乳腺癌，BRCA突变去势抵抗性前列腺癌，转移性去势抵抗性前列腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Talazoparib、Talazoparib Tosilate、talazoparib

+ [13]

靶点

PARP x PARP1 x PARP2

作用机制

PARP抑制剂(聚腺苷二磷酸核糖聚合酶抑制剂)、PARP1抑制剂(聚腺苷二磷酸核糖聚合酶1抑制剂)、PARP2抑制剂(聚腺苷二磷酸核糖聚合酶2抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病泌尿生殖系统疾病+ [7]

在研适应症

乳腺癌BRCA突变去势抵抗性前列腺癌转移性去势抵抗性前列腺癌+ [30]

非在研适应症

晚期子宫内膜癌儿童恶性实体瘤慢性淋巴细胞白血病+ [15]

原研机构

BioMarin Pharmaceutical, Inc.

在研机构

Pfizer Inc.Pfizer Europe MA EEIG

PF Consumer Healthcare Canada ULC

+ [5]

非在研机构

MediVation, Inc.

Calithera Biosciences, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2018-10-16),

gBRCA突变/HER2阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)

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结构

分子式C26H22F2N6O4S

InChIKeyQUQKKHBYEFLEHK-QNBGGDODSA-N

CAS号1373431-65-2

查看全部结构式(2)

关联

120

项与甲苯磺酸他拉唑帕利相关的临床试验

NCT04982848 / Not yet recruitingN/A

A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)

Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.

开始日期2024-12-31

申办/合作机构

Pfizer Inc.

CTRI/2024/10/076008 / Not yet recruitingN/AIIT

Retrospective observational study of safety and efficacy of Talazoparib in BRCA1/2 or PALB2 mutation breast cancer. - Nil

开始日期2024-11-10

申办/合作机构-

NCT05873192 / Not yet recruiting临床2期IIT

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer

To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

开始日期2024-09-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与甲苯磺酸他拉唑帕利相关的临床结果

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100 项与甲苯磺酸他拉唑帕利相关的转化医学

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100 项与甲苯磺酸他拉唑帕利相关的专利（医药）

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486

项与甲苯磺酸他拉唑帕利相关的文献（医药）

2024-12-01·European Journal of Medicinal Chemistry

Isoxazole compounds: Unveiling the synthetic strategy, in-silico SAR & toxicity studies and future perspective as PARP inhibitor in cancer therapy

Review

作者: Malik, Udita ; Pal, Dilipkumar

Latest developments in cancer treatment have shed a light on the crucial role of PARP inhibitors that enhance the treatment effectiveness by modifying abnormal repair pathways. PARP inhibitors, such as Olaparib, Rucaparib, Niraparib, and Talazoparib have been approved in a number of cancers including BRCA 1/BRCA2 associated malignancies although there are many difficulties as therapeutical resistance. Besides the conventional synthetic drugs, natural compounds such as flavones and flavonoids have been found to be PARP inhibitors but only in preclinical studies. Isoxazole is very important class of potential candidates for medicinal chemistry with anti-cancer and other pharmacological activities. At present, there are no approved PARP inhibitors of isoxazole origin but their ability to hit many pathways inside the cancer cells points out on its importance for future treatments design. In drug development, isoxazoles are helpful because of the molecular design flexibility that may be enhanced using various synthetic approaches. This review highlights the molecular mechanisms of PARP inhibition, importance of isoxazole compounds and present advances in their synthetic strategies that demonstrate promise for these agents as new anticancer drugs. It emphasizes that isoxazole-based PARP inhibitors compounds could be novel anti-cancer drugs. Through this review, we hope to grow a curiosity in additional explorations of isoxazole-based PARP inhibitors and their applications in the trends of novel insights towards precision cancer therapy.

2024-12-01·European Journal of Cancer

Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: Safety analyses from the randomized, placebo-controlled, phase III TALAPRO-2 study

Article

作者: Zschäbitz, Stefanie ; Oldenburg, Jan ; De Giorgi, Ugo ; Azad, Arun A. ; Saad, Fred ; Fizazi, Karim ; DeAnnuntis, Liza ; Dunshee, Curtis ; Carles, Joan ; Jones, Robert J. ; Matsubara, Nobuaki ; Shore, Neal D. ; Shore, Neal D ; Agarwal, Neeraj ; Azad, Arun A ; Jones, Robert J ; Zielinski, Michael A. ; Fong, Peter C.C. ; Zielinski, Michael A ; Fay, Andre P ; Fay, Andre P. ; Fong, Peter C C ; Di Santo, Nicola ; Joung, Jae Young ; Lin, Xun

BACKGROUNDThis detailed analysis further characterizes the safety profile of talazoparib plus enzalutamide in the ongoing randomized, phase III TALAPRO-2 study in patients with metastatic castration-resistant prostate cancer (mCRPC). In both the all-comers and homologous recombination repair (HRR)-deficient populations, talazoparib plus enzalutamide significantly improved radiographic progression-free survival compared with placebo plus enzalutamide.METHODSThe talazoparib plus enzalutamide safety populations in TALAPRO-2 included 398 patients from cohort 1 (all-comers, unselected for HRR gene alterations) and 198 patients from the combined HRR-deficient population (patients from the all-comers population with HRR gene alterations plus subsequently enrolled patients with HRR gene alterations; cohort 2). Patients received talazoparib 0.5 mg (0.35 mg, moderate renal impairment) and enzalutamide 160 mg once daily. Safety analyses evaluated common treatment-emergent adverse events (TEAE), their type, severity, timing, seriousness, and relationship to study treatment.RESULTSIn the all-comers (n = 398) and HRR-deficient populations (n = 198), all-cause grade 3/4 (G3/4) TEAEs with talazoparib plus enzalutamide were reported in 71.9 % and 66.2 % of patients, respectively. Most common G3/4 hematologic TEAEs were anemia (46.7 % and 40.9 %, respectively), neutropenia (18.3 % and 18.7 %), and thrombocytopenia (7.3 % and 7.1 %). Median time to event was 3.3 and 3.3 months for G3/4 anemia, 2.3 and 2.3 months for G3/4 neutropenia, and 2.3 and 1.5 months for G3/4 thrombocytopenia. Maximum hemoglobin reduction occurred after 13 and 15 weeks of treatment. 18.8 % and 10.1 % of patients discontinued talazoparib. TEAEs were managed with dose interruption (62.1 % and 57.6 %), reduction (52.8 % and 52.0 %), hematologic supportive care (13.1 % and 10.6 %), and packed red blood cell transfusions (39.2 % and 35.9 %).CONCLUSIONTalazoparib plus enzalutamide had a generally manageable safety profile in patients with mCRPC within the all-comers and the HRR-deficient populations.CLINICALTRIALSGOV IDENTIFIERNCT03395197.

2024-11-01·Expert Opinion on Drug Safety

PARP inhibitor-related acute renal failure: a real-world study based on the FDA adverse event reporting system database

Article

作者: Ren, Xiayang ; Wang, Yanfeng ; Sun, Ping

BACKGROUNDCurrent clinical trial data on PARP inhibitors (PARPis)-related acute renal failure (ARF) are not entirely representative of real-world situations. Therefore, in this study, the US Food and Drug Administration Adverse Event Reporting System (FAERS) was used to evaluate PARPis-related ARF.RESEARCH DESIGN AND METHODSData were obtained from 1 January 2015, to 30 September 2023. ARF event reports were analyzed based on four algorithms. The time-to-onset (TTO) and clinical outcomes of PARPis-associated ARF were assessed.RESULTSThe total included cases were 2726. Significant signals were observed for olaparib, niraparib, and rucaparib (reporting odds ratio (ROR): 1.62, 95% confidence interval (CI): 1.49-1.78, 1.25, 95% CI: 1.19-1.32 and 1.59, 95% CI: 1.47-1.72 respectively). The median TTO of ARF onset was 57, 36, and 85 days for olaparib, niraparib, and rucaparib, respectively. The proportion of deaths with olaparib (9.88%) was significantly higher than for niraparib (2.52%) and rucaparib (2.94%) (p < 0.005). The proportion of life-threatening adverse events associated with niraparib (4.89%) was significantly higher than for rucaparib (0.98%) (p < 0.005).CONCLUSIONSARF and PARPi were related, with the exception of talazoparib. More emphasis should be given to PARPis-related ARF due to the high proportion of serious AEs and delayed adverse reactions.

167

项与甲苯磺酸他拉唑帕利相关的新闻（医药）

2024-11-15

·生物制药进展杂评

全球药物研发进展周报摘要（2024.11.02-11.08）：

全球批准 1、Regeneron公司Dupilumab获EC批准扩展适应症人群，用于治疗1岁儿童嗜酸性粒细胞性食管炎(EoE)； 2、Autolus Therapeutics 公司Obecabtagene autoleucel获FDA批准上市，用于治疗复发或难治性B细胞急性淋巴细胞白血病（r/r B-ALL）的成年患者； 3、Pfizer公司Talazoparib获NMPA批准上市，用于治疗转移性去势抵抗性前列腺癌（mCRPC）； 4、正大天晴Garsorasib获NMPA批准上市，用于治疗至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者；全球申报5、Ionis Pharmaceuticals公司Donidalorsen的NDA获FDA受理，用于预防12岁及以上成人和儿童患者遗传性血管性水肿（HAE）的发作； 6、迪哲医药向FDA递交Sunvozertinib的NDA申请，用于治疗既往经含铂化疗治疗时或治疗后出现疾病进展，并且经FDA批准的试剂盒检测确认，存在表皮生长因子受体（EGFR）20号外显子插入突变（exon20ins）的局部晚期或转移性非小细胞肺癌（NSCLC）的成人患者； 7、Mustang Bio 公司MB-108获FDA孤儿药资格认定，用于治疗恶性胶质瘤； 8、亚盛医药Lisaftoclax获NMPA拟纳入优先审评，用于治疗难治或复发性慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）; 临床进展 1、济煜医药启动JMKX-001899的III期临床，用于治疗既往经治的KRAS G12C突变阳性晚期或转移性非小细胞肺癌； 2、首药控股公布终止SY-1530的临床开发，用于单药治疗复发/难治性套细胞淋巴瘤（MCL）等B细胞来源非霍奇金淋巴瘤（NHL）； 3、康方生物公布AK-132的临床前积极数据，用于治疗CLDN18.2+/CD47+肿瘤； 4、驯鹿生物公布Equecabtagene Autoleucel的Ib/II期临床积极数据，用于治疗复发/难治性多发性骨髓瘤。

上市批准优先审批临床3期孤儿药

2024-11-10

·信狐药迅

一线治疗非小细胞肺癌！上海倍而达三代EGFR抑制剂「瑞齐替尼」新适应症获批上市| 新获批（11.4-11.10）

每周药品注册获批数据，分门别类呈现，一目了然。(11.4-11.10）新药上市申请药品名称企业注册分类受理号甲磺酸瑞齐替尼胶囊上海倍而达药业有限公司1CXHS2400007盐酸凯普拉生片江苏柯菲平医药股份有限公司2.4CXHS2300078聚乙二醇重组人生长激素注射液长春金赛药业有限责任公司2.2CXSS2300057 新药临床申请药品名称企业注册分类受理号CPI-818片嘉兴和剂药业有限公司1CXHL2400893CPI-818片嘉兴和剂药业有限公司1CXHL2400892HYP-6589片四川汇宇海玥医药科技有限公司1CXHL2400863HYP-6589片四川汇宇海玥医药科技有限公司1CXHL2400862LPM682000012片山东绿叶制药有限公司1CXHL2400827LPM682000012片山东绿叶制药有限公司1CXHL2400826LPM682000012片山东绿叶制药有限公司1CXHL2400825BCM899颗粒上海云晟研新生物科技有限公司2.2CXHL2400858BCM899颗粒上海云晟研新生物科技有限公司2.2CXHL2400857注射用艾博韦泰前沿生物药业(南京)股份有限公司2.4CXHL2400865利多卡因丙胺卡因气雾剂江苏联环药业股份有限公司3CYHL2400176雷诺嗪缓释片北京阳光诺和药物研究股份有限公司3CYHL2400173雷诺嗪缓释片北京阳光诺和药物研究股份有限公司3CYHL2400172四价流感重组蛋白疫苗广东华南疫苗股份有限公司1.3CXSL24005289MW2821迈威(上海)生物科技股份有限公司1CXSL2400572ZT006片北京质肽生物医药科技有限公司1CXSL2400569ZT006片北京质肽生物医药科技有限公司1CXSL2400568ZT006片北京质肽生物医药科技有限公司1CXSL2400567ZT006片北京质肽生物医药科技有限公司1CXSL2400566ZT006片北京质肽生物医药科技有限公司1CXSL2400565ZT006片北京质肽生物医药科技有限公司1CXSL2400564CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2400560CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2400559艾米迈托赛注射液铂生卓越生物科技(北京)有限公司1CXSL2400557RJMty19注射液浙江瑞加美生物科技有限公司1CXSL2400553JCXH-211注射液嘉晨西海(杭州)生物技术有限公司1CXSL2400540靶向CD19非病毒PD1定点整合CAR-T细胞注射液上海邦耀生物科技有限公司1CXSL2400533 仿制药申请药品名称企业注册分类受理号维生素B6注射液江苏润恒制药有限公司3CYHS2402860复方聚乙二醇电解质散(II)南京海纳制药有限公司3CYHS2400148复方聚乙二醇电解质散(II)黑龙江博宇制药有限公司3CYHS2303588注射用拉氧头孢钠山东晶辉生物技术有限公司3CYHS2303220注射用拉氧头孢钠山东晶辉生物技术有限公司3CYHS2303219注射用拉氧头孢钠山东晶辉生物技术有限公司3CYHS2303221帕拉米韦注射液陕西博森生物制药股份集团有限公司3CYHS2302082注射用盐酸罗沙替丁醋酸酯郑州维先医药科技有限公司3CYHS2301977硝普钠注射液成都新恒创药业有限公司3CYHS2301634盐酸多巴酚丁胺注射液成都瑞尔医药科技有限公司3CYHS2301571依巴斯汀口服溶液湖南金圃医药科技有限公司3CYHS2301495法莫替丁注射液四川制药制剂有限公司3CYHS2301317盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司3CYHS2301170盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司3CYHS2301169膦甲酸钠注射液华仁药业股份有限公司3CYHS2301137己酮可可碱注射液武汉海特生物制药股份有限公司3CYHS2301000盐酸昂丹司琼片杭州和泽坤元药业有限公司3CYHS2300910盐酸昂丹司琼片杭州和泽坤元药业有限公司3CYHS2300909盐酸去氧肾上腺素注射液石家庄四药有限公司3CYHS2300901聚乙烯醇滴眼液四川海梦智森生物制药有限公司3CYHS2300897帕米膦酸二钠注射液仁合益康集团有限公司3CYHS2300892头孢氨苄干混悬剂上海金城素智药业有限公司3CYHS2300839盐酸去氧肾上腺素注射液南京恒道医药科技股份有限公司3CYHS2300808甲氨蝶呤片江苏百奥信康医药科技有限公司3CYHS2300574左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300334左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300333左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300332左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300331盐酸多巴酚丁胺注射液浙江沣华医药科技有限公司3CYHS2300301布洛芬混悬滴剂天大医药科技(珠海)有限公司3CYHS2300001国;CYHS2300001米诺地尔搽剂浙江远力健药业有限责任公司3CYHS2201287国;CYHS2201287注射用头孢唑肟钠山东晶辉生物技术有限公司4CYHS2403004注射用头孢唑肟钠山东晶辉生物技术有限公司4CYHS2403003注射用头孢唑肟钠山东晶辉生物技术有限公司4CYHS2403002盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448地夸磷索钠滴眼液江苏远恒药业有限公司4CYHS2400248氧(液态)重庆川维林德气体有限责任公司4CYHS2400178麦考酚钠肠溶片山东新时代药业有限公司4CYHS2303659巴氯芬片重庆士立德医药科技有限公司4CYHS2302507玻璃酸钠滴眼液山东华鲁制药有限公司4CYHS2302277阿戈美拉汀片宝利化(南京)制药有限公司4CYHS2302145左卡尼汀口服溶液浙江长典药物技术开发有限公司4CYHS2302108玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301914玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301913注射用头孢唑肟钠海南全星制药有限公司4CYHS2301760硫辛酸注射液江苏睿实生物科技有限公司4CYHS2301742注射用头孢唑肟钠广州艾奇西新药研究有限公司4CYHS2301641左卡尼汀注射液舒美奇成都生物科技有限公司4CYHS2301604左卡尼汀注射液舒美奇成都生物科技有限公司4CYHS2301603马来酸氟伏沙明片上海理想制药有限公司4CYHS2301497莫匹罗星软膏河南羚锐制药股份有限公司4CYHS2301424二甲双胍恩格列净片天大药业(珠海)有限公司4CYHS2301425马来酸阿法替尼片江苏华阳制药有限公司4CYHS2301281伏立康唑干混悬剂健康元药业集团股份有限公司4CYHS2301217左氧氟沙星滴眼液石家庄凯赛医药科技有限公司4CYHS2301194瑞巴派特片福安药业集团宁波天衡制药有限公司4CYHS2301188熊去氧胆酸胶囊浙江寰领医药科技有限公司4CYHS2300582左氧氟沙星片吉林长白山药业集团股份有限公司4CYHS2300552地夸磷索钠滴眼液南京黄龙生物科技有限公司4CYHS2300464阿加曲班注射液海南葫芦娃药业集团股份有限公司4CYHS2300184克林霉素磷酸酯外用溶液江苏知原药业股份有限公司4CYHS2300147注射用替考拉宁海南倍特药业有限公司4CYHS2300059盐酸环喷托酯滴眼液山东绅联药业股份有限公司4CYHS2300007国;CYHS2300007盐酸美金刚片成都百裕制药股份有限公司4CYHS2201963国;CYHS2201963盐酸乐卡地平片兆科药业(广州)有限公司4CYHS2201840国;CYHS2201840注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201554国;CYHS2201554注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201552国;CYHS2201552注射用多种维生素(12)山东鲁盛制药有限公司4CYHS2201289国;CYHS2201289沙库巴曲缬沙坦钠片山东凤凰制药股份有限公司4CYHS2200423国;CYHS2200423屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200412国;CYHS2200412乌司奴单抗注射液杭州中美华东制药有限公司3.3CXSS2300065 进口申请药品名称企业注册分类受理号甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300032甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300031甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300030甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300029灌注用盐酸氨酮戊酸己酯Photocure ASA5.1JXHS2300108Acalabrutinib Maleate片AstraZeneca Pty Ltd.5.1JXHS2300077Acalabrutinib Maleate片AstraZeneca Pty Ltd.5.1JXHS2300076阿伐可泮硬胶囊Vifor Fresenius Medical Care Renal Pharma France5.1JXHS2200125国;JXHS2200125纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400015纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400014冻干膀胱灌注用卡介苗(日本株)Japan BCG Laboratory3.1JXSS2400032伊布替尼胶囊Natco Pharma Limited5.2JYHS2300009恩扎卢胺软胶囊Dr. Reddy's Laboratories Limited5.2JYHS2200042国;JYHS2200042AMG 193Amgen Inc.1JXHL2400211 中药相关申请药品名称企业注册分类受理号椒七麝凝胶贴膏湖南九典制药股份有限公司1.1CXZS2300028 注：橙色字体部分结论为不批准或收到通知件；

细胞疗法免疫疗法疫苗申请上市临床申请

2024-11-10

·药筛

湖南九典椒七麝凝胶贴膏未获批 | 新药周报（11.4-11.10）

统计每周新药申报、上市申请（11.4-11.10） 1、新药上市申请获批药品名称企业名称分类受理号阿伐可泮胶囊Vifor Fresenius Medical Care Renal Pharma France5.1JXHS2200125冻干膀胱灌注用卡介苗（日本株）Japan BCG Laboratory3.1JXSS2400032灌注用盐酸氨酮戊酸己酯Photocure ASA5.1JXHS2300108甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300031甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300030甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300029甲苯磺酸他拉唑帕利胶囊Pfizer Europe MA EEIG2.4JXHS2300032甲磺酸瑞齐替尼胶囊上海倍而达药业有限公司1CXHS2400007椒七麝凝胶贴膏湖南九典制药股份有限公司1.1CXZS2300028聚乙二醇重组人生长激素注射液长春金赛药业有限责任公司2.2CXSS2300057马来酸阿可替尼片AstraZeneca Pty Ltd5.1JXHS2300076马来酸阿可替尼片AstraZeneca Pty Ltd5.1JXHS2300077纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400014纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400015乌司奴单抗注射液杭州中美华东制药有限公司;江苏赛孚士生物技术有限公司3.3CXSS2300065盐酸凯普拉生片江苏柯菲平医药股份有限公司2.4CXHS2300078 2、新药上市申请受理药品名称企业名称分类受理号艾可瑞妥单抗注射液AbbVie Deutschland GmbH & Co. KG3.1JXSS2400101艾可瑞妥单抗注射用浓溶液AbbVie Deutschland GmbH & Co. KG3.1JXSS2400100氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400092氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400090氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400091氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400088氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400093氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400089五味消毒颗粒南京中山制药有限公司3.1CXZS2400034 数据来源：摩熵医药相关阅读：葛蓝新通乙肝新药帕拉德福韦片获批上市 | 新药周报（10.28-11.3）山东罗欣替戈拉生HP新适应症获批 | 新药报（10.21-10.27）君实 PCSK9昂戈瑞西单抗获批上市 | 新药报（10.14-10.20）齐鲁艾帕洛利托沃瑞利单抗，康方伊努西单抗获批上市 | 新药周动态（10.7-10.13）

上市批准

100 项与甲苯磺酸他拉唑帕利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲苯磺酸他拉唑帕利	L01XX60	DB11760

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
乳腺癌	美国	Pfizer Inc.	2024-03-07
BRCA突变去势抵抗性前列腺癌	日本	Pfizer Japan, Inc.	2024-01-18
转移性去势抵抗性前列腺癌	挪威	Pfizer Inc.	2024-01-08
转移性去势抵抗性前列腺癌	欧盟	Pfizer Inc.	2024-01-08
转移性去势抵抗性前列腺癌	列支敦士登	Pfizer Inc.	2024-01-08
转移性去势抵抗性前列腺癌	冰岛	Pfizer Inc.	2024-01-08
HRR 基因突变去势抵抗性前列腺癌	澳大利亚	Pfizer Australia Pty Ltd.	2019-11-18
转移性乳腺癌	加拿大	PF Consumer Healthcare Canada ULC	2019-09-06
HR阳性乳腺癌	冰岛	Pfizer Europe MA EEIG	2019-06-20
HR阳性乳腺癌	挪威	Pfizer Europe MA EEIG	2019-06-20
HR阳性乳腺癌	欧盟	Pfizer Europe MA EEIG	2019-06-20
HR阳性乳腺癌	列支敦士登	Pfizer Europe MA EEIG	2019-06-20
gBRCA突变/HER2阴性乳腺癌	美国	Pfizer Inc.	2018-10-16

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
去势抵抗性前列腺癌	申请上市	美国	Pfizer Inc.	2023-02-17
转移性去势抵抗性前列腺癌	申请上市	美国	Pfizer Inc.	2023-02-16
局部晚期乳腺癌	药物发现	俄罗斯	Pfizer Inc.	2013-10-14
局部晚期乳腺癌	药物发现	比利时	Pfizer Inc.	2013-10-14
局部晚期乳腺癌	药物发现	德国	Pfizer Inc.	2013-10-14
局部晚期乳腺癌	药物发现	西班牙	Pfizer Inc.	2013-10-14
局部晚期乳腺癌	药物发现	巴西	Pfizer Inc.	2013-10-14
局部晚期乳腺癌	药物发现	韩国	Pfizer Inc.	2013-10-14
局部晚期乳腺癌	药物发现	乌克兰	Pfizer Inc.	2013-10-14

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03395197 (TALAPRO-2, Pubmed \| Eur J Cancer)	临床3期	转移性去势抵抗性前列腺癌 HRR gene alterations	-	Talazoparib 0.5 mg	顧醖顧憲構膚顧製選選(製鏇遞餘顧憲膚鹽鹹鏇) = 膚艱顧選淵製繭築繭鑰鹹網廠夢蓋窪網齋觸築 (構鏇衊蓋襯獵蓋積鹹獵 ) 更多	积极	2024-12-01
				Enzalutamide 160 mg	顧醖顧憲構膚顧製選選(製鏇遞餘顧憲膚鹽鹹鏇) = 顧衊鑰鬱醖齋襯淵製窪鹹網廠夢蓋窪網齋觸築 (構鏇衊蓋襯獵蓋積鹹獵 ) 更多
NCT03395197 (TALAPRO-2, PipelineReview) 人工标引	临床3期	转移性去势抵抗性前列腺癌	-	talazoparib + enzalutamide	(顧醖鑰鹽築鏇觸築衊窪) = Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. 窪襯遞範窪艱構壓遞獵 (醖簾繭網窪餘鏇襯構憲 )	积极	2024-10-10
ASTRO	N/A	广泛期小细胞肺癌	-	Talazoparib	積壓鹽壓醖製壓淵鹹廠(獵憲夢繭齋鏇選鬱選淵) = 1 Gr3 TRT or talazoparib+TRT related non-hematologic AE: esophagitis 餘襯齋遞鹹積蓋餘膚鑰 (餘鬱襯範構齋鏇鏇淵築 ) 更多	-	2024-10-01
				Consolidative Thoracic Radiotherapy (CTRT)
EUCTR2020-001105-24-FR (GETUG-TALASUR, ESMO2024) 人工标引	临床2期	转移性尿路上皮癌维持	47	Talazoparib+Avelumab	(構遞選構淵願獵窪鬱餘) = 顧鏇製齋獵齋淵選餘獵繭簾淵構窪積鹽膚淵醖 (製觸淵夢選鑰淵觸觸鏇, 3.7 ~ 9.1) 更多	不佳	2024-09-15
NCT03395197 (TALAPRO-2, ESMO2024) 人工标引	临床3期	转移性去势抵抗性前列腺癌一线	125	Talazoparib + Enzalutamide	(襯遞膚網鑰鬱壓觸構鑰) = 壓鑰鹹壓觸醖憲壓繭廠鬱簾窪鏇壓範鹹淵製獵 (築製衊製衊艱獵願鑰築 ) 更多	积极	2024-09-15
				Placebo + Enzalutamide	(襯遞膚網鑰鬱壓觸構鑰) = 夢簾鹹觸繭積餘齋積繭鬱簾窪鏇壓範鹹淵製獵 (築製衊製衊艱獵願鑰築 ) 更多
NCT03395197 (TALAPRO-2, ESMO2024)	临床3期	转移性去势抵抗性前列腺癌 HRR deficient	-	Talazoparib + Enzalutamide	(鹽襯顧積艱夢壓願廠網) = 憲鏇糧顧壓襯願鹽壓製鏇襯廠網餘鑰遞遞糧壓 (範餘獵築糧醖鬱觸壓壓, 5.6 ~ 16.4)	积极	2024-09-15
				Placebo + Enzalutamide	(鹽襯顧積艱夢壓願廠網) = 憲網廠襯糧鑰遞範鬱繭鏇襯廠網餘鑰遞遞糧壓 (範餘獵築糧醖鬱觸壓壓, 1.8 ~ 11.0)
NCT02912572 (CTgov)	临床2期	转移性子宫内膜恶性肿瘤 \| 复发性子宫内膜癌	106	Avelumab+Talazoparib (MSS Avelumab/Talazoparib Combination Arm)	夢鏇襯構餘齋蓋廠選齋(糧願選積鹹夢淵餘願積) = 窪壓醖齋製鹹夢觸夢膚蓋襯廠齋窪網廠築淵網 (夢齋壓夢網範鑰夢積蓋, 餘淵願鑰淵襯齋繭餘艱 ~ 憲齋淵齋觸築鏇衊糧繭) 更多	-	2024-07-05
				Avelumab+Axitinib (MSS Avelumab/Axitinib Combination Arm)	夢鏇襯構餘齋蓋廠選齋(糧願選積鹹夢淵餘願積) = 構夢廠壓願衊獵築鏇獵蓋襯廠齋窪網廠築淵網 (夢齋壓夢網範鑰夢積蓋, 繭醖鏇窪糧獵遞鑰鏇餘 ~ 網夢築鏇衊遞齋築顧鏇) 更多
NCT02693535 (Targeted Agent and Profiling Utilization Registry Study, Pubmed)	临床2期	晚期恶性实体瘤 \| 多发性骨髓瘤	-	Talazoparib	衊醖鹹膚夢選鬱遞蓋艱(鑰衊醖廠窪繭顧鬱衊淵) = 觸艱鹹蓋蓋壓鹹選築網範鑰選積鑰淵構積糧鑰 (製壓衊獵獵醖鏇簾鹹築, 43 ~ 100)	积极	2024-06-01
NCT04740190 (TAC-GReD, ASCO2024) 人工标引	临床2期	复发性恶性胶质瘤	33	Talazoparib + carboplatin	(壓餘範餘選蓋齋製鑰膚) = 夢繭齋選觸繭構醖淵獵憲網範糧夢繭獵鑰艱淵 (積膚觸顧製膚網夢構鏇, 16.2 ~ 51.9) 更多	积极	2024-05-24
NCT04337970 (ASCO2024)	临床1/2期	局部晚期透明细胞肾细胞癌 HIF proteins	23	Talazoparib 0.5 mg	(網齋選憲憲遞鏇積顧壓) = 餘簾網網憲餘壓製齋觸廠鏇齋廠鬱選簾襯衊齋 (網範鹽蓋網齋鑰鹹鏇餘, 0 ~ 30) 更多	不佳	2024-05-24