This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.
This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.
To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.
Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.

开始日期2024-09-30

申办/合作机构

Bayer AG

ACTRN12624000582550 / Not yet recruiting临床2期

Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide (WOMBAT) - ANZUP 2201

开始日期2024-09-06

申办/合作机构

Australian & New Zealand Urogenital & Prostate Cancer Trials

NCT06401980 / Not yet recruiting临床2期IIT

Addition of Darolutamide to First Line Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): a Randomized Open Label Phase II Trial

Despite improvements in treatment, metastatic prostate cancer remains incurable, especially in the case of pretreated metastatic castration-resistant disease (mCRPC), where treatment options are limited, leading to an unmet need. The paradigm shift in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has affected the treatment landscape for mCRPC patients. Many have already received androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), making first-line mCRPC treatment challenging.
The Swiss Group for Clinical Cancer Research (SAKK) has shown in previous studies that maintenance treatment with an ARPI, such as darolutamide, can improve radiographic progression-free survival (rPFS) in pretreated mCRPC patients. In the SAKK 08/16 trial, darolutamide maintenance was found to prolong PFS compared to placebo, especially in patients who responded well to prior ARPI treatment.
Based on these findings, the hypothesis is that continued AR-pathway blockade with darolutamide, initiated in patients progressing from mHSPC to mCRPC on ARPI treatment, can improve outcomes when added to standard first-line mCRPC therapy and continued as maintenance. The proposed study aims to evaluate the efficacy of darolutamide, combined with physician-choice standard of care (including taxane chemotherapy, olaparib, radium 223, or LuPSMA), followed by maintenance therapy, on rPFS for patients in the first-line setting of mCRPC.

开始日期2024-08-01

申办/合作机构

Swiss Group for Clinical Cancer Research

100 项与达罗他胺相关的临床结果

登录后查看更多信息

100 项与达罗他胺相关的转化医学

登录后查看更多信息

100 项与达罗他胺相关的专利（医药）

登录后查看更多信息

278

项与达罗他胺相关的文献（医药）

2024-05-01·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

作者: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Navneesh, N ; Verma, Sant Kumar ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

2024-01-01·European urology oncology

A Phase 2 Randomized Open-label Study of Oral Darolutamide Monotherapy Versus Androgen Deprivation Therapy in Men with Hormone-sensitive Prostate Cancer (EORTC-GUCG 1532)

Article

作者: Krzystyniak, Joanna ; Gontero, Paolo ; Gomez-Veiga, Francisco ; Khaled, Hussein ; Tombal, Bertrand F ; Loriot, Yohann ; Roumeguere, Thierry Andre ; Gomez-Ferrer, Alvaro ; López-Campos, Fernando ; Herrera-Imbroda, Bernardo ; Fournier, Beatrice ; D'Hondt, Lionel A ; Ost, Piet ; Villà, Salvador ; Musoro, Jammbe ; Quivrin, Magali ; Pretzenbacher, Yassin

BACKGROUND AND OBJECTIVE:

Darolutamide is an androgen receptor inhibitor that increases overall survival in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer (PCa). This phase 2 study assessed the efficacy and safety of darolutamide as monotherapy without ADT in patients with eugonadal testosterone levels.

METHODS:

This was a 24-wk, open-label, randomized study of patients with hormone-sensitive, histologically confirmed PCa requiring gonadotropin-releasing hormone (GnRH); an Eastern Cooperative Oncology Group performance status score of 0/1; and life expectancy >1 yr. All patients received darolutamide 600 mg bid or a commercially available GnRH analog. The primary endpoint is a prostate-specific antigen (PSA) response, defined as a ≥80% decline at week 24 relative to baseline in the darolutamide study arm. The GnRH arm is used as an internal control. The secondary endpoints included changes in T levels, safety/tolerability, and quality of life.

KEY FINDINGS AND LIMITATIONS:

Among 61 men enrolled, the median (range) age was 72 yr (53-86 yr); 42.6% of them had metastases. In the darolutamide arm, the evaluable population with available PSA values at baseline and week 24 consisted of 23 patients. Twenty-three (100%) evaluable darolutamide patients achieved a PSA decline of >80% at week 24 (primary endpoint), with a median (range) decrease of -99.1% (-91.9%, -100%). Serum T levels increased by a median (range) of 44.3 (5.7-144.0) at week 24, compared with baseline. In the darolutamide arm, 48.4% of men reported drug-related adverse events (AEs; mostly grade 1 or 2). The most frequent treatment-emergent AEs included gynecomastia (35.5%), fatigue (12.9%), hot flush (12.9%), and hypertension (12.9%). Health-related quality of life measures are descriptive, and GnRH arm results will be presented as an internal reference.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Darolutamide monotherapy was associated with a significant PSA response in nearly all men with hormone-naïve PCa. Testosterone-level changes and most common AEs (gynecomastia, fatigue, hypertension, and hot flush) were consistent with potent androgen receptor inhibition.

PATIENT SUMMARY:

In this study, we report the first use of darolutamide, a novel antiandrogen, as monotherapy without androgen deprivation therapy (ADT). The study shows that darolutamide induce a profound suppression of prostate-specific antigen in all patients, with a safety profile different from that of ADT.

2024-04-01·Clinical genitourinary cancer

Real-World Evidence of Triplet Therapy in Metastatic Hormone-Sensitive Prostate Cancer: An Austrian Multicenter Study

Article

作者: Stoiber, Franz ; Lenart, Sebastian ; Kamhuber, Christoph ; Bauernhofer, Thomas ; Berger, Andreas ; Weiss, Sarah ; Laimer, Sarah ; Ofner, Heidemarie ; Wiesinger, Clemens ; Höfner, Thomas ; Lusuardi, Lukas ; Heidegger, Isabel ; Loidl, Wolfgang ; Bergmaier, Antonia ; Hruby, Stephan ; Bauinger, Severin ; Drerup, Martin ; Krause, Steffen ; Griessner, Hubert ; Kafka, Mona ; Artamonova, Nastasiia ; Heinrich, Elmar ; Bektic, Jasmin ; Giannini, Giulia ; Horninger, Wolfgang ; Müldür, Ecan ; Vallet, Sonia ; Schachtner, Gert ; Nagele, Udo ; Kramer, Gero ; Schneider, Magdalena ; Neuwirt, Hannes ; Pfuner, Jacob ; Winder, Thomas ; Madersbacher, Stephan ; Luger, Ferdinand ; Ponholzer, Anton

INTRODUCTION:

Two randomized trials demonstrated a survival benefit of triplet therapy (androgen deprivation therapy [ADT]) plus androgen receptor pathway inhibitor [ARPI] plus docetaxel) over doublet therapy (ADT plus docetaxel), thus changing treatment strategies in metastatic hormonesensitive prostate cancer (mHSPC).

PATIENTS AND METHODS:

We conducted the first real-world analysis comprising 97 mHSPC patients from 16 Austrian medical centers, among them 79.4% of patients received abiraterone and 17.5% darolutamide treatment. Baseline characteristics and clinical parameters during triplet therapy were documented. Mann-Whitney U test for continuous or X²-test for categorical variables was used. Variables on progression were tested using logistic regression analysis and tabulated as hazard ratios (HR), 95% confidence interval (CI).

RESULTS:

Of 83.5% patients with synchronous and 16.5% with metachronous disease were included. 83.5% had high-volume disease diagnosed by conventional imaging (48.9%) or PSMA PET-CT (51.1%). While docetaxel and ARPI were administered consistent with pivotal trials, prednisolone, prophylactic gCSF and osteoprotective agents were not applied guideline conform in 32.5%, 37%, and 24.3% of patients, respectively. Importantly, a nonsimultaneous onset of chemotherapy and ARPI, performed in 44.3% of patients, was associated with significantly worse treatment response (P = .015, HR 0.245). Starting ARPI before chemotherapy was associated with significantly higher probability for progression (P = .023, HR 15.781) than vice versa. Strikingly, 15.6% (abiraterone) and 25.5% (darolutamide) low-volume patients as well as 14.4% (abiraterone) and 17.6% (darolutamide) metachronous patients received triplet therapy. Adverse events (AE) occurred in 61.9% with grade 3 to 5 in 15% of patient without age-related differences. All patients achieved a PSA decline of 99% and imaging response was confirmed in 88% of abiraterone and 75% of darolutamide patients.

CONCLUSIONS:

Triplet therapy arrived in clinical practice primarily for synchronous high-volume mHSPC. Regardless of selected therapy regimen, treatment is highly effective and tolerable. Preferably therapy should be administered simultaneously, however if not possible, chemotherapy should be started first.

205

项与达罗他胺相关的新闻（医药）

2024-06-23

·药渡

欧洲杯来了！哪些国家最有望夺得“最佳药物管道”奖杯？

来源：药渡撰文：Maskey 编辑：哦呼欧洲杯激战正酣，各国球队为了荣誉和胜利而奋力拼搏。但如果换个角度，设想一下，若是让这些参加欧洲杯的国家在“最佳药物管道”这一特殊领域展开角逐，谁又将脱颖而出，问鼎桂冠呢？目前，世界各地的制药公司都在竞相开发最具创新性和最有效的常见人类疾病治疗方法。他们进行临床前研究和临床试验，希望他们的治疗方法能得到监管机构的批准。监管机构会为可能治疗严重疾病的新型试验药物授予突破性疗法认定和快速通道认定。近年来，越来越多的新型治疗方法（如细胞和基因疗法、单克隆抗体和抗体-药物偶联物）已获得监管机构的批准[1]。因此，制药公司正在加大对这些创新疗法的开发投入。一些最大的制药公司位于欧洲，所有这些公司都在建立庞大的创新疗法药物管线。图1.近年来美国食品药品监督管理局(FDA)批准的新分子实体（NME）和生物制剂的数量【1】图2.获得批准的单克隆抗体百分比【2】德国拜耳是德国领先的制药公司之一。老年性黄斑变性药物阿柏西普、前列腺癌药物达罗他胺、抗凝药物利伐沙班和慢性肾病药物Finerenone是其产品组合中最有价值的药物。该公司正在开发33种新疗法，其中19种疗法正在进行1期临床试验，3种疗法正在进行2期临床试验[3]。该公司正在测试几种创新的重组腺相关病毒 (rAAV) 基因疗法，用于治疗亨廷顿氏病、帕金森氏病和庞贝氏病。另一家德国制药公司勃林格殷格翰正在临床试验中测试40多种药物[4]。该公司已经开发出用于治疗多种疾病的小分子药物、T细胞接合剂和癌症疫苗。该公司的产品组合中包括有效的治疗药物，包括肺纤维化药物尼达尼布和抗糖尿病药物恩格列净。默克集团是另一家德国制药公司，正在开发10多种用于治疗癌症、自身免疫性疾病和疟疾的药物[5]。其药物管线中一些有前景的在研药物包括小分子药物Enpatoran、抗体药物偶联物M9140和免疫检查点抑制剂avelumab。 BioNtech也是一家德国大型生物制药公司，与辉瑞公司成功开发了COVID-19疫苗BNT162b2(Comirnaty)。该公司还在对患有不同类型癌症（如结直肠癌和胰腺导管腺癌）的患者测试癌症疫苗Autogene Cevumeran[6]。BioNTech SE正在临床试验中测试30多种治疗方法，包括mRNA治疗、细胞疗法、基于蛋白质的疗法和小分子免疫调节剂。这些治疗方法旨在治疗癌症和传染病。其管道中最有前途的候选药物之一是单克隆抗体Gotistobart，正在非小细胞肺癌患者中进行测试。该公司开发的其他重要药物包括双特异性抗体Acasunlimab、BNT312/GEN1042和BNT327/PM8002。德国规模较小的生物制药公司也在努力扩大其药物研发线。Ethris开发了一种新型吸入式mRNA治疗药物ETH47，用于治疗呼吸道病毒感染。海德堡制药公司研发线中的一种主要候选药物是用于治疗多发性骨髓瘤的抗体-药物偶联物HDP-101。Affimed开发了用于治疗非小细胞肺癌的双特异性先天细胞接合剂AFM24。Atai Life Sciences研发线中有几种用于治疗抑郁症和焦虑症的药物。法国法国最大的制药公司赛诺菲拥有庞大的药物管线，包括60多种临床阶段治疗药物[7]。该公司正在开发双特异性抗体、疫苗、单克隆抗体、NK细胞接合剂、酶替代疗法和基因疗法。其最畅销的药物是与Regeneron合作开发的单克隆抗体度匹鲁单抗。该药物已被批准用于多种适应症，例如特应性皮炎、嗜酸性食管炎和哮喘。其投资组合中的另一项重要资产是与阿斯利康合作开发的呼吸道合胞病毒 (RSV) 疫苗nirsevimab。其管线中的几种药物，如小分子药物SAR441566、单克隆抗体Amlitelimab和单克隆抗体Frexalimab，都有可能获得监管部门的批准并成为变革性的治疗方法。法国还有几家不太知名的制药公司，包括Genfit、Abivax和Enterome，它们正在研发新的创新疗法。Genfit正在开发治疗胆管癌和高氨血症的新疗法。今年6月，FDA加速批准其药物Elafibranor，用于治疗原发性胆汁性胆管炎。Amolyt Pharma的药物管线包括治疗肢端肥大症和甲状旁腺功能减退症的药物。Enterome正在开发新的基于肽的免疫疗法，用于治疗惰性非霍奇金淋巴瘤和胶质母细胞瘤。Abivax已开发小分子药物obefazimod，用于治疗溃疡性结肠炎和克罗恩病。Antabio正在开发治疗铜绿假单胞菌感染和医院内感染的药物。Ipen的临床阶段管线中有10多种药物，包括治疗偏头痛、阿拉吉耶综合征、多发性骨髓瘤和胆道闭锁的药物[8]。英国英国-瑞典制药公司阿斯利康拥有最大的药物管线之一，拥有超过90种不同的临床阶段治疗药物[9]。该公司正在开发用于治疗癌症、呼吸系统疾病、代谢疾病、肾脏疾病和心血管疾病的新药。它拥有非常强大的肿瘤学产品组合，包括抗体药物偶联物trastuzumab deruxtecan和酪氨酸激酶抑制剂奥希替尼。该公司还通过购买和公司收购在其管线中增加了嵌合抗原受体T细胞(CAR-T)疗法、呼吸道合胞病毒疫苗和2型糖尿病药物。其与第一三共联合开发的抗体药物偶联物Datopotamab deruxtecan可能很快会在美国获得监管部门的批准。葛兰素史克 (GSK) 已开发出60多种用于治疗艾滋病毒、癌症、传染病以及呼吸道和免疫疾病的药物。该公司最近开发的最成功的治疗方法之一是呼吸道合胞病毒疫苗Arexvy，该疫苗已获得FDA批准用于50岁以上的人群[10]。该公司在开发高效疫苗方面有着良好的记录，例如Gardasil、Arexvy和 Shingrix。今年，GSK收购了一家新兴生物制药公司Aiolos Bio，该公司开发了一种新型哮喘药物。 Verona Pharma开发了一种用于治疗慢性阻塞性肺病的药物Ensifentrine，今年可能会获得FDA的批准。Ellipses Pharma正在对2期临床试验中的四种药物进行评估[11]。该公司正在研发不同类别的药物，例如用于治疗癌症的双重抑制剂、纳米颗粒-药物偶联物和选择性雄激素受体调节剂 (SARM)。Evox Therapeutics正在临床前研究中开发外泌体递送的腺相关病毒(AAV) 基因疗法，用于治疗苯丙酮尿症和心血管疾病[12]。瑞士罗氏的研发管线中有70多种药物[13]。该公司开发的转化疗法之一是双特异性单克隆抗体Faricimab，用于治疗糖尿病性黄斑水肿和新生血管性年龄相关性黄斑变性。其他成功获得监管部门批准的重要治疗方法是抗体-药物偶联物polatuzumab vedotin-piiq双特异性单克隆抗体Emicizumab和双特异性抗体glofitamab-gxbm。其阿尔茨海默氏症药物gantenerumab在3期临床试验中未能显示出疗效。该公司已将小分子抑制剂camonsertib和双特异性抗体RG6286等抗癌药物从其管线中移除。罗氏正在优先考虑那些更有可能获得监管机构批准的治疗方法。诺华是全球销售额最大的制药公司之一。其药物研发管线中有超过60种治疗方法[14]。其研发管线包括单克隆抗体、CAR-T疗法、基因疗法、小分子抑制剂、合成小干扰RNA (siRNA) 和其他治疗不同疾病的药物。其产品组合中的重要资产是心力衰竭组合药物Sacubitril/valsartan、多发性硬化症药物 Ofatumumab、乳腺癌药物ribociclib和高脂血症药物inclisiran。其布鲁顿氏酪氨酸激酶(BTK)抑制剂remibrutinib很有可能被批准用于治疗慢性自发性荨麻疹。 ADC Therapeutics正在临床试验中测试大约3种治疗方法[14]。该公司开发了抗体药物偶联物loncastuximab tesirine-lpyl，该药物已获得FDA加速批准，用于治疗大B细胞淋巴瘤。Alentis Therapeutics的研发管线中有大约4种治疗方法，包括抗体药物偶联物和单克隆抗体[15]。图3.销售额最高的制药公司和治疗方法【16】丹麦丹麦制药公司诺和诺德是欧洲最大的制药公司之一。诺和诺德的药物管线包括35多种药物，其中大多数药物正在对患有非酒精性脂肪性肝炎和糖尿病等慢性疾病的患者进行测试[17]。其最成功的药物是用于治疗肥胖症和糖尿病的索马鲁肽。诺和诺德开发了一种每周一次的糖尿病药物胰岛素Icodec，该药物已获准在欧洲使用。Genmab有10多种治疗方法正在临床试验中测试。它与辉瑞联合开发了抗体-药物偶联物tisotumab vedotin，该药物已获准用于治疗宫颈癌。其T细胞结合双特异性抗体epcoritamab也已获准用于治疗弥漫性大B细胞淋巴瘤。比利时比利时生物制药公司Union Chimique Belge (UCB)正在开发用于治疗系统性红斑狼疮和严重纤维肌痛综合征等神经和自身免疫性疾病的药物。其研发管线中有大约10种小分子药物和单克隆抗体[18]。其药物bimekizumab已在美国获批用于治疗斑块状银屑病。荷兰荷兰制药公司Argenx开发了抗体片段efgartigimod，该片段已获批用于治疗全身性重症肌无力。该公司正在对患有干燥综合征和特发性炎症性肌病的患者进行efgartigimod测试。该公司正在研发的另一种药物是单克隆抗体Empasiprubart，该药物已被开发用于治疗多灶性运动神经病。总之，欧洲几家大型制药公司正在开发用于多种疾病的一流和一流药物。这些公司通过研究、收购和与其他公司的联合合作建立了强大的药物管线。在这些欧洲国家中，德国、英国、瑞士和法国都有成熟和新兴的生物制药公司，专注于开发创新疗法。大多数公司都开发出了有效的治疗方法，并已在许多国家获准使用。编者按：在这场假想的“最佳药物管道”欧洲杯中，每个国家都有机会展现自己的实力和风采，我们都期待看到其在“赛场”上展现出最佳的状态。未来我们应给予各国更多在医药研究上付出与收获的关注，以及他们为全人类的健康福祉所作出的杰出贡献。参考文献（可上下滑动）： [1] Senior, M. (2023). Fresh from the biotech pipeline: fewer approvals, but biologics gain share. nature biotechnology, 41(2), 174. [2] Walsh, G., & Walsh, E. (2022). Biopharmaceutical benchmarks 2022. Nature Biotechnology, 40(12), 1722-1760. [3] Bayer (2024, 30 April ). Pharmaceuticals Pipeline Overview and Progress. https://www.bayer.com/sites/default/files/ph-rd-pipeline-2024-05-final-1.pdf [4] Boehringer Ingelheim (n.d.). Boehringer Ingelheim Human Pharma Clinical Pipeline. https://www.boehringer-ingelheim.com/bipdf/pipeline-february-2024 [5] Merck Group (n.d.). HEALTHCARE PIPELINE. https://www.merckgroup.com/en/research/healthcare-pipeline.html [6] BioNTech SE (2024, 7 April). Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer. https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized [7] Sanofi (n.d.). Our Pipeline. https://www.sanofi.com/en/our-science/our-pipeline [8] Ipsen (n.d.). Pipeline. https://www.ipsen.com/pipeline/ [9] AstraZeneca (n.d.). Our pipeline. https://www.astrazeneca.com/our-therapy-areas/pipeline.html#cvrm [10] GSK. (2024, 7 June). US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-adults-aged-50-59-at-increased-risk/#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,who%20are%20at%20increased%20risk. [11] Ellipses Pharma (n.d.). PORTFOLIO. https://ellipses.life/portfolio/ [12] Evox Therapeutics (n.d.). Pipeline. https://www.evoxtherapeutics.com/pipeline/ [13] Johnston, I (2024, 24 April). Roche cuts drug pipeline in effort to revitalise business. Financial Times https://www.ft.com/content/d2dfc0c4-85e0-4cf5-b926-c10d630b2772 [14] ADC Therapeutics (n.d.). Our Pipeline. https://www.adctherapeutics.com/our-pipeline/ [15] Alentis Therapeutics (n.d.). Novel therapies for cancer and fibrosis. https://alentis.ch/pipeline/ [16] Verdin, P. (2024). Top companies and drugs by sales in 2023. Nature reviews. Drug Discovery. [17] Novo Nordisk (n.d.). R&D pipeline. https://www.novonordisk.com/science-and-technology/r-d-pipeline.html [18] UCB (n.d.). PIPELINE. https://www.ucb.com/our-science/pipeline *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容美国Arthrosi公司创新药AR882溶解痛风石，2期临床试验成果亮相2024欧洲风湿病学大会全球First-in-class！迪哲医药戈利昔替尼重磅获批 2024年上半年FDA批准药物或新适应症（下）点击蓝字关注我们

基因疗法疫苗突破性疗法信使RNA临床1期

2024-06-05

·E药经理人

FDA批准康朴生物开展KPG-121联合阿比特龙一线治疗mCPRC的II/III期临床试验

中国合肥，2024年6月5日--康朴生物医药技术（合肥）有限公司（以下简称“康朴生物”）今日宣布其自主开发的分子胶KPG-121联合阿比特龙用于一线治疗mCRPC的II/III期临床试验申请已于近日获得美国食品药品监督管理局（FDA）批准。 KPG-121是CRBN E3泛素连接酶复合物CRL4CRBN调节剂，靶向诱导酪蛋白激酶1α（CK1α）和转录因子Aiolos（IKZF3）及Ikaros（IKZF1）的泛素化降解。KPG-121具有抑制细胞增殖和抗血管生成活性，以及增强免疫调节功能。与雄激素受体拮抗剂单独治疗相比，在异种移植模型中，KPG-121与雄激素受体拮抗剂（包括恩扎卢胺、阿比特龙、阿帕他胺或达罗他胺）联用时，可显著提高抗肿瘤作用。KPG-121与恩扎卢胺、阿比特龙或阿帕他胺联用治疗转移性和非转移性去势抵抗性前列腺的 I 期临床研究（NCT03569280) 已在美国完成，展现了良好的安全性、耐受性、药代动力学特征及积极的治疗效果。关于康朴生物康朴生物是一家处于临床阶段的创新型生物医药企业。立足创新驱动，聚焦癌症、自身免疫疾病、炎症等治疗领域，康朴生物以国际领先的新一代蛋白质泛素化及其降解技术NeoMIDES®和gDACs®、X-SYNERGY®等自主专利技术平台为基础，致力于开发面向全球、具有全球自主知识产权的小分子靶向免疫调节创新药物。

临床1期临床申请蛋白降解靶向嵌合体

2024-06-05

·PRNewswire

FDA Approved Phase II/III Clinical Study of KPG-121 in Combination with Abiraterone as a First Line Treatment for mCRPC

HEFEI, China, June 5, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of KPG-121 in combination with Abiraterone for a first-line treatment of metastatic castration resistant prostate cancer (mCRPC). Discovered by Kangpu Biopharmaceuticals, KPG-121 is a modulator of the Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN targeting rapid ubiquitination and degradation of casein kinase 1α (CK1α) and transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-121 promotes anti-proliferation and anti-angiogenesis activities and enhances immunomodulatory properties. KPG-121 significantly improves anti-tumor efficacies when combined with androgen-receptor antagonists including enzalutamide, abiraterone acetate, apalutamide, or darolutamide in xenograft models when compared to the androgen-receptor antagonist therapy alone. A Phase I study to evaluate the safety, pharmacokinetics, and efficacy of KPG-121 when combined with enzalutamide, abiraterone, or apalutamide for the treatment of patients with metastatic or non-metastatic castration-resistant prostate cancer was completed in the US (NCT03569280). KPG-121 was generally well tolerated and demonstrated a favorable pharmacokinetic profile as well as promising efficacy. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein ubiquitination and degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES®, gDACs®, and X-SYNERGY®. For more information, please visit . Contact: Florence Liu [email protected] SOURCE Kangpu Biopharmaceuticals

临床1期临床申请临床结果

100 项与达罗他胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11045	达罗他胺	L02BB06	DB12941

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
前列腺癌转移	日本	Bayer AG	2023-02-24
转移性去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2022-08-05
前列腺癌	巴西	Bayer AG	2020-01-01
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
复发性前列腺癌	临床3期	美国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	中国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	日本	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	澳大利亚	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	奥地利	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	比利时	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	巴西	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	加拿大	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	捷克	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	丹麦	Bayer AG	2023-04-03

登录后查看更多信息

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


ASCO2024	N/A	去势敏感前列腺癌	10	Darolutamide + Chemotherapy + ADT	淵構糧蓋窪製鹹壓鏇艱(鹽壓簾選膚鏇壓糧窪餘) = 5 patients (50%) presented asthenia 築壓鹹選繭顧繭範鹹壓 (築淵醖構鬱觸膚衊鹽糧 ) 更多	积极	2024-05-24
NCT02799602 (ARASENS, ASCO2024)	临床3期	激素依赖性前列腺癌	1,305	Darolutamide 600 mg	範積製築簾顧築選窪醖(廠衊鏇網淵壓鏇膚築窪) = 餘獵憲膚獵鏇衊憲襯廠醖範築鹹襯衊觸衊襯鏇 (繭淵淵醖選顧壓廠繭憲 )	积极	2024-05-24
				Placebo	範積製築簾顧築選窪醖(廠衊鏇網淵壓鏇膚築窪) = 鹹鹽範範艱艱醖壓遞獵醖範築鹹襯衊觸衊襯鏇 (繭淵淵醖選顧壓廠繭憲 )
NCT04122976 (DAROL, AUA2024)	N/A	去势抵抗性前列腺癌	550	Darolutamide	製衊製齋網鬱簾齋醖積(襯餘顧鑰餘糧淵膚餘壓) = 醖襯壓蓋憲繭觸鹹製憲蓋壓鏇構遞簾鹹淵觸窪 (簾壓憲鏇鑰築獵襯網積 ) 更多	积极	2024-05-01
MP60-18 (AUA2024)	N/A	去势敏感前列腺癌	319	DARO plus ADT (doublet therapy [DT])	網鏇網範齋顧網簾選鹹(艱鹹糧鬱衊憲鑰鏇鹹簾) = 願鹹顧憲衊觸觸獵選鹹蓋廠遞構衊遞鑰齋廠膚 (網遞網顧餘鹽觸廠製壓 ) 更多	积极	2024-05-01
ARASENS (ASCO_GU2024) 人工标引	临床3期	去势敏感前列腺癌	-	DarolutamiDocetaxeltaxel + ADT	觸夢鬱淵壓鬱鹹蓋獵艱(艱築淵選選鏇選夢餘築) = 廠襯網窪餘艱壓壓膚憲鬱範壓膚鬱鏇鏇簾窪遞 (窪鹽餘齋積淵簾簾齋夢, 6.54 ~ 9.14) 更多	积极	2024-01-25
				DarolutamidecetDocetaxelT	觸夢鬱淵壓鬱鹹蓋獵艱(艱築淵選選鏇選夢餘築) = 鏇顧壓醖積壓觸鹹觸鹹鬱範壓膚鬱鏇鏇簾窪遞 (窪鹽餘齋積淵簾簾齋夢, 4.92 ~ 6.96) 更多
ARASENS (ESMO_ASIA2023)	临床3期	转移性去势抵抗性前列腺癌	1,305	Darolutamide 600 mg	鬱糧構獵窪築蓋鑰選鏇(構齋糧觸鹹願簾淵窪膚): HR = 0.64 (95% CI, 0.41 ~ 0.99) 更多	积极	2023-12-02
				Placebo
NCT02799602 (ARASENS, ESMO2023)	临床3期	去势敏感前列腺癌	1,306	Darolutamide 600 mg	願製廠鑰廠獵鹽網窪餘(製憲製顧獵網壓築糧廠): HR = 0.2 (95% CI, 0.15 ~ 0.27) 更多	-	2023-10-22
				Placebo
NCT04157088 (CTgov)	临床2期	转移性去势抵抗性前列腺癌 \| 去势抵抗性前列腺癌	30	Darolutamide (Nubeqa, BAY1841788)	齋網築餘餘積餘淵衊夢(醖鹽顧蓋鹽網繭窪構構) = 憲襯繭製艱構選淵衊醖築網鏇鬱齋繭顧鑰膚夢 (築衊蓋鏇艱顧齋糧築觸, 願襯鏇蓋繭觸構築齋獵 ~ 糧廠鑰壓鑰艱蓋齋膚觸) 更多	-	2023-08-04
NCT02799602 (ARASENS, ASCO2023)	临床3期	去势敏感前列腺癌	1,305	Darolutamide + ADT + docetaxel	夢網遞齋夢蓋餘築選簾(壓繭鏇窪壓淵構範積製): 0.79 (95% CI, 0.66 ~ 0.95), P-Value = 0.006	积极	2023-05-31
				Placebo + ADT + docetaxel
DEAR (ASCO2023)	N/A	去势抵抗性前列腺癌	870	Darolutamide	鹹範鹹衊鹽選廠選廠築(遞憲襯齋願憲構網餘醖) = 鏇艱鏇夢築簾選夢觸簾壓艱餘製範繭獵鬱選獵 (餘壓選夢廠壓繭獵艱範 ) 更多	积极	2023-05-31
				Enzalutamide	鹹範鹹衊鹽選廠選廠築(遞憲襯齋願憲構網餘醖) = 遞醖齋構憲積鹽艱遞夢壓艱餘製範繭獵鬱選獵 (餘壓選夢廠壓繭獵艱範 ) 更多