恩扎卢胺(Enzalutamide) - 药物靶点：AR_在研适应症：前列腺癌，去势敏感前列腺癌，HRR 基因突变去势抵抗性前列腺癌_专利_临床

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxal in Patients With Metastatis Castration-Resistant Prostate Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

开始日期2026-03-31

申办/合作机构

Roche Holding AG

NCT06616155

/ Recruiting临床1/2期IIT

Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.

开始日期2026-01-30

申办/合作机构

Rogel Cancer Center: University of Michigan

[+1]

NCT07226986

/ Recruiting临床1/2期

A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.

开始日期2025-12-19

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与恩扎卢胺相关的临床结果

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100 项与恩扎卢胺相关的转化医学

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100 项与恩扎卢胺相关的专利（医药）

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3,817

项与恩扎卢胺相关的文献（医药）

2026-02-01·Materials Today Bio

Daidzein-engineered high-accumulation self-therapeutic nanoplatform drives androgen receptor degradation via ubiquitination-proteasome system to overcome enzalutamide resistance in castration-resistant prostate cancer

Article

作者: Li, Xinyin ; Wu, Jun ; Zhao, Yi ; Dai, Chunlei ; Xie, Zhaoxiang ; Wang, Liying ; Xie, Junjia ; Li, Minghui ; Huang, Hai ; Xiong, Zhi ; Li, Kaiwen

High levels of androgen receptor (AR) are associated with poor prognosis and drug resistance in castration-resistant prostate cancer (CRPC), and monotherapy with AR antagonists such as enzalutamide (Enz) is currently inadequate to meet the clinical needs. Dual-targeted therapeutic strategy of AR degradation combined with AR inhibition is a promising strategy to improve the efficacy and to address the problem of drug resistance in CRPC, thus the development of safer, stable, and effective agents with AR-degrading activity is urgent. In our study, we found that daidzein, a phytoestrogen, could reduce the risk of prostate cancer, exhibited a good affinity for AR and down-regulated AR levels. Consequently, we developed daidzein-based, redox-responsive self-therapeutic nanocarriers to deliver Enz (D44DA@Enz NPs) to realize the dual-targeted therapeutic strategy against AR in CRPC. The results showed that D44DA NPs facilitated AR degradation via the ubiquitin-proteasome pathway, which combined with the inhibitory effect of Enz on AR nuclear translocation greatly improved the efficacy against CRPC. In vivo studies, D44DA NPs demonstrated approximately 40-fold increased enrichment at the tumor site, exhibited excellent self-antitumor activity and synergistically enhanced the therapeutic effects of Enz with minimal toxic side effects. In summary, this study provides a highly promising AR-degrading active nanoplatform and dual-targeted AR therapeutic strategy for the treatment of CRPC.

2026-02-01·Non-coding RNA Research

Circadian rhythm-related miR-6883-5p suppresses enzalutamide-resistant prostate cancer

Article

作者: Hou, Jianquan ; Figueiro, Mariana G ; Padanilam, Babu J ; Yue, Wenchang ; Li, Chao ; You, Jiawei ; Natasha, Kyprianou ; Liu, Jiapeng ; Tewari, Ashutosh K ; Wang, Tao ; Sun, Jiale

The increasing incidence of prostate cancer (PCa), particularly the emergence of treatment-resistant castration-resistant prostate cancer (CRPC), has intensified research efforts to address this lethal disease. Circadian rhythm gene alterations have been identified as critical factors influencing PCa progression and treatment resistance, warranting further investigation into their roles in PCa biology. In this study, we identified a significant downregulation of PER1 and its associated miRNA, miR-6883-5p, in PCa cells and clinical samples, suggesting their potential clinical relevance. Functional analyses demonstrated that miR-6883-5p suppresses the proliferation of enzalutamide-resistant PCa cells both in vitro and in vivo by directly targeting AR-V7. Furthermore, we delineated the regulatory functions of the transcription factors BMAL1 and CLOCK in promoting the expression of PER1 and miR-6883-5p, while miR-6883-5p negatively regulates CLOCK expression, thereby impacting the transcription-translation feedback loop (TTFL) of circadian genes. Collectively, these findings uncover a regulatory axis involving circadian rhythm components, miR-6883-5p, AR-V7, and PCa progression, providing new mechanistic insights into treatment resistance in CRPC and highlighting the circadian clock as a potential therapeutic target.

2026-02-01·Bioactive Materials

Biomimetic bone niche reconstructs proliferation-inhibited and therapy-resistant bone-metastatic prostate cancer

作者: Fu, Xihong ; Chen, Lianheng ; Luo, Yu ; Liu, Chun ; Zhao, Ying ; Huang, Jianfeng ; Peng, Zhongte ; Zou, Xuenong ; Peng, Xinsheng ; Lin, Qijun ; Liu, Huiling ; Chen, Xin ; Peng, Yujiao ; Yang, Lei

Prostate cancer bone metastases often harbor a rare subset of tumor cells with suppressed proliferation, contributing to therapy resistance and disease relapse. However, the lack of physiologically relevant in vitro models has hindered mechanistic and therapeutic advances. Here, we engineered a 3D bone-like microenvironment by integrating calcium phosphate scaffolds, decellularized extracellular matrix (dECM), mesenchymal stem cells (MSCs), and osteoblasts. This biomimetic niche induced a proliferation-inhibited state in prostate cancer cells, closely mirroring transcriptomic signatures identified from patient-derived single-cell RNA sequencing datasets. Tumor cells in this niche also displayed enzalutamide resistance, accompanied by metabolic reprogramming and activation of pro-survival signaling. This platform provides a clinically relevant tool for modeling bone metastatic prostate cancer and accelerating the development of therapies targeting resistant tumor states.

1,454

项与恩扎卢胺相关的新闻（医药）

2026-01-09

·微雅集

▶【盘点】影像见微，探针致远：复肿核医学科2025科研进展

复旦大学附属肿瘤医院核医学科是“上海分子影像探针工程技术研究中心”及市科委新型放射性药物研发与应用评价平台，具备放射性药品IV类资质，已推动50余种新型分子影像探针临床转化。科室聚焦肿瘤精准诊疗的迫切需要，借助核医学分子探针的优势，已经形成鲜明的核医学分子探针研发与转化的优势与特色。近年来在人才梯队、国家级/省部级科研项目、GCP临床研究、国际高水平论文、专利与成果转化方面持续取得进展，学科影响力稳步提升。继往开来，深耕不辍。2025年，我科在分子影像与精准诊疗领域再结硕果，多项研究实现从基础到临床的关键突破。特此遴选十篇代表性工作，以飨读者。一：J Nucl Med｜Nectin-4靶向PET新探针Ga-68-FZ-NR-1实现TNBC的“首次人体”评价。 Nectin-4 是三阴性乳腺癌（TNBC）的新兴诊疗生物标志物。复旦肿瘤医院团队基于环肽结构设计并合成了多种 Nectin-4 靶向Ga-68 标记PET示踪剂（Ga-68-FZ-NR-1/2/3），经体外与动物模型系统筛选后确定Ga-68-FZ-NR-1作为候选探针，表现出更优的靶向效率、良好的药代与安全性；进一步在 9 例 TNBC 的首次人体探索中，Ga-68-FZ-NR-1 PET/CT 可稳定显示肿瘤病灶，与 F-18-FDG 的病灶检出相互印证，并与活检免疫组化的 Nectin-4 高表达相一致，为 TNBC 的 Nectin-4 无创分层评估及靶向治疗人群筛选提供了可转化的分子影像工具依据。第一作者：孙犁，2023级博士后。原文链接：https://pubmed.ncbi.nlm.nih.gov/39947908/ 二：EJNMMI｜Nectin-4靶向放射性配体[Ga-68]Ga-FZNR-1在胰腺导管腺癌（PDAC）中完成头对头PET/CT验证，实现Nectin-4表达的无创定量与分期增益本研究针对PDAC患者开展Nectin-4 靶向PET探针 [Ga-68]Ga-FZNR-1 的前瞻性临床探索。结果显示，[Ga-68]Ga-FZNR-1 在远处转移诊断上呈现更高的特异度与准确度。更重要的是，该探针还能够定量评估Nectin-4表达。因此，[Ga-68]Ga-FZNR-1 PET显像既可以作为PDAC患者重要的伴随诊断工具，又可以对Nectin-4 表达进行全身无创定量监测，用于患者分层与疗效/预后评估。第一作者：姜春娟，博士，复旦大学附属肿瘤医院核医学科副主任医师。原文链接：https://pubmed.ncbi.nlm.nih.gov/41134323/ 三：Granzyme B PET/CT预测微卫星稳定型胃癌患者化疗联合免疫治疗疗效的临床价值近年来，颗粒酶B（Granzyme B，GzmB）靶向成像已成为监测免疫治疗疗效的前沿方向。复旦肿瘤医院在该领域有深厚积累，前期首创研发有自主知识产权的专利（GZB），并初步探讨其应用价值，成果发表在权威期刊（Adv Sci.2021;8:e2102500，Eur J Nucl Med Mol Imaging. 2023;50:275-286）。在免疫监测疗效领域，团队的新型GzmB靶向探针[68Ga]Ga-NOTA-GSI，在胃癌患者中初步证实了其临床价值（J Nucl Med. 2024,65(11):1695-1701）。本次研究深度验证[68Ga]Ga-NOTA-GSI PET/CT在胃癌精准诊疗中的作用，系统评估其在微卫星稳定型胃癌患者化疗联合免疫治疗中的预测价值。研究结果表明，治疗后肿瘤[68Ga]Ga-NOTA-GSI的摄取水平与治疗应答呈正相关，摄取越高，疗效越好；其中，SUVmax ≥ 2.6可作为独立预测指标，提示患者无进展生存期显著延长。此外，该探针在新辅助、辅助及姑息治疗多种临床场景中均表现出良好的稳定性与可靠性，为个体化疗效评估与治疗策略的动态调整提供了有力的影像学依据，具有广阔的临床转化前景。第一作者，刘秋芳，博士，复旦大学附属肿瘤医院核医学科主治医师。四：J Med Chem｜首个CTSD靶向Ga-68 PET示踪剂用于乳腺癌分子影像本研究针对肿瘤进展关键生物标志物——溶酶体天冬氨酸蛋白酶Cathepsin D（CTSD），开发了首款靶向放射性示踪剂。优选化合物[Ga-68]Ga-NOTA-FZCD-3具有以下特性：高亲和力（KD=0.65μM）与快速代谢（t1/2=16.61min）；肿瘤特异性摄取（乳腺癌MDA-MB-175VII模型1h摄取3.63%ID/g，T/NT=7.65）；稳定性与安全性（血液>2h稳定，无毒性信号）。该示踪剂展现出肿瘤早期检测、分层及疗效监测的转化价值。第一作者：席悦，2025届博士毕业生。原文链接：https://doi.org/10.1021/acs.jmedchem.5c02151 五：J Med Chem｜CDK4/6靶向PET示踪剂用于乳腺癌CDK4/6抑制剂敏感性无创评估本研究针对乳腺癌 CDK4/6 抑制剂（palbociclib 为代表）临床应答 / 耐药痛点，开发验证 PET 示踪剂 [Ga-68] Ga-DOTA-Bua-CDKi，用于无创筛选敏感患者、指导个体化治疗。采用 “构象非限制” 设计，通过柔性烷基链连接 DOTA-Ga-68 与药物母核以尽量保留与靶蛋白结合并优化体内理化性质;在敏感性递减乳腺癌细胞系及移植瘤模型中验证。结果显示探针可 PET/CT 区分高敏感模型（MCF-7 移植瘤 60min 摄取 8.40±0.85 % D/g，三模型摄取差异显著），摄取具特异性并完成了初步生物安全性评估，支持其作为疗效敏感评估型分子影像工具的转化潜力。第一作者：吉梦静，2025届硕士毕业生。原文链接：https://doi.org/10.1021/acs.jmedchem.4c02672 六：Theranostics｜CCK2R靶向新型诊疗探针推动NET核素诊疗转化本团队针对神经内分泌肿瘤高表达靶点CCK2R，原创设计了二聚体诊疗探针DOTA-CCK2R-dimer，实现了“一探针双核素”诊疗一体化（Ga-68用于PET显像、Lu-177用于核素治疗）。相比单体探针，该二聚体在体内具有更优的肿瘤靶向性与滞留能力。治疗上，Lu-177标记的二聚体能选择性清除高增殖、低分化肿瘤亚群；联合mTOR抑制剂RAD001后，通过抑制谷胱甘肽解毒通路、增强氧化应激，进一步协同增效，并提示GSTK1为潜在放射敏感性调控分子。该研究为CCK2R阳性难治性神经内分泌肿瘤提供了新的精准诊疗联合策略。第一作者：卞琳杰，2023级在读博士。原文链接：https://www.thno.org/v15p9306.htm 七：EJNMMI｜新型AR靶向PET探针（[Ga-68]Ga-DOTA-FZAR-2）完成从动物到首次人体验证本研究成功开发了基于恩杂鲁胺的系列Ga-68标记PET探针，用于前列腺癌雄激素受体（AR）显像。临床前研究证实了其对AR的特异性靶向。其中，优选探针[Ga-68]Ga-DOTA-FZAR-2在首次人体试验（8例前列腺癌患者）中表现出良好的安全性，并于给药后1h达到较优显像窗口（SUVmean约2.84，肿瘤/肌肉比约7.97），展现了其在无创监测与评估前列腺癌AR表达中的临床转化潜力。第一作者：林纾怡，2023级在读硕士。原文链接：https://pubmed.ncbi.nlm.nih.gov/40986091/ 八：EJNMMI｜AG10改造PSMA-617（AP-01）显著延长循环半衰期并提升中等PSMA表达肿瘤的诊疗效能该研究围绕“如何提高核素治疗药物对PSMA中度阳性肿瘤的治疗效果”这一科学问题展开。AG10通过赖氨酸连接臂偶联PSMA-617，获得AP-01。AP-01与PSMA-617具有相当的体外亲和力（IC50≈3.42 nM）。但是经过AG10优化后，AP-01的体内循环半衰期明显延长（55.03 min vs 16.00 min），68Ga-AP-01与68Ga-PSMA-617经尾静脉注射4h后，PSMA中度阳性的22Rv1皮下瘤模型对二者的摄取分别为（18.07 %ID/g vs 9.27 %ID/g），Lu-177-AP-01与Lu-177-PSMA-617经尾静脉注射后，22Rv1皮下瘤模型中，最高靶本比分别为（49.28 vs 8.39）。由于肿瘤摄取的提高，177Lu-AP-01的肿瘤抑制效率明显高于Lu-177-PSMA-617（88.63% vs 73.36%）。第一作者：刘毅，博士，复旦大学附属肿瘤医院核医学科规培医生。原文链接：https://link.springer.com/article/10.1007/s00259-025-07704-2 九：EJNMMI｜ENT1靶向尿苷转运PET/NIR-II双模态平台用于精准诊断与术中导航针对ENT1（SLC29A1）介导的尿苷转运缺乏高灵敏度成像工具的问题，研究构建了双探针平台：[Ga-68]Ga-DOTA-FZUD 用于PET代谢成像，ICG-FZUD 用于NIR-II荧光术中导航。该平台在多种肿瘤模型中表现出与ENT1表达一致的摄取差异（如ENT1较高的胰腺癌模型AsPC-1/Panc-1摄取更高），肿瘤/肌肉比稳定>3.5；NIR-II成像可清晰勾勒肿瘤边界，并展示穿越血脑屏障实现原位胶母瘤可视化；同时在人胃癌切除标本离体成像中也验证了选择性摄取与病理一致性，提示具备“诊断—导航”一体化转化潜力。第一作者：卞琳杰，2023级在读博士。原文链接：https://pubmed.ncbi.nlm.nih.gov/40991020/ 十：J Med Chem｜Linker驱动的FAPI三聚体突破——Ga-68/Lu-177-DOTA-FAPI-FUSCC-Tri 显著提升肿瘤摄取与滞留，实现FAP阳性肿瘤诊疗一体化围绕FAP靶向探针“多价化”策略的关键瓶颈（空间位阻与药代学），研究原创设计新型三聚体linker（FUSCC），构建 Ga-68/Lu-177-DOTA-FAPI-FUSCC-Tri 并系统评估。该三聚体相较单体表现出更强FAP结合亲和力（0.621 vs 3.5 nM）、肿瘤摄取提升约3.5倍且肿瘤滞留显著延长；同时作为首批Ga-68标记FAPI三聚体完成体内验证，并进一步探索Lu-177标记的放射性配体治疗，在FAP阳性模型中显示明确的抗肿瘤效应，为FAP靶向“显像+治疗”一体化提供了可推广的新范式。第一作者：程华，2023级博士后。原文链接：https://doi.org/10.1021/acs.jmedchem.5c01873 END 编辑:唐亦睿初审:杨忠毅审核:宋少莉【微雅集公众号】•第1443期

2026-01-09

·和泽医药

喜报 | 和泽医药持续助力多个项目获批

2026开新局，喜讯启新章。和泽医药实力护航，以专业赋能助力多家合作伙伴项目获批。热/烈/祝/贺 CELEBRATE GOOD NEWS 恩扎卢胺软胶囊和泽医药助力合作伙伴嘉亨（珠海横琴）医药科技有限公司持有的恩扎卢胺软胶囊按化学药品4类顺利获批。恩扎卢胺软胶囊由Medivation公司和安斯泰来（Astellas）公司合作开发，于2012年8月31日经美国食品药品管理局（FDA）批准用于治疗已扩散或复发的晚期男性去势耐受前列腺癌（castration-resistant prostate cancer），商品名为Xtandi，规格为40mg。原研于2019年11月进入国内市场，适应症为用于有高危转移风险的非转移性去势抵抗性前列腺癌（NM-CRPC）成年患者；雄激素剥夺治疗（ADT）失败后无症状或有轻微症状且未接受化疗的转移性去势抵抗性前列腺癌（CRPC）成年患者的治疗。富马酸伏诺拉生片和泽医药助力合作伙伴裕松源药业有限公司持有的富马酸伏诺拉生片按化学药品4类顺利获批。富马酸伏诺拉生片适用于反流性食管炎；与适当的抗生素联用以根除幽门螺杆菌。伏诺拉生以钾离子竞争性方式可逆性抑制H+、K+-ATP酶活性，可长时间停留于胃壁细胞部位而抑制胃酸的生成，可有效抑制胃肠道上部粘膜损伤的形成。地屈孕酮片和泽医药助力合作伙伴桂林朗科制药有限公司持有的地屈孕酮片按化学药品4类顺利获批。地屈孕酮是一种口服可吸收的合成孕激素，可使子宫内膜进入分泌期，从而预防由雌激素诱导的子宫内膜增生和/或癌变增加的风险。地屈孕酮不具有雌激素、雄激素、合成代谢和皮质激素性质。地屈孕酮可用于治疗内源性孕酮不足引起的疾病，如痛经、子宫内膜异位症、继发性闭经、月经周期不规则、功能失调性子宫出血、经前期综合征、孕激素缺乏所致先兆性流产或习惯性流产、黄体不足所致不孕症用于辅助生殖技术中的黄体支持。硫酸阿托品注射液和泽医药助力合作伙伴西安利君制药有限责任公司持有的硫酸阿托品注射液顺利获批，并通过一致性评价。硫酸阿托品注射液由田辺三菱製薬株式会社/ニプロESファーマ株式会社研发，于1947年11月在日本上市。临床上用于各种内脏绞痛，如胃肠绞痛及膀胱刺激症状；全身麻醉前给药，严重盗汗和流涎症；迷走神经过度兴奋所致的窦房阻滞、房室阻滞等缓慢型心律失常，也可用于继发于窦房结功能低下而出现的室性异位节律；抗休克；以及解救有机磷酸酯类中毒。注射用哌拉西林钠和泽医药助力合作伙伴国药集团威奇达药业有限公司持有的注射用哌拉西林钠成功通过一致性评价。注射用哌拉西林钠适用于敏感肠杆菌科细菌、铜绿假单胞菌、不动杆菌属所致的败血症、上尿路及复杂性尿路感染、呼吸道感染、胆道感染、腹腔感染、盆腔感染以及皮肤、软组织感染等。哌拉西林与氨基糖苷类联合应用亦可用于有粒细胞减少症免疫缺陷病人的感染。 END

2026-01-09

·BioSpace

Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer

Fast Track Designation Highlights Potential of Enolen to Address Unmet Medical Need for Patients with Low to Intermediate Risk, Localized Prostate Cancer Company Expects to Provide Initial Findings from Enolen’s Phase 1 Trial Later This Year SAN CARLOS, Calif.--(BUSINESS WIRE)-- Alessa Therapeutics (“Alessa”), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Enolen ® , the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer. Fast Track designation is granted by the FDA to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. “Receiving Fast Track designation for Enolen is further evidence of the urgent need for new treatment options for early-stage prostate cancer. Patients living with prostate cancer deserve an alternative to active surveillance or being faced with the considerable negative side effects common with the more aggressive treatment options available today,” said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. “We will continue to collaborate closely with the FDA to advance a new treatment option for men suffering not only from the disease itself, but who often face a heavy burden in deciding between not treating their cancer or pursuing therapies with significant health and lifestyle consequences.” Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the potential side effects of systemic anti-androgen and testosterone-lowering drugs, including sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events. Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the potential negative side effects which can result from systemic exposure. Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to present initial findings from the study in 2026. About Alessa Therapeutics Alessa Therapeutics is a clinical-stage biopharmaceutical company pioneering a proprietary drug-delivery technology platform for the sustained and localized release of clinically proven prostate cancer therapies. Developed by Dr. Pamela Munster and her team at the University of California, San Francisco, Alessa’s patented drug-eluting implants, each about the size of a grain of rice, can provide two or more years of continuous drug elution directly to diseased tissue, thus eliminating the side effects that can result from systemic exposure to certain prostate cancer drugs. Alessa is advancing a pipeline of drug-eluting implants, initially focused on prostate cancer, with the Company’s lead clinical program, Enolen ® , currently being studied in a Phase 1 clinical trial for the treatment of low to intermediate risk, localized prostate cancer. Founded in 2018, Alessa is backed by leading healthcare investors including Cure Ventures and Mission BioCapital. Learn more at alessatherapeutics.com. Contacts Media Contact Rachel Ford Hutman Rachel@fordhutmanmedia.com (301) 801-5540

快速通道临床1期

100 项与恩扎卢胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10218	恩扎卢胺	L02BB04	DB08899

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
前列腺癌	韩国	Astellas Pharma Korea, Inc.	2024-12-03
去势敏感前列腺癌	美国	Astellas Pharma US, Inc.	2023-11-16
HRR 基因突变去势抵抗性前列腺癌	美国	Pfizer Inc.	2023-06-20
转移性前列腺癌	日本	Astellas Pharma, Inc.	2020-05-29
去势抵抗性前列腺癌	欧盟	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	冰岛	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	列支敦士登	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	挪威	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	欧盟	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	冰岛	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	列支敦士登	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	挪威	Astellas Pharma Europe Ltd.	2013-06-21
转移性去势抵抗性前列腺癌	美国	Astellas Pharma US, Inc.	2012-08-31

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
晚期三阴性乳腺癌	临床3期	美国	Astellas Pharma, Inc.	2016-09-01
晚期三阴性乳腺癌	临床3期	美国	Pfizer Inc.	2016-09-01
晚期三阴性乳腺癌	临床3期	美国	MediVation, Inc.	2016-09-01
前列腺腺癌	临床3期	美国	Astellas Pharma US, Inc.	2014-01-22
前列腺腺癌	临床3期	美国	MediVation, Inc.	2014-01-22
前列腺腺癌	临床3期	加拿大	MediVation, Inc.	2014-01-22
前列腺腺癌	临床3期	加拿大	Astellas Pharma US, Inc.	2014-01-22
复发性前列腺癌	临床3期	美国	Astellas Pharma US, Inc.	2014-01-22
复发性前列腺癌	临床3期	美国	MediVation, Inc.	2014-01-22
复发性前列腺癌	临床3期	加拿大	Astellas Pharma US, Inc.	2014-01-22

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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


NCT02319837 (EMBARK, Pubmed \| J Urol)	临床3期	非转移性前列腺癌	468	Enzalutamide plus leuprolide	膚範醖鏇廠蓋餘網製蓋(鏇鹹膚顧選淵鑰網鹹餘) = 積觸範簾廠選壓鹹膚觸鏇製憲齋構積衊顧壓願 (醖醖網鏇願艱衊憲鬱觸, 83.0 ~ 90.4) 更多	积极	2025-12-17
				Enzalutamide monotherapy	膚範醖鏇廠蓋餘網製蓋(鏇鹹膚顧選淵鑰網鹹餘) = 窪範簾願夢製鑰簾築鏇鏇製憲齋構積衊顧壓願 (醖醖網鏇願艱衊憲鬱觸, 85.6 ~ 92.4) 更多
NCT03751436 (Pubmed \| Cancer Chemother Pharmacol)	临床1期	转移性去势抵抗性前列腺癌 BCL-2	10	Enzalutamide (160 mg/d) with Venetoclax (metastatic castration-resistant prostate cancer)	鏇糧艱鑰餘壓簾積蓋繭(網網鹽鹹餘壓遞獵簾簾) = 餘糧壓窪蓋衊衊淵壓襯獵襯顧襯網蓋網鑰築膚 (壓衊繭繭鹽願繭願鏇鹽, 1 ~ 35) 更多	积极	2025-12-01
NCT02203695 (SALV-ENZA, CTgov)	临床2期	非转移性前列腺癌 \| 前列腺腺癌	86	Enzalutamide (SRT Plus Enzalutamide)	蓋製鑰醖壓獵簾網餘觸 = 製餘鬱遞糧築鹽鹹遞壓鏇簾簾襯齋構壓齋網構 (襯選鏇範鹽衊齋選衊衊, 醖糧糧憲膚範範膚繭壓 ~ 觸製獵醖網艱鬱範襯積) 更多	-	2025-10-24
				SRT (SRT Plus Placebo)	蓋製鑰醖壓獵簾網餘觸 = 艱壓築遞窪築製積衊壓鏇簾簾襯齋構壓齋網構 (襯選鏇範鹽衊齋選衊衊, 壓窪顧窪製選糧積顧構 ~ 願憲製構膚艱艱顧窪淵) 更多
NCT02319837 (EMBARK, N Engl J Med \| Company_Website \| ESMO2025) 人工标引	临床3期	非转移性前列腺癌	1,068	Enzalutamide + Leuprolide	餘選觸鬱構糧蓋齋糧鹹(衊襯築襯鬱積憲鹹觸鑰) = 選艱築糧積願壓衊憲夢鹹遞齋蓋鹹蓋繭鹽範艱 (糧醖遞齋製鑰蓋製簾願, 73.9 ~ 83.1)	积极	2025-10-19
				Enzalutamide monotherapy	餘選觸鬱構糧蓋齋糧鹹(衊襯築襯鬱積憲鹹觸鑰) = 憲壓鏇膚遞憲壓積選鏇鹹遞齋蓋鹹蓋繭鹽範艱 (糧醖遞齋製鑰蓋製簾願, 67.6 ~ 77.9)
NCT02319837 (EMBARK, Pubmed \| N Engl J Med)	临床3期	非转移性前列腺癌	823	Enzalutamide plus leuprolide	鹽襯願壓醖醖鬱遞獵醖(窪獵壓襯願窪衊鬱蓋膚) = 糧壓鑰衊選壓窪網鑰觸製獵獵鬱繭夢鬱鹹觸顧 (簾蓋鹹蓋蓋鑰蓋築鏇憲, 73.9 ~ 83.1)	积极	2025-10-19
				Leuprolide alone	鹽襯願壓醖醖鬱遞獵醖(窪獵壓襯願窪衊鬱蓋膚) = 選網鑰窪願願築醖窪壓製獵獵鬱繭夢鬱鹹觸顧 (簾蓋鹹蓋蓋鑰蓋築鏇憲, 64.0 ~ 74.3)
NCT02446405 (ENZAMET, ESMO2025)	临床3期	激素依赖性前列腺癌	1,125	Docetaxel + Enzalutamide	鑰夢觸願鑰網壓繭願糧(遞憲窪觸範醖壓夢積淵): HR = 1.02 (95.0% CI, 0.92 ~ 1.12), P-Value = 0.72	不佳	2025-10-17
				No Docetaxel + Enzalutamide
NCT02319837 (EMBARK, ESMO2025)	临床3期	前列腺癌	1,138	Enzalutamide + Leuprolide	餘壓鑰糧觸膚膚築夢鹽(願齋蓋壓鏇廠鏇顧鬱壓) = 壓獵願壓餘憲夢艱構網鹽鹽範衊積鑰簾鏇範蓋 (艱蓋夢構築鬱壓糧淵鹹 ) 更多	积极	2025-10-17
				Leuprolide	餘壓鑰糧觸膚膚築夢鹽(願齋蓋壓鏇廠鏇顧鬱壓) = 鬱糧簾憲簾衊鹽壓願衊鹽鹽範衊積鑰簾鏇範蓋 (艱蓋夢構築鬱壓糧淵鹹 ) 更多
NCT02319837 (EMBARK, ESMO2025)	临床3期	非转移性前列腺癌	1,068	Enzalutamide + Leuprolide	選膚壓廠觸獵淵廠醖願(淵顧齋壓膚顧簾齋壓鑰): HR = 0.597 (95.0% CI, 0.444 ~ 0.804), P-Value = 0.0006 更多	积极	2025-10-17
				Leuprolide
ESMO2025	N/A	去势敏感前列腺癌	455	Darolutamide + Docetaxel	齋鑰窪簾夢網鏇襯壓積(壓鏇選衊鏇淵獵壓簾獵) = 窪構觸遞鹽膚衊鏇襯獵簾齋鹽繭淵廠製衊鹹夢 (夢製窪積衊積網顧鏇鬱 )	积极	2025-10-17
				Apalutamide	齋鑰窪簾夢網鏇襯壓積(壓鏇選衊鏇淵獵壓簾獵) = 選蓋積衊遞築醖繭夢鹹簾齋鹽繭淵廠製衊鹹夢 (夢製窪積衊積網顧鏇鬱 )
NCT00268476 (STAMPEDE, ESMO2025)	临床3期	激素依赖性前列腺癌	6,292	ADT alone (M0)	願艱廠衊蓋膚襯衊艱獵(鑰窪窪淵選夢遞蓋鏇齋) = 糧顧醖鑰簾壓齋構蓋遞衊遞遞顧齋鏇選糧夢製 (廠顧鏇獵衊艱憲膚窪鬱, 12 ~ 22) 更多	不佳	2025-10-17
				ADT alone (M1)	願艱廠衊蓋膚襯衊艱獵(鑰窪窪淵選夢遞蓋鏇齋) = 齋觸憲餘積膚鑰廠蓋構衊遞遞顧齋鏇選糧夢製 (廠顧鏇獵衊艱憲膚窪鬱, 5 ~ 10)