DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07450599

/ Not yet recruiting临床2期

CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer

Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.
The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.
The main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).
The study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.
Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.
2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.
During the study, the doctors and their study team will:
* take blood and urine samples
* check the participants' health parameters
* do physical examinations
* check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
* take tumor samples
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
About 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.

开始日期2026-04-15

申办/合作机构

Bayer AG

NCT07476677

/ Not yet recruiting临床2期IIT

A Phase II Prospective, Open-Label Clinical Study of Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer

This is a two-Parallel cohort, prospective study, aimed to explore Efficacy and safety of neoadjuvant Darolutamide with or without ADT in high-risk/very high-risk localized-stage prostate cancer. Two parallel cohorts will enroll 30 patients with high-risk/very high-risk localized-stage prostate cancer according to the criteria, respectively. Eligible patients in cohort 1 will receive 600 mg of Darolutamide orally daily, and patients in cohort 2 will receive 600 mg of Darolutamide orally daily combined with ADT. The selection of the two parallel cohorts will be determined by the clinician. Considering that ADT treatment will bring typical adverse-reactions such as hot flashes, gynecomastia, fatigue, and sexual dysfunction, the clinician will decide the enrollment cohort based on the patient's specific clinical condition. After both cohorts receive 3-6 months of neoadjuvant treatment, these patients will receive robotic-assisted laparoscopic prostatectomy (RALP) ± standard lymph node dissection (LND), and the specific surgical plan will be formulated by the clinician. Patients will receive postoperative adjuvant therapy as same as the original prescription according to different conditions (the application of postoperative adjuvant radiotherapy is determined by the clinician). Follow-up: (1) PSA and testosterone levels: Monitor monthly for the first 6 months. Monitor every 3 months within 2 years. Monitor every 6 months thereafter. (2) Radiological evaluation: Monitor every 6 minutes within 2 years after surgery, and every 12 minutes thereafter.

开始日期2026-04-01

申办/合作机构

中国医学科学院肿瘤医院

100 项与达罗他胺相关的临床结果

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100 项与达罗他胺相关的转化医学

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100 项与达罗他胺相关的专利（医药）

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481

项与达罗他胺相关的文献（医药）

2026-04-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Progression-free survival with darolutamide and docetaxel vs. androgen receptor pathway inhibitors vs. docetaxel in metastatic hormone-sensitive prostate cancer: A real-world multicenter retrospective study

Article

作者: Schlack, Katrin ; Seitz, Anna Katharina ; Kappler, Paula ; Darr, Christopher ; Schnabel, Marco J ; Cathomas, Richard ; Paffenholz, Pia ; Steinestel, Julie ; Müller, Marten ; Unland-Gies, Daniel ; Rinderknecht, Emily ; Burger, Maximilian ; Richter, Julika ; Bielstein, Gloria ; Breyer, Johannes ; Heidegger, Isabel ; Bastian, Julius L D

BACKGROUND AND OBJECTIVE:

In metastatic hormone-sensitive prostate cancer (mHSPC), first-line treatment with either docetaxel + androgen deprivation therapy (ADT) or androgen receptor pathway inhibitors (ARPI) + ADT represented the standard of care. Triplet therapy (docetaxel + ARPI + ADT) has shown superiority over docetaxel + ADT, leading to regulatory approval. However, real-world data directly comparing ARPI + ADT and triplet therapy are lacking. This study evaluates real-world outcomes across 3 treatment regimens using inverse probability of treatment weighting (IPTW).

METHODS:

We retrospectively analyzed data from 13 centers of men with mHSPC treated with docetaxel + ADT, ARPI (apalutamide or enzalutamide) + ADT, or darolutamide + docetaxel + ADT. The primary endpoint was progression-free survival (PFS); secondary endpoints included adverse events. To address baseline imbalances, IPTW was employed. Time-to-event data were analyzed using weighted Cox proportional hazards regression with robust variance estimation.

RESULTS:

After excluding incomplete cases, 346 men were analyzed: 58 (16.8%) received docetaxel + ADT, 203 (58.7%) ARPI + ADT, and 85 (24.6%) triplet therapy. Before weighting, triplet patients demonstrated more adverse baseline features. After achieving covariate balance through IPTW adjustment, no significant differences in PFS were observed, with hazard ratios of 1.60 (95% CI: 0.78-3.28, P = 0.20) for docetaxel + ADT and 0.70 (95% CI: 0.36-1.35, P = 0.29) for ARPI + ADT compared to triplet therapy. Grade ≥3 adverse events occurred in 36.2%, 10.9%, and 31.8% of patients, respectively (P < 0.001).

CONCLUSIONS:

In this IPTW-adjusted real world cohort, triplet therapy was not significantly associated with improved PFS compared to ARPI + ADT or docetaxel + ADT. These findings should be interpreted in the context of limited sample size and follow-up, and further prospective studies are warranted.

2026-03-01·EUROPEAN JOURNAL OF CANCER

Use of concomitant G-CSF in maintaining efficacious dose and safe delivery of docetaxel in combination with darolutamide in ARASENS: A phase III study

Article

作者: Tombal, Bertrand ; Verholen, Frank ; Hussain, Maha ; Fizazi, Karim ; Ong, Michael ; Smith, Matthew ; Lalani, Aly-Khan A ; Suzuki, Hiroyoshi ; Srinivasan, Shankar ; Saad, Fred ; Pham, Ha

BACKGROUND:

We assessed the impact of granulocyte colony-stimulating factor (G-CSF) use and docetaxel relative dose intensity (RDI) on the safety profile of the ARASENS (NCT02799602) triplet regimen with darolutamide in patients with metastatic hormone-sensitive prostate cancer.

METHODS:

Patients were randomized to darolutamide 600 mg orally twice daily or placebo, with androgen deprivation therapy (ADT) and docetaxel. Baseline characteristics, G-CSF use, and safety were analyzed according to docetaxel RDI (≤85 % vs >85 %).

RESULTS:

Of 1273 patients with docetaxel RDI data (darolutamide n = 637; placebo n = 636), > 97 % received an efficacious dose of docetaxel (RDI >80 %). Patient demographics and baseline disease characteristics were generally similar between RDI subgroups; > 60 % of patients with RDI ≤ 85 % were from the Asia-Pacific region. Concomitant G-CSF, with/without docetaxel dose modification, was used in 42.4 % (darolutamide) and 44.6 % (placebo) of patients, mainly as secondary prophylaxis; 61.3 % (darolutamide) and 64.4 % (placebo) received both docetaxel dose modifications and G-CSF. Grade ≥ 3 treatment-emergent adverse events (TEAEs), grade ≥ 3 neutropenia, and grade ≥ 3 febrile neutropenia were higher with docetaxel RDI ≤ 85 %, but docetaxel discontinuation rates were similar between subgroups (RDI ≤85 %: darolutamide 7.2 %, placebo 10.8 %; RDI >85 %: darolutamide 8.1 %, placebo 10.5 %). TEAEs leading to docetaxel dose modification were more frequent with docetaxel RDI ≤ 85 % (darolutamide 92.8 %; placebo 97.3 %) versus RDI > 85 % (darolutamide 26.0 %; placebo 25.3 %).

CONCLUSION:

Appropriate docetaxel dose modifications and early G-CSF use allowed almost all patients to receive an efficacious dose of docetaxel in combination with darolutamide and ADT and may prevent neutropenic complications in patients receiving docetaxel.

PRIOR PRESENTATION:

Previously presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium, San Francisco, CA.

2026-03-01·Cancer diagnosis & prognosis

Real-world Treatment Selection and Shared Decision-making in De Novo Metastatic Castration-sensitive Prostate Cancer in Japan

Article

作者: Takayama, Azusa ; Shiraishi, Yuta ; Furubayashi, Nobuki ; Negishi, Takahito ; Tsujita, Jiro ; Nakamura, Motonobu

Background/Aim: This study aimed to describe the selection of first-line treatment and early outcomes in patients with de novo metastatic castration-sensitive prostate cancer (mCSPC) after the introduction of triplet therapy in Japan. Patients and Methods: We retrospectively investigated 46 patients with de novo mCSPC treated at a specialist Japanese cancer center between March 2023 and August 2025. The patients were grouped according to whether they received androgen deprivation therapy (ADT) alone (the monotherapy group), doublet therapy consisting of ADT and an androgen receptor signaling inhibitor (the doublet group), or triplet therapy consisting of ADT with docetaxel 70 mg/m² and darolutamide (the triplet group). Results: The median patient age was 73 years, and most patients had LATITUDE high-risk disease and CHAARTED high-volume disease. Patients in the monotherapy group were significantly older than those in the doublet group and triplet group (80 vs. 74 and 69 years, respectively, p<0.001). A prostate-specific antigen level of <0.2 ng/ml was detected in 27% of patients in the monotherapy group, 67% of those in the doublet group, and 63% of those in the triplet group, with ≥90% declines in 80%, 92% and 100%, respectively. In the triplet group, febrile neutropenia occurred in 5.3% of patients, interstitial pneumonitis in 5.3%, and peripheral neuropathy in 10.5%. Conclusion: In Japan, treatment intensity in patients with de novo mCSPC is determined mainly by age rather than by metastatic burden.

585

项与达罗他胺相关的新闻（医药）

2026-04-01

·FierceBiotech

Oric chases Pfizer into phase 3 hailing prostate cancer edge, but investors send stock down

Oric plans to start a phase 3 trial in the first half of the year.\n Oric Pharmaceuticals has picked the phase 3 dose for its prostate cancer prospect, barreling into the pivotal program while outlining a claimed edge over Pfizer’s rival candidate. But investors sent the stock down as they digested Oric’s phase 1b data and choice of pivotal treatment regimen.The phase 3 trial, which will start in the first half of the year, will test 400 mg, once-daily doses of Oric’s PRC2 inhibitor rinzimetostat in combination with Bayer’s Nubeqa in metastatic castration-resistant prostate cancer patients previously treated with abiraterone. At an interim phase 1b analysis, 33% of patients on the regimen had at least a 50% decline in prostate-specific antigen (PSA). Oric reported a 40% rate of PSA50 across all doses in November. California-based Oric reported an 84% radiographic progression-free survival (rPFS) rate after five months. The company said the rPFS results were consistent with Pfizer’s rival EZH2 inhibitor, mevrometostat, and better than standard-of-care therapies, including Novartis’ Pluvicto.On a call with investors to discuss the results, Oric Chief Medical Officer Pratik Multani, M.D., said the biotech chose 400 mg, not 600 mg, for the phase 3 dose after seeing no statistical relationship between exposure and efficacy. The 400 mg dose performed numerically better than the 600 mg dose on some measures, Multani said, and the confidence intervals overlapped. While the efficacy data suggested the doses are comparable, the safety and tolerability results pointed to a clear advantage for 400 mg. Oric saw more toxicity and dose modifications at the 600-mg dose, leading it to advance the lower dose into phase 3. Citi analysts called the choice of dose “logical” in a note to investors.Safety and tolerability are key to Oric’s plans. Pfizer has taken mevrometostat into phase 3 based on data that suggest it matches rinzimetostat’s efficacy. Lagging behind its rival, Oric sees mevrometostat’s rates of gastrointestinal and hematological adverse events, plus cases of dysgeusia and alopecia, as areas to gain an edge. Oric CEO Jacob Chacko told investors rinzimetostat’s safety profile “looks markedly better.”Another analyst asked about Nubeqa\'s selection as a phase 3 combination drug. Oric also studied its candidate with Johnson & Johnson’s Erleada. Like Nubeqa, Erleada is an androgen receptor inhibitor. Chacko said Oric chose Nubeqa to avoid the drug-drug interactions associated with Erleada, adding that the company could combine rinzimetostat with J&J’s product in future phase 3 studies. Oric shares were trading down 24% to $9.60 in the first hour of trading Wednesday, compared to a Tuesday closing price of $12.67. Citi analysts said the stock drop could reflect confusion about the choice of the 400-mg dose or “possibly misguided expectations of greater efficacy” compared to mevrometostat. While Pfizer’s candidate is leading the race, the analysts said the safety data support Oric’s belief that rinzimetostat can claim a substantial share of the post-abiraterone market.

临床3期临床结果临床1期临床2期

2026-04-01

·拜耳中国

加速增长：拜耳处方药史上最强的产品组合和前景广阔的研发管线

五大增长催化剂助力拜耳处方药打造史上最强大的产品组合； 2025年创下纪录，获得五项首次获批（三项新产品获批、两项新适应症获批），以及六项积极III期临床试验结果；预计2026年将在重点治疗领域取得多项关键研发管线里程碑；拜耳处方药确认双重目标：从2027年起恢复中个位数增长，并从2028年起实现营业利润率提升，到2030年达到30%。柏林，2026年4月1日——在拜耳处方药2026年全球媒体日活动上，拜耳集团管理委员会成员、拜耳处方药事业部全球总裁Stefan Oelrich阐述了公司如何通过持续专注于科学和业务优先，推动实现2030年业务增长目标。 Stefan Oelrich 拜耳集团管理委员会成员、拜耳处方药事业部全球总裁 “凭借坚定的业务准则和严谨的科学态度，我们正在见证变革性战略带来的回报，它正推动着当下和未来的增长。得益于史上最强大的处方药产品组合、多元化的研发管线以及日益人工智能化的运营模式，我们有望从2027年起恢复中个位数增长，并从2028年开始扩大利润率，到2030年达到30%。” 关键治疗领域的五大增长催化剂推动拜耳处方药未来十年的业绩增长 Christine Roth 拜耳处方药执行副总裁、全球产品战略与商业化负责人兼领导团队成员 “我们的目标是提供first-in-class或best-in-class产品，满足患者需求。过去几年，我们做出的大胆选择正在赋能团队，加速创新，最终将为患者和公司带来实实在在的影响。” ASUNDEXIAN（在研）向上滑动阅览最新进展：拜耳正在对一款活化凝血因子XI（XIa）抑制剂进行临床开发，即asundexian。在非心源性缺血性卒中或高风险短暂性脑缺血发作（TIA）患者中，在接受抗血小板联合治疗基础上， asundexian在减少缺血性卒中复发方面优于安慰剂。 Asundexian已被美国食品药品监督管理局（FDA）授予快速通道资格。凝血因子XIa是凝血途径中的一种蛋白质，抑制凝血因子XIa的目的，是将止血与血栓形成进行解耦，从而在保留正常止血功能的同时，防止病理性血栓的形成。1，2，3 迄今，asundexian尚未被任何国家的监管机构批准用于任何适应症治疗。重要性：全球每年约有1200万人发生卒中4，其中80%为缺血性卒中5。尽管当前已有不少卒中二级预防的治疗措施，仍有五分之一的卒中幸存者将在五年内再次发生卒中。6 达罗他胺/诺倍戈Ⓡ 向上滑动阅览最新进展：达罗他胺是首个与雄激素受体抑制剂（ADT）联合使用用于治疗转移性激素敏感性前列腺癌（mHSPC）的雄激素受体抑制剂（ARi），无论患者是否接受化疗。拜耳的目标是成为第二代雄激素受体抑制剂的全球领导者。一项III期临床试验正在评估在激素敏感性前列腺癌（HSPC）治疗中，达罗他胺联合ADT对比单独使用ADT对激素敏感性高风险生化复发（BCR）前列腺癌患者的疗效。这些患者经传统影像学检查未证实疾病转移，而基线PSMA PET/CT结果为阳性。达罗他胺具有独特的分子结构，能够通过抑制雄激素受体功能，抑制前列腺癌细胞的生长。重要性：前列腺癌是男性第二常见癌症7。2022年，全球约有40万男性死于该疾病。8 非奈利酮/可申达Ⓡ 向上滑动阅览最新进展：非奈利酮是一种选择性非甾体类盐皮质激素受体拮抗剂（nsMRA），也是首个在五项关键性的III期研究中显示出心血管和/或肾脏获益的靶向盐皮质激素受体（MR）的药物，这些研究针对的是：左心室射血分数（LVEF）≥40%的心力衰竭患者 2型糖尿病相关的慢性肾脏病（CKD）患者 1型糖尿病相关的慢性肾脏病患者以及非糖尿病慢性肾脏病患者基于其心血管和肾脏获益，我们预期非奈利酮将成为综合治疗方案中的重要支柱。拜耳非奈利酮在全球100多个国家获批用于治疗2型糖尿病相关的慢性肾脏病成人患者，在中国的商品名为可申达Ⓡ。在美国和、日本和欧盟，非奈利酮也已获批用于治疗LVEF≥40%的心力衰竭（HF），该适应症的上市申请目前在中国等多个市场接受审评。非奈利酮的临床项目包括十项III期研究，分别针对心力衰竭和慢性肾脏病，其中五项已完成。非奈利酮是一种选择性非甾体类盐皮质激素受体拮抗剂，具有独特的作用机制，可靶向心血管和肾脏病中的炎症和纤维化病理过程。重要性：全球有超过8.75亿人患有慢性肾脏病和/或心力衰竭9，10，由于全球生活方式趋势、人口老龄化和糖尿病发病率上升，同时罹患这两种疾病的风险正不断攀升9，11，12，13，14。无论是慢性肾脏病还是心力衰竭患者，均面临较低的生存率。当这两种疾病同时存在，住院、疾病进展和死亡的风险会进一步增加。15 ACORAMIDIS / BEYONTTRA™ 向上滑动阅览最新进展： Beyonttra旨在通过模拟转甲状腺素蛋白（TTR）基因中一种天然存在的“保护性突变”（T119M），有效稳定TTR四聚体，从而用于治疗转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）的根本原因。拜耳致力于在欧洲快速且持续地推广Beyonttra，用于治疗转甲状腺素蛋白淀粉样变性心肌病。该药已在欧盟获批用于治疗野生型或变异型转甲状腺素蛋白淀粉样变性心肌病的成年患者。16 重要性：转甲状腺素蛋白淀粉样变性心肌病是一种常被漏诊的进行性、潜在致命的心脏病，由转甲状腺素蛋白不稳定引起。这种不稳定会导致淀粉样蛋白沉积在心脏中，从而严重损害心脏功能17，18。据估计，转甲状腺素淀粉样变性心肌病正在影响全球40万人19，其中欧洲约有19万人。20 ELINZANENTANT / LYNKUET™ 向上滑动阅览最新进展： Elinzanetant是全球首个双重神经激肽靶向疗法（NK-1和NK-3受体拮抗剂）。 Elinzanetant在美国和其他市场以LynkuetTM的商品名获批用于治疗绝经相关中重度血管舒缩症状（VMS），在欧盟获批用于治疗与绝经相关的或乳腺癌辅助内分泌治疗（AET）引起的中重度血管舒缩症状，使其成为欧盟该适应症中唯一获批的治疗选择。不断增加的证据表明，雌激素活性下降会导致表达NK-1和NK-3受体的kisspeptin、神经激肽B和强啡肽（KNDy）过度活跃，从而导致调节体温和睡眠的中枢功能紊乱，最终引发VMS。 Elinzanetant通过拮抗NK-1和NK-3受体发挥作用，不仅能够降低血管舒缩症状的发生频率和严重程度，还能在改善睡眠障碍和提升生活质量方面带来额外获益。重要性：预计到2030年，全球绝经期女性人数将增至12亿，而这一生理阶段正值女性社交和职业活跃期21。2020年，全球新增乳腺癌病例230万例，其中近70%为激素受体阳性肿瘤，患者需要接受抗雌激素治疗，而这可能会引发绝经期症状。22，23，24，25 重塑研发管线，助力未来增长 Christian Rommel 博士拜耳处方药执行副总裁、全球研发负责人兼领导团队成员 “我们通过创新和差异化产品重塑研发管线，这一战略正在释放潜力：2025年，三个新产品获批，重磅产品的两项新适应症获批，六项III期临床试验取得积极结果，创下业绩纪录。2026年，我们预计将在心血管和肿瘤等核心治疗领域的精准治疗、再生细胞和基因疗法，以及分子影像等多个领域取得关键里程碑，进一步验证以创新驱动影响的战略。” 精准药物研发进展 225Ac-PSMA-Trillium (BAY 3563254) 向上滑动阅览最新进展： 225Ac-PSMA-Trillium（BAY 3563254）是一种在研靶向α疗法（TAT），用于治疗晚期转移性去势抵抗性前列腺癌（mCRPC）患者。正在进行的全球I期首次人体剂量递增PAnTHa研究取得了令人振奋的结果，支持将225Ac-PSMA-Trillium推进到下一阶段的临床开发。靶向α疗法是拜耳精准肿瘤学战略支柱，有望加速为转移性去势抵抗性前列腺癌患者的新型治疗方案的开发进程。重要性：前列腺癌是男性第二常见癌症7，其中转移性去势抵抗性前列腺癌患者中位生存期小于三年。26，27 Vividion Therapeutics总裁兼首席执行官Aleksandra Rizo博士表示： “ 小分子药物凭借其可及性、可预测性和全球可扩展性，仍然是提供具有深远影响疗法的最有效途径之一。我们正利用化学蛋白质组学筛选平台，针对以往被认为无法成药的驱动基因，推进癌症和免疫疾病口服疗法的研发。随着我们自主研发的三种分子进入临床开发阶段，我们正致力于将研究成果转化为有望改变患者命运的新药。 ” WRN抑制剂（VVD-214）向上滑动阅览最新进展： WRN抑制剂（VVD-214）是一种新型的共价、不可逆的Werner解旋酶（WRN）抑制剂，旨在利用微卫星不稳定性高表达（MSI-High）的癌细胞对WRN介导的DNA修复机制的特异性依赖。这种癌症特异性机制有望在降低毒性和副作用的情况下控制疾病进展并提高患者生存率。它是全球首个进入临床试验的WRN共价抑制剂。在一项I期临床试验中，VVD-214耐受性良好，并在微卫星不稳定性高表达的实体瘤患者中显示出令人鼓舞的活性。拜耳计划继续开展Ib期临床试验，并启动II期临床试验，以评估VVD-214在晚期微卫星不稳定性高表达（MSI-High）或错配修复缺陷型（dMMR）结直肠癌患者中的有效性。重要性：结直肠癌（CRC）是全球第三大常见癌症，每年新增病例近200万28。约15%的结直肠癌为MSI-High，这构成了规模最大的MSI-High患者人群29，也为靶向治疗提供了巨大的机会。VVD-214在其他MSI-High癌症中也具有潜在的治疗价值，包括子宫内膜癌、卵巢癌和胃癌。 GIRK4抑制剂（BAY 3670549）最新进展： GIRK4抑制剂（BAY 3670549）是一种高选择性G蛋白偶联内向整流钾通道4（GIRK4）抑制剂，有望帮助控制房颤（AFib）患者心脏细胞的电活动。该GIRK4抑制剂源于与美国麻省理工学院和哈佛大学博德研究所的战略研究联盟。 I期临床试验已启动。重要性：房颤是最常见的心律失常（心律不齐）类型，正在影响全球超过6000万人，也是卒中和心力衰竭的重要危险因素。30，31，32 塞伐艾替尼向上滑动阅览最新进展：塞伐艾替尼是一种新型口服、可逆性的小分子酪氨酸激酶抑制剂（TKI），可阻断参与癌细胞生长的特定酪氨酸激酶活性。塞伐艾替尼已在美国和中国获得突破性疗法认定，用于携带人表皮生长因子受体2（HER2）激活突变的非小细胞肺癌（NSCLC）成人患者的一线治疗。在美国和加拿大，塞伐艾替尼以商品名HyrnuoTM获批用于既往接受过治疗的晚期HER2突变非小细胞肺癌患者。重要性：非小细胞肺癌是最常见的肺癌类型，占所有肺癌病例的85%以上33，其中2-4%为HER2突变非小细胞肺癌。34，35 基因疗法和细胞疗法产品组合有望为患者带来变革性影响基因疗法 AskBio首席执行官Gustavo Pesquin表示： “ 通过将 AskBio 的腺相关病毒一体化平台（从衣壳创新到生产）与拜耳的全球开发和运营能力相结合，我们正在努力开发有望改变罕见病和常见病患者生活的药物。 ” AB-1002 最新进展： AB-1002 是一种单次给药的在研基因疗法，目前正被开发用于治疗射血分数降低的心力衰竭（HFrEF）患者。 II期临床研究的最后一名受试者已完成随机分组。重要性：据估计，全球约有6400万人患有心力衰竭。尽管疗法不断优化，但死亡率和发病率仍然很高。36，37 Ametefgene parvec (AB-1005) 最新进展： Ametefgene parvec是一种单次给药的在研基因疗法，旨在针对帕金森病（PD）的潜在生物学机制，从而恢复神经元功能，并有可能延缓疾病进展。进行中的II期临床试验正在美国、德国、波兰和英国的多个临床中心招募受试者。重要性：过去25年间，帕金森病的患病率翻了一番。目前全球约有近1200万人罹患帕金森病。现有治疗方案的疗效通常会在数年后逐渐减退，患者随后会出现运动波动及治疗相关性运动障碍。38，39 细胞疗法 BlueRock Therapeutics公司总裁兼首席执行官Seth Ettenberg表示： “ 对于以不可逆细胞损失为特征的疾病，再生医学提供了一种根本性的全新治疗方法。我们正在推进新型细胞疗法进入临床开发阶段，同时实现可规模化、可重复的制造。 ” Bemdaneprocel 最新进展： Bemdaneprocel是一种单次给药的在研细胞疗法，旨在替代帕金森病中丢失的多巴胺能神经元。 Bemdaneprocel目前正在美国、加拿大和澳大利亚的多个临床中心进行III期临床试验。重要性：过去25年间，帕金森病的患病率翻了一番。目前全球约有近1200万人罹患帕金森病。现有治疗方案的疗效通常会在数年后逐渐减退，患者随后会出现运动波动及治疗相关性运动障碍。38，39 OpCT-001 最新进展： OpCT-001是一种研究性诱导多能干细胞（iPSC）衍生的感光细胞疗法，用于治疗原发性感光细胞疾病。 OpCT-001已获得美国FDA快速通道资格认定，目前正在进行I/IIa期临床试验。美国FDA已授予OpCT-001治疗视网膜色素变性的孤儿药资格认定。重要性：原发性感光细胞疾病是遗传性视网膜疾病的一个亚群，会导致儿童和成人不可逆的视力丧失。目前针对原发性感光细胞疾病的治疗选择非常有限。仅在美国，受该疾病影响的人数预估为11万人。40，41，42 推动医学影像领域的创新拜耳影像诊断业务全球研发负责人Konstanze Diefenbach博士表示： “ 医学影像正在迅速发展，变得更加个性化，并越来越深入地融入患者的就医流程。在拜耳，我们正在引领推动这一领域的创新——从低剂量对比剂、更智能的互联工作流，到新的分子方法。通过实现更早、更准确的诊断，我们帮助临床医生选择精确的治疗方案，改善患者护理。 ” Gadoquatrane 向上滑动阅览最新进展： Gadoquatrane是一种新一代高弛豫率、低剂量的大环状钆基MRI对比剂，用于检测和显示成人及儿童（包括新生儿）全身各部位及中枢神经系统的病变。 Gadoquatrane在所有大环状MRI对比剂中钆剂量最低，与目前市售其他制剂相比，每次检查可减少高达 60%的钆剂量，同时仍能保持图像质量。拜耳于2026年3月宣布，该产品在日本以 Ambelvist™ 为商品名获全球首次批准上市。目前拜耳已向包括中国等在内的多个国家和地区的监管机构递交了gadoquatrane的上市申请。重要性： MRI对比剂有助于疾病的诊断、治疗决策以及多种疾病的随访监测。低剂量MRI对比剂之所以重要，是因为可以降低患者一生中的钆暴露量。各国监管机构和医学学会一贯建议，在满足诊断目的的前提下使用尽可能低的钆剂量。这一原则适用于所有患者，尤其是那些需要多次进行MRI增强检查的患者（如癌症等慢性疾病患者）、肾功能受损患者以及儿童。据估计，2024年全球使用的钆基对比剂剂量超过6000万剂次。43 分子示踪剂AT-01和 AT-05 向上滑动阅览最新进展： AT-01 和 AT-05 是在研的非侵入性泛淀粉样分子影像示踪剂，专门用于以高敏感性和高特异性检测淀粉样蛋白沉积，从而支持对心脏淀粉样变性及其他类型系统性淀粉样变性的准确诊断。通过进军诊断示踪剂领域，拜耳进一步彰显其在分子影像领域持续拓展的雄心，同时巩固其在心血管精准医疗领域的领先地位。 AT-01（124-Iodine-evuzamitide）是一种 PET（正电子发射断层显像）示踪剂，是首个用于心脏淀粉样变性的淀粉样蛋白沉积影像剂，已获得美国FDA授予的“突破性疗法”认定，并在美国和欧盟均获得“孤儿药”资格，目前其Ⅲ期临床研究已完成给药。 AT-05（99mTc-p5+14）是一种SPECT（单光子发射计算机断层显像扫描）示踪剂，目前处于I期临床试验阶段，有望拓宽诊断选择。重要性：随着针对既往治疗手段不足的疾病不断出现新疗法，在分子水平上对疾病进行精准检测和监测变得愈发重要。AT-01和AT-05的研发有望满足对系统性淀粉样变性，尤其是心脏淀粉样变性，进行早期且准确诊断的迫切临床需求。心脏淀粉样变性是一种目前明显诊断不足且常常致命的心脏疾病，据估计在全球范围内影响超过40万名患者。44，45 通过将内部人工智能与战略合作伙伴关系相结合，提升研发生产力拜耳处方药研发数据科学与人工智能高级副总裁兼负责人Sai Jasti表示： “ 我们的目标是到2030年利用人工智能将研发生产力提高40%。通过将人工智能平台架构与匿名的以患者为中心的数据相结合，数据科学家能够最大化内部生物制剂产品组合，验证人工智能模型，拓展解决方案，最终加快药物发现进程。 ” 拜耳已与美国范德比尔特大学医学中心、芬兰FinnGen以及新加坡PRECISE等组织建立战略合作伙伴关系，利用结合了匿名化数据和人工智能驱动分析的全球生态系统，加快心血管和肾脏病等关键领域的药物研发进程。拜耳公司近期也与Cradle公司签署了合作协议。Cradle公司的平台旨在压缩研发周期，并以更优的速度和精度，推动更高质量的分子进入临床开发阶段。在整个价值链中，人工智能正日益成为拜耳运营中不可或缺的一部分。从全球产品和市场的端到端规划，到新一代智能体工具套件，人工智能正在重塑拜耳员工的工作方式。向上滑动阅览参考文献 Fredenburgh JC, Weitz JI. Factor XI as a target for new anticoagulants. Hamostaseologie. 2021;41(2):104–110. Fredenburgh JC, Gross PL, Weitz JI. Emerging anticoagulant strategies. Blood. 2017;129(2):147–154. Weitz JI, Chan NC. Advances in antithrombotic therapy. Arterioscler Thromb Vasc Biol. 2019;39(1):7–12. Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29. National Institute of Neurological Disorders and Stroke. Stroke Overview. 2025. Available at: https://www.ninds.nih.gov/health-information/stroke/stroke-overview. Last accessed: March 2026. Kolmos M, Christoffersen L, Kruuse C. Recurrent Ischemic Stroke – A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2021;30(8):105935. National Cancer Institute. Cancer Stat Facts: Common Cancer Sites. Available at: https://seer.cancer.gov/ statfacts/html/common.html. Last accessed: March 2026. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-63. Francis A, et al. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol. 2024;20(7), 473-485. Savarese G, et al. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovascular research. 2022;118(17):3272-87. World Obesity Federation. World Obesity Atlas 2024. 2024. Available at: https:// data.worldobesity.org/publications/?cat=22. Last accessed: March 2026. Zhou B, et al. Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304): 957–80. Ong KL, et al. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023; 402(10397): 203–34. Brauer M, et al. Global burden and strength of evidence for 88 risk factors in 204 countries and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024; 403(10440): 2162 - 2203. Lam C, et al. Kidney Disease and Heart Failure: Recent Advances and Current Challenges: Conclusions From a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. J Am Coll Cardiol HF. 2026:102943. doi: 10.1016/j.jchf.2026.102943. Acoramidis SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/beyonttra-epar-product-information_en.pdf. Last accessed: March 2026. Lauppe RE, et al. Nationwide prevalence and characteristics of transthyretin amyloid cardiomyopathy in Sweden. Open Heart. 2021:8(2):e001755. doi: 10.1136/openhrt-2021-001755. Jain A, Zahra F. Transthyretin amyloid cardiomyopathy (ATTR-CM). ClinicalTrials.gov. Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM). 2024. Available at: https://clinicaltrials.gov/study/NCT03860935. Last accessed: March 2026. https://www.ema.europa.eu/en/documents/orphan-maintenance-report/beyonttra-orphan-designation-withdrawal-assessment-report-initial-authorisation_en.pdf Hill K. The demography of menopause. Maturitas. 1996;23(2):113-27. World Health Organization. Breast cancer. 2025. Available at: https://www.who.int/news-room/fact-sheets/detail/breast-cancer. Last accessed: March 2026. Selli C, et al. Accurate prediction of response to endocrine therapy in breast cancer patients: current and future biomarkers. Breast Cancer Research. 2016;18:118. doi: 10.1186/s13058-016-0779-0. Burstein HJ, et al. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update. Journal of Clinical Oncology. 2019;37(5):423-38. Cucciniello L, et al. Estrogen deprivation effects of endocrine therapy in breast cancer patients: Incidence, management and outcome. Cancer Treatment Reviews. 2023;120:102624. Freedland SJ, et al. Real-world treatment patterns and overall survival among men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in the US Medicare population. Prostate Cancer Prostatic Dis. 2024;27(2):327-33. Verry C, et al. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022;17(4):441-51. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi: 10.3322/caac.21660. Vilar E, Gruber SB. Microsatellite instability in colorectal cancer-the stable evidence. Nat Rev Clin Oncol. 2010;7(3):153-62. Linz D, et al. Atrial fibrillation: epidemiology, screening and digital health. The Lancet Regional Health – Europe. 2024;37(100786). Volume 37, 100786. American Heart Association. Why Atrial Fibrillation Matters. 2025. Available at: https://www.heart.org/en/health-topics/atrial-fibrillation/why-atrial-fibrillation-af-or-afib-matters. Last accessed: March 2026. Kornej J, et al. Atrial fibrillation: global burdens and global opportunities. Heart. 2021;107:516-18. Molina JR, et al. Non–Small Cell Lung Cancer: Epidemiology, Risk Factors, Treatment, and Survivorship. Mayo Clin Proc. 2008;83(5):584-94. Yu X, et al. HER2-Altered Non-Small Cell Lung Cancer: Biology, Clinicopathologic Features, and Emerging Therapies. Front Oncol. 2022;12-860313. doi: 10.3389/fonc.2022.860313. Stephens P, et al. Lung cancer: intragenic ERBB2 kinase mutations in tumours. Nature. 2004;431(7008):525-26. Savarese G, et al. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023;118(17):3272-87. Myhre PL, et al. Digital tools in heart failure: addressing unmet needs. Lancet Digit Health. 2024;6(10):e755-e766. Mayo Clinic. Parkinson’s disease. 2024. Available at: https://www.mayoclinic.org/diseases-conditions/parkinsons-disease/diagnosis-treatment/drc-20376062. Last accessed: March 2026. Luo Y, et al. Global, regional, national epidemiology and trends of Parkinson's disease from 1990 to 2021: findings from the Global Burden of Disease Study 2021. Front Aging Neurosci. 2025;16:1498756. doi: 10.3389/fnagi.2024.1498756. National Institute on Deafness and Other Communications Disorders. Usher Syndrome. 2017. Available at: https://www.nidcd.nih.gov/health/usher-syndrome#b. Last accessed: March 2026. Hamel CP. Cone rod dystrophies. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC1808442/. Last accessed: March 2026. O’Neal TB, et al. Retinitis Pigmentosa. StatPearls. 2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK519518/. Last accessed: March 2026. Endrikat, J et al. Rationales for Non-standard GBCA Dosing—Low?—High?—When? and Why?: A Literature-based Study. Investigative Radiology. 2025. doi: 10.1097/RLI.0000000000001259. Kim M, et al. Comparative Outcomes of a Transthyretin Amyloid Cardiomyopathy Cohort Versus Patients With Heart Failure With Preserved Ejection Fraction Enrolled in the TOPCAT Trial. J Am Heart Assoc. 2023;12(15):e029705. https://doi.org/10.1161/JAHA.123.029705. ClinicalTrials.gov. Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM). Available at: https://clinicaltrials.gov/study/NCT03860935. Last accessed: March 2026. 关于拜耳拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2025财年，拜耳的员工人数约为88,000名，销售额为456亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站www.bayer.com上公开的拜耳各项报告中。拜耳没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。拜耳是一家在全球范围内运营子公司的控股公司。本文中所提及的“拜耳”或“公司”可能根据具体语境指一个或多个子公司。

2026-04-01

·EndPoints

Oric to advance prostate cancer drug to Phase 3, but combo choice raises doubts

Oric Pharmaceuticals on Tuesday detailed its plans to advance a PRC2 inhibitor into a registrational program for prostate cancer after sharing results from a Phase 1b trial. But the company’s shares $ORIC dropped by as much as 25% before market open Wednesday as investors had reservations about the biotech’s choice of androgen receptor inhibitor it will combine the investigational drug with. Oric said it plans to advance its candidate, known as rinzimetostat, and Bayer’s Nubeqa into a Phase 3 study. The trial will enroll 600 patients with metastatic castration-resistant prostate cancer (mCRPC) across more than 20 countries. It is set to start in the first half of this year. Jefferies analysts wrote Wednesday that the negative stock move might be due to onlookers thinking that Johnson & Johnson’s Erleada would have been a “better fit strategically” than Nubeqa. Results from a recent head-to-head real-world analysis show Erleada cut the risk of death by 51% compared with Nubeqa in certain prostate cancer patients, although they aren’t the same ones Oric is targeting. Oric’s early-phase trial recruited mCRPC patients who had a median two prior lines of therapy, including previous treatment with abiraterone. The analysts wrote that Oric decided to opt for Nubeqa because it has a lower risk of drug-drug interactions with the investigational drug compared with Erleada. Oric’s choice of combination approach was also based on data from the Phase 1b trial, which tested two different doses of rinzimetostat with Nubeqa, but also with Erleada. The Tuesday release did not report data with Erleada. Results from the Phase 1b trial also led to Oric choosing the lower dose (400 mg) of rinzimetostat versus a higher one (600 mg). The company said that the higher dose was associated with a “modestly higher rate of adverse events.” The most common side effects at the lower dose were fatigue, diarrhea and nausea. There were no grade 4 or 5 events associated with the regimen. The company added both doses had “comparable efficacy,” although the Tuesday data were not split by dose level. Of the 18 evaluable patients treated with the investigational combo of rinzimetostat and Nubeqa, 84% were still alive with no disease progression at five months with a median follow-up of 4.9 months. With the caveat of cross-trial comparison, the Tuesday data are “consistent with” the results attained by Pfizer’s candidate, called mevrometostat, in combination with Xtandi in a Phase 3 trial, despite Oric patients being more heavily pretreated, the Jefferies analysts said. Both rinzimetostat and mevrometostat inhibit the PRC2 complex, but via different subunits — rinzimetostat targets EED, while mevrometostat acts on EZH2. Editor’s note: This story was updated to clarify drug mechanisms.

临床3期临床1期临床2期临床终止临床结果

100 项与达罗他胺相关的药物交易

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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,

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适应症	国家/地区	公司	日期
激素依赖性前列腺癌	欧盟	Bayer AG	2023-03-20
激素依赖性前列腺癌	冰岛	Bayer AG	2023-03-20
激素依赖性前列腺癌	列支敦士登	Bayer AG	2023-03-20
激素依赖性前列腺癌	挪威	Bayer AG	2023-03-20
去势敏感前列腺癌	中国	Bayer HealthCare Pharmaceuticals, Inc.	2023-03-16
转移性前列腺癌	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

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适应症	最高研发状态	国家/地区	公司	日期
局限性前列腺癌	临床3期	法国	Bayer AG	2025-04-10
局限性前列腺癌	临床3期	马提尼克	Bayer AG	2025-04-10
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

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临床结果

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分期

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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


NCT06190899 (ASCO_GU2026)	临床1/2期	转移性去势抵抗性前列腺癌	56	Gedatolisib 120 mg + Darolutamide	選齋願廠鹹鏇簾觸膚艱(鏇鑰憲糧夢構範蓋鬱顧) = 繭鹹製膚繭廠餘糧顧築餘淵餘壓壓淵鏇網齋願 (廠繭膚網壓襯憲廠襯醖 ) 更多	积极	2026-02-26
				Gedatolisib 180 mg + Darolutamide	觸鬱壓鹽蓋簾鏇獵壓糧(觸獵壓鹽餘鬱鏇積襯鏇) = 糧壓夢繭醖願艱夢艱築繭糧艱壓襯積衊壓選齋 (範衊製膚衊壓鬱積選夢 ) 更多
NCT04736199 (ARANOTE, ASCO_GU2026)	临床3期	激素依赖性前列腺癌	669	Darolutamide + ADT	製鏇齋餘製範齋鑰窪醖(鬱選糧選鑰齋繭鹹積鑰) = 蓋醖鹹醖鑰糧衊構窪鑰製繭築窪願壓獵繭憲艱 (鏇醖遞鹽鬱築窪網顧繭 ) 更多	积极	2026-02-26
				Placebo + ADT	製鏇齋餘製範齋鑰窪醖(鬱選糧選鑰齋繭鹹積鑰) = 艱襯餘憲顧繭築艱廠製製繭築窪願壓獵繭憲艱 (鏇醖遞鹽鬱築窪網顧繭 ) 更多
NCT05900973 (Daro-PET, ASCO_GU2026)	临床2期	局限性前列腺癌	16	Darolutamide 600 mg	壓艱繭觸製願遞壓鹽構(觸夢製艱遞膚範範積鹹) = No adverse events were reported, and all patients completed treatment. 蓋構襯廠鹹廠窪顧遞窪 (積衊願淵淵簾繭積壓鑰 )	积极	2026-02-26
NCT02799602 (ARASENS, ASCO_GU2026)	临床3期	激素依赖性前列腺癌	1,305	darolutamide+androgen deprivation therapy+docetaxel	餘齋願艱鹽餘選衊選鹹(衊鏇選鬱顧餘構網醖簾) = 鏇築夢餘繭製鹹構願願艱餘鏇構網鏇醖觸範網 (製觸顧廠顧構顧壓築憲 ) 更多	积极	2026-02-26
				placebo+androgen deprivation therapy+docetaxel	餘齋願艱鹽餘選衊選鹹(衊鏇選鬱顧餘構網醖簾) = 簾糧襯膚鬱鑰衊觸獵鏇艱餘鏇構網鏇醖觸範網 (製觸顧廠顧構顧壓築憲 ) 更多
NCT05526248 (ARAMON, ASCO_GU2026)	临床2期	去势敏感前列腺癌	23	Darolutamide 600 mg	壓壓糧網製蓋願壓餘糧(鬱獵觸觸糧鏇製顧網齋) = 艱簾鹽鏇製願餘衊簾齋網觸獵衊鑰鹹膚艱築餘 (窪鬱鏇憲齋衊壓艱壓糧 ) 更多	积极	2026-02-26
ASCO_GU2026	N/A	去势抵抗性前列腺癌	96	enzalutamide	壓築繭窪膚鹹衊鬱憲襯(遞獵襯網範觸鬱範鹹餘) = 憲鹽顧夢鬱夢網餘網顧艱築餘淵觸糧齋淵構鑰 (願積蓋鹹淵鬱選憲繭餘 ) 更多	积极	2026-02-26
				apalutamide	壓築繭窪膚鹹衊鬱憲襯(遞獵襯網範觸鬱範鹹餘) = 廠醖遞鑰壓鏇膚衊築範艱築餘淵觸糧齋淵構鑰 (願積蓋鹹淵鬱選憲繭餘 ) 更多
ASCO_GU2026	N/A	前列腺癌	195	Abiraterone acetate	願鏇範選繭襯繭鑰鏇觸(選願膚鹹淵餘憲蓋齋鹹) = 憲製選餘醖築構壓淵願積選顧觸壓鑰願醖夢衊 (齋鬱簾構鹽遞觸獵醖淵 ) 更多	不佳	2026-02-26
				Apalutamide	願鏇範選繭襯繭鑰鏇觸(選願膚鹹淵餘憲蓋齋鹹) = 衊襯餘鹽鑰夢願襯構構積選顧觸壓鑰願醖夢衊 (齋鬱簾構鹽遞觸獵醖淵 ) 更多
NCT05526248 (ARAMON, Pubmed \| Eur Urol Focus)	临床2期	去势敏感前列腺癌 \| 非转移性前列腺癌	23	Darolutamide 600 mg	襯鬱醖醖遞廠積齋範廠(簾製鬱憲壓膚鹽醖膚遞) = Most AEs were grade 1/2, including feminizing AEs, occurring mainly during the first 6 months 鑰獵積鑰憲觸鑰網艱壓 (夢壓觸夢積選鹽糧觸衊 )	积极	2026-02-01
NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	临床3期	去势抵抗性前列腺癌	1,509	Darolutamide + ADT	繭醖夢顧鏇簾壓遞積艱(構窪觸襯遞夢齋積窪餘): HR = 0.36 (95.0% CI, 0.26 ~ 0.48) 更多	积极	2026-01-01
				Placebo + ADT
ARAMIS (ESMO_ASIA2025)	临床3期	去势抵抗性前列腺癌	76	Darolutamide + androgen-deprivation therapy	齋衊築淵簾鬱鑰鬱選鏇(蓋鏇夢廠衊獵鑰壓簾繭) = 鏇齋夢鏇範鑰齋淵淵鑰膚夢窪廠築蓋簾獵襯鑰 (製鹽積衊遞艱築願網選 ) 更多	积极	2025-12-05