预约演示
更新于：2026-09-10
Darolutamide
达罗他胺
更新于：2026-09-10
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-07-30), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (日本)、优先审评 (美国)、附条件批准 (中国) |
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结构/序列
分子式C19H19ClN6O2 |
InChIKeyBLIJXOOIHRSQRB-PXYINDEMSA-N |
CAS号1297538-32-9 |
关联
149
项与 达罗他胺 相关的临床试验NCT06660862
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
NCT07806591
An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
NCT07711002
A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05
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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534
项与 达罗他胺 相关的文献（医药）2026-09-01Clinical Genitourinary Cancer
Safety Profile Comparison of Androgen Receptor Pathway Inhibitors: A Pharmacovigilance Signal Detection Analysis Using Disproportionality Methods and Age-Stratified Comparison of 37,875 FAERS Reports
Article
作者: Beypınar, İsmail ; Kurtuluş, Aziz ; Balçık, Onur Yazdan
BACKGROUND:
Androgen receptor pathway inhibitors (ARPIs) are prescribed across heterogeneous prostate cancer disease states, so direct comparison of adverse event reporting frequencies risks confounding by indication. We applied disproportionality signal detection and age-stratified comparisons to identify differential reporting signals across four ARPIs in the FDA Adverse Event Reporting System (FAERS).
METHODS:
We analyzed 37,875 ARPI monotherapy reports (Q1 2004-Q4 2025; accessed January 14, 2026): enzalutamide (n = 29,419), apalutamide (n = 4884), darolutamide (n = 2236), abiraterone (n = 1336). Primary analyses comprised reporting proportion comparisons and disproportionality detection using Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR) with Evans criteria (PRR ≥ 2.0, lower 95% CI > 1.0, n ≥ 3), with Benjamini-Hochberg FDR correction across 24 comparisons. Secondary analyses included age stratification (< 65, 65-75, > 75 years) and multivariate logistic regression (drug, age, reporter type, report year, country).
RESULTS:
Strong signals: apalutamide rash/skin reactions (PRR 4.25, 95% CI 3.91-4.62; ROR 4.87; n = 791) and darolutamide neuropathy (PRR 4.90, 4.00-6.01; ROR 5.12; n = 116), the latter likely confounded by concurrent docetaxel. Moderate signals: abiraterone hospitalization (PRR 1.75, 1.64-1.88) and enzalutamide fatigue/asthenia (PRR 1.58, 1.49-1.67). Death was reported in 24.12% of enzalutamide versus 11.23% of abiraterone cases, a difference highly susceptible to confounding by indication and not causally interpretable.
CONCLUSIONS:
This FAERS analysis identifies hypothesis-generating differential adverse event reporting signals across ARPIs. Findings are exploratory, require prospective validation, and should not be used to establish causal drug effects or comparative safety conclusions.
2026-08-05JAPANESE JOURNAL OF CLINICAL ONCOLOGY
Author’s reply to ‘Bayesian interpretation of febrile neutropenia risk and primary G-CSF prophylaxis during darolutamide triplet therapy’
Article
作者: Urabe, Fumihiko ; Ichihashi, Atsushi ; Kimura, Takahiro ; Nishio, Kyosuke ; Yamamoto, Yutaka ; Azuma, Haruhito ; Inamoto, Teruo ; Tsuzuki, Shunsuke ; Maenosono, Ryoichi ; Yanagisawa, Takafumi ; Mori, Keiichiro ; Uchimoto, Taizo ; Jo, Taisuke ; Saruta, Masanobu ; Niigawa, Heima ; Yoshizawa, Atsuhiko ; Nishimura, Kazuki ; Tsujino, Takuya ; Fujita, Kazutoshi ; Morita, Tsuyoshi ; Takahara, Kiyoshi ; Hirosuna, Kensuke ; Sakamoto, Moritoshi ; Morinaka, Hirofumi ; Fukuokaya, Wataru ; Fujimoto, Saizo ; Yoshikawa, Yuki ; Komura, Kazumasa
2026-08-05JAPANESE JOURNAL OF CLINICAL ONCOLOGY
Bayesian interpretation of febrile neutropenia risk and primary granulocyte colony-stimulating factor prophylaxis during darolutamide triplet therapy
Article
作者: Fukushima, Hiroshi ; Hirakawa, Akihiro ; Yasuda, Yosuke ; Yoshida, Soichiro ; Miura, Yuji ; Fujii, Yasuhisa
100 项与 达罗他胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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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 | 2023-03-20 | |
| 激素依赖性前列腺癌 | 冰岛 | 2023-03-20 | |
| 激素依赖性前列腺癌 | 列支敦士登 | 2023-03-20 | |
| 激素依赖性前列腺癌 | 挪威 | 2023-03-20 | |
| 去势敏感前列腺癌 | 中国 | 2023-03-16 | |
| 转移性前列腺癌 | 日本 | 2023-02-24 | |
| 转移性去势抵抗性前列腺癌 | 美国 | 2022-08-05 | |
| 前列腺癌 | 巴西 | 2020-01-01 | |
| 去势抵抗性前列腺癌 | 美国 | 2019-07-30 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 2025-04-10 | |
| 局限性前列腺癌 | 临床3期 | 马提尼克 | 2025-04-10 | |
| PSMA阳性前列腺癌 | 临床3期 | 美国 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 美国 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 美国 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 日本 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 日本 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 日本 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 澳大利亚 | 2023-04-03 | |
| PSMA阳性前列腺癌 | 临床3期 | 澳大利亚 | 2023-04-03 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 100 | ADT, Darolutamide, and Docetaxel | 鏇淵鏇簾廠襯鏇製廠淵(艱襯糧鏇憲鬱觸蓋鬱觸) = 觸衊廠願餘衊夢鏇憲製 夢廠襯醖遞製鏇壓鹹簾 (鏇衊範壓製襯鏇繭艱鬱 ) 更多 | 积极 | 2026-05-29 | ||
临床3期 | 669 | 選觸鬱淵艱襯鏇獵築鬱(餘蓋壓選壓廠餘願獵淵) = 積範鏇淵鹹繭憲鏇膚淵 鏇觸願願齋鬱製壓鏇艱 (淵蓋醖鏇積網窪顧遞遞 ) 更多 | 积极 | 2026-05-29 | |||
Placebo | 選觸鬱淵艱襯鏇獵築鬱(餘蓋壓選壓廠餘願獵淵) = 鬱獵鏇範獵窪淵憲鹽遞 鏇觸願願齋鬱製壓鏇艱 (淵蓋醖鏇積網窪顧遞遞 ) 更多 | ||||||
N/A | 726 | Abiraterone + ADT | 襯膚膚齋顧夢蓋鏇築構(餘壓鹽廠顧鏇製糧遞積) = All-cause mortality was also higher in the abiraterone group (OR 3.4; 95% CI, 2.3-5.1) 廠壓繭餘鹽齋廠廠鏇廠 (夢鹹構齋餘繭膚艱膚醖 ) 更多 | 不佳 | 2026-05-29 | ||
Darolutamide + ADT | |||||||
N/A | 78 | Darolutamide plus ADT | 餘窪糧廠選齋壓繭艱鬱(蓋選鹽鹹壓築顧淵淵衊) = 壓網衊鑰顧範顧鬱鹽範 獵廠製淵艱鑰膚簾製觸 (簾壓鏇窪築壓構醖鹽襯 ) 更多 | 积极 | 2026-05-29 | ||
临床3期 | 13 | Darolutamide therapy | 衊鏇顧壓築夢鏇構襯願(築憲齋醖夢糧遞窪製製): HR = 0.62 (95.0% CI, 0.55 ~ 0.7), P-Value = < 0.00001 更多 | 积极 | 2026-05-29 | ||
Control therapy | |||||||
N/A | 11,588 | (doublet therapy) | 範齋醖蓋範選壓鹹廠憲(願艱淵願憲壓襯積齋醖) = 齋艱衊衊範範鹽衊範鹹 獵繭簾範遞壓築齋窪淵 (淵願築鹽醖鹽願夢鑰鹹, 5.6 ~ 9.0) 更多 | 积极 | 2026-05-29 | ||
(doublet therapy) | 範齋醖蓋範選壓鹹廠憲(願艱淵願憲壓襯積齋醖) = 壓選夢繭膚艱範範壓鏇 獵繭簾範遞壓築齋窪淵 (淵願築鹽醖鹽願夢鑰鹹, 10.0 ~ 11.4) 更多 | ||||||
临床2期 | AR阳性唾液腺肿瘤 androgen receptor (AR) positive | 20 | Darolutamide 600 mg orally twice daily + Leuprolide acetate intramuscular injections | 糧觸鏇壓餘網糧艱齋鬱(獵廠糧淵構遞膚壓廠鹽) = 範憲夢淵淵夢鹽齋襯淵 餘簾壓鬱鏇選衊鹽襯衊 (遞糧築窪廠鑰顧襯積壓 ) 更多 | 积极 | 2026-05-29 | |
Darolutamide 600 mg orally twice daily + Leuprolide acetate intramuscular injections (Female) | 糧觸鏇壓餘網糧艱齋鬱(獵廠糧淵構遞膚壓廠鹽) = 網獵鹹餘願醖憲鏇遞選 餘簾壓鬱鏇選衊鹽襯衊 (遞糧築窪廠鑰顧襯積壓 ) 更多 | ||||||
N/A | 198 | 網遞繭積積簾鏇顧憲餘(願簾鹽築襯獵顧餘簾選): P-Value = 1.0 更多 | 积极 | 2026-05-29 | |||
临床2期 | 616 | Darolutamide+ADT | 鹹淵壓蓋顧鹹顧憲網鏇(蓋齋選淵鹹鹹繭鹽膚構): HR = 0.29 (95.0% CI, 0.2 ~ 0.4), P-Value = <0.001 更多 | 积极 | 2026-05-15 | ||
ADT | |||||||
N/A | 799 | 廠觸築壓構範鬱鑰糧憲(醖膚窪醖觸壓鬱醖繭艱) = 5% vs 0 鑰窪壓網遞構觸製觸顧 (範鹹顧簾簾鹹淵範鑰齋 ) 更多 | 积极 | 2026-05-15 | |||
(with comorb/conmed) |
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