TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

开始日期2025-11-03

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06660862

/ Not yet recruiting临床4期IIT

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2025-11-01

申办/合作机构

The University of Chicago

NCT07142551

/ Not yet recruiting临床2期IIT

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.

开始日期2025-10-30

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

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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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468

项与达罗他胺相关的文献（医药）

2026-03-01·Biomaterials advances

PEGylated liposomes co-encapsulating darolutamide and hesperetin for enhanced prostate cancer therapy: 2D, 3D PC3 models and in-vivo evaluation

Article

作者: Khemchandani, Rahul ; Pawar, Avinash ; Pardhi, Ekta ; Mehra, Neelesh Kumar ; Smanthula, Gananadhamu ; Patil, Ruchita

In this study, a darolutamide and hesperetin co-loaded PEGylated liposomal formulation (DHLP) was developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The formulation was prepared using the ethanol injection method, followed by membrane extrusion through a 100 nm polycarbonate filter to ensure size uniformity. The optimized DHLP liposomal formulation exhibited a clear bluish appearance, with a mean particle size of 106.5 ± 3.2 nm, a polydispersity index of 0.128 ± 0.023, and a zeta potential of -14.10 ± 0.25 mV, indicating colloidal stability and uniformity. Spherical morphology was confirmed through microscopic analysis. High encapsulation efficiencies were achieved for both DA (90.1 ± 3.3 %) and HE (91.3 ± 2.7 %). For both medication, in vitro drug release experiments showed a sustained release profile from the DHLP. Cytotoxicity assessment in PC3 prostate cancer cells revealed a 2.83-fold increase in cytotoxicity compared to free DA solution, a 3.89-fold increase compared to free HE solution, and a 1.47-fold improvement over the combined DA-HE solution. The combination index value of 0.89 confirmed synergistic anticancer activity. DHLPs inhibited cell migration, increased ROS generation, and reduced 3D spheroid size, with enhanced cellular uptake contributing to improved therapeutic efficacy. In-vivo pharmacokinetic studies in BALB/c mice demonstrated a 1.7- and 3.4-fold increase in the plasma half-life of DA and HE, respectively, compared to their free drug solutions. Biodistribution studies revealed reduced accumulation of DHLP in vital organs compared to the free drug solution. Acute toxicity assessment at three dose levels showed no histopathological alterations, indicating a favorable safety profile. These results imply that DHLP is a potential nanocarrier system for the effective management of prostate cancer.

2025-12-15·INTERNATIONAL JOURNAL OF CANCER

Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases

Article

作者: Huang, Zhaohui ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Sha ; Li, Xinyu ; Huo, Xiaotong ; Wu, Junyan

Abstract:

Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025 = 4.12, IC 025 = 1.70, N = 30; EudraVigilance, ROR 025 = 11.54, IC 025 = 2.84, N = 55; JADER, ROR 025 = 2.90, IC 025 = 1.33, N = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N = 29, EudraVigilance, ROR 025 = 30.96, IC 025 = 3.74, N = 58; JADER, ROR 025 = 5.34, IC 025 = 1.85, N = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N = 38; EudraVigilance, ROR 025 = 25.06, IC 025 = 3.53, N = 55; JADER, ROR 025 = 0.62, IC 025 = 0.19, N = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N = 7; EudraVigilance, ROR 025 = 4.18, IC 025 = 1.02, N = 5; JADER, ROR 025 = 1.05, IC 025 = 0.45, N = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.

2025-11-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Novel androgen receptor inhibitors in prostate cancer: What do we know so far?

Review

作者: Rifaldi, Francesca ; Sporeni, Silvio ; Montagna, Benedetta ; Secondino, Simona ; Naspro, Richard Lawrence John ; Pedrazzoli, Paolo ; Tortorella, Anna ; Lanzetta, Irene ; Figini, Simone ; Lancia, Andrea ; Chiellino, Silvia

Prostate cancer (PC) is the second most common cancer among males, following lung cancer, more frequently occurring at an advanced age. Even nowadays, early diagnosis represents a challenge and validated screening methods are still missing. To date, multiple therapeutic strategies are available and a tailored approach is possible. The backbone of PC therapy is represented by the inhibition of the androgen signaling pathway, which mediates tumor cells growth. In this current therapeutic scenario, androgen-receptors signaling inhibitors (ARSIs) play a role in improving cancer treatment. This paper provides an overview of the currently available treatment options, focusing on the new drugs (ARSIs), their actual implications and future developments. METHODS: We conducted a research from Pubmed and Embase database regarding the terms 'prostate cancer', 'ARSI', 'androgen receptor inhibitors', ''enzalutamide", "apalutamide", and "Darolutamide". Original full-text articles published in English were reviewed. Based on this research 185 potentially relevant articles were found, limiting our research to the period 2019-2025 of publication. 75 articles were excluded on the basis of abstract, title or the content.

398

项与达罗他胺相关的新闻（医药）

2025-10-27

·investors.oricpharma.com

ORIC® Pharmaceuticals Presented Preclinical Data at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics Supporting Best-in-Class Potential of ORIC-944 to Treat Patients With Prostate Cancer and Other Solid Tumors

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Oct. 27, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, presented posters at the 2025 EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics highlighting preclinical data that further illustrate the potential for ORIC-944, a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, to treat prostate cancer and various other solid tumors. “These preclinical data underscore the potential of ORIC-944 to overcome resistance not only in prostate cancer but in other solid tumors and highlight that the therapeutic potential of PRC2 inhibition may be maximized in combination with inhibitors of key tumor drivers, including AR inhibitors and KRAS inhibitors,” said Lori Friedman, PhD, chief scientific officer. “Based on these data and clinical findings to date, we continue to believe ORIC-944 is a potential best-in-class PRC2 inhibitor with potential in both castration-resistant and castration-sensitive prostate cancer, as well as multiple other tumor types.” Key findings of posters presented at the 2025 EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics: PRC2 inhibition enhances AR inhibitor response to delay treatment relapse in castration-sensitive prostate cancer by restricting adaptation of tumor cells in preclinical studies ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with androgen receptor (AR) inhibition, synergistically impaired tumor growth, significantly improved survival and extended the duration of response to AR inhibitors in vivo by restricting cellular plasticity and delaying prostate tumor adaptation in castration-sensitive prostate cancer (CSPC). Transcriptional effects induced by combining ORIC-944 and AR inhibitors were comparable across all AR inhibitors tested (i.e., darolutamide, apalutamide or enzalutamide), and consistent with transcriptional effects of mevrometostat and AR inhibitor combination. Mechanistically, ORIC-944 in combination with AR inhibition in CSPC was linked to increased luminal cell state, and the restriction of lineage adaptation through reduced chromatin accessibility at binding sites of transcription factors associated with lineage diversification and cell plasticity such as FOXA, HNF1A and ONECUT2. These results were reproduced with mevrometostat and AR inhibitor combination and are consistent with what was previously reported in preclinical studies of CRPC. PRC2 inhibition enhances KRAS inhibitor response to delay treatment relapse in KRAS-mutant preclinical lung and colorectal cancer models ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with KRAS inhibition, significantly improved efficacy and progression-free survival in KRAS G12C mutant non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models, demonstrating that PRC2 inhibition can deepen and extend responses by preventing or delaying resistance to KRAS inhibition. PRC2 activity is increased in tumors from KRAS-mutant NSCLC and CRC patients, and transcriptional analysis from in vivo studies of CRC demonstrated that PRC2 inhibition drives tumor cell differentiation. ORIC-944 combined with the KRAS inhibitor adagrasib, regressed 100% of tumors in KRAS-mutant adenocarcinoma and squamous NSCLC xenograft models in vivo. The combination also prevented adagrasib tumor relapse and extended progression-free survival in a KRAS G12C adenocarcinoma NSCLC xenograft model. About ORIC-944 ORIC-944 is a potent and selective allosteric PRC2 inhibitor via EED subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement, and a favorable safety profile. ORIC-944 continues to further demonstrate a potential best-in-class profile with positive interim PSA response data generated in an ongoing Phase 1b trial in combination with ERLEADA® (apalutamide) and in combination with NUBEQA® (darolutamide) for prostate cancer (NCT05413421). About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the continued clinical development of ORIC-944 and its best-in-class potential; the potential advantages of ORIC-944, including in combination with KRAS inhibitors in lung and colorectal cancers; the development plans and timelines for ORIC-944; plans underlying ORIC’s clinical trials and development; and statements by the company’s chief scientific officer . Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements; the potential market for our product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2025, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact: Dominic Piscitelli, Chief Financial Officer dominic.piscitelli@oricpharma.com info@oricpharma.com

临床1期AACR会议临床结果

2025-10-25

·知乎专栏

2025年下半年药品获批追踪（持续更新）

下面是2025年下半年起，截止2025年10月，全球药物获批情况汇总，持续更新中。信息来源是各国家和地区监管部门网站和fiercepharma网站，内容可能有误，请私信作者修改。10月24日更新Syndax Pharmaceuticals 的白血病药物 Revuforj 获得FDA批准第二个适应症，用于治疗1岁及以上复发或难治性急性髓系白血病（AML）且携带易感核仁磷酸蛋白1（NPM1）突变的患者。该药物此前已于去年11月获批用于治疗赖氨酸甲基转移酶2A（KMT2A）基因重排的AML患者。Azurity Pharmaceuticals 的高血压药物 Javadin 获得FDA批准。这是一种即用型口服可乐定溶液，适用于吞咽片剂或胶囊有困难的患者，是首个用于治疗高血压的即释、即用型口服可乐定制剂。拜耳（Bayer）的激素敏感性前列腺癌（HSPC）药物 Nubeqa 获得英国国家健康与护理卓越研究所（NICE）的批准，可与雄激素剥夺疗法（ADT）联合使用，用于不适合化疗的晚期HSPC患者。10月22日更新安进（Amgen）和阿斯利康（AstraZeneca）的 Tezspire 获得FDA批准新适应症，作为附加维持疗法，用于治疗成人和儿童慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）。这是首个靶向胸腺基质淋巴细胞生成素（TSLP）的生物制剂。欧盟委员会也批准了该药物用于成人重度CRSwNP。安斯泰来（Astellas）和默克（Merck）的 Padcev 与 Keytruda 联合疗法向FDA提交申请，用于治疗某些肌肉浸润性膀胱癌（MIBC）患者，FDA已设定2026年4月7日为决定日期。勃林格殷格翰（Boehringer Ingelheim）的特发性肺纤维化（IPF）治疗药物 Jascayd 在中国国家药品监督管理局（NMPA）获批，这是继其在美国FDA获批后的第二个主要市场批准。赛诺菲（Sanofi）和再生元（Regeneron）的 Dupixent 在加拿大获批新适应症，作为附加维持疗法，用于治疗血液嗜酸性粒细胞增高（2型炎症）且控制不佳的慢性阻塞性肺病（COPD）成人患者。10月21日更新Summit Therapeutics 和康方生物（Akeso）计划向FDA申请其PD-1xVEGF双特异性抗体 ivonescimab 与化疗联合，用于治疗既往接受过治疗的EGFR突变非鳞状非小细胞肺癌（NSCLC）患者。10月15日更新葛兰素史克（GSK）的带状疱疹疫苗 Shingrix 在中国获得批准扩大适用范围，用于18岁及以上因免疫缺陷或免疫抑制而感染风险增加的成人。10月13日更新梯瓦（Teva）的 Uzedy（一种长效利培酮）获得FDA批准，作为单药或附加疗法（联合锂或丙戊酸盐），用于成人I型双相情感障碍（BD-1）的维持治疗。Celltrion 的 Eydenzelt 获得FDA批准，这是再生元和拜耳的眼科药物 Eylea 的一种生物类似药。MannKind 的吸入式胰岛素粉末 Afrezza 已提交FDA审评，用于儿童和青少年，FDA预计在2026年5月29日前做出决定。艾伯维（AbbVie）的 Rinvoq 两项适应症获得FDA调整，用于治疗中度至重度活动性溃疡性结肠炎（UC）和克罗恩病（CD）的范围扩大。10月9日更新辉瑞（Pfizer）的肺癌药物 Lorviqua 获得英国NICE的批准，作为间变性淋巴瘤激酶（ALK）阳性晚期非小细胞肺癌（NSCLC）患者的一线治疗。强生（Johnson & Johnson）的 Simponi 获得FDA批准扩大标签，用于治疗中度至重度溃疡性结肠炎（UC）的儿童患者。Arcutis Biotherapeutics 的 Zoryve 乳膏获得FDA批准，用于治疗2至5岁患有轻度至中度特应性皮炎的儿童。10月3日更新FDA批准了第二种堕胎药米非司酮的仿制药，来自 Evita Solution。9月29日更新强生的 Tremfya 获得FDA批准，用于治疗两个儿科患者群体：6岁及以上、体重至少40公斤的中度至重度斑块状银屑病（PsO）儿童，以及6岁及以上、体重至少40公斤的活动性银屑病关节炎儿童。9月24日更新阿斯利康和第一三共（Daiichi Sankyo）的 Enhertu 与罗氏（Roche）的 Perjeta 联合用药获得FDA优先审评资格，作为HER2阳性转移性乳腺癌的一线治疗，决定日期为2026年1月23日。渤健（Biogen）和卫材（Eisai）的 Leqembi 在澳大利亚获批，用于治疗因阿尔茨海默病引起的轻度认知障碍或轻度痴呆的成年患者。9月18日更新渤健的 Zurzuvae 在欧洲获批，成为欧洲首个用于治疗产后抑郁症（PPD）的药物。Ono Pharmaceutical 子公司 Deciphera 的 Romvimza (vimseltinib) 在欧洲获批，用于治疗有症状的腱鞘巨细胞瘤（TGCT）成人患者。阿斯利康的哮喘急救吸入剂 Airsupra 的FDA标签更新，加入了新的研究证据，进一步证明其疗效。9月17日更新阿斯利康的免疫疗法药物 Imfinzi (durvalumab) 获得英国NICE推荐，用于治疗局限期小细胞肺癌（LS-SCLC）的成人患者。9月15日更新诺和诺德（Novo Nordisk）的口服GLP-1药物 Rybelsus 在欧洲获批标签更新，以反映其心血管获益。Krystal Biotech 的局部基因疗法 Vyjuvek 获得FDA标签更新，允许用于新生儿，并允许患者和护理人员在家中给药。9月11日更新FDA决定不再需要就 Travere Therapeutics 的 Filspari 用于局灶节段性肾小球硬化症（FSGS）的申请召开咨询委员会会议，目标行动日期为2026年1月13日。赛诺菲的 Tzield (teplizumab) 在中国获批，成为首个用于自身免疫性1型糖尿病（T1D）的疾病修饰疗法。9月9日更新武田（Takeda）的 Vonvendi 获得FDA标签扩展，批准作为常规预防性用药，以减少成人血管性血友病（VWD）患者的出血事件频率，并批准用于儿童的点播和围手术期出血管理。Medison Pharma 和益普生（Ipsen）的 Bylvay 在加拿大获批，用于治疗12岁及以上Alagille综合征患者的胆汁淤积性瘙痒。9月4日更新诺瓦瓦克斯（Novavax）的LP.8.1配方COVID-19疫苗 Nuvaxovid 在日本获得监管批准。FDA将其对 Agios 的 Pyrukynd 用于地中海贫血的决定目标日期推迟三个月至12月7日。罗氏的中外制药（Chugai）宣布将为其杜氏肌营养不良症基因疗法 Elevidys 实施新的安全措施。9月3日更新卫材已开始向FDA滚动提交其皮下注射版 Leqembi Iqlik 的申请，寻求批准其作为每周一次的起始剂量。8月29日更新FDA为卫材和渤健的阿尔茨海默病治疗药物 Leqembi 的处方信息增加了更早的安全监测建议。Travere Therapeutics 的IgA肾病药物 Filspari 的FDA处方信息中增加了新的安全监测语言。GSK 的非复杂性尿路感染（uUTI）治疗药物 Blujepa 在英国获批。渤健的 Zurzuvae 在英国获批，用于治疗中度或重度产后抑郁症。8月27日更新百济神州（BeOne Medicines）的PD-1药物 Tevimbra 在欧洲获批，联合含铂化疗作为新辅助治疗，随后进行Tevimbra单药治疗，用于可切除的非小细胞肺癌（NSCLC）成人患者。8月26日更新欧盟委员会批准了吉利德科学（Gilead Sciences）的长效注射剂 Yeytuo，用于预防HIV感染。加拿大批准了 Moderna 更新版的Spikevax，其COVID-19 mRNA疫苗靶向当前流行的SARS-CoV-2 LP.8.1变体。8月25日更新FDA批准安进的 Repatha 用于因低密度脂蛋白胆固醇（LDL-C）控制不佳而导致主要不良心血管事件（MACE）风险增加的成人。中国监管机构批准了阿斯利康和第一三共的 Datroway 用于晚期HR阳性、HER2阴性乳腺癌成人患者。8月22日更新英国NICE批准了安斯泰来的 Padcev 和默克的 Keytruda 联合用药，作为不适合铂类化疗的不可切除或转移性尿路上皮癌患者的治疗方案。中国监管机构批准了全球首个六价轮状病毒疫苗。8月20日更新Madrigal 的 Rezdiffra 在欧洲获得有条件批准，用于治疗伴有中度至晚期肝纤维化的非肝硬化性代谢功能障碍相关脂肪性肝炎（MASH）成人患者。8月19日更新诺和诺德的 Ozempic 在加拿大获批新用途，可用于降低成人2型糖尿病和慢性肾脏病（CKD）患者的肾功能持续下降、终末期肾病和心血管死亡风险。8月18日更新Valneva 的基孔肯雅热疫苗 Ixchiq 在加拿大获批扩大使用范围，可用于12岁及以上人群。SpringWorks Therapeutics 获准在欧洲推出全球首个硬纤维瘤治疗药物 Ogsiveo。8月14日更新Shilpa Medicare 的去氧熊胆酸 (NorUDCA) 片剂在印度获批，成为全球首个针对非酒精性脂肪性肝病 (NAFLD) 的疗法。8月11日更新GSK 的 gepotidacin 获得FDA优先审评资格，作为非复杂性泌尿生殖道淋病的一种潜在治疗方法，预计将于12月11日做出决定。英国NICE批准了 Chiesi 的 Raxone 用于治疗由莱伯遗传性视神经病变（LHON）引起的12岁及以上患者的视力障碍。8月6日更新FDA批准了梯瓦的 Ajovy 用于6至17岁、体重至少45公斤的儿童和青少年发作性偏头痛的预防性治疗。8月4日更新诺华（Novartis）的 Leqvio 获得FDA标签扩展，可作为单一疗法用于成人高胆固醇血症。诺和诺德的 Alhemo 也获得了FDA的标签扩展，用于治疗无抑制物的A型或B型血友病患者。7月30日更新阿斯利康将其 Imfinzi 推进至早期胃癌领域的申请获得了FDA的优先审评资格。艾伯维已向FDA提交其 Venclexta 与阿斯利康的 Calquence (acalabrutinib) 的固定疗程、全口服联合方案的申请，用于未经治疗的慢性淋巴细胞白血病（CLL）患者。PTC Therapeutics 的 Sephience 获得了FDA的广泛标签，涵盖了成人和儿童苯丙酮尿症（PKU）的所有疾病亚型。Ascendis Pharma 的 Skytrofa 现已获得FDA批准，可替代美国患有罕见病生长激素缺乏症（GHD）的成年人的内源性生长激素。7月24日更新GSK 的 Blenrep 在欧盟获批，作为联合疗法用于治疗既往至少接受过一线治疗的多发性骨髓瘤患者。欧盟委员会批准了强生的 Darzalex 皮下制剂的新适应症，作为单药疗法用于有发展为多发性骨髓瘤风险的惰性多发性骨髓瘤（SMM）成人患者。欧盟委员会还批准了益普生的 Cabometyx 用于治疗成人不可切除或转移性、分化良好的胰腺和胰腺外神经内分泌肿瘤（pNETs和epNETs）。7月23日更新罗氏的 Itovebi 方案在欧洲获批，可用于治疗某些乳腺癌患者。加拿大监管机构批准了 Vertex 的新型囊性纤维化三联疗法 Alyftrek。7月21日更新美国FDA已接受百时美施贵宝（BMS）的TYK2抑制剂 Sotyktu 作为活动性银屑病关节炎成人治疗的标签扩展申请。英国NICE已批准树木花粉片 Itulazax。ALK 的肾上腺素鼻喷雾剂 EURneffy 于周五在英国获得监管批准。7月17日更新GSK 的带状疱疹疫苗 Shingrix 将推出一种新的预充式注射器，并已获得FDA批准。英国NICE扩大了对诺华的 Kisqali 的推荐范围，使其适用于更广泛的激素受体阳性、HER2阴性早期乳腺癌患者。强生的创新性膀胱癌疗法 TAR-200 将获得FDA的快速审评。阿斯利康和第一三共的 Enhertu 再获FDA突破性疗法认定，此次是其与罗氏的 Perjeta (pertuzumab) 联合用药，作为不可切除或转移性HER2阳性乳腺癌患者的一线治疗。7月15日更新Vertex Pharmaceuticals 与英国国家医疗服务体系（NHS England）就其囊性纤维化新药 Alyftrek 达成报销协议。7月14日更新GSK 的呼吸道合胞病毒疫苗 Arexvy 标签扩展申请正在FDA审评中，寻求批准用于18至49岁有严重感染风险的成年人。Atara Biotherapeutics 已重新提交其生物制品许可申请，用于 Ebvallo 治疗2岁及以上患有爱泼斯坦-巴尔病毒阳性移植后淋巴增殖性疾病（EBV+ PTLD）的患者。7月11日更新欧洲药品管理局（EMA）安全委员会审查后，取消了对 Valneva 的基孔肯雅热疫苗的临时限制。Moderna 的COVID-19疫苗 Spikevax 在美国获得全面批准，用于6个月至11岁的有疾病风险增加的儿童。7月10日更新英国NICE批准了礼来（Eli Lilly）的 Omvoh (mirikizumab) 用于中度至重度活动性克罗恩病成人患者。NICE还批准了百济神州的BTK抑制剂 Brukinsa (zanubrutinib) 用于复发或难治性套细胞淋巴瘤（MCL）。百济神州的PD-1抑制剂 Tevimbra (tislelizumab) 在欧盟获批，联合化疗用于转移性或复发性鼻咽癌（NPC）成人患者的初始治疗。亚盛医药（Ascentage Pharma）的B细胞淋巴瘤2（Bcl-2）选择性抑制剂 lisaftoclax 在中国获批，用于既往至少接受过一种治疗（包括BTK抑制剂）的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）成人患者。7月8日更新强生已向FDA提交一份补充新药申请，利用 Caplyta (lumateperone) 在预防精神分裂症患者复发方面的积极数据。英国药品和保健品管理局（MHRA）已批准 ImmunityBio 的淋巴细胞刺激剂 Anktiva 与卡介苗（BCG）联合使用，用于治疗BCG无应答的非肌层浸润性膀胱癌伴原位癌（NMIBC CIS）。7月2日更新FDA已授予默克的肺动脉高压（PAH）新药 Winrevair (sotatercept) 的申请优先审评资格，并设定了10月25日的目标日期，以决定是否更新该药的标签。Vertex Pharmaceuticals 的囊性纤维化（CF）药物 Alyftrek 在欧洲获得批准。Hikma 的一种新型即用型抗生素万古霉素输液制剂 Tyzavan 获得了FDA的批准。信息来源：

抗体药物偶联物疫苗申请上市生物类似药

2025-10-22

·PRNewswire

RedHill Biopharma Receives Nasdaq Staff Determination Notification

On October 16, 2025, the Company received a Staff Determination notification from The Nasdaq Stock Market LLC regarding continued non-compliance with the minimum stockholders' equity requirements for continued listing, pursuant to Listing Rule 5550(b)(1) Following RedHill's transaction with Cumberland Pharmaceuticals Inc., announced October 20, 2025, the Company believes that its stockholders' equity now exceeds the minimum $2.5 million requirement and that it is well positioned to maintain compliance The Company intends to appeal Staff's determination to a Hearings Panel,pursuant to the Nasdaq Listing Rule 5800 Series and present its case. The Panel has the authority to determine whether the Company has regained compliance or to grant up to a 180-day extension to regain compliance Submission of a hearing request will stay any delisting or suspension action of the Company's American Depositary Shares, and RedHill remains listed and traded on the Nasdaq Capital Market, pending the hearing There can be no assurance that the Panel will grant an extension of the compliance period or that the outcome of the hearing will be favorable to the Company TEL AVIV, Israel and RALEIGH, N.C., Oct. 22, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that on October 16, 2025, it received a Nasdaq Staff Determination letter indicating that the Company had not met the minimum stockholders' equity requirements ("Minimum Equity Requirement") for continued listing, pursuant to Listing Rule 5550(b)(1), by the required compliance date of October 13, 2025. The Company intends to appeal Staff's determination at a hearing before the Nasdaq Listing Qualifications Panel (the "Panel") and present its position. The Panel has the authority to determine whether the Company has regained compliance or grant up to a 180-day extension to regain compliance. On April 17, 2025, Nasdaq notified the Company that it was no longer in compliance with the Minimum Equity Requirement and on August 8, 2025, Nasdaq granted an extension letter granting the Company additional time until October 13, 2025, to regain compliance. Following RedHill's transaction with Cumberland Pharmaceuticals Inc., announced October 20, 2025, the Company believes that its stockholders' equity now exceeds the minimum $2.5 million and that it is well positioned to maintain compliance. The submission of a hearing request will stay any delisting or suspension action of the American Depositary Shares. RedHill remains listed and traded on the Nasdaq Capital Market pending Nasdaq Panel decision. There can be no assurance that the Panel will grant an extension or that the outcome of the hearing will be favorable to the Company. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[1]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding the strategic transaction with Cumberland and are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Staff Determination Notification from the Nasdaq LLC may not be withdrawn and that the Company may be delisted from the Nasdaq Capital Market; the risk that the strategic transaction with Cumberland will not bring the currently anticipated benefits to RedHill's global Talicia business or to RedHill's financial position, costs or its broader strategic objectives; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate and Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Corporate [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: . Logo: SOURCE RedHill Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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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
去势敏感前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2025-06-03
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
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

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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

适应症

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


ESMO2025	N/A	激素依赖性前列腺癌	1,189	ADT + Docetaxel + Darolutamide	網簾廠積鹽選齋餘醖糧(網鏇繭膚觸膚膚製選遞): HR = 0.42 (95.0% CI, 0.21 ~ 0.82)	积极	2025-10-17
				ADT + Docetaxel
NCT05526248 (ARAMON, CTgov)	临床2期	去势敏感前列腺癌 \| 非转移性前列腺癌	28	Darolutamide(BAY1841788, Nubeqa)	夢淵膚繭簾網淵蓋窪鏇(壓壓範壓襯壓繭艱蓋構) = 鹹製廠鹹壓糧繭願鏇顧製範淵鹽範構醖選糧鹹 (鬱夢膚衊願鬱鑰窪夢鑰, 顧夢壓壓蓋鑰顧餘餘網 ~ 齋顧簾鬱鹽淵淵選範鹽) 更多	-	2025-10-15
NCT04736199 (ARANOTE, CTgov)	临床3期	激素依赖性前列腺癌	669	Androgen deprivation therapy (ADT)+Darolutamide (Nubeqa, BAY1841788) (Darolutamide+ADT)	簾製醖餘壓膚壓範淵築(壓齋觸鹹積艱餘艱廠鬱) = 壓蓋繭壓蓋襯糧遞築餘鬱範簾鹹醖襯餘窪鬱淵 (窪製衊醖膚製壓繭憲網, 廠蓋鑰艱鏇鹽夢構積簾 ~ 鬱選鑰積獵積鏇鬱壓壓) 更多	-	2025-08-08
				Androgen deprivation therapy (ADT) (Placebo+ADT)	簾製醖餘壓膚壓範淵築(壓齋觸鹹積艱餘艱廠鬱) = 築製艱願鹹餘蓋淵鬱淵鬱範簾鹹醖襯餘窪鬱淵 (窪製衊醖膚製壓繭憲網, 獵艱襯襯製顧窪顧齋願 ~ 網膚艱壓繭齋醖蓋淵鏇) 更多
NCT02799602 (ARASENS, Pubmed) 人工标引	临床3期	激素依赖性前列腺癌	810	Darolutamide + docetaxel + androgen-deprivation therapy (ADT) (first subsequent therapy was ARPI)	顧鏇糧齋願窪鹹廠糧壓(夢憲鹽遞範夢簾遞襯蓋) = 積鑰鹽繭網網選鏇鹹鹹製蓋獵夢遞範壓選餘壓 (顧獵壓廠艱網鏇構鹹鬱 )	积极	2025-06-20
				Darolutamide + docetaxel + androgen-deprivation therapy (ADT) (first subsequent therapy was taxane)	顧鏇糧齋願窪鹹廠糧壓(夢憲鹽遞範夢簾遞襯蓋) = 觸艱築鹹遞餘獵糧淵構製蓋獵夢遞範壓選餘壓 (顧獵壓廠艱網鏇構鹹鬱 )
NCT03385655 (PC_BETS, ASCO2025)	临床2期	转移性去势抵抗性前列腺癌 AR mutation	72	Darolutamide 600mg od	鬱憲蓋膚鹽鬱艱艱齋膚(膚醖鹹遞顧夢願積艱餘) = 11% 鹹選繭襯夢鏇襯淵遞選 (簾襯餘夢選襯蓋窪範夢 ) 更多	积极	2025-05-30
NCT05694819 (DISCOVARY, ASCO2025)	临床2期	AR阳性唾液腺肿瘤 androgen receptor (AR)-positive	33	Darolutamide	網獵醖憲餘範廠願築觸(齋衊淵願窪網鹹糧齋簾) = 壓夢願憲壓顧網遞餘獵淵淵鬱淵壓鏇範獵餘餘 (範製網壓糧範窪壓壓築 ) 更多	积极	2025-05-30
ASCO2025	N/A	激素依赖性前列腺癌	188	darolutamide (Non-metastatic hormone-sensitive prostate cancer (nmHSPC))	遞淵繭蓋壓窪襯遞餘範(鬱糧選築壓膚膚衊壓遞) = Common side effects included fatigue 餘蓋襯淵夢遞築衊製範 (淵夢鹹獵鹹遞窪範簾製 ) 更多	积极	2025-05-30
				darolutamide (Metastatic hormone-sensitive prostate cancer (mHSPC))
NCT04736199 (ARANOTE, ASCO2025)	临床3期	激素依赖性前列腺癌	-	Darolutamide 600 mg twice daily	鏇壓獵鏇範網積餘構簾(築製網糧觸範築繭築積): HR = 0.72 (95% CI, 0.54 ~ 0.96) 更多	积极	2025-05-30
				Placebo
NCT03383679 (UCBG 3-06 START, Pubmed \| Lancet Oncol)	临床2期	晚期三阴性乳腺癌 AR positivity	94	Darolutamide 600 mg	繭鑰願積遞築繭築網窪(鹽齋夢築構夢襯壓構窪) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) 獵膚築艱鹽繭膚蓋蓋觸 (窪鏇構餘廠築齋膚網淵 ) 更多	不佳	2025-03-01
				Capecitabine minimum 1000 mg/m2
NCT06013475 (DEAR-EXT, ASCO_GU2025) 人工标引	N/A	去势抵抗性前列腺癌	1,205	DarolutamideDarolutamide (DARO) (Black pts)	-	积极	2025-02-13
				DarolutamideDarolutamide (DARO) (White pts)