硼[10B]法仑(Borofalan (10B)) - 在研适应症：头颈部肿瘤，复发性头颈癌_专利_临床

概要

基本信息

药物类型

小分子化药、治疗用放射药物

别名

4,4'-Bisphenol A、4,4'-Isopropylidenediphenol、Bisphenol-A

+ [10]

靶点-

作用机制

电离辐射发射源

治疗领域

肿瘤

在研适应症

头颈部肿瘤复发性头颈癌

非在研适应症-

原研机构

Stella Pharma Corp.

在研机构

Stella Pharma Corp.

海南普利制药股份有限公司中硼（厦门）生物医药有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (2020-03-25),

头颈部肿瘤

最高研发阶段(中国)临床1期

特殊审评-

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结构

分子式C9H12BNO4

InChIKeyNFIVJOSXJDORSP-ULMHTEDTSA-N

CAS号80994-59-8

关联

17

项与硼[10B]法仑相关的临床试验

NCT06668987 / Recruiting临床1/2期

A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA As Boron Carrier in Recurrent Meningioma

This Phase I/II study, titled 'A Study to Evaluate the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as a Boron Carrier in Recurrent Meningioma', aims to assess the efficacy of B10 L-BPA with BNCT in patients with recurrent meningioma. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for recurrent meningioma treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.

开始日期2024-10-14

申办/合作机构-

ChiCTR2400082903 / Suspended临床1期IIT

A Phase I study of safety, tolerability, pharmacokinetics, and efficacy of boron neutron capture therapy (BNCT) with NBB-001 and boron neutron capture therapy system in patients with recurrent head and neck malignancies

开始日期2024-04-10

申办/合作机构-

JPRN-jRCT2032230554 / Recruiting临床1期IIT

Phase I clinical BNCT Trial to evaluate the safty of iBNCT001 and SPM-011, Accelerator-Based novel High-Power Neutron Source in patient with newly diagnosed glioblastoma - iBNCT-GBM-01

开始日期2023-12-07

申办/合作机构-

100 项与硼[10B]法仑相关的临床结果

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100 项与硼[10B]法仑相关的转化医学

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100 项与硼[10B]法仑相关的专利（医药）

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8,697

项与硼[10B]法仑相关的文献（医药）

2025-06-01·Journal of Environmental Sciences

Facile synthesis of boron-doped porous biochar as a metal-free adsorbent for efficient removal of aqueous tetracycline antibiotics

Article

作者: Xu, Lu ; Qi, Yuetong ; Wang, Chengzhi ; Wang, Kai ; Jin, Xin ; He, Shaolei ; Wang, Qize ; Jin, Pengkang

This study introduced a microwave-assisted pyrolysis method for the rapid and efficient preparation of boron-doped porous biochar. The resulting biochar exhibited a large specific surface area (933.39 m²/g), a rich porous structure (1.044 cm³/g), and abundant active sites. Consequently, the prepared boron-doped porous biochar exhibited higher efficiency in adsorbing tetracycline with a maximum adsorption capacity of 413.223 mg/g, which significantly exceeded that of unmodified biochar and most commercial and reported adsorbents. The correlation analysis between the adsorption capacity and adsorbent characteristics revealed that the formation of the -BCO₂ group enhanced π-π electron donor-acceptor interactions between boron-doped porous biochar and tetracycline. This mechanism mainly contributed to the enhanced adsorption of tetracycline by boron-doped porous biochar. Additionally, the as-prepared boron-doped porous biochar exhibited broad applications in removing antibiotics (tetracycline), phenolics (bisphenol A), and dyes (methylene blue and rhodamine B). Moreover, the boron-doped porous biochar exhibited satisfactory stability, and its adsorption capacity can be nearly completely regenerated through simple heat treatment. This study provides new insights into the effectiveness of boron-doped carbonaceous materials in removing antibiotic contaminants.

2025-05-01·Journal of Environmental Sciences

Efficient activation of peroxymonosulfate for catalytic degradation of organic pollutants by simultaneously using low-level cobalt ions and calcium carbonate micro-particles

Article

作者: Zhou, Yu ; Wang, Xiaobo ; Huang, Shuangshuang ; Wang, Nan ; Zhu, Lihua

An efficient catalytic system was developed to remove various organic pollutants by simultaneously using low-level cobalt ions, calcium carbonate micro-particles and peroxymonosulfate (PMS). A simple base-induced precipitation was used to successfully loaded Co-centered reactive sites onto the surface of CaCO₃ microparticles. Under optimal conditions at 25 °C, 10 mg/L methylene blue (MB) could be completely degraded within 10 min with 480 µg/L Co²⁺, 0.4 g/L CaCO₃ microparticles (or 0.4 g/L Co@CaCO₃) and 0.1 g/L PMS. The MB degradation followed the pseudo first order kinetics with a rate constant of 0.583 min^-1, being 8.3, 11.5 and 53.0 times that by using Co-OH (0.07 min^-1), Co²⁺ (0.044 min^-1) and CaCO₃ (0.011 min^-1) as the catalyst, respectively. It was confirmed that there was a synergistic effect in the catalytic activity between Co species and the CaCO₃ particles but the major contributor was the highly dispersed Co species. When Co²⁺-containing simulated electroplating wastewater was used as the Co²⁺ source, not only the added MB was also completely degraded within 5 min in this catalytic system, but also the coexisting heavy metal ions were substantially removed. The presently developed method was applied to simultaneously treat organic wastewater and heavy metals wastewater. The present method was also successfully used to efficiently degrade other organic pollutants including bisphenol A, sulfamethoxazole, rhodamine B, tetrabromobisphenol A, ofloxacin and benzoic acid. A catalytic mechanism was proposed for the PMS activation by Co@CaCO₃. The surface of CaCO₃ particles favors the adsorption of Co²⁺. More importantly, the surface of CaCO₃ particles provides plentiful surface -OH and -CO₃²⁺, and these surface groups complex with Co²⁺ to produce more catalytically active species such as surface [CoOH]^-, resulting in rapid Co²⁺/Co³⁺ cycling and electron transfer. These interactions cause the observed synergistic effect between Co species and CaCO₃ particles in PMS activation. Due to good cycle stability, strong anti-interference ability and wide universality, the new method will have broad application prospects.

2025-05-01·Journal of Environmental Sciences

The effects of 17β-trenbolone and bisphenol A on sexual behavior and social dominance via the hypothalamic-pituitary-gonadal axis in male mice

Article

作者: Sun, Minghe ; Luan, Jialu ; Zhao, Qili ; Zhang, Shuhui ; Bai, Huijuan ; Feng, Xizeng ; Sun, Mingzhu ; Zhao, Xin ; Yu, Qian ; Fu, Zhenhua ; Zuo, Xiang

17β-Trenbolone (17-TB) is well documented as an environmental endocrine disruptor in aquatic biological studies, but its effects on mammals remain poorly understood. Furthermore, 17-TB acts as a hormone with properties similar to testosterone, and the consequences of juvenile exposure on adult social behavior remain uncertain. Bisphenol A (BPA) acts as an estrogen-like hormone, compared to 17-TB. Three-week-old male Balb/c mice were exposed orally to 17-TB (100 µg/(kg·day)) and BPA (4 mg/(kg·day)) for 28 days. Assessments of social interactions and a three-chamber test showed that 17-TB increased virility in male mice, intensified both male and female sexual behavior, and attracted and accepted female mice. It also increased social dominance through tube tests in male mice and markedly activated the c-Fos⁺ immune response in the medial prefrontal cortex (mPFC) and basal amygdala (BLA). ELISA data showed that 17-TB and BPA exposure significantly affected serum gonadotropin-releasing hormone (GnRH), growth hormone (GH), estradiol (E2), and luteinizing hormone (LH) levels, as well as testicular lesions and androgen receptor (ARβ) and estrogen receptor (ERα) synthesis. Testicular transcriptomic analysis further confirmed that could disrupt steroid synthesis and linoleic acid-related biometabolic processes. These findings suggest the influence of 17-TB and BPA exposure on sexual behavior and fertility in male mice, possibly through modulation of the hypothalamic-pituitary-gonadal axis. This study provides insights relevant to human reproductive health and neuro-social behavioral research, and the potential risk of environmental disturbances should not be overlooked.

33

项与硼[10B]法仑相关的新闻（医药）

2024-11-14

·Business Wire

TAE Life Sciences and Stella Pharma Announce Strategic Agreement for Development and Commercialization of BPA for BNCT Cancer Therapy in the USA and Europe

IRVINE, Calif.--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leader in developing boron neutron capture therapy (BNCT) technology and associated innovative boron target drugs, and Stella Pharma, the pioneering developer of boronophenylalanine (BPA) under the product name Steboronine® for BNCT, are pleased to announce a strategic collaboration focused on the development, commercialization and expansion of BNCT using BPA in the United States and European markets. Stella Pharma’s BPA drug is the world’s first and only clinically approved boron drug for BNCT, marking a breakthrough in cancer treatment. Japan became the first country to approve BNCT for the treatment of head and neck cancers, using Stella Pharma’s pioneering BPA drug. Now, Stella Pharma, as the leading producer and supplier of BPA, has joined forces with TAE Life Sciences to expand the adoption of BNCT worldwide. Supporting the Future of BNCT Therapy The collaboration objectives include extensive international cooperation in the development and commercialization of BNCT and BPA across the USA and Europe with clinical trials anticipated to begin in 2026. TLS will serve as the exclusive commercial partner for Stella Pharma’s BPA in these regions, representing a significant expansion of BNCT accessibility outside of Asia. “ Our partnership with Stella Pharma combines our shared commitment to advancing BNCT as a viable cancer treatment for patients worldwide,” said Rob Hill, CEO of TAE Life Sciences. “ We are excited to bring the proven benefits of BPA to U.S. and European healthcare institutions and to support BNCT globally with this powerful therapeutic solution.” Both companies have also committed to supporting BNCT equipment vendors across all markets in implementing BPA-based BNCT treatments. By fostering partnerships within the BNCT ecosystem, TLS and Stella Pharma aim to enhance the clinical reach of BNCT in treating recurrent head and neck cancers and advancing clinical studies for other cancers, including brain, skin, breast, esophagus, and lung cancers. “ Our alliance with TAE Life Sciences marks a significant step in expanding the reach of BPA-based BNCT treatments beyond Asia,” said Koki Uehara, President and Chief Operating Officer of Stella Pharma. “ We look forward to collaborating internationally to develop and commercialize BNCT and aim to deliver these advancing cancer treatments to patients and their families worldwide.” Exploring Future Opportunities Together Stella Pharma and TAE Life Sciences share a vision of advancing BNCT treatment for hard-to-treat cancers and pledge to explore additional areas for collaboration. Through this alliance, they seek to accelerate innovation, expand treatment options, and ultimately improve outcomes for cancer patients worldwide.

上市批准

2024-11-08

·今日头条

硼中子疗法上市4年，真实监测结果公布，头颈癌完全缓解率≥46%

2020年一款号称“治疗”获得日本厚生劳动省的医疗设备批准，用于局部晚期或复发性头颈癌的治疗，日本也成为了首个批准硼中子疗法的国家！如今这款抗癌黑科技已上市4年，知名期刊《Cancers》报道了该疗法上市后的真实监测结果，一起来看看吧！一、硼中子俘获疗法：精准狙击癌细胞，重塑头颈癌治疗格局头颈癌包括源自头颈部解剖区域的恶性肿瘤，包括鼻腔、鼻旁窦、咽、喉、口腔、舌头、周围面部组织和一些腺体组织，其中鳞状细胞癌 (SCC) 占头颈部恶性肿瘤的 90%左右。头颈癌的常见治疗方案包括手术治疗、放射疗法、全身药物治疗等，具体治疗方法取决于肿瘤分期、肿瘤位置、患者一般状况等多种因素。由于头颈癌位置的特殊性，其毒性限制是治疗绕不开的难题。而硼中子俘获疗法（BNCT）的出现有望逆转这一难题， BNCT是一种将硼药物、中子束相结合的选择性粒子放射疗法，其主要是利用超热中子源，选择性杀灭可收硼的肿瘤细胞，同时最大限度的减少对周围健康组织、细胞的伤害。硼中子俘获疗法已获批用于无法切除的晚期或复发性头颈部肿瘤的治疗。此外，该疗法在治疗乳腺癌、黑色素瘤等方面，也具有不俗的疗效。值得一提的是，硼中子俘获疗法的单次治疗时间为30～50分钟左右，换言之，最快约30分钟左右，即可达到杀伤癌细胞的目的。而且大多患者通常仅需照射1次，部分患者可能需要照射2次（注：具体治疗次数，需由专业医生根据患者病情、个体情况等，进行评估后决定）。二、硼中子疗法上市后，真实监测结果：头颈癌完全缓解率≥46% 《Cancers》报道的这项“硼中子俘获疗法（BNCT）联合硼法兰（10B），治疗局部晚期或局部复发性头颈癌（LA/LR-HNC）真实世界安全性和有效性的研究，共入组155例可评估疗效的患者，包括137例头颈部鳞状细胞癌（SCCHN）患者、17例头颈部非鳞状细胞癌（NSCCHN）患者、1例胶质母细胞瘤患者。结果显示如下： 1、全部可评估疗效的头颈癌（HNC）患者（n=154）：总体完全缓解（CR）率高达 46.1% ，除外1例6个月时肿瘤反应数据不足的患者。 2、头颈部鳞状细胞癌（SCCHN）患者（n=137）：客观缓解率（ORR）高达72.3% ，其中 46.0%的患者幸运地获得了完全缓解（CR）， 26.3%达到部分缓解（PR）。总生存（OS）率分别为 78.8% （1年OS率）vs 60.7% （2年OS率）。 3、头颈部非鳞状细胞癌（NSCCHN）患者（n=17）：客观缓解率（ORR）达到 64.7% ，其中 47.1%的患者幸运地获得了完全缓解（CR）， 17.7% 达到部分缓解（PR）。 1年总生存（OS）率高达100% （详见下图）。 ▼复发性鳞状细胞癌和非鳞状细胞癌患者总生存期Kaplan–Meier曲线 ▲图源“MDPI”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除注： ①SCCHN：头颈部鳞状细胞癌； ②NSCCHN：头颈部非鳞状细胞癌。三、小编寄语总之，这项治疗真实观察结果，再次验证了硼中子俘获疗法对复发性头颈癌的潜在疗效，且安全性可控。硼中子俘获疗法作为抗癌领域冉冉升起的新星，不仅在日本获批上市，拥有了合法身份。近期中国科学院高能物理研究所也宣布，我国首台自主研发的硼中子俘获治疗(BNCT)实验装置研制成功，小编也希望早日迎来中国硼中子疗法获批上市的好消息！想了解硼中子俘获疗法更多讯息的患者，可将治疗经历、近期影像及病理学检查结果，提交至全球肿瘤医生网医学部，进行初步评估或了解详细的入排标准。四、参考资料 [1]Sato M,et al. Safety of Boron Neutron Capture Therapy with Borofalan (10B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance[J]. Cancers, 2024, 16(5): 869. https://www.mdpi.com/2072-6694/16/5/869 本文为全球肿瘤医生网原创，未经授权严禁转载

放射疗法临床结果临床3期

2024-08-21

·drugs

Phenol, Paraben Exposure Linked to Hypertension During Pregnancy

WEDNESDAY, Aug. 21, 2024 -- Phenol and paraben exposure may be associated with hypertension during pregnancy, according to a study published online Aug. 14 in Environmental Health Perspectives . Julia R. Varshavsky, M.P.H., Ph.D., from the Bouvé College of Health Sciences at Northeastern University in Boston, and colleagues examined associations between individual phenols, parabens, and their mixture on maternal blood pressure (BP) measurements and hypertension during pregnancy among 1,433 women. The relationships were examined cross-sectionally at two time points during pregnancy (16 to 20 and 24 to 28 weeks of gestation) and longitudinally. The researchers found that exposure to multiple analytes and the overall mixture was associated with a trend toward higher odds of hypertension during pregnancy, especially at 24 to 28 weeks of gestation (adjusted mixture odds ratio, 1.57). Individual analytes were also associated with lower systolic BP (SBP) and higher diastolic BP (DBP), with the results from the linear mixed models most consistent for methyl paraben or propyl paraben with increased DBP (β = 0.78 and 0.85, respectively), and for bisphenol A, which was associated with lower SBP (β = −0.57). There was evidence of effect modification by fetal sex, with a strong inverse association between overall exposure mixture and SBP among those carrying female fetuses. "These everyday products that we think are safe may be actually harming us and our babies at a critical time during pregnancy," Varshavsky said in a statement. "In the largest study to date, we found that the combined effect of phenol and paraben mixtures increased risk of hypertension during pregnancy among a vulnerable population of women in Puerto Rico who are also dealing with a disproportionate burden of exposure to other toxic chemicals, poverty, and climate change-related disasters like hurricanes and flooding." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

100 项与硼[10B]法仑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX	DB06973

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
头颈部肿瘤	日本	Stella Pharma Corp.	2020-03-25

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
复发性头颈癌	临床1期	中国	中硼（厦门）生物医药有限公司	2024-04-01

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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


ADA2024	N/A	超敏反应	-	Oral Bisphenol A Administration at 50 Î¼g/kg body weight	製獵獵鹹鬱繭醖積襯網(獵膚鬱膚製選廠構淵鹹) = 簾製鬱遞願鏇願鬱鹹製選夢選選築齋夢鹽顧簾 (憲簾築夢鬱齋築餘淵醖, 0.01)	-	2024-06-21
				Bisphenol A (Oral Placebo Administration)	製獵獵鹹鬱繭醖積襯網(獵膚鬱膚製選廠構淵鹹) = 淵鬱獵糧壓繭壓衊鏇獵選夢選選築齋夢鹽顧簾 (憲簾築夢鬱齋築餘淵醖, 0.01)
UEGW	N/A	代谢功能障碍相关的脂肪肝病	-	BISPHENOL A (Healthy individuals)	夢夢遞蓋膚鑰憲願觸淵(廠淵夢鹹鬱築蓋窪鑰製) = 壓鬱繭範觸廠範鹹壓鏇壓顧製繭壓鏇窪鹹範廠 (襯襯簾鬱衊襯襯艱憲觸 )	-	2023-10-15
				BISPHENOL A (NASH patients)	夢夢遞蓋膚鑰憲願觸淵(廠淵夢鹹鬱築蓋窪鑰製) = 願壓壓窪夢繭窪醖壓觸壓顧製繭壓鏇窪鹹範廠 (襯襯簾鬱衊襯襯艱憲觸 )
EASD2021	N/A	胰岛素瘤	-	Bisphenol-A (BPA) 1 μM	範膚憲餘夢壓齋積積廠(艱壓膚糧願選積鑰網遞) = 鹽廠衊簾鹽襯選夢獵壓糧餘餘簾齋襯夢廠艱淵 (壓淵襯蓋夢鏇淵糧鏇鹽 )	不佳	2021-09-28
EASD2020	N/A	-	-	bisphenol-A (3T3-L1 cells)	顧艱範網醖獵網壓壓選(憲繭壓夢鏇鬱築廠積網) = not enhanced by BPA exposure 淵願壓糧鹽襯壓憲襯蓋 (淵鹽鏇壓廠簾築遞築網 ) 更多	-	2020-09-22
				bisphenol-A (NIH-3T3 cells)
JPRN-JapicCTI-194640 (ESMO2019)	临床2期	复发性头颈癌 \| 复发性头颈部鳞状细胞癌	-	borofalan(10B) (SPM-011) (AB-BNCT with borofalan(10B))	齋醖餘襯醖選顧衊鏇簾(鑰鹹衊壓蓋製獵襯鏇餘) = 願淵網觸製鏇壓膚壓繭鹽網糧餘襯壓蓋製糧鹽 (構蓋醖鬱夢選鹹艱醖觸 ) 更多	-	2019-09-30
AAI2018	N/A	中性粒细胞趋化反应异常	-	Bisphenol-A	壓鬱餘餘築鹽積網鏇網(積選衊鹹膚艱遞壓鏇鑰) = 4 to 6 day post fertilization (dpf) zebrafish exposed to environmentally relevant doses of BPA show reduced background expression of CXCL-8 襯艱醖壓窪選餘製壓鹽 (願糧餘積鬱夢願糧襯醖 ) 更多	-	2018-05-01
ASN2017	N/A	Bisphenol A (BPA)	-	Bisphenol A (BPA-free polynephron dialyzers)	衊餘憲夢繭觸構鑰淵觸(廠窪鑰網衊憲網夢鹽齋) = 簾獵膚壓糧憲製衊襯積獵觸觸蓋餘獵淵壓鹽憲 (願願願衊築糧衊衊壓範, 7.97)	积极	2017-10-31
				Bisphenol A (BPA-containing polysulfone dialyzers)	衊餘憲夢繭觸構鑰淵觸(廠窪鑰網衊憲網夢鹽齋) = 淵壓憲簾築糧積壓簾壓獵觸觸蓋餘獵淵壓鹽憲 (願願願衊築糧衊衊壓範, 20.38)
SP491 (ERA2017)	N/A	Bisphenol A (BPA)	58	Polinephron (PN)	觸簾壓築顧壓觸繭壓餘(獵蓋鹽鹹餘選獵顧齋製) = 壓糧鑰範艱鹹網鬱憲醖構齋願觸醖齋糧壓選觸 (顧選簾憲獵遞壓遞築餘 )	积极	2017-05-26
				Bisphenol A (BPA) (Polysulphone (PS))	觸簾壓築顧壓觸繭壓餘(獵蓋鹽鹹餘選獵顧齋製) = 艱衊範網餘夢憲糧餘襯構齋願觸醖齋糧壓選觸 (顧選簾憲獵遞壓遞築餘 )
SFN2015	N/A	-	-	Bisphenol A (Vehicle)	簾膚窪蓋構範鑰壓網鏇(獵繭選簾製繭選餘製簾) = 艱獵窪鏇膚築糧願網衊窪襯窪獵積願廠築鹹蓋 (簾簾願夢糧鹽網鹽膚蓋 ) 更多	-	2015-10-19
				Bisphenol A (BPA) 200 ng/ml	積艱遞壓襯蓋選製選憲(鑰獵範夢繭獵蓋網艱鹽) = 醖鏇蓋夢鹹壓鬱獵憲積夢糧蓋願鏇膚鏇鑰鑰顧 (簾築憲願鏇蓋夢製鏇憲 ) 更多
FP520 (ERA2015)	N/A	BPA	69	Polinephron (PN)	鏇選齋簾構簾膚繭襯襯(構遞鬱艱選選製蓋夢構) = 範蓋觸壓齋鹹繭願網鑰顧鑰鬱蓋構鬱顧膚範構 (餘衊觸範衊夢繭築餘簾 ) 更多	不佳	2015-05-21
				Bisphenol A (BPA) (Polysulphone (PS))	觸鹹齋醖衊鹹積選網遞(繭壓鑰淵壓蓋築鬱顧繭) = 鬱憲齋壓衊醖構範築廠選蓋範積願簾膚淵獵蓋 (壓憲壓襯衊範鬱築鹽醖 ) 更多