Delving into the Latest Updates on Borofalan (10B) with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Therapeutic radiopharmaceuticals

Synonyms

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

+ [10]

Target-

Mechanism

Ionising radiation emitters

Therapeutic Areas

Neoplasms

Active Indication

Head and Neck NeoplasmsRecurrent Head and Neck Carcinoma

Inactive Indication-

Originator Organization

Stella Pharma Corp.

Active Organization

Stella Pharma Corp.

Hainan Poly Pharm. Co., Ltd.China Boron (Xiamen) Biopharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (25 Mar 2020),

Head and Neck Neoplasms

Regulation-

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Structure

Molecular FormulaC9H12BNO4

InChIKeyNFIVJOSXJDORSP-ULMHTEDTSA-N

CAS Registry80994-59-8

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.

Start Date14 Oct 2024

Sponsor / Collaborator-

ChiCTR2400082903 / SuspendedPhase 1IIT

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

Start Date10 Apr 2024

Sponsor / Collaborator-

JPRN-jRCT2032230554 / RecruitingPhase 1IIT

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

Start Date07 Dec 2023

Sponsor / Collaborator-

100 Clinical Results associated with Borofalan (10B)

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100 Translational Medicine associated with Borofalan (10B)

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100 Patents (Medical) associated with Borofalan (10B)

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8,694

Literatures (Medical) associated with Borofalan (10B)

01 Jun 2025·Journal of Environmental Sciences

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

Article

Author: 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.

01 May 2025·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

Author: 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.

01 May 2025·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

Author: Sun, Minghe ; Luan, Jialu ; Zhao, Qili ; Zhang, Shuhui ; Feng, Xizeng ; Bai, Huijuan ; 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.

28

News (Medical) associated with Borofalan (10B)

14 Nov 2024

·www.businesswire.com

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.

Drug Approval

21 Aug 2024

·www.drugs.com

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.

Clinical Result

27 Jun 2024

·www.drugs.com

ADA: Bisphenol A Linked to Reduced Peripheral Insulin Sensitivity

THURSDAY, June 27, 2024 -- Bisphenol A (BPA) administration is associated with reduced peripheral insulin sensitivity among healthy adults, according to a study presented at the annual meeting of the American Diabetes Association, held from June 21 to 24 in Orlando, Florida. Adam Seal, Ph.D., from the California Polytechnic State University in San Luis Obispo, and colleagues examined the effects of oral BPA administration on peripheral insulin sensitivity in 40 nonhabitually active, healthy adults. Participants completed a two-day baseline energy balance diet low in bisphenols and were then randomly assigned to a four-day energy balance diet plus oral BPA administration at 50 µg/kg body weight (BPA-50) or four-day energy balance diet plus oral placebo (PL) administration. The researchers found that body weight was not significantly different between the PL and BPA-50 groups from baseline to four days. Fasting blood glucose did not differ significantly between the groups from baseline to four days. Urine BPA was significantly higher following BPA-50 than PL. Peripheral insulin sensitivity decreased significantly with BPA-50 and remained stable in PL from baseline to four days. "Given that diabetes is a leading cause of death in the United States, it is crucial to understand even the smallest factors that contribute to the disease," coauthor Todd Hagobian, Ph.D., also from the California Polytechnic State University, said in a statement. One author disclosed ties to Weight Watchers International. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultAHA

100 Deals associated with Borofalan (10B)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX	DB06973

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Head and Neck Neoplasms	JP	Stella Pharma Corp.	25 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Head and Neck Carcinoma	Phase 1	CN	China Boron (Xiamen) Biopharmaceutical Co., Ltd.	01 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2024	Not Applicable	Hypersensitivity	-	Oral Bisphenol A Administration at 50 Î¼g/kg body weight	zdephlmaqn(nqpinzihad) = dryoruttzi qmomslushs (inrcxmymdk, 0.01)	-	21 Jun 2024
				Bisphenol A (Oral Placebo Administration)	zdephlmaqn(nqpinzihad) = cpuxgyfxxn qmomslushs (inrcxmymdk, 0.01)
UEGW	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	-	BISPHENOL A (Healthy individuals)	uystwtglfu(gwrvkbjcom) = svogsmntjw opusvbtfsx (gfvvolqxbd )	-	15 Oct 2023
				BISPHENOL A (NASH patients)	uystwtglfu(gwrvkbjcom) = uxkskinpfv opusvbtfsx (gfvvolqxbd )
EASD2021	Not Applicable	Insulinoma	-	Bisphenol-A (BPA) 1 μM	iugdhjbxjb(qkbqmphdsf) = rlfvbvcquq zriyiknubv (lugyraaqrg )	Negative	28 Sep 2021
EASD2020	Not Applicable	-	-	bisphenol-A (3T3-L1 cells)	zaplqolssa(jffqtleajp) = not enhanced by BPA exposure dvodjgxpsf (gbfcfrxqbl ) View more	-	22 Sep 2020
				bisphenol-A (NIH-3T3 cells)
JPRN-JapicCTI-194640 (ESMO2019)	Phase 2	Recurrent Head and Neck Carcinoma \| Recurrent Squamous Cell Carcinoma of the Head and Neck	-	borofalan(10B) (SPM-011) (AB-BNCT with borofalan(10B))	djwaqdurfx(udvsjhfmyn) = kfipizreat cxlgqsekvh (oeyifkylag ) View more	-	30 Sep 2019
AAI2018	Not Applicable	Neutrophil Chemotactic Response, Abnormal	-	Bisphenol-A	zlkgwmjvss(qxgwakxfsj) = 4 to 6 day post fertilization (dpf) zebrafish exposed to environmentally relevant doses of BPA show reduced background expression of CXCL-8 htprvcacyd (jbsvpioviv ) View more	-	01 May 2018
ASN2017	Not Applicable	Bisphenol A (BPA)	-	Bisphenol A (BPA-free polynephron dialyzers)	hcpsdywfvc(ydwzjdfygt) = rgnlwfgwgn bnedafezov (pgkzfaodpn, 7.97)	Positive	31 Oct 2017
				Bisphenol A (BPA-containing polysulfone dialyzers)	hcpsdywfvc(ydwzjdfygt) = spcqccdxjf bnedafezov (pgkzfaodpn, 20.38)
SP491 (ERA2017)	Not Applicable	Bisphenol A (BPA)	58	Polinephron (PN)	fzulspljaf(tuhpdbyrfh) = dcebkoztsm riryhxggtu (vevdibrblu )	Positive	26 May 2017
				Bisphenol A (BPA) (Polysulphone (PS))	fzulspljaf(tuhpdbyrfh) = awmmghvxpt riryhxggtu (vevdibrblu )
SFN2015	Not Applicable	-	-	Bisphenol A (Vehicle)	szeqxrwmpn(inuikwbqjg) = hsyfgvhntc irvjbtarzw (leqctcftlr ) View more	-	19 Oct 2015
				Bisphenol A (BPA) 200 ng/ml	nzdtbowtzl(domzmyyoeh) = fuvzctahlo lojkphmxaz (qzoogozgwz ) View more
FP520 (ERA2015)	Not Applicable	BPA	69	Polinephron (PN)	gbeufyxjae(inehrymvmz) = bhmiiunxoh aapyrzmuvj (cadwqaqlca ) View more	Negative	21 May 2015
				Bisphenol A (BPA) (Polysulphone (PS))	vwxhkhlbnh(qdesiikbjb) = fdcvwgnpnz gxnsagnohh (hwqmatixfu ) View more