This study will determine if ingestion of 3 g/d betaine versus placebo for two weeks prior to a 60-km cycling time trial will improve performance, moderate exercise-induced gut permeability, and improve metabolic recovery.

Start Date13 Aug 2024

Sponsor / Collaborator

Appalachian State University

[+1]

RBR-2bd7gnb

/ Not yet recruitingNot ApplicableIIT

Chronic effects of Betaine supplementation on Lipid and Glycemic profile, Anthropometric and Cardiovascular parame-ters, and on Physical Exercise practice in adults engaged in Weightlifting: a randomized, double-blind, placebo-contro-lled study -

Start Date10 Jun 2024

Sponsor / Collaborator

Universidade Federal de Juiz de Fora

[+1]

100 Clinical Results associated with Betaine

100 Translational Medicine associated with Betaine

100 Patents (Medical) associated with Betaine

14,958

Literatures (Medical) associated with Betaine

01 Jun 2025·Case Studies in Chemical and Environmental Engineering

Untargeted metabolomic LC-HRMS combined with chemometric reveal metabolites change from sorghum flakes affected by food processing

Author: Anggraeni, Ayu Septi ; Suratno ; Noviana, Ika Mulawati Purwanti ; Utami, Indrawati Dian ; Nurfahmi, Laely ; Khasanah, Yuniar ; Alam, Lucky Prabowo Miftachul ; Windarsih, Anjar

A non-targeted UHPLC-HRMS metabolomics approach combined with chemometric anal. was employed to assess the change in metabolite profiles of sorghum flakes based on food processing techniques.The result showed that fatty acids were the most abundant metabolites, followed by lipids, amino acids, alkaloids, amines, and polyphenols, representing key metabolic markers influenced by food processing in sorghum flakes.Specific metabolites, including 15S-Hydroxyeicosatrienoic acid (15S-HETrE), terminaline, vitamin E acetate, furan fatty acid F6, all-trans-retinal, and fingolimod, exhibited increased concentrations during oven processing compared to raw sorghum, likely due to their thermal stability.This study provides valuable insights into effect of food processing effect on metabolites profiles.

01 Apr 2025·FOOD CHEMISTRY

Unbiased Metabolomic and Chemometric profiles of three Sargassum polycystum extracts using GCMS and LCMS/MS: content analysis, correlation analysis and molecular docking

Article

Author: Alallam, Batoul ; Abdulameed, Hassan Taiye ; Lim, Vuanghao

Sargassum polycystum (S. polycystum) is a brown macroalga with a high phytochemical content, making it a nutritious and bioactive food source. However, information on factors contributing to health benefits, like antioxidants and cytotoxicity, is less explored for Malaysian S. polycystum. In this study, three extracts of S. polycystum were characterized using a combination of analytical techniques. Despite similar carbohydrate content across all extracts, water extract exhibited the highest protein [21.90 ± 1.01 albumin equivalent (μg/mg)] and phenolic [7.73 ± 1.95 gallic acid equivalent (μg/mg)] contents. However, it displayed the lowest antioxidant and anticancer activities [half-maximal inhibitory concentration (IC₅₀) of > 2000 μg/mL]. Interestingly, ethanolic extract demonstrated the strongest scavenging activity (IC₅₀ of 397.90 ± 20.43 μg/mL) and selective anticancer activity against MCF7 breast cancer cells (IC₅₀ of 338.63 ± 48.98 μg/mL). Untargeted metabolomic profiling confirmed the differences in the chemical composition of the extracts. Subsequently, correlation and docking analyses were used to identify the potential bioactive compounds within the extracts. The ethanolic extract is a rich source of these bioactive compounds with superior antioxidant and anticancer properties, highlighting the need for further research on its potential utility in the food industry.

01 Apr 2025·JOURNAL OF HAZARDOUS MATERIALS

Glycine betaine enhances heavy metal phytoremediation via rhizosphere modulation and nitrogen metabolism in king grass-Serratia marcescens strain S27 symbiosis

Article

Author: Wang, Miaomiao ; Yu, Yang ; Guo, Yuanyuan ; Sun, Xiaoyan ; Wang, Meng ; Zhu, Zhiqiang ; Huang, Yanmeng ; Dong, Xuezhi ; Li, Dong ; Feng, Huiping ; Xu, Shunqing ; Cheng, Shaoqi ; Chen, Feifei ; Ye, Dandan ; Duan, Yali

Microbe-Assisted Phytoremediation (MAP) is an eco-friendly method for remediating soil contaminated with heavy metals such as cadmium (Cd) and chromium (Cr). This study demonstrates the potential of a king grass-Serratia marcescens strain S27 (KS) co-symbiotic system to enhance heavy metal remediation. The KS symbiosis increased the biomass of king grass by 48 % and enhanced the accumulation of Cd and Cr in the whole plant by 2.75-fold and 1.82-fold, respectively. Root exudates like γ-aminobutyric acid (GABA), glycine betaine (GB), and allantoin (Alla) were tested for enhancing the KS symbiotic, with 0.75 mM GB (GB_3X-KS) showing the highest removal efficiencies at 15.1 % for Cd and 14.2 % for Cr. Correlation analysis indicated a link between this enhancement and increased soil nitrogen content. Mechanistic studies revealed GB treatment altered the rhizosphere microbial community, promoting denitrifying bacteria and upregulating nitrogen transformation genes (nrfA) by over 7-fold. GB also enhanced nitrogen assimilation enzymes and antioxidant defenses in king grass, facilitating Cd and Cr transport and sequestration. X-ray fluorescence imaging and two-dimensional correlation spectroscopy showed GB promoted Cd and Cr accumulation in the xylem and phloem of king grass, with phenols and alcohols as key functional groups. The study highlights the potential of the GB-KS symbiotic system for effective soil remediation.

News (Medical) associated with Betaine

07 Feb 2025

·ir.etonpharma.com

Eton Pharmaceuticals Expands Patent Portfolio with Issuance of New U.S. Patent for ET-600

« Back to news - Product has patent protection through 2044 - - Expected to be listed in the U.S. Food and Drug Administration’s (FDA) Orange Book upon the product’s approval – DEER PARK, Ill., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent No. 12,214,010, covering its ET-600 product candidate’s proprietary formulation of desmopressin oral solution. The patent expires in 2044 and is expected to be listed in the FDA Orange Book upon the product’s approval. The Company has an additional patent application related to the product under review with the USPTO. ET-600 is a proprietary formulation of desmopressin oral solution under development for the treatment of diabetes insipidus. Desmopressin is the standard of care for diabetes insipidus, but there is not an FDA-approved oral liquid formulation. Currently, desmopressin is only FDA-approved in injectable, tablet, and nasal form, none of which fully meet the pediatric need for small, precise, and titratable doses. As a result, most pediatric patients use unapproved liquid suspensions from compounding pharmacies, attempt to cut and measure fractional tablets, or take daily injections. “This patent strengthens our growing intellectual property portfolio and underscores our commitment to delivering innovative treatments to underserved patient populations. The pediatric endocrinology community has expressed the significant need for a liquid form of desmopressin that can accurately and efficiently deliver small doses for children, and we are proud to have developed a formulation to meet their needs and to see our innovation recognized with a patent,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. ET-600 previously passed a pilot bioequivalence study in 2024 and is currently undergoing its pivotal bioequivalence study. The Company expects to have study results at the end of February. If results are positive, the company anticipates filing a New Drug Application (NDA) with the FDA for the product by the second quarter of 2025. About Diabetes Insipidus Diabetes insipidus is a rare condition in which the body produces too much urine and is not able to retain water. If left untreated, diabetes insipidus can cause excessive dehydration and delayed or stunted growth in children. The condition is estimated to affect about 1 in 25,000 people, or approximately 3,000 pediatric patients in the United States. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com Source: Eton Pharmaceuticals, Inc. Source: Eton Pharmaceuticals

Drug ApprovalNDA

06 Feb 2025

·ir.etonpharma.com

Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400

DEER PARK, Ill., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for ET-400. The new PDUFA goal date is May 28, 2025. The Company was notified that the FDA requires additional time to conduct a full review of supplemental information that was provided in December in response to an FDA request. The FDA communicated that it has applied a standard three-month extension from the original goal date of February 28, 2025. Eton believes it has fully addressed all questions from the FDA and there are no outstanding requests. “We are confident in the strength of our NDA package and look forward to ensuring access to patients in need of this important pediatric rare disease therapy immediately after FDA approval this year. We do not expect this standard extension to significantly affect our internal 2025 revenue projections,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com Source: Eton Pharmaceuticals, Inc. Source: Eton Pharmaceuticals

NDA

26 Dec 2024

·www.globenewswire.com

Eton Pharmaceuticals Closes Acquisition of Increlex® (mecasermin injection)

Acquisition bolsters Eton’s commercial pediatric endocrinology portfolio Product is now available through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions Dec. 20, 2024 -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has completed its previously announced asset purchase of Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). Increlex® is a biologic product used to treat pediatric patients 2 years of age and older who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD). “We are excited to close this transformational acquisition and add another important treatment to our commercial portfolio. Increlex® is perfectly aligned with our expertise and strong relationships in pediatric endocrinology and we’re well-positioned to leverage our existing sales team to increase awareness of SPIGFD, an underdiagnosed and undertreated condition,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “In the U.S., Increlex® is now available through a specialty pharmacy dedicated to rare and chronic conditions and we are proud to be able to continue supplying this crucial product worldwide without disruption.” Increlex® is a biologic product used to treat pediatric patients 2 years of age and older who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1). The medicine is approved in 41 territories, including the United States (U.S.) and the European Union (EU). It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex® is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD. Increlex® is now available in the United States exclusively through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients, and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients. Outside the U.S., Ipsen will continue distributing Increlex® during a six-month transition period, after which Eton will take over commercialization. The transaction was financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings. Clinicians seeking to prescribe Increlex® can e-prescribe by selecting AnovoRx #5 or fax in a patient referral form to 855-831-2039. Additional product details can be found on the product website, https://www.increlex.com/en-us. Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has six commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalAcquisition

100 Deals associated with Betaine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Betaine	A16AA06	DB06756

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Homocystinuria	AU	Recordati SpA	01 Oct 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refsum Disease, Infantile	Phase 3	CA	Recordati SpA	-
Zellweger Syndrome	Phase 3	CA	Recordati SpA	-
Primary Hyperoxaluria Type 1	Phase 2	US	National Institute of Diabetes & Digestive & Kidney Diseases	01 Feb 2007
Angelman Syndrome	Preclinical	US	University of California	01 Dec 2011
Angelman Syndrome	Preclinical	US	National Institutes of Health	01 Dec 2011
Angelman Syndrome	Preclinical	US	Rady Children's Hospital-San Diego	01 Dec 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2023	Phase 1	Metabolic dysfunction-associated steatotic liver disease	44	Betaine 4 g/d	hdhoxxalsv(dlvpakwype) = scfvgwsnqs dwuatakikc (nsacvgdekf ) View more	-	10 Nov 2023
				Betaine 8 g/d	cxxqnttfvy(izrhlytpyg) = unlgqxgpbr kbgzvitsye (lrndqddswk ) View more
EASD2022	Not Applicable	-	-	Betaine	wvlqanvwuw(xchqdpwlpc) = sosclnsxfe iaimxszqmj (gchyaxhidq ) View more	-	22 Sep 2022
				Control (BSA or palmitate)	wvlqanvwuw(xchqdpwlpc) = nmgosxqqmk iaimxszqmj (gchyaxhidq ) View more
DDW2022	Not Applicable	Nonalcoholic Steatohepatitis	-	BETAINE (Normal Chow Diet (NCD))	fmkvyakxme(xajpjwvhkp) = lskotmqphb cffchpiigu (qoqwwwjrvg )	-	23 May 2022
NCT01950039 (CTgov)	Phase 2	Obesity	28	Betaine (Betaine)	qlfpmvytfx(vgrxzjifya) = mufsqgflcp gyuwdvcxyv (mnnzuiqtei, ozbzmxysqk - awkghcifzz) View more	-	20 Apr 2021
				Placebo (Placebo)	qlfpmvytfx(vgrxzjifya) = auwngyutjo gyuwdvcxyv (mnnzuiqtei, nbgcaiikuv - patlqmdzwo) View more
NCT01838941 (CTgov)	Phase 3	Peroxisome Biogenesis Disorders	12	Betaine	zqalikfuyt(llayulcjjo) = odebpzrxne juduchbuxs (fbksszerxr, hdkqwahegm - iidezuxjnt) View more	-	28 Jun 2016
NCT01749982 (CABS, CTgov)	Phase 4	-	60	Placebo (Placebo)	joidkmntcr(lbwfgwssgn) = gwnbowvxnn gpvrrjyudg (ameyqenglf, yuwfabeuwm - uwgcfkkwwl) View more	-	28 Aug 2014
				Choline bitartrate (Choline Bitartrate)	joidkmntcr(lbwfgwssgn) = ozrkrpnire gpvrrjyudg (ameyqenglf, geoyplpvzz - xvnjvgphuj) View more
NCT00283387 (CTgov)	Phase 2	Primary Hyperoxaluria Type 1	15	Placebo+Betaine (Betaine)	riwpxozjda(gmxykcnjcp) = ovpdljrsiz glptwbgxza (nhmwhnnsiy, kwgcapvgyc - jellzissrj) View more	-	01 Jan 2013
				Placebo+Betaine (Placebo)	riwpxozjda(gmxykcnjcp) = uoydtphtii glptwbgxza (nhmwhnnsiy, bxbxfbjdot - odwzvorjuo) View more
NCT00348933 (CTgov)	Not Applicable	Angelman Syndrome	90	Metafolin+B12+Creatine+Betaine (Treatment (Metafolin/Creatine/Betaine/B12))	pmtwqsfudp(kvlnbwrpim) = jwkzmbhovw pfiujzcrfr (yogyrljnqp, suayaznfbd - vuviyvnrjp) View more	-	24 Sep 2012
				Metafolin (Treatment (Metafolin/Creatine/Betain/B12))	hjlsyrlwxc(glxsyvqwas) = emsjfjnhcp btupgeaiim (lpwlewgahh, rmbrzomyzw - uddceitgpr) View more
ASN2011	Not Applicable	Primary Hyperoxaluria Type 1 AGXT genotypes \| I244T mutation	15	Betaine 10 gm	wszlrmvoyu(nysmxccbvk) = kjeeajsumm unryrwvsxg (ylpiccfrdt, 0.97)	Negative	08 Nov 2011
				Placebo	wszlrmvoyu(nysmxccbvk) = zjmdhvkacq unryrwvsxg (ylpiccfrdt, 0.71)

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