A Randomized, Controlled, Double-Blind Clinical Trial on the Efficacy and Safety of Amlodipine Folic Acid Tablets Combined with 5-Methyltetrahydrofolate Tablets in Lowering Homocysteine in Hypertensive Patients with MTHFR 677 TT Genotype

开始日期2025-02-19

申办/合作机构

北京大学第一医院

NCT06218030

/ Recruiting临床4期IIT

PSIY-744-23: Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study

The goal of this feasibility study is to determine the tolerability and safety of add on treatment with L-methylfolate in patients with treatment-resistant generalized anxiety disorder (GAD). The primary objective is to monitor for side effects and other risks associated with the treatment. Secondary objectives are to compare the severity of symptoms, serum levels of folate, vitamin B12, C-reactive protein and homocysteine before and after treatment. Participants will continue with their usual treatment for GAD and receive add on treatment with L-methylfolate 15 mg per day for 8 weeks. All participants will receive the same intervention.

开始日期2024-10-22

申办/合作机构

Kingston Health Sciences Centre

ChiCTR2400089135

/ Suspended早期临床1期IIT

A Single-center, Randomized, Controlled, Double-blind Clinical Study to Evaluate the Effect of 6S-5-Methyltetrahydrofolate on Immunometabolic Function and Disease Activity in Ankylosing Spondylitis

开始日期2024-09-24

申办/合作机构-

100 项与左甲柳叶酸钙相关的临床结果

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100 项与左甲柳叶酸钙相关的转化医学

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100 项与左甲柳叶酸钙相关的专利（医药）

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项与左甲柳叶酸钙相关的文献（医药）

2025-05-01·Advances in ophthalmology practice and research

The effect of a specific vitamin supplement containing L-methylfolate (Ocufolin forte) in patients with neovascular age-related macular degeneration

Article

作者: Josifova, Tatjana ; Konieczka, Katarzyna ; Schötzau, Andreas ; Flammer, Josef

Background:

Patients with nAMD often have pathologically elevated homocysteine (Hcy) and increased retinal venous pressure (RVP). We tested whether the administration of a specific vitamin preparation containing L-methylfolate (Ocufolin forte) as an addition to anti-VEGF therapy reduces these two risk factors and favorably influences the disease course.

Methods:

A total of 27 eyes/27 patients with intra- and subretinal fluid, Hcy above 12 μmol/L, RVP of at least 8 mm above the IOP, and an IOP between 10 and 20 mmHg were included in this study. All eyes received three injections of 0.05 ml aflibercept at one-month intervals as clinically indicated. Fifteen patients additionally received one capsule of Ocufolin forte per day (Ocufolin group, OG), and the other twelve patients served as a control group (control group, CG). The following factors were measured before therapy and four months later: blood Hcy, best-corrected visual acuity (BCVA), intra-ocular pressure (IOP), RVP, optical coherence tomography (OCT), and optical coherence tomography - angiography (OCTA).

Results:

Hcy decreased on average by 5.58 μmol/L in the OG and by 0.57 μmol/L in the CG. The RVP decreased on average by 4.60 mmHg in the OG and by 0.75 mmHg in the CG. The difference between the two groups was significant for both parameters (P <0.001); 66% of the OG and 41% of the CG had no retinal fluid at the end of the study. After the completion of the study, the injection intervals could be extended more often in the OG patients than in the CG patients.

Conclusions:

When Ocufolin forte was added to the standard therapy, RVP and Hcy were reduced to a significantly greater extent than without Ocufolin forte. In addition, Ocufolin had a positive influence on morphology and future treatment intervals with anti-VEGF therapy.

2025-03-01·Animal Nutrition

Folic acid alleviates the negative effects of dexamethasone induced stress on production performance in Hyline Brown laying hens

Article

作者: Wang, Yumeng ; Liu, Yanli ; Li, Sijing ; Niu, Yuxin ; Liu, Xiaoying ; Wang, Chaohui ; Yang, Xiaojun ; Yang, Xin ; Sun, Xi ; Ren, Zhouzheng ; Li, Yun

Multiple stressors are believed to deteriorate production performance and cause substantial economic losses in commercial poultry farming. Folic acid (FA) is an antioxidant compound that can improve oocyte function and regulate gut microbiota composition. The current study was conducted to investigate the role of FA in alleviating stress and improving production performance. Sixty Hyline Brown laying hens at 21 weeks of age were randomly divided into three groups, with 10 replicates in each group and each replicate containing two chickens. Each group received basic diet and saline injection (Con group), basic diet with dexamethasone (DXM) injection (DXM group), or basic diet supplemented with FA (13 mg/kg in the premix) with DXM injection (FA group). The feeding trial lasted five weeks. Birds in the DXM and FA groups receiving subcutaneous DXM injections at a dosage of 4.50 mg/kg per day during the first seven days of the trial. Results showed that the levels of corticosterone, triglyceride, total cholesterol, and malondialdehyde in serum were significantly increased in the DXM group (P < 0.05), while the concentrations of FA and 5-methyltetrahydrofolate were decreased in the DXM group (P < 0.05). Laying hens in the DXM group had lower laying rates and egg quality, including egg weight, eggshell thickness, eggshell strength, albumen height, and Haugh units (P < 0.05). Conversely, FA alleviated these negative impacts. Through transcriptome analysis, a total of 247 and 151 differentially expressed genes were identified among the three groups, and 32 overlapped genes were further identified. Moreover, 44 and 59 differential metabolites were influenced by DXM and FA, respectively. Kyoto Encyclopedia of Genes and Genomes enrichment from the transcriptome and metabolomics showed that the reduced production performance may be due to the disturbance of oocyte production, calcium metabolism, and oxidative stress. Analysis of 16S rRNA gene amplicon sequences revealed the differential microbial composition and potential functional changes among the different groups. LEfSe analysis showed that Mucispirillum and Nautella were the predominant bacteria in the DXM group, while Clostridium was the predominant bacteria in the FA group. Functional prediction demonstrated that stressors enhanced fatty acid biosynthesis, while betaine biosynthesis and retinol metabolism were elevated in the FA group. Dietary FA reversed the elevated levels of bile acids (BA), including cholic acid, taurodeoxycholic acid, and taurochenodeoxycholic acid (P < 0.05). The DXM group showed an overall decrease in short-chain fatty acids (SCFA), but FA restored the concentrations of acetic acid, propionic acid, and isobutyric acid (P < 0.05). In conclusion, this study reveals that dietary FA can alleviate the degradation of production performance caused by stress through improving circulating antioxidant capacity, maintaining intestinal microbiota homeostasis, and regulating SCFA and BA biosynthesis. Thus, highlighting the prominent role of gut microbe-host interactions in alleviating multi-stresses.

2025-01-01·3 Biotech

5-Methyltetrahydrofolate and aqueous extract of Spirulina (Arthrospira) ameliorate diabetes and associated complications in STZ-induced diabetic rats

Article

作者: Puthusseri, Bijesh ; Rudrappa, Sudha ; Pathikkal, Ajana ; Prasanthan, Aparna ; Chauhan, Vikas Singh ; Haritha, P K ; Bhaskar, T Krishna

Supplementary Information:

The online version contains supplementary material available at 10.1007/s13205-024-04170-9.

项与左甲柳叶酸钙相关的新闻（医药）

2024-01-02

·SYNAPSE

Exploring MR antagonists: What They Are and How to Keep Up with the Latest Advances

The role of the MR (Mineralocorticoid Receptor) in the human body is crucial for maintaining electrolyte and fluid balance. MR is a type of receptor found in various tissues, including the kidneys, heart, and brain. When activated by the hormone aldosterone, MR regulates the reabsorption of sodium and water in the kidneys, leading to increased blood volume and blood pressure. This receptor also plays a role in regulating potassium levels and maintaining the balance of electrolytes. Dysfunction of the MR can lead to conditions such as hypertension, electrolyte imbalances, and cardiovascular diseases. Understanding the role of MR is essential for developing targeted therapies in the pharmaceutical industry. Based on the analysis of the target MR, it is evident that Bayer AG and Pfizer Inc. are among the companies growing fastest in this field. The R&D progress of these companies, along with oOh!media Group Pty Ltd., Daiichi Sankyo Co., Ltd., CMP Development LLC, Estetra SPRL, and China National Pharmaceutical Group Co., Ltd., is promising. The approved indications cover a wide range of therapeutic areas, indicating the diversity of research in the target MR. Small molecule drugs dominate the development phases, suggesting intense competition in this area. The involvement of various countries/locations, including China, highlights the global nature of the target MR. Overall, the current competitive landscape indicates a promising future for the development of drugs under the target MR. How do they work?MR antagonists, also known as mineralocorticoid receptor antagonists, are a class of drugs that block the action of the mineralocorticoid receptor. The mineralocorticoid receptor is a protein found in various tissues, including the kidney, heart, and brain, and it plays a crucial role in regulating electrolyte balance and blood pressure. From a biomedical perspective, MR antagonists are primarily used in the treatment of conditions such as hypertension (high blood pressure) and heart failure. By blocking the mineralocorticoid receptor, these drugs inhibit the effects of aldosterone, a hormone that promotes sodium and water retention and potassium excretion. This leads to a reduction in fluid volume and blood pressure, helping to manage hypertension and improve symptoms in heart failure patients. Common examples of MR antagonists include spironolactone and eplerenone. These drugs are typically prescribed in combination with other medications to optimize blood pressure control and manage fluid balance in patients with cardiovascular disorders. It's important to note that MR antagonists should be used under medical supervision, as they can have potential side effects and interactions with other medications. Close monitoring of electrolyte levels, particularly potassium, is necessary during treatment with MR antagonists to prevent imbalances. List of MR AntagonistsThe currently marketed MR antagonists include: FinerenoneDrospirenoneEsaxerenoneVistaMRDrospirenone/Ethinyl Estradiol/Levomefolate CalciumDrospirenone/EstetrolDrospirenone/EstradiolEplerenoneDrospirenone/Ethinyl EstradiolFludrocortisone AcetateFor more information, please click on the image below. What are MR antagonists used for?MR antagonists are primarily used in the treatment of conditions such as hypertension (high blood pressure) and heart failure. For more information, please click on the image below to log in and search. How to obtain the latest development progress of MR antagonists?In the Synapse database, you can keep abreast of the latest research and development advances of MR antagonists anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

2023-08-02

·Pharmaceutical Technology

FDA warns of reduced efficacy for oral birth control pill Tydemy

Phalguni Deswal @Phalguni_GD The US FDA recently approved Perrigo’s Opill (norgestrel), which does not require a prescription. Credit: Africa Studio / Shutterstock. The US Food and Drug Administration (FDA) has issued a customer warning for Lupin Pharmaceuticals’ oral birth control pill Tydemy. The FDA warns of reduced efficacy of Tydemy due to decreased levels of one of the inactive ingredients, ascorbic acid. Recommended Reports Reports LOA and PTSR Model - Zoliflodacin in Uncomplicated Cervical And Urethral Gonorrhea GlobalData Reports LOA and PTSR Model - Palonosetron Hydrochloride La in Chemotherapy Induced Nausea and Vomiting GlobalData View all Companies Intelligence Lupin Ltd Perrigo Company Lupin Pharmaceuticals Inc NDC View all The reduced efficacy is associated with two US lots, L200183 (expiry date January 2024; NDC Number 68180-904-71) and L201560 (expiry date September 2024; NDC Number 68180-904-73) distributed from 3 June 2022 to 31 May 2023. On 28 July, Lupin issued a voluntary recall for the two lots following an out-of-specification (OOS) test reporting low levels of ascorbic acid and high levels of a known impurity in the L200183 lot. Tydemy (drospirenone / ethinyl estradiol / levomefolate calcium) is a prescription oral contraceptive that prevents pregnancy by raising folate levels. As per Lupin ’s 28 July press release , the reduction in ascorbic acid could impact Tydemy’s efficacy and could lead to an unexpected pregnancy. The US FDA recently approved Perrigo’s Opill (norgestrel) , which does not require a prescription, while many other contraceptives such as Tydemy need one. Global sales of contraceptives are expected to reach £8.2bn by 2027, as per GlobalData forecasts. GlobalData has also identified an unmet need for hormone-free birth control pills. To that end, Singapore-based Navad Life Sciences is developing an oestrogen-free oral contraceptive , NA-0113, which is currently in a Phase II trial. GlobalData is the parent company of Pharmaceutical Technology . Other women’s health drug in Lupin’s pipeline includes Solosec (secnidazole), which is marketed for bacterial vaginosis.

上市批准临床2期临床3期

2023-08-02

·drugs

Some Lots of Tydemy Birth Control Pills Recalled Due to 'Reduced Effectiveness'

WEDNESDAY, Aug. 2, 2023 -- Certain lots of the prescription birth control pill Tydemy may be less effective than expected, potentially resulting in an unintended pregnancy, because the pills do not contain enough of an active ingredient. The U.S. Food and Drug Administration warned consumers about the issue Tuesday following a company announcement about the issue on July 29. Two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium) made by Lupin Pharmaceuticals do not contain the correct level of ascorbic acid, the FDA noted. Lots L200183 and L201560, in 28-dose blister packs, were distributed throughout the United States between June 3, 2022, and May 31, 2023. "To date, Lupin has received no reports of adverse events related to either recalled batches," the company noted. "Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy." Patients should continue taking their medication, the FDA said, but they should also immediately contact their health care provider for advice about an alternative method of birth control. The company had previously voluntarily recalled the two lots of Tydemy at the wholesale level. "Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 9:00 a.m. to 5:00 p.m. EST," Lupin instructed in its statement. "For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton." The FDA also encouraged health care providers and patients to report any adverse events or quality problems with this or other medications to the agency’s MedWatch Adverse Event Reporting program. Sources U.S. Food and Drug Administration, Aug. 1, 2023 Posted August 2023

100 项与左甲柳叶酸钙相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D09354	左甲柳叶酸钙	B03A	DB11256

研发状态

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适应症	国家/地区	公司	日期
膳食补充剂	美国	Merck KGaA	2009-11-23

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适应症	最高研发状态	国家/地区	公司	日期
避孕	临床1期	荷兰	Bayer AG	2006-10-01
天使综合征	临床前	美国	Rady Children's Hospital-San Diego	2011-12-01
天使综合征	临床前	美国	University of California	2011-12-01
天使综合征	临床前	美国	National Institutes of Health	2011-12-01

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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


AAN2018	N/A	MTHFR mutations \| folate metabolism	146	l-methylfolate calcium 15mg	構夢夢鹹鹹齋積衊糧願(獵壓選糧願壓壓構鏇積) = Rates of laboratory abnormalities did not differ significantly between populations (p=0.13) 窪糧鹽襯膚願製窪積積 (鬱憲繭憲鏇構憲製遞築 )	积极	2018-04-10
				l-methylfolate calcium 7.5mg
NCT01853280 (CTgov)	临床2/3期	注意缺陷障碍伴多动	47	L-methylfolate+OROS-Methylphenidate	衊衊選築築憲憲鏇範遞(齋選夢鹹繭鹽壓選鑰餘) = 積糧遞艱淵蓋淵獵淵襯遞憲繭繭觸壓醖衊膚觸 (觸衊憲網窪襯選淵壓鹽, 10.4) 更多	-	2017-11-14
NCT01570088 (Pubmed \| J Nutr)	N/A	-	45	Wheat rolls fortified with microencapsulated L-5-MTHF	積遞鏇壓齋憲醖繭顧淵(積糧簾選繭淵齋憲鏇廠) = 淵膚願襯淵遞艱繭憲憲遞範鑰簾憲願夢獵憲醖 (選衊鏇鏇鬱簾鏇繭蓋觸 ) 更多	-	2013-06-01
				Wheat rolls fortified with equimolar folic acid	積遞鏇壓齋憲醖繭顧淵(積糧簾選繭淵齋憲鏇廠) = 糧鑰餘遞遞衊蓋遞窪鑰遞範鑰簾憲願夢獵憲醖 (選衊鏇鏇鬱簾鏇繭蓋觸 ) 更多
NCT00348933 (CTgov)	N/A	天使综合征	90	Metafolin+B12+Creatine+Betaine (Treatment (Metafolin/Creatine/Betaine/B12))	壓糧範鑰鏇衊醖鬱觸簾(範選簾鑰醖襯窪鹽齋顧) = 憲齋鏇遞夢積願獵艱鹽鹽鏇廠簾壓觸顧淵憲選 (繭艱夢願餘遞範積簾積, 7.8) 更多	-	2012-09-24
				Metafolin (Treatment (Metafolin/Creatine/Betain/B12))	襯夢網選網憲憲積艱鑰(衊顧構顧齋遞醖遞願鏇) = 獵觸鏇範鑰淵鏇鏇願醖顧廠窪範鏇網鑰選觸遞 (壓憲齋餘願蓋繭構願憲, 224.5) 更多
Pubmed \| Am J Nephrol	N/A	终末期肾脏病	341	50 mg i.v. 5-MTHF	餘鬱遞衊遞衊範窪簾壓(積鏇網糧廠築繭積願鑰) = 蓋鏇夢廠觸廠淵鹽網範觸膚獵網襯艱網鹽願艱 (範糧壓窪顧願鹽鹽積鏇 )	-	2008-01-01
				5 mg/day oral folic acid	餘鬱遞衊遞衊範窪簾壓(積鏇網糧廠築繭積願鑰) = 鑰鑰齋鬱鏇廠築餘築艱觸膚獵網襯艱網鹽願艱 (範糧壓窪顧願鹽鹽積鏇 )