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

Start Date19 Feb 2025

Sponsor / Collaborator

Peking University First Hospital

[+2]

NCT06218030

/ RecruitingPhase 4IIT

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, homocysteine, tumor necrosis factor alpha and interleukin 6 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.

Start Date22 Oct 2024

Sponsor / Collaborator

Queen's University

ChiCTR2400089135

/ Not yet recruitingEarly Phase 1IIT

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

Start Date24 Sep 2024

Sponsor / Collaborator

Shanghai Changzheng Hospital

100 Clinical Results associated with Levomefolate calcium

100 Translational Medicine associated with Levomefolate calcium

100 Patents (Medical) associated with Levomefolate calcium

601

Literatures (Medical) associated with Levomefolate calcium

01 Nov 2025·FOOD CHEMISTRY

Folate content and stability in commercial beers: Correlations with phenolic compounds

Article

Author: Liu, Xiaozhen ; Zheng, Jinxian ; Li, Longqing ; Yu, Xiangying ; Li, Yuting ; Jin, Mingyu ; Huang, Weiming ; Yan, Jing-Kun ; Liu, Fengyuan

Folate content and stability in commercial beers were investigated using a UHPLC-Q-TOF-MS/MS method. Sixteen commercial beers from a local market contained total folate ranging from 35.0 to 199.6 μg/L, with 5-methyltetrahydrofolate (5-MTHF) as the predominant form (21-70 %). Principal component analysis revealed distinct clustering patterns among beer types and positive correlations between phenolic content and folate levels. During in vitro digestion, beers with higher phenolic content demonstrated enhanced stability of reduced folates, particularly in stout beer containing 493 mg GAE/L phenolics. Under accelerated storage (60 °C, 10 days), all samples showed significant folate degradation despite varying phenolic levels. While total phenolic content remained stable during storage, antioxidant capacity consistently declined across all samples, suggesting complex protective mechanisms beyond simple antioxidant activity. These findings provide valuable insights into folate-phenolic interactions in beer matrices and their implications for nutritional value preservation during processing and storage.

31 Aug 2025·Cureus Journal of Medical Science

Outcome of Percutaneous Coronary Intervention for Left Versus Non-left Main Coronary Artery in Acute Coronary Syndrome: A Comparative Study

Article

Author: Shafique, A M ; Iqbal, S M Mamun ; Mondal, Neuton ; Hasan, Mohammad Jahid

BACKGROUND AND OBJECTIVE:

Acute coronary syndromes (ACS), particularly those affecting the left main coronary artery (LMCA), are associated with high morbidity and mortality. The objective of the present study was to investigate long-term outcomes in patients who underwent percutaneous coronary intervention (PCI) for ACS affecting the LMCA compared to those with non-LMCA involvement.

METHODS:

This interventional study was conducted at the Department of Cardiology of MH Shamorita Medical College Hospital in Dhaka, Bangladesh, from January 2023 to June 2024. A total of 101 patients with ACS who underwent PCI participated in the study. Of whom, 51 were in the LMCA group and 50 were in the non-LMCA group. Follow-up assessment was done at the third, sixth, and 12th months, focusing on major adverse cardiovascular events (MACE) as the primary endpoint and persistent symptoms, repeat revascularization, and stent thrombosis as secondary endpoints.

RESULTS:

The mean age of the LMCA and non-LMCA groups was 56 and 54 years, respectively, with a higher female proportion in the LMCA group. The patients in the LMCA group presented with more complex lesions, with a mean synergy between percutaneous coronary intervention with Taxus and cardiac surgery (SYNTAX) score of 23.6. The MACE rate was notably higher in the LMCA group at 6%, compared to 2% in the non-LMCA group (p=0.013). Myocardial infarction (MI) occurred in 4% of the LMCA group, with no events in the non-LMCA group. Persistent symptoms and repeat revascularization were also more prevalent in the LMCA group (6% and 4%, respectively, p-value <0.05).

CONCLUSIONS:

Patients with ACS involving the LMCA experienced higher rates of adverse outcomes, particularly MI and repeat revascularization, following PCI compared to non-LMCA cases.

01 May 2025·CLINICAL NUTRITION

Associations of maternal serum folate, vitamin B12 and their imbalance with gestational diabetes mellitus: The mediation effects of the methionine cycle related metabolites

Article

Author: Li, Wei ; Zhou, Qianling ; Wang, Jiaqi ; Li, Zhiwen ; Zeng, Xiaoling ; Liu, Xiyao ; Lou, Yaxin ; Hou, Yanmei ; An, Meijing

BACKGROUND & AIMS:

Maternal high level of folate and low level of vitamin B12, namely "folate and vitamin B12 imbalance", has been found to be associated with metabolic disorders, such as gestational diabetes mellitus (GDM). The aims of this study were to explore the associations of maternal serum folate, vitamin B12 and their imbalance in early pregnancy with GDM, and to explore the potential mediation effects of the methionine cycle related metabolites on the above associations.

METHODS:

This nested case-control study (172 GDM case-control pairs) was conducted based on a prospective birth cohort. Serum concentrations of 5-methyltetrahydrofolate (5-MTHF), vitamin B12 and methionine cycle related metabolites [S-adenosylmethionine (SAM), S-adenosylhomocysteine (SAH) and Homocysteine (Hcy)] were detected. 5-MTHF (nmol/L)/vitamin B12 (pmol/L) times 1000 was calculated to indicate the imbalance status of folate and vitamin B12. Conditional logistic regression was performed to analyze the associations of 5-MTHF, vitamin B12 and their imbalance with GDM. The mediation effect models were applied to explore the mechanism.

RESULTS:

High serum level of 5-MTHF in early pregnancy was related to a higher risk of GDM (OR = 2.00, 95%CI: 1.19-3.37). Compared with the group of the lowest tertile concentration of vitamin B12, the group of the highest concentration had a lower risk of GDM (OR = 0.33, 95%CI: 0.11-0.97). Higher 5-MTHF/vitamin B12 was associated with a higher risk of GDM (OR = 1.67, 95%CI: 1.08-2.56). Besides, no significant mediation effect of methionine cycle related metabolites was found on the associations of folate, vitamin B12 and the imbalance status with the risk of GDM.

CONCLUSIONS:

High maternal serum folate, low vitamin B12 levels and the resulting imbalance may increase the risk of GDM. The theory of "folate trap" could not explain the effect of folate, vitamin B12 and their imbalance on GDM.

News (Medical) associated with Levomefolate calcium

23 Aug 2024

·pharma.economictimes.indiatimes.com

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

Drug Approval

02 Jan 2024

·synapse.patsnap.com

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!

02 Aug 2023

·www.pharmaceutical-technology.com

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.

Drug ApprovalPhase 2Phase 3

100 Deals associated with Levomefolate calcium

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KEGG	Wiki	ATC	Drug Bank
D09354	Levomefolate calcium	B03A	DB11256

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dietary Supplement	United States	Merck KGaA	23 Nov 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 1	Netherlands	Bayer AG	01 Oct 2006
Angelman Syndrome	Preclinical	United States	Rady Children's Hospital-San Diego	01 Dec 2011
Angelman Syndrome	Preclinical	United States	National Institutes of Health	01 Dec 2011
Angelman Syndrome	Preclinical	United States	University of California	01 Dec 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01853280 (CTgov)	Phase 2/3	Attention Deficit Disorder With Hyperactivity	47	L-methylfolate+OROS-Methylphenidate	znbxryndqm(xyobcciyqw) = metoxpjnhr drwbfjftxi (mxvuuqxcvd, 10.4) View more	-	14 Nov 2017
NCT01570088 (Pubmed \| J Nutr)	Not Applicable	-	45	Wheat rolls fortified with microencapsulated L-5-MTHF	rtdhyfvukz(iwfrupiieb) = ykwwedurta rvjyjwqhtp (hkxkrlgsmp ) View more	-	01 Jun 2013
				Wheat rolls fortified with equimolar folic acid	rtdhyfvukz(iwfrupiieb) = jexjebdoka rvjyjwqhtp (hkxkrlgsmp ) View more
NCT00348933 (CTgov)	Not Applicable	Angelman Syndrome	90	B12+Metafolin+Creatine+Betaine (Treatment (Metafolin/Creatine/Betaine/B12))	xdbfmwsgia(breyglgeha) = clmbfpvubr ovxjpzqaid (eociihslhz, 7.8) View more	-	24 Sep 2012
				Metafolin (Treatment (Metafolin/Creatine/Betain/B12))	qotnphjrsc(egfcfohrtg) = enuhenysfw wxvvrcrsql (geovgizzne, 224.5) View more
NCT01253187 (CTgov)	Phase 1	Contraception	44	EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) (EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300))	lwsdlzhdvb(lvkgkskfgk) = usmwvupcmy cxxkfwugpm (bxdfnbgjqj, dfzteiwqhj - gxalhgoiir) View more	-	09 May 2011
				EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca) (EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca))	lwsdlzhdvb(lvkgkskfgk) = pzjrddzskv cxxkfwugpm (bxdfnbgjqj, civagwwtdb - sgbwjbbbza) View more

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