Multicenter, Double Blind, Randomized, Placebo-controlled Trial to Exploring the Role of Eye-Brain Multimodal Imaging in Diagnosing and Treating Neurovascular Coupling Impairment in Diabetes Mellitus

This study intends to take the critical pathological mechanism of diabetic neurovascular coupling injury (NCI) as the starting point and utilize multi-modal imaging (MMI) technology of the eyes and brain as a means to conduct in-depth, integrated, and interdisciplinary research with Traditional Chinese Medicine (TCM) syndrome studies. The aim is to establish diagnostic and therapeutic standards for diabetic NCI, based on Eye-Brain Multimodal Imaging technology, providing objective and quantitative evidence for early disease diagnosis and therapeutic effect evaluation. Simultaneously, investigators will conduct multicenter, randomized, placebo-controlled, double-blind clinical trials to systematically investigate the clinical efficacy and safety of Tangshen'an Granule in preventing and treating diabetic NCI. By obtaining high-quality evidence-based data on TCM, this study aims to enhance the level of prevention and treatment with TCM and clinical service capabilities, thereby providing new ideas and directions for research.

Start Date01 Oct 2025

Sponsor / Collaborator

Chengdu University of Traditional Chinese Medicine

CTRI/2024/10/075367

/ Not yet recruitingNot ApplicableIIT

A prospective, open-label, randomized, comparative clinical trial to assess theefficacy and safety of a novel Methylcobalamin Nasal Spray (NASO B12) or oral B12 supplementation in the treatment of subjects with vitamin B12 deficiencyas well as to evaluate the duration of efficacy - Nill

Start Date28 Oct 2024

Sponsor / Collaborator-

CTRI/2024/10/074789

/ Not yet recruitingNot Applicable

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence studyof Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions. - NIL

Start Date07 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Mecobalamin

100 Translational Medicine associated with Mecobalamin

100 Patents (Medical) associated with Mecobalamin

2,120

Literatures (Medical) associated with Mecobalamin

01 Sep 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Methylcobalamin-loaded ultra-flexible liposomes: a nanocarrier approach for modulating melanocyte homeostasis and addressing pigmentation imbalances

Article

Author: Erkut, Tülay Selin ; Gümüşderelioğlu, Menemşe ; Coşkun, Sema

Although various therapeutic approaches have been developed for hyperpigmentation, the reliability and efficacy of these treatments remain controversial. This study investigates the effect of methylcobalamin encapsulated in ultra-flexible liposomes on melanocyte homeostasis and evaluates its antioxidant potential for treating pigmentation disorders. Ultra-flexible liposomes with a final lipid concentration of 10 mM were prepared using soy phosphatidylcholine and sodium cholate via the thin-film hydration method. The particle sizes of blank and methylcobalamin-loaded liposomes were 118 ± 9 nm and 124 ± 3 nm, respectively, demonstrating their suitability for in vitro drug release, permeability studies and biomedical applications. Dynamic Light Scattering analysis confirmed the formation of ultra-flexible liposomes with a negative surface charge, similar to cell membranes. Stability studies showed that both particle size and zeta potential remained stable for up to 4 weeks, indicating the structural integrity of the formulation. Approximately 70 % of the encapsulated methylcobalamin was released within 24 h, with an encapsulation efficiency of around 42 %. These liposomes, with a deformability index close to 1, penetrated deeper into the epidermis and dermis of porcine ear skin compared to the free drug. Cell culture studies demonstrated the biocompatibility of the liposomes, with no cytotoxic effects on human dermal fibroblasts and a high uptake rate by human dermal melanocytes. In vitro experiments on melanocyte cells showed a reduction in melanin content, tyrosinase activity, and reactive oxygen species levels, indicating the antioxidant potential of methylcobalamin. In conclusion, methylcobalamin-loaded ultra-flexible liposomes appear to be promising nanocarriers for the targeted treatment of pigmentation disorders.

11 Jul 2025·MEDICINE

Central nervous system superficial siderosis: A case report and literature review

Review

Author: Li, Hong ; Xu, Qun ; Di, Mingxue ; Wen, Shengnan ; Yang, Guang

Rationale::

Superficial siderosis of the central nervous system (SSCNS) is a rare condition characterized by iron deposition on the surface tissues of the central nervous system. However, the diagnosis and treatment of diseases lack uniform principles.

Patient concerns::

A 64-year-old woman who was admitted to our hospital with progressive difficulty walking.

Diagnoses::

Based on the patient’s history of traumatic lumbar fractures, progressive hearing loss, and physical examination findings indicative of cerebellar ataxia, sensorineural deafness, and bilateral pyramidal tract involvement, combined with susceptibility-weighted imaging revealing linear low-signal intensities on the surfaces of the cerebral hemispheres, sulci, and spinal cord, a diagnosis of SSCNS was made.

Interventions::

The patient received treatment with Ginkgo biloba leaf extract tablets, mecobalamin, and vitamin B1.

Outcomes::

Her symptoms remained stable.

Lessons::

A literature review has revealed that most patients with SSCNS exhibit diverse clinical manifestations. Clinicians should consider SSCNS in patients presenting with hearing impairment and gait ataxia, particularly those receiving anticoagulant therapy, brain injury, or surgical intervention. The clinical manifestations, imaging findings, management strategies, and prognosis of these cases are discussed, highlighting the key roles of magnetic resonance imaging and susceptibility-weighted imaging in establishing a definitive diagnosis. In addition, the importance of a multidisciplinary team approach in providing holistic care for individuals has been emphasized. Clinicians are advised to investigate SSCNS in patients with hearing impairment and gait ataxia, particularly in those with a history of brain injury or surgery, using magnetic resonance imaging results.

23 Jun 2025·Scientific Reports

Green and white analytical approach for parallel quantification of gabapentin and methylcobalamin in medicinal products using inventive RP-HPLC technique.

Article

Author: Mohamed, Mahmoud A ; Binsaleh, Ammena Y ; Saleh, Sayed M ; Alminderej, Fahad M ; Alsehli, Bandar R ; Mahgoub, Samar M

A simple, selective, and environmentally sustainable RP-HPLC method was developed for simultaneous quantification of gabapentin (GAB) and Methylcobalamin (MET) in pharmaceutical products. Separation was achieved on a Zorbax Eclipse C8 column (150 × 4.6 mm, 3.5 μm) using a green mobile phase of potassium phosphate buffer (pH 6.9)/acetonitrile (95:5 v/v) at 2.0 mL/min, with detection at 210 nm. Total analysis time was 10 min with 100 µL injection volume. The method showed excellent linearity (3-50 µg/mL; R² > 0.9998), LODs (0.60-0.80 µg/mL), and LOQs (2.00-2.50 µg/mL). Environmental sustainability was validated by multiple metrics: AGREE (0.70), AGREEprep (0.71), and Analytical Eco-Scale (80), confirming superior greenness. Forced degradation studies demonstrated stability-indicating capability per ICH guidelines. This eco-friendly approach provides a reliable solution for quality control of GAB/MET formulations while minimizing environmental impact.

News (Medical) associated with Mecobalamin

17 Oct 2024

·pharma.economictimes.indiatimes.com

NPPA fixes retail price of 20 formulation drugs

New Delhi: The National Pharmaceutical Pricing Authority ( NPPA ) on Wednesday fixed the retail price of 20 new drugs under the provisions of the Drugs Prices Control Order (DPCO), 2013. These drugs are used for the treatment of various health-related problems . Bisoprolol and Amlodipine Tablet combination is used to treat blood pressure and Levosalbutamol and Ipratropium Bromide Respules combination helps in relaxing muscles of the airways and makes breathing easier. They are manufactured by Higgs Healthcare and Mankind Prime Labs Pvt Ltd. Other drugs like Atorvastatin , Aspirin and Clopidogrel Capsule combination manufactured by Surien Pharmaceuticals (P) Ltd./Unison Pharmaceuticals Pvt. Ltd. are used to prevent clot formation in the blood vessels. It also helps to reduce increased cholesterol and triglycerides levels. The decision regarding fixed price has been taken in the latest meeting. The retail price of cefuroxime axetil tablet from Dr Reddy's Laboratories, L- Carnitinr mecobalamin and folic acid tablet from cadila Pharmaceuticals was also fixed. Recently in a press statement the Union Ministry of Health, NPPA announced the revision of prices of eight scheduled drugs to meet the twin objectives of availability and affordability. "After detailed deliberations in the full Authority meeting held on 8th October, 2024, invoking extraordinary powers under Para 19 of the DPCO, 2013, and in larger public interest, NPPA has approved increase in the ceiling prices of eleven (11) scheduled formulations of eight (8) drugs by 50% of their current ceiling prices," reads the statement. It further states, "Most of these drugs are low-cost and generally used as first line treatment crucial to the public health programmes of the country. These drugs are used for treatment of Asthma, Glaucoma, Thalassemia, Tuberculosis, mental health disorders, etc." (ANI)

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

26 Jan 2024

·www.eisai.com

EISAI SUBMITS NEW DRUG APPLICATION FOR MECOBALAMIN ULTRAHIGH-DOSE FORMULATION IN JAPAN FOR THE INDICATION OF AMYOTROPHIC LATERAL SCLEROSIS

For Print（224KB） January 26, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan. In May 2022, ultrahigh-dose mecobalamin received orphan drug designation by the Ministry of Health, Labour and Welfare (MHLW). This application is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), a Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients, that was conducted as an investigator-initiated trial by a research team with Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University, and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, and Professor Satoshi Kuwabara (Coordinating Investigator), the Department of Neurology, Chiba University Graduate School of Medicine. The results of JETALS were published in the peer-reviewed journal JAMA Neurology. ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 3 to 6 years from the onset of the disease. The number of patients in Japan is estimated to be approximately 10,000. Currently, there is no curative treatment established for ALS, and since there are only limited number of medicines approved in Japan and abroad, this is a disease with significant unmet medical needs. Eisai considers neurology a therapeutic area of focus. As a human healthcare company, Eisai is committed to fulfill unmet medical needs in neurology and further its contribution to improving the benefit of patients and the people in the daily living domain. Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors] Mecobalamin (generic name, development code: E0302) is approved and marketed as Methycobal®, a 500 µg injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency. Methycobal is also approved as a tablet formulation (250µg and 500 µg) as well as a fine granule formulation (0.1%) indicated for the treatment of peripheral neuropathies. While the mechanism of action of mecobalamin in amyotrophic lateral sclerosis (ALS) is not known, it has been suggested in non-clinical research that mecobalamin may have efficacy through a neuroprotective effect and regeneration of nerve axons. Since the 1990s, clinical research has been carried out on ultrahigh-dose mecobalamin in ALS by a study group on neurodegenerative disease, funded through the Ministry of Health, Labour and Welfare's Specified Disease Treatment Research Program. Short- and long-term trials of intramuscular injection of mecobalamin at 25 mg and 50 mg per day, which is respectively 50 and 100 times the approved dosage of Methycobal, suggested that ultrahigh-dose mecobalamin could have a clinical effect in ALS. Therefore, Eisai had conducted the Phase II/III clinical trial (Study 761) since 2006 and submitted a new drug application for ultrahigh-dose mecobalamin as treatment for ALS in May 2015 but withdrew the application in March 2016 after the Pharmaceuticals and Medical Devices Agency (PMDA) indicated that additional clinical trials were necessary. Following favorable clinical trial results in JETALS, Eisai prepared to file a new drug application for ALS in Japan. Full text（224KB）

Phase 3NDAOrphan DrugDrug Approval

100 Deals associated with Mecobalamin

External Link

KEGG	Wiki	ATC	Drug Bank
D03246	Mecobalamin	B03BA05	DB03614

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Amyotrophic Lateral Sclerosis	Japan	Eisai Co., Ltd.	24 Sep 2024
Peripheral Nervous System Diseases	Japan	Tsuruhara Pharmaceutical Co. Ltd.	16 Apr 1987
Neuralgia	China	Eisai China, Inc.	-
Neuritis	China	Eisai China, Inc.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Methylmalonic Acidemia	Preclinical	United States	National Institutes of Health	22 Oct 2024

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03548311 (Pubmed \| JAMA Neurol)	Phase 3	Amyotrophic Lateral Sclerosis	130	Methylcobalamin	ezzzkdqsyt(bagmsgfstz) = titzknzxls agelqxtryh (cjmxkspilt )	Positive	09 May 2022
				Placebo	ezzzkdqsyt(bagmsgfstz) = hfewwcobrz agelqxtryh (cjmxkspilt )
NCT04372316 (Pubmed \| Sci Rep)	Phase 2	Diabetic peripheral neuropathy	-	Mecobalamin intramuscular injections	oladhuprvd(ylagbswutl) = zlcbwbryzq eszskvcpqh (ragrtbjtgo )	Positive	19 Jul 2021
				Mecobalamin oral tablets	oladhuprvd(ylagbswutl) = olllhwhjdl eszskvcpqh (ragrtbjtgo )

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