MedPath

Cobamamide

Generic Name
Cobamamide
Brand Names
EnBrace HR, EnLyte
Drug Type
Small Molecule
Chemical Formula
C72H100CoN18O17P
CAS Number
13870-90-1
Unique Ingredient Identifier
F0R1QK73KB

Overview

Cobamamide is one of the active forms of vitamin B12 that is also known as adenosylcobalamin or dibencozide. This drug is available as a nutritional supplement to prevent vitamin B12 deficiency. Vitamin B12 is a collective term for these variously substituted corrinoids. The principal biochemical participants are two coenzyme forms of Vitamin B12 that are produced and activated in two separate cellular compartments: methylcobalamin in the cytosol and adenosylcobalamin in the mitochondria . Vitamin B12 (cyancobalamin, Cbl) has two active co-enzyme forms, methylcobalamin (MeCbl) and adenosylcobalamin (AdCbl). There has been a shift in the treatment of vitamin B12 deficiency such that MeCbl is being extensively used and promoted. This exists despite the fact that both MeCbl and AdCbl are necessary for life and have vastly different metabolic fates and functions. MeCbl is mainly involved along with folate in hematopoiesis and the growth of the brain during childhood. Deficiency of AdCbl disturbs the carbohydrate, fat and amino-acid metabolism, and therefore interferes with the formation of myelin. It is therefore important to treat vitamin B12 deficiency with a combination of MeCbl and AdCbl or hydroxocobalamin or cobalamin . Vitamin B12 has important physiological roles including DNA synthesis, myelin formation in the nervous system, red blood cell formation, as well as fatty acid and amino acid metabolism . Please refer to the entry Vitamin B12 for more information on this entry.

Indication

用于各种原因导致的周围神经病变,对各种神经痛如三叉神经痛、坐骨神经痛、多发性神经炎、神经根炎、神经麻痹均有效;各种原因导致的肝炎、肝硬化;风湿性心脏病、关节炎、肌肉和关节劳损;甲基丙二酸血症、萎缩性胃炎、胃大部切除术患者;巨幼红细胞性贫血、营养不良性贫血、妊娠期贫血、恶性贫血;放射线和药物引起的白细胞减少、口腔溃疡。

Associated Conditions

  • Malnutrition
  • Vitamin B12 Deficiency
  • Weight Loss

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/07/13
Not Applicable
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Jaymac Pharma
64661-650
ORAL
50 ug in 1 1
6/9/2019
Jaymac Pharma
64661-793
ORAL
50 ug in 1 1
7/18/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Cobamamide Capsules
国药准字H20253418
化学药品
胶囊剂
2/20/2025
Cobamamide Capsules
国药准字H20249040
化学药品
胶囊剂
10/9/2024
Cobamamide Capsules
国药准字H20253704
化学药品
胶囊剂
3/25/2025
Cobamamide Capsules
国药准字H20243489
化学药品
胶囊剂
4/11/2024
Cobamamide Capsules
国药准字H20253590
化学药品
胶囊剂
3/11/2025
Cobamamide Capsules
国药准字H20253651
化学药品
胶囊剂
3/18/2025
Cobamamide Capsules
国药准字H20254021
化学药品
胶囊剂
4/30/2025
Cobamamide Capsules
国药准字H20254058
化学药品
胶囊剂
4/30/2025
Cobamamide Capsules
国药准字H20244639
化学药品
胶囊剂
8/5/2024
Cobamamide Capsules
国药准字H20213912
化学药品
胶囊剂
11/30/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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