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Vitamin B12
Vitamin B12 is a Vitamin / Essential nutrient Small molecule drug developed by Acrotech Biopharma Inc.. It is currently FDA-approved for Vitamin B12 deficiency anemia, Pernicious anemia, B12 deficiency due to malabsorption or dietary insufficiency. Also known as: cobalamin, Vit B12, Cyanocobalamin, Vitabee 12.
Vitamin B12 acts as a coenzyme essential for DNA synthesis, myelin formation, and cellular energy metabolism.
Vitamin B12 is a water-soluble vitamin that serves as a vital cofactor in DNA synthesis, fatty acid, and amino acid metabolism. It plays an essential role in the nervous system by supporting myelin synthesis and is critical for the maturation of red blood cells in the bone marrow.
At a glance
| Generic name | Vitamin B12 |
|---|---|
| Also known as | cobalamin, Vit B12, Cyanocobalamin, Vitabee 12 |
| Sponsor | Acrotech Biopharma Inc. |
| Drug class | Vitamin / Essential nutrient |
| Target | Methionine synthase, methylmalonyl-CoA mutase |
| Modality | Small molecule |
| Therapeutic area | Hematology / Neurology |
| Phase | FDA-approved |
Mechanism of action
Vitamin B12 (cobalamin) functions as a cofactor for methionine synthase and methylmalonyl-CoA mutase, enzymes critical for nucleotide synthesis and mitochondrial metabolism. It is required for proper red blood cell formation, neurological function, and maintenance of myelin sheaths around nerve fibers. Deficiency leads to megaloblastic anemia and neurological complications that are reversed by B12 supplementation.
Approved indications
- Vitamin B12 deficiency anemia
- Pernicious anemia
- B12 deficiency due to malabsorption or dietary insufficiency
- Neurological complications of B12 deficiency
Common side effects
- Injection site reactions (pain, redness)
- Hypokalemia
- Itching or rash
- Headache
Key clinical trials
- Iron and Immune Response to Vaccine (IRONMUM) (NA)
- Clinical and Laboratory Study of Methylmalonic Acidemia
- Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
- Effect of Vitamin D and Folic Acid on Mild Cognitive Impairment (NA)
- Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults (NA)
- Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention (NA)
- Combination Gerotherapeutic Interventions for Healthspan Improvement (PHASE3)
- A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vitamin B12 CI brief — competitive landscape report
- Vitamin B12 updates RSS · CI watch RSS
- Acrotech Biopharma Inc. portfolio CI
Frequently asked questions about Vitamin B12
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Related
- Drug class: All Vitamin / Essential nutrient drugs
- Target: All drugs targeting Methionine synthase, methylmalonyl-CoA mutase
- Manufacturer: Acrotech Biopharma Inc. — full pipeline
- Therapeutic area: All drugs in Hematology / Neurology
- Indication: Drugs for Vitamin B12 deficiency anemia
- Indication: Drugs for Pernicious anemia
- Indication: Drugs for B12 deficiency due to malabsorption or dietary insufficiency
- Also known as: cobalamin, Vit B12, Cyanocobalamin, Vitabee 12
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing