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Mecobalamin IM injection
Mecobalamin IM injection is a Vitamin B12 analog Small molecule drug developed by Eisai Co., Ltd.. It is currently FDA-approved for Vitamin B12 deficiency with neurological manifestations, Peripheral neuropathy associated with B12 deficiency, Subacute combined degeneration.
Mecobalamin is an active form of vitamin B12 that replenishes cellular cobalamin stores and restores normal methylation and energy metabolism.
Mecobalamin is a small molecule administered via intramuscular (IM) injection, used to treat conditions such as Diabetic Peripheral Neuropathy and Peripheral Neuropathy, as well as Amyotrophic Lateral Sclerosis (ALS).
At a glance
| Generic name | Mecobalamin IM injection |
|---|---|
| Sponsor | Eisai Co., Ltd. |
| Drug class | Vitamin B12 analog |
| Target | Methionine synthase; B12-dependent enzymes |
| Modality | Small molecule |
| Therapeutic area | Neurology; Hematology |
| Phase | FDA-approved |
Mechanism of action
Mecobalamin is a methylcobalamin derivative that acts as a cofactor for methionine synthase and other B12-dependent enzymes essential for DNA synthesis, myelin formation, and neuronal function. It crosses the blood-brain barrier more effectively than cyanocobalamin and is directly utilized in cellular metabolism without requiring enzymatic conversion. This makes it particularly effective for treating B12 deficiency-related neurological conditions.
Approved indications
- Vitamin B12 deficiency with neurological manifestations
- Peripheral neuropathy associated with B12 deficiency
- Subacute combined degeneration
- Pernicious anemia with neurological complications
Common side effects
- Injection site reactions
- Headache
- Dizziness
- Itching or rash
- Hypokalemia (rare)
Key clinical trials
- Clinical Trial of Ultra-high Dose Methylcobalamin for ALS (PHASE3)
- Needle-Free Subcutaneous Injector and Conventional Intramuscular Injection of Mecobalamin in Diabetes Peripheral Neuropathy (NA)
- A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS) (PHASE2, PHASE3)
- A Study in Patients With Amyotrophic Lateral Sclerosis (ALS) (PHASE2, PHASE3)
- Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109) (PHASE4)
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:
- Mecobalamin IM injection CI brief — competitive landscape report
- Mecobalamin IM injection updates RSS · CI watch RSS
- Eisai Co., Ltd. portfolio CI
Frequently asked questions about Mecobalamin IM injection
What is Mecobalamin IM injection?
How does Mecobalamin IM injection work?
What is Mecobalamin IM injection used for?
Who makes Mecobalamin IM injection?
What drug class is Mecobalamin IM injection in?
What development phase is Mecobalamin IM injection in?
What are the side effects of Mecobalamin IM injection?
What does Mecobalamin IM injection target?
Related
- Drug class: All Vitamin B12 analog drugs
- Target: All drugs targeting Methionine synthase; B12-dependent enzymes
- Manufacturer: Eisai Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Neurology; Hematology
- Indication: Drugs for Vitamin B12 deficiency with neurological manifestations
- Indication: Drugs for Peripheral neuropathy associated with B12 deficiency
- Indication: Drugs for Subacute combined degeneration
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing