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Nucleotides + B12
Nucleotides + B12 is a Nutritional supplement / Vitamin combination Small molecule drug developed by Fundação Educacional Serra dos Órgãos. It is currently FDA-approved for Nutritional supplementation for nucleotide and B12 deficiency, Support for hematopoiesis and cellular metabolism. Also known as: Group A.
Nucleotides provide building blocks for DNA and RNA synthesis, while B12 (cobalamin) supports methylation reactions and red blood cell formation.
Nucleo CMP and Neurorubine combination therapy has been studied for its potential in treating classical trigeminal neuralgia, with one clinical trial suggesting it provides sustained long-term pain control compared to conventional carbamazepine therapy. Additionally, this combination has been investigated in clinical trials for other conditions, including neuropathic pain, hepatitis C, lymphoma, and T-cell conditions.
At a glance
| Generic name | Nucleotides + B12 |
|---|---|
| Also known as | Group A |
| Sponsor | Fundação Educacional Serra dos Órgãos |
| Drug class | Nutritional supplement / Vitamin combination |
| Modality | Small molecule |
| Therapeutic area | Hematology / Nutritional deficiency |
| Phase | FDA-approved |
Mechanism of action
Nucleotides (adenine, guanine, cytosine, thymine, uracil derivatives) serve as precursors for nucleic acid synthesis and cellular energy metabolism. Vitamin B12 is an essential cofactor for methionine synthase and methylmalonyl-CoA mutase, critical for DNA synthesis, myelin formation, and erythropoiesis. Together, this combination supports cellular proliferation and hematopoietic function.
Approved indications
- Nutritional supplementation for nucleotide and B12 deficiency
- Support for hematopoiesis and cellular metabolism
Common side effects
- Gastrointestinal upset
- Allergic reactions (rare)
Key clinical trials
- Combination Gerotherapeutic Interventions for Healthspan Improvement (PHASE3)
- Nucleo CMP and Neurorubine Versus Carbamazepine for Classical Trigeminal Neuralgia (PHASE2)
- Evaluation of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy (PHASE4)
- Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies (PHASE1, PHASE2)
- Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy (PHASE2, PHASE3)
- Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma (NA)
- Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma (PHASE1, PHASE2)
- Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection. (PHASE3)
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:
- Nucleotides + B12 CI brief — competitive landscape report
- Nucleotides + B12 updates RSS · CI watch RSS
- Fundação Educacional Serra dos Órgãos portfolio CI
Frequently asked questions about Nucleotides + B12
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Related
- Drug class: All Nutritional supplement / Vitamin combination drugs
- Manufacturer: Fundação Educacional Serra dos Órgãos — full pipeline
- Therapeutic area: All drugs in Hematology / Nutritional deficiency
- Indication: Drugs for Nutritional supplementation for nucleotide and B12 deficiency
- Indication: Drugs for Support for hematopoiesis and cellular metabolism
- Also known as: Group A
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing