Cyanocobalamin

Evidence Level: L5

Predicted Indications: 1

Cyanocobalamin

Pharmacist Assessment Report

Cyanocobalamin: vitamin B12 (cobalamin) → biotin metabolic disease

One-Sentence Summary

Cyanocobalamin is a synthetic form of vitamin B12, a cobalamin cofactor used to correct B12-related deficiency states. The TxGNN model predicts it may be relevant to biotin metabolic disease, but the evidence is thin: 0 clinical trials and 1 publication (a general review on vitamin production, not a study of this disease).

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	biotin metabolic disease
TxGNN Prediction Score	0.9960
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (8 of 8) – CDSCO approval status is not included in this data
Number of Listed Products	8 (valid: 8)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data is not available in the data compiled for this report. Cyanocobalamin is known to act as a cofactor for two enzymes: methionine synthase and methylmalonyl-CoA mutase.

Biotin metabolic diseases (for example biotinidase deficiency or holocarboxylase synthetase deficiency) involve defects in biotin recycling or in biotin-dependent carboxylases. The only link to cyanocobalamin is a loose shared pathway context: propionyl-CoA carboxylase depends on biotin, while methylmalonyl-CoA mutase depends on cobalamin, and both sit on the propionyl-CoA/methylmalonate route.

This overlap is the more likely source of the high model score than any therapeutic benefit. The score of 0.9960 reflects a model-based prediction only, and no data compiled here supports a direct treatment effect. The prediction should be treated as a hypothesis.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
1368195	1992	Review	Journal of Chemical Technology and Biotechnology	Overview of biotechnological production of vitamins and coenzymes; does not study biotin metabolic disease or treatment with cyanocobalamin

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
173652	Polybion Injection 2ml	Ampoule of 5 injections	Not recorded
94517	Genoplex-L Syrup	Bottle of 60 ml syrup	Not recorded
26103	Bvigor Sublingual tablet Cherry	Strip of 10 sublingual tablets	Not recorded
233952	VIB 12 1000mcg Injection	Vial of 1 ml injection	Not recorded
224998	Titoebion Injection	Vial of 2 ml injection	Not recorded

All 8 licences are currently valid; the table lists the first five.

Review correction (2026-11-06): Originally stated: “All 8 licences are single-ingredient products and currently valid; the table lists the first five.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Please refer to the package insert for safety information.

The drug-interaction screening returned 313 records. The ones listed are mostly minor, including acid-suppressing drugs (famotidine, ranitidine, cimetidine, omeprazole, pantoprazole, esomeprazole, lansoprazole, rabeprazole) and potassium chloride. Several others have an unrated level, including metformin, glimepiride, acarbose, rosiglitazone, doxycycline, mesalazine, morphine and sucralfate.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests only on a model score. No clinical trial or publication directly studies cyanocobalamin in biotin metabolic disease, and the mechanistic link is indirect, so the evidence level is L5.

To proceed, the following is needed:

Mechanism-of-action data for cyanocobalamin, to test the proposed pathway link
Preclinical or clinical studies directly addressing biotin metabolic disease
Package insert warnings and contraindications from the licence holders
Review of the large set of recorded drug interactions for relevance to the intended population

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient products and”	Corrected	Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.