{"slug":"vitamin-b12","seoKey":"vitaminb12","inn":"cyanocobalamin","displayName":"Vitamin B12","codes":["B03BA01"],"synonyms":["cyanocobalamin","cobalamin","vitamin B-12","cyanocobalaminum","cianocobalamina","CN-Cbl","cyanocob(III)alamin","5,6-dimethylbenzimidazolyl-cyanocobamide","hydroxocobalamin, methylcobalamin (mecobalamin) and adenosylcobalamin (cobamamide) are related B12 forms with their own registry numbers"],"legalClass":"rx","identifiers":{"cas":"68-19-9","pubchemCid":166596686,"unii":"P6YC3EG204","inchikey":"RMRCNWBMXRMIRW-WZHZPDAFSA-L","drugbankId":"DB00115","chemblId":"CHEMBL2110563","wikidataQid":"Q252251","formula":"C63H88CoN14O14P","molecularWeight":1355.4},"approvals":[{"market":"US","status":"approved_rx","note":"Injectable cyanocobalamin is approved and prescription-only: numerous generic applications are listed with prescription marketing status, and the labelling carries 'Rx only'. The labelled use is vitamin B12 deficiency due to malabsorption, including pernicious anaemia. A nasal spray was approved on 2005-01-31; the approval database lists it as discontinued for reasons other than safety or effectiveness, while the labelling database still shows a 2026 label, and generic nasal sprays are prescription-only as well. The nasal spray label gives 1942 as the initial US approval. Oral cyanocobalamin and methylcobalamin are sold as dietary supplements; this was inferred from the market, not confirmed through a primary regulator source. Methylcobalamin is on the list of bulk substances under evaluation for pharmacy compounding.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:cyanocobalamin"},{"market":"EU","status":"scheduled","note":"Recorded as scheduled in the sense of regulated supply that differs by member state, not as a prescription requirement: there is no centralised authorisation for cyanocobalamin as a vitamin medicine, and authorisations and dispensing categories are national and not uniform, as Germany shows with pharmacy-only injections that need no prescription. The only centrally authorised B12 form is high-strength hydroxocobalamin as an antidote for cyanide poisoning, authorised on 2007-11-23. Food supplements fall under the supplements directive, and there is no harmonised maximum amount for B12. Whether methylcobalamin and adenosylcobalamin are permitted supplement forms under the EU list could not be verified, because the legal database returned empty responses.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/cyanokit"},{"market":"DE","status":"scheduled","note":"Recorded as scheduled because the injections are authorised medicines restricted to pharmacies, NOT because they need a prescription: they are pharmacy-only and available without one. The annex of prescription-only substances was checked in the original on 2026-09-23: cyanocobalamin, cobalamin, mecobalamin, cobamamide and vitamin B12 are not listed, and its single entry ending in '-obalamin' covers hydroxocobalamin for cyanide poisoning only. A German injection label states 'Verkaufsabgrenzung: Apothekenpflichtig' (pharmacy-only). Oral products are sold as non-prescription medicines, low-strength ones also as food supplements. The substance is not named in the annex to the anti-doping act.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","note":"Injections are prescription-only medicines. This rests on two current hydroxocobalamin injection labels, revised on 2024-01-23 and 2024-06-18, which state that legal category. No current label for a British cyanocobalamin injection was found; the former product's label returned HTTP 404. Oral cyanocobalamin tablets are authorised, but their dispensing category was not stated in the retrieved label.","source":"https://www.medicines.org.uk/emc/product/100455/smpc"},{"market":"AU","status":"scheduled","note":"Recorded as scheduled only in the sense of a registered medicine; under the Poisons Standard itself the injection is NOT scheduled and needs no prescription. The registered hydroxocobalamin injection, first registered on 2006-09-25, states 'Not Scheduled'. The Poisons Standard contains no cobalamin entry, and its prescription entry for cobalt for human therapeutic use does not capture cobalamins according to that sponsor classification. Caveat: the June 2024 edition was checked, not the current one, and no Australian cyanocobalamin injection label was retrieved.","source":"https://medsinfo.com.au/api/documents/Neo-B12_Injection_PI?format=pdf"},{"market":"CA","status":"scheduled","note":"Recorded as scheduled because injections are authorised medicines with a restricted supply schedule, NOT because they need a prescription: cyanocobalamin injections carry the drug product database schedule 'Ethical', a non-prescription status for products marketed to health professionals; one of them has been marketed since 2018-01-16. Oral products are listed as well. Caveat: the prescription drug list was not queried separately; the classification rests on the database schedule field.","source":"https://health-products.canada.ca/api/drug/drugproduct/?lang=en&type=json&brandname=CYANOCOBALAMIN"},{"market":"CH","status":"approved_rx","note":"Injections of cyanocobalamin and hydroxocobalamin are in dispensing category B, which requires a prescription, according to the list of authorised packs as of 2026-08-31. Oral single-ingredient products are in category D, which needs no prescription. High-strength hydroxocobalamin as a cyanide antidote is in category A.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/authorized-medicines/list-of-authorized-medicinal-products.html"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00106886","name":"HOPE-2: folic acid, B6 and B12 in vascular disease or diabetes (no effect on the main heart outcome)","phase":"Phase 4","n":5522,"status":"UNKNOWN"},{"nct":"NCT00266487","name":"NORVIT: folic acid and B12 with or without B6 after a heart attack (no effect on the combined outcome)","n":3749,"status":"COMPLETED"},{"nct":"NCT00354081","name":"WENBIT: folic acid and B12 with or without B6 in heart patients (pooled with NORVIT for later analyses)","phase":"Phase 3","status":"COMPLETED"},{"nct":"NCT00375388","name":"HOME: metformin in type 2 diabetes on insulin, with B12 levels as an outcome","phase":"Phase 3","n":390,"status":"COMPLETED"},{"nct":"NCT03548311","name":"JETALS: methylcobalamin in early amyotrophic lateral sclerosis (Japan)","phase":"Phase 3","n":130,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q252251","https://pubchem.ncbi.nlm.nih.gov/compound/166596686","https://go.drugbank.com/drugs/DB00115","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2110563/"],"lastVerified":"2026-09-24","version":"1.0","published":true,"locale":"en","title":"Vitamin B12: what the studies show, status and safety","summary":"Vitamin B12 is not a peptide. It is an essential vitamin built around a cobalt atom, and it appears in this register because it is sold alongside weight-loss injections, often mixed into them. Its one proven use is treating and preventing a deficiency, including the one that long-term metformin can cause. In people without a deficiency, trials with more than 71,000 participants found no benefit for the heart, and pooled data on 22,000 people found none for memory and thinking. Injections need a prescription in the United States, Switzerland and the United Kingdom, but not in Germany.","updated":"2026-09-24","url":"https://mypep.app/peptides/vitamin-b12"}