Drugs / Vitamin B12
last change Jun 2026 re-read 8 days ago

Vitamin B12

English name Cyanocobalamin

Other / unclassified

Developed for
vitamin B12 deficiency · anemia · myocardial infarction · psoriasis · aphthous stomatitis · carpal tunnel syndrome · end stage renal failure · hyperhomocysteinemia
+38 more · psychotic disorder · acute myocardial infarction · Alzheimer disease · Angelman syndrome · atherosclerosis · atopic eczema · autism · cardiomyopathy · cardiovascular disorder · cerebral infarction · chronic hepatitis C virus infection · circadian rhythm sleep disorder · congenital anomaly of cardiovascular system · congestive heart failure · coronary artery disorder · coronary atherosclerosis · cranial nerve palsy · depressive disorder · hyperlipidemia · hypertension, pregnancy-induced · infectious disease with sepsis · iron deficiency anemia · kidney failure · male infertility · myocardial ischemia · neural tube defect · obstructive sleep apnea syndrome · papilloma · pulmonary embolism · stomatitis · stroke disorder · transient ischemic attack · traumatic brain injury · venous thromboembolism · cognitive disorder · COVID-19 · disorder of iron metabolism and transport · premature ejaculation
Investigated by
Brigham and Women's Hospital · Foundation for Anesthesia Education and Research · National Institute on Aging (NIA) · Tanta University · University of Aarhus · Washington University School of Medicine
+89 more · Aarelab AG · Abbott · Abbott Diagnostics Division · Aga Khan University · Alzheimer's Disease Cooperative Study (ADCS) · Australian Government Department of Health and Ageing · Australian National University · Babujinaya Cela · Baylor College of Medicine · Boston Children's Hospital · Canadian Institutes of Health Research (CIHR) · Casa de Saúde santa Marcelina · Centers for Disease Control and Prevention · Centre Hospitalier St Anne · Centro di Ricerca Clinica Salentino · Commonwealth Scientific and Industrial Research Organisation, Australia · Dalia Salah Saif · Delhi University · Emisphere Technologies, Inc. · Emory University · Fan Zeng · Federal University of São Paulo · Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway · Fundação Educacional Serra dos Órgãos · Georgetown University · Ghana Health Services · Greenwood Genetic Center · Göteborg University · Hamilton Health Sciences Corporation · Harvard School of Public Health (HSPH) · Indian Council of Medical Research · Inland Norway University of Applied Sciences · Innlandet Hospital Trust · Johns Hopkins Bloomberg School of Public Health · KRL Hospital, Islamabad · Laboratorios Silanes S.A. de C.V. · Leiner Health Products · Medice Arzneimittel Pütter GmbH & Co KG · Meir Medical Center · Melbourne Health · Muhammad · National Center for Complementary and Integrative Health (NCCIH) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of General Medical Sciences (NIGMS) · National Institute of Neurological Disorders and Stroke (NINDS) · Netherlands Heart Foundation · Northwell Health · Office of Dietary Supplements (ODS) · Ondokuz Mayıs University · Pak Emirates Military Hospital · Pan American Laboratories · Phoenix VA Health Care System · Population Health Research Institute · Radboud University Medical Center · Rady Children's Hospital, San Diego · Rare Diseases Clinical Research Network · Rigshospitalet, Denmark · Ruhr University of Bochum · Second Affiliated Hospital of Nanchang University · Soroka University Medical Center · Spartanburg Regional Healthcare System · Stanley Medical Research Institute · Staten Island University Hospital · Swedish Orphan Biovitrum · The Council on Health and Rehabilitation, Norway · The International Federation of Red Cross and Red Crescent Societies · The Norwegian Council on Cardiovascular Disease · The Research Council of Norway · The Royal Norwegian Ministry of Health · Tri-Service General Hospital (TSGH) · UMC Utrecht · US Department of Veterans Affairs · Unity Health Toronto · all 95 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) CYANOCOBALAMIN — 1997-06-25 fda.gov ↗
Approved US (FDA) BEROCCA PN — 1947-07-28 fda.gov ↗

Trials 59

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials · 1 missed
Phase 0 NCT05330936 Jan 2021 → Sep 2022 psoriasis Pak Emirates Military Hospital Completed No outcome recorded
Phase 0 NCT03437824 Oct 2017 → Apr 2019 vitamin B12 deficiency University of Southern California Completed Missed primary
Phase 13 trials
Phase 1 NCT04235426 Jan 2018 → Jan 2021 carpal tunnel syndrome Dalia Salah Saif Unknown No outcome recorded
Phase 1 NCT01864824 Jun 2013 → Jul 2014 — Harvard School of Public Health (HSPH) Completed No outcome recorded
Phase 1 NCT01306123 Feb → May 2011 — Swedish Orphan Biovitrum Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01704599 Jan 2009 → Jun 2013 psoriasis Wayne State University Terminated No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT06098456 Nov 2023 → May 2024 papilloma Centro di Ricerca Clinica Salentino Completed No outcome recorded
Phase 2 NCT03778008 Dec 2018 → Dec 2019 stomatitis Second Affiliated Hospital of Nanchang University Unknown No outcome recorded
Phase 2 NCT02773147 Apr 2016 → Nov 2018 HIV infectious disease Göteborg University Unknown No outcome recorded
Phase 2 NCT01490944 Jan → Nov 2012 anemia Indian Council of Medical Research Unknown No outcome recorded
Phase 2 NCT00214682 Oct 2005 → Jan 2011 depressive disorder Australian National University Completed No outcome recorded
Phase 2 NCT00000541 May 1993 → Jul 2005 coronary atherosclerosis, myocardial infarction, myocardial ischemia Brigham and Women's Hospital Completed Missed primary
Phase 2/34 trials · 3 missed
Phase 2/3 NCT05005897 Dec 2021 → Oct 2025 overdue vitamin B12 deficiency Innlandet Hospital Trust Recruiting No outcome recorded
Phase 2/3 NCT00202280 Sep 2004 → Sep 2006 psychotic disorder Melbourne Health Completed Missed primary
Phase 2/3 NCT00064753 May 2002 → Oct 2011 cardiovascular disorder, chronic kidney disease National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed Missed primary
Phase 2/3 NCT00114400 Nov 2000 → Feb 2007 atherosclerosis National Institute on Aging (NIA) Completed Missed primary
Phase 310 trials · 3 missed
Phase 3 NCT06966856 Dec 2026 → Dec 2028 expected vitamin B12 deficiency Tanta University Not yet recruiting No outcome recorded
Phase 3 NCT06517823 Apr → Oct 2024 — Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 3 NCT05796401 Dec 2023 → Dec 2026 expected psychotic disorder Centre Hospitalier St Anne Recruiting No outcome recorded
Phase 3 NCT05958277 Jun 2021 → Jan 2023 traumatic brain injury KRL Hospital, Islamabad Completed No outcome recorded
Phase 3 NCT02007837 Jan → Apr 2018 hypertension, pregnancy-induced UMC Utrecht Unknown No outcome recorded
Phase 3 NCT00116493 Apr 2004 → May 2007 anemia Johns Hopkins Bloomberg School of Public Health Completed Missed primary
Phase 3 NCT00056225 Jan 2003 → Jun 2007 Alzheimer disease National Institute on Aging (NIA) Completed Missed primary
Phase 3 NCT00032435 May 2001 → Aug 2006 end stage renal failure, kidney failure US Department of Veterans Affairs Completed Missed primary
Phase 3 NCT00350116 Jan 2001 → Dec 2004 psoriasis Ruhr University of Bochum Completed No outcome recorded
Phase 3 NCT00004734 Sep 1996 → Feb 2004 cerebral infarction, myocardial infarction National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 49 trials · 2 missed
Phase 4 NCT07592897 Jun → Nov 2026 expected — University of Sao Paulo Not yet recruiting No outcome recorded
Phase 4 NCT07523646 May 2026 → Apr 2028 expected anemia, infective endocarditis Rigshospitalet, Denmark Recruiting No outcome recorded
Phase 4 NCT07029698 Apr → Oct 2025 vitamin B12 deficiency Medice Arzneimittel Pütter GmbH & Co KG Completed No outcome recorded
Phase 4 NCT05221892 Nov 2021 → Mar 2023 — Fundação Educacional Serra dos Órgãos Completed No outcome recorded
Phase 4 NCT02120274 Mar 2014 → May 2016 Flaviviridae infectious disease, chronic hepatitis C virus infection Federal University of São Paulo Terminated No outcome recorded
Phase 4 NCT01832129 May 2013 → Dec 2015 vitamin B12 deficiency University Hospital, Basel, Switzerland Completed Missed primary
Phase 4 NCT03221816 Dec 2008 → Jan 2010 hyperhomocysteinemia, hyperlipidemia Casa de Saúde santa Marcelina Completed No outcome recorded
Phase 4 NCT00326833 Jan 2006 → Dec 2010 vitamin B12 deficiency University of Aarhus Unknown No outcome recorded
Phase 4 NCT00106886 Dec 1999 → Oct 2005 cancer, myocardial infarction, stroke disorder Hamilton Health Sciences Corporation Unknown Missed primary
Phase not applicable24 trials · 3 missed
— NCT06749756 Feb 2025 → Feb 2026 overdue infectious disease with sepsis Fan Zeng Recruiting No outcome recorded
— NCT06301685 Mar → Jun 2024 autism Muhammad Unknown No outcome recorded
— NCT06249490 Feb → May 2024 obstructive sleep apnea syndrome Zeng Changhao Unknown No outcome recorded
— NCT04343170 Sep 2023 → Sep 2024 idiopathic scoliosis, iron deficiency anemia Tanta University Completed No outcome recorded
— NCT06347250 Jan 2022 → May 2023 cranial nerve palsy Babujinaya Cela Completed No outcome recorded
— NCT06042738 Mar → Nov 2021 male infertility Ondokuz Mayıs University Completed No outcome recorded
— NCT03802422 Apr 2019 → Apr 2020 carpal tunnel syndrome Tri-Service General Hospital (TSGH) Withdrawn No outcome recorded Stop: Enrollment
— NCT01127724 Jun 2012 → Oct 2014 aphthous stomatitis Meir Medical Center Terminated No outcome recorded Stop: Enrollment
— NCT01317849 Jul 2011 → Jun 2016 transient ischemic attack Xijing Hospital Withdrawn No outcome recorded Stop: Business
— NCT01474486 Apr 2010 → Feb 2016 cardiomyopathy, congestive heart failure Phoenix VA Health Care System Completed No outcome recorded
Comparator or background therapy37 trials
Phase 1 NCT05426395 Comparator Jun 2023 → Jan 2024 overdue vitamin B12 deficiency George Washington University Active not recruiting No outcome recorded
Phase 1 NCT05027126 Background Feb → Nov 2019 — Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 1 NCT03101579 Background Mar 2017 → Sep 2018 malignant tumor of meninges The First Hospital of Jilin University Completed No outcome recorded
Phase 1/2 NCT05289908 Background Feb 2022 → Mar 2023 malignant leptomeningeal tumor The First Hospital of Jilin University Completed No outcome recorded
Phase 1/2 NCT04708340 Comparator Mar 2021 → Oct 2022 COVID-19, acute respiratory distress syndrome Reven Pharmaceuticals, Inc. Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2023-07-03 Lupin Limited Regulatory Lupin Receives Approval from U.S. FDA for Cyanocobalamin Nasal Spray lupin.com ↗
2022-04-18 Zydus Lifesciences Limited Regulatory Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection zyduslife.com ↗
Zydus Lifesciences Ltd. (Formerly known as Cadila Healthcare Ltd.) has received final approval from the USFDA to market Cyanocobalamin Injection in the strengths of 1,000 mcg/mL,10,000 mcg/10 mL (1,000 mcg/mL), and 30,000 mcg/30 mL (1,000 mcg/mL) Multiple -Dose Vials.

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 104 sources stand behind the page.

FieldValueCited text
Known as vitamin B(12) “with daily multivitamins [vitamin A (300 microg, as retinol palmitate), vitamin E (6 mg tocopherol equivalents), vitamin B-12 (0.9 microg), vitamin C (15 mg), riboflavin (0.5...” PMID 19535425 ↗ Jun 2009
76

“We randomly assigned 5522 patients 55 years of age or older who had vascular disease or diabetes to daily treatment either with the combination of 2.5 mg of folic acid, 50 mg...” PMID 16531613 ↗ Mar 2006

“We conducted a trial using methylation-promoting dietary supplements (betaine, metafolin, creatine, and vitamin B(12) ) in an attempt to reduce antisense transcript production,...” PMID 22002941 ↗ Oct 2011

“food supplement containing 2000 mg L-carnitine, 2000 mg fructose, 932 mg acetyl L-carnitine, 225 mg vitamin C, 115 mg citric acid, 50 mg coenzyme Q10, 14 mg zinc, 115 µg...” NCT06042738 ↗

“Specifically for this study, the methyl donor supplement has been made by Jamieson Laboratories, and consists of 50mg Vitamin B6 and 1 mg Vitamin B12, (both within Health...” NCT01864824 ↗

“Based on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and...” NCT06304116 ↗

“The patients were provided with Stellate ganglion block , using 0.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). once a day, 10 days totally.” NCT06319612 ↗

“the patients in the observation group were provided with Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).” NCT06255730 ↗

“Participants received a daily capsule containing 40 mg of folic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo.” PMID 17848650 ↗ Sep 2007

“The patients were provided with Stellate ganglion block , using 0.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).” NCT06304090 ↗

“the patients were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).” NCT06301685 ↗

Show 66 more sources

Known as B12 “high-dose folate, vitamin B(6), and vitamin B(12) supplementation” PMID 18854539 ↗ Oct 2008
6

“(2 mg folic acid, 25 mg vitamin B(6), and 500 μg vitamin B(12))” PMID 22554931 ↗ May 2012

“high-dose folate (folic acid), B6, and B12 supplementation” NCT00056225 ↗

“50 mcg cyanocobalamin (B12) and biotin” NCT01474486 ↗

“Includes vitamins A, C, B12, E, and B2” NCT00116493 ↗

“Cyanocobalamin (vitamin B12) - 12 mcg” NCT07592897 ↗

“Vitamin B12 2.6 µg” NCT05426395 ↗

Known as Cyanocobalamin “The experimental group received one tablet of Tenavit® (pyridoxine hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40mg) daily and the placebo group received the...” NCT03221816 ↗
32

“Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and...” NCT04708340 ↗

“Participants received a daily capsule containing 40 mg of folic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo.” PMID 17848650 ↗ Sep 2007

“Complex B ((Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) 1 tablet enteral route every 6 horas for 4 days or until ICU discharge” NCT04197115 ↗

“Group O-oral was given 28 tablets of 1000 µg cyanocobalamin in a monthly punch card fitted with an electronic monitoring system.” PMID 28421567 ↗ Apr 2017

“Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral” NCT05027126 ↗

“Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo” NCT06516094 ↗

“Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day” NCT02620345 ↗

“5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day.” NCT01095211 ↗

“IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.” NCT00901394 ↗

“Vitamin B12 (Cyanocobalamin) - 500 mcg” NCT07296354 ↗

Show 22 more sources

Known as hydroxocobalamin “High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The...” PMID 36174744 ↗ Sep 2022
Known as methycobal “Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.” NCT03802422 ↗
Known as Nascobal “Nascobal nasal spray (cyanocobalamin, USP)” NCT01306123 ↗
Known as Vitarubin-superconc “Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc.” NCT02031289 ↗
Action Inhibit “homocysteine levels can be reduced by administration of high dose supplements of folate (folic acid) and vitamins B6 and B12” NCT00056225 ↗
Modality Other / unclassified “an adjunctive B-vitamin supplement” PMID 30771856 ↗ Jan 2019
Route Oral “Participants will be randomly assigned to receive three capsules of either vitamin B12 or placebo daily.” NCT00120484 ↗