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cyanocobalamin

Trade name: berocca

Small moleculeapproved

Approved

Jul 28, 1947

Cyanocobalamin is a form of vitamin B12 used to treat and prevent vitamin B12 deficiency except in the presence of cyanide toxicity. The deficiency may occur in pernicious anemia, following surgical removal of the stomach, with fish tapeworm, or due to bowel cancer. It is used by mouth, by injection into a muscle, or as a nasal spray. — Wikipedia

Clinical trial activity

110 trials · 152 clinical orgs · 54 marketing orgs

Phase 1
12
Phase 2
44
Phase 3
19
Phase 4
16

Earliest trial started May 1, 1993 (NCT00000541)

Timeline

1940s

  1. Jul 28, 1947

    Roche — Earliest FDA Approval

  2. Jul 28, 1947

    Roche — Marketing Organization

  3. Jul 28, 1947

    Roche — NDA Organization

  4. Sep 15, 1949

    Bayer — NDA Secondary Org

  5. Dec 6, 1949

    Warner Chilcott — Marketing Organization

  6. Dec 6, 1949

    Warner Chilcott — NDA Secondary Org

1950s

  1. Sep 29, 1950

    Bristol-Myers Squibb — NDA Secondary Org

  2. Feb 20, 1953

    Hospira — Marketing Organization

  3. Feb 20, 1953

    Hospira — NDA Secondary Org

  4. Jul 14, 1958

    Belmar Pharmacy — NDA Secondary Org

1960s

  1. Jun 21, 1968

    Mallinckrodt — Marketing Organization

  2. Jun 21, 1968

    Mallinckrodt — NDA Secondary Org

1970s

  1. Dec 21, 1970

    Bracco — Marketing Organization

  2. Dec 21, 1970

    Bracco — NDA Secondary Org

  3. Oct 20, 1971

    West-Ward Pharmaceutical — Marketing Organization

  4. Apr 26, 1972

    Sankyo — Marketing Organization

  5. Apr 26, 1972

    Lutipold — Marketing Organization

  6. Sep 20, 1972

    Accord Research — Marketing Organization

  7. Mar 21, 1973

    American Home Products — Marketing Organization

  8. Jun 20, 1973

    Fresenius — Marketing Organization

  9. Jun 22, 1973

    Del Laboratories — Marketing Organization

  10. Jul 9, 1973

    Eli Lilly — Marketing Organization

  11. Jan 29, 1974

    Watson Pharmaceuticals — Marketing Organization

  12. Jan 29, 1974

    Dr. Reddy's Laboratories — Marketing Organization

  13. Jun 10, 1974

    General Electric — Marketing Organization

  14. Jun 10, 1974

    General Electric — NDA Secondary Org

  15. Sep 12, 1979

    Lyphomed, Inc. — Marketing Organization

1980s

  1. Feb 22, 1980

    Armour & Company — Marketing Organization

  2. Feb 22, 1980

    Armour & Company — NDA Secondary Org

  3. Nov 6, 1981

    Abraxis — Marketing Organization

  4. Nov 6, 1981

    Abraxis — NDA Secondary Org

  5. Apr 7, 1982

    Sanofi-Aventis — Marketing Organization

  6. Jul 13, 1982

    Watson Pharmaceuticals — NDA Secondary Org

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

  3. Nov 5, 1996

    Endo Pharmaceuticals — Marketing Organization

  4. Nov 5, 1996

    Par Pharmaceuticals — NDA Secondary Org

2000s

  1. May 18, 2000

    Sandoz — Marketing Organization

  2. May 18, 2000

    Sandoz — NDA Secondary Org

  3. May 18, 2000

    Novartis — NDA Secondary Org

  4. Sep 23, 2003

    Mylan — Marketing Organization

  5. Jan 31, 2005

    Endo Pharmaceuticals — NDA Secondary Org

  6. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  7. Jul 27, 2007

    PH HEALTH — Marketing Organization

2010s

  1. Dec 11, 2015

    Somerset Pharmaceuticals — Marketing Organization

  2. Jun 5, 2017

    PHARMOBEDIENT — Marketing Organization

  3. Dec 18, 2018

    Vitruvias Therapeutics — Marketing Organization

2020s

  1. Sep 9, 2020

    Perrigo — Marketing Organization

  2. Sep 9, 2020

    Padagis Us — Marketing Organization

  3. Sep 24, 2020

    Gland Pharma Ltd — Marketing Organization

  4. Sep 24, 2020

    Fosun — Marketing Organization

  5. Dec 8, 2020

    Aurobindo Pharma — Marketing Organization

  6. Dec 8, 2020

    Eugia Pharma — Marketing Organization

  7. Jan 4, 2021

    Novartis — Marketing Organization

  8. Aug 20, 2021

    Exeltis — Marketing Organization

  9. Apr 15, 2022

    Sola Pharms — Marketing Organization

  10. Apr 15, 2022

    Zydus Discovery DMCC — Marketing Organization

  11. Nov 15, 2022

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  12. Nov 15, 2022

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  13. Jun 30, 2023

    Lupin — Marketing Organization

  14. Jul 10, 2024

    Mankind Pharma — Marketing Organization

  15. Nov 15, 2024

    Nanjing King-Friend — Marketing Organization

  16. Nov 15, 2024

    Meitheal — Marketing Organization

  17. Apr 9, 2026

    Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 28, 1947

Chemistry & pharmacology

Loading structure…

SMILES

[57Co+3].[C-]#N.C[C@H](CNC(=O)CC[C@]1(C)[C@@H](CC(N)=O)C2[N-]C1=C(C)C3=NC(=CC4=NC(=C(C)C5=N[C@]2(C)[C@@](C)(CC(N)=O)[C@@H]5CCC(N)=O)[C@@](C)(CC(N)=O)[C@@H]4CCC(N)=O)C(C)(C)[C@@H]3CCC(N)=O)OP([O-])(=O)O[C@@H]6[C@@H](CO)O[C@@H]([C@@H]6O)N7C=[NH]C8=CC(C)=C(C)C=C78
Mol. weight
1356.4 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • behepan
  • behepan
  • berubigen
  • berubigen
  • betalin 12
  • calomist
  • calomist
  • cobamin
  • cobavite
  • cobavite
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamin
  • cyanocobalamine
  • cyanocobalamine
  • cyanocob(iii)alamin
  • cyanocob(iii)alamin
  • cyanovit-b12
  • cycobemin
  • cycobemin
  • cytacon
  • cytacon
  • cytamen
  • cytamen
  • nascobal
  • nascobal
  • redisol
  • redisol
  • rubivite
  • rubivite
  • rubramin
  • rubramin
  • rubramin pc
  • rubramin pc
  • ruvite
  • ruvite
  • vibalt
  • vibalt
  • vibisone
  • vibisone
  • vitamin b12
  • vitamin b12
  • vitamin b12
  • vitamin b12
  • vitamin b12
  • vitamin b12
  • vitamin b 12
  • vitamin b 12
  • vitamin b12a
  • vitamin b12a
  • vitamin b-12b
  • vitamin b-12b
  • vitamin b12 complex
  • vitamin b12 complex
  • vitamin b12 nos
  • vitamin b12 nos
  • vitamins b12
  • vi-twel
  • vi-twel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06966856Phase 3Dec 30, 2026Tanta University
NCT07004465N/AAug 19, 2025Karbala University
NCT07029698Phase 4Apr 16, 2025Medice Arzneimittel Pütter GmbH & Co KG
NCT06517823Phase 3Apr 26, 2024Clinical Research Institute S.C., Laboratorios Silanes S.A. de C.V.
NCT06186154Phase 1Jan 31, 2024University of British Columbia
NCT05785585N/ASep 9, 2023Eurecat, Laboratorio Echevarne
NCT05221892Phase 4Nov 22, 2021Fundação Educacional Serra dos Órgãos
NCT05005897Phase 2/Phase 3 (Phase 3)Oct 15, 2021Inland Norway University of Applied Sciences, Sykehuset Innlandet HF, University of Bergen, University of Oslo
NCT04387201Phase 4May 15, 2020University of Texas at Houston
NCT04150042Phase 2Mar 31, 2020General Oncology, Inc.
NCT04197115Phase 3Sep 1, 2019IMSS Hospital General de Zona 11
NCT04585334Phase 4Mar 25, 2019Fidia Advanced Biopolymers
NCT03877523N/AOct 3, 2018Institute for Atherosclerosis Research, Russia
NCT03437824Early Phase 1 (Phase 1)Oct 1, 2017University of Southern California
NCT02693717Phase 2May 9, 2017Eli Lilly, University of Texas at Houston
NCT02786823Phase 2/Phase 3 (Phase 3)May 1, 2017All India Institute of Medical Sciences
NCT02934438N/AOct 1, 2016HumanN, Methodist Cancer Center, Houston, Texas
NCT02837367Phase 1/Phase 2 (Phase 2)Sep 1, 2016Romania:The National Authority for Scientific Research, University of Medicine and Pharmacy Victor Babes Timisoara
NCT02735317Phase 2Apr 1, 2016Sun Yat-Sen University
NCT02773147Phase 2Apr 1, 2016University of Gothenburg
Showing 20 of 110 trials
Page 1 / 6

Organizations

Research & Development (152)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Spectrum PharmaceuticalsFor profit8822007
Eli LillyFor profit7312005
Harvard UniversityAcademic/Hospital5441993
Aarhus UniversityAcademic/Hospital3322005
Ben Gurion UniversityAcademic/Hospital3222006
National Institutes of Health (NIH)Government3032006
Saarland UniversityAcademic/Hospital3312009
Sun Yat-Sen UniversityAcademic/Hospital3312009
University of BergenAcademic/Hospital3121999
All India Institute of Medical SciencesAcademic/Hospital2122012
Emisphere Technologies, Inc.For profit2212008
Foundation for Anesthesia Education and ResearchAcademic/Hospital2012008
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, NorwayAcademic/Hospital2021998
GenentechFor profit2012006
Georgetown UniversityAcademic/Hospital2121999
Government of NorwayGovernment2021998
HumanNFor profit2122016
MerckFor profit2111998
National Cancer Institute (NCI)Government2112004
National Institute on Aging (NIA)Government2212000
152 organizations
Page 1 / 8

Marketing (70)

OrganizationOrg typeRelationshipDate
AbraxisFor profitMKTGNov 6, 1981
AbraxisFor profitNDA2Nov 6, 1981
Accord ResearchFor profitMKTGSep 20, 1972
Akorn, Inc.For profitMKTG—
American Home ProductsFor profitMKTGMar 21, 1973
ApotexFor profitMKTGApr 9, 2026
Armour & CompanyFor profitMKTGFeb 22, 1980
Armour & CompanyFor profitNDA2Feb 22, 1980
Aurobindo PharmaFor profitMKTGDec 8, 2020
BayerFor profitNDA2Sep 15, 1949
Belmar PharmacyFor profitNDA2Jul 14, 1958
BraccoFor profitMKTGDec 21, 1970
BraccoFor profitNDA2Dec 21, 1970
Bristol-Myers SquibbFor profitNDA2Sep 29, 1950
Del LaboratoriesFor profitMKTGJun 22, 1973
Dr. Reddy's LaboratoriesFor profitMKTGJan 29, 1974
Eli LillyFor profitMKTGJul 9, 1973
Endo PharmaceuticalsFor profitMKTGNov 5, 1996
Endo PharmaceuticalsFor profitNDA2Jan 31, 2005
Eugia PharmaFor profitMKTGDec 8, 2020
ExeltisFor profitMKTGAug 20, 2021
FosunFor profitMKTGSep 24, 2020
FreseniusFor profitMKTGJun 20, 1973
General ElectricFor profitMKTGJun 10, 1974
General ElectricFor profitNDA2Jun 10, 1974
Gland Pharma LtdFor profitMKTGSep 24, 2020
Gland Pharma LtdFor profitSYNSep 24, 2020
HospiraFor profitMKTGFeb 20, 1953
HospiraFor profitNDA2Feb 20, 1953
LupinFor profitMKTGJun 30, 2023
LutipoldFor profitMKTGApr 26, 1972
Lyphomed, Inc.For profitMKTGSep 12, 1979
MallinckrodtFor profitMKTGJun 21, 1968
MallinckrodtFor profitNDA2Jun 21, 1968
Mankind PharmaFor profitMKTGJul 10, 2024
MeithealFor profitMKTGNov 15, 2024
MerckFor profitNDA2—
MylanFor profitMKTGSep 23, 2003
MylanFor profitSYNJun 5, 2017
Nanjing King-FriendFor profitMKTGNov 15, 2024
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGNov 15, 2022
NovartisFor profitNDA2May 18, 2000
NovartisFor profitMKTGJan 4, 2021
PH HEALTHFor profitMKTGJul 27, 2007
PHARMOBEDIENTFor profitMKTGJun 5, 2017
Padagis UsFor profitMKTGSep 9, 2020
Par PharmaceuticalsFor profitNDA2Nov 5, 1996
PerrigoFor profitMKTGSep 9, 2020
Pharmacia & UpjohnFor profitNDA2—
RocheFor profitMKTGJul 28, 1947
RocheFor profitNDAJul 28, 1947
SOLOPAKFor profitMKTG—
Sagent Pharmaceuticals, Inc.For profitMKTGNov 15, 2022
SandozFor profitSYNJan 4, 2021
SandozFor profitMKTGMay 18, 2000
SandozFor profitNDA2May 18, 2000
SankyoFor profitMKTGApr 26, 1972
Sanofi-AventisFor profitMKTGApr 7, 1982
Savage LabsFor profitMKTG—
Sola PharmsFor profitMKTGApr 15, 2022
Somerset PharmaceuticalsFor profitMKTGDec 11, 2015
Teligent PharmaceuticalsFor profitNDA2—
Vitruvias TherapeuticsFor profitMKTGDec 18, 2018
Warner ChilcottFor profitMKTGDec 6, 1949
Warner ChilcottFor profitNDA2Dec 6, 1949
Watson PharmaceuticalsFor profitMKTGJan 29, 1974
Watson PharmaceuticalsFor profitNDA2Jul 13, 1982
West-Ward PharmaceuticalFor profitSYNApr 12, 1974
West-Ward PharmaceuticalFor profitMKTGOct 20, 1971
Zydus Discovery DMCCFor profitMKTGApr 15, 2022