ergocalciferol

Trade name: drisdol

Small moleculeapproved

Approved

Jan 11, 1941

Ergoalcifediol (Vitamin D2) is a fat soluble steroid hormone precursor of vitamin D. The principal biologic function of vitamin D is the maintenance of normal levels of serum calcium and phosphorus in the bloodstream by enhancing the efficacy of the small intestine to absorb these minerals from the diet. Cholecalciferol is synthesized within our bodies naturally, but if UV exposure is inadequate or the metabolism of cholecalciferol is abnormal, then an exogenous source is required. Vitamin D2 is converted to 25-hydroxyvitamin D (25OHD) in the liver, and then to the active form, 1,25-dihydroxyvitamin D (1,25(OH)2D), in the kidney. Once transformed, it binds to the vitamin D receptor, which leads to a variety of regulatory roles. Vitamin D plays an important role in maintaining calcium balance and in the regulation of parathyroid hormone (PTH). It promotes renal reabsorption of calcium, increases intestinal absorption of calcium and phosphorus, and increases calcium and phosphorus mobilization from bone to plasma. Very few foods naturally contain vitamin D. Sources that contain the vitamin include fatty fish, the liver and fat of aquatic mammals (e.g., seals, polar bears), and eggs from chickens fed vitamin D-fortified feed. As such, many countries have instituted policies to fortify certain foods with vitamin D to compensate for the potentially low exposures of skin to sunlight. Vitamin D deficiency results in inadequate mineralization of bone or compensatory skeletal demineralization and causes decreased ionized calcium concentrations in blood and a resultant increase in the production and secretion of PTH. Increase in PTH stimulates the mobilization of skeletal calcium, inhibits renal excretion of calcium, and stimulates renal excretion of phosphorus. This results in normal fasting serum calcium concentrations and low or near-normal serum phosphorus. The enhanced mobilization of skeletal calcium induced by this secondary hyperparathyroidism leads porotic bone. Ergoalcifediol is used for use in the management of hypocalcemia and its clinical manifestations in patients with hypoparathyroidism, as well as for the treatment of familial hypophosphatemia (vitamin D resistant rickets). This drug has also been used in the treatment of nutritional rickets or osteomalacia, vitamin D dependent rickets, rickets or osteomalacia secondary to long-term high dose anticonvulsant therapy, early renal osteodystrophy, osteoporosis (in conjunction with calcium), and hypophosphatemia associated with Fanconi syndrome (with treatment of acidosis). Ergocalciferol is manufactured and marketed under various names, including Deltalin (Eli Lilly and Company), Drisdol (Sanofi-Synthelabo) and Calcidol (Patrin Pharma). — NCATS

Clinical trial activity

94 trials · 109 clinical orgs · 24 marketing orgs

Phase 1
9
Phase 2
14
Phase 3
9
Phase 4
23

Earliest trial started Dec 1, 2002 (NCT00157066)

Timeline

1940s

  1. Jan 11, 1941

    Sterling Drug — Earliest FDA Approval

  2. Jan 11, 1941

    Validus Pharmaceuticals — NDA Secondary Org

  3. Jan 11, 1941

    Validus Pharmaceuticals — Marketing Organization

  4. Jan 11, 1941

    Sterling Drug — NDA Organization

  5. Jan 11, 1941

    ESJAY PHARMA — Marketing Organization

  6. Jul 28, 1947

    Roche — Marketing Organization

  7. Jul 28, 1947

    Roche — NDA Secondary Org

1950s

  1. Feb 20, 1953

    Hospira — Marketing Organization

  2. Feb 20, 1953

    Hospira — NDA Secondary Org

1970s

  1. Mar 26, 1973

    West-Ward Pharmaceutical — Marketing Organization

  2. Jun 12, 1973

    Eli Lilly — Marketing Organization

  3. Jul 13, 1973

    Impax Laboratories — Marketing Organization

  4. Sep 26, 1974

    Chartwell Pharmaceuticals — Marketing Organization

  5. Sep 26, 1974

    Lannett Company, Inc. — Marketing Organization

  6. Oct 16, 1978

    Bionpharma Inc — Marketing Organization

1980s

  1. Nov 6, 1981

    Abraxis — Marketing Organization

  2. Nov 6, 1981

    Abraxis — NDA Secondary Org

  3. Jul 13, 1982

    Watson Pharmaceuticals — Marketing Organization

  4. Jul 13, 1982

    Watson Pharmaceuticals — NDA Secondary Org

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

  3. May 20, 2009

    Orit Labs Llc — Marketing Organization

  4. May 20, 2009

    Alembic — Marketing Organization

  5. Dec 29, 2009

    Sun Pharmaceuticals — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 2 Sponsor(trial)

  2. Jul 14, 2010

    Sigmapharm Laboratories — Marketing Organization

  3. Aug 3, 2010

    Strides Pharma Science — Marketing Organization

  4. Aug 3, 2010

    ONESOURCE SPECIALTY — Marketing Organization

  5. Dec 7, 2018

    Puracap Pharmaceutical — Marketing Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedJan 11, 1941

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@@H](C)\C=C\[C@@H](C)[C@H]1CC[C@@H]2[C@]1(C)CCC\C2=C/C=C3/C[C@@H](O)CCC3=C
Mol. weight
396.6484 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • (3β,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
  • (3β,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
  • (5z,7e,22e)-(3s)-9,10-seco-5,7,10(19),22-ergostatetraen-3-ol
  • (5z,7e,22e)-(3s)-9,10-seco-5,7,10(19),22-ergostatetraen-3-ol
  • (5z,7e,22e)-(3s)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
  • (5z,7e,22e)-(3s)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
  • activated ergosterol
  • activated ergosterol
  • calciferol
  • calciferol
  • calciferol
  • calciferol
  • calciferol
  • calciferol in arach oil
  • caltrate
  • caltrate
  • caltrate
  • deltalin
  • deltalin
  • d-forte
  • drisdol
  • drisdol
  • drisdol
  • eciferol d2
  • ercalciol
  • ercalciol
  • ercalciol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciferol
  • ergocalciférol
  • ergocalciférol
  • ergocalciferolum
  • ergocalciferolum
  • ergo-d2
  • ergoral d2
  • ergorone
  • lanes
  • oleovitamin d
  • oleovitamin d
  • oleovitamin d2
  • oleovitamin d2
  • oleovitamin d, synthetic
  • oleovitamin d, synthetic
  • osto-d2
  • sterogyl
  • sterogyl
  • sterogyl-15
  • sterogyl 15h
  • uvesterol d
  • uvesterol d
  • vitamina d2
  • vitamina d2
  • vitamin d2
  • vitamin d2
  • vitamin d2
  • vitamin d2
  • vitamin d2
  • vitamin d2
  • vitamin d 2
  • vitamin d 2

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06791044N/AJun 1, 2025Dionyssiotis, Yannis, M.D.
NCT06642441N/AOct 18, 2024Qinghai University
NCT06642428N/AOct 15, 2024Qinghai University
NCT07310329N/AApr 27, 2024Wroclaw University of Health and Sport Sciences
NCT06516094Phase 3Apr 11, 2024Consultorio Médico "Dr. Rodrigo Suárez Otero", Imacen S.A. de C.V., Laboratorios Silanes S.A. de C.V.
NCT06176157Phase 4Dec 31, 2023Ain Shams University
NCT06172764Phase 4Dec 12, 2023Dow University of Health Sciences, Duke University, University of Karachi
NCT06158932N/ASep 8, 2023Citruslabs, Optify
NCT06148545N/AMar 30, 2023University of Hasanuddin
NCT05673980N/ADec 18, 2022Peking University
NCT05458024Phase 2Dec 8, 2022National Institutes of Health (NIH), University of North Carolina at Chapel Hill
NCT05619289Phase 2Nov 30, 2022National Center for Complementary and Integrative Health (NCCIH), University of North Carolina at Chapel Hill
NCT05549154N/AOct 1, 2022Jiao Tong University
NCT05434377N/AAug 31, 2022Chulalongkorn University
NCT04909931N/AJun 15, 2021Rajavithi Hospital, Bangkok
NCT06142136N/AMar 28, 2021Pauls Stradins Clinical University Hospital
NCT04591847Phase 3Oct 19, 2020Rajavithi Hospital, Bangkok
NCT04450199Early Phase 1 (Phase 1)Jul 24, 2020Allegheny Health Network, The Podiatry Foundation, West Penn Hospital
NCT04385940Phase 3May 31, 2020University of Alberta
NCT04472481Phase 4Sep 6, 2019Loughborough University, Tanta University
Showing 20 of 94 trials
Page 1 / 5

Organizations

Research & Development (109)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital7712006
Department of Veteran AffairsGovernment5422006
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government5022008
Rajavithi Hospital, BangkokAcademic/Hospital4422014
Boston UniversityAcademic/Hospital3322006
King Faisal Specialist HospitalAcademic/Hospital3032009
King Faisal UniversityAcademic/Hospital3332009
University of MassachusettsAcademic/Hospital3322009
American Heart AssociationAcademic/Hospital2022008
Barts & The London NHS TrustAcademic/Hospital2222002
Capital Medical UniversityAcademic/Hospital2212012
Chulalongkorn UniversityAcademic/Hospital2222017
Creighton UniversityAcademic/Hospital2222010
Government of ChinaGovernment2012012
Jiao Tong UniversityAcademic/Hospital2212015
Karolinska InstituteAcademic/Hospital2222009
National Kidney FoundationAcademic/Hospital2022009
New York City Health and Hospitals CorporationAcademic/Hospital2222008
Peking UniversityAcademic/Hospital2212012
Qinghai UniversityAcademic/Hospital2212024
109 organizations
Page 1 / 6

Marketing (31)

OrganizationOrg typeRelationshipDate
AbraxisFor profitMKTGNov 6, 1981
AbraxisFor profitNDA2Nov 6, 1981
AlembicFor profitMKTGMay 20, 2009
Bionpharma IncFor profitMKTGOct 16, 1978
Bionpharma IncFor profitSYNOct 16, 1978
Chartwell PharmaceuticalsFor profitMKTGSep 26, 1974
Chartwell PharmaceuticalsFor profitSYNMay 20, 2009
Chase Pharmaceuticals CorporationFor profitMKTG
ESJAY PHARMAFor profitMKTGJan 11, 1941
Eli LillyFor profitMKTGJun 12, 1973
Everylife Foundation for Rare DiseasesAcademic/HospitalMKTG
HospiraFor profitMKTGFeb 20, 1953
HospiraFor profitNDA2Feb 20, 1953
Impax LaboratoriesFor profitMKTGJul 13, 1973
Lannett Company, Inc.For profitMKTGSep 26, 1974
ONESOURCE SPECIALTYFor profitMKTGAug 3, 2010
Orit Labs LlcFor profitMKTGMay 20, 2009
Puracap PharmaceuticalFor profitMKTGDec 7, 2018
RocheFor profitMKTGJul 28, 1947
RocheFor profitNDA2Jul 28, 1947
Sigmapharm LaboratoriesFor profitMKTGJul 14, 2010
Sterling DrugFor profitNDAJan 11, 1941
Strides Pharma ScienceFor profitMKTGAug 3, 2010
Sun PharmaceuticalsFor profitMKTGDec 29, 2009
Teligent PharmaceuticalsFor profitNDA2
Validus PharmaceuticalsFor profitNDA2Jan 11, 1941
Validus PharmaceuticalsFor profitMKTGJan 11, 1941
VitarineFor profitMKTG
Watson PharmaceuticalsFor profitMKTGJul 13, 1982
Watson PharmaceuticalsFor profitNDA2Jul 13, 1982
West-Ward PharmaceuticalFor profitMKTGMar 26, 1973