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doxercalciferol

Trade name: hectorol

Small moleculeapproved

Approved

Jun 9, 1999

Doxercalciferol is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, as well as for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease. Doxercalciferol is marketed under the brand name Hectorol by Genzyme Corporation, and is manufactured by Catalent Pharma Solutions, Inc. — NCATS

Clinical trial activity

20 trials · 16 clinical orgs · 26 marketing orgs

Phase 1
2
Phase 2
7
Phase 3
2
Phase 4
10

Earliest trial started Nov 1, 2000 (NCT00560300)

Timeline

1990s

  1. Jun 9, 1999

    Bone Care International — Earliest FDA Approval

  2. Jun 9, 1999

    Bone Care International — NDA Organization

  3. Jun 9, 1999

    Sanofi — NDA Secondary Org

  4. Jun 9, 1999

    Sanofi-Synthelabo — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Mar 15, 2011

    Cobrek Pharmaceuticals — Marketing Organization

  2. Sep 23, 2011

    West-Ward Pharmaceutical — Marketing Organization

  3. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  4. Aug 30, 2013

    Hikma — Marketing Organization

  5. Feb 4, 2014

    Sandoz — Marketing Organization

  6. Feb 4, 2014

    Novartis — Marketing Organization

  7. Feb 4, 2014

    Caplin Point Laboratories — Marketing Organization

  8. May 7, 2015

    Akorn, Inc. — Marketing Organization

  9. May 7, 2015

    Epic Pharma Llc — Marketing Organization

  10. Sep 9, 2016

    ANDA Repository — Marketing Organization

  11. Sep 9, 2016

    Rising Pharmaceuticals — Marketing Organization

  12. May 24, 2017

    Amneal Pharmaceuticals — Marketing Organization

  13. Jul 24, 2018

    Hospira — Marketing Organization

  14. Jul 24, 2018

    Hospira — NDA Secondary Org

  15. Jul 24, 2018

    Pfizer — NDA Secondary Org

  16. Nov 1, 2018

    Lupin — Marketing Organization

  17. Sep 26, 2019

    Gland Pharma Ltd — Marketing Organization

  18. Sep 26, 2019

    Fosun — Marketing Organization

  19. Nov 14, 2019

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Feb 7, 2020

    Nanjing King-Friend — Marketing Organization

  2. Feb 7, 2020

    Meitheal — Marketing Organization

  3. Sep 15, 2020

    Heritage Pharma — Marketing Organization

  4. Sep 15, 2020

    Emcure — Marketing Organization

  5. Jan 24, 2022

    Eugia Pharma — Marketing Organization

  6. Jun 15, 2023

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 9, 1999

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)C[C@H](O)C3=C
Mol. weight
412.6478 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

Prodrug

Sources

Also known as

  • 1 alpha-hydroxyergocalciferol
  • 1-alpha-hydroxyergocalciferol
  • 1-alpha-hydroxyergocalciferol
  • 1alpha-hydroxyvitamin d2
  • 1alpha-hydroxyvitamin d2
  • 1alpha-hydroxyvitamin d2
  • 1alpha(oh)2d2
  • 1alpha-ohd2
  • 1-hydroxyergocalciferol
  • 1-hydroxyergocalciferol
  • 1-hydroxyvitamin d2
  • 1-hydroxyvitamin d2
  • (1s,3r,5z,7e,22e)-9,10-secoergosta-5,7,10,22-tetraene-1,3-diol
  • (1s,3r,5z,7e,22e)-9,10-secoergosta-5,7,10,22-tetraene-1,3-diol
  • 1α-hydroxyergocalciferol
  • 1α-hydroxyergocalciferol
  • doxacalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferol
  • doxercalciferolum
  • doxercalciferolum
  • hectorol
  • hectorol
  • hectorol
  • hectorol
  • hectorol
  • hectorol
  • hectorol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02859896Phase 3Jan 19, 2017Sanofi
NCT02282813Phase 3Apr 1, 2013Opko
NCT00889629Phase 4Nov 1, 2008State University of New York, State University of New York, Brooklyn
NCT00792857Phase 1Nov 1, 2008Opko
NCT00749736Phase 4Jul 1, 2008Indiana University
NCT00601107Phase 2Apr 1, 2008Genzyme
NCT00646282Phase 4Apr 1, 2008Emory University
NCT00502268Phase 4Feb 1, 2008Southeast Renal Research Institute
NCT00528788Phase 4Sep 1, 2007Duke University, Genzyme, The University of Texas, Dallas
NCT00511017Phase 1Aug 1, 2007University of Texas at Houston
NCT00463021Phase 4Apr 1, 2007Genzyme
NCT00454350Phase 4Feb 1, 2007Genzyme
NCT00418600Phase 4Nov 1, 2006Genzyme
NCT00257920Phase 4Jun 1, 2006Abbott
NCT00285467N/AJan 1, 2006Indiana University
NCT00123461Phase 4Jul 1, 2005Genzyme
NCT00052832Phase 2Sep 1, 2002National Cancer Institute (NCI), University of Wisconsin
NCT00582582Phase 2Apr 1, 2002Genzyme, Sanofi, University of Wisconsin
NCT00022412Phase 2Aug 1, 2001National Cancer Institute (NCI), University of Wisconsin
NCT00560300Phase 2Nov 1, 2000National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenzymeFor profit7522002
University of WisconsinAcademic/Hospital3312001
Indiana UniversityAcademic/Hospital2222006
National Cancer Institute (NCI)Government2012001
OpkoFor profit2222008
SanofiFor profit2122002
AbbottFor profit1112006
Duke UniversityAcademic/Hospital1112007
Emory UniversityAcademic/Hospital1112008
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1112000
Southeast Renal Research InstituteAcademic/Hospital1112008
State University of New YorkAcademic/Hospital1112008
State University of New York, BrooklynAcademic/Hospital1012008
The University of Texas, DallasAcademic/Hospital1012007
University of California, Los AngelesAcademic/Hospital1012000
University of Texas at HoustonAcademic/Hospital1112007
16 organizations
Page 1 / 1

Marketing (34)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGSep 9, 2016
Akorn, Inc.For profitSYNMay 7, 2015
Akorn, Inc.For profitMKTGMay 7, 2015
AlembicFor profitMKTGJun 15, 2023
Amneal PharmaceuticalsFor profitMKTGMay 24, 2017
Amneal PharmaceuticalsFor profitSYNMay 24, 2017
Bone Care InternationalFor profitNDAJun 9, 1999
Caplin Point LaboratoriesFor profitMKTGFeb 4, 2014
Cobrek PharmaceuticalsFor profitMKTGMar 15, 2011
EmcureFor profitMKTGSep 15, 2020
Epic Pharma LlcFor profitMKTGMay 7, 2015
Eugia PharmaFor profitMKTGJan 24, 2022
FosunFor profitMKTGSep 26, 2019
Gland Pharma LtdFor profitMKTGSep 26, 2019
Gland Pharma LtdFor profitSYNSep 26, 2019
Heritage PharmaFor profitMKTGSep 15, 2020
HikmaFor profitMKTGAug 30, 2013
HikmaFor profitSYNSep 23, 2011
HospiraFor profitMKTGJul 24, 2018
HospiraFor profitNDA2Jul 24, 2018
LupinFor profitMKTGNov 1, 2018
LupinFor profitSYNNov 1, 2018
MeithealFor profitMKTGFeb 7, 2020
Nanjing King-FriendFor profitMKTGFeb 7, 2020
NovartisFor profitMKTGFeb 4, 2014
PfizerFor profitNDA2Jul 24, 2018
Rising PharmaceuticalsFor profitSYNSep 9, 2016
Rising PharmaceuticalsFor profitMKTGSep 9, 2016
SandozFor profitMKTGFeb 4, 2014
SandozFor profitSYNFeb 4, 2014
SanofiFor profitNDA2Jun 9, 1999
Sanofi-SynthelaboFor profitNDA2Jun 9, 1999
Sun PharmaceuticalsFor profitMKTGNov 14, 2019
West-Ward PharmaceuticalFor profitMKTGSep 23, 2011