paricalcitol

Trade name: zemplar

Small moleculeapproved

Approved

Apr 17, 1998

Paricalcitol (Zemplar) is a synthetic vitamin D(2) analogue that inhibits the secretion of parathyroid hormone (PTH) through binding to the vitamin D receptor. It is approved in the US and in most European nations for intravenous use in the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure in adult, and in the US paediatric, patients. Paricalcitol effectively reduced elevated serum PTH levels and was generally well tolerated in children and adults with secondary hyperparathyroidism associated with chronic renal failure. In well designed clinical trials, paricalcitol was as effective as calcitriol and as well tolerated in terms of the incidence of prolonged hypercalcaemia and/or elevated calcium-phosphorus product (Ca x P). Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion. — NCATS

Clinical trial activity

97 trials · 87 clinical orgs · 22 marketing orgs

Phase 1
12
Phase 2
45
Phase 3
24
Phase 4
28

Earliest trial started Jan 1, 2002 (NCT00053378)

Timeline

1990s

  1. Apr 17, 1998

    AbbVie — Earliest FDA Approval

  2. Apr 17, 1998

    AbbVie — NDA Secondary Org

  3. Apr 17, 1998

    AbbVie — NDA Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 27, 2011

    Sandoz — Marketing Organization

  2. Jul 27, 2011

    Novartis — Marketing Organization

  3. Sep 27, 2013

    Teva — Marketing Organization

  4. Mar 27, 2014

    Bionpharma Inc — Marketing Organization

  5. Jun 24, 2014

    Dr. Reddy's Laboratories — Marketing Organization

  6. Jun 24, 2014

    Rising Pharmaceuticals — Marketing Organization

  7. Jun 24, 2014

    ANDA Repository — Marketing Organization

  8. Jun 24, 2014

    Chartwell Pharmaceuticals — Marketing Organization

  9. Oct 21, 2014

    Hospira — NDA Secondary Org

  10. Oct 21, 2014

    Hospira — Marketing Organization

  11. Nov 18, 2014

    Hikma — NDA Secondary Org

  12. Jan 13, 2016

    Amneal Pharmaceuticals — Marketing Organization

  13. Jan 14, 2016

    Aurobindo Pharma — Marketing Organization

  14. Feb 4, 2016

    Accord Research — NDA Secondary Org

  15. Feb 24, 2016

    Lotus Pharmaceutical — Marketing Organization

  16. Feb 24, 2016

    Alvogen — Marketing Organization

  17. Aug 17, 2016

    Caplin Point Laboratories — Marketing Organization

  18. Oct 7, 2016

    Marksans Pharma — Marketing Organization

  19. Oct 16, 2017

    Akorn, Inc. — Marketing Organization

  20. Oct 16, 2017

    Epic Pharma Llc — Marketing Organization

  21. Nov 2, 2017

    Mylan — Marketing Organization

  22. Oct 9, 2018

    Eugia Pharma — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedApr 17, 1998

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](\C=C\[C@H](C)C(C)(C)O)[C@H]1CC[C@@H]2[C@]1(C)CCC\C2=C/C=C3C[C@@H](O)C[C@H](O)C3
Mol. weight
416.6365 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

  • 19-nor-1,25-(oh)2d2
  • 19-nor-1alpha,25-dihydroxyvitamin d2
  • 19-nor-1alpha,25-dihydroxyvitamin d2
  • 19-nor-1alpha,25-dihydroxyvitamin d2
  • abbott brand of paricalcitol
  • compound 49510
  • compound 49510
  • paracalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol
  • paricalcitol-d6
  • paricalcitol-d6
  • zemplar
  • zemplar
  • zemplar
  • zemplar
  • zemplar
  • zemplar
  • zemplar
  • zemplar

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06209268N/AOct 1, 2024University of Split
NCT05664880Early Phase 1 (Phase 1)Jan 31, 2023Cedars-Sinai Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT05365893Early Phase 1 (Phase 1)Oct 20, 2021National Cancer Institute (NCI), Temple University
NCT04994080Phase 3Sep 1, 2021Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT04617067Phase 2Oct 16, 2020Cancer Trials Ireland, William Beaumont Hospitals
NCT04524702Phase 2Sep 14, 2020Emory University, National Cancer Institute (NCI)
NCT04064827Phase 3Dec 10, 2019AbbVie
NCT03883919Phase 1Jul 31, 2019Ipsen, Washington University in St. Louis
NCT04054362Phase 2Nov 29, 2018Barts & The London NHS Trust
NCT03520790Phase 1/Phase 2 (Phase 2)Jul 31, 2018American Association for Cancer Research, Harvard University, Lustgarten Foundation, Stand Up To Cancer
NCT03415854Phase 2Jan 31, 2018Cancer Research UK, HonorHealth Research Institute, Imaging Endpoints, Lustgarten Foundation, Mayo Clinic, Princeton University, Salk Institute for Biological Studies, Stand Up To Cancer, TGen Drug Development, University of California, San Diego, University of London, University of Pennsylvania
NCT03331562Phase 2Dec 27, 2017Merck, Stand Up To Cancer, TGen Drug Development
NCT03300921Phase 1Sep 28, 2017University of Pennsylvania
NCT03519308Early Phase 1 (Phase 1)Aug 4, 2017University of Pennsylvania
NCT02930902Phase 1Feb 20, 2017Merck, University of Texas at Houston
NCT02754726Phase 2Apr 1, 2016Bristol-Myers Squibb, HonorHealth Research Institute
NCT02686827Phase 2Oct 1, 2015University of Amsterdam
NCT02876211Phase 4Dec 1, 2014Hospital Son Espases, Son Espases University
NCT01630408N/AMar 1, 2014Harvard University
NCT02030860N/AJan 1, 2014University of Pennsylvania
Showing 20 of 97 trials
Page 1 / 5

Organizations

Research & Development (87)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbottFor profit402252002
AbbVieFor profit8622008
National Cancer Institute (NCI)Government5022008
University of PennsylvaniaAcademic/Hospital5442008
Harvard UniversityAcademic/Hospital4232008
Effice Servicios Para la Investigacion S.L.For profit3112012
Stand Up To CancerAcademic/Hospital3012017
Wake Forest UniversityAcademic/Hospital3322008
Cedars-Sinai Medical CenterAcademic/Hospital2222003
GenzymeFor profit2212007
HonorHealth Research InstituteAcademic/Hospital2212016
Indiana UniversityAcademic/Hospital2222006
Lustgarten FoundationAcademic/Hospital2012018
Mario Negri InstituteAcademic/Hospital2212009
Mayo ClinicAcademic/Hospital2122007
MerckFor profit2022017
State University of New York, BuffaloAcademic/Hospital2212004
TGen Drug DevelopmentAcademic/Hospital2112017
The University of Hong KongAcademic/Hospital2222008
University of CopenhagenAcademic/Hospital2222007
87 organizations
Page 1 / 5

Marketing (29)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJun 24, 2014
AbbVieFor profitNDA2Apr 17, 1998
AbbVieFor profitNDAApr 17, 1998
Accord ResearchFor profitNDA2Feb 4, 2016
Akorn, Inc.For profitMKTGOct 16, 2017
AlvogenFor profitMKTGFeb 24, 2016
Amneal PharmaceuticalsFor profitMKTGJan 13, 2016
Amneal PharmaceuticalsFor profitSYNMar 9, 2017
Aurobindo PharmaFor profitMKTGJan 14, 2016
Bionpharma IncFor profitMKTGMar 27, 2014
Bionpharma IncFor profitSYNMar 27, 2014
Caplin Point LaboratoriesFor profitMKTGAug 17, 2016
Chartwell PharmaceuticalsFor profitMKTGJun 24, 2014
Dr. Reddy's LaboratoriesFor profitMKTGJun 24, 2014
Dr. Reddy's LaboratoriesFor profitSYNAug 17, 2016
Epic Pharma LlcFor profitMKTGOct 16, 2017
Eugia PharmaFor profitMKTGOct 9, 2018
HikmaFor profitNDA2Nov 18, 2014
HospiraFor profitNDA2Oct 21, 2014
HospiraFor profitMKTGOct 21, 2014
Lotus PharmaceuticalFor profitMKTGFeb 24, 2016
Marksans PharmaFor profitMKTGOct 7, 2016
MylanFor profitMKTGNov 2, 2017
NovartisFor profitMKTGJul 27, 2011
Rising PharmaceuticalsFor profitSYNJun 24, 2014
Rising PharmaceuticalsFor profitMKTGJun 24, 2014
SandozFor profitMKTGJul 27, 2011
SandozFor profitSYNJul 27, 2011
TevaFor profitMKTGSep 27, 2013