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calcitriol

Trade name: rocaltrol

Small moleculeapproved

Approved

Aug 17, 1978

Calcitriol is a hormone and the active form of vitamin D, normally made in the kidney. It is also known as 1,25-dihydroxycholecalciferol. It binds to and activates the vitamin D receptor in the nucleus of the cell, which then increases the expression of many genes. Calcitriol increases blood calcium mainly by increasing the uptake of calcium from the intestines. — Wikipedia

Clinical trial activity

141 trials · 130 clinical orgs · 28 marketing orgs

Phase 1
30
Phase 2
55
Phase 3
11
Phase 4
35

Earliest trial started Mar 1, 1976 (NCT00001151)

Timeline

1970s

  1. Jan 1, 1976

    Earliest Phase 2 Sponsor(trial)

  2. Aug 17, 1978

    Validus Pharmaceuticals — Earliest FDA Approval

  3. Aug 17, 1978

    Validus Pharmaceuticals — NDA Secondary Org

  4. Aug 17, 1978

    Validus Pharmaceuticals — NDA Organization

  5. Aug 17, 1978

    ESJAY PHARMA — Marketing Organization

1980s

  1. Sep 25, 1986

    AbbVie — NDA Secondary Org

1990s

  1. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Oct 12, 2001

    Teva — Marketing Organization

  2. Dec 31, 2002

    Hospira — Marketing Organization

  3. Feb 20, 2003

    Fresenius — Marketing Organization

  4. Jul 18, 2003

    West-Ward Pharmaceutical — Marketing Organization

  5. Jul 18, 2003

    Hikma — Marketing Organization

  6. Sep 17, 2003

    Rockwell Medical Inc — Marketing Organization

  7. Sep 26, 2003

    Lutipold — Marketing Organization

  8. Sep 26, 2003

    Sankyo — Marketing Organization

  9. Feb 8, 2006

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  10. Jan 29, 2008

    Akorn, Inc. — Marketing Organization

  11. Jan 29, 2008

    LONG GROVE PHARMS — Marketing Organization

  12. Jan 23, 2009

    Galderma — NDA Secondary Org

2010s

  1. May 24, 2013

    Bionpharma Inc — Marketing Organization

  2. Dec 12, 2014

    Strides Pharma Science — Marketing Organization

  3. Dec 12, 2014

    ONESOURCE SPECIALTY — Marketing Organization

  4. Jun 14, 2017

    Amneal Pharmaceuticals — Marketing Organization

  5. Nov 21, 2018

    Invatech — Marketing Organization

  6. Nov 21, 2018

    Elysium Health — Marketing Organization

  7. Nov 21, 2018

    Rising Pharmaceuticals — Marketing Organization

  8. Feb 21, 2019

    Sun Pharmaceuticals — Marketing Organization

  9. Oct 23, 2019

    Gland Pharma Ltd — Marketing Organization

2020s

  1. Feb 3, 2020

    Fosun — Marketing Organization

  2. Jul 28, 2023

    Patrin Pharma Inc — Marketing Organization

  3. Jul 28, 2023

    ANDA Repository — Marketing Organization

  4. Feb 27, 2026

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 17, 1978

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](CCCC(C)(C)O)[C@H]1CC[C@H]2\C(CCC[C@]12C)=C\C=C3\C[C@@H](O)C[C@H](O)C3=C
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, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 1,25-dhcc
  • 1,25-dhcc
  • 1,25-dihydroxycholecalciferol
  • 1,25-dihydroxycholecalciferol
  • 1,25 dihydroxy vitamin d3
  • 1,25 dihydroxy vitamin d3
  • 1,25-dihydroxyvitamin d3
  • 1alpha,25-dihydroxycholecalciferol
  • 1alpha,25-dihydroxycholecalciferol
  • 1-alpha-25-dihydroxyvitamin d3
  • 1-alpha-25-dihydroxyvitamin d3
  • 1alpha,25-dihydroxyvitamin d3
  • 1alpha,25-dihydroxyvitamin d3
  • (1s,3r,5z,7e)-9,10-secocholesta-5,7,10-triene-1,3,25-triol
  • (1s,3r,5z,7e)-9,10-secocholesta-5,7,10-triene-1,3,25-triol
  • 1α,25-dihydroxycholecalciferol
  • 1α,25-dihydroxycholecalciferol
  • 1α,25-dihydroxyvitamin d3
  • 1α,25-dihydroxyvitamin d3
  • 1α,25(oh)2d3
  • 1α,25(oh)2d3
  • (1α,3β,5z,7e)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
  • (1α,3β,5z,7e)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
  • (5z,7e)-(1s,3r)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
  • (5z,7e)-(1s,3r)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
  • calcijex
  • calcijex
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriol
  • calcitriolum
  • calcitriolum
  • calcitrol
  • dihydroxycholecalciferol
  • dihydroxycholecalciferol
  • dihydroxyvitamin d3
  • dihydroxyvitamin d 3
  • ro-215535
  • ro-215535
  • rocaltrol
  • rocaltrol
  • rocaltrol
  • rocaltrol
  • rocaltrol
  • rocaltrol
  • rocaltrol
  • silkis
  • silkis
  • topitriol
  • topitriol
  • topitriol
  • vectical
  • vectical

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07299552N/ADec 30, 2025Univerisiti Sains Malaysia
NCT07200349N/ANov 1, 2025Al Azhar University
NCT06261905Phase 1Mar 13, 2024University of Pennsylvania, Yale University
NCT06288451Phase 2Mar 11, 2024National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington
NCT06306131Phase 2Dec 10, 2023InnovaGyn, Inc., National Institutes of Health (NIH)
NCT06141239N/ADec 1, 2023Chang Gung University
NCT05902078Phase 4Jun 30, 2023Chugai, Jiao Tong University
NCT05720273Phase 4Apr 1, 2023Shandong Province Qianfoshan Hospital
NCT05601531N/ADec 1, 2022Chang Gung University
NCT05415254N/AJun 12, 2022Jiao Tong University
NCT05298163N/AApr 30, 2022University of Indonesia
NCT05920512Phase 1/Phase 2 (Phase 2)Apr 1, 2022People's Liberation Army of China
NCT04801303Phase 4Aug 25, 2021Institut de Recerca Biomèdica de Lleida, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Universitat de Lleida
NCT05765617Phase 2Jul 1, 2021Universitas Sebelas Maret
NCT04967469N/ASep 1, 2020Rajavithi Hospital, Bangkok
NCT04386811Phase 1May 31, 2020Yale University
NCT04286529Phase 1Mar 2, 2020Mayo Clinic
NCT05202496N/ANov 20, 2019Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
NCT04094805Phase 4Oct 1, 2019Shandong University
NCT04826133Early Phase 1 (Phase 1)Mar 27, 2019Yale University
Showing 20 of 141 trials
Page 1 / 8

Organizations

Research & Development (130)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government12031996
GaldermaFor profit10932006
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government10331976
NovaceaFor profit8732002
State University of New York, BuffaloAcademic/Hospital8832002
Harvard UniversityAcademic/Hospital6532009
AbbottFor profit5312003
Oregon Health and Science UniversityAcademic/Hospital5421999
Cornell UniversityAcademic/Hospital4221999
Seoul National UniversityAcademic/Hospital4412012
University of PittsburghAcademic/Hospital4421996
Department of Veteran AffairsGovernment3322007
MerckFor profit3231997
National Institutes of Health (NIH)Government3111976
Yale UniversityAcademic/Hospital3312019
AventisFor profit2022002
Boston UniversityAcademic/Hospital2011998
Capital Medical UniversityAcademic/Hospital2212012
Chang Gung UniversityAcademic/Hospital2212022
Chinese University of Hong KongAcademic/Hospital2212006
130 organizations
Page 1 / 7

Marketing (35)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJul 28, 2023
AbbVieFor profitNDA2Sep 25, 1986
Akorn, Inc.For profitMKTGJan 29, 2008
Amneal PharmaceuticalsFor profitMKTGJun 14, 2017
Bionpharma IncFor profitMKTGMay 24, 2013
Bionpharma IncFor profitSYNMay 24, 2013
ESJAY PHARMAFor profitMKTGAug 17, 1978
Elysium HealthFor profitMKTGNov 21, 2018
FosunFor profitMKTGFeb 3, 2020
FreseniusFor profitSYNDec 31, 2002
FreseniusFor profitMKTGFeb 20, 2003
GaldermaFor profitNDA2Jan 23, 2009
Gland Pharma LtdFor profitMKTGOct 23, 2019
Gland Pharma LtdFor profitSYNFeb 3, 2020
HikmaFor profitMKTGJul 18, 2003
HikmaFor profitSYNJul 18, 2003
HospiraFor profitMKTGDec 31, 2002
InvatechFor profitMKTGNov 21, 2018
LONG GROVE PHARMSFor profitMKTGJan 29, 2008
LutipoldFor profitMKTGSep 26, 2003
ONESOURCE SPECIALTYFor profitMKTGDec 12, 2014
Patrin Pharma IncFor profitMKTGJul 28, 2023
Rising PharmaceuticalsFor profitMKTGNov 21, 2018
Rockwell Medical IncFor profitMKTGSep 17, 2003
Sagent Pharmaceuticals, Inc.For profitMKTGFeb 8, 2006
SankyoFor profitMKTGSep 26, 2003
Strides Pharma ScienceFor profitMKTGDec 12, 2014
Sun PharmaceuticalsFor profitMKTGFeb 21, 2019
Sun PharmaceuticalsFor profitSYNFeb 21, 2019
TevaFor profitMKTGOct 12, 2001
TevaFor profitSYNMar 31, 2003
Validus PharmaceuticalsFor profitNDA2Aug 17, 1978
Validus PharmaceuticalsFor profitNDAAug 17, 1978
West-Ward PharmaceuticalFor profitMKTGJul 18, 2003
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGFeb 27, 2026