Drugs / Doxercalciferol

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) HECTOROL 2004-04-23 – 2025-06-11 fda.gov
Approved US (FDA) HECTOROL 1999-06-09 fda.gov

Trials 17 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00511017 Aug 2007 → Sep 2010 cancer M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 23 trials
Phase 2 NCT00601107 Apr 2008 → Feb 2009 psoriasis Genzyme, a Sanofi Company Completed No outcome recorded
Phase 2 NCT00582582 Apr 2002 → Apr 2007 prostate cancer University of Wisconsin, Madison Terminated No outcome recorded
Phase 2 NCT00560300 Nov 2000 → Nov 2006 renal osteodystrophy National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07660536 Nov 1989 → Apr 1992 osteoporosis Creighton University Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02859896 Jan 2017 → Jun 2025 secondary hyperparathyroidism of renal origin Sanofi Terminated No outcome recorded
Phase 3 NCT02282813 Apr 2013 → May 2015 chronic kidney disease, secondary hyperparathyroidism of renal origin, vitamin D deficiency OPKO Health, Inc. Completed No outcome recorded
Phase 48 trials
Phase 4 NCT00889629 Nov 2008 → Jan 2010 chronic kidney disease Mariana Markell Completed No outcome recorded
Phase 4 NCT00646282 Apr 2008 → Jan 2010 secondary hyperparathyroidism Emory University Terminated No outcome recorded
Phase 4 NCT00528788 Sep 2007 → Aug 2012 chronic renal failure syndrome, secondary hyperparathyroidism of renal origin Duke University Completed No outcome recorded
Phase 4 NCT00463021 Apr → Dec 2007 secondary hyperparathyroidism of renal origin Genzyme, a Sanofi Company Completed No outcome recorded
Phase 4 NCT00454350 Feb → Jul 2007 secondary hyperparathyroidism of renal origin Genzyme, a Sanofi Company Completed No outcome recorded
Phase 4 NCT00418600 Nov 2006 → Jun 2007 secondary hyperparathyroidism of renal origin Genzyme, a Sanofi Company Completed No outcome recorded
Phase 4 NCT00135304 Aug 2005 → Oct 2006 secondary hyperparathyroidism of renal origin Amgen Completed No outcome recorded
Phase 4 NCT00123461 Jul 2005 → Oct 2007 chronic kidney disease, kidney failure, secondary hyperparathyroidism of renal origin Genzyme, a Sanofi Company Completed No outcome recorded
Phase not applicable2 trials
NCT07640347 Jul 2026 → May 2027 expected secondary hyperparathyroidism of renal origin Chittagong Medical College Not yet recruiting No outcome recorded
NCT00285467 Jan 2006 → Dec 2009 renal osteodystrophy Indiana University Completed No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00792857 Comparator Nov 2008 → Sep 2009 chronic renal failure syndrome, secondary hyperparathyroidism of renal origin OPKO IP Holdings II, Inc. Completed No outcome recorded
Phase 43 trials
Phase 4 NCT01181531 Comparator Oct 2010 → Jul 2012 secondary hyperparathyroidism Amgen Completed No outcome recorded
Phase 4 NCT00502268 Comparator Feb 2008 → Feb 2009 calcinosis, end stage renal failure, secondary hyperparathyroidism Southeast Renal Research Institute Withdrawn No outcome recorded
Phase 4 NCT00257920 Comparator Jun 2006 → Jan 2008 end stage renal failure, secondary hyperparathyroidism of renal origin Abbott Completed No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as doxercalciferol “Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT)” NCT01181531
18

doxercalciferolNCT00135304

NCT00454350

NCT00502268

NCT07640347

NCT00889629

NCT00418600

NCT02859896

NCT07660536

NCT00646282

NCT00123461

NCT00582582

NCT00601107

NCT02282813

NCT00528788

NCT00511017

NCT00792857

NCT00463021

NCT00285467

Known as 1 alpha D2 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00560300
Known as 1-.alpha.-hydroxyergocalciferol ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810
Known as 1-hydroxyergocalciferol ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810
Known as 1.alpha.-hydroxyvitamin d2 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810
Known as 1alpha OH vitamin D2 “Patients randomized to group 1 will have the administration of 1alpha OH vitamin D2 (Hectorol) targeted to achieve serum PTH levels between 150-300 ng/ml using a Bayer Centaur...” NCT00502268
Known as GZ427397 “Drug: Doxercalciferol (GZ427397)” NCT02859896
Known as Hectorol “The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney...” NCT00123461
6

“Patients randomized to group 1 will have the administration of 1alpha OH vitamin D2 (Hectorol) targeted to achieve serum PTH levels between 150-300 ng/ml using a Bayer Centaur...” NCT00502268

Hectorol (doxercalciferol injection)” NCT00454350

Hectorol® (doxercalciferol capsules)” NCT00418600

“doxercalciferol capsules, Hectorol®” NCT07660536

Hectorol (doxercalciferol capsules)” NCT00463021

NCT00257920

Known as Hectorol (the other name for Doxercalciferol) Hectorol (the other name for Doxercalciferol)NCT00889629
Known as TSA-840 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810
Action Activate “Vitamin D receptor agonist” CHEMBL1200810
Modality Small molecule CHEMBL1200810
Route Intravenous “Vitamin D administered IV” NCT00135304
Target VDR “Vitamin D receptor agonist” CHEMBL1200810