Paricalcitol
Other / unclassified targets VDR via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ZEMPLAR | — | 2000-02-02 – 2016-10-18 | fda.gov ↗ |
| Approved | US (FDA) | ZEMPLAR | — | 1998-04-17 | fda.gov ↗ |
Trials 71 · started per year
Also used as a comparator or background therapy in 28 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT03331562 Comparator | Dec 2017 → Jun 2020 | pancreatic adenocarcinoma | Translational Genomics Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01136564 Comparator | Jul 2010 → Dec 2011 | chronic kidney disease | Erling Bjerregaard Pedersen | Completed | No outcome recorded |
| Phase 2 | NCT01003275 Comparator | Oct 2009 → Nov 2011 | chronic kidney disease | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00421733 Comparator | Dec 2006 → Jun 2009 | diabetic kidney disease | Abbott | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01204528 Comparator | Sep 2010 → Jun 2013 | chronic kidney disease | Danderyd Hospital | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01436747 Comparator | Jul 2012 → Oct 2014 | disease related to solid organ transplantation, proteinuria | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 3 | NCT01138475 Comparator | Jul 2010 → Aug 2015 | secondary hyperparathyroidism | Kerstyn C. Zalesin, M.D. | Completed | No outcome recorded |
| Phase 3 | NCT01071070 Comparator | Nov 2009 → Nov 2010 | chronic kidney disease | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00616902 Comparator | Jan → May 2009 | end stage renal failure | Abbott | Terminated | No outcome recorded |
| Phase 3 | NCT00646035 Comparator | Jan → Nov 2002 | end stage renal failure | Abbott | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT03588884 Comparator | Jun 2018 → Apr 2020 | chronic kidney disease, secondary hyperparathyroidism of renal origin, vitamin D deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01442272 Comparator | Jan → Oct 2012 | chronic renal failure syndrome, vitamin D deficiency | Hospital Universitario de Canarias | Unknown | No outcome recorded |
| Phase 4 | NCT01181531 Comparator | Oct 2010 → Jul 2012 | secondary hyperparathyroidism | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00977080 Comparator | Nov 2009 → May 2011 | chronic kidney disease, secondary hyperparathyroidism of renal origin | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT01265615 Comparator | Oct 2009 → Apr 2010 | cardio-renal syndrome, chronic transplant rejection | Ural State Medical University | Completed | No outcome recorded |
| Phase 4 | NCT00958451 Comparator | Jul 2009 → Jan 2011 | chronic kidney disease, secondary hyperparathyroidism of renal origin | Salem Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00752102 Comparator | Sep 2008 → Oct 2013 | calcinosis, chronic kidney disease, vitamin D deficiency | Joslin Diabetes Center | Completed | No outcome recorded |
| Phase 4 | NCT00537979 Comparator | Sep 2007 → Jul 2010 | secondary hyperparathyroidism | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00463021 Background | Apr → Dec 2007 | secondary hyperparathyroidism of renal origin | Genzyme, a Sanofi Company | Completed | 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 |
| Phase 4 | NCT00294866 Comparator | Mar 2006 → Jan 2008 | kidney failure | Fresenius Medical Care North America | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06209268 Comparator | May → Oct 2025 overdue | infectious disease with sepsis | University of Split, School of Medicine | Not yet recruiting | No outcome recorded |
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT01792206 Comparator | Sep 2009 → Nov 2012 | chronic kidney disease, type 2 diabetes mellitus | Scott and White Hospital & Clinic | Unknown | No outcome recorded |
| — | NCT00915876 Comparator | Mar 2009 → Mar 2011 | chronic kidney disease | Amy Barton Pai | Completed | No outcome recorded |
| — | NCT00469599 Comparator | Jul 2007 → Sep 2010 | chronic kidney disease, secondary hyperparathyroidism of renal origin, vitamin D deficiency | Zealand University Hospital | Terminated | No outcome recorded |
| — | NCT00587158 Comparator | Jan 2007 → Nov 2011 | end stage renal failure, secondary hyperparathyroidism | Mayo Clinic | Completed | No outcome recorded |
| — | NCT00428246 Comparator | Nov 2006 → Jul 2007 | chronic kidney disease, hypertensive disorder | Indiana University | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2013-10-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of Generic Zemplar® in the United States tevapharm.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Paricalcitol | “Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT)” NCT01181531 ↗94“effect of oral paricalcitol (2 μg/day) was investigated in 26 patients with non-diabetic, albuminuric stage III-IV CKD.” PMID 23889806 ↗ Jul 2013 “Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease” NCT01792206 ↗ “calcitriol and paricalcitol-"Zemplar®") at the maximum dose of 6 mcg/week of paricalcitol("Zemplar®")of equivalent” NCT02273570 ↗ “Patients in the experimental arm received 2 micrograms Paricalcitol capsules daily, for 12 weeks.” NCT01680198 ↗ “Oral paricalcitol was developed to provide a convenient, alternative therapy” NCT00800358 ↗ “Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)” NCT01820078 ↗ “Paricalcitol (Zemplar)” NCT03138720 ↗ “paricalcitol” NCT00135304 ↗ “Paricalcitol” NCT04054362 ↗ “paricalcitol” NCT00257920 ↗ |
| Known as | 19-NOR-1 ALPHA, 25 - (OH)D | “Intravenous Paricalcitol (ZEMPLAR™) [19-NOR-1 ALPHA, 25 - (OH)D] With Zoledronic Acid (Zometa™)” NCT00258258 ↗1“Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D]” NCT00217477 ↗ |
| Known as | 19-nor-1,25-dihydroxyvitamin D2 | “Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of...” NCT00599963 ↗1“The third generation of vitamin D analogues is composed of a group of 1- and 25-hydroxylated vitamin D compounds with either ring structure modifications...” NCT06209268 ↗ |
| Known as | COMPOUND 49510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200622 ↗ |
| Known as | Paricalcitol (Zemplar) | “Paricalcitol (Zemplar)” NCT03138720 ↗ |
| Known as | PCT | “testing the effect of VDR activation by paricalcitol (PCT) on endothelium-dependent flow-mediated vasodilatation (FMD)” PMID 29668990 ↗ May 2019 |
| Known as | Zemplar | “Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease” NCT01792206 ↗15“calcitriol and paricalcitol-"Zemplar®") at the maximum dose of 6 mcg/week of paricalcitol("Zemplar®")of equivalent” NCT02273570 ↗ “Intravenous Paricalcitol (ZEMPLAR™) [19-NOR-1 ALPHA, 25 - (OH)D] With Zoledronic Acid (Zometa™)” NCT00258258 ↗ “Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months” NCT01442272 ↗ “Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D]” NCT00217477 ↗ “Zemplar (paricalcitol) 2ug daily, oral intake” NCT01694160 ↗ “paricalcitol injection (Zemplar)” NCT00053378 ↗ “Zemplar (paricalcitol injection)” NCT00463021 ↗ “Zemplar (paricalcitol injection)” NCT00062699 ↗ “Zemplar (Paricalcitol injection)” NCT00454350 ↗ “Paricalcitol (Zemplar)” NCT03415854 ↗ “Paricalcitol (Zemplar)” NCT00637897 ↗ |
| Action | Activate | “Selective vitamin D receptor activation with paricalcitol” PMID 21055801 ↗ Nov 2010 |
| Modality | Other / unclassified | “paricalcitol, a vitamin D analog” PMID 18606901 ↗ Jul 2008 |
| Route | Oral | “Patients receive oral paricalcitol daily for 4 months” NCT00064376 ↗ |
| Target | VDR | “VDR activation by paricalcitol (PCT)” PMID 29668990 ↗ May 2019 |