paricalcitol
Trade name: zemplar
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
Earliest trial started Jan 1, 2002 (NCT00053378)
Timeline
1990s
2000s
2010s
- Jul 27, 2011
Sandoz — Marketing Organization
- Jul 27, 2011
Novartis — Marketing Organization
- Sep 27, 2013
Teva — Marketing Organization
- Mar 27, 2014
Bionpharma Inc — Marketing Organization
- Jun 24, 2014
Dr. Reddy's Laboratories — Marketing Organization
- Jun 24, 2014
Rising Pharmaceuticals — Marketing Organization
- Jun 24, 2014
ANDA Repository — Marketing Organization
- Jun 24, 2014
Chartwell Pharmaceuticals — Marketing Organization
- Oct 21, 2014
Hospira — NDA Secondary Org
- Oct 21, 2014
Hospira — Marketing Organization
- Nov 18, 2014
Hikma — NDA Secondary Org
- Jan 13, 2016
Amneal Pharmaceuticals — Marketing Organization
- Jan 14, 2016
Aurobindo Pharma — Marketing Organization
- Feb 4, 2016
Accord Research — NDA Secondary Org
- Feb 24, 2016
Lotus Pharmaceutical — Marketing Organization
- Feb 24, 2016
Alvogen — Marketing Organization
- Aug 17, 2016
Caplin Point Laboratories — Marketing Organization
- Oct 7, 2016
Marksans Pharma — Marketing Organization
- Oct 16, 2017
Akorn, Inc. — Marketing Organization
- Oct 16, 2017
Epic Pharma Llc — Marketing Organization
- Nov 2, 2017
Mylan — Marketing Organization
- Oct 9, 2018
Eugia Pharma — Marketing Organization
Indications
Studied for
- Adenocarcinoma · Phase 2
- Albuminuria · Phase 3
- Anemia · Phase 4
- Breast Neoplasms · Phase 1
- Cardio-Renal Syndrome · Phase 4
- Cardiovascular Diseases · Phase 4
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Colorectal Neoplasms · Phase 1
- Coronary Artery Disease · Phase 3
- Diabetes Mellitus, Type 2 · Phase 2
- Diabetic Nephropathies · Phase 4
- Dialysis · Phase 4
- Gastric Bypass · Phase 3
- Glioblastoma · Phase 3
- Glomerulonephritis, IGA · Phase 3
- Healthy Volunteers · Phase 1
- Hypercalcemia · Phase 4
- Hyperparathyroidism · Phase 4
- Hyperparathyroidism, Secondary · Phase 4
- Hyperphosphatemia · Phase 4
- Hypersensitivity · Phase 2
- Hypertrophy, Left Ventricular · Phase 3
- Hypocalcemia · Phase 2
- Hypophosphatemia, Familial · Phase 3
- Inflammation · Phase 2
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 3
- Leukemia · Phase 2
- Metabolism · Phase 4
- Multiple Myeloma · Phase 1
- Myelodysplastic Syndromes · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pancreatitis, Chronic · Early Phase 1
- Parathyroid Hormone · Phase 4
- Prostatic Neoplasms · Phase 2
- Proteinuria · Phase 3
- Renal Dialysis · Phase 4
- Renal Insufficiency · Phase 4
- Vascular Calcification · Phase 4
- Vitamin D Deficiency · Phase 4
Mechanism of action
- Vitamin D receptorAGONIST
VDR agonist
Approval history
- approvedApr 17, 1998
Chemistry & pharmacology
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
- WikipediaParicalcitol ↗
- NCATS6702D36OG5 ↗
- ChEMBLCHEMBL1200622 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06209268 | N/A | Oct 1, 2024 | University of Split |
| NCT05664880 | Early Phase 1 (Phase 1) | Jan 31, 2023 | Cedars-Sinai Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT05365893 | Early Phase 1 (Phase 1) | Oct 20, 2021 | National Cancer Institute (NCI), Temple University |
| NCT04994080 | Phase 3 | Sep 1, 2021 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT04617067 | Phase 2 | Oct 16, 2020 | Cancer Trials Ireland, William Beaumont Hospitals |
| NCT04524702 | Phase 2 | Sep 14, 2020 | Emory University, National Cancer Institute (NCI) |
| NCT04064827 | Phase 3 | Dec 10, 2019 | AbbVie |
| NCT03883919 | Phase 1 | Jul 31, 2019 | Ipsen, Washington University in St. Louis |
| NCT04054362 | Phase 2 | Nov 29, 2018 | Barts & The London NHS Trust |
| NCT03520790 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2018 | American Association for Cancer Research, Harvard University, Lustgarten Foundation, Stand Up To Cancer |
| NCT03415854 | Phase 2 | Jan 31, 2018 | Cancer 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 |
| NCT03331562 | Phase 2 | Dec 27, 2017 | Merck, Stand Up To Cancer, TGen Drug Development |
| NCT03300921 | Phase 1 | Sep 28, 2017 | University of Pennsylvania |
| NCT03519308 | Early Phase 1 (Phase 1) | Aug 4, 2017 | University of Pennsylvania |
| NCT02930902 | Phase 1 | Feb 20, 2017 | Merck, University of Texas at Houston |
| NCT02754726 | Phase 2 | Apr 1, 2016 | Bristol-Myers Squibb, HonorHealth Research Institute |
| NCT02686827 | Phase 2 | Oct 1, 2015 | University of Amsterdam |
| NCT02876211 | Phase 4 | Dec 1, 2014 | Hospital Son Espases, Son Espases University |
| NCT01630408 | N/A | Mar 1, 2014 | Harvard University |
| NCT02030860 | N/A | Jan 1, 2014 | University of Pennsylvania |
Organizations
Research & Development (87)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Abbott | For profit | 40 | 22 | 5 | 2002 |
| AbbVie | For profit | 8 | 6 | 2 | 2008 |
| National Cancer Institute (NCI) | Government | 5 | 0 | 2 | 2008 |
| University of Pennsylvania | Academic/Hospital | 5 | 4 | 4 | 2008 |
| Harvard University | Academic/Hospital | 4 | 2 | 3 | 2008 |
| Effice Servicios Para la Investigacion S.L. | For profit | 3 | 1 | 1 | 2012 |
| Stand Up To Cancer | Academic/Hospital | 3 | 0 | 1 | 2017 |
| Wake Forest University | Academic/Hospital | 3 | 3 | 2 | 2008 |
| Cedars-Sinai Medical Center | Academic/Hospital | 2 | 2 | 2 | 2003 |
| Genzyme | For profit | 2 | 2 | 1 | 2007 |
| HonorHealth Research Institute | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Indiana University | Academic/Hospital | 2 | 2 | 2 | 2006 |
| Lustgarten Foundation | Academic/Hospital | 2 | 0 | 1 | 2018 |
| Mario Negri Institute | Academic/Hospital | 2 | 2 | 1 | 2009 |
| Mayo Clinic | Academic/Hospital | 2 | 1 | 2 | 2007 |
| Merck | For profit | 2 | 0 | 2 | 2017 |
| State University of New York, Buffalo | Academic/Hospital | 2 | 2 | 1 | 2004 |
| TGen Drug Development | Academic/Hospital | 2 | 1 | 1 | 2017 |
| The University of Hong Kong | Academic/Hospital | 2 | 2 | 2 | 2008 |
| University of Copenhagen | Academic/Hospital | 2 | 2 | 2 | 2007 |
Marketing (29)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Jun 24, 2014 |
| AbbVie | For profit | NDA2 | Apr 17, 1998 |
| AbbVie | For profit | NDA | Apr 17, 1998 |
| Accord Research | For profit | NDA2 | Feb 4, 2016 |
| Akorn, Inc. | For profit | MKTG | Oct 16, 2017 |
| Alvogen | For profit | MKTG | Feb 24, 2016 |
| Amneal Pharmaceuticals | For profit | MKTG | Jan 13, 2016 |
| Amneal Pharmaceuticals | For profit | SYN | Mar 9, 2017 |
| Aurobindo Pharma | For profit | MKTG | Jan 14, 2016 |
| Bionpharma Inc | For profit | MKTG | Mar 27, 2014 |
| Bionpharma Inc | For profit | SYN | Mar 27, 2014 |
| Caplin Point Laboratories | For profit | MKTG | Aug 17, 2016 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 24, 2014 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jun 24, 2014 |
| Dr. Reddy's Laboratories | For profit | SYN | Aug 17, 2016 |
| Epic Pharma Llc | For profit | MKTG | Oct 16, 2017 |
| Eugia Pharma | For profit | MKTG | Oct 9, 2018 |
| Hikma | For profit | NDA2 | Nov 18, 2014 |
| Hospira | For profit | NDA2 | Oct 21, 2014 |
| Hospira | For profit | MKTG | Oct 21, 2014 |
| Lotus Pharmaceutical | For profit | MKTG | Feb 24, 2016 |
| Marksans Pharma | For profit | MKTG | Oct 7, 2016 |
| Mylan | For profit | MKTG | Nov 2, 2017 |
| Novartis | For profit | MKTG | Jul 27, 2011 |
| Rising Pharmaceuticals | For profit | SYN | Jun 24, 2014 |
| Rising Pharmaceuticals | For profit | MKTG | Jun 24, 2014 |
| Sandoz | For profit | MKTG | Jul 27, 2011 |
| Sandoz | For profit | SYN | Jul 27, 2011 |
| Teva | For profit | MKTG | Sep 27, 2013 |