Active Ingredient History
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
Drug Pricing (per unit)
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| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Hyperparathyroidism, Secondary (approved 1998)
Adenocarcinoma (Phase 2)
Albuminuria (Phase 3)
Anemia (Phase 4)
Breast Neoplasms (Phase 1)
Cardio-Renal Syndrome (Phase 4)
Cardiovascular Diseases (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)
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)
| Trial | Phase | Start Date | Organizations | Indications |
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