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Label indication ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. ZEMPLAR is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis ( 1 ). FDA label
Paricalcitol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Paricalcitol Capsules, 4 mcg | EXPERIMENTAL | Paricalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited |
| Zemplar Capsules, 4 mcg | EXPERIMENTAL | Zemplar Capsules, 4 mcg of Abott Laboratories USA |
| Name | Type | Description |
|---|---|---|
| Paricalcitol Capsules, 4 mcg | DRUG | Paricalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: * Healthy, adult, human volunteers between 18 and 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India. * Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2. * Have no significan...
Paricalcitol is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. Its therapeutic indications are currently undisclosed. It has been studied in a Phase 1 bioequivalence trial in healthy volunteers, but no approved uses are specified in the available information.
Paricalcitol targets the vitamin D receptor (VDR) and acts as an agonist. By binding to VDR, it modulates gene expression related to calcium and phosphate homeostasis. This mechanism is characteristic of vitamin D receptor activators.
Paricalcitol is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker symbol RDY. The company is responsible for the clinical development of this small molecule drug candidate.
Paricalcitol is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The only listed trial is a completed Phase 1 study.
Paricalcitol has been studied in one completed clinical trial: NCT02322632, titled "Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions." This Phase 1 trial enrolled 69 healthy volunteers in India and was randomized and controlled.