Overview
Paricalcitol is a synthetic vitamin D analog. Paricalcitol has been used to reduce parathyroid hormone levels. Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.
Background
Paricalcitol is a synthetic vitamin D analog. Paricalcitol has been used to reduce parathyroid hormone levels. Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.
Indication
For treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4
Associated Conditions
- Secondary Hyperparathyroidism (SHPT)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/17 | Not Applicable | Not yet recruiting | University of Split, School of Medicine | ||
2022/12/27 | Early Phase 1 | Recruiting | |||
2021/08/06 | Phase 3 | UNKNOWN | |||
2020/11/05 | Phase 2 | Completed | |||
2020/08/24 | Phase 2 | Active, not recruiting | |||
2019/08/22 | Phase 3 | Recruiting | |||
2019/08/13 | Phase 2 | Active, not recruiting | |||
2019/03/21 | Phase 1 | Completed | |||
2018/07/17 | Phase 4 | Completed | |||
2018/05/11 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MARKSANS PHARMA LIMITED | 25000-014 | ORAL | 2 ug in 1 1 | 5/26/2017 | |
| Banner Life Sciences LLC. | 69387-104 | ORAL | 2 mg in 1 1 | 9/15/2015 | |
| Bryant Ranch Prepack | 63629-2453 | ORAL | 2 ug in 1 1 | 8/16/2016 | |
| Dr. Reddy's Laboratories, Inc. | 43598-564 | INTRAVENOUS | 5 ug in 1 mL | 5/31/2019 | |
| Dr. Reddy's Laboratories, Inc. | 43598-563 | INTRAVENOUS | 2 ug in 1 mL | 5/31/2019 | |
| AbbVie Inc. | 0074-9037 | ORAL | 2 ug in 1 1 | 11/22/2022 | |
| Amneal Pharmaceuticals LLC | 70121-1034 | INTRAVENOUS | 5 ug in 1 mL | 5/25/2019 | |
| Dr. Reddy's Laboratories Limited | 55111-665 | ORAL | 4 ug in 1 1 | 4/27/2017 | |
| Eugia US LLC | 55150-214 | INTRAVENOUS | 10 ug in 2 mL | 11/9/2023 | |
| Banner Pharmacaps | 10888-5002 | ORAL | 2 ug in 1 1 | 12/3/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Paricalcitol Injection | 国药准字H20249108 | 化学药品 | 注射剂 | 10/22/2024 | |
| Paricalcitol Injection | 国药准字H20223304 | 化学药品 | 注射剂 | 5/10/2022 | |
| Paricalcitol Injection | 国药准字H20193419 | 化学药品 | 注射剂 | 10/14/2024 | |
| Paricalcitol Injection | 国药准字H20203147 | 化学药品 | 注射剂 | 4/9/2020 | |
| Paricalcitol Injection | 国药准字H20193418 | 化学药品 | 注射剂 | 10/14/2024 | |
| Paricalcitol Injection | 国药准字H20213094 | 化学药品 | 注射剂 | 2/2/2021 | |
| Paricalcitol Injection | 国药准字HJ20181071 | 化学药品 | 注射剂 | 11/4/2022 | |
| Paricalcitol Injection | 国药准字H20234752 | 化学药品 | 注射剂 | 12/29/2023 | |
| Paricalcitol Injection | 国药准字H20183043 | 化学药品 | 注射剂 | 11/21/2022 | |
| Paricalcitol Injection | 国药准字H20203146 | 化学药品 | 注射剂 | 4/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PARACORD SOLUTION FOR INJECTION 5MCG/1ML | N/A | N/A | N/A | 3/12/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||