Overview
Doxercalciferol is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, as well as for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease. Doxercalciferol is marketed under the brand name Hectoral by Genzyme Corporation, and is manufactured by Catalent Pharma Solutions, Inc.
Indication
Doxercalciferol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, as well as for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease.
Associated Conditions
- Secondary Hyperparathyroidism (SHPT)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/08/09 | Phase 3 | Active, not recruiting | |||
2014/11/04 | Phase 3 | Completed | |||
2009/04/29 | Phase 4 | Completed | Mariana Markell | ||
2008/11/18 | Phase 1 | Completed | |||
2008/03/28 | Phase 4 | Terminated | |||
2008/01/25 | Phase 2 | Completed | Genzyme, a Sanofi Company | ||
2007/09/12 | Phase 4 | Completed | |||
2007/08/03 | Phase 1 | Terminated | |||
2007/07/17 | Phase 4 | Withdrawn | |||
2007/04/19 | Phase 4 | Completed | Genzyme, a Sanofi Company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| West-Ward Pharmaceuticals Corp. | 0054-0338 | ORAL | 0.5 ug in 1 1 | 4/25/2017 | |
| Alembic Pharmaceuticals Inc. | 62332-690 | INTRAVENOUS | 4 ug in 2 mL | 6/20/2023 | |
| Eugia US LLC | 55150-358 | INTRAVENOUS | 4 ug in 2 mL | 2/8/2024 | |
| Eugia US LLC | 55150-359 | INTRAVENOUS | 4 ug in 2 mL | 2/8/2024 | |
| West-Ward Pharmaceuticals Corp. | 0054-0339 | ORAL | 2.5 ug in 1 1 | 4/25/2017 | |
| Chartwell RX, LLC | 62135-452 | ORAL | 2.5 ug in 1 1 | 1/30/2023 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-538 | ORAL | 0.5 ug in 1 1 | 10/28/2021 | |
| Genzyme Corporation | 58468-0126 | INTRAVENOUS | 2 ug in 1 mL | 4/27/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1393 | INTRAVENOUS | 2 ug in 1 mL | 12/25/2023 | |
| Gland Pharma Limited | 68083-300 | INTRAVENOUS | 4 ug in 2 mL | 9/30/2019 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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