Overview
Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of vitamin D. It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys. Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure. In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.
Background
Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of vitamin D. It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys. Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure. In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.
Indication
Alfacalcidol is indicated in adult patients with chronic renal failure for the management of hypocalcemia, secondary hyperparathyroidism, or osteodystrophy. Alfacalcidol is indicated in the management of nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.
Associated Conditions
- Hypocalcemia
- Hypophosphatemic Rickets
- Nutritional Rickets
- Osteodystrophy
- Osteomalacia
- Rickets
- Secondary Hyperparathyroidism (SHPT)
- Hypophosphatemic osteomalacia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/04/25 | Phase 4 | Not yet recruiting | Chinese SLE Treatment And Research Group | ||
2024/02/22 | Phase 4 | Not yet recruiting | |||
2023/08/29 | Phase 2 | Recruiting | |||
2022/08/17 | Phase 3 | Completed | |||
2021/07/19 | Not Applicable | Completed | |||
2020/05/28 | Phase 3 | Completed | Syarif Hidayatullah State Islamic University Jakarta | ||
2019/09/11 | Phase 4 | Completed | |||
2017/09/26 | Phase 4 | UNKNOWN | |||
2017/07/07 | Phase 4 | Completed | |||
2017/05/10 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
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 |
---|---|---|---|---|---|
ALFOST CAPSULES 0.25MCG | SIN16483P | CAPSULE, LIQUID FILLED | 0.25mcg | 5/5/2022 | |
ALFOST CAPSULES 1.0MCG | SIN16484P | CAPSULE, LIQUID FILLED | 1mcg | 5/5/2022 | |
ONE-ALPHA CAPSULE 0.25 mcg | SIN05972P | CAPSULE, LIQUID FILLED | 0.25 mcg | 5/14/1991 | |
ONE-ALPHA CAPSULES 0.5 mcg | SIN11062P | CAPSULE, LIQUID FILLED | 0.5 mcg | 7/14/1999 | |
ONE-ALPHA INJECTION 2 mcg/ml | SIN06140P | INJECTION | 2 mcg/ml | 6/20/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Alfacalcidol Soft Capsules | 国药准字H19991114 | 化学药品 | 胶囊剂 | 1/22/2020 | |
Alfacalcidol Soft Capsules | truemed ltd, israel | 国药准字HJ20171204 | 化学药品 | 胶囊剂 | 4/10/2025 |
Alfacalcidol Soft Capsules | truemed ltd, israel | 国药准字HJ20171203 | 化学药品 | 胶囊剂 | 4/10/2025 |
Alfacalcidol Soft Capsules | truemed ltd, israel | 国药准字HJ20171205 | 化学药品 | 胶囊剂 | 4/10/2025 |
Alfacalcidol Soft Capsules | truemed ltd, israel | 国药准字HJ20171202 | 化学药品 | 胶囊剂 | 4/10/2025 |
Alfacalcidol Soft Capsules | 国药准字H20010320 | 化学药品 | 胶囊剂 | 6/8/2020 | |
Alfacalcidol Soft Capsules | 国药准字HJ20130514 | 化学药品 | 胶囊剂 | 7/13/2023 | |
Alfacalcidol Soft Capsules | 国药准字HJ20130513 | 化学药品 | 胶囊剂 | 7/13/2023 | |
Alfacalcidol Soft Capsules | 国药准字H20020501 | 化学药品 | 胶囊剂 | 9/25/2019 | |
Alfacalcidol Soft Capsules | 国药准字H20074109 | 化学药品 | 胶囊剂 | 8/18/2022 |
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. |