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.
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 |
|---|---|---|---|---|---|
| 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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ONE-ALPHA | 02242502 | Solution - Intravenous | 2 MCG / ML | 2/20/2001 | |
| SANDOZ ALFACALCIDOL | 02533316 | Capsule - Oral | 0.25 MCG | 4/24/2023 | |
| ALFACALCIDOL CAPSULES | Strides Pharma Canada Inc | 02523078 | Capsule - Oral | 1 MCG | N/A |
| ALFACALCIDOL CAPSULES | Strides Pharma Canada Inc | 02523051 | Capsule - Oral | 0.25 MCG | N/A |
| SANDOZ ALFACALCIDOL | 02533324 | Capsule - Oral | 1 MCG | 4/24/2023 | |
| ONE-ALPHA | 00474517 | Capsule - Oral | 0.25 MCG | 12/31/1980 | |
| ONE-ALPHA | 02239431 | Capsule - Oral | 0.5 MCG | N/A | |
| ONE-ALPHA | 02240329 | Drops - Oral | 2 MCG / ML | 12/4/2000 | |
| ONE-ALPHA SOL 0.2MCG/ML | 00759546 | Liquid - Oral | .2 MCG / ML | 12/31/1989 | |
| ONE-ALPHA | 00474525 | Capsule - Oral | 1 MCG | 12/31/1980 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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