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Alfacalcidol

Generic Name
Alfacalcidol
Brand Names
One-alpha
Drug Type
Small Molecule
Chemical Formula
C27H44O2
CAS Number
41294-56-8
Unique Ingredient Identifier
URQ2517572

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.
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