Eldecalcitol

Overview

Eldecalcitol (ED-71), a vitamin D analog, is a more potent inhibitor of bone resorption than alfacalcidol in an estrogen-deficient rat model of osteoporosis. Eldecalcitol, effectively and safely increased lumbar and hip bone mineral density (BMD) in osteoporotic patients who also received vitamin D3 supplementation.

Indication

Investigated for use/treatment in osteoporosis.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia	2024/08/05	NCT06537115	Phase 4	Recruiting	Zhejiang Provincial People's Hospital
A Study on the Prevention and Treatment of GIOP With Eldecalcitol	2024/04/25	NCT06385093	Phase 4	Not yet recruiting	Chinese SLE Treatment And Research Group
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis	2023/06/13	NCT05902078	Phase 4	Recruiting	Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.	2023/06/01	NCT05884372	Phase 4	Recruiting	Xi'an Honghui Hospital
Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis	2022/06/27	NCT05433207	N/A	Not yet recruiting	Chugai Pharmaceutical
Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects	2022/06/06	NCT05406050	Phase 1	Completed	The Affiliated Hospital of Qingdao University
The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis	2014/12/03	NCT02306187	Phase 1	Recruiting	Shinshu University
Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol	2013/11/01	NCT01974167	Not Applicable	UNKNOWN	e-GLORIA trial Protocol Review Committee
A New Active Vitamin D, ED-71 for Osteoporosis	2005/09/05	NCT00144456	Phase 3	Completed	Chugai Pharmaceutical

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
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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

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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