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One-Alpha

(Alfacalcidol)

ApprovedSmall molecule

Alfacalcidol is used to treat low calcium levels in the blood and bone disease caused by kidney problems or low parathyroid hormone levels. It helps your body absorb calcium and maintain strong bones.[2] One-Alpha is currently approved and in use across 13 indications[4].[1]

One-Alpha is one of 308 small molecule programs targeting Calcification. It is currently in Approved.

13

Indications

21

Total Trials

1

Active Trials

307

Competitors

Pipeline

Status by Indication[4][1]

Indication

CalcificationActive, not recruiting

Muscular DiseaseActive, not recruiting

Oral Squamous Cell CarcinomaActive, not recruiting

Diabetic NephropathyActive, not recruiting

Postmenopausal OsteoporosisActive, not recruiting

Pelvic Organ ProlapseActive, not recruiting

Secondary HyperparathyroidismActive, not recruiting

HypoparathyroidismActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

OsteoarthritisActive, not recruiting

CalcificationPhase 2

Active, not recruiting

Muscular DiseasePhase 3

Active, not recruiting

Oral Squamous Cell CarcinomaPhase 2/Phase 3

Active, not recruiting

Diabetic NephropathyApproved

Active, not recruiting

Postmenopausal OsteoporosisPhase 3

Active, not recruiting

Pelvic Organ ProlapsePhase 3

Active, not recruiting

Secondary HyperparathyroidismPreclinical

Active, not recruiting

HypoparathyroidismPhase 2

Active, not recruiting

Chronic Kidney DiseasePhase 2

Active, not recruiting

OsteoarthritisPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

778 competitors in Osteoarthritis

#DrugCompanyPhaseTrials

One-Alpha

Epidiolex

Jazz Pharmaceuticals

Toradol

Voltaren

CCerimon Pharmaceuticals

Enbrel

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Catapres

Boehringer Ingelheim

Glucophage

Boehringer Ingelheim

Paracetamol

Chirocaine

PPurdue Pharma LP

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Osteoporosis3 trials

A New Active Vitamin D, ED-71 for Osteoporosis

Completed· Roche logo

Roche·Phase 3·NCT00144456·1,056 enrolled

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

Unknown status·YYonsei University·Phase 4·NCT06272227·340 enrolled

Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol

Unknown status·Ee-GLORIA trial Protocol Review Committee·N/A·NCT01974167·400 enrolled

Secondary Hyperparathyroidism2 trials

Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.

Completed·PPhramongkutklao College of Medicine and Hospital·N/A·NCT02895061·502 enrolled

Treatment of Secondary Hyperparathyroidism in the Uremic Patient

Terminated·ZZealand University Hospital·N/A·NCT00469599·86 enrolled

Prevention2 trials

Fall Prevention by Alfacalcidol and Training

Withdrawn·RRuhr University of Bochum·Phase 4·NCT00483275·484 enrolled

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Not yet recruiting·CChinese SLE Treatment And Research Group·Phase 4·NCT06385093·314 enrolled

Randomized Controlled Trial1 trial

The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial

Completed·IIndonesia University·Phase 3·NCT02327091·122 enrolled

Vitamin D1 trial

The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Unknown status·SSeoul National University Hospital·Phase 4·NCT01765010·88 enrolled

12 more indications

Postmenopausal Osteoporosis1 trial

Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Completed· Eisai logo

Eisai·Phase 3·NCT00165698·240 enrolled

Diabetic Nephropathy1 trial

Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan

Completed·TThe Third Xiangya Hospital of Central South University·Phase 4·NCT03147677·60 enrolled

Respiratory Infection1 trial

Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly

Unknown status·IIndonesia University·Phase 4·NCT03292744·110 enrolled

Nephropathy1 trial

Active Vitamin D And Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy

Completed·UUniversity of Aarhus·Phase 4·NCT03210688·71 enrolled

Hypoparathyroidism1 trial

Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02824718·16 enrolled

Postmenopausal Women1 trial

Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)

Completed·—·Phase 4·NCT00168909·282 enrolled

Chronic Kidney Disease1 trial

Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Unknown status·RRamathibodi Hospital·Phase 2·NCT01364688·80 enrolled

Pelvic Organ Prolapse1 trial

Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

Completed·UUniversitas Padjadjaran·Phase 3·NCT05505253·48 enrolled

Oral Squamous Cell Carcinoma1 trial

Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2/3·NCT06016400·412 enrolled

Valve Replacement Surgery1 trial

Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

Completed·—·Phase 4·NCT04085770·86 enrolled

Renal Failure1 trial

Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·N/A·NCT04967469·60 enrolled

Osteoarthritis1 trial

Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients

Completed·—·Phase 3·NCT04405960·146 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Alfacalcidol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — One-Alpha drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alfacalcidol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alfacalcidol. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Vitamin D Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

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