Hectorol

(doxercalciferol)

ApprovedSmall molecule

Sanofi

Hectorol is one of 117 small molecule programs targeting Kidney Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

116

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Kidney DiseaseTerminated

Kidney TransplantActive, not recruiting

Secondary HyperparathyroidismActive, not recruiting

PsoriasisActive, not recruiting

Kidney DiseasePhase 3

Terminated

Kidney TransplantApproved

Active, not recruiting

Secondary HyperparathyroidismPhase 3

Active, not recruiting

PsoriasisPhase 2

Active, not recruiting

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Hectorol

Sanofi

Approved

1 2

Stelara

Johnson & Johnson

Preclinical

37 3

Taltz

Eli Lilly

Preclinical

20 4

Bimzelx

UCB

Preclinical

17 5

Humira

CCelltrion

Preclinical

42 6

Raptiva

Roche

Preclinical

10 7

Remicade

OOrganon and Co

Preclinical

20 8

Siliq

BBausch Health Americas, Inc.

Preclinical

14 9

Victoza

Novo Nordisk

Preclinical

2 10

Lovenox

Sanofi

Preclinical

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

Clinical

Trials by Indication[1]

Kidney Transplant2 trials

Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

Completed·MMariana Markell·Phase 4·NCT00889629·39 enrolled

Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients

Terminated·EEmory University·Phase 4·NCT00646282·12 enrolled

Secondary Hyperparathyroidism2 trials

Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

Completed·OOPKO IP Holdings II, Inc.·Phase 1·NCT00792857·24 enrolled

Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

Completed·IIndiana University School of Medicine·N/A·NCT00285467·55 enrolled

Vitamin D1 trial

How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Completed·—·Phase 4·NCT00528788·24 enrolled

Pediatric Solid Tumors1 trial

Doxercalciferol in Recurrent Pediatric Solid Tumors

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT00511017·1 enrolled

Psoriasis1 trial

A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis

Completed· Sanofi logo

Sanofi·Phase 2·NCT00601107·111 enrolled

2 more indications

Kidney Disease1 trial

An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Terminated· Sanofi logo

Sanofi·Phase 3·NCT02859896·21 enrolled

Unspecified1 trial

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

Completed·OOPKO Health, Inc.·Phase 3·NCT02282813·298 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 6, 2000

HECTOROL

NDA NDA021027

Apr 23, 2004

HECTOROL

NDA NDA020862

Jul 24, 2018

DOXERCALCIFEROL

NDA NDA208614

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for doxercalciferol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — doxercalciferol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for doxercalciferol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208614). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Sanofi

Hectorol

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Kidney Transplant2 trials

Secondary Hyperparathyroidism2 trials

Vitamin D1 trial

Pediatric Solid Tumors1 trial

Psoriasis1 trial

Kidney Disease1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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