Hyperparathyroidism, Secondary

Endocrinology
6
Pipeline Programs
2
Companies
3
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
2
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
2100%
+ 1 programs with unclassified modality

On Market (3)

Approved therapies currently available

U
DOXERCALCIFEROLApproved
doxercalciferol
Unknown Company
injection2015
Sanofi
HECTOROLApproved
doxercalciferol
Sanofi
injection2000
U
PARSABIVApproved
etelcalcetide
Unknown Company
intravenous2017

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Sanofi
SanofiPARIS, France
1 program
1
doxercalciferolPhase 41 trial
Active Trials
NCT00528788Completed24Est. Aug 2012
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
2
EtelcalcetidePhase 3Peptide1 trial
EtelcalcetidePhase 3Peptide1 trial
Active Trials
NCT01932970Completed158Est. Feb 2017
NCT01785849Completed508Est. Jun 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Sanofidoxercalciferol
AmgenEtelcalcetide
AmgenEtelcalcetide

Clinical Trials (3)

Total enrollment: 690 patients across 3 trials

NCT00528788Sanofidoxercalciferol

How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Start: Sep 2007Est. completion: Aug 201224 patients
Phase 4Completed
NCT01932970AmgenEtelcalcetide

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Start: Aug 2013Est. completion: Feb 2017158 patients
Phase 3Completed
NCT01785849AmgenEtelcalcetide

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Start: Mar 2013Est. completion: Jun 2014508 patients
Phase 3Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
Peptide is the dominant modality (100% of programs)
2 companies competing in this space

Related Indications

Acromegaly(67)Growth Hormone Deficiency(39)Growth Hormone Disorder(37)Hypogonadism(21)Secondary Hyperparathyroidism(13)Hypoparathyroidism(12)Thyroid Eye Disease(11)Adult Growth Hormone Deficiency(10)Hypothyroidism(9)Cushing's Syndrome(9)