Secondary Hyperparathyroidism

Endocrinology
11
Pipeline Programs
5
Companies
24
Clinical Trials
2 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
4
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
2100%
+ 6 programs with unclassified modality

On Market (4)

Approved therapies currently available

Sanofi
HECTOROLApproved
doxercalciferol
Sanofi
injection2000
U
PARICALCITOLApproved
paricalcitol
Unknown Company
Vitamin D2 Analog [EPC]intravenous2017
U
PARSABIVApproved
etelcalcetide
Unknown Company
intravenous2017
AbbVie
ZEMPLARApproved
paricalcitol
AbbVie
Vitamin D2 Analog [EPC]intravenous1998

Competitive Landscape

5 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ParicalcitolN/A2 trials
Active Trials
NCT04064827Terminated2Est. Jun 2025
NCT01939977Completed148Est. Dec 2015
Sanofi
SanofiPARIS, France
1 program
1
HECTOROL(Hectorol)Phase 45 trials
Active Trials
NCT02859896Terminated21Est. Jun 2025
NCT00463021Completed36Est. Dec 2007
NCT00454350Completed12Est. Jul 2007
+2 more trials
Amgen
AmgenTHOUSAND OAKS, CA
3 programs
3
AMG 073Phase 35 trials
EtelcalcetidePhase 3Peptide5 trials
EtelcalcetidePhase 3Peptide1 trial
Active Trials
NCT00110929Completed850
NCT00042432Completed54Est. Aug 2003
NCT00037635Completed400Est. Mar 2003
+8 more trials
Abbott
AbbottABBOTT PARK, IL
2 programs
1
1
paricalcitolPhase 31 trial
ParicalcitolPhase 21 trial
Active Trials
NCT00701805Completed107Est. Dec 2009
NCT01341782Completed255Est. Apr 2012
Astellas
AstellasChina - Shenyang
1 program
1
ASP7991Phase 21 trial
Active Trials
NCT02133404Completed62Est. Nov 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
AmgenEtelcalcetide
AbbVieParicalcitol
SanofiHectorol
SanofiHectorol
SanofiHectorol
SanofiHectorol
AmgenAMG 073
AbbVieParicalcitol
AmgenEtelcalcetide
AmgenEtelcalcetide
AmgenEtelcalcetide
SanofiHectorol
AmgenEtelcalcetide
AmgenEtelcalcetide
AmgenEtelcalcetide

Showing 15 of 24 trials with date data

Clinical Trials (24)

Total enrollment: 5,447 patients across 24 trials

NCT03182699AmgenEtelcalcetide

Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients

Start: Oct 2017Est. completion: Dec 201962 patients
Phase 4Completed
NCT01939977AbbVieParicalcitol

Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.

Start: Jan 2014Est. completion: Dec 2015148 patients
Phase 4Completed
NCT00463021SanofiHectorol

A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

Start: Apr 2007Est. completion: Dec 200736 patients
Phase 4Completed
NCT00454350SanofiHectorol

A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis

Start: Feb 2007Est. completion: Jul 200712 patients
Phase 4Completed
NCT00418600SanofiHectorol

A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

Start: Nov 2006Est. completion: Aug 200736 patients
Phase 4Completed
NCT00123461SanofiHectorol

Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

Start: Jul 2005Est. completion: Oct 200770 patients
Phase 4Completed
NCT00037518AmgenAMG 073

A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

Start: Apr 200146 patients
Phase 4Completed
NCT04064827AbbVieParicalcitol

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Start: Sep 2020Est. completion: Jun 20252 patients
Phase 3Terminated
NCT03969329AmgenEtelcalcetide

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Start: Dec 2019Est. completion: Jun 202724 patients
Phase 3Recruiting
NCT03633708AmgenEtelcalcetide

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Start: Apr 2019Est. completion: Jan 202956 patients
Phase 3Recruiting
NCT03299244AmgenEtelcalcetide

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Start: May 2018Est. completion: Apr 2020637 patients
Phase 3Completed
NCT02859896SanofiHectorol

Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Start: Jan 2017Est. completion: Jun 202521 patients
Phase 3Terminated
NCT02102204AmgenEtelcalcetide

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Start: Mar 2014Est. completion: Jun 2017902 patients
Phase 3Completed
NCT01896232AmgenEtelcalcetide

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start: Aug 2013Est. completion: Jan 2015683 patients
Phase 3Completed
NCT01785875AmgenEtelcalcetide

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start: Jul 2013Est. completion: Jul 2015891 patients
Phase 3Completed
NCT01341782Abbottparicalcitol

Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Start: May 2011Est. completion: Apr 2012255 patients
Phase 3Completed
NCT00037635AmgenAMG 073

A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

Start: Dec 2001Est. completion: Mar 2003400 patients
Phase 3Completed
NCT03795558AmgenEtelcalcetide

A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

Start: May 2019Est. completion: Mar 202237 patients
Phase 2Completed
NCT02133404AstellasASP7991

A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

Start: Mar 2014Est. completion: Nov 201462 patients
Phase 2Completed
NCT00701805AbbottParicalcitol

Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Start: Jul 2008Est. completion: Dec 2009107 patients
Phase 2Completed
NCT00110929AmgenAMG 073

Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Start: Nov 2002850 patients
Phase 2Completed
NCT00042432AmgenAMG 073

Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Start: Jun 2002Est. completion: Aug 200354 patients
Phase 2Completed
NCT00936988AmgenAMG 073

A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism

Start: Nov 2000Est. completion: Dec 200545 patients
Phase 2Completed
NCT02833857AmgenEtelcalcetide

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

Start: Mar 2017Est. completion: Oct 201811 patients
Phase 1Completed

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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

4 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 5,447 patients
5 companies competing in this space

Related Indications

Acromegaly(67)Growth Hormone Deficiency(39)Growth Hormone Disorder(37)Hypogonadism(21)Hypoparathyroidism(12)Thyroid Eye Disease(11)Adult Growth Hormone Deficiency(10)Hypothyroidism(9)Cushing's Syndrome(9)Growth Hormone Deficiency in Children(5)