Parsabiv

(Etelcalcetide)

ApprovedPeptide

KK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

Parsabiv is a peptide that works as a Calcium Sensing Receptor Agonist; Calcium Sensing Receptor Agonist.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Parsabiv is one of 106 small molecule programs targeting Parathyroid Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

105

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Parathyroid DiseaseActive, not recruiting

Myelodysplastic SyndromeApproved

Chronic Kidney DiseaseApproved

Secondary HyperparathyroidismCompleted

Parathyroid DiseaseApproved

Active, not recruiting

Myelodysplastic SyndromeApproved

Approved

Chronic Kidney DiseaseApproved

Approved

Secondary HyperparathyroidismPhase 3

Completed

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Parsabiv

KK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

Approved

19 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Flomax

Activase

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Secondary Hyperparathyroidism

NCT03969329

Q1 2029

Phase 3Recruiting

Secondary Hyperparathyroidism

NCT03633708

Clinical

Trials by Indication[1]

Secondary Hyperparathyroidism13 trials

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

Completed· Amgen logo

Amgen·Phase 3·NCT01785849·508 enrolled

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Completed·KKAI Pharmaceuticals·Phase 1·NCT01134562·28 enrolled

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

Completed· Amgen logo

Amgen·Phase 3·NCT01788046·515 enrolled

Show 10 more trials

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

Completed· Amgen logo

Amgen·Phase 3·NCT01785875·891 enrolled

Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

Completed·KKAI Pharmaceuticals·Phase 2·NCT01414114·37 enrolled

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

Completed· Amgen logo

Amgen·Phase 3·NCT02102204·902 enrolled

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

Completed· Amgen logo

Amgen·Phase 3·NCT01932970·158 enrolled

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

Completed· Amgen logo

Amgen·Phase 3·NCT03299244·637 enrolled

Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism

Terminated·KKAI Pharmaceuticals·Phase 2·NCT01576146·30 enrolled

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

Recruiting· Amgen logo

Amgen·Phase 3·NCT03633708·56 enrolled

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

Completed· Amgen logo

Amgen·Phase 1·NCT02833857·11 enrolled

Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Completed·KKAI Pharmaceuticals·Phase 2·NCT01254565·87 enrolled

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Recruiting· Amgen logo

Amgen·Phase 3·NCT03969329·24 enrolled

CKD-MBD1 trial

The Effect of Etelcalcetide on CKD-MBD

Completed·TThomas Nickolas, MD MS·Phase 2·NCT03960437·22 enrolled

Calcification1 trial

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

Completed·PPrim. Priv. Doz. Dr. Daniel Cejka·Phase 2·NCT03795558·37 enrolled

Phase 11 trial

A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416

Completed· Amgen logo

Amgen·Phase 1·NCT03283098·33 enrolled

Tics1 trial

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

Completed·KKAI Pharmaceuticals·Phase 1·NCT01134549·32 enrolled

2 more indications

End Stage Renal Disease (ESRD)1 trial

Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis

Completed· Amgen logo

Amgen·Phase 1·NCT02054572·6 enrolled

NAC1 trial

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

Completed· Amgen logo

Amgen·Phase 3·NCT01896232·683 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 7, 2017

PARSABIV

NDA NDA208325

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Etelcalcetide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Etelcalcetide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Etelcalcetide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208325). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Parsabiv. U.S. Food & Drug Administration.
[6]
SEC EDGAR — K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Calcium Sensing Receptor Agonist; Calcium Sensing Receptor Agonist[2]
Modality: Peptide[2]
Highest Phase: Approved[1]
Company: KK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

Patent Landscape[5]

Patent Cliff

Jul 29, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8377880Jul 29, 2030

9701712Jul 29, 2030

9278995Jul 29, 2030

8999932Feb 7, 2031

10344765Jun 27, 2034

3 more patents

11162500Jun 27, 2034

9820938Jun 27, 2034

11959486Jun 27, 2034

Parsabiv

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2029

Trials by Indication[1]

Secondary Hyperparathyroidism13 trials

CKD-MBD1 trial

Calcification1 trial

Phase 11 trial

Tics1 trial

End Stage Renal Disease (ESRD)1 trial

NAC1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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