PARSABIV (etelcalcetide)
PARSABIV is indicated for the treatment of Secondary Hyperparathyroidism; Chronic Kidney Disease.
How PARSABIV Works
Etelcalcetide is a calcimimetic agent that functions as an allosteric modulator of the calcium-sensing receptor (CaSR). By binding to the CaSR, it enhances the receptor's activation by extracellular calcium, which leads to a reduction in the secretion of parathyroid hormone (PTH) from parathyroid chief cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-02-07
- Patent Cliff
- 2034
- Revenue
- $84M (Q3-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PARSABIV Approval History
What PARSABIV Treats
2 indicationsPARSABIV is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Hyperparathyroidism
- Chronic Kidney Disease
PARSABIV Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PARSABIV
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03969329 | 20170724 | Ph 3 | recruiting | A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis |
| NCT03633708 | 20140315 2017-002411-34 | Ph 3 | recruiting | A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis |
| NCT03960437 Parsabiv-MBD results posted | AAAR6244 | Ph 2 | completed | The Effect of Etelcalcetide on CKD-MBD |
| NCT03795558 | Etelcalcetide-T50-CKD5D | Ph 2 | completed | A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients |
| NCT03299244 results posted | 20150238 | Ph 3 | completed | Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) |
| NCT03283098 results posted | 20140197 | Ph 1 | completed | A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416 |
| NCT01785849 results posted | 20120229 KAI-4169-006, 2012-002805-23 | Ph 3 | completed | Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis |
| NCT01788046 results posted | 20120230 KAI-4169-007, 2012-002806-31 | Ph 3 | completed | Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis |
| NCT01896232 results posted | 20120360 2013-000192-33 | Ph 3 | completed | Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet |
| NCT02833857 results posted | 20140336 2015-005051-28 | Ph 1 | completed | A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis |
| NCT01785875 results posted | 20120231 KAI-4169-008, 2012-002808-41 | Ph 3 | completed | Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis |
| NCT01932970 results posted | 20120359 2013-000964-28, KAI-4169 | Ph 3 | completed | Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide |
| NCT01134562 results posted | KAI-4169-002 20130139 | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism |
| NCT02102204 results posted | 20130213 2013-004136-30, KAI-4169 | Ph 3 | completed | Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis |
| NCT01134549 results posted | KAI-4169-001 20130107 | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers |
| NCT01576146 results posted | KAI-4169-005-01 20120334 | Ph 2 | terminated | 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 |
| NCT01254565 results posted | KAI-4169-003 20120330 | Ph 2 | completed | Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism |
| NCT01414114 results posted | KAI-4169-005 20120331 | Ph 2 | completed | Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PARSABIV FDA Label Details
Indications & Usage
FDA Label (PDF)PARSABIV is indicated for the treatment of Secondary Hyperparathyroidism; Chronic Kidney Disease.
PARSABIV Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for PARSABIV
Revenue Insights
- • Q3-2025: $84M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 72 active patents
Trial Analysis
- • 18 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment