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Parsabiv (ETELCALCETIDE)
Etelcalcetide enhances calcium-sensing receptor activation, reducing PTH secretion.
Parsabiv (etelcalcetide) is a small molecule calcium-sensing receptor agonist developed by Kai Pharms Inc, targeting the extracellular calcium-sensing receptor. It is FDA-approved since 2017 for the treatment of secondary hyperparathyroidism. Parsabiv works by activating the calcium-sensing receptor, which helps regulate parathyroid hormone levels. The drug is patented and has no generic manufacturers. Key safety considerations include its potential to cause hypocalcemia.
At a glance
| Generic name | ETELCALCETIDE |
|---|---|
| Sponsor | Kai Pharms Inc |
| Drug class | Calcium-sensing Receptor Agonist |
| Target | CaSR |
| Modality | Recombinant protein |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Etelcalcetide works by binding to the calcium-sensing receptor (CaSR) on parathyroid chief cells. This binding increases the sensitivity of the receptor to extracellular calcium, leading to decreased secretion of parathyroid hormone (PTH).
Approved indications
- Secondary Hyperparathyroidism in CKD on Hemodialysis
Common side effects
- blood calcium decreased
- muscle spasms
- diarrhea
- nausea
- vomiting
- headache
- hypocalcemia
- paresthesia
Key clinical trials
- A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis (PHASE3)
- A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis (PHASE3)
- MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease (PHASE2)
- Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
- The Effect of Etelcalcetide on CKD-MBD (PHASE2)
- A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients (PHASE2)
- Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) (PHASE3)
- Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Parsabiv CI brief — competitive landscape report
- Parsabiv updates RSS · CI watch RSS
- Kai Pharms Inc portfolio CI