Overview
Etelcalcetide is a calcimimetic drug for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis. Etelcalcetide was approved (trade name Parsabiv) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis in February, 2017.
Indication
Etelcalcetide is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Associated Conditions
- Secondary Hyperparathyroidism (SHPT)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/15 | Phase 2 | Recruiting | Shaanxi Micot Technology Limited Company | ||
2019/05/31 | Phase 3 | Recruiting | |||
2019/05/23 | Phase 2 | Completed | Thomas Nickolas, MD MS | ||
2019/01/07 | Phase 2 | Completed | Prim. Priv. Doz. Dr. Daniel Cejka | ||
2018/08/16 | Phase 3 | Recruiting | |||
2017/10/03 | Phase 3 | Completed | |||
2017/09/14 | Phase 1 | Completed | |||
2016/07/14 | Phase 1 | Completed | |||
2014/04/02 | Phase 3 | Completed | |||
2013/08/30 | Phase 3 | Completed |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/11/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PARSABIV SOLUTION FOR INJECTION 10 mg/2 mL | SIN15452P | INJECTION, SOLUTION | 10 mg/2 mL | 3/14/2018 | |
| PARSABIV SOLUTION FOR INJECTION 5 mg/mL | SIN15451P | INJECTION, SOLUTION | 5 mg/mL | 3/14/2018 | |
| PARSABIV SOLUTION FOR INJECTION 2.5 mg/0.5 mL | SIN15450P | INJECTION, SOLUTION | 2.5 mg/0.5 mL | 3/14/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Etelcalcetide Hydrochloride Injection | 国药准字HJ20230046 | 化学药品 | 注射剂 | 5/6/2023 | |
| Etelcalcetide Hydrochloride Injection | 国药准字HJ20230047 | 化学药品 | 注射剂 | 5/6/2023 | |
| Etelcalcetide Hydrochloride Injection | 国药准字HJ20230048 | 化学药品 | 注射剂 | 5/6/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PARSABIV SOLUTION FOR INJECTION 10 MG/2 ML | N/A | N/A | N/A | 3/23/2018 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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