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etelcalcetide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| peptides and glycopeptides | 5181 | 1262780-97-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Etelcalcetide is a synthetic peptide calcimimetic agent which reduces parathyroid hormone (PTH) secretion through binding and activation of the calcium-sensing receptor. The reduction in PTH is associated with a concomitant decrease in serum calcium and phosphate levels.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2.10 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 1.98 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.67 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 19.05 hours | Lombardo F, Berellini G, Obach RS |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHUK,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FGFR1,FLT3,GRK2,GSK3B,IGF1R,IKBKB,ITK,JAK1,JAK2,JAK3,MAP2K1,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 66 | |||
| kinase-selectivity-class | GRK2,PDK1 | 2 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 7, 2017 | FDA | KAI PHARMS INC | |
| Nov. 11, 2016 | EMA | Amgen Europe B.V. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Shunt stenosis | 674.23 | 41.48 | 85 | 1778 | 474 | 90626110 |
| Shunt occlusion | 393.91 | 41.48 | 55 | 1808 | 720 | 90625864 |
| Underdose | 317.74 | 41.48 | 92 | 1771 | 53925 | 90572659 |
| Blood parathyroid hormone increased | 188.83 | 41.48 | 36 | 1827 | 3401 | 90623183 |
| Blood calcium decreased | 153.25 | 41.48 | 46 | 1817 | 30136 | 90596448 |
| Hypocalcaemia | 110.53 | 41.48 | 39 | 1824 | 42329 | 90584255 |
| Blood parathyroid hormone abnormal | 80.92 | 41.48 | 12 | 1851 | 242 | 90626342 |
| Peripheral arterial occlusive disease | 56.05 | 41.48 | 14 | 1849 | 4607 | 90621977 |
| Pemphigoid | 55.57 | 41.48 | 16 | 1847 | 9010 | 90617574 |
| Nausea | 53.37 | 41.48 | 87 | 1776 | 1110229 | 89516355 |
| Shunt malfunction | 50.92 | 41.48 | 7 | 1856 | 80 | 90626504 |
| Shunt infection | 48.17 | 41.48 | 7 | 1856 | 122 | 90626462 |
| Angina unstable | 45.48 | 41.48 | 13 | 1850 | 7130 | 90619454 |
| Cardiac failure | 45.02 | 41.48 | 28 | 1835 | 109468 | 90517116 |
| Calciphylaxis | 44.83 | 41.48 | 11 | 1852 | 3365 | 90623219 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Shunt stenosis | 831.41 | 40.82 | 118 | 2016 | 659 | 42618542 |
| Shunt occlusion | 443.60 | 40.82 | 71 | 2063 | 956 | 42618245 |
| Blood parathyroid hormone increased | 294.82 | 40.82 | 55 | 2079 | 1872 | 42617329 |
| Underdose | 287.36 | 40.82 | 80 | 2054 | 16586 | 42602615 |
| Hypocalcaemia | 189.60 | 40.82 | 67 | 2067 | 30106 | 42589095 |
| Peripheral arterial occlusive disease | 185.19 | 40.82 | 47 | 2087 | 6791 | 42612410 |
| Blood calcium decreased | 123.41 | 40.82 | 38 | 2096 | 11070 | 42608131 |
| Shunt aneurysm | 60.40 | 40.82 | 8 | 2126 | 23 | 42619178 |
| Angina unstable | 58.93 | 40.82 | 22 | 2112 | 11426 | 42607775 |
| Blood calcium abnormal | 57.34 | 40.82 | 12 | 2122 | 734 | 42618467 |
| Shunt infection | 56.04 | 40.82 | 9 | 2125 | 122 | 42619079 |
| Blood parathyroid hormone abnormal | 46.16 | 40.82 | 8 | 2126 | 176 | 42619025 |
| Parathyroid gland enlargement | 46.11 | 40.82 | 8 | 2126 | 177 | 42619024 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Shunt stenosis | 1529.71 | 39.07 | 203 | 3013 | 1213 | 110584870 |
| Shunt occlusion | 862.10 | 39.07 | 126 | 3090 | 1611 | 110584472 |
| Hypocalcaemia | 272.00 | 39.07 | 93 | 3123 | 65273 | 110520810 |
| Peripheral arterial occlusive disease | 270.51 | 39.07 | 61 | 3155 | 9219 | 110576864 |
| Underdose | 262.77 | 39.07 | 90 | 3126 | 63464 | 110522619 |
| Blood parathyroid hormone increased | 197.38 | 39.07 | 41 | 3175 | 4207 | 110581876 |
| Angina unstable | 115.95 | 39.07 | 35 | 3181 | 16397 | 110569686 |
| Blood calcium decreased | 110.85 | 39.07 | 41 | 3175 | 35804 | 110550279 |
| Shunt infection | 105.10 | 39.07 | 16 | 3200 | 269 | 110585814 |
| Shunt aneurysm | 88.92 | 39.07 | 11 | 3205 | 32 | 110586051 |
| Cerebral infarction | 83.12 | 39.07 | 37 | 3179 | 51801 | 110534282 |
| Cardiac failure | 71.03 | 39.07 | 52 | 3164 | 187574 | 110398509 |
| Myocardial ischaemia | 62.68 | 39.07 | 25 | 3191 | 26659 | 110559424 |
| Aortic valve stenosis | 55.61 | 39.07 | 16 | 3200 | 6334 | 110579749 |
| Calciphylaxis | 52.58 | 39.07 | 14 | 3202 | 4173 | 110581910 |
| Parathyroid gland enlargement | 49.07 | 39.07 | 8 | 3208 | 212 | 110585871 |
| Fall | 44.83 | 39.07 | 70 | 3146 | 603412 | 109982671 |
| Sudden death | 44.23 | 39.07 | 19 | 3197 | 24376 | 110561707 |
| Hypercalcaemia | 43.53 | 39.07 | 23 | 3193 | 46634 | 110539449 |
| Bile duct stone | 42.64 | 39.07 | 13 | 3203 | 6276 | 110579807 |
| Large intestine polyp | 41.99 | 39.07 | 16 | 3200 | 15101 | 110570982 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | H05BX04 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents |
| FDA MoA | N0000020081 | Increased Calcium-sensing Receptor Sensitivity |
| FDA EPC | N0000175902 | Calcium-sensing Receptor Agonist |
Related Drugs by ATC class:
H05BX Other anti-parathyroid agents 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Secondary hyperparathyroidism | indication | 91478007 | DOID:12466 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 1.83 | acidic |
| pKa2 | 12.62 | acidic |
| pKa3 | 13.21 | acidic |
| pKa4 | 13.22 | acidic |
| pKa5 | 13.76 | acidic |
| pKa6 | 13.85 | acidic |
| pKa7 | 11.35 | Basic |
| pKa8 | 10.93 | Basic |
| pKa9 | 10.57 | Basic |
| pKa10 | 10.15 | Basic |
| pKa11 | 8.46 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 9701712 | July 29, 2030 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 2.5MG/0.5ML (2.5MG/0.5ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 9701712 | July 29, 2030 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 5MG/ML (5MG/ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 9701712 | July 29, 2030 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 10MG/2ML (5MG/ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 8999932 | Feb. 7, 2031 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 2.5MG/0.5ML (2.5MG/0.5ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 8999932 | Feb. 7, 2031 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 5MG/ML (5MG/ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 8999932 | Feb. 7, 2031 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 10MG/2ML (5MG/ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 11959486 | June 27, 2034 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 2.5MG/0.5ML (2.5MG/0.5ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 11959486 | June 27, 2034 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
| 5MG/ML (5MG/ML) | PARSABIV | KAI PHARMS INC | N208325 | Feb. 7, 2017 | RX | SOLUTION | INTRAVENOUS | 11959486 | June 27, 2034 | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Extracellular calcium-sensing receptor | GPCR | AGONIST | EC50 | 4.60 | IUPHAR | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 60ME133FJB | UNII |
| 1334237-71-6 | SECONDARY_CAS_RN |
| 4037030 | VANDF |
| C3713906 | UMLSCUI |
| CHEBI:134700 | CHEBI |
| CHEMBL3545184 | ChEMBL_ID |
| D10676 | KEGG_DRUG |
| 71511839 | PUBCHEM_CID |
| DB12865 | DRUGBANK_ID |
| CHEMBL3545183 | ChEMBL_ID |
| 9809 | INN_ID |
| C583569 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8375 | IUPHAR_LIGAND_ID |
| 1156090004 | SNOMEDCT_US |
| 723539000 | SNOMEDCT_US |
| 763584002 | SNOMEDCT_US |
| 251837 | MMSL |
| 32350 | MMSL |
| 33154 | MMSL |
| d08523 | MMSL |
| 017097 | NDDF |
| 017098 | NDDF |
| 1876119 | RXNORM |
| 60ME133FJB | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PARSABIV | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-740 | INJECTION, SOLUTION | 2.50 mg | INTRAVENOUS | NDA | 28 sections |
| PARSABIV | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-741 | INJECTION, SOLUTION | 5 mg | INTRAVENOUS | NDA | 28 sections |
| PARSABIV | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-742 | INJECTION, SOLUTION | 10 mg | INTRAVENOUS | NDA | 28 sections |