Paricalcitol
Zemplar (paricalcitol) is a small molecule pharmaceutical. Paricalcitol was first approved as Zemplar on 1998-04-17. It is used to treat hyperparathyroidism in the USA. The pharmaceutical is active against vitamin D3 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Zemplar (generic drugs available since 2011-07-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Paricalcitol
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ZEMPLAR | AbbVie | N-020819 RX | 1998-04-17 | 3 products, RLD, RS |
ZEMPLAR | AbbVie | N-021606 RX | 2005-05-26 | 2 products, RLD |
PARICALCITOL | ACCORD HLTHCARE | N-207174 RX | 2016-02-04 | 3 products |
PARICALCITOL | Hikma Pharmaceuticals | N-205917 RX | 2014-11-18 | 3 products |
PARICALCITOL | Hospira | N-201657 RX | 2014-10-21 | 3 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
paricalcitol | ANDA | 2023-02-27 |
zemplar | New Drug Application | 2021-04-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
hyperparathyroidism | EFO_0008506 | D006961 | E21.3 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
PARICALCITOL, ZEMPLAR, ABBVIE | |||
2023-10-18 | ODE*, ODE-125 |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J2501 | Injection, paricalcitol, 1 mcg |
Clinical
Clinical Trials
329 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 9 | 26 | 4 | 1 | 36 | 71 |
Exocrine pancreatic insufficiency | D010188 | K86.81 | 2 | 4 | 14 | 8 | 8 | 34 | |
Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 3 | 1 | 2 | 4 | 10 | 20 |
Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 2 | 8 | 4 | 4 | 18 |
Pancreatitis | D010195 | EFO_0000278 | K85 | 3 | 2 | 1 | 1 | 11 | 17 |
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 2 | 7 | 9 |
Pancreatic pseudocyst | D010192 | HP_0005206 | K86.3 | — | — | — | 1 | 4 | 5 |
Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | 1 | — | 1 |
Pancreas transplantation | D016035 | — | — | — | 1 | — | 1 | ||
Celiac disease | D002446 | EFO_0001060 | K90.0 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 16 | 21 | 8 | — | 48 | 83 |
Pancreatic fistula | D010185 | — | 1 | 2 | — | 11 | 14 | ||
Steatorrhea | D045602 | 1 | 1 | 2 | — | — | 4 | ||
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | 2 | 3 |
Pancreatectomy | D010180 | EFO_0002581 | — | — | 2 | — | 1 | 3 | |
Circulating neoplastic cells | D009360 | — | — | 1 | — | 1 | 2 | ||
Sepsis | D018805 | A41.9 | — | 1 | 1 | — | — | 1 | |
Child nutrition disorders | D015362 | — | 1 | 1 | — | — | 1 | ||
Malabsorption syndromes | D008286 | EFO_0009554 | K90 | — | — | 1 | — | — | 1 |
Eructation | D004884 | R14.2 | — | — | 1 | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pancreatic cyst | D010181 | HP_0001737 | K86.2 | — | — | — | — | 9 | 9 |
Pancreatic diseases | D010182 | K86.9 | — | — | — | — | 6 | 6 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 5 | 5 |
Acute necrotizing pancreatitis | D019283 | — | — | — | — | 4 | 4 | ||
Adenocarcinoma | D000230 | — | — | — | — | 4 | 4 | ||
Overweight | D050177 | E66.3 | — | — | — | — | 2 | 2 | |
Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
Gallstones | D042882 | EFO_0004210 | — | — | — | — | 2 | 2 | |
Endoscopic retrograde cholangiopancreatography | D002760 | — | — | — | — | 2 | 2 | ||
Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PARICALCITOL |
INN | — |
Description | Paricalcitol is a seco-cholestane and a hydroxy seco-steroid. It has a role as an antiparathyroid drug. It is functionally related to a vitamin D2. |
Classification | Small molecule |
Drug class | vitamin D analogs |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | C[C@@H](/C=C/[C@@H](C)[C@H]1CC[C@H]2/C(=C/C=C3C[C@@H](O)C[C@H](O)C3)CCC[C@@]21C)C(C)(C)O |
Identifiers
PDB | — |
CAS-ID | 131918-61-1 |
RxCUI | 73710 |
ChEMBL ID | CHEMBL1200622 |
ChEBI ID | 7931 |
PubChem CID | 5281104 |
DrugBank | DB00910 |
UNII ID | — |
Target
Agency Approved
VDR
VDR
Organism
Homo sapiens
Gene name
VDR
Gene synonyms
NR1I1
NCBI Gene ID
Protein name
vitamin D3 receptor
Protein synonyms
1,25-dihydroxyvitamin D3 receptor, Nuclear receptor subfamily 1 group I member 1, protein phosphatase 1, regulatory subunit 163, vitamin D (1,25- dihydroxyvitamin D3) receptor
Uniprot ID
Mouse ortholog
Vdr (22337)
vitamin D3 receptor (Q922X0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zemplar - AbbVie
$
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£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,628 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,163 adverse events reported
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