Paricalcitol
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
Paricalcitol, Zemplar (discontinued: Paricalcitol, Zemplar)
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 Healthcare | N-207174 RX | 2016-02-04 | 3 products |
| PARICALCITOL | Hikma Pharmaceuticals | N-205917 RX | 2014-11-18 | 3 products |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| paricalcitol | ANDA | 2024-08-12 |
| zemplar | New Drug Application | 2024-08-07 |
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
119 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 9 | 19 | 17 | 19 | 63 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 8 | 17 | 15 | 15 | 54 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | 4 | 8 | 20 | 16 | 48 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | — | 4 | 7 | 20 | 15 | 46 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 4 | 4 | 13 | 7 | 28 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 2 | 2 | 6 | 7 | 17 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 5 | 6 | 6 | 17 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 2 | 1 | 3 | 2 | 9 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | 3 | 1 | 2 | 1 | 7 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | 2 | 2 | 1 | 5 |
Show 13 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 2 | — | 1 | 3 |
| Rickets | D012279 | HP_0002748 | E55.0 | — | — | 2 | — | — | 2 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 2 | — | — | 2 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | 2 | — | — | 2 |
| Gastric bypass | D015390 | EFO_0005244 | — | — | — | 1 | — | — | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
| Avitaminosis | D001361 | EFO_0005878 | E56.9 | — | — | 1 | — | — | 1 |
| Hypophosphatemia | D017674 | HP_0002148 | — | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 6 | 7 | — | — | — | 12 |
| Adenocarcinoma | D000230 | — | — | — | 6 | — | — | — | 6 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | 2 | — | — | — | 3 |
| Insulin resistance | D007333 | HP_0000855 | — | 1 | 1 | — | — | — | 2 |
| Kidney transplantation | D016030 | — | — | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | 1 | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Mucinous adenocarcinoma | D002288 | — | — | 1 | — | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Cystadenocarcinoma | D003536 | — | — | 1 | — | — | — | — | 1 |
| Pancreatitis | D010195 | HP_0001733 | K85 | 1 | — | — | — | — | 1 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fabry disease | D000795 | Orphanet_324 | E75.21 | — | — | — | — | 1 | 1 |
| Hereditary nephritis | D009394 | EFO_0004128 | Q87.81 | — | — | — | — | 1 | 1 |
| Hematuria | D006417 | HP_0000790 | R31 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
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 | — |
| 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
No data
Financial
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Zemplar – AbbVie
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Estimated US medical usage
Paricalcitol
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,007 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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12,687 adverse events reported
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