calcifediol indications/contra

Stem definitionDrug idCAS RN
Vitamin D analogues/derivatives 464 19356-17-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • calcifediol
  • calcidiol
  • calderol
The major circulating metabolite of VITAMIN D3. It is produced in the LIVER and is the best indicator of the body's vitamin D stores. It is effective in the treatment of RICKETS and OSTEOMALACIA, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties.
  • Molecular weight: 400.65
  • Formula: C27H44O2
  • CLOGP: 7.27
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 2
  • TPSA: 40.46
  • ALOGS: -5.26
  • ROTB: 6

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Aug. 5, 1980 FDA

FDA Adverse Event Reporting System

None

Pharmacologic Action:

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SourceCodeDescription
ATC A11CC06 ALIMENTARY TRACT AND METABOLISM
VITAMINS
VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
Vitamin D and analogues
MeSH PA D050071 Bone Density Conservation Agents
MeSH PA D006133 Growth Substances
MeSH PA D018977 Micronutrients
MeSH PA D014815 Vitamins
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:50733 nutraceutical

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Hypophosphatemia indication 4996001
Hypocalcemia indication 5291005
Renal osteodystrophy indication 16726004 DOID:13068
Rickets indication 41345002 DOID:10609
Hyperphosphatemia contraindication 20165001 DOID:0050459
Hypervitaminosis D contraindication 27712000 DOID:9971
Sarcoidosis contraindication 31541009 DOID:13404
Hypercalcemia contraindication 66931009 DOID:12678
Kidney disease contraindication 90708001 DOID:2527
Kidney stone contraindication 95570007
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
Vitamin D deficiency off-label use 34713006

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.03MG RAYALDEE OPKO IRELAND GLOBAL N208010 June 17, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8207149 April 25, 2028 TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH STAGE 3 OR 4 CHRONIC KIDNEY DISEASE USING CONTROLLED RELEASE, ORAL 25-HYDROXYVITAMIN D
0.03MG RAYALDEE OPKO IRELAND GLOBAL N208010 June 17, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8778373 April 25, 2028 ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE
0.03MG RAYALDEE OPKO IRELAND GLOBAL N208010 June 17, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9408858 April 25, 2028 USE OF CONTROLLED RELEASE 25-HYDROXYVITAMIN D IN TREATING SECONDARY HYPERPARATHYROIDISM IN PATIENTS HAVING CHRONIC KIDNEY DISEASE
0.03MG RAYALDEE OPKO IRELAND GLOBAL N208010 June 17, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9498486 April 25, 2028 USE OF EXTENDED RELEASE ORAL 25-HYDROXYVITAMIN D3 IN TREATING SECONDARY HYPERPARATHYROIDISM IN ADULT PATIENTS HAVING CHRONIC KIDNEY DISEASE STAGE 3 OR STAGE 4
0.03MG RAYALDEE OPKO IRELAND GLOBAL N208010 June 17, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8426391 Aug. 27, 2028 USE OF SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN TREATING PATIENTS HAVING 25-HYDROXYVITAMIN D INSUFFICIENCY OR DEFICIENCY

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.03MG RAYALDEE OPKO IRELAND GLOBAL N208010 June 17, 2016 RX CAPSULE, EXTENDED RELEASE ORAL June 17, 2019 NEW PRODUCT

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Vitamin D3 receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL

External reference:

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IDSource
DB00146 DRUGBANK_ID
4022405 VUID
N0000020410 NUI
C0006657 UMLSCUI
6921 IUPHAR_LIGAND_ID
D00122 KEGG_DRUG
4022405 VANDF
N0000006507 NDFRT
N0000020410 NDFRT
1889 RXNORM
259337002 SNOMEDCT_US
4321 MMSL
d03127 MMSL
001016 NDDF
88519001 SNOMEDCT_US
5283731 PUBCHEM_CID
D002112 MESH_DESCRIPTOR_UI
CHEMBL3544909 ChEMBL_ID
P6YZ13C99Q UNII
63283-36-3 SECONDARY_CAS_RN
CHEBI:17933 CHEBI
VDY PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Rayaldee HUMAN PRESCRIPTION DRUG LABEL 1 70301-1001 CAPSULE, EXTENDED RELEASE 30 ug ORAL NDA 16 sections