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Calcifediol
Rayaldee (calcifediol) is a small molecule pharmaceutical. Calcifediol was first approved as Calderol on 1982-01-01. It is known to target vitamin D 25-hydroxylase.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Rayaldee (discontinued: Calderol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcifediol
Tradename
Company
Number
Date
Products
RAYALDEEEirgen PharmaN-208010 RX2016-06-17
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
rayaldeeNew Drug Application2020-12-07
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Calcifediol, Rayaldee, Eirgen
98616442034-03-14DP
103000782034-03-14DP
103575022034-03-14DP
112535282034-03-14DP
84263912028-08-27U-1872
83614882028-07-19DP
82071492028-04-25U-1871
87783732028-04-25U-1873
94088582028-04-25U-1888
94984862028-04-25U-1920
99251472028-04-25DPU-2255, U-2256, U-2257, U-2258, U-2259
111545092028-04-25U-3248
89064102027-02-02DP
99435302027-02-02U-2274
102134422027-02-02DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11C: Vitamin a and d, incl. combinations of the two
— A11CC: Vitamin d and analogues
— A11CC06: Calcifediol
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H05: Calcium homeostasis
— H05B: Anti-parathyroid agents
— H05BX: Other anti-parathyroid agents in atc
— H05BX05: Calcifediol
HCPCS
No data
Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I501—1327
Chronic renal insufficiencyD051436N18—1—113
Diabetes mellitusD003920EFO_0000400E08-E13———1—1
HypertensionD006973EFO_0000537I10———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autism spectrum disorderD000067877F84.0—12——3
Autistic disorderD001321EFO_0003758F84.0—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SeizuresD012640G40.421———2
Parkinson diseaseD010300EFO_0002508G20—1———1
Hepatocellular carcinomaD006528C22.011———1
Hypokalemic periodic paralysisD020514G72.3—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E111————1
Alzheimer diseaseD000544EFO_0000249F031————1
EpilepsyD004827EFO_0000474G40.91————1
Drug resistant epilepsyD0000692791————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCALCIFEDIOL
INNcalcifediol
Description
Calcidiol is a hydroxycalciol that is calciol in which the hydrogen at position 25 has been replaced by a hydroxy group. A prehormone resulting from the oxidation of calciol in the liver, it is further hydroxylated in the kidney to give calcitriol, the active form of vitamin D3. It has a role as a bone density conservation agent, a nutraceutical, a metabolite, a human metabolite and a mouse metabolite. It is a hydroxycalciol, a member of D3 vitamins and a diol.
Classification
Small molecule
Drug classvitamin D analogs
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=C1CC[C@H](O)C/C1=C/C=C1\CCC[C@@]2(C)[C@H]1CC[C@@H]2[C@H](C)CCCC(C)(C)O.O
Identifiers
PDB—
CAS-ID19356-17-3
RxCUI1855064
ChEMBL IDCHEMBL3544909
ChEBI ID—
PubChem CID5283731
DrugBankDB00146
UNII IDT0WXW8F54E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP2R1
CYP2R1
Organism
Homo sapiens
Gene name
CYP2R1
Gene synonyms
NCBI Gene ID
120227
Protein name
vitamin D 25-hydroxylase
Protein synonyms
Cytochrome P450 2R1, cytochrome P450, family 2, R1, cytochrome P450, family 2, subfamily R, polypeptide 1
Uniprot ID
Q6VVX0
Mouse ortholog
Cyp2r1 (244209)
vitamin D 25-hydroxylase (Q6VVW9)
Variants
Clinical Variant
No data
Financial
Rayaldee - Opko Health
$
€
£
₣
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,134 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,045 adverse events reported
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