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Calcitriol
Rocaltrol, Vectical (calcitriol) is a small molecule pharmaceutical. Calcitriol was first approved as Rocaltrol on 1982-01-01. It is used to treat hyperparathyroidism, hypocalcemia, psoriasis, rickets, and vitamin e deficiency in the USA. The pharmaceutical is active against vitamin D3 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
Rocaltrol, Vectical (generic drugs available since 2001-10-12, discontinued: Calcijex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcitriol
Tradename
Company
Number
Date
Products
VECTICALGaldermaN-022087 RX2009-01-23
1 products, RLD, RS
ROCALTROLValidus PharmaceuticalsN-018044 RX1982-01-01
2 products, RLD
ROCALTROLValidus PharmaceuticalsN-021068 RX1998-11-20
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
calcitriolANDA2023-06-19
rocaltrolNew Drug Application2021-01-26
vecticalNew Drug Application2020-07-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hyperparathyroidismEFO_0008506D006961E21.3
hypocalcemiaHP_0002901D006996E83.51
psoriasisEFO_0000676D011565L40
ricketsEFO_0005583D012279E55.0
vitamin e deficiency—D014811E56.0
Agency Specific
FDA
EMA
Expiration
Code
CALCITRIOL, VECTICAL, GALDERMA LABS LP
2023-07-17NPP
Patent Expiration
No data
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
— A11CC04: Calcitriol
D: Dermatologicals
— D05: Antipsoriatics
— D05A: Antipsoriatics for topical use
— D05AX: Other antipsoriatics for topical use in atc
— D05AX03: Calcitriol
HCPCS
Code
Description
J0636
Injection, calcitriol, 0.1 mcg
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G43———145
AnalgesiaD000698———1—1
FibromyalgiaD005356EFO_0005687M79.1———1—1
Primary hyperparathyroidismD049950EFO_0008519E21.0———1—1
HypercalcemiaD006934E83.52———1—1
PainD010146EFO_0003843R52———1—1
Rib fracturesD012253———1—1
HypothyroidismD007037EFO_0004705E03.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postmenopausal osteoporosisD015663EFO_00038542—4——6
OsteoarthritisD010003EFO_0002506M15-M19212——5
OsteoporosisD010024EFO_0003882M81.0—12——3
PostmenopauseD017698——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CalcinosisD002114—1———1
Giant cell granulomaD006101K06.8—1———1
Metabolic bone diseasesD001851HP_0000938—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine without auraD020326EFO_0005296G43.0————22
Migraine with auraD020325EFO_0005295G43.1————22
Nephrogenic diabetes insipidusD018500N25.1————11
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9————11
Brain concussionD001924S06.0————11
Post-traumatic headacheD051298G44.3————11
Cluster headacheD003027HP_0012199G44.00————11
Familial hypophosphatemic ricketsD053098————11
HypophosphatemiaD017674HP_0002148————11
Ulcerative colitisD003093EFO_0000729K51————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCALCITRIOL
INNcalcitriol
Description
Calcitriol is a hydroxycalciol that is calcidiol in which the pro-S hydrogen of calcidiol is replaced by a hydroxy group. It is the active form of vitamin D3, produced fom calciol via hydoxylation in the liver to form calcidiol, which is subsequently oxidised in the kidney to give calcitriol. It has a role as a bone density conservation agent, an antipsoriatic, an immunomodulator, an antineoplastic agent, a calcium channel modulator, a nutraceutical, a calcium channel agonist, a metabolite, a hormone, a human metabolite and a mouse metabolite. It is a hydroxycalciol, a member of D3 vitamins and a triol.
Classification
Small molecule
Drug classvitamin D analogs
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=C1/C(=C\C=C2/CCC[C@@]3(C)[C@H]2CC[C@@H]3[C@H](C)CCCC(C)(C)O)C[C@@H](O)C[C@@H]1O
Identifiers
PDB3VT7
CAS-ID32222-06-3
RxCUI1894
ChEMBL IDCHEMBL846
ChEBI ID17823
PubChem CID5280453
DrugBankDB00136
UNII IDFXC9231JVH (ChemIDplus, GSRS)
Target
Agency Approved
VDR
VDR
Organism
Homo sapiens
Gene name
VDR
Gene synonyms
NR1I1
NCBI Gene ID
7421
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
Q5PSV3
Mouse ortholog
Vdr (22337)
vitamin D3 receptor (Q922X0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,276 adverse events reported
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