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Calcipotriene
Dovonex, Enstilar, Sorilux, Taclonex, Wynzora (calcipotriene) is a small molecule pharmaceutical. Calcipotriene was first approved as Dovonex on 1993-12-29. It is used to treat psoriasis in the USA. The pharmaceutical is active against vitamin D3 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Dovonex, Sorilux (generic drugs available since 2008-05-06)
Combinations
Enstilar, Taclonex, Wynzora (generic drugs available since 2008-05-06)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Betamethasone dipropionate
+
Calcipotriene
Tradename
Company
Number
Date
Products
TACLONEXLEO PharmaN-021852 RX2006-01-09
1 products, RLD, RS
TACLONEXLEO PharmaN-022185 RX2008-05-09
1 products, RLD, RS
ENSTILARLEO PharmaN-207589 RX2015-10-16
1 products, RLD, RS
WYNZORAMC2 TherapeuticsN-213422 RX2020-07-20
1 products, RLD, RS
Calcipotriene
Tradename
Company
Number
Date
Products
DOVONEXLEO PharmaN-020273 RX1993-12-29
1 products, RLD
DOVONEXLEO PharmaN-020554 RX1996-07-22
1 products, RLD, RS
SORILUXMayne GroupN-022563 RX2010-10-06
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
calcipotrieneANDA2023-05-08
dovonexNew Drug Application2020-01-22
enstilarNew Drug Application2021-10-18
soriluxNew Drug Application2019-11-13
taclonexNew Drug Application2022-05-24
wynzoraNew Drug Application2021-12-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriasisEFO_0000676D011565L40
Agency Specific
FDA
EMA
Expiration
Code
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, WYNZORA, MC2
2023-07-20NDF
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, ENSTILAR, LEO PHARMA AS
2023-01-30PED
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, TACLONEX, LEO PHARMA AS
2023-01-25PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Betamethasone Dipropionate / Calcipotriene, Enstilar, Leo Pharma As
91197812031-06-10DPU-1761, U-2627
95662862031-06-10DP
101306402031-06-10DP
106176982031-06-10DP
106609082031-06-10DPU-2627
106823642031-06-10DP
106881082031-06-10U-2627
107167992031-06-10DP
Calcipotriene, Sorilux, Mayne Pharma
82635802028-05-07DPU-1280, U-2662
86291282026-05-26DPU-1280, U-1767, U-2662
Betamethasone Dipropionate / Calcipotriene, Wynzora, Mc2
102652652027-09-27DP
ATC Codes
D: Dermatologicals
— D05: Antipsoriatics
— D05A: Antipsoriatics for topical use
— D05AX: Other antipsoriatics for topical use in atc
— D05AX02: Calcipotriol
— D05AX52: Calcipotriol, combinations
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pituitary neoplasmsD010911—13115
AcromegalyD000172———415
Pituitary acth hypersecretionD047748EFO_1001110E24.0—111—3
Parkinson diseaseD010300EFO_0002508G20———213
Fertilization in vitroD005307———2—2
Prostatic neoplasmsD011471C61———1—1
MelanomaD008545———1—1
Neuroendocrine tumorsD018358EFO_1001901D3A.8———1—1
Dumping syndromeD004377EFO_1001307K91.1———1—1
Drug-related side effects and adverse reactionsD064420T88.7———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian hyperstimulation syndromeD016471114—16
InfertilityD007246EFO_0000545—44——4
ProlactinomaD015175HP_0006767—11—34
Restless legs syndromeD012148EFO_0004270G25.81——2——2
Acth-secreting pituitary adenomaD049913——1——1
AdenomaD000236——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndometriosisD004715EFO_0001065N80—2———2
Cocaine-related disordersD019970F1411———2
Substance-related disordersD019966EFO_0003890F1311———2
Body weightD001835EFO_000433811———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138102————2
Breast neoplasmsD001943EFO_0003869C501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinsonian disordersD020734HP_0001300————11
Polycystic ovary syndromeD011085EFO_0000660E28.2————11
Insulin resistanceD007333EFO_0002614————11
HyperprolactinemiaD006966E22.1————11
RecurrenceD012008————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Migraine disordersD008881EFO_0003821G43————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCALCIPOTRIENE
INNcalcipotriol
Description
Calcipotriol is a seco-cholestane that is 26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene carrying additional hydroxy substituents at positions 1, 3 and 24. It is used (as its hydrate) in combination with betamethasone dipropionate, a corticosteroid, for the topical treatment of plaque psoriasis in adult patients. It has a role as a drug allergen and an antipsoriatic. It is a member of cyclopropanes, a secondary alcohol, a triol, a hydroxy seco-steroid and a seco-cholestane.
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)/C=C/[C@@H](O)C2CC2)C[C@@H](O)C[C@@H]1O
Identifiers
PDB1S19
CAS-ID112965-21-6
RxCUI29365
ChEMBL IDCHEMBL1200666
ChEBI ID50749
PubChem CID5288783
DrugBankDB02300
UNII ID143NQ3779B (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
Wynzora - Novan
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,850 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,622 adverse events reported
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