Calcipotriene
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 diseases | D017437 |
Trade Name
FDA
EMA
Dovonex, Sorilux (generic drugs available since 2008-05-06)
CombinationsEnstilar, 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 |
|---|---|---|---|---|
| TACLONEX | LEO Pharma | N-021852 RX | 2006-01-09 | 1 products, RLD, RS |
| TACLONEX | LEO Pharma | N-022185 RX | 2008-05-09 | 1 products, RLD, RS |
| ENSTILAR | LEO Pharma | N-207589 RX | 2015-10-16 | 1 products, RLD, RS |
| WYNZORA | MC2 Therapeutics | N-213422 RX | 2020-07-20 | 1 products, RLD, RS |
Calcipotriene
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DOVONEX | LEO Pharma | N-020273 RX | 1993-12-29 | 1 products, RLD |
| DOVONEX | LEO Pharma | N-020554 RX | 1996-07-22 | 1 products, RLD, RS |
| SORILUX | Mayne Group | N-022563 RX | 2010-10-06 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| calcipotriene | ANDA | 2024-01-23 |
| calcipotriene 0.005% / clobetasol propionate 0.05% | unapproved drug other | 2019-05-20 |
| calcipotriene 0.005% / diclofenac sodium 3% / hyaluronic acid sodium salt 2% / niacinamide 2% | unapproved drug other | 2019-05-06 |
| calcipotriene 0.005% / niacinamide 4% | unapproved drug other | 2019-05-13 |
| calcipotriene 0.005% / triamcinolone acetonide 0.1% | unapproved drug other | 2019-05-10 |
| calcipotriene 0.005% and betamethasone dipropionate 0.064% | ANDA | 2016-01-14 |
| calcipotriene and betamethasone dipropionate | ANDA | 2024-02-08 |
| calcitrene | ANDA | 2019-01-23 |
| calsodore | ANDA | 2023-08-02 |
| dermetazole | unapproved drug other | 2022-10-18 |
Show 10 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriasis | EFO_0000676 | D011565 | L40 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, WYNZORA, MC2 | |||
| 2023-07-20 | NDF | ||
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, ENSTILAR, LEO PHARMA AS | |||
| 2023-01-30 | PED | ||
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, TACLONEX, LEO PHARMA AS | |||
| 2023-01-25 | PED | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Betamethasone Dipropionate / Calcipotriene, Wynzora, Mc2 | |||
| 11638711 | 2039-03-18 | DP | |
| 10265265 | 2027-09-27 | DP | |
| Betamethasone Dipropionate / Calcipotriene, Enstilar, Leo Pharma As | |||
| 9119781 | 2031-06-10 | DP | U-1761, U-2627 |
| 9566286 | 2031-06-10 | DP | |
| 10130640 | 2031-06-10 | DP | |
| 10617698 | 2031-06-10 | DP | |
| 10660908 | 2031-06-10 | DP | U-2627 |
| 10682364 | 2031-06-10 | DP | |
| 10688108 | 2031-06-10 | U-2627 | |
| 10716799 | 2031-06-10 | DP | |
| Calcipotriene, Sorilux, Mayne Pharma | |||
| 8263580 | 2028-05-07 | DP | U-1280, U-2662 |
| 8629128 | 2026-05-26 | DP | U-1280, U-1767, U-2662 |
HCPCS
No data
Clinical
Clinical Trials
183 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 31 | 36 | 32 | 25 | 20 | 135 |
| Skin and connective tissue diseases | D017437 | — | — | 1 | 2 | — | 1 | — | 4 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | 1 | 1 | 1 | — | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | 1 | — | 1 |
| Papulosquamous skin diseases | D017444 | — | L40-L45 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma | D002294 | — | — | 1 | 3 | 1 | — | — | 4 |
| Basal cell carcinoma | D002280 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Actinic keratosis | D055623 | — | L57.0 | 3 | 3 | — | — | 1 | 7 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | 2 | — | — | — | 2 |
| Immunotherapy | D007167 | — | — | — | 2 | — | — | — | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | 1 | — | — | 1 | 2 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 1 | 1 | — | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | — | 1 |
| Radiodermatitis | D011855 | — | L58 | — | 1 | — | — | — | 1 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | 1 | — | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | 1 | — | — | — | — | 1 |
| Vasoconstriction | D014661 | — | — | 1 | — | — | — | — | 1 |
| Photoallergic dermatitis | D017454 | — | L56.2 | 1 | — | — | — | — | 1 |
| Phototoxic dermatitis | D017484 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Squamous cell neoplasms | D018307 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | — | — | — | 2 | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | — | — | — | 1 | 1 |
| Topical administration | D000287 | — | — | — | — | — | — | 1 | 1 |
| Allergic contact dermatitis | D017449 | — | L23 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Calcipotriene |
| INN | calcipotriol |
| 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 class | vitamin 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
| PDB | — |
| CAS-ID | 112965-21-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200666 |
| ChEBI ID | 50749 |
| PubChem CID | 5288783 |
| DrugBank | DB02300 |
| UNII ID | 143NQ3779B (ChemIDplus, GSRS) |
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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Wynzora – Novan
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Estimated US medical usage
Calcipotriene
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Betamethasone
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Calcipotriene
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,172 adverse events reported
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