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ulobetasol propionate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| prednisone and prednisolone derivatives | 1349 | 66852-54-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
used in ointment to treat psoriasis; Ulobetasol cream contains 0.05% 6-fluoroclobetasol 17-propionate
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.468 | Moderate | 0.76 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.084 | Moderate | 0.76 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 72.611 | 10^-6 cm/s | Moderate | 0.76 |
| dh-clint | Dog hepatocyte intrinsic clearance | 72.611 | uL/min/10^6 cells | Moderate | 0.76 |
| dppb | Dog plasma protein binding (% unbound) | 2.700 | % | Moderate | 0.76 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 4.450 | % | Moderate | 0.76 |
| herg | hERG pIC50 | 4.814 | pIC50 | Moderate | 0.76 |
| hh-clint | Human hepatocyte intrinsic clearance | 59.020 | uL/min/10^6 cells | Moderate | 0.76 |
| hlm-clint | Human liver microsomal intrinsic clearance | 216.770 | uL/min/mg protein | Moderate | 0.76 |
| hppb | Human plasma protein binding (% unbound) | 2.800 | % | Moderate | 0.76 |
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK | 19 | |||
| kinase-selectivity-class | GRK2,MAP2K6 | 2 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 2.051 | Moderate | 0.76 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 4.315 | Moderate | 0.76 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 133.968 | Moderate | 0.76 | |
| mppb | Mouse plasma protein binding (% unbound) | 2.360 | Moderate | 0.76 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 15.276 | Moderate | 0.76 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 5.340 | % | Moderate | 0.76 |
| rat-kpuu-brain | Rat brain Kpuu | 0.354 | % | Moderate | 0.76 |
| rh-clint | Rat hepatocyte intrinsic clearance | 133.045 | uL/min/10^6 cells | Moderate | 0.76 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 18.260 | % | Moderate | 0.76 |
| rppb | Rat plasma protein binding (% unbound) | 1.900 | % | Moderate | 0.76 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 12.218 | uM | Moderate | 0.76 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 17, 1990 | FDA | RANBAXY |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Psoriasis | 139.14 | 27.69 | 66 | 1861 | 147688 | 90478832 |
| Dermatitis atopic | 73.50 | 27.69 | 25 | 1902 | 23447 | 90603073 |
| Drug ineffective | 60.82 | 27.69 | 106 | 1821 | 1384192 | 89242328 |
| Product use in unapproved indication | 58.86 | 27.69 | 52 | 1875 | 336184 | 90290336 |
| Noninfective encephalitis | 51.15 | 27.69 | 9 | 1918 | 523 | 90625997 |
| Product dose omission issue | 37.35 | 27.69 | 38 | 1889 | 291649 | 90334871 |
| Dry skin | 36.68 | 27.69 | 23 | 1904 | 88050 | 90538470 |
| Suspected COVID-19 | 36.62 | 27.69 | 9 | 1918 | 2677 | 90623843 |
| Papule | 30.93 | 27.69 | 10 | 1917 | 7992 | 90618528 |
| Actinic keratosis | 30.25 | 27.69 | 8 | 1919 | 3180 | 90623340 |
| Skin exfoliation | 28.93 | 27.69 | 18 | 1909 | 67895 | 90558625 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Psoriasis | 136.41 | 40.37 | 49 | 975 | 48555 | 42571756 |
| Drug ineffective | 97.85 | 40.37 | 95 | 929 | 630102 | 41990209 |
| Dermatitis atopic | 64.62 | 40.37 | 20 | 1004 | 12384 | 42607927 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Psoriasis | 163.90 | 24.75 | 71 | 2094 | 139922 | 110447212 |
| Dermatitis atopic | 85.38 | 24.75 | 28 | 2137 | 25513 | 110561621 |
| Dry skin | 54.64 | 24.75 | 31 | 2134 | 107622 | 110479512 |
| Noninfective encephalitis | 42.80 | 24.75 | 8 | 2157 | 708 | 110586426 |
| Skin exfoliation | 35.94 | 24.75 | 22 | 2143 | 87629 | 110499505 |
| Product dose omission issue | 33.25 | 24.75 | 36 | 2129 | 321746 | 110265388 |
| Pruritus | 31.32 | 24.75 | 47 | 2118 | 581513 | 110005621 |
| Suspected COVID-19 | 30.18 | 24.75 | 8 | 2157 | 3485 | 110583649 |
| Drug ineffective | 28.45 | 24.75 | 79 | 2086 | 1520461 | 109066673 |
| Eczema | 26.73 | 24.75 | 17 | 2148 | 72276 | 110514858 |
| Trichophytosis | 26.36 | 24.75 | 5 | 2160 | 479 | 110586655 |
| Injection site pain | 25.90 | 24.75 | 24 | 2141 | 177898 | 110409236 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D05AX55 | DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use |
| ATC | D07AC21 | DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III) |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D014662 | Vasoconstrictor Agents |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
Related Drugs by ATC class:
D05AX Other antipsoriatics for topical use 7 drugs
D07AC Corticosteroids, potent (group III) 20 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Atopic dermatitis | indication | 24079001 | DOID:3310 |
| Contact dermatitis | indication | 40275004 | DOID:2773 |
| Seborrheic dermatitis | indication | 50563003 | DOID:8741 |
| Lichen simplex chronicus | indication | 53891004 | |
| Granuloma annulare | indication | 65508009 | DOID:3777 |
| Pruritus ani | indication | 90446007 | |
| Discoid lupus erythematosus | indication | 200938002 | |
| Plaque psoriasis | indication | 200965009 | |
| Scalp psoriasis | indication | 238608008 | |
| Pruritus of genital organs | indication | 267802000 | |
| Eruption of skin | indication | 271807003 | DOID:0050486 |
| Primary cutaneous T-cell lymphoma | indication | 400122007 | |
| Skin ulcer | contraindication | 46742003 | |
| Hypopituitarism | contraindication | 74728003 | DOID:9406 |
| Fissure in skin | contraindication | 95321009 | |
| Skin irritation | contraindication | 367466007 | |
| Atrophoderma | contraindication | 399979006 | |
| Peripheral vascular disease | contraindication | 400047006 | |
| Denuded skin | contraindication | 418242004 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.48 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 10478502 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11839656 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11986527 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01% | BRYHALI | BAUSCH | N209355 | Nov. 6, 2018 | RX | LOTION | TOPICAL | 10478502 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01% | BRYHALI | BAUSCH | N209355 | Nov. 6, 2018 | RX | LOTION | TOPICAL | 11839656 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01% | BRYHALI | BAUSCH | N209355 | Nov. 6, 2018 | RX | LOTION | TOPICAL | 11986527 | Nov. 2, 2031 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.05% | ULTRAVATE | LACER PHARMA | N208183 | Nov. 6, 2015 | RX | LOTION | TOPICAL | 8962028 | June 19, 2033 | USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 10426787 | June 6, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11648256 | June 6, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | 11679115 | June 6, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 0.05% | LEXETTE | MAYNE PHARMA | N210566 | May 24, 2018 | DISCN | AEROSOL, FOAM | TOPICAL | 11020407 | Nov. 30, 2036 | FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glucocorticoid receptor | Nuclear hormone receptor | AGONIST | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019575 | VUID |
| N0000147674 | NUI |
| D04409 | KEGG_DRUG |
| 4019575 | VANDF |
| 4019773 | VANDF |
| CHEBI:135782 | CHEBI |
| CHEMBL1200908 | ChEMBL_ID |
| C064466 | MESH_SUPPLEMENTAL_RECORD_UI |
| 6918178 | PUBCHEM_CID |
| DB00596 | DRUGBANK_ID |
| 41208 | RXNORM |
| 4815 | MMSL |
| 63970 | MMSL |
| 003564 | NDDF |
| 003565 | NDDF |
| 126085005 | SNOMEDCT_US |
| 764616008 | SNOMEDCT_US |
| 764617004 | SNOMEDCT_US |
| C0098735 | UMLSCUI |
| C0082787 | UMLSCUI |
| 5311167 | PUBCHEM_CID |
| 91A0K1TY3Z | UNII |
| 91A0K1TY3Z | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Bryhali | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-0002 | LOTION | 0.10 mg | TOPICAL | NDA | 24 sections |
| Duobrii | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-0653 | LOTION | 0.10 mg | TOPICAL | NDA | 25 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0339 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0640 | CREAM | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21922-108 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 18 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-250 | CREAM | 0.50 mg | TOPICAL | ANDA | 22 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45802-129 | CREAM | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45802-131 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 21 sections |
| LEXETTE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51862-618 | AEROSOL, FOAM | 0.50 mg | TOPICAL | ANDA | 26 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52565-073 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52959-961 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 22 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4907 | CREAM | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5482 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8664 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8665 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Halobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68308-769 | AEROSOL, FOAM | 0.50 mg | TOPICAL | ANDA | 28 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70752-119 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-1396 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2067 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2258 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2331 | CREAM | 0.50 mg | TOPICAL | ANDA | 20 sections |
| ULTRAVATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73159-008 | LOTION | 0.50 mg | TOPICAL | NDA | 26 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 85437-008 | LOTION | 0.50 mg | TOPICAL | NDA authorized generic | 26 sections |