Stem definition | Drug id | CAS RN |
---|---|---|
systemic antifungal agents, miconazole derivatives | 4874 | 164650-44-6 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
June 6, 2014 | FDA | DOW PHARM | |
July 4, 2014 | PMDA |
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 |
---|---|---|---|---|---|---|
Bronchopulmonary aspergillosis allergic | 75.63 | 44.03 | 14 | 981 | 1177 | 50602952 |
Lung opacity | 74.52 | 44.03 | 15 | 980 | 1958 | 50602171 |
Total lung capacity decreased | 74.50 | 44.03 | 14 | 981 | 1277 | 50602852 |
Blood calcium increased | 54.17 | 44.03 | 15 | 980 | 7704 | 50596425 |
Aspiration | 51.46 | 44.03 | 15 | 980 | 9249 | 50594880 |
Bronchiectasis | 49.91 | 44.03 | 15 | 980 | 10268 | 50593861 |
Euglycaemic diabetic ketoacidosis | 47.31 | 44.03 | 11 | 984 | 2808 | 50601321 |
Rales | 46.04 | 44.03 | 14 | 981 | 9964 | 50594165 |
Sputum discoloured | 46.01 | 44.03 | 15 | 980 | 13380 | 50590749 |
Blood test abnormal | 44.30 | 44.03 | 14 | 981 | 11305 | 50592824 |
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 |
---|---|---|---|---|---|---|
Nail discolouration | 60.26 | 37.28 | 10 | 322 | 794 | 29573401 |
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 |
---|---|---|---|---|---|---|
Bronchopulmonary aspergillosis allergic | 71.89 | 39.54 | 14 | 1201 | 1608 | 64495909 |
Total lung capacity decreased | 71.06 | 39.54 | 14 | 1201 | 1708 | 64495809 |
Lung opacity | 67.91 | 39.54 | 15 | 1200 | 3184 | 64494333 |
Blood calcium increased | 53.28 | 39.54 | 15 | 1200 | 8527 | 64488990 |
Nail discolouration | 49.09 | 39.54 | 11 | 1204 | 2489 | 64495028 |
Bronchiectasis | 45.82 | 39.54 | 15 | 1200 | 14125 | 64483392 |
Dermatitis contact | 43.65 | 39.54 | 13 | 1202 | 8987 | 64488530 |
Aspiration | 43.21 | 39.54 | 15 | 1200 | 16870 | 64480647 |
Blood test abnormal | 43.03 | 39.54 | 14 | 1201 | 12929 | 64484588 |
Sputum discoloured | 42.39 | 39.54 | 15 | 1200 | 17841 | 64479676 |
Liver function test increased | 41.02 | 39.54 | 17 | 1198 | 30953 | 64466564 |
Rales | 40.79 | 39.54 | 14 | 1201 | 15215 | 64482302 |
Euglycaemic diabetic ketoacidosis | 40.65 | 39.54 | 11 | 1204 | 5399 | 64492118 |
None
Source | Code | Description |
---|---|---|
ATC | D01AC19 | DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR TOPICAL USE Imidazole and triazole derivatives |
FDA CS | M0002083 | Azoles |
FDA EPC | N0000175487 | Azole Antifungal |
MeSH PA | D000890 | Anti-Infective Agents |
MeSH PA | D000935 | Antifungal Agents |
CHEBI has role | CHEBI:77884 | sterol 14alpha-demethylase inhibitor |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Onychomycosis due to Trichophyton mentagrophytes | indication | 23549005 | |
Onychomycosis due to dermatophyte | indication | 402134005 | |
Onychomycosis of toenails | indication | 403059006 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 13.3 | acidic |
pKa2 | 7.37 | Basic |
pKa3 | 1.38 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 7214506 | Feb. 22, 2026 | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 10512640 | Jan. 3, 2028 | TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 11213519 | Jan. 3, 2028 | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 9566272 | Jan. 3, 2028 | TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 9877955 | Jan. 3, 2028 | TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 8039494 | July 8, 2030 | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 10342875 | Oct. 2, 2034 | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 10828293 | Oct. 2, 2034 | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 10864274 | Oct. 2, 2034 | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | 10478601 | April 25, 2035 | TOPICAL TREATMENT OF TINEA UNGUIUM BY USING AN APPLICATOR FOR APPLYING A SOLUTION FOR TREATING TINEA UNGUIUM TO AN AFFECTED PART OF A PATIENT |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
10% | JUBLIA | BAUSCH | N203567 | June 6, 2014 | RX | SOLUTION | TOPICAL | April 27, 2023 | NEW PATIENT POPULATION |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Lanosterol 14-alpha demethylase | Enzyme | INHIBITOR | CHEMBL | CHEMBL |
ID | Source |
---|---|
D10021 | KEGG_DRUG |
4033415 | VUID |
N0000190763 | NUI |
4033415 | VANDF |
CHEBI:82718 | CHEBI |
CHEMBL2103877 | ChEMBL_ID |
C431707 | MESH_SUPPLEMENTAL_RECORD_UI |
9349 | INN_ID |
DB09040 | DRUGBANK_ID |
J82SB7FXWB | UNII |
489181 | PUBCHEM_CID |
1539753 | RXNORM |
221737 | MMSL |
30345 | MMSL |
015550 | NDDF |
703880007 | SNOMEDCT_US |
703881006 | SNOMEDCT_US |
C3273754 | UMLSCUI |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
JUBLIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-5400 | SOLUTION | 100 mg | TOPICAL | NDA | 26 sections |
JUBLIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-5400 | SOLUTION | 100 mg | TOPICAL | NDA | 26 sections |