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 |
---|---|---|---|---|---|---|
Total lung capacity decreased | 90.82 | 41.14 | 17 | 1125 | 1472 | 56289453 |
Bronchopulmonary aspergillosis allergic | 84.97 | 41.14 | 16 | 1126 | 1430 | 56289495 |
Lung opacity | 83.14 | 41.14 | 17 | 1125 | 2324 | 56288601 |
Blood calcium increased | 62.04 | 41.14 | 17 | 1125 | 8137 | 56282788 |
Aspiration | 59.26 | 41.14 | 17 | 1125 | 9604 | 56281321 |
Rales | 57.26 | 41.14 | 17 | 1125 | 10823 | 56280102 |
Sputum discoloured | 56.74 | 41.14 | 18 | 1124 | 14274 | 56276651 |
Bronchiectasis | 56.36 | 41.14 | 17 | 1125 | 11417 | 56279508 |
Blood test abnormal | 50.32 | 41.14 | 16 | 1126 | 12768 | 56278157 |
Obstructive airways disorder | 49.46 | 41.14 | 17 | 1125 | 17265 | 56273660 |
Euglycaemic diabetic ketoacidosis | 45.61 | 41.14 | 11 | 1131 | 3178 | 56287747 |
Liver function test increased | 44.83 | 41.14 | 18 | 1124 | 28115 | 56262810 |
Nail discolouration | 42.95 | 41.14 | 10 | 1132 | 2486 | 56288439 |
Haemoptysis | 42.34 | 41.14 | 17 | 1125 | 26543 | 56264382 |
Metabolic alkalosis | 41.63 | 41.14 | 10 | 1132 | 2841 | 56288084 |
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 | 59.44 | 36.43 | 10 | 347 | 859 | 31696128 |
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 |
---|---|---|---|---|---|---|
Total lung capacity decreased | 86.89 | 39.06 | 17 | 1353 | 1952 | 70925122 |
Bronchopulmonary aspergillosis allergic | 80.80 | 39.06 | 16 | 1354 | 1953 | 70925121 |
Lung opacity | 76.14 | 39.06 | 17 | 1353 | 3696 | 70923378 |
Blood calcium increased | 61.20 | 39.06 | 17 | 1353 | 8976 | 70918098 |
Sputum discoloured | 52.69 | 39.06 | 18 | 1352 | 18833 | 70908241 |
Bronchiectasis | 51.44 | 39.06 | 17 | 1353 | 16080 | 70910994 |
Rales | 50.40 | 39.06 | 17 | 1353 | 17118 | 70909956 |
Aspiration | 49.88 | 39.06 | 17 | 1353 | 17658 | 70909416 |
Blood test abnormal | 49.00 | 39.06 | 16 | 1354 | 14574 | 70912500 |
Nail discolouration | 47.94 | 39.06 | 11 | 1359 | 2695 | 70924379 |
Liver function test increased | 45.80 | 39.06 | 19 | 1351 | 33828 | 70893246 |
Obstructive airways disorder | 43.40 | 39.06 | 17 | 1353 | 26096 | 70900978 |
Dermatitis contact | 42.30 | 39.06 | 13 | 1357 | 9736 | 70917338 |
Euglycaemic diabetic ketoacidosis | 39.23 | 39.06 | 11 | 1359 | 5996 | 70921078 |
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 |
1539753 | RXNORM |
221737 | MMSL |
30345 | MMSL |
015550 | NDDF |
703880007 | SNOMEDCT_US |
703881006 | SNOMEDCT_US |
C3273754 | UMLSCUI |
489181 | PUBCHEM_CID |
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 |
JUBLIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-5400 | SOLUTION | 100 mg | TOPICAL | NDA | 26 sections |