efinaconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
systemic antifungal agents, miconazole derivatives	4874	164650-44-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: efinaconazole jublia KP-103	Efinaconazole is an azole antifungal. Efinaconazole inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes. Molecular weight: 348.40 Formula: C18H22F2N4O CLOGP: 2.42 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 54.18 ALOGS: -2.76 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

efinaconazole
jublia
KP-103

Efinaconazole is an azole antifungal. Efinaconazole inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes.

Molecular weight: 348.40
Formula: C18H22F2N4O
CLOGP: 2.42
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 54.18
ALOGS: -2.76
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 4, 2014	PMDA
June 6, 2014	FDA	DOW PHARM

FDA Adverse Event Reporting System (Female)

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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	153.14	40.16	30	1937	2153	63484902
Bronchopulmonary aspergillosis allergic	146.07	40.16	29	1938	2229	63484826
Lung opacity	142	40.16	30	1937	3138	63483917
Blood calcium increased	109.72	40.16	30	1937	9320	63477735
Aspiration	105.30	40.16	30	1937	10821	63476234
Rales	100.64	40.16	30	1937	12667	63474388
Sputum discoloured	97.29	40.16	31	1936	16316	63470739
Bronchiectasis	93.55	40.16	30	1937	16112	63470943
Blood test abnormal	90.38	40.16	29	1938	15600	63471455
Obstructive airways disorder	86.23	40.16	30	1937	20669	63466386

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FDA Adverse Event Reporting System (Male)

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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	49.46	35.40	10	902	1001	34955018

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FDA Adverse Event Reporting System (Geriatric)

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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	176.44	37.03	36	2694	2869	79738789
Bronchopulmonary aspergillosis allergic	168.72	37.03	35	2695	3026	79738632
Lung opacity	155.73	37.03	36	2694	5138	79736520
Blood calcium increased	130.77	37.03	36	2694	10364	79731294
Sputum discoloured	108.51	37.03	37	2693	21706	79719952
Rales	107.56	37.03	36	2694	19965	79721693
Aspiration	107.28	37.03	36	2694	20122	79721536
Blood test abnormal	103.72	37.03	34	2696	17676	79723982
Bronchiectasis	103.58	37.03	36	2694	22350	79719308
Obstructive airways disorder	91.64	37.03	36	2694	31423	79710235

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D01AC19	DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR TOPICAL USE Imidazole and triazole derivatives
CHEBI has role	CHEBI:77884	sterol 14alpha-demethylase inhibitor
FDA CS	M0002083	Azoles
FDA EPC	N0000175487	Azole Antifungal
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000935	Antifungal Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID
Onychomycosis due to Trichophyton mentagrophytes	indication	23549005
Onychomycosis due to dermatophyte	indication	402134005
Onychomycosis of toenails	indication	403059006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.3	acidic
pKa2	7.37	Basic
pKa3	1.38	Basic

Orange Book patent data (new drug applications)

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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	11654139	Oct. 2, 2034	TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES

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Orange Book exclusivity data (new drug applications)

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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

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Lanosterol 14-alpha demethylase	Enzyme		F2SHH3_TRIRC	INHIBITOR				CHEMBL	CHEMBL

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External reference:

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ID	Source
015550	NDDF
1539753	RXNORM
221737	MMSL
30345	MMSL
4033415	VUID
4033415	VANDF
489181	PUBCHEM_CID
703880007	SNOMEDCT_US
703881006	SNOMEDCT_US
9349	INN_ID

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Pharmaceutical products:

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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

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