Efinaconazole

Summary

Efinaconazole (CHEMBL2103877) is an approved small-molecule EC 1.14.13.70 (sterol 14α-demethylase) inhibitor (ATC D01AC19); indicated across 2 conditions including tinea infection and tinea unguium.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: D01AC19
• Indications: 2 conditions
• Clinical trials: 5
• Chemistry: 348.4 Da · C18H22F2N4O

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2103877
Name	Efinaconazole
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	489181
ChEBI	CHEBI:82718
ATC	D01AC19
Molecular formula	C18H22F2N4O
Molecular weight	348.4
InChIKey	NFEZZTICAUWDHU-RDTXWAMCSA-N

SMILES: C[C@H]([C@](CN1C=NC=N1)(C2=C(C=C(C=C2)F)F)O)N3CCC(=C)CC3

IUPAC name: (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylidenepiperidin-1-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol

ChEBI definition: A member of the class of triazoles that is butan-2-ol which is substituted at positions 1, 2, and 3 by 1,2,4-triazol-1-yl, 2,4-difluorophenyl, and 4-methylenepiperidin-1-yl groups, respectively (the 2R,3R stereoisomer). It is an antifungal drug used for the topical treatment of onychomycosis (a nail infection caused mainly by dermatophytes).

Pharmacological roles (ChEBI): EC 1.14.13.70 (sterol 14α-demethylase) inhibitor.

Also known as: Clenafin, Efinaconazol, Efinaconazole, IDP-108, Jublia, KP-103, EFINACONAZOLE, efinaconazole

Patent coverage: 473 distinct patent families (1,012 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 1,001 (99%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
tinea infection	4	MONDO:0005982	EFO:0007510
tinea unguium	4	MONDO:0001628	MONDO:0001628

Clinical trials

Total trials: 5.

Phase distribution

Phase	Trials
PHASE3	3
PHASE4	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02812771	PHASE4	COMPLETED	Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
NCT03110029	PHASE4	COMPLETED	Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
NCT01007708	PHASE3	COMPLETED	The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
NCT01008033	PHASE3	COMPLETED	Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
NCT03168841	PHASE3	COMPLETED	Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).