Onychomycosis

18
Pipeline Programs
9
Companies
19
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
9
0
3
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 17 programs with unclassified modality

On Market (1)

Approved therapies currently available

U
EFINACONAZOLEApproved
efinaconazole
Unknown Company
topical2022

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pierre Fabre
Pierre FabreFrance - Aignan
2 programs
1
AmorolfinePhase 41 trial
Keratolytic/AntifungalN/A1 trial
Active Trials
NCT00808366Unknown228Est. Oct 2009
NCT01014637Unknown260Est. Sep 2011
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
1
EfinaconazolePhase 4Small Molecule1 trial
Active Trials
NCT02812771CompletedEst. Jan 2019
GSK
GSKLONDON, United Kingdom
4 programs
2
1
1
Itraconazole 100mg capsulesPhase 31 trial
Albaconazole 100mgPhase 21 trial
Albaconazole tablet 400mgPhase 11 trial
AlbaconozolePhase 1Small Molecule1 trial
Active Trials
NCT01039883Completed40Est. Jan 2010
NCT01014962Completed24Est. Dec 2009
NCT00730405Completed582Est. Feb 2010
+1 more trials
Novartis
NovartisBASEL, Switzerland
2 programs
1
terbinafine hydrogen chloridePhase 31 trial
Spread of Dermatophytes Among FamiliesN/A1 trial
Active Trials
NCT00233493Completed50Est. May 2013
NCT00459537Completed1,029Est. Jan 2009
ME Therapeutics
ME TherapeuticsNEW YORK, NY
1 program
1
Nailner 2 in 1Phase 31 trial
Active Trials
NCT02961634UnknownEst. Aug 2017
Pfizer
PfizerNEW YORK, NY
6 programs
1
5
AN2690Phase 21 trial
AN2690Phase 21 trial
AN2690Phase 21 trial
AN2690 Solution, 5.0%Phase 21 trial
AN2690 Solution, 5.0%Phase 21 trial
+1 more programs
Active Trials
NCT00680095Completed37Est. Feb 2007
NCT00679601Completed20Est. May 2007
NCT00680160Completed15Est. May 2007
+3 more trials
DermBiont
DermBiontMA - Boston
1 program
1
DBI-001Phase 21 trial
Active Trials
NCT05491603Suspended60Est. Nov 2023
Abeona Therapeutics
Abeona TherapeuticsCLEVELAND, OH
1 program
1
EcoNail™Phase 21 trial
Active Trials
NCT00385502CompletedEst. Jun 2008
M&
Merck & Co.RAHWAY, NJ
1 program
1
SCH 56592Phase 21 trial
Active Trials
NCT00491764Completed218Est. Dec 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Bausch HealthEfinaconazole
Pierre FabreAmorolfine
ME TherapeuticsNailner 2 in 1
Novartisterbinafine hydrogen chloride
GSKItraconazole 100mg capsules
DermBiontDBI-001
GSKAlbaconazole 100mg
Merck & Co.SCH 56592
PfizerAN2690
PfizerAN2690 Solution, 5.0%
Abeona TherapeuticsEcoNail™
PfizerAN2690
PfizerAN2690
PfizerAN2690 Solution, 5.0%
GSKAlbaconazole tablet 400mg

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 4,093 patients across 19 trials

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

Start: Aug 2016Est. completion: Jan 2019
Phase 4Completed

Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis

Start: Aug 2009Est. completion: Sep 2011260 patients
Phase 4Unknown

Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis

Start: Apr 2017Est. completion: Aug 2017
Phase 3Unknown
NCT00459537Novartisterbinafine hydrogen chloride

Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

Start: Mar 2007Est. completion: Jan 20091,029 patients
Phase 3Completed
NCT00356915GSKItraconazole 100mg capsules

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

Start: Jul 2006Est. completion: Oct 20081,381 patients
Phase 3Completed

A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis

Start: Nov 2023Est. completion: Nov 202360 patients
Phase 2Suspended
NCT00730405GSKAlbaconazole 100mg

Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

Start: Jul 2008Est. completion: Feb 2010582 patients
Phase 2Completed

A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)

Start: Jun 2007Est. completion: Dec 2008218 patients
Phase 2Completed

Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)

Start: Mar 2007Est. completion: May 200720 patients
Phase 2Completed
NCT01278394PfizerAN2690 Solution, 5.0%

Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

Start: Mar 2007Est. completion: Jul 200829 patients
Phase 2Completed

A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail

Start: Sep 2006Est. completion: Jun 2008
Phase 2Completed

Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

Start: Jun 2006Est. completion: Aug 200760 patients
Phase 2Completed

Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)

Start: Apr 2006Est. completion: May 200715 patients
Phase 2Completed
NCT00679523PfizerAN2690 Solution, 5.0%

Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

Start: Nov 2005Est. completion: Feb 200760 patients
Phase 2Completed
NCT01039883GSKAlbaconazole tablet 400mg

A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule

Start: Nov 2009Est. completion: Jan 201040 patients
Phase 1Completed
NCT01014962GSKAlbaconozole

A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus

Start: Aug 2009Est. completion: Dec 200924 patients
Phase 1Completed

Cumulative Irritation Test

Start: Jan 2007Est. completion: Feb 200737 patients
Phase 1Completed
NCT00808366Pierre FabreKeratolytic/Antifungal

Efficacy and Safety of RV4104A Ointment in Onychomycosis

Start: Oct 2008Est. completion: Oct 2009228 patients
N/AUnknown
NCT00233493NovartisSpread of Dermatophytes Among Families

Spread of Dermatophytes Among Families

Start: Mar 2005Est. completion: May 201350 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
9 companies competing in this space