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Onychomycosis

32
Pipeline Programs
24
Companies
38
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
7
0
15
0
7
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
5100%
+ 40 programs with unclassified modality

Competitive Landscape

24 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
6 programs
1
4
1
Tavaborole 5% Topical SolutionPhase 41 trial
AN2690Phase 21 trial
AN2690Phase 22 trials
AN2690Phase 21 trial
AN2690 Solution, 5.0%Phase 21 trial
+1 more programs
Active Trials
NCT00680095Completed37Est. Feb 2007
NCT00680160Completed15Est. May 2007
NCT00679601Completed20Est. May 2007
+4 more trials
Quanta Therapeutics
Quanta TherapeuticsCA - South SF
1 program
1
AmorolfinePhase 4
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
1
efinaconazolePhase 4Small Molecule1 trial
Active Trials
NCT02812771Completed62Est. Jan 2019
Moberg Pharma
Moberg PharmaSweden - Stockholm
4 programs
1
1
1
MOB015BPhase 31 trial
MOB015Phase 21 trial
MOB015BPhase 11 trial
K101 nail solutionN/A1 trial
Active Trials
NCT01180491Completed75Est. Nov 2010
NCT03244280Completed20Est. Apr 2018
NCT01246518Completed250Est. Oct 2012
+1 more trials
Sandoz
SandozAustria - Kundl
4 programs
3
terbinafinePhase 31 trial
terbinafinePhase 31 trial
terbinafine hydrogen chloridePhase 31 trial
Spread of Dermatophytes Among FamiliesN/A1 trial
Active Trials
NCT00233493Completed50Est. May 2013
NCT00443898Completed518
NCT00443820Completed526Est. Jun 2008
+1 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
4 programs
2
1
1
Itraconazole 100mg capsulesPhase 3
Albaconazole 100mgPhase 2
Albaconazole tablet 400mgPhase 1
AlbaconozolePhase 1Small Molecule
Bayer
BayerLEVERKUSEN, Germany
1 program
1
Bifonazole cream 1%Phase 31 trial
Active Trials
NCT00781820Completed693Est. Jan 2010
Almirall
AlmirallSpain - Barcelona
1 program
1
terbinafine hydrochloridePhase 31 trial
Active Trials
NCT03094468Withdrawn0Est. Dec 2019
Meiji Seika Pharma
Meiji Seika PharmaJapan - Tokyo
2 programs
1
1
ME1111 Solution, Low strengthPhase 21 trial
ME1111 solutionPhase 11 trial
Active Trials
NCT01841996Completed24
NCT02022215Completed304Est. Mar 2016
BioTherapeutics Inc
BioTherapeutics IncVA - Blacksburg
2 programs
2
Terbinafine HClPhase 21 trial
Terbinafine HydrochloridePhase 21 trial
Active Trials
NCT01484145Completed25Est. Apr 2012
NCT01080079Completed168Est. Jun 2012
AmtixBio
AmtixBioKorea - Hanam
1 program
1
ATB1651Phase 22 trials
Active Trials
NCT06327295Recruiting120Est. Jan 2026
NCT05089409Completed30Est. Sep 2023
Hallux
HalluxCA - Laguna Hills
1 program
1
HTS-519 InsertPhase 21 trial
Active Trials
NCT02798380Completed30Est. Oct 2018
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
SCH 56592Phase 21 trial
Active Trials
NCT00491764Completed218Est. Dec 2008
MSD
MSDIreland - Ballydine
1 program
1
SCH 56592Phase 2
Abeona Therapeutics
Abeona TherapeuticsCLEVELAND, OH
1 program
1
econazolePhase 2Small Molecule1 trial
Active Trials
NCT00385502Completed40Est. Jun 2008
Axiom
AxiomCA - San Francisco
1 program
1
terbinafinePhase 21 trial
Active Trials
NCT07382427Not Yet Recruiting200Est. Feb 2028
Galderma
GaldermaTX - Dallas
1 program
1
PathformerPhase 11 trial
Active Trials
NCT00941317Completed25Est. Sep 2009
Combined Therapeutics
1 program
1
itraconazolePhase 1Small Molecule1 trial
Active Trials
NCT05578950Completed100Est. Aug 2022
GSK
GSKLONDON, United Kingdom
4 programs
Albaconazole tablet 400mgPHASE_11 trial
AlbaconozolePHASE_1Small Molecule1 trial
Albaconazole 100mgPHASE_21 trial
Itraconazole 100mg capsulesPHASE_31 trial
Active Trials
NCT01039883Completed40Est. Jan 2010
NCT01014962Completed24Est. Dec 2009
NCT00730405Completed582Est. Feb 2010
+1 more trials
Pierre Fabre
Pierre FabreFrance - Aignan
2 programs
Keratolytic/AntifungalN/A1 trial
AmorolfinePHASE_41 trial
Active Trials
NCT00808366Unknown228Est. Oct 2009
NCT01014637Unknown260Est. Sep 2011
Novartis
NovartisBASEL, Switzerland
2 programs
Spread of Dermatophytes Among FamiliesN/A
terbinafine hydrogen chloridePHASE_3
DermBiont
DermBiontMA - Boston
1 program
DBI-001PHASE_21 trial
Active Trials
NCT05491603Suspended60Est. Nov 2023
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
SCH 56592PHASE_2
ME Therapeutics
ME TherapeuticsNEW YORK, NY
1 program
Nailner 2 in 1PHASE_31 trial
Active Trials
NCT02961634UnknownEst. Aug 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Bausch Healthefinaconazole
PfizerTavaborole 5% Topical Solution
Pierre FabreAmorolfine
Moberg PharmaMOB015B
Almirallterbinafine hydrochloride
ME TherapeuticsNailner 2 in 1
BayerBifonazole cream 1%
Sandozterbinafine hydrogen chloride
Sandozterbinafine
Sandozterbinafine
GSKItraconazole 100mg capsules
Axiomterbinafine
AmtixBioATB1651
DermBiontDBI-001
HalluxHTS-519 Insert

Showing 15 of 38 trials with date data

Clinical Trials (38)

Total enrollment: 7,708 patients across 38 trials

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

Start: Aug 2016Est. completion: Jan 201962 patients
Phase 4Completed
NCT03405818PfizerTavaborole 5% Topical Solution

An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents

Start: Oct 2015Est. completion: Jul 201755 patients
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

A Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

Start: May 2022Est. completion: Jan 2025350 patients
Phase 3Active Not Recruiting
NCT03094468Almirallterbinafine hydrochloride

Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis

Start: May 2017Est. completion: Dec 20190
Phase 3Withdrawn

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

Start: Apr 2017Est. completion: Aug 2017
Phase 3Unknown
NCT00781820BayerBifonazole cream 1%

Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste

Start: Oct 2008Est. completion: Jan 2010693 patients
Phase 3Completed
NCT00459537Sandozterbinafine 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

Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

Start: Dec 2006518 patients
Phase 3Completed

Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

Start: Dec 2006Est. completion: Jun 2008526 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
NCT07382427Axiomterbinafine

A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails

Start: Mar 2026Est. completion: Feb 2028200 patients
Phase 2Not Yet Recruiting

A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

Start: Jul 2024Est. completion: Jan 2026120 patients
Phase 2Recruiting

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
NCT02798380HalluxHTS-519 Insert

Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail

Start: Jul 2016Est. completion: Oct 201830 patients
Phase 2Completed
NCT02022215Meiji Seika PharmaME1111 Solution, Low strength

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Start: Dec 2013Est. completion: Mar 2016304 patients
Phase 2Completed

Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

Start: Dec 2011Est. completion: Apr 201225 patients
Phase 2Completed

Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

Start: Dec 2010Est. completion: Oct 2012250 patients
Phase 2Completed
NCT01080079BioTherapeutics IncTerbinafine Hydrochloride

Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis

Start: May 2010Est. completion: Jun 2012168 patients
Phase 2Completed
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

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 EcoNailâ„¢ in the Treatment of Fungus Infections of the Great Toenail

Start: Sep 2006Est. completion: Jun 200840 patients
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

A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis

Start: Mar 2022Est. completion: Sep 202330 patients
Phase 1Completed

Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis

Start: Mar 2022Est. completion: Aug 2022100 patients
Phase 1Completed

A Study of the Systemic Absorption of MOB015B

Start: Dec 2017Est. completion: Apr 201820 patients
Phase 1Completed

Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

Start: Mar 201324 patients
Phase 1Completed
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

Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis

Start: Jul 2009Est. completion: Sep 200925 patients
Phase 1Completed

Cumulative Irritation Test

Start: Jan 2007Est. completion: Feb 200737 patients
Phase 1Completed
NCT01180491Moberg PharmaK101 nail solution

A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

Start: Sep 2010Est. completion: Nov 201075 patients
N/ACompleted
NCT00808366Pierre FabreKeratolytic/Antifungal

Efficacy and Safety of RV4104A Ointment in Onychomycosis

Start: Oct 2008Est. completion: Oct 2009228 patients
N/AUnknown
NCT00233493SandozSpread of Dermatophytes Among Families

Spread of Dermatophytes Among Families

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

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

7 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 7,708 patients
24 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.