Jublia (efinaconazole) / Kaken Pharma, Bausch Health, Dong-A, Tanabe Pharma, Almirall - LARVOL DELTA

Enhanced transungual delivery from a film-forming nail platform under wash conditions: Evidence from bovine hoof and human nail models. (PubMed, J Pharm Sci) - "In a 28-day once-daily distal human nail model, the optimized terbinafine formulation (HLK-5003) maintained cumulative permeation and antifungal activity whereas the solution comparator showed minimal delivery and no detectable inhibition; advantages for the efinaconazole and amorolfine formulations were not established. These in vitro findings indicate that rapid film formation and wash-resistant reservoir behavior can improve sustained transungual delivery in a formulation- and API-dependent manner."

Journal • Infectious Disease

Antifungal drug discovery accelerated by high-throughput experimentation and direct-to-biology assays | Poster Board #1415 (ACS-Fall 2026) - "We are developing novel CYP51 inhibitors based on the scaffold of efinaconazole, which performed well in preliminary cytotoxicity assays against A. fumigatus, a highly pathogenic mold infectious to humans and B. dendrobatidis, a chytrid fungus causing severe population decline in amphibians...Their structure-activity relationships (SAR) will be explored further in a second HTE campaign, and the best compounds identified by cytotoxicity assay will be purified and their IC50 values determined. This workflow allows for the synthesis of more effective, chemically diverse drugs in a high-throughput fashion, while accelerating the rate at which novel compounds can be assayed for their bioactivity."

Clinical Management of Antifungal-Resistant Dermatophytosis in Japan. (PubMed, Med Mycol J) - "For suspected terbinafine-resistant infections, non-SQLE azoles, such as luliconazole and lanoconazole, are recommended because of their 10- to 100-fold increased activity against Trichophyton species. Oral fosravuconazole and topical agents such as 10% efinaconazole or 5% luliconazole have proven effective for onychomycosis. Ongoing surveillance, appropriate antifungal stewardship, and timely adjustment of treatment regimens are essential to prevent the further spread of antifungal-resistant dermatophytosis."

Journal • Review • Dermatology • Infectious Disease • SQLE

Baseline Nail Thickness and Great Toenail Involvement Are Associated With Poor Response to Topical Antifungal Therapy for Onychomycosis: A Lesion-Level Generalized Estimating Equations Analysis. (PubMed, J Dermatol) - "We retrospectively studied patients with onychomycosis treated with topical luliconazole 5% nail solution or efinaconazole 10% solution between 2017 and 2021. Sensitivity analyses using a linear mixed-effects model showed consistent directions of effect. Great toenail involvement appears to be a robust predictor of poor response to topical therapy, and increased nail thickness may particularly hinder achieving complete cure; these findings warrant cautious interpretation given the retrospective, non-randomized design."

Journal • Infectious Disease

Antifungal efficacy of a novel nitric oxide releasing solution in the presence of keratin. (PubMed, Front Cell Infect Microbiol) - "This study evaluated the antifungal activity of a nitric oxide-releasing solution (NORS) against clinical isolates of Trichophyton mentagrophytes, Trichophyton tonsurans, and Epidermophyton floccosum, comparing MIC and MFC profiles to efinaconazole and assessing keratin associated inhibition relative to terbinafine. Unlike terbinafine, whose efficacy decreased significantly in keratin-rich environments, NORS retained antifungal activity in the presence of human nail keratin. These results support further clinical evaluation of NO-based antifungals as potential treatments for onychomycosis and tinea pedis."

Journal • Dermatology • Infectious Disease

Response to Reich and Lipner, "Defining an onychomycosis cohort: The importance of mycologic sampling". (PubMed, JAAD Int) - No abstract available

Journal • Infectious Disease

Antifungal Efficacy of a Novel Nitric Oxide Releasing Solution in the Presence of Keratin (AAD 2026) - "Aim: To evaluate the antifungal activity of a nitric oxide-releasing solution (NORS) against clinical dermatophyte isolates compared with efinaconazole, and to assess its performance relative to terbinafine in the presence of keratin... NORS demonstrated broad-spectrum fungicidal activity and retained efficacy in keratin-rich environments, highlighting its potential as a novel topical therapy for onychomycosis and tinea pedis. Clinical studies are warranted to confirm in vivo efficacy."

Clinical • Infectious Disease

Countering an Emerging Threat: Terbinafine-resistant and Itraconazole-resistant Trichophyton indotineae Strains are Highly Susceptible to a Novel Antifungal Nitric Oxide Releasing Gel (AAD 2026) - "Strat-M synthetic dermal membranes were placed on SDA plates seeded with fungal lawns and treated with NORS-gel, terbinafine, efinaconazole, or placebo, and zones of inhibition were measured. NORS-gel represents a promising strategy for the management of resistant dermatophytoses. Further clinical studies are needed to confirm efficacy and safety in patients."

Infectious Disease

Activity of Topical Antifungals Against the Terbinafine-Resistant Dermatophyte Trichophyton indotineae: In Vivo Analysis (AAD 2026) - "These results were confirmed in this in vivo model of T. indotineae dermatophytosis, in which efinaconazole demonstrated clinical efficacy 1.6- and ~3-fold higher than tavaborole and ciclopirox, respectively. These findings suggest efinaconazole may be effective in treatment of onychomycosis from terbinafine-resistant T. indotineae."

Preclinical • Infectious Disease

In vitro antifungal susceptibility testing of large collections of Fusarium isolates: emphasising on the potent inhibitory effect of efinaconazole (ESCMID Global 2026) - No abstract available

Preclinical

A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Onyx Axiom

New P2 trial • Infectious Disease

Telemedicine visits for new onychomycosis diagnoses result in fewer antifungal prescriptions than in-person care: A retrospective cohort study. (PubMed, JAAD Int) - No abstract available

Journal • Retrospective data • Infectious Disease

Topical Efinaconazole 10% for Onychomycosis: Pooled Phase 3 Analysis in White, Black, and Asian Participants. (PubMed, J Drugs Dermatol) - P3 | "Topical efinaconazole 10% showed favorable efficacy/safety in White, Asian, and Black participants with mild-to-moderate onychomycosis. Results were generally consistent with the overall phase 3 populations and position efinaconazole as an efficacious treatment for patients, regardless of race. &nbsp."

Clinical • Journal • P3 data • Infectious Disease

Treating Onychomycosis with Efinaconazole: Considerations for Diverse Patient Groups. (PubMed, J Fungi (Basel)) - "Healthcare providers are advised to check for concomitant tinea pedis, which increases the risk of relapse or re-infection, and advise patients on nail polish use, which may degrade after topical antifungal application. A shared decision-making framework can help improve treatment compliance and patient satisfaction."

Journal • Review • Dermatology • Infectious Disease • Mood Disorders

Enhanced Efinaconazole Permeation and Activity Against Trichophyton rubrum and Trichophyton mentagrophytes with a Self-Nanoemulsifying Drug Delivery System. (PubMed, Pharmaceutics) - "Particle size, PDI, zeta potential, and drug content remained stable over six months under all storage conditions. A 10% w/w EFN SNEDDS enhanced solubility, transungual permeation, and antifungal efficacy while maintaining robust stability, supporting its potential as an ethanol-free therapy for onychomycosis."

Journal • Infectious Disease

Onychomycosis in Diabetics: A Common Infection with Potentially Serious Complications. (PubMed, Life (Basel)) - "Systemic antifungals such as terbinafine and itraconazole are considered first-line therapies, particularly for moderate to severe onychomycosis...For patients with mild to moderate disease, or contraindications to oral therapy, topical agents such as efinaconazole or tavaborole offer viable alternatives. Adjunctive measures, including education on foot hygiene, prompt treatment of tinea pedis, and environmental sanitization, are important in preventing recurrence and reinfection. This review summarizes the epidemiology, diagnosis, and treatment considerations for onychomycosis in diabetic patients, emphasizing the need for individualized care to improve outcomes in this high-risk population."

Journal • Review • Cardiovascular • Dermatology • Diabetes • Infectious Disease • Metabolic Disorders • Mood Disorders • Pain • Peripheral Arterial Disease

Onychomycosis in special populations. (PubMed, Future Microbiol) - "Topical antifungals such as efinaconazole, tavaborole, and ciclopirox can be considered for mild to moderate onychomycosis. This review provides an in-depth overview of the epidemiology, diagnosis, and management of onychomycosis in special populations, underscoring the importance of individualized care to improve outcomes and reduce recurrence."

Journal • Review • Dermatology • Diabetes • Hepatology • Immunology • Infectious Disease • Metabolic Disorders • Psoriasis • Transplantation

Comprehending the Potential of Topical Therapies for the Treatment of Onychomycosis. (PubMed, Recent Adv Drug Deliv Formul) - "The main challenge associated with topical therapy was found to be the unique structure of the nails, hampering drug penetration to the infection site and inducing fungal drug resistance. Conventional treatment methods, as well as novel techniques developed for topical therapy, like microporation, ionotophoresis, laser, and photodynamic therapy, have also been explored. Oral antifungals are most commonly used for moderate to severe onychomycosis as they provide greater cure rates, whereas topical application of antifungals is advocated for mild to moderate infections as it possesses a better safety profile. Efinaconazole solution (10%), tavaborole solution (5%), and ciclopirox nail lacquer (8%) for topical use are accepted by the Food and Drug Administration (FDA) for the management of onychomycosis. Laser treatment is approved in the United States for the short-term improvement of clear nails in fungal infections, but the clinical outcomes have not yet reached optimal..."

Journal • Infectious Disease

Emerging Antifungal-Resistant Onychomycosis in a Dermatology Clinic in Kumamoto, Japan. (PubMed, Med Mycol J) - "These strains were highly sensitive to ravuconazole, efinaconazole, and luliconazole. Fosravuconazole (n = 13) and topical efinaconazole (n = 4) could cure the disease...Non-albicans Candida isolates showed low sensitivity to itraconazole and fluconazole. Trichosporon species (n = 2) were isolated from fingernail onychomycosis."

Journal • Dermatology • Infectious Disease

Antifungal Agents' Trends of Utilization, Spending, and Prices in the US Medicaid Programs: 2009-2023. (PubMed, Antibiotics (Basel)) - "Nystatin was the most frequently utilized SFI agent, while fluconazole emerged as the most commonly prescribed agent for invasive fungal infections (IFIs)...After being introduced to the market, efinaconazole became the most expensive SFI agent over the years. Isavuconazole, the latest approved IFI medication, demonstrated sustained utilization, reimbursement, and price increases...However, this study is limited by the lack of clinical outcome data and information on off-label use. Additionally, reimbursement data may not accurately reflect actual drug prices."

Journal • Reimbursement • US reimbursement • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of Efinaconazole 10% Topical Solution for Treatment of Onychomycosis in Older Adults: A Post Hoc Analysis of Two Phase 3 Randomised Trials. (PubMed, Mycoses) - P3 | "Efinaconazole 10% solution showed similar efficacy/safety in participants aged ≥ 65 years to the overall phase 3 population, despite potential age-related nail changes. These results demonstrate the benefits of efinaconazole in older patients with onychomycosis."

Journal • P3 data • Retrospective data • Infectious Disease

Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology. (PubMed, Therapie) - "Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment."

Adverse events • Journal • Dermatology

Evaluation of the efficacy of novel topical antifungal agents against dermatophytes in North India: A prospective study. (PubMed, Curr Med Mycol) - "This study aimed to investigate the antifungal susceptibility of efinaconazole, tavaborole, luliconazole, and sertaconazole against dermatophytes isolated from cases of dermatophytosis. Tavaborole ECVs for T. mentagrophytes/interdigitale, T. tonsurans, T. rubrum, and E. floccosum were 0.5, 0.5, 0.25, and 0.016 µg/ml, respectively. The results from the present study on the in vitro performance of newer topical antifungals suggested that they hold significant promise as prospective candidates for advancing the development of new antifungal treatments for dermatophytosis."

Journal • Dermatology • Infectious Disease

Determination of Efinaconazole in Plasma using Validated LC-MS/MS Technique. (PubMed, Drug Metab Bioanal Lett) - "The validated LC-MS/MS method has exceptional sensitivity, specificity, selectivity, rapid analysis, minimal requirement of sample quantity, wide dynamic range of concentration, robustness, and reproducibility, making it an indispensable tool, especially in fields of in vitro Permeation Testing (IVPT), in vitro Release Testing (IVRT), Pharmacokinetic, Toxicology, Clinical studies, and in drug development program for the quantification of Efinaconazole."

Journal • Infectious Disease

Evaluation of Efinaconazole as a Potential Armament Against Multidrug-Resistant Yeast Candida auris (AAD 2025) - "In a proof-of-concept study, efinaconazole possessed potent inhibitory activity against C. auris that was greater than fluconazole, itraconazole, and terbinafine [5]...The effect of efinaconazole will be compared with tavaborole against 15 clinically isolated strains of C. auris (10 antifungal resistant/5 antifungal susceptible based on preliminary screening)...Investigation of all 15 C. auris strains is ongoing and full results will be presented. Results from these in vitro analyses will provide important mechanistic information on the antifungal activity efinaconazole against antifungal-resistant C. auris strains, which represent a growing threat to public health."

Infectious Disease