Nailin (fosravuconazole) / DNDi, Eisai, Sato Pharma - LARVOL DELTA

Early Assessment of Antibody Decline and Treatment Discrimination in Chagas Patients Using the MultiCruzi Serological Multiplex Assay (ASTMH 2025) - P2 | "Furthermore, the conducted approach identified a clear difference in the efficacy of Benznidazole and E1224.MultiCruzi shows promise as an efficient tool for early assessment of treatment efficacy in Chagas disease and for discrimination between treatments. By enabling timely monitoring of immune responses, this approach could significantly improvetherapeutic decision-making and disease management."

Clinical

The Potential of Luliconazole as an Adjuvant Therapy for Terbinafine-Resistant Trichophyton Species (EADV 2025) - "Clinical outcomes varied; several cases reported complete resolution with luliconazole monotherapy, while others required adjunctive treatment with systemic antifungals such as itraconazole or fosravuconazole. Luliconazole shows promise as a therapeutic option for terbinafine-resistant dermatophytosis, particularly when used adjunctively. Its high potency, favorable safety profile, and efficacy across various Trichophyton species support its potential role in clinical management. However, current evidence is limited to small-scale studies and case reports."

Clinical • Dermatology • Infectious Disease

Population pharmacokinetic-pharmacodynamic analysis of benznidazole monotherapy and combination therapy with fosravuconazole in chronic Chagas disease (BENDITA). (PubMed, PLoS Negl Trop Dis) - P2 | "This study supports prior findings that the standard 8-week benznidazole regimen is excessive. Future trials using qPCR in factorial randomized designs should evaluate both treatment duration and dosing to optimize tolerability while maintaining efficacy."

Journal • Monotherapy • PK/PD data

The Current Landscape of Repurposed Drugs for Fungal Neglected Tropical Diseases. (PubMed, Curr Fungal Infect Rep) - "Newer antifungals such as fosravuconazole have matched the efficacy of currently available drugs while reducing adverse events and pill burden. Other promising treatment strategies involve the use of immunomodulators (e.g., imiquimod), steroids (e.g., prednisolone), or non-steroidal anti-inflammatory agents in combination with traditional antifungal agents. Frequently repurposed drugs include itraconazole, posaconazole, voriconazole, amphotericin B, terbinafine, potassium iodide, and 5-flucytosine...Systematic collection of this drug repurposing data and analyzing it in aggregate using platforms such as CURE ID has the potential to generate efficacy signals for drugs. These promising candidates can then be studied comprehensively in clinical trials for drug approval."

Journal • Dermatology • Infectious Disease

Quantifying anti-trypanosomal treatment effects in chronic indeterminate Chagas disease: a secondary analysis of individual patient data from two proof-of-concept trials. (PubMed, Lancet Microbe) - P2 | "Therapeutic assessments in Chagas disease must account probabilistically for qPCR test performance and low post-treatment parasite densities. In chronic Chagas disease in Bolivia, once-weekly benznidazole dosing for 8 weeks or daily dosing over 4 weeks have similar efficacies as the current 8 weeks daily regimen. These results suggest that the total benznidazole dose in the standard of care regimen is excessive."

Journal

Diagnosis of Onychomycosis and Real-World Data of Oral Fosravconazole in Japan. (PubMed, Med Mycol J) - "Fosravuconazole L-lysine ethanolate (F-RVCZ) is an azole antifungal drug that has been prescribed in Japan since 2018 for the oral treatment of onychomycosis...Real-world case reports suggest that F-RVCZ is effective in treating other forms of tinea such as tinea capitis and tinea corporis. The diagnosis of onychomycosis is typically based on KOH direct examination; however, the dermatophyte test strip is used in specific situations where microscopy is difficult to perform such as in house-call medical practice."

Journal • Real-world evidence • Review • Dermatology • Infectious Disease • Nephrology • Renal Disease

Topical Luliconazole Treatment for Hyperkeratotic Tinea Pedis. (PubMed, Mycopathologia) - "The resistant case showed a partial improvement with topical luliconazole and was successfully treated with oral fosravuconazole. These findings suggest that 1% topical luliconazole is effective for treating hyperkeratotic tinea pedis."

Journal • Dermatology • Infectious Disease

Tinea Capitis Caused by Trichophyton tonsurans That Responded to Fosravuconazole. (PubMed, Med Mycol J) - "Treatment of tinea capitis requires oral antifungal therapy; however, side effects associated with long-term administration sometimes occur. Oral treatment with F-RVCZ was found to be effective and had the advantage of relatively few side effects."

Journal • Dermatology • 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

Pharmacokinetics and Pharmacodynamics of Fosravuconazole, Itraconazole and Hydroxyitraconazole in Sudanese Patients With Eumycetoma. (PubMed, J Infect Dis) - "Ravuconazole and itraconazole showed non-linear clearance with no clear exposure-response relationship. The 200 mg fosravuconazole dose is preferred for future use over 300 mg, as it lowers pill burden and enhances cost-effectiveness."

Journal • PK/PD data

Widespread Majocchi's Granuloma Caused by Multidrug-Resistant Trichophyton rubrum Successfully Treated With Amphotericin B and Posaconazole. (PubMed, J Dermatol) - "Oral fosravuconazole and topical luliconazole were administered for 18 months, resulting in invasive dermatophytosis with a high β-d-glucan level of 7320 pg/mL. The MICs of amphotericin B, posaconazole, griseofulvin, itraconazole, voriconazole, ravuconazole, and terbinafine were 0.5, 0.5, 8, 16, 8, 16, and 32 μg/mL, respectively...Posaconazole may be a promising agent for the treatment of multidrug-resistant dermatophytes. We present the first reported case of multiazole-resistant T. rubrum resulting from prolonged fosravuconazole treatment."

Journal • Dermatology • SQLE

A balancing act: Navigating the advantages and challenges of pioneering mycetoma treatment in Sudan-A landmark trial by the Mycetoma Research Center. (PubMed, PLoS Negl Trop Dis) - "As the first randomised clinical trial assessing a new mycetoma treatment, it compared fosravuconazole with the current standard of care, itraconazole. This clinical trial, conducted in a difficult socio-political situation in Sudan, was only made possible by the exceptional efforts of the MRC. This groundbreaking study not only advances treatment options for mycetoma but also enhances research capacity in an endemic region, paving the way for future investigations into neglected tropical diseases."

Clinical • Journal • Infectious Disease

Successful treatment of lymphocutaneous sporotrichosis with fosravuconazole. (PubMed, J Dermatol) - No abstract available

Journal

Onychomycosis caused by Aspergillus species belonging to section Circumdati. (PubMed, J Dermatol) - "They were successfully treated with oral fosravuconazole. We discuss 14 cases of onychomycosis caused by Aspergillus section Circumdati."

Journal • Infectious Disease

Kidney injury associated with fosravuconazole L-lysine ethanolate. (PubMed, Clin Exp Nephrol) - "Kidney injury is caused by F-RVCZ more frequently than previously reported, but the mechanism remains unclear."

Journal • Infectious Disease • Renal Disease

Exploratory study on short-term administration of oral fosravuconazole for tinea pedis. (PubMed, J Dermatol) - "We investigated the clinical efficacy of short-term, oral fosravuconazole (F-RVCZ) therapy for tinea pedis, commonly known as athlete's foot. All adverse drug reactions (ADRs) were within expectations and there were no cases of discontinuation due to ADRs or serious ADRs. Short-term oral F-RVCZ therapy is expected to be as effective or more effective than terbinafine and itraconazole, which have already been approved in Japan and may be a useful option for the treatment of tinea pedis."

Journal • Dermatology

Impact of new antifungal medications on onychomycosis prescriptions and costs in Japan: A nationwide claims database study. (PubMed, J Dermatol) - "We analyzed the annual prescription volumes and medical costs of four antifungal medications: efinaconazole, luliconazole, fosravuconazole, and terbinafine. The substantial increase in medical costs also highlights the economic burden of onychomycosis and the need for cost-effective treatment strategies. This study provides valuable insights into the real-world prescription trends and medical costs of onychomycosis treatment in Japan, suggesting an opportunity to assess potential gaps between guideline recommendations and clinical practice."

Claims database • Journal • Dermatology • Infectious Disease

Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial. (PubMed, Lancet Infect Dis) - P2 | "Treatment with either dose of fosravuconazole was not superior to itraconazole, and the two doses had a numerically lower efficacy. However, fosravuconazole presented no new safety signals, and its lower pill burden and reduced risk of drug-drug interactions compared with the relatively expensive and inaccessible itraconazole suggests further research into effective treatments with a shorter duration and higher cure rate, without the need for surgery are warranted."

Combination therapy • Head-to-Head • Journal • P2 data • Surgery • Dermatology • Hepatology • Immunology • Infectious Disease • Inflammation

Terbinafine-resistant tinea pedis and tinea unguium in Japanese military personnel. (PubMed, J Dermatol) - No abstract available

Journal • Dermatology • Infectious Disease

Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan (clinicaltrials.gov) - P2 | N=104 | Completed | Sponsor: Drugs for Neglected Diseases | Unknown status ➔ Completed

Combination therapy • Head-to-Head • Surgery • Trial completion

Safety and efficacy of new generation azole antifungals in the management of recalcitrant superficial fungal infections and onychomycosis. (PubMed, Expert Rev Anti Infect Ther) - "When there is resistance to terbinafine, itraconazole or fluconazole, or when these agents cannot used, for example, due to potential drug interactions with the patient's current medications, clinicians may need to consider off-label use of new generation azoles, such as voriconazole, posaconazole, fosravuconazole, or oteseconazole. Fluconazole is a consideration but is generally less effective and its use may be off-label in many countries. For difficult-to-treat skin fungal infections and onychomycosis, that have failed terbinafine, itraconazole and fluconazole, we propose consideration of off-label voriconazole or posaconazole."

Journal • Review • Infectious Disease

Dermatophytomas in Onychomycosis: A Scoping Review of Prevalence, Diagnosis, and Treatment. (PubMed, J Am Podiatr Med Assoc) - "There is little published information regarding dermatophytomas in onychomycosis. More clinical research and physician education are needed. Although dermatophytomas have historically been considered difficult to treat, the efficacy data gathered in this scoping review have demonstrated that newer topical treatments are effective, as are oral antifungals in combination with chemical or surgical methods."

Journal • Review • Infectious Disease

Long-term follow-up study of the efficacy of fosravuconazole in the treatment of onychomycosis in elderly patients. (PubMed, J Dermatol) - "The results suggest that re-administration of fosravuconazole is safe and as effective as the first administration for elderly patients with recurrent onychomycosis. This study was registered at UMIN-CTR (UMIN000053516)."

Journal • Dermatology • Infectious Disease • Pain

Effects of additional oral fosravuconazole l-lysine ethanolate therapy following inadequate response to initial treatment for onychomycosis: A multicenter, randomized controlled trial. (PubMed, J Dermatol) - "In Group B, three of 75 patients (4.0%) experienced three adverse drug reactions, all observed during additional treatment; none were serious. A high complete cure rate is possible without additional F-RVCZ treatment when nail involvement decreases by ≥55% at week 24; however, when the reduction is <55% at week 24, additional F-RVCZ treatment should be considered to improve the cure rate."

Clinical • Journal • Infectious Disease

Receipt survey of prescription continuation rates for patients with onychomycosis and web-based survey of dermatologists on prescribing policies for onychomycosis therapeutics. (PubMed, J Dermatol) - "However, the study also confirmed that topical drugs are still prescribed for some disease types for which oral drugs are better suited. To ensure complete cure without patient drop-out, oral drugs with a high probability of achieving complete cure and a high continuation rate should be prescribed for patients with onychomycosis."

Journal • Dermatology • Infectious Disease