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

Tissue-Specific Parasite Persistence Following Chemotherapy in a Drug-Resistant Trypanosoma cruzi Preclinical Model. (PubMed, ACS Infect Dis) - "Here, we investigated the tissue distribution of an intrinsically drug-resistant T. cruzi strain in a murine model of acute infection and evaluated the effects of short-term treatment with benznidazole or E1224 on parasite burden and host immune responses. Parasite loads were quantified by qPCR in multiple tissues before and after cyclophosphamide-induced immunosuppression, and plasma cytokines were measured to assess systemic immune responses...Acute infection induced a robust pro-inflammatory response, and parasite reduction was accompanied by decreased Th1 cytokine levels. These findings demonstrate parasite persistence within defined tissue reservoirs despite chemotherapy, suggesting tissue-specific survival as a potential biological basis for therapeutic failure."

Journal • Preclinical • Infectious Disease • Inflammation

A Case of Kerion Celsi due to Trichophyton rubrum Successfully Treated with Fosravuconazole. (PubMed, Med Mycol J) - "The oral antifungal medicines approved for treatment of tinea capitis in Japan are limited to itraconazole and terbinafine hydrochloride. However, itraconazole has many contraindicated drugs, and antifungal resistance has recently become a major concern.As the challenge of drug-resistant fungi is expected to become more significant in the future, the clinical benefits of using fosravuconazole L-lysine ethanolate (F-RVCZ) for treating kerion celsi may increase. Our experience suggests that F-RVCZ could be a valuable therapeutic option."

Journal • Dermatology

A serological method's ability to distinguish treatment regimens by assessing early antibody decline in Chagas patients: insights from E1224 data. (PubMed, J Infect Dis) - "MultiCruzi enables the early assessment of treatment-associated biological responses in adults with Chagas disease, with antibody decline serving as an exploratory pharmacodynamic marker."

Journal

Evaluation of Hepatic and Renal Function Algorithms for Fosravuconazole in Real-World Clinical Practice. (PubMed, Med Mycol J) - "Algorithm-based monitoring enabled safe fosravuconazole administration. This practical approach may help clinicians adopt oral antifungal therapy more confidently as first-line treatment for onychomycosis."

Journal • Real-world evidence • Retrospective data • Infectious Disease

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

New and Investigational Treatment Options for Dermatomycosis in the Era of Antifungal Resistance. (PubMed, J Fungi (Basel)) - "Olorofim and ME1111 represent novel drug classes that target intracellular metabolism. New agents belonging to the azole class demonstrate reduced drug-drug interactions (oteseconazole), a broader antifungal spectrum (voriconazole), and reduced pharmacokinetic complexity (fosravuconazole, super-bioavailable itraconazole)...Based on our current understanding of dermatophyte immunity, antimicrobial peptides and vaccines targeting virulence factors (e.g., subtilisins) represent novel strategies. Nanotechnology platforms also show promise in introducing new antifungal agents (e.g., metal nanoparticles, nitric oxide-releasing nanoparticles), as well as developing topical formulations to enhance the bioavailability and safety profiles of existing antifungals (amphotericin B, ketoconazole, voriconazole)."

Journal • Review • Dermatology

Advances in the treatment of mycetoma: the emerging role of nanomedicine. (PubMed, Nanomedicine (Lond)) - "Moreover, newer antifungal agents such as fosravuconazole have shown efficacy comparable to or greater than itraconazole, the standard-of-care medication for mycetoma, with added practical advantages for use in endemic settings. This review summarizes current treatment challenges, advances in drug discovery and repurposing, and emerging nanomedicine approaches. Together, progress in these areas provides a foundation for developing improved and accessible therapies for mycetoma."

Journal • Infectious Disease

Changes in Renal Function Tests During Short-Term Administration of Oral Fosravuconazole for Tinea Pedis. (PubMed, J Dermatol) - No abstract available

Journal • Dermatology

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