fosmanogepix (APX001) / Basilea, Pfizer - LARVOL DELTA

Non-Aspergillus molds. (PubMed, JHLT Open) - "In general, lipid preparations of amphotericin B or azole antifungals (voriconazole, posaconazole, isavuconazole) are frequently used for treatment. Investigational therapies such as fosmanogepix or olorofim are promising as future treatment modalities for some of these difficult-to-treat non-Aspergillus molds."

Journal • Review • Cardiovascular • Hematological Disorders • Infectious Disease • Neutropenia • Respiratory Diseases • Thrombosis • Transplantation

Successful treatment of a resistant invasive disseminated Fusarium infection in an immunocompetent patient. (PubMed, Med Mycol Case Rep) - "Here, we describe a case of an immunocompetent patient with invasive disseminated fusariosis with multifocal abscess formation after major traumatic injury. We report a significant clinical improvement with clinically relevant reduction of abscesses without major treatment toxicity after treatment with fosmanogepix."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Invasive mould infection in children - advances made or obstacles remaining? (PubMed, Clin Microbiol Infect) - "There has been much progress in IMI management with recent development of novel diagnostic methods, new antifungals, and immunotherapeutic approaches. Ongoing paediatric studies are required to inform optimal implementation of these tools into clinical practice."

IO biomarker • Journal • Review • Infectious Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function. (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Basilea Pharmaceutica | Recruiting ➔ Completed

Trial completion • Hepatology

Value of the France Early Access Pathways: Highlighting Benefits for Patients and Industry Sponsors of the Novel Therapeutic Fosmanogepix Addressing High Unmet Clinical Needs in Invasive Fungal Infections (ISPOR-EU 2025) - "Beyond patient access, France's AAC pathway offers additional value, enabling sponsors to generate early evidence, build regulatory relationships, and prepare for market entry. Early engagement with national access frameworks can be a valuable component in drug development of therapies addressing high unmet clinical needs. Integrating early access strategies into broader Health Economics and Outcomes Research (HEOR) and market access planning is a key aspect in this Health Policy and Regulatory Research."

Clinical • Infectious Disease

THE FUNGI ISN'T SO FUN ANYMORE (CHEST 2025) - "Blood cultures confirmed fungemia from Candida auris that was sensitive to Amphotericin B and Anidulafungin which the patient was initiated on. This case highlights an emerging alternative for treating Candida Auris fungemia that is resistant to conventional antifungals. Fosmanogepix is available for compassionate use as part of a clinical trial and should be considered for relevant patient population."

Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Diabetic Nephropathy • Heart Failure • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Pituitary Gland Carcinoma • Renal Disease • Septic Shock • Type 2 Diabetes Mellitus

Optimizing Antifungal Therapies for Candida Infections: Evidence, Resistance, and Emerging Approaches. (PubMed, Clin Microbiol Infect) - "The increasing burden of antifungal resistance highlights the need for optimized therapeutic strategies and improved diagnostic tools. Combination therapies and novel antifungals offer promising alternatives, but further research is essential to evaluate their clinical efficacy. Strengthening antifungal stewardship programs and enhancing surveillance for resistance patterns are critical to managing Candida infections effectively and mitigating the public health threat posed by resistant strains."

Journal • Review • Candidiasis • Infectious Disease

Antifungal treatment strategies and their impact on resistance development in clinical settings. (PubMed, J Antimicrob Chemother) - "New antifungal agents, such as rezafungin, olorofim and fosmanogepix, along with long-acting and advanced formulations plus combination regimens, show substantial promise for managing resistance and improving treatment outcomes. Addressing antifungal resistance demands a multifaceted 'One Health' approach that integrates robust diagnostics, antifungal stewardship (AFS), precision medicine and collaborative global efforts. By advancing drug formulations, enhancing diagnostic tools and implementing forward-thinking AFS practices, the healthcare community can better tackle the escalating burden of fungal infections and deliver improved patient outcomes."

IO biomarker • Journal • Infectious Disease

New and emerging drugs for the treatment of invasive fungal infections. (PubMed, Expert Opin Pharmacother) - "Data were identified using PubMed searches for the terms 'antifungal,' 'olorofim,' 'SUBA-itraconazole,' 'ibrexafungerp,' 'rezafungin,' 'fosmanogepix,' and 'encochleated amphotericin B.' Approved agents include ibrexafungerp, an oral triterpenoid inhibitor of 1,3-β-D-glucan synthase; rezafungin, a long-acting echinocandin with weekly dosing; and SUBA-itraconazole, a reformulation of itraconazole with more consistent absorption. Despite improvements, gaps remain in treatments for severe IFI, particularly given increasing resistance. These agents represent significant advances, but further research is needed to define their use in patient management."

Journal • Review • Dermatology • Infectious Disease

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function. (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Basilea Pharmaceutica | Active, not recruiting ➔ Recruiting

Enrollment open • Hepatology

Fosmanogepix Expanded Access Experience in Patients With Invasive Aspergillosis (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Fosmanogepix Expanded Access Experience in Patients With Fusarium Infections (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Fosmanogepix Expanded Access Experience in Patients With Fusarium Infections (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Fosmanogepix Expanded Access Experience in Patients With Invasive Aspergillosis (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections. (clinicaltrials.gov) - P3 | N=219 | Recruiting | Sponsor: Basilea Pharmaceutica | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Innovative antifungal strategies to combat drug-resistant Candida auris: recent advances and clinical implications. (PubMed, Front Cell Infect Microbiol) - "Notably, several synthetic compounds such as rezafungin and fosmanogepix are in clinical trials for C. auris infections. Despite these promising developments, majority of studies have been conducted in vitro, with a relative lack of in vivo or human research. Therefore, further investigation is needed to validate the efficacy and safety of these alternative antifungal strategies for the treatment of drug-resistant C. auris infections."

Journal • Review • Infectious Disease

Clinical impact of fluconazole-resistant Candida parapsilosis: a narrative review. (PubMed, Future Microbiol) - "Treatment options are limited: echinocandins and liposomal amphotericin B (L-AmB) are commonly used alternatives, but their use is challenged by intrinsic and emerging echinocandin resistance and L-AmB toxicity and cost. Novel agents such as rezafungin, fosmanogepix, and ibrexafungerp have shown promising activity against fluconazole-resistant C. parapsilosis, though further clinical studies are needed to confirm their efficacy. This narrative review aims to summarize current evidence on the epidemiology, clinical implications, and therapeutic approaches for fluconazole-resistant C. parapsilosis infections."

Journal • Review • Infectious Disease

Candidemia: An Update on Epidemiology, Risk Factors, Diagnosis, Susceptibility, and Treatment. (PubMed, Pathogens) - "Regarding treatment, the use of micafungin and anidulafungin in patients with obesity defined by a BMI > 30 kg/m2 has shown higher survival rates and therapeutic success. Meanwhile, newer antifungals such as rezafungin and fosmanogepix have demonstrated excellent results in the treatment of these patients. Therefore, this review aims to update the epidemiology and risk factors of candidemia, as well as analyze the diagnostic tools and treatments currently available."

Journal • Review • Dermatology • Genetic Disorders • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Neutropenia • Obesity • Oncology • Transplantation • CRP

A Study of Fosmanogepix in Healthy Adult Chinese Subjects (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: Basilea Pharmaceutica | Active, not recruiting ➔ Completed

Trial completion

Disseminated Musculoskeletal Coccidioidomycosis in an Immunocompetent Host: A Rare Case Requiring Extensive Spinal and Pelvic Surgery. (PubMed, Cureus) - "Despite antifungal therapy, his disease progressed, necessitating escalation of treatment from fluconazole to isavuconazole and liposomal amphotericin B, followed by initiation of fosmanogepix as part of the approved treatment regimen. This case highlights the importance of high clinical suspicion, aggressive surgical intervention, and multidisciplinary management in complex disseminated coccidioidomycosis, even in immunocompetent hosts."

Journal • Infectious Disease • Musculoskeletal Diseases • Orthopedics • Respiratory Diseases

Fungal meningitis in U.S. Patients who Received Epidural Anesthesia in Matamoros, Mexico. (PubMed, Clin Infect Dis) - "Clinicians should maintain suspicion for fungal meningitis in patients with negative bacterial culture, viral culture and molecular testing with a history of epidural anesthesia for any reason."

Journal • Aesthetic Medicine • Anesthesia • CNS Disorders • Infectious Disease

In vitro effects of the new antifungal compound manogepix (APX001) against the three most clinically relevant species of Sporothrix. (PubMed, Braz J Microbiol) - "Fosmanogepix, a prodrug converted into manogepix within the host, has demonstrated broad-spectrum antifungal activity, including other thermodimorphic fungal species...Furthermore, manogepix demonstrated a lower geometric mean of MIC values compared to the antifungal drugs and indifferent interactions with itraconazole, terbinafine and amphotericin B. Prolonged exposure to subinhibitory manogepix concentrations did not induce resistance in the tested strains. These findings indicate manogepix as a promising candidate for the treatment of sporotrichosis, offering a potential alternative in cases of resistance or treatment failure with current antifungals. Further studies are needed to confirm this activity in clinical settings, particularly in diverse geographic regions and against a broader range of Sporothrix strains."

Journal • Preclinical • Dermatology

A Study of Fosmanogepix in Healthy Adult Chinese Subjects (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Basilea Pharmaceutica | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function. (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: Basilea Pharmaceutica | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Hepatology

A Novel Clinical Presentation: First Documented Case of Candida Auris Empyema Thoracis (ATS 2025) - "He was found to have pneumonia due to Pseudomonas, and was treated with parenteral cefepime...He was treated with meropenem, vancomycin, anidulafungin, and liposomal amphotericin B. The pleural C. auris strain was susceptible to anidulafungin (MIC = 0.25 ug/ml)...We await the results of ongoing clinical trials with newly developed phase 2 clinical trial antifungal agents such as fosmanogepix, ibrexafungerp, and T-2307, a novel arylamidine, for advances in anti-C. auris treatment options."

Clinical • Acute Kidney Injury • Diabetes • Diabetic Nephropathy • Infectious Disease • Metabolic Disorders • Pneumonia • Renal Disease • Respiratory Diseases • Septic Shock