fosmanogepix (APX001) / Basilea, Pfizer - LARVOL DELTA

Past, present, and emerging antifungals against Fusarium and other rare non-aspergillus hyalohyphomycetes: a narrative review. (PubMed, Expert Opin Pharmacother) - "Both rezafungin and ibrexafungerp have limited efficacy and clinical experience in treating mold infections. Fosmanogepix and olorofim hold promise for treating invasive mold infections, including hyalohyphomycoses; however, given in-vitro antifungal susceptibility variability against hyalohyphomycetes, and lack of clinical trial information, future studies are needed."

Journal • Review • Candidiasis • Infectious Disease

Fosmanogepix expanded access experience in patients with Lomentospora prolificans infections (ESCMID Global 2026) - No abstract available

Clinical • Infectious Disease

Fosmanogepix and ceftibuten-ledaborbactam - lead assets in an innovative anti-infective portfolio (ESCMID Global 2026) - "Organised by Basilea"

IPT16 - Fosmanogepix and ceftibuten-ledaborbactam - lead assets in an innovative anti-infective portfolio (ESCMID Global 2026) - "Fosmanogepix, a first-in-class gepix antifungal available in intravenous and oral formulations, has shown promising efficacy and safety in ongoing Expanded Access Program studies provides a potential new broad-spectrum therapy for patients with resistant, refractive or deep-seated invasive yeast or mold infections. Ceftibuten-ledaborbactam is a new oral beta-lactam/beta-lactamase inhibitor combination, offering an effective treatment for complicated urinary tract Infections caused by resistant Gram-negative bacteria, enabling patients to receive therapy outside the hospital and supporting more flexible, patient-centered care."

Infectious Disease • Nephrology

Fosmanogepix expanded access in patients with invasive mould infections from Germany, Austria, and Switzerland (ESCMID Global 2026) - No abstract available

Clinical • Infectious Disease

Multisystem Lomentospora prolificans progression on fosmanogepix despite in vitro activity: a call for expanding clinical research on novel antifungals. (PubMed, ASM Case Rep) - "Fosmanogepix and olorofim are novel antifungal agents with promising activity against difficult-to-treat molds, including L. prolificans, and show potential for excellent central nervous system penetration. While prior case reports have described successful outcomes with novel agents, publication bias may overrepresent favorable results. This case supports the urgent need for rigorous evaluation of emerging antifungal therapies in real-world settings."

Journal • Preclinical • CNS Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Oncology • Peripheral T-cell Lymphoma • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Transplantation

Drug-Resistant Candida auris and Mucor in Liver Transplant: Fosmanogepix as Salvage Therapy (SCCM 2026) - "His postoperative course was further complicated by a persistent abdominal wall infection involving drug-resistant C. auris and M. circinelloides, unresponsive to amphotericin B, micafungin, and posaconazole. The observed decline in beta-D-glucan and transition to oral therapy contributed to infection control and stabilization. Fosmanogepix may provide a much-needed alternative for transplant recipients with multidrug resistant fungal infections unresponsive to existing therapies."

Fibrosis • Hepatology • Immunology • Infectious Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Respiratory Diseases • Transplantation

Comprehensive Review of Candidozyma (Candida) auris Management: Insights From the Society of Infectious Diseases Pharmacists. (PubMed, Pharmacotherapy) - "The role of triazoles and amphotericin B is significantly limited by resistance and associated toxicities, while newer agents such as ibrexafungerp, fosmanogepix, and rezafungin show promising in vitro activity but lack substantial supporting clinical data. Despite growing awareness, effective decolonization strategies are lacking, and recurrence and transmission continue to pose challenges. Ongoing efforts to refine antifungal therapy, improve rapid diagnostics, and strengthen infection control practices are essential to mitigating the spread of this pathogen and optimizing outcomes for patients."

Journal • Review • CNS Disorders • Infectious Disease • Psychiatry

Innovations in the management of Candida infections (PubMed, Dtsch Med Wochenschr) - "The newly licensed echinocandin Rezafungin broadens the therapeutic options available for invasive candidiasis. Ibrexafungerp and Fosmanogepix are promising alternative treatment options for systemic Candida infections in late-stage clinical development."

Journal • Review • Candidiasis • Infectious Disease

Why do we urgently need a new treatment for cerebral aspergillosis? (PubMed, Expert Rev Anti Infect Ther) - "Voriconazole, posaconazole, and isavuconazole are recommended as primary therapy, and therapeutic drug monitoring guided higher doses of azoles may improve outcomes. Olorofim and fosmanogepix are promising agents for the future."

Journal • Cognitive Disorders • Pulmonary Disease • Respiratory Diseases

The challenges of Candidozyma auris: updates on the laboratory investigation, infection prevention and management. (PubMed, Future Microbiol) - "Given the issues with multi-drug resistance, studies exploring the use of ibrexafungerp and fosmanogepix alone or in combination with echinocandins are urgently needed. In addition to evaluating combination therapy and newer antifungals, future priorities for C. auris include increasing global awareness, the development of accessible, rapid diagnostic methods and antifungal susceptibility methodology, investigation of optimal disinfection strategies, and clinical studies better characterizing clinical outcomes."

Journal • Review • Candidiasis • Infectious Disease

Precision dosing of systemic antifungals in adults: therapeutic drug monitoring, empiric dose optimization and barriers to implementation. (PubMed, J Antimicrob Chemother) - "This review synthesizes current evidence and recommendations for antifungal TDM across available and emerging agents, including triazoles, flucytosine, echinocandins, amphotericin B, and novel therapies such as ibrexafungerp, olorofim and fosmanogepix. Voriconazole, posaconazole and itraconazole exhibit substantial interpatient variability and concentration-dependent toxicity, supporting routine TDM. Fluconazole is generally predictable but may warrant monitoring in critically ill patients, those on renal replacement therapy, or with central nervous system infections, though empiric dose escalation is often more practical. Isavuconazole has more stable PK, limiting TDM to select high-risk scenarios...Liposomal amphotericin B exhibits complex PK with plasma concentrations poorly reflecting active drug, precluding reliable TDM...Despite strong justification, real-world utilization remains inconsistent, constrained by access, logistics and interpretive challenges. Expanding..."

Journal • Review • Infectious Disease • Obesity • Renal Disease

Treatment of pulmonary mucormycosis: current concepts. (PubMed, Expert Rev Anti Infect Ther) - "We emphasize aggressive host factor optimization (glycemic control, immunosuppression reduction) and outline the evidence-based antifungal strategy: liposomal amphotericin B (L-AMB) for induction, followed by oral maintenance (posaconazole or isavuconazole)...Combination antifungal therapy lacks definite evidence and should be reserved for severe or refractory cases. Future research priorities include prospective evaluation of treatment strategies, host-directed therapies, emerging antifungals (oral nanocrystal amphotericin, fosmanogepix, etc.), and systematic assessment of adjunctive modalities."

Journal • Review • Immunology • Infectious Disease • Nephrology • Renal Disease • Transplantation

Antifungal treatment strategies in intensive care unit patients. (PubMed, Eur J Clin Invest) - "Optimizing antifungal stewardship through individualized therapy and early diagnosis remains essential to improve outcomes in this high-risk population."

Journal • Review • Candidiasis • Critical care • Human Immunodeficiency Virus • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Invasive Pulmonary Aspergillosis in Non-Neutropenic Patients: An Evolving Clinical Paradigm. (PubMed, Diagnostics (Basel)) - "Voriconazole remains the first-line treatment, though therapeutic drug monitoring is essential to ensure efficacy and minimize toxicity. Isavuconazole represents an effective alternative, offering comparable efficacy, improved safety, predictable pharmacokinetics, and convenient once-daily dosing. Liposomal amphotericin B serves as a valuable option in severe or refractory cases due to its broad-spectrum activity and reduced nephrotoxicity...Emerging antifungal agents, including olorofim, ibrexafungerp, and fosmanogepix, show promise against resistant Aspergillus species, expanding treatment options. Overall, IPA management in non-neutropenic patients requires a multidisciplinary, patient-centered approach integrating established antifungals, supportive care, and novel therapeutic advances."

Journal • Review • Hematological Disorders • Infectious Disease • Neutropenia • Pulmonary Disease • Respiratory Diseases

Management of fusariosis in transplant patients. (PubMed, Expert Rev Anti Infect Ther) - "Key topics include the trimodal timing of fusariosis after HCT, species distribution across geographic regions, diagnostic challenges with culture and nonspecific biomarkers, and therapeutic outcomes with amphotericin B formulations and voriconazole. Emerging agents such as fosmanogepix and novel molecular platforms are also discussed. Despite its rarity, fusariosis poses a disproportionate threat to transplant recipients due to diagnostic delays, lack of randomized trials, and few effective antifungal options. Incorporating rapid molecular diagnostics, next-generation antifungals, and immune-directed strategies will be critical to improving real-world outcomes and survival."

Journal • Infectious Disease • Solid Organ Transplantation • Transplantation

Rho2-dependent cell wall remodeling boosts the fungistatic activity of manogepix against Aspergillus fumigatus. (PubMed, Cell Surf) - "Fosmanogepix is a new antifungal agent currently undergoing phase 3 clinical trials...We show that both mutants, especially Δrho2 but also ΔmidA, fail to upregulate cell wall chitin to wild-type-like levels in response to manogepix. These results implicate a role for the Rho2-dependent stress response in the fungistatic activity of manogepix against A. fumigatus."

Journal

Identification of Antifungal Agents AR-12 and Fosmanogepix as Anti-Trypanosoma cruzi Drugs through an Enhanced Fluorogenic β-Galactosidase Phenotypic Screening Assay. (PubMed, ACS Infect Dis) - "Finally, the assay was adapted to a semiautomatic methodology and used to explore dual combinations of the active antifungals in the primary screening and with benznidazole. The multitarget compound AR-12 (IC50 = 1.9 μM) and the Gwt1 inhibitor Fosmanogepix (IC50 = 7.2 μM) resulted in bona fide hits, inhibiting parasite replication with only low-to-moderate toxicity on Vero host cells, thus suggesting potential for repurposing to Chagas disease."

Journal

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