fosmanogepix (APX001) / Basilea, Pfizer - LARVOL DELTA

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

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"

IPT15 - 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

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

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