Trial reportThe Journal of antimicrobial chemotherapy2023
Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial.
Trial report in The Journal of antimicrobial chemotherapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03604705 (An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.
- Brazilian guidelines for the diagnosis and treatment of candidemia and invasive candidiasis in adults and children.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesGuideline
- Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Pharmacokinetics, safety, and tolerability of fosmanogepix IV to oral switch and multiple IV doses in healthy participants.Antimicrobial agents and chemotherapy · 2024Trial
- Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida aurisAntimicrobial agents and chemotherapy · 2023Trial
- Fosmanogepix: A comprehensive review of its origin, mechanism, antifungal efficacy, and resistance (Review).Biomedical reports · 2026Review
- Fosmanogepix Treatment for Coccidioidomycosis Under an Expanded Access Program.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- New Perspectives on Antimicrobial Agents: Fosmanogepix.Antimicrobial agents and chemotherapy · 2026Review
- Manogepix demonstrates potentAntimicrobial agents and chemotherapy · 2026Article
- Invasive Candidiasis in Critically Ill Patients: Fundamental Concepts and Future Directions.Chest · 2026Review
- Current and emerging therapies for fungal biofilms and systemic infections.Critical reviews in microbiology · 2026Review
- The Upcoming Antifungal Drugs in Clinical Development for the Treatment of Invasive Candidiasis.Infection and drug resistance · 2026Review
- Tackling a global threat: a clinical scenario-based framework for preventing and managingFrontiers in cellular and infection microbiology · 2026Review
- StudyingPharmaceuticals (Basel, Switzerland) · 2025Review
- Invasive candidiasis in intensive care medicine: shaping the future of diagnosis and therapy.Intensive care medicine · 2025Review
- Mutations in transcription factors that confer fluconazole resistance also confer reduced susceptibility to manogepix inAntimicrobial agents and chemotherapy · 2025Article
- Candidemia: An Update on Epidemiology, Risk Factors, Diagnosis, Susceptibility, and Treatment.Pathogens (Basel, Switzerland) · 2025Review
- Resilience in Resistance: The Role of Cell Wall Integrity in Multidrug-Resistant Candida.Journal of fungi (Basel, Switzerland) · 2025Review
- Invasive Candidiasis in the Intensive Care Unit: Where Are We Now?Journal of fungi (Basel, Switzerland) · 2025Review
- Article
- Virtual screening assisted identification of a phytocompound as potent inhibitor against Candida lusitaniae; an in-silico study.BMC infectious diseases · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 10 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFosmanogepix is a first-in-class antifungal targeting the fungal enzyme Gwt1, with broad-spectrum activity against yeasts and moulds, including multidrug-resistant fungi, formulated for intravenous (IV) and oral administration.
methodsThis global, multicenter, non-comparative study evaluated the safety and efficacy of fosmanogepix for first-line treatment of candidaemia in non-neutropenic adults. Participants with candidaemia, defined as a positive blood culture for Candida spp. within 96 h prior to study entry, with ≤2 days of prior systemic antifungals, were eligible. Participants received fosmanogepix for 14 days: 1000 mg IV twice daily on Day 1, followed by maintenance 600 mg IV once daily, and optional switch to 700 mg orally once daily from Day 4. Eligible participants who received at least one dose of fosmanogepix and had confirmed diagnosis of candidaemia (<96 h of treatment start) composed the modified intent-to-treat (mITT) population. Primary efficacy endpoint was treatment success at the end of study treatment (EOST) as determined by the Data Review Committee. Success was defined as clearance of Candida from blood cultures with no additional antifungal treatment and survival at the EOST.
resultsTreatment success was 80% (16/20, mITT; EOST) and Day 30 survival was 85% (17/20; 3 deaths unrelated to fosmanogepix). Ten of 21 (48%) were switched to oral fosmanogepix. Fosmanogepix was well tolerated with no treatment-related serious adverse events/discontinuations. Fosmanogepix had potent in vitro activity against baseline isolates of Candida spp. (MICrange: CLSI, 0.002-0.03 mg/L).
conclusionsResults from this single-arm Phase 2 trial suggest that fosmanogepix may be a safe, well-tolerated, and efficacious treatment for non-neutropenic patients with candidaemia, including those with renal impairment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.