Trial reportAntimicrobial agents and chemotherapy2023
Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers.
Trial report in Antimicrobial agents and chemotherapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers.
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.
A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects
A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001
Who cites it
28 citing papers in PubMed, 42 citations in OpenAlex.
- 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
- 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
- Use of Expanded Access Fosmanogepix in Two Pediatric Patients With Rhino-Orbital-Cerebral Mucormycosis.Pharmacotherapy · 2026Article
- New Perspectives on Antimicrobial Agents: Fosmanogepix.Antimicrobial agents and chemotherapy · 2026Review
- Novel Inositol Acyltransferase (Gwt1) Inhibitor for Fungal Keratitis Treatment: Evaluation of In Vitro and In Vivo Efficacy and Safety.Investigative ophthalmology & visual science · 2026Article
- Echinocandin tolerance and persistencemBio · 2026Article
- Advances in cryptococcal infections-associated immunopathology and potential therapeutic strategies.Frontiers in pharmacology · 2026Review
- Azole-ResistantJournal of fungi (Basel, Switzerland) · 2025Review
- Endemic Mycoses for Pulmonary Clinicians: From Nodules to ARDS.CHEST pulmonary · 2025Review
- Invasive Aspergillosis in the Intensive Care Unit.Journal of fungi (Basel, Switzerland) · 2025Review
- Overcoming antifungal resistance inFrontiers in cellular and infection microbiology · 2025Review
- New antifungal strategies and drug development against WHO critical priority fungal pathogens.Frontiers in cellular and infection microbiology · 2025Review
- Structural insights into the inhibition mechanism of fungal GWT1 by manogepix.Nature communications · 2024Article
- Transposon-sequencing (Tn-seq) of the Candida glabrata reference strain CBS138 reveals epigenetic plasticity, structural variation, and intrinsic mechanisms of resistance to micafungin.G3 (Bethesda, Md.) · 2024Article
- A phase 1 open label study to assess the human mass balance and metabolite profile ofAntimicrobial agents and chemotherapy · 2024Article
- Current Perspectives of Antifungal Therapy: A Special Focus onJournal of fungi (Basel, Switzerland) · 2024Review
- A Mini-Review of In Vitro Data forJournal of fungi (Basel, Switzerland) · 2024Review
- Protein lipidation in health and disease: molecular basis, physiological function and pathological implication.Signal transduction and targeted therapy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Fosmanogepix (FMGX, APX001), a first-in-class, intravenous (i.v.) and oral (p.o.) antifungal prodrug candidate is currently in clinical development for the treatment of invasive fungal infections. Manogepix (MGX, APX001A), the active moiety of FMGX, interferes with cell wall synthesis by targeting fungal glycosylphosphatidylinositol-anchored cell wall transfer protein 1, thereby causing loss of cell viability. Data from two phase 1, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) studies evaluating safety, tolerability, and pharmacokinetics of FMGX (doses up to 1,000 mg, i.v. and p.o.) are presented. Eligible participants were healthy adults (aged 18 to 55 years) randomized to receive either FMGX or placebo. Across both phase 1 studies, 151 of 154 participants (aged 23 to 35 years; FMGX: 116, placebo: 38) completed the study. Administration of FMGX i.v. demonstrated linear- and dose-proportional pharmacokinetics of MGX in terms of geometric mean maximum concentration of drug in serum (
Indexed as
Identifiers
What OpenQuestion holds
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.