Drugs / Fosmanogepix
last change Aug 2026 re-read 9 days ago

Fosmanogepix

also known as APX001 · FMGX · E1211 · PF 07842805

Small molecule targets PIGW via inhibition

Developed for
fungal infectious disease · candidemia · acute myeloid leukemia
Investigated by
Basilea Pharmaceutica · Biomedical Advanced Research and Development Authority · The Clinical Trials Centre Cologne

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT06961708 Apr → Jul 2025 — Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT05582187 Oct 2022 → Oct 2025 — Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT04166669 Nov 2019 → Mar 2020 fungal infectious disease Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT04804059 Aug → Sep 2018 fungal infectious disease Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT03333005 Nov 2017 → Oct 2018 acute myeloid leukemia Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT02957929 Oct 2016 → Apr 2017 fungal infectious disease Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT02956499 May 2016 → Jul 2017 fungal infectious disease Basilea Pharmaceutica Completed No outcome recorded
Phase 23 trials
Phase 2 NCT04240886 Jan 2020 → Mar 2022 fungal infectious disease Basilea Pharmaceutica Terminated No outcome recorded Stop: Business
Phase 2 NCT04148287 Dec 2019 → Nov 2020 candidemia Basilea Pharmaceutica Completed No outcome recorded
Phase 2 NCT03604705 Oct 2018 → Mar 2020 candidemia Basilea Pharmaceutica Completed No outcome recorded
Phase 32 trials
Phase 3 NCT06925321 Aug 2025 → Feb 2028 expected fungal infectious disease Basilea Pharmaceutica Recruiting No outcome recorded
Phase 3 NCT05421858 Dec 2024 → Jan 2028 expected candidemia Basilea Pharmaceutica Recruiting No outcome recorded
Phase not stated1 trial
— NCT06433128 — fungal infectious disease Basilea Pharmaceutica Available No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2025-04-16 Basilea Pharmaceutica Results Basilea reports presentation of new data for fosmanogepix, isavuconazole (Cresemba®) and ceftobiprole (Zevtera®) at ESCMID Global 2025 basilea.com ↗
More than 250 patients from 11 countries with serious or life-threatening invasive fungal infections, who progressed on antifungal standard-of-care treatment, experienced treatment-limiting toxicities, or had infections with resistant fungal pathogens, received fosmanogepix via expanded access to date (NCT06433128).

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as Fosmanogepix “Fosmanogepix [FMGX; active form manogepix (MGX)], a novel antifungal, is currently being studied for the treatment of invasive fungal diseases caused by Candida spp.,...” PMID 39012090 ↗ Jul 2024
7

“Fosmanogepix (FMGX, APX001), a first-in-class, intravenous (i.v.) and oral (p.o.) antifungal prodrug candidate” PMID 36988461 ↗ Mar 2023

NCT06925321 ↗

NCT04240886 ↗

NCT05421858 ↗

NCT06961708 ↗

NCT05582187 ↗

NCT06433128 ↗

Known as APX001 “Fosmanogepix (FMGX, APX001), a first-in-class, intravenous (i.v.) and oral (p.o.) antifungal prodrug candidate” PMID 36988461 ↗ Mar 2023
4

NCT03333005 ↗

NCT03604705 ↗

NCT04166669 ↗

NCT04148287 ↗

Known as E1211 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297591 ↗
Known as FMGX “Fosmanogepix [FMGX; active form manogepix (MGX)], a novel antifungal, is currently being studied for the treatment of invasive fungal diseases caused by Candida spp.,...” PMID 39012090 ↗ Jul 2024
3

“Fosmanogepix (FMGX) inhibits glycosylphosphatidylinositol anchored cell wall transfer protein 1, essential for anchoring mannoproteins to fungal cell wall, critical for host invasion.” PMID 40203286 ↗ Dec 2025

“Fosmanogepix [FMGX; active moiety manogepix (MGX)] targets glycosylphosphatidylinositol-anchored mannoprotein synthesis and maturation, essential for fungal virulence.” PMID 38757982 ↗ May 2024

“Fosmanogepix (FMGX, APX001), a first-in-class, intravenous (i.v.) and oral (p.o.) antifungal prodrug candidate” PMID 36988461 ↗ Mar 2023

Known as PF 07842805 “A Phase 1, Open-label, Single-dose, Parallel Cohort Study to Assess the Pharmacokinetics and Safety of Fosmanogepix (PF 07842805) in Adult Participants With Varying Degrees of...” NCT05582187 ↗
Action Inhibit “interferes with cell wall synthesis by targeting fungal glycosylphosphatidylinositol-anchored cell wall transfer protein 1” PMID 36988461 ↗ Mar 2023
Modality Small molecule — CHEMBL4297591 ↗
Route Intravenous “Administered by Intravenous Infusion” NCT02956499 ↗
Target GWT1 “a novel Gwt-1 inhibitor” PMID 39012090 ↗ Jul 2024