Clinical Trials

Multiple Phase I and Phase II clinical trials have evaluated Manogepix, administered as its prodrug fosmanogepix, in healthy adults, individuals with hepatic impairment, and patients with invasive fungal infections. Sponsored by pharmaceutical entities including Pfizer and Basilea Pharmaceutica, these studies encompass pharmacokinetic, safety, drug-interaction, and efficacy evaluations. Across this trial landscape, recruitment statuses include completed, active not recruiting, and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05582187 COMPLETED
Hepatic Impairment
Basilea Pharmaceutica
 2022-10-31 PHASE1
NCT06961708 COMPLETED
Healthy
Basilea Pharmaceutica
 2025-04-14 PHASE1
NCT05582187 Active not recruiting
Hepatic Impairment
Basilea Pharmaceutica
 2022-10-31 Phase 1
NCT04240886 TERMINATED
Invasive Fungal Infections
Basilea Pharmaceutica
 2020-01-04 PHASE2
NCT04240886 Terminated
Invasive Fungal Infections
Pfizer
 2020-01-04 Phase 2
NCT04166669 Completed
Fungal Infection
Pfizer
 2019-11-12 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-12-19)

Check the Manogepix (E1210) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Manogepix selectively binds to and inhibits Gwt1 (GPI-anchored wall transfer protein 1), blocking the early stages of glycosylphosphatidylinositol anchor biosynthesis and preventing the proper cross-linking of mannoproteins into the fungal cell wall. This disruption severely compromises fungal cell wall integrity and leads to cell death, providing the mechanistic basis for its clinical utility against invasive fungal infections and mold pathogens.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.