Product Description
Amplyxs lead compound, Fosmanogepix (APX001), is a novel investigational asset under development for the treatment of invasive fungal infections. Fosmanogepix has a novel mechanism of action with the potential to target fungal strains resistant to standard of care therapy. (Sourced from: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-acquires-amplyx-pharmaceuticals)
Mechanisms of Action: GWT1 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral, Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Basilea Pharmaceutica
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Bulgaria, China, France, Germany, Greece, Italy, Netherlands, Spain, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Candidemia|Candidiasis, Invasive|Communicable Diseases|Other
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05582187 |
C4791019 | P1 |
Completed |
Other |
2025-10-16 |
12% |
2025-11-14 |
|
NCT06925321 |
FMGX-CS-302 | P3 |
Recruiting |
Communicable Diseases |
2028-02-01 |
13% |
2025-07-31 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05421858 |
FMGX-CS-301 | P3 |
Recruiting |
Candidemia|Candidiasis, Invasive |
2028-01-30 |
12% |
2024-12-20 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06961708 |
FMGX-CP-109 | P1 |
Completed |
Healthy Volunteers |
2025-07-15 |
88% |
2025-08-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-516216-16-00 |
FMGX-CS-302 | P3 |
Not yet recruiting |
Other |
2028-02-01 |
|||
2022-500455-23-00 |
FMGX-CS-301 | P3 |
Recruiting |
Candidemia|Candidiasis, Invasive |
2028-01-22 |
12% |
2025-05-02 |
Treatments |