Fosmanogepix Drug Asset Due Diligence Report 2026

This Fosmanogepix Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 3

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Fosmanogepix can convert its Small molecule drug profile and GWT1 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Fosmanogepix (query alias: Fosmanogepix)
Modality / target	Small molecule drug; GWT1; PIGW inhibitors
Highest global status	Phase 3
Originator	Eisai Co., Ltd.
Active developers	Basilea Pharmaceutica AG, Basilea Pharmaceutica International Ltd., Quotient Sciences Ltd.

The MCP disease footprint includes Invasive Fungal Infections, Invasive aspergillosis, Mucormycosis. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06925321	Phase 3	Recruiting	234	Day 42 all-cause mortality rate
NCT06961708	Phase 1	Completed	54	Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1
NCT05582187	Phase 1	Completed	28	Maximum Observed Plasma Concentration (Cmax) of manogepix

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

A Phase 1, Randomized, Single-center, Double-blind, Placebo-controlled Study of Fosmanogepix Administered as Single and Multiple Doses in Healthy Adult Chinese Subjects

Phase 1; n=54; evaluation: not stated. Reported fields: -; Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1(Geometric Mean) = 10865 ng/mL (Geometric Coefficient of Variation, 12.9); -

Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by <i>Aspergillus</i> Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS)

Phase 2; n=21; evaluation: Positive. Reported fields: Adverse Event: Adverse events (AEs) = 258 adverse events (AEs) were reported (n=21)

A phase 1 open label study to assess the human mass balance and metabolite profile of 14C-fosmanogepix, a novel Gwt-1 inhibitor in healthy male participants

Phase 1; n=10; evaluation: Positive. Reported fields: Recovery of radioactivity = 82.4 % ; Recovery of radioactivity = 90.2 %

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Fosmanogepix addresses Invasive Fungal Infections, Invasive aspergillosis, Mucormycosis. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 3 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2023-11-13	Basilea announces acquisition of fosmanogepix, a phase-3-ready broad-spectrum antifungal	Phase 2	US$37.0M upfront
2021-04-28	Pfizer Acquires Amplyx Pharmaceuticals	Preclinical	Financial terms not disclosed
2015-01-01	Amplyx Pharmaceuticals was licensed E1211 and E1210 from Eisai in 2015	Not disclosed	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO