Olorofim Drug Asset Due Diligence Report 2026

This Olorofim 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 Olorofim can convert its Small molecule drug profile and A.fumigatus DHODH biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Olorofim (query alias: olorofim)
Modality / target	Small molecule drug; A.fumigatus DHODH; A.fumigatus DHODH inhibitors
Highest global status	Phase 3
Originator	F2G Ltd.
Active developers	F2G Ltd., Shionogi & Co., Ltd.

The MCP disease footprint includes Invasive aspergillosis, Invasive Fungal Infections, Coccidioidomycosis. 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
NCT07385638	Phase 2	Not yet recruiting	12	Safety: Number of participants with ≥1 treatment-emergent adverse event
JPRN-jRCT2031230016	Phase 1	Complete	24	Primary PK parameters: Cmax and AUC0-last for olorofim.
ChiCTR2400089611	Phase 1	Completed	12	Cmax and AUC0-last of Olorofim

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

Evaluation of the cytochrome P450-mediated drug interaction profile of olorofim

Phase 1; n=96; evaluation: Positive. Reported fields: AUC(ketoconazole) = 35.0 %

Olorofim in combination with azole antifungals: results from the Phase 2 salvage therapy study

Phase 2; n=105; evaluation: Positive. Reported fields: Mycoses Study Group-European Organization for Research and Treatment of Cancer (MSG-EORTC) responses(Day 42) = 24.0 % ; -

Olorofim for the treatment of invasive fungal diseases in patients with few or no therapeutic options: a single-arm, open-label, phase 2b study

Phase 2; n=204; evaluation: Positive. Reported fields: Gastrointestinal intolerance = 10 %

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

Olorofim addresses Invasive aspergillosis, Invasive Fungal Infections, Coccidioidomycosis. 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: 1 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
2022-05-16	Shionogi partners with F2G to jointly develop and market olorofim for invasive fungal infections in Europe and Asia.	Phase 2	US$100.0M upfront; US$380.0M milestones; US$480.0M stated total

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