Opelconazole Drug Asset Due Diligence Report 2026

This Opelconazole 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.

Discontinued

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: HOLD / OPTION

Decision memo

Preserve optionality until clinical differentiation, transaction economics, and freedom-to-operate are sufficiently de-risked.

The central underwriting question is whether Opelconazole can convert its Small molecule drug profile and fungal CYP51A1 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Opelconazole (query alias: opelconazole)
Modality / target	Small molecule drug; fungal CYP51A1; fungal CYP51A1 inhibitors
Highest global status	Discontinued
Originator	Pulmocide Ltd.
Active developers	Not disclosed

The MCP disease footprint includes no disclosed indication. 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
NCT05238116	Phase 3	Terminated	85	Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
NCT05037851	Phase 2	Completed	102	Proportion of Participants Who Completed 12 Weeks of Therapy
NCT03870841	Phase 2	Terminated	4	Adverse events (AEs)

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 Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Phase 3; n=85; evaluation: not stated. Reported fields: High Risk Participants = 5 participants ; High Risk Participants = 9 participants ; -

Pulmocide Announces Termination of Opera-T Phase 3 Study with Opelconazole

Phase 3; n=190; evaluation: Negative. Reported fields: death = numerically higher ; death = numerically higher

Pulmocide Announces Successful Results from the OPERA-S Study: a Phase 2 Safety Study with Inhaled Opelconazole

临床2期; n=102; evaluation: 积极. Reported fields: DoT = 69.7 % ; DoT = 72.3 %

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

Opelconazole addresses its disclosed development indications. 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: 14 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

Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: fungal CYP51A1 records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2026-04-21	博济医药签订1400万元技术转让合同出售氟康唑滴耳液项目	Approved	US$2.1M stated total
2024-07-16	卫材就一款口服药物达成授权合作！治疗“灰指甲”等真菌感染	Not disclosed	Financial terms not disclosed
2023-12-04	Aspen Global Incorporated将收购山德士在中国的业务，即山德士中国100%股份	Approved	US$100.6M 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

HOLD / OPTION