Opicapone Drug Asset Due Diligence Report 2026

This Opicapone 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.

Approved

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 Opicapone can convert its Small molecule drug profile and COMT biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Opicapone (query alias: opicapone)
Modality / target	Small molecule drug; COMT; COMT inhibitors
Highest global status	Approved
Originator	BIAL-Portela & Cia SA
Active developers	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., Maxx Pharma Pty Ltd, Ono Pharmaceutical Co., Ltd.

The MCP disease footprint includes Parkinson Disease. 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
NCT07403799	Not Applicable	Active, not recruiting	200	Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment.
CTR20260993	Not Applicable	已完成	48	Not disclosed
CTR20260228	Not Applicable	进行中（尚未招募）	24	Not disclosed

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

Treatment Stability Across Different ADD-ON Therapies in Fluctuating Parkinson’s Disease

Not Applicable; n=160; evaluation: Positive. Reported fields: AE = predominantly dyskinesia (6.9%) and hallucinations (5%) % ; AE = predominantly dyskinesia (6.9%) and hallucinations (5%) % ; AE = 15.0 %

Safety and tolerability of overnight switching from Eetacapone to Opicapone in fluctuating Parkinson’s disease: An open-label preliminary trial in Koreans

Not Applicable; n=20; evaluation: Positive. Reported fields: AE = Neither new dyskinesia nor safety concerns were observed

Long-Term Effect of Opicapone in Parkinson’s Patients Without Motor Complications: 1.5-year EPSILON Study Findings

Phase 3; n=125; evaluation: Positive. Reported fields: AE = Opicapone was well-tolerated. ; AE = Opicapone was well-tolerated.

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

Opicapone addresses Parkinson Disease. 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: 5 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
2023-12-07	Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)	Approved	Financial terms not disclosed
2021-07-19	Medis will distribute BIAL's eslicarbazepine acetate for Epilepsy in the Czech Republic and Slovakia, as well as opicapone for Parkinson's disease in 12 CEE countries.	Approved	Financial terms not disclosed
2018-03-05	SK Chemicals to market Bial’s Parkinson's disease treatment	Approved	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

The milestone feed surfaced a patent-application signal described as “Oral solution containing opicapone clathrate compound and preparation method of oral solution”. The milestone feed surfaced a patent-application signal described as “Prodrugs of opicapone”. The milestone feed surfaced a patent-application signal described as “Opicapone and levodopa for the treatment of parkinson's disease”.

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