Lurasidone Hydrochloride Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Lurasidone Hydrochloride 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
127
Registered trials
66
Result records
5
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 Lurasidone Hydrochloride can convert its Small molecule drug profile and 5-HT2A receptor x D2 receptor biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Lurasidone Hydrochloride (query alias: lurasidone) |
|---|---|
| Modality / target | Small molecule drug; 5-HT2A receptor x D2 receptor; 5-HT2A receptor antagonists, D2 receptor antagonists |
| Highest global status | Approved |
| Originator | Sumitomo Pharma Co., Ltd. |
| Active developers | Sumitomo Pharma Co., Ltd., Sichuan Kelun Pharmaceutical Co., Ltd., Angelini Pharma Italia Aziende Chimiche Riunite Angelini Franc |
The MCP disease footprint includes Depressive Disorder, Major, Bipolar Disorder, Bipolar I disorder. 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 |
|---|---|---|---|---|
| JPRN-jRCTs021240065 | Phase 4 | Recruiting | 39 | 治療開始 12週後のJESSスコアのベースラインからの変化量 |
| JPRN-jRCTs071260015 | Phase 4 | 募集中 | 30 | ・ 治療開始 8週後における起床時刻のベースラインからの変化量(Fitbit) |
| CTR20252467 | Not Applicable | 已完成 | 86 | 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
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Phase 4; n=101; evaluation: not stated. Reported fields: -; -; Change in Positive Symptoms of Schizophrenia(Mean) = 24.2 units on a scale (Standard Deviation, 4.3)
Treatment satisfaction and effectiveness of Lurasidone on quality of life and functioning in adult patients with schizophrenia in the real-world Italian clinical practice: a prospective 3-month observational study
Not Applicable; n=not disclosed; evaluation: Positive. Reported fields: QoL and Functioning Score = reaching a mean change from baseline of 9.8 at the end of the study
NRX-101 (D-cycloserine plus lurasidone) vs. lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior: a randomized prospective phase 2 trial
Phase 2; n=22; evaluation: Positive. Reported fields: Depressive relapse = 40 %
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
Lurasidone Hydrochloride addresses Depressive Disorder, Major, Bipolar Disorder, Bipolar I disorder. 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 |
|---|---|---|---|
| 2017-11-21 | Sumitomo Dainippon Pharma Co., Ltd. and Angelini S.p.A. Announce Partnership for Commercialization of Latuda in Europe | Approved | Financial terms not disclosed |
| 2017-04-10 | Bukwang to develop and commercialize Sumitomo's lurasidone for schizophrenia in Korea | Phase 3 | Financial terms not disclosed |
| 2015-07-15 | Sumitomo Dainippon Pharma Announces Commercialization Partnership with Servier on Its Atypical Antipsychotic Agent Latuda (lurasidone hydrochloride) for Australia | 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 film comprising lurasidone”. The milestone feed surfaced a patent-application signal described as “Spectrofluorimetric method for determination of lurasidone hydrochloride in pharmaceutical dosage form and uses thereof”. The milestone feed surfaced a patent-application signal described as “Pharmaceutical composition containing lurasidone hydrochloride”.
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
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.
