Belinostat Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Belinostat 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
57
Registered trials
47
Result records
6
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 Belinostat can convert its Small molecule drug profile and HDACs biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Belinostat (query alias: belinostat) |
|---|---|
| Modality / target | Small molecule drug; HDACs; HDAC inhibitors, Epigenetic drug |
| Highest global status | Approved |
| Originator | Valerio Therapeutics SA |
| Active developers | Acrotech Biopharma LLC, CGeneTech (Suzhou, China) Co. Ltd., Alexandria University |
The MCP disease footprint includes Peripheral T-Cell Lymphoma, Thymic Epithelial Tumor, Thymoma. 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 |
|---|---|---|---|---|
| NCT06072131 | Phase 3 | Recruiting | 504 | PFS |
| NCT06406465 | Phase 2 | Recruiting | 60 | To determine if pharmacogenomic intervention can normalize the area under the curve (AUC) at cycle 6 between UGT1A1*28 and UGT1A1*60 genotypes) of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide |
| NCT05627245 | Phase 1 | Active, not recruiting | 48 | Maximum tolerated dose (Dose escalation) |
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
REAL-WORLD OUTCOMES OF BELINOSTAT IN RELAPSED REFRACTORY T-CELL LYMPHOMAS: A REPORT FROM THE LYMPHOMA STUDY GROUP OF TURKISH SOCIETY OF HEMATOLOGY
Not Applicable; n=59; evaluation: Positive. Reported fields: Adverse Event: cytopenias = Belinostat was well tolerated, with TEAEs primarily manifesting as mild (grade 1 or 2). The main adverse events included cytopenias, particularly neutropenia, and transaminitis
A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
Phase 2; n=15; evaluation: not stated. Reported fields: Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) = 3 Participants ; -; -
A Phase 1 Study of MLN4924 (Pevonedistat) and Belinostat in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Phase 1; n=18; evaluation: not stated. Reported fields: -; -; Recommended Phase 2 Dose (RP2D) for the Combination of MLN4924 (Pevonedistat) and Belinostat = 0 Participants
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
Belinostat addresses Peripheral T-Cell Lymphoma, Thymic Epithelial Tumor, Thymoma. 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: 6 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 |
|---|---|---|---|
| 2020-04-06 | Onxeo grants Acrotech the rights to Belinostat in all territories. | Approved | US$6.6M stated total |
| 2019-01-18 | Spectrum Pharmaceuticals Announces the Completion of the Sale of its Marketed Portfolio | Approved | US$160.0M upfront; US$140.0M milestones; US$300.0M stated total |
| 2018-06-07 | Onxeo Secures $7.5 Million of Non-Dilutive Capital from SWK Holdings Corporation Through Sale of Rights Related to Future Beleodaq® Royalties | Approved | US$7.5M upfront; US$13.5M milestones; US$21.0M 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
The milestone feed surfaced a patent-application signal described as “New application of belinostat or pharmaceutically acceptable salt thereof”.
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.
