Tivozanib Drug Asset Due Diligence Report 2026

This Tivozanib 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 Tivozanib can convert its Small molecule drug profile and PDGFRβ x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Tivozanib (query alias: tivozanib)
Modality / target	Small molecule drug; PDGFRβ x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit; PDGFRβ inhibitors, VEGFR1 antagonists, VEGFR2 antagonists
Highest global status	Approved
Originator	Kyowa Kirin Co., Ltd.
Active developers	AVEO Pharmaceuticals, Inc., Kyowa Kirin Co., Ltd., Kyowa Hakko Kirin Pharma, Inc.

The MCP disease footprint includes Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Wet age-related macular degeneration. 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
NCT06661720	Phase 3	Recruiting	1040	Disease-free survival (DFS)
NCT06116890	Phase 2	Active, not recruiting	180	Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
NCT06116916	Phase 2	Active, not recruiting	150	Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline

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

Second-line TKI therapy following first-line immune checkpoint inhibitor combinations in metastatic RCC: A systematic review and meta-analysis of safety outcomes.

Not Applicable; n=1093; evaluation: Positive. Reported fields: Grade ≥3 adverse events = 30.0 % ; Grade ≥3 adverse events = 60.0 % ; Grade ≥3 adverse events = 48.0 %

Real-world efficacy and safety of tivozanib in metastatic renal cell carcinoma in a diverse cohort: A multicenter study from the City of Hope enterprise.

Not Applicable; n=83; evaluation: Positive. Reported fields: AE(all-grade) = 87.0 %

Short term intensified pembrolizumab and tivozanib for high-risk renal cell carcinoma: STRIKE! (Alliance A032201).

Phase 3; n=106; evaluation: Positive. Reported fields: AE(discontinuation) = 16.0 % ; -

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

Tivozanib addresses Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Wet age-related macular degeneration. 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: 8 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
2022-10-18	LG Chem acquires AVEO Pharmaceuticals, Inc.	Approved	US$566.0M stated total
2022-01-05	NiKang Therapeutics and AVEO Oncology Announce a Clinical Trial Collaboration and Supply Agreement to Evaluate the Combination of NKT2152, a HIF2α Inhibitor, and FOTIVDA® (tivozanib) for the Treatment of Advanced Clear Cell Renal Cell Carcinoma	Phase 1/2	Financial terms not disclosed
2021-12-03	Recordati acquires EUSA Pharma (UK) Ltd.	Approved	US$848.8M 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 “Tivozanib for treating posterior segment eye diseases”.

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