Rivaroxaban Drug Asset Due Diligence Report 2026

This Rivaroxaban 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

837

Registered trials

344

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

1. Asset identity and development status

Asset	Rivaroxaban (query alias: Rivaroxaban)
Modality / target	Small molecule drug; factor Xa; factor Xa inhibitors
Highest global status	Approved
Originator	Bayer AG
Active developers	Bayer AG, Bayer Yakuhin Ltd., Viatris Ltd. (New Zealand)

The MCP disease footprint includes Coronary Disease, Thromboembolism, Thrombosis. 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
NCT07699796	Phase 4	Completed	564	Incidence of clinically significant EHIT (AVF class ≥II)
ChiCTR2600126943	Phase 4	Not yet recruiting	340	The incidence of thrombus progression at 12 weeks after medication
ChiCTR2600125914	Phase 4	Recruiting	98	Thrombosis incidence rate

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

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

Phase 4; n=2760; evaluation: not stated. Reported fields: The Rate of Adjudicated Clinically Relevant Bleeding (CRB) Events = 96 Participants ; -; The Rate of Adjudicated Clinically Relevant Bleeding (CRB) Events = 44 Participants

2188-P: Clinical Benefits and Risks of Reduced-Dose vs. Standard-Dose Direct Oral Anticoagulants in Patients with Atrial Fibrillation: An Observational Analysis of Veterans Affairs Data

Not Applicable; n=369480; evaluation: Positive. Reported fields: Major bleeding(patients < 65): HR = 1.13, P-Value = 0.04; Major bleeding(patients < 65): HR = 1.13, P-Value = 0.04

Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease

Phase 3; n=1458; evaluation: Negative. Reported fields: Major bleeding = 44.0 Pts ; Major bleeding = 64.0 Pts

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

Rivaroxaban addresses Coronary Disease, Thromboembolism, Thrombosis. 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: 1 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
2026-03-16	上海奥全AUSUSVAR®利伐沙班分散片和美国销售公司签署美国市场销售许可	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 “Soft gelatin capsule formulation of rivaroxaban nanosuspension and method thereof”. The milestone feed surfaced a patent-application signal described as “Preparation method of rivaroxaban intermediate”. The milestone feed surfaced a patent-application signal described as “Rivaroxaban orally disintegrating tablet and preparation method 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