Milvexian Drug Asset Due Diligence Report 2026

This Milvexian 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.

Phase 3

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

1. Asset identity and development status

Asset	Milvexian (query alias: milvexian)
Modality / target	Small molecule drug; FXIa; factor XIa inhibitors
Highest global status	Phase 3
Originator	Bristol Myers Squibb Co.
Active developers	Bristol Myers Squibb Co., Janssen Cilag SpA, Janssen Research & Development LLC

The MCP disease footprint includes Atrial Fibrillation, Systemic embolism, Acute Coronary Syndrome. 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
NCT05757869	Phase 3	Active, not recruiting	20284	Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
NCT05754957	Phase 3	Completed	14194	Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
EUCTR2024-000583-38-3RD	Phase 1		48	Plasma milvexian Cmax and AUC∞

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

Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial

Phase 2; n=2366; evaluation: Negative. Reported fields: Composite endpoint(ischaemic stroke or incident covert brain infarct) = 15.4 % (90.2% CI, 13.4 - 17.6); Composite endpoint(ischaemic stroke or incident covert brain infarct) = 15.6 % (90.2% CI, 13.9 - 17.5); Composite endpoint(ischaemic stroke or incident covert brain infarct) = 15.3 % (90.2% CI, 12.8 - 19.7)

A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants With Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules

Phase 1; n=17; evaluation: not stated. Reported fields: -; -; Absolute Bioavailability (F)(Geometric Mean) = 54.2 Percentage of drug (90% Confidence Interval, 48.9 - 63.7)

A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

Phase 2; n=2366; evaluation: not stated. Reported fields: Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90 = 16.8 Percentage of participants (95% Confidence Interval, 14.2 - 19.4); Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90: Relative Risk (RR) = 0.99(95% CI, 0.87 - 1.10); Relative Risk (RR) = 0.99(95% CI, 0.83 - 1.15); Relative Risk (RR) = 0.93(95% CI, 0.76 - 1.16); Relative Risk (RR) = 0.92(95% CI, 0.73 - 1.18); Relative Risk (RR) = 0.91(95% CI, 0.69 - 1.31); Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90: Relative Risk (RR) = 0.99(95% CI, 0.87 - 1.10); Relative Risk (RR) = 0.99(95% CI, 0.83 - 1.15); Relative Risk (RR) = 0.93(95% CI, 0.76 - 1.16); Relative Risk (RR) = 0.92(95% CI, 0.73 - 1.18); Relative Risk (RR) = 0.91(95% CI, 0.69 - 1.31)

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

Milvexian addresses Atrial Fibrillation, Systemic embolism, Acute Coronary Syndrome. 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
2018-04-16	Janssen Announces Worldwide Development and Commercialization Collaboration with Bristol-Myers Squibb to Advance a Next-Generation Therapy for Cardiovascular Diseases	Phase 1	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 “Process for preparation of milvexian and solid-state forms thereof”. The milestone feed surfaced a patent-application signal described as “Use of milvexian in the treatment and prevention of thrombotic conditions in patients with atrial fibrilation”. The milestone feed surfaced a patent-application signal described as “Use of milvexian in the treatment and prevention of thrombotic conditions in patients with cardiovascular or cerebrovascular 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