Dabigatran Etexilate Mesylate Drug Due Diligence Report 2026

This Dabigatran Etexilate Mesylate 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

369

Registered trials

167

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 Dabigatran Etexilate Mesylate can convert its Small molecule drug profile and thrombin biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Dabigatran Etexilate Mesylate (query alias: dabigatran)
Modality / target	Small molecule drug; thrombin; thrombin inhibitors
Highest global status	Approved
Originator	C.H. Boehringer Sohn AG & Co. KG
Active developers	Boehringer Ingelheim International GmbH, Teva GmbH, Boehringer Ingelheim Pharmaceuticals, Inc.

The MCP disease footprint includes Recurrent deep vein thrombosis, Systemic embolism, Atrial Fibrillation. 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
NCT07629999	Phase 1	Not yet recruiting	118	Number of participants with Adverse Events (AE)
NCT07515339	Phase 1	Withdrawn	Not disclosed	Cmax of rosuvastatin
NCT07358416	Not Applicable	Active, not recruiting	500	Bleeding

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

CHARACTERIZATION AND TREATMENT OF VENOUS THROMBOTIC EVENTS IN PATIENTS WITH VEXAS SYNDROME: A SINGLE CENTRE EXPERIENCE

Not Applicable; n=7; evaluation: Positive. Reported fields: -; -; DVT = 3.0 Pts

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)

Phase 4; n=101; evaluation: not stated. Reported fields: -; Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist = 0 Participants ; Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist = 0 Participants

EFFECTIVENESS AND SAFETY OF DIRECT ORAL ANTICOAGULANTS IN HIGH-RISK CANCER PATIENTS WITH ATRIAL FIBRILLATION AND/OR VENOUS THROMBOEMBOLISM: REAL-WORLD EVIDENCE

Not Applicable; n=200; evaluation: Positive. Reported fields: Recurrent VTE = 1.51 % ; Recurrent VTE = 2.23 %

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

Dabigatran Etexilate Mesylate addresses Recurrent deep vein thrombosis, Systemic embolism, Atrial Fibrillation. 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
2024-11-20	勃林格殷格翰中国和国药控股达成战略合作	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 “Preparation method of dabigatran etexilate mesylate crystal form I”. The milestone feed surfaced a patent-application signal described as “Pharmaceutical Composition Containing Dabigatran Etexilate And Preparation Method Thereof”. The milestone feed surfaced a patent-application signal described as “Novel process for the preparation of dabigatran”.

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