Bosentan Drug Asset Due Diligence Report 2026

This Bosentan 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

175

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 Bosentan can convert its Small molecule drug profile and ETA x ETB biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Bosentan (query alias: bosentan)
Modality / target	Small molecule drug; ETA x ETB; ETA agonists, ETB antagonists
Highest global status	Approved
Originator	F. Hoffmann-La Roche Ltd.
Active developers	Janssen-Cilag Pty Ltd., Janssen-Cilag International NV, Janssen Pharmaceutical KK

The MCP disease footprint includes Ulcer, Familial Primary Pulmonary Hypertension, Idiopathic pulmonary arterial hypertension. 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
NCT07649941	Phase 1	Recruiting	16	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
NCT07081932	Phase 1	Completed	16	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
TCTR20260321006	Not Applicable	Completed	84	Not disclosed

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

The Effect of Multiple Oral Doses of Bosentan on the Steady State Kinetics of BI 425809 After Oral Administration to Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Trial)

Phase 1; n=14; evaluation: not stated. Reported fields: Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)(Geometric Least Squares Mean) = 1957.60 hours * nanomole/liter (h*nmol/L) (Standard Error, NA); Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)(Geometric Least Squares Mean) = 4063.86 hours * nanomole/liter (h*nmol/L) (Standard Error, NA); Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)(Geometric Least Squares Mean): Ratio of adjusted geometric means [%] = 48.17(90% CI, 44.51 - 52.14)

An Open-Label, Multicenter Study to Assess the Potential Effects of Bosentan (a Moderate CYP3A4 Inducer) on the Pharmacokinetics of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

Phase 1; n=11; evaluation: not stated. Reported fields: Cmax(Geometric Mean) = 20.71 μg/L/mg (Geometric Coefficient of Variation, 54.81); Cmax(Geometric Mean): Least-squares geometric mean ratio = 96.83(90% CI, 81.09 - 115.62); Cmax(Geometric Mean) = 21.39 μg/L/mg (Geometric Coefficient of Variation, 49.56)

A Real-world Pharmacovigilance Study on Endothelin Receptor Antagonists for Treatment of Pulmonary Artery Hypertension

Not Applicable; n=not disclosed; evaluation: not stated. Reported fields: Adverse Event: death = Macitentan and Bosentan had statistically significant ROR of deaths when compared to Ambrisentan ; Adverse Event: death = Macitentan and Bosentan had statistically significant ROR of deaths when compared to Ambrisentan ; Adverse Event: death = Macitentan and Bosentan had statistically significant ROR of deaths when compared to Ambrisentan

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

Bosentan addresses Ulcer, Familial Primary Pulmonary Hypertension, Idiopathic pulmonary arterial hypertension. 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: 0 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

Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: ETA x ETB records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
No matched asset transaction returned.

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 “Bosentan loaded transdermal patch formulation for topical delivery and in-vitro evaluation”. The milestone feed surfaced a patent-application signal described as “Bosentan pharmaceutical compositions”. The milestone feed surfaced a patent-application signal described as “Application of bosentan in preparation of medicine for treating pain of tourniquet of clinical patient”.

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