Digoxin Drug Asset Due Diligence Report 2026

This Digoxin 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

254

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 Digoxin can convert its Small molecule drug profile and Na/K-ATPase biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Digoxin (query alias: digoxin)
Modality / target	Small molecule drug; Na/K-ATPase; Na/K-ATPase inhibitors
Highest global status	Approved
Originator	GSK Plc
Active developers	Shanghai Harvest Pharmaceutical Co., Ltd, Hikma Pharmaceuticals International Ltd., Azurity Pharmaceuticals, Inc.

The MCP disease footprint includes Arrhythmias, Cardiac, Acute congestive heart failure, Tachycardia. 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
NCT07550816	Phase 1	Recruiting	60	Area under the concentration-time curve of metformin within dosing interval (12 hours) at steady state
CTR20261860	Phase 1	进行中（尚未招募）	48	Not disclosed
NCT07570082	Phase 1	Active, not recruiting	46	Cohort 1: Pharmacokinetics (AUC 0-last)

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.

Reproduce the asset-to-trial workflow with PatSnap MCP

3. Clinical readouts: what is known

A Study to Investigate the Effects of Multiple Doses of BI 425809 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Midazolam, Warfarin and Omeprazole) and a P Glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Male Subjects

Phase 1; n=13; evaluation: not stated. Reported fields: Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Geometric Mean) = 16.0 nanogram (ng)*hour (h)/millilitre (mL) (Geometric Coefficient of Variation, 29.3); Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Geometric Mean) = 23.5 nanogram (ng)*hour (h)/millilitre (mL) (Geometric Coefficient of Variation, 33.4); Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Geometric Mean) = 19.0 nanogram (ng)*hour (h)/millilitre (mL) (Geometric Coefficient of Variation, 40.8)

Transporter Profiling Study for P-glycoprotein 1 (P-gp), Organic Anion Transporter 1 (OAT1), Organic Anion Transporter 3 (OAT3), Organic Cation Transporter 2 (OCT2), Multidrug and Toxin Extrusion Protein 1 (MATE1), Multidrug and Toxin Extrusion Protein 2-K (MATE2-K), Organic Anion Transporting Polypeptide 1B1 (OATP1B1), Organic Anion Transporting Polypeptide 1B3 (OATP1B3) and Breast Cancer Resistance Protein (BCRP) in Healthy Subjects and in Patients With Stage 4 (F4) Liver Fibrosis / Cirrhosis.

Not Applicable; n=28; evaluation: not stated. Reported fields: Area Under the Concentration Time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24)(Geometric Least Squares Mean) = 704.6 hours*nanomole/liters (h*nmol/l) (Standard Error, NA); Area Under the Concentration Time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24)(Geometric Least Squares Mean): Adjusted geometric mean ratio = 127.2(90% CI, 85.4 - 189.6); Adjusted geometric mean ratio = 745.7(90% CI, 464.9 - 1196); Area Under the Concentration Time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24)(Geometric Least Squares Mean) = 120.2 hours*nanomole/liters (h*nmol/l) (Standard Error, NA)

Quantification and impact of circulating cardiotonic steroids in the RATE-AF randomised trial of patients with atrial fibrillation and heart failure

Phase 3; n=160; evaluation: Positive. Reported fields: NT-pro-B-type natriuretic peptide(12-month): Geometric mean ratio = 0.78(95.0% CI, 0.61 - 0.99), P-Value = 0.006; NT-pro-B-type natriuretic peptide(12-month): Geometric mean ratio = 0.78(95.0% CI, 0.61 - 0.99), P-Value = 0.006

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

Digoxin addresses Arrhythmias, Cardiac, Acute congestive heart failure, Tachycardia. 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: 10 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: Na/K-ATPase records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2025-04-07	Sun Pharma to commercialize Daewoong's Fexuclue against GERD and erosive esophagitis in India	Approved	Financial terms not disclosed
2024-04-01	Daewoong, Chong Kun Dang to co-market GERD drug Fexuclue	Approved	Financial terms not disclosed
2024-02-01	Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research	Preclinical	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 “Combinations comprising VAV1-targeting degraders”. The milestone feed surfaced a patent-application signal described as “Inhibition of hypoxia signaling pathway by PLK1 inhibitor”. The milestone feed surfaced a patent-application signal described as “Nanoparticle-based theranostic platform for diagnosis and treatment of senescence-related pathologies”.

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