Nerandomilast Drug Asset Due Diligence Report 2026

This Nerandomilast 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

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 Nerandomilast can convert its Small molecule drug profile and PDE4B biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Nerandomilast (query alias: nerandomilast)
Modality / target	Small molecule drug; PDE4B; PDE4B inhibitors
Highest global status	Approved
Originator	Boehringer Ingelheim Pharmaceuticals, Inc.
Active developers	Boehringer Ingelheim GmbH, Boehringer Ingelheim Pharma GmbH & Co., KG, Boehringer Ingelheim International GmbH

The MCP disease footprint includes Progressive pulmonary fibrosis, Idiopathic Pulmonary Fibrosis, CREST 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
NCT07570888	Phase 4	Not yet recruiting	120	Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis
NCT07540988	Phase 3	Not yet recruiting	466	Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
NCT07497087	Phase 3	Not yet recruiting	448	Time to the first occurrence of disease progression or all-cause death

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

PRELIMINARY BASELINE CHARACTERISTICS OF PARTICIPANTS RANDOMIZED INTO THE ONGOING PHASE 2B CONQUEST TRIAL FOR INTERSTITIAL LUNG DISEASE ASSOCIATED WITH SYSTEMIC SCLEROSIS

Phase 2; n=127; evaluation: Positive. Reported fields: FVC = <80 % predicted

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Phase 3; n=1178; evaluation: not stated. Reported fields: Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52(Least Squares Mean) = -165.77 Milliliters (mL) (95% Confidence Interval, -190.52 to -141.03); Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52(Least Squares Mean) = -98.59 Milliliters (mL) (95% Confidence Interval, -123.74 to -73.44); Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52(Least Squares Mean): Mean Difference (Net) = 81.14(95% CI, 45.95 - 116.32), P-Value = <0.0001; Mean Difference (Net) = 67.18(95% CI, 31.91 - 102.46), P-Value = 0.0002

Relative Bioavailability of Two Different Formulations of Nerandomilast and Investigation of the Food Effect on New Formulation Following Oral Administration in Healthy Adult Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-way Crossover Trial)

Phase 1; n=15; evaluation: not stated. Reported fields: AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T1 vs Reference R(Geometric Least Squares Mean) = 2647.2 hours*nanomoles/Liter (h·nmol/L) (Standard Error, NA); AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T1 vs Reference R(Geometric Least Squares Mean): Ratio of adjusted geometric means (T1/R) = 103.23(90% CI, 97.31 - 109.52); AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T1 vs Reference R(Geometric Least Squares Mean): Ratio of adjusted geometric means (T1/R) = 103.23(90% CI, 97.31 - 109.52)

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

Nerandomilast addresses Progressive pulmonary fibrosis, Idiopathic Pulmonary Fibrosis, CREST 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: 6 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: PDE4B records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2026-05-13	盛睿泽华与药欣生物达成战略合作 AI 驱动创新药研发再获重要进展	Preclinical	Financial terms not disclosed
2023-09-06	Palisade Bio Transforms GI-Focused Pipeline Through Exclusive Worldwide Licensing Agreement with Giiant Pharma, Inc. for Multiple Oral Drug Candidates Targeting Inflammatory Bowel Disease	Preclinical	Financial terms not disclosed
2021-09-27	Innovent and UNION Therapeutics Enter into Strategic Collaboration and License Agreement for Orismilast, a Next-generation PDE4 Inhibitor for Inflammatory Dermatology Conditions	Phase 2	US$20.0M upfront; US$247.0M milestones; US$267.0M stated total

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 “Pharmaceutical composition comprising nerandomilast”. The milestone feed surfaced a patent-application signal described as “Method of manufacturing a pharmaceutical composition comprising nerandomilast”.

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