Comprehensive Report on the Investigational Compound BI-3031185

1. Executive Summary

BI-3031185 is an orally administered small molecule investigational drug, classified as a New Molecular Entity (NME), currently under development by the global pharmaceutical company Boehringer Ingelheim. The compound is in the early stages of Phase 1 clinical development, with studies primarily focused on evaluating its safety, tolerability, and pharmacokinetic profile in healthy male volunteers. Completed and ongoing trials are assessing single ascending doses, multiple ascending doses, the influence of food on bioavailability, and potential drug-drug interactions, notably with Midazolam, a CYP3A4 probe substrate.

To date, the specific mechanism of action and the intended therapeutic target(s) for BI-3031185 have not been publicly disclosed by the developer. Preclinical development was reportedly completed in Germany prior to February 2024, enabling the transition to human trials. While associated patent information is indicated in some databases, specific details are not publicly available. The compound does not currently hold Orphan Drug Status. The successful outcome of the current Phase 1 program, particularly regarding safety and pharmacokinetic characterization, will be crucial in determining the future development pathway for BI-3031185, including its potential progression into patient-based studies and the eventual elucidation of its therapeutic utility.

2. Introduction to BI-3031185

Overview

BI-3031185 is an investigational compound that has recently entered the clinical phase of drug development. The "BI" prefix in its designation is characteristic of compounds originating from the research and development portfolio of Boehringer Ingelheim, a prominent global pharmaceutical company.[1] As with many compounds in the nascent stages of clinical investigation, publicly available information regarding the specific attributes and therapeutic aims of BI-3031185 is limited. This scarcity of detailed public disclosure is a common practice in the pharmaceutical industry during early development, often to maintain a competitive edge and protect proprietary information as the compound's potential is being explored.[1]

Development Rationale

The advancement of BI-3031185 into Phase 1 clinical trials signifies that it has successfully navigated the prerequisite preclinical evaluation stages. While the specific development rationale for BI-3031185 has not been explicitly detailed in the available information, its entry into human testing implies that preclinical studies (both in vitro and in vivo) have provided sufficient evidence of a potentially favorable safety profile and a pharmacological basis to warrant investigation in human subjects.[1] The typical pharmaceutical research and development pathway involves rigorous preclinical assessment of a compound's biological activity, safety, and pharmacokinetic properties before it can be administered to humans.[1]

The limited public information on BI-3031185, especially concerning its precise mechanism of action and specific therapeutic target, is a hallmark of early-phase drug development. Pharmaceutical companies usually exercise a degree of confidentiality at this juncture for strategic and competitive reasons.[1] Detailed disclosures often occur later in the development cycle, typically coinciding with Phase 2 studies or the publication of initial clinical trial results, once a clearer understanding of the drug's profile and potential is established and intellectual property positions are more solidified. Therefore, the current paucity of specific molecular and therapeutic details for BI-3031185 is not anomalous but rather reflects its early position in the drug development pipeline.

3. Compound Profile

Chemical Nature

BI-3031185 has been identified as a small molecule drug.[3] Furthermore, it is classified as a New Molecular Entity (NME).[2] The NME designation is significant as it indicates that BI-3031185 is a novel active substance that has not been previously authorized for medicinal use in humans. Small molecule drugs are typically characterized by their lower molecular weight, which often allows for oral administration and the ability to penetrate cell membranes to interact with intracellular targets. This is consistent with the oral tablet formulation being used in its clinical trials.[4] The novelty implied by its NME status suggests that BI-3031185 may operate through a new biological pathway or offer a differentiated therapeutic approach compared to existing treatments.

Developer

The originator and ongoing developer of BI-3031185 is Boehringer Ingelheim (also referred to as Boehringer Ingelheim GmbH or Boehringer Ingelheim International GmbH in various sources).[1] Boehringer Ingelheim is a research-driven global pharmaceutical company with a substantial investment in discovering and developing new medicines across various therapeutic areas.[9]

Mechanism of Action (MoA)

The specific mechanism of action for BI-3031185 is currently Undefined or Unknown according to multiple drug information databases.[1] Synapse Patsnap also indicates that the pharmacological action is undefined.[4] This lack of a publicly defined MoA is characteristic for investigational drugs in early-phase clinical trials. The elucidation of its MoA will be a critical step in understanding its therapeutic potential and differentiating it from other agents.

Target Therapeutic Area(s)

The target therapeutic area(s) for BI-3031185 are currently Unspecified in the available documentation.[2] Ongoing and completed Phase 1 clinical trials are being conducted in "Healthy" volunteers.[3] This is a standard approach for initial safety, tolerability, and pharmacokinetic assessments and does not, by itself, reveal the intended disease indication(s). While Boehringer Ingelheim has established therapeutic areas of focus, such as oncology, respiratory diseases, cardiovascular-renal-metabolic (CRM) conditions, mental health, and immunology [9], no direct connection between BI-3031185 and any of these specific areas has been provided in the reviewed materials.

4. Preclinical Development Summary

Overview

Information regarding the preclinical development of BI-3031185 indicates that these studies were conducted in Germany, with the compound administered orally (PO). This phase of development was noted as completed before February 2024.[2] This timeline is consistent with the initiation of the first Phase 1 clinical trial for BI-3031185 shortly thereafter.

Implication

The successful completion of preclinical studies is a critical milestone in drug development. It suggests that BI-3031185 demonstrated an acceptable preliminary safety profile in animal models and exhibited a pharmacological rationale sufficient to justify its investigation in human subjects.[1] Preclinical programs typically involve a battery of in vitro assays and in vivo animal studies designed to assess a compound's biological activity, mechanism of action (to some extent), absorption, distribution, metabolism, excretion (ADME) properties, and toxicology. The transition from preclinical to clinical development indicates that the data package submitted to regulatory authorities met the required standards for safety and scientific merit to proceed with first-in-human trials.

The progression from the reported completion of preclinical development before February 2024 [2] to the initiation of the Phase 1 trial NCT06255340, which was created on February 19, 2024, and started recruiting in the same month [2], illustrates a standard and relatively seamless transition. This suggests that no major, publicly disclosed impediments were encountered during the preclinical phase that might have significantly delayed or halted the compound's advancement into clinical testing. Such a smooth transition implies that the preclinical data were robust enough to support the application for human trials.

5. Clinical Development Program

Current Phase of Development

BI-3031185 is currently in Phase 1 of clinical development.[2] This is the initial stage of human testing, primarily designed to assess the safety, tolerability, and pharmacokinetic properties of a new investigational drug.

Overall Objectives of Current Clinical Phase

The principal objectives of the ongoing and recently completed Phase 1 trials for BI-3031185 are to thoroughly investigate its safety, tolerability, and pharmacokinetics (PK) in healthy male subjects.[5] These investigations encompass several key aspects:

• Evaluation of single ascending doses (SAD) to determine initial safety and PK parameters across a range of doses.
• Assessment of multiple ascending doses (MAD) to understand safety and PK upon repeated administration.
• Determination of the effect of food on the bioavailability of BI-3031185.
• Investigation of potential drug-drug interactions (DDI), specifically with Midazolam as a probe substrate.

This systematic approach is standard for early-phase clinical development, aiming to build a foundational understanding of how the drug behaves in humans before it is administered to patient populations.

Detailed Clinical Trial Information

The clinical development program for BI-3031185 currently comprises at least three identified Phase 1 studies. The details are summarized in Table 1.

Table 1: Summary of Clinical Trials for BI-3031185

Trial Identifier (NCT ID, EudraCT/CTIS No., Other IDs)	Official/Brief Title	Phase	Status (Last Known)	Study Design	Interventions (Drug, Dose, RoA, Comparator)	Subject Population (Condition, Key Inclusion/Exclusion Criteria, N)	Primary Endpoints	Sponsor	Key Dates (Start, Primary Completion, Last Update)	Locations (if specified)
NCT06255340 4; 2	A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects	Phase 1A 4	Completed (Sep 19, 2024) 5	Randomized, single-blind, placebo-controlled (SAD part); Randomized, open-label, two-way cross-over (food-effect part)	BI-3031185 (oral tablet, single rising doses), Placebo 4	Healthy male subjects	Safety, Tolerability, Pharmacokinetics (PK) of single doses, Relative bioavailability with/without food 4	Boehringer Ingelheim 4	Start: Feb 2024 (recruitment) 5; Primary Completion: Aug 28, 2024 3; Last Update (AdisInsight): Nov 18, 2024 5	Germany (implied by sponsor's base for early dev.)
NCT06916702 6; (also U1111-1311-3555 7, 1516-0002 7)	A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men / Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)	Phase 1 2	Recruiting (as of Apr 10, 2025 8) / Not Yet Recruiting (as of Apr 9, 2025 6)	Single-blind, randomized, placebo-controlled, parallel group, multiple rising doses	BI-3031185 (oral, multiple rising doses), Placebo, Midazolam (oral) 6	Healthy male subjects, 18-50 years, BMI 20.0-29.9 kg/m², weight ≥60 kg. Estimated N=60 7	Safety, Tolerability, PK of multiple doses 6	Boehringer Ingelheim 6	Start: Apr 14, 2025 6; Primary Completion: Mar 12, 2026 7; Last Update (AdisInsight): Apr 15, 2025 8	Germany (PO) 2
CTIS2023-507941-28-00 4; (also 1516-0001 4)	Title: 1516-0001 (Brief title from Synapse)	Phase 1 4	Not yet recruiting (as of Mar 20, 2025 4)	Not specified	Not specified	Not specified	Not specified	Boehringer Ingelheim International GmbH 4	Start: Mar 11, 2024 4	European Union (implied by CTIS identifier)

The designs of these initial Phase 1 trials—encompassing single ascending dose (SAD), food effect, multiple ascending dose (MAD), and drug-drug interaction (DDI) assessments with a CYP3A4 probe substrate (Midazolam)—reflect a systematic and conventional strategy for characterizing the fundamental clinical pharmacology of BI-3031185.[4] This foundational dataset is indispensable before the compound can be advanced into studies involving patient populations or more complex trial designs. The progression from SAD and food effect studies (NCT06255340) to MAD and DDI studies (NCT06916702) is a logical sequence, where findings from earlier investigations inform the design and conduct of subsequent ones.

The inclusion of Midazolam in trial NCT06916702 is particularly noteworthy.[6] Midazolam is a sensitive substrate for Cytochrome P450 3A4 (CYP3A4), a major enzyme involved in the metabolism of a vast number of marketed drugs. Evaluating the interaction between BI-3031185 and Midazolam will provide critical insights into whether BI-3031185 inhibits or induces CYP3A4, or if its own pharmacokinetics are significantly influenced by this enzyme system. Understanding this DDI potential early in development is vital for defining safe co-administration guidelines with other medications, informing potential dosage adjustments, and contributing to the drug's labeling information should it eventually reach the market. This proactive assessment aligns with good clinical pharmacology practices and addresses a key regulatory consideration.

The CTIS identifier (CTIS2023-507941-28-00) likely corresponds to one of the NCT-registered trials within the European Union, possibly NCT06255340, given the similar start dates and sponsor information.[4]

6. Pharmacokinetics (PK)

Investigational Focus

A central focus of the Phase 1 clinical program for BI-3031185 is the comprehensive characterization of its pharmacokinetic profile.[5] The objectives of both NCT06255340 and NCT06916702 explicitly include the investigation of PK parameters.

Parameters Being Studied

The clinical trials are designed to assess several key pharmacokinetic aspects:

• Single Ascending Dose PK: Trial NCT06255340 was designed to evaluate the PK of BI-3031185 after single, escalating oral doses. This typically involves measuring parameters such as maximum concentration (Cmax​), time to maximum concentration (Tmax​), area under the concentration-time curve (AUC), and half-life (t1/2​) to understand dose proportionality and basic absorption and elimination characteristics.[4]
• Multiple Ascending Dose PK: Trial NCT06916702 aims to determine the PK profile of BI-3031185 following multiple, escalating oral doses. This allows for the assessment of drug accumulation, time to reach steady-state concentrations, and PK parameters at steady state.[6]
• Effect of Food on Bioavailability: A component of NCT06255340 was a randomized, open-label, two-way cross-over comparison to assess the relative bioavailability of BI-3031185 when administered as an oral tablet with and without food.[4] This is crucial for understanding how food intake might affect the drug's absorption and systemic exposure.
• Drug-Drug Interaction PK: Trial NCT06916702 includes the co-administration of BI-3031185 with Midazolam to evaluate potential pharmacokinetic interactions, primarily focusing on the CYP3A4 metabolic pathway.[6]

Formulation

BI-3031185 is being administered as an oral tablet in trial NCT06255340.[4] Oral administration (PO) is also indicated for NCT06916702 [2], consistent with its nature as a small molecule drug.

The comprehensive suite of PK assessments planned (SAD, MAD, food effect, DDI) represents a thorough approach for an early-phase program. This systematic investigation is designed to build a detailed understanding of the drug's absorption, distribution, metabolism, and excretion (ADME) characteristics under various clinically relevant conditions. The data generated from these studies will be fundamental for selecting appropriate doses and dosing regimens for subsequent Phase 2 trials, should the compound progress.

7. Safety and Tolerability Profile

Primary Objective

A primary objective across all listed Phase 1 clinical trials for BI-3031185 is the rigorous investigation of its safety and tolerability in healthy male volunteers.[5] This is a cornerstone of first-in-human studies.

Data Availability

Given that trial NCT06255340 was completed relatively recently (September 2024) and trial NCT06916702 is currently recruiting or not yet recruiting (as of April 2025), detailed safety and tolerability results from these studies are not yet publicly available within the provided information.[5] The findings from NCT06255340 would typically inform the dose escalation and safety monitoring strategies for NCT06916702.

Population

The study population for these initial Phase 1 trials consists of healthy male subjects, generally aged between 18 and 50 years. Key inclusion criteria include a Body Mass Index (BMI) between 20.0 and 29.9 kg/m² and a body weight of at least 60 kg. Participants are required to have no clinically relevant findings in their medical history, physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory tests that would contraindicate their participation or confound safety assessments.[7] This selection of a healthy, relatively homogenous population is standard practice for Phase 1 studies to minimize variability and clearly assess the drug's intrinsic safety profile.

While specific adverse event (AE) data for BI-3031185 are not yet available, the conduct of these trials adheres to International Council for Harmonisation-Good Clinical Practice (ICH-GCP) guidelines, as referenced in the informed consent process.[7] This ensures rigorous monitoring for a comprehensive range of potential adverse events, serious adverse events (SAEs), and any dose-limiting toxicities (DLTs). Standard safety assessments include regular physical examinations, monitoring of vital signs, ECGs, and comprehensive clinical laboratory panels. The term "tolerability," frequently cited as an objective [5], specifically refers to the degree to which subjects can endure the effects of the drug, which is primarily gauged by the incidence, nature, and severity of observed adverse events.

8. Regulatory Status

Orphan Drug Status

BI-3031185 does not currently hold Orphan Drug Status.[2] This designation is typically granted by regulatory authorities like the FDA or EMA to encourage the development of drugs for rare diseases or conditions.

Current Approval Status

BI-3031185 is an investigational compound and is not approved for marketing in any jurisdiction. Its current Phase 1 development status inherently classifies it as investigational.[1] The general drug approval processes overseen by regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) are extensive and require successful completion of multiple clinical trial phases (Phase 1, 2, and 3) to demonstrate safety and efficacy.[1]

Regulatory Submissions

To conduct the ongoing clinical trials, Boehringer Ingelheim has made necessary regulatory submissions:

• Clinical trial applications (CTAs) or equivalents have been approved by national competent authorities in the relevant jurisdictions where the trials are being conducted. For instance, trial NCT06916702 is taking place in Germany [2], implying approval from German regulatory authorities.
• Trial NCT06255340 has been registered on ClinicalTrials.gov.[14]
• Trial NCT06916702 has also been registered on ClinicalTrials.gov.[6]
• The identifier CTIS2023-507941-28-00 suggests a registration within the EU Clinical Trials Information System, likely for a trial site within the European Union.[4]

The absence of Orphan Drug Status for BI-3031185 at this stage suggests that the initial development focus is likely not on a rare disease, or such a designation has not yet been pursued or granted by Boehringer Ingelheim. The compound appears to be progressing along a standard regulatory pathway for a new molecular entity. While Boehringer Ingelheim has obtained expedited designations like FDA Fast Track or Breakthrough Therapy for other compounds in its pipeline (e.g., nerandomilast [10]), there is no indication from the available information that BI-3031185 has received any such special regulatory status thus far. Such designations can, however, be sought at later stages of development if supportive data emerge.

9. Intellectual Property

Patent Information

Information regarding specific patents exclusively covering BI-3031185 is limited in the publicly accessible portions of the provided documents. Synapse Patsnap indicates that there are "100 Patents (Medical) associated with BI-3031185," but access to the detailed list and content of these patents requires a login.[4] No specific patent numbers for BI-3031185 itself are disclosed.

While general patents held by Boehringer Ingelheim for various other compounds and technologies are mentioned (e.g., isoindolinone substituted indoles [16], DLL3-CD3 bispecific antibodies [17], and other small molecules [12]), these are not directly linked to BI-3031185 in the provided text.

The mention of a significant number of patents associated with BI-3031185, even without specific public details, underscores the proprietary nature of this investigational compound.[4] For a New Molecular Entity (NME) [2] developed by a major pharmaceutical company like Boehringer Ingelheim, establishing robust and comprehensive patent protection is a standard and critical component of the R&D and commercialization strategy. Such patent portfolios typically aim to cover the composition of matter (the chemical structure of BI-3031185 itself), methods of its manufacture, pharmaceutical formulations, and various methods of its use in treating specific conditions (once identified). This intellectual property framework is essential for securing market exclusivity if the drug is eventually approved, thereby allowing the company to recoup its substantial R&D investments and fund further innovation. The current lack of public detail on these specific patents is also typical for assets in the early stages of clinical development.

10. Discussion and Future Outlook

Current Stage Analysis

BI-3031185 is situated at a very early and foundational stage of clinical development. The current Phase 1 trials are meticulously designed to address fundamental questions regarding its safety profile in humans, its pharmacokinetic behavior (how the body absorbs, distributes, metabolizes, and excretes it), and its potential for interactions with other drugs. The reported completion of the initial Phase 1 study, NCT06255340, which assessed single ascending doses and the effect of food [5], represents a positive milestone. This has likely provided the necessary data and confidence to proceed with the subsequent, more complex Phase 1 study, NCT06916702, which evaluates multiple ascending doses and drug-drug interactions.[6]

Key Unanswered Questions

Despite the progress into Phase 1, several critical questions about BI-3031185 remain unanswered from the publicly available information:

• Mechanism of Action: The most significant unknown is the precise biological target and the molecular mechanism through which BI-3031185 exerts its effects. The elucidation of its MoA is paramount as it will ultimately define its therapeutic potential and its novelty.
• Therapeutic Indication(s): The specific disease(s) or condition(s) that Boehringer Ingelheim intends to target with BI-3031185 remain undisclosed.
• Efficacy: As is standard for Phase 1 trials in healthy volunteers, no efficacy data (i.e., evidence of therapeutic benefit in a disease state) are available or expected from the current studies.
• Detailed Long-Term Safety Profile: While initial safety and tolerability are being assessed, the full safety profile, particularly with chronic administration or in specific patient populations, is yet to be determined.

Potential Next Steps (Contingent on Phase 1 Outcomes)

The future development trajectory of BI-3031185 is heavily contingent on the outcomes of the ongoing Phase 1 program. Assuming the data from these studies demonstrate an acceptable safety and tolerability profile, predictable and manageable pharmacokinetics, and no insurmountable drug-drug interaction issues, the logical next step would be to advance BI-3031185 into Phase 2a clinical trials.

Phase 2a studies typically represent the first administration of the investigational drug to patients with the intended target disease(s). The primary objectives of such studies are to gather preliminary evidence of clinical activity or proof-of-concept, further evaluate safety in a patient population, and refine the dose and dosing regimen for larger, confirmatory Phase 2b or Phase 3 trials. The dose selection for these patient studies would be directly informed by the comprehensive PK and safety data generated during the Phase 1 program.

The outcomes of the current Phase 1 program, particularly the ongoing NCT06916702 involving multiple doses and DDI assessment, will be pivotal. Favorable safety and PK data are fundamental prerequisites for committing the substantial resources required for later-stage clinical development. Any significant safety concerns, highly variable or otherwise problematic PK characteristics (e.g., very poor bioavailability, unmanageable food effects, or severe DDI potential that cannot be mitigated) could lead to the termination of the program or necessitate a major re-evaluation of its development strategy. Conversely, a clean safety profile and predictable pharmacokinetics would build the necessary confidence for Boehringer Ingelheim to invest in more complex and costly Phase 2 trials.

While the specific therapeutic target for BI-3031185 remains unknown, Boehringer Ingelheim maintains a robust and diverse R&D pipeline with clearly stated strategic focus areas, including oncology, respiratory diseases, cardiovascular-renal-metabolic (CRM) conditions, mental health, and immunology.[9] It is plausible, though currently speculative, that BI-3031185 is being developed to address an unmet need within one of these core areas. The company's significant R&D investments, amounting to EUR 6.2 billion in 2024 (of which EUR 5.7 billion was for Human Pharma) [11], underscore a strong commitment to advancing innovative therapies. As more data on BI-3031185, particularly regarding its mechanism of action, becomes available, its strategic fit within Boehringer Ingelheim's broader portfolio and therapeutic ambitions will become clearer. Recent company communications emphasize a focus on new product launches and continued pipeline advancement.[11]

11. Conclusion

BI-3031185 is an oral small molecule New Molecular Entity developed by Boehringer Ingelheim, currently navigating the early stages of Phase 1 clinical development. The ongoing clinical program is methodically designed to establish a foundational understanding of its safety, tolerability, and pharmacokinetic profile in healthy male volunteers. Key investigations include single and multiple ascending dose evaluations, assessment of food effects on bioavailability, and the potential for drug-drug interactions, notably via the CYP3A4 metabolic pathway using Midazolam.

At present, the precise mechanism of action and the intended target therapeutic indication(s) for BI-3031185 have not been disclosed by the developer. The successful completion of the Phase 1 program, yielding favorable safety and pharmacokinetic data, will be a critical determinant for its progression into patient-based studies (Phase 2), where its therapeutic potential can begin to be explored. The journey of BI-3031185 through these initial clinical hurdles will be closely watched to ascertain its future role in addressing unmet medical needs.

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