Innovate

Innovation is central to our business strategy and foundational to our ability to improve access to and delivery of healthcare. We are operating in an era of unprecedented opportunity for medical discovery, and our priority is to maintain a productive discovery engine, develop medicines to improve lives, and manufacture them at the scale required to reach patients worldwide. Our approach spans the full arc of innovation — from expanding the range of diseases we can treat through new modalities and therapeutic platforms, to preparing markets, providers, and health systems so that when a medicine is approved, patients can benefit without delay. Across that arc, we focus on making disciplined decisions about which programs to advance, compressing the timelines that separate discovery from patient access, designing clinical trials that reflect the populations who carry the burden of disease, building an external ecosystem that extends our reach, and deploying advanced technologies to accelerate discovery.

An Expanding Toolbox for Unmet Medical Needs

Our mission is to develop the next generation of treatments that change the way medicine works today. We invest more than $13 billion annually in R&D, focused on addressing significant unmet medical needs across therapeutic areas including cardiometabolic conditions like diabetes and obesity, neuroscience, oncology, and immunology. We are building an expanding set of modalities: small molecules, peptides, antibodies, gene therapy, siRNA, antibody-drug conjugates, and radioligand therapies, each deployed against the targets and diseases where it offers the highest biologic rationale. As science advances, we continuously add new tools and modalities to stay at the frontier of what is possible.

This work requires both long-term commitment and the willingness to invest in solutions for diseases with significant unmet need. For example, developing a disease-modifying treatment for Alzheimer’s disease required 35 years of research, multiple clinical trial failures, and billions of dollars of investment. Tirzepatide, a medicine for diabetes and obesity, was discovered in a scientific program that began years before obesity became a commercial priority for Lilly. We sustain this capacity by reinvesting the returns from successful medicines into the next wave of research, and by being willing to make bold bets early. This cycle is visible today: returns from our cardiometabolic health portfolio are fueling investment in oncology, neuroscience, immunology and other areas, both internally and through business development.

Our innovation trajectory is moving toward prevention — developing therapies that intervene earlier in disease progression, such as preventing the onset of type 2 diabetes or delivering genetic medicines that address the root cause of disease. We are also focused on overcoming barriers to adherence, because the full health benefit of any medicine depends on patients being able to stay on therapy over time.

Compressing R&D Timelines

Our development approach is built on a core principle: relentlessly reduce time for the things we can control. This means compressing timelines all the way back into early research, accelerating decision-making at every stage, and making at-risk investments — committing resources to prepare for the next phase of development even before data for the current stage is available. In pre-clinical research, we work to speed the scientific flywheel of design-make-test-analyze to get answers to fundamental chemical and biological questions faster.

We invest at risk because waiting for certainty at each stage costs patients time. In the process, we’ve reduced the average time between the first tested human dose and medicine launch from eleven years to six.

This approach also extends to clinical trial supply — the investigational medicines used in the clinical studies required for regulatory approval. The Lilly Medicine Foundry, currently under construction in Lebanon, Indiana, is intended to bring a portion of clinical supply production in-house by combining process research, manufacturing, and technology development in a single facility. Previously, early-stage clinical supply was largely outsourced. The Foundry is designed to give us direct control over development timelines and accelerate the time from process development to first-in-patient dosing. The facility's flexible design will support production across multiple molecule types, including small molecules, biologics, and nucleic acid therapies, with first clinical supply expected in 2027.

Compressing timelines also requires making quality decisions about which programs to advance. Moving a molecule into Phase 3 testing is one of the most consequential and resource-intensive steps in drug development. Our approach is to invest in rigorous Phase 2 work that validates the therapeutic hypothesis and establishes a clear understanding of a medicine's performance before that commitment is made. This reduces the risk of late-stage failures and ensures that the programs we advance are designed to succeed. By strengthening the evidence base earlier, we improve both the quality and the speed of our development portfolio.

Clinical Trials: Inclusive and Accessible

Lilly develops medicines that make life better for people around the world, and that mission depends on clinical research that reflects the range of those we aim to reach living with the burden of disease. Clinical trials are studies conducted with people to evaluate how well a medicine or therapy works and how safe it is. As part of this work, we develop diagnostic tools and capabilities—including biomarkers, imaging approaches, and screening methods—that help identify potential participants for clinical trials and often continue to support broader patient access after a medicine is approved.

We design clinical trials to reflect and reach patients carrying the burden of disease, across geographies, backgrounds, health conditions, and life circumstances. This means embedding trials in the communities where patients already receive care — reducing the practical, logistical, and emotional barriers that can make participation difficult. When a diagnosis is new and decisions feel overwhelming, access to a clinical trial shouldn't depend on where someone lives.

To make that possible, we integrate community-focused approaches, including partnerships with local organizations, telehealth, and digital tools, to better align clinical research with how healthcare is delivered today. Participants in trials often receive either standard-of-care treatment or investigational therapy, alongside closer monitoring and access to specialized clinical expertise — a potential benefit to communities we engage.

What we learn from representative populations also strengthens future research. Trial enrollment that reflects the real-world burden of disease produces more applicable results, allowing us to design trials that are increasingly reflective of the population affected by the disease.

Ultimately, broad access and participation in clinical research is how we develop medicines—and the supporting tools to find and reach patients — that serve patients and communities everywhere.

Better Endpoints, Better Access

In addition to our focus on developing new medicines, we invest in evolving how they are tested and approved, with the goal of improving the patient experience and efficiency of healthcare delivery. We run the studies needed to validate patient-centric trial designs, often in parallel with established practices, and bring that evidence to regulators to update standards across the industry. A few examples include:

• In MASH (metabolic dysfunction-associated steatohepatitis, a progressive and serious form of fatty liver disease), proving a treatment works has traditionally required liver biopsies — an invasive procedure that carries real risk for patients and discourages many from participating in clinical trials. We set out to change that, reducing exposure to these procedures for trial participants, including those receiving placebo. In our Phase 2 SYNERGY-NASH trial, we tested tirzepatide using traditional biopsies while simultaneously collecting imaging and blood-based measures, building the evidence that less invasive tests could be equally reliable. That work is paying off: in August 2025, the FDA took a foundational step by formally beginning the qualification process for a non-invasive imaging test as a valid endpoint in MASH drug trials — a process Lilly supported alongside other developers. Our newest Phase 3 trials for tirzepatide and retatrutide, registered in September 2025, have already moved fully to non-invasive imaging and blood-based measures — replacing biopsy requirements entirely.

• In Alzheimer's disease, diagnosis today often requires expensive brain imaging scans (PET) or invasive spinal fluid testing. We're investing in a simpler alternative: a blood test that can detect the disease. Through a long-standing partnership with Roche Diagnostics, the jointly developed Elecsys pTau217 blood test received FDA Breakthrough Device Designation in April 2024. In parallel, Lilly has clinically validated its own version of the test, with peer-reviewed studies in JAMA showing accuracy comparable to PET imaging. A reliable blood test makes diagnosis faster, less invasive, and more widely available — lowering barriers to both clinical trial enrollment and patient access to treatment.

The result: less invasive procedures, faster enrollment, and shorter trials — accelerating the path from discovery to approved medicine, and ultimately into the hands of patients who need it.

Concurrent Development Across Indications

Across our portfolio, where the science indicates potential benefit, we initiate new indication and line extension (NILEX) trials alongside lead indications at pivotal trial start. NILEX encompasses two dimensions: pursuing additional disease areas or disease stages where the mechanism of action may work, and developing new delivery methods such as new formulations, devices, or dosing regimens, that can expand who benefits from a given medicine.

This represents a fundamental shift in how we sequence development. Historically, the industry prioritized addressing the primary condition first — completing Phase 3, then deciding what additional conditions to pursue. Our approach changes the timing: we investigate additional conditions earlier and in parallel, sometimes beginning in Phase 2, so that when a medicine reaches approval, evidence across multiple indications is already well advanced. This means making more at-risk investment and the possibility of more failures along the way, but for the molecules that become medicines, we can help more patients faster. This strategy extends beyond individual molecules to entire mechanistic classes. We are now exploring applications of incretin biology across neuroscience and immunology — areas where the same underlying science may address conditions far beyond the original hypothesis focused on diabetes and chronic weight management.

Intentional Development for Resource-Limited Populations

We embed considerations for bringing innovation to low- and middle-income countries (LMICs) early in the development process. This includes formulations, combinations, dosing regimens, and delivery mechanisms and manufacturing-based solutions designed for the needs of patients in resource-limited settings. By considering the unique needs of people living in those geographies from the earliest stages of development, we can create medicines that are not only scientifically advanced but also practical and affordable for everyone who can benefit from them.

Enabling the Early-Stage Biotech Ecosystem

Sustained innovation depends on leveraging good science wherever it originates — combining the strengths of academia, biotechnology, and large pharmaceutical companies. Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem, working across all therapeutic areas to remove barriers and accelerate promising science.

The platform operates through four integrated pillars:

• Lilly Ventures serves as an investor and strategic partner to the global biotech ecosystem, providing capital and collaboration to early-stage companies working across therapeutic areas. Through customized engagement models, we co-invest alongside syndicate partners to support companies at critical stages of development — when the right investment can accelerate progress from promising science to clinical proof-of-concept.

• Lilly Gateway Labs provides state-of-the-art laboratory facilities and scientific engagement for early-stage biotechs, with sites in San Francisco, San Diego, Boston, Beijing, and Shanghai, and recently announced in Philadelphia and Seoul. The model is intentionally focused — placed in geographies where we believe it can make the most difference.

• Lilly ExploR&D aims to empower early-stage companies by deploying our research and development teams to provide customized expertise, with a wide range of capabilities and offerings across many therapeutic areas and platforms. We offer integrated drug development consulting and support from early discovery through clinical proof-of-concept.

• Lilly TuneLab is a collaborative artificial intelligence/machine learning platform that provides access to drug discovery models built on proprietary Lilly data generated over decades at a cost exceeding $1 billion — a scale of investment that most biotech companies could not replicate independently. In exchange, participating companies contribute data via federated learning, improving the models for everyone without sharing proprietary molecular information.

Catalyze360 is open to all areas of science. The biotech ecosystem requires navigating the capital markets and demonstrating value early. This platform provides emerging companies with access to Lilly’s funding capabilities, vendor relationships, subject matter experts, and connections we have built over decades — resources that can be difficult for smaller organizations to access independently.

Accelerating Discovery Through Artificial Intelligence

Traditional drug discovery has been an inherently artisanal process — chemists, engineers, and biologists building medicines one iteration at a time, with even the most productive teams testing just a few thousand molecule ideas per year per target. We are investing in AI to complement the expertise of our scientists with computational tools that dramatically expand the scope of what is possible. We are optimistic about the vast opportunity of AI in drug development, but acknowledge we are still in the early stages of potential impact.

AI dramatically expands what is computationally possible in early discovery, but the pace of clinical development is ultimately set by biology. The opportunity is to compress the stages we can control — molecular design, target identification, manufacturing optimization — while the science of human disease progresses on its own timeline. This requires dedicated scientific models built for pharmaceutical applications, not general-purpose tools adapted from other domains.

We are also building an external partnership ecosystem for AI in drug development, including collaborations with Isomorphic Labs (leveraging AlphaFold technology), OpenAI (discovering novel antimicrobials targeting drug-resistant bacteria), Insilico Medicine, and Genetic Leap (RNA-targeted therapies). A number of the proprietary AI models will be made available through Lilly TuneLab, extending these capabilities beyond Lilly to the broader biotech ecosystem.

Investing Early to Overcome Health System Barriers

Innovation readiness is the bridge between research & development and getting our medicines to more patients faster. It means building and executing one integrated plan to ensure the environment is ready for new innovations.

This planning starts early: evidence generation, quality improvement initiatives and targeted stakeholder engagement are underway well before launch. The goal is to ensure the ecosystem is prepared for the new medicines when they come to market. Innovation readiness is a cross-cutting enabler that precedes and supports the reception of new innovative medicines at every downstream stage of the patient journey — from regulatory approval through coverage, access and education.

Intellectual Property as a Foundation for Innovation and Access

The innovation described throughout this section depends on a reliable intellectual property framework — one that sustains investment in high-risk research and ensures that the benefits of that research eventually become broadly accessible.

Intellectual property (IP) protections play a critical role in providing necessary incentives that sustain investment in drug development and drive innovations. Developing a new medicine is a high-risk, high-cost endeavor, and robust, reliable, predictable, and enforceable IP protections provide a measure of certainty of return on that investment that encourages continued investment in areas of significant unmet medical need, such as Alzheimer’s disease. Without strong IP protections, innovation would largely focus on low-risk ventures, which may leave many serious diseases without effective treatments. At the same time, the eventual expiration of IP protections opens the door to generic and biosimilar competition, extending the access to affordable medicines even further.

Two important forms of IP protections for medicines are:

• Patents, which prevent anyone other than the inventor from copying and selling the invention for a set period of time (20 years from the application date of the patent); and

• Data exclusivity, which prohibits third parties, for a set period of time, from using or relying on an innovator’s valuable clinical trial data to obtain regulatory approval for their own product.

At Lilly, we use patents to protect meaningful innovation that enables sustainable investment in the research and development required to discover, develop, and deliver new medicines. We also recognize that patents are limited in scope and duration, and we support healthy markets for generics and biosimilars when those protections expire, including removal of regulatory, pricing, reimbursement, and access barriers. While our standard practice is to not file patent applications in Least Developed Countries, we also tailor our approach in these geographies where unique local challenges may call for voluntary licensing, non-assert policies, or selective filing strategies, alongside capacity-building initiatives that foster local innovation ecosystems.

In 2021, Lilly joined the IP PACT (IP Principles for Advancing Cures and Therapies), a multi-company initiative affirming the biopharmaceutical industry’s commitment to innovation and keeping patients at the center of our work. The IP PACT includes ten principles guiding the way our industry uses IP, including facilitating collaboration and partnerships, acting responsibly in patent proceedings and supporting vibrant generic and biosimilar markets. The principles are intended to balance the needs of patients, society and our business — to further healthcare innovation and help patients live longer, healthier lives.

In 2025 and early 2026, we made significant advances across the innovation strategy by compressing development timelines, expanding our external ecosystem, and building new capabilities in artificial intelligence.

Foundayo: One Molecule, the Full Model

Foundayo (orforglipron) — approved in the U.S. in April 2026 for chronic weight management — is the first molecule where our intentional access strategy came together on a single asset. The choice of an oral small molecule over an injectable peptide was made with patient reach in mind: easier to manufacture at scale, easier to ship and store, and easier for patients to take. Multi-indication planning was in place years before approval, including trials for use in type 2 diabetes, obstructive sleep apnea, and other conditions alongside the lead weight management indication. Innovation readiness work — evidence generation, payer engagement, and provider education — was underway well before launch so that coverage, distribution, and patient support were ready on day one. The result is a path for a medicine to reach patients on a timeline, and at a scale, that would not have been possible a decade ago.

NILEX Plans

In 2025, 100% of new molecules entering late-stage development had multi-indication plans already in place — mapping out additional diseases, formulations, and delivery methods the medicine could address beyond the initial use. This is evidence that planning for the broadest possible patient benefit is becoming embedded in how we develop medicines, rather than treated as an afterthought.

We accelerated our NILEX strategy by advancing concurrent trial plans for two major programs. As of April 30, 2026:

• For eloralintide, alongside a lead weight management indication, we are simultaneously pursuing two additional indications as well as an add-on to weekly incretins therapy, all in Phase 3 testing.

• For brenipatide, we are simultaneously pursuing indications for alcohol use disorder and major depressive disorder, both in Phase 3, as well as five additional indications in Phase 2.

Biotech Ecosystem

Our external innovation ecosystem continued to grow.

• In January 2025, Lilly Ventures partnered with Andreessen Horowitz to launch a $500 million Biotech Ecosystem Venture Fund.

• Gateway Labs expanded to six global sites with the announcement of a Philadelphia location in November 2025, followed by a new site in Korea announced in March 2026 through a collaboration with Samsung Biologics. Resident companies have collectively raised more than $3 billion, fueling progress on over 50 therapeutic programs.

• In September 2025, we launched the TuneLab platform with ready-to-use AI/ML models spanning discovery and preclinical workflows — making our proprietary computational tools available to the broader biotech community for the first time through a federated learning model.

AI Acceleration

On artificial intelligence, we are moving from idea to infrastructure:

• In October 2024, we appointed our first Chief AI Officer.

• In October 2025, we announced a collaboration with NVIDIA to create an AI co-innovation lab focused on applying AI to tackle some of the most enduring challenges in the pharmaceutical industry.

• In February 2026, at our Indianapolis campus, we launched LillyPod, a supercomputer designed to enable scientists to train AI models on millions of experiments, expanding the scope of drug discovery from the thousands of molecule ideas testable in a wet lab to the billions evaluable computationally.

We have deployed internal AI models proposing molecules with novel motifs for drug targets and launched an internal platform connecting employees to AI learning resources. These capabilities are now being applied across discovery, development, and manufacturing workflows as we work to embed computational intelligence into every layer of our science.

Innovation Readiness

In 2024, we formalized our Innovation Readiness approach to preparing markets and health systems ahead of new medicine launches. Since then, we have completed landscape assessments for 31 disease states across 16 portfolio assets. We built and funded Innovation Readiness execution plans for the U.S. and many key international markets — across obesity, Alzheimer’s disease, cardiovascular disease, and lung cancer, with execution well underway in 2026. These plans align evidence generation, quality improvement initiatives (efforts to close clinical care gaps by addressing system barriers to optimize care delivery), and ecosystem stakeholder engagement so that when approvals occur, the healthcare ecosystem is prepared. In 2025, the Brain Health Matters public health campaign for Alzheimer’s disease was launched — an example of how this preparation translates into real-world action before a medicine reaches the market.

The next chapter of Lilly's innovation strategy is defined not by any single molecule but by the convergence of therapeutic platforms that, taken together, represent a fundamentally expanded capacity to intervene in human disease.

We are advancing gene editing technologies with the potential to make one-time genetic corrections that address the root cause of disease. Radioligand therapies are expanding our ability to deliver targeted radiation directly to cancer cells that have resisted conventional approaches. Engineered RNA and in vivo cell therapies are opening pathways to reprogram biology from within, including the potential to turn a patient's own cells into durable, cancer-fighting agents without the need for complex ex vivo manufacturing. And in diabetes, our longest-standing therapeutic area, we are pursuing glucose-sensing insulin, a molecule designed to activate only when blood sugar rises, representing more than a century of insulin science compressed into a single engineered peptide.

In 2025 and early 2026, we expanded into infectious disease through three acquisitions, establishing a new platform commitment backed by dedicated R&D investment. This reflects a deliberate decision to apply Lilly's development capabilities to a category of disease with enormous global burden and significant unmet need, particularly in low- and middle-income countries.

Across these platforms, our trajectory is moving toward prevention: intervening earlier in disease progression, identifying risk before symptoms appear, and ultimately shifting the standard of care from treatment to interception. The tools now exist to screen and prevent disease the way we screen and prevent certain cardiovascular events today. We realize this ambition will require continued investment in diagnostics, in clinical evidence that validates earlier intervention, and in preparing health systems to act on what the science makes possible.

What distinguishes this moment is not any one of these platforms in isolation. It is that we are building capability across all of them simultaneously, supported by AI-enabled discovery, at-risk investment in parallel development, and an external ecosystem designed to accelerate promising science wherever it originates. The result is an innovation engine positioned to deliver not just more medicines, but fundamentally different kinds of medicines, for diseases and populations that the industry has not yet been able to reach.

Resources

• Lilly Science

• Lilly Clinical Trials and Research

• Diversity in Clinical Trials

• Lilly Catalyze360

• The Co-Innovation Lab

• Lilly Medicine Foundry

Related Topics

• Approve

• Reach

• Supply

• Educate

• Patient Safety

• Bioethics

• Responsible Use of AI