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Clinical Development Pipeline
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Molecule & potential indication data as of April 30, 2026
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Phase 1
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Phase 1 projects are no longer disclosed.
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**Pipeline Disclaimer**
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The information included on this site reflects Eli Lilly and Company's clinical development pipeline and is not intended for promotional purposes. It includes both new molecular entities as well as select new indications or line extensions of currently approved products that are in clinical development. There are significant risks and uncertainties in pharmaceutical research and development. Scientific and regulatory hurdles may cause pipeline molecules to be discontinued or delayed, or to fail to reach the market. There can be no guarantee that pipeline molecules will receive regulatory approval or that they will prove to be commercially successful. Information is current as of April 30, 2026. Lilly assumes no duty to update this information. For competitive reasons, some pipeline molecules are not identified. Property of Eli Lilly and Company.
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Frequently asked questions
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Thank you for visiting Lilly’s clinical development pipeline site. This interactive page is designed to give you a better understanding of the molecules and potential indications Lilly is currently developing for people around the world. Below are responses to some frequently asked questions regarding the site’s information and how it is displayed.
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How does Lilly define First Submission?
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Lilly defines First Submission as the initial submission of a regulatory dossier to a health authority to obtain regulatory approval for Lilly to market any indication or product form of a potential new medicine in one of the major markets (US, EU, China or Japan).
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Lilly defines First Submission as the initial submission of a regulatory dossier to a health authority to obtain regulatory approval for Lilly to market any indication or product form of a potential new medicine in one of the major markets (US, EU, China or Japan).
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How does Lilly define First Submission?
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Lilly defines First Submission as the initial submission of a regulatory dossier to a health authority to obtain regulatory approval for Lilly to market any indication or product form of a potential new medicine in one of the major markets (US, EU, China or Japan).
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For competitive reasons, some pipeline molecules are not identified.
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Why are some targets undisclosed?
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For competitive reasons, some pipeline molecules are not identified.
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For competitive reasons, some pipeline molecules are not identified.
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How does Lilly define First Registration Dose?
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Lilly defines First Registration Dose as the date of the first dose administered in the first large-scale pivotal study designed or intended to support registration in a major market (US, EU, China or Japan). This may occur before all Phase 2 studies have been completed. This dose may be active LY, placebo or comparator.
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For competitive reasons, some pipeline molecules are not identified.
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What is the difference between a small and large molecule?
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A new small molecule, or chemical entity, is a molecule that is chemically derived, or synthesized, through chemical processes, and are typically administered orally. A new large molecule, or biologic entity, is comprised of biological products such as proteins, peptides or antibodies, and are typically administered intravenously or subcutaneously.
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For competitive reasons, some pipeline molecules are not identified.
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Abbreviations & Icons
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A new small molecule, or chemical entity, is a molecule that is chemically derived, or synthesized, through chemical processes, and are typically administered orally. A new large molecule, or biologic entity, is comprised of biological products such as proteins, peptides or antibodies, and are typically administered intravenously or subcutaneously.
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α: alpha
β: beta
NME: new molecular entity
NILEX: new indication or line extension
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How does Lilly define First Efficacy Dose?
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Lilly defines First Efficacy Dose as the date of the first dose administered to patients with the disease the molecule is being studied to treat, in a clinical study in which efficacy is a primary endpoint. The outcome of the clinical study should provide meaningful data on efficacy that drives a decision on whether to pursue development of the targeted indication for the molecule. This dose may be active LY, placebo or comparator.
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For competitive reasons, some pipeline molecules are not identified.
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Why are some molecules in the pipeline followed by a 1 or 2?
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In some cases, the pipeline includes two or more molecules that act on the same disease target. To distinguish these molecules until a nonproprietary name is granted, they are numbered on Lilly’s pipeline website.
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For competitive reasons, some pipeline molecules are not identified.
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What is the significance of the indications listed for each molecule?
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For each molecule, the lead indication, or indication that is furthest along in clinical development, is listed in the molecule’s “box” on the pipeline overview page. If a molecule is being studied for multiple indications, select additional indications will be listed in the molecule’s full description, which is displayed once you click the molecule’s box on the pipeline overview page.
For New Indication or Line Extension (NILEX) molecules, the indication listed is the new indication undergoing clinical study and not the indication which is already approved for marketing by a regulatory agency.
For New Indication or Line Extension (NILEX) molecules, the indication listed is the new indication undergoing clinical study and not the indication which is already approved for marketing by a regulatory agency.
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For competitive reasons, some pipeline molecules are not identified.
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What is the significance of the position of a molecule within a particular phase of development (Phase 1, 2, 3 or Regulatory Review) as compared to other molecules in that same phase?
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Molecules are listed in alphabetical order by phase in development.
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For competitive reasons, some pipeline molecules are not identified.
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How does Lilly define First Human Dose?
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Lilly defines First Human Dose as the date of the first dose administered in the initial clinical study of the molecule given to healthy volunteers. This is typically a single-dose pharmacokinetic safety study (study of how the investigational medicine acts on the body over a period of time, from a safety perspective). This dose may be active LY, placebo or comparator.
In some cases, such as oncology and autoimmunity, the First Human Dose is given to patients with the disease the molecule is being studied to treat.
In some cases, such as oncology and autoimmunity, the First Human Dose is given to patients with the disease the molecule is being studied to treat.
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For competitive reasons, some pipeline molecules are not identified.
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What is a commercial collaboration?
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Some pipeline molecules will be commercialized (sold and marketed) with other companies after the medicine is approved. This is referred to as a commercial collaboration.
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For competitive reasons, some pipeline molecules are not identified.
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Which molecules include links to press releases and what are the criteria for press release inclusion?
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For molecules in Phase 3 development and under regulatory review, Lilly’s interactive pipeline website includes links to press releases issued January 1, 2010, through the pipeline date listed at the top of the site.
For announcements related to molecules in other phases (Phase 1, Phase 2, NILEX), as well as broader pipeline announcements, please visit the press release archives in the Lilly.com Newsroom.
For announcements related to molecules in other phases (Phase 1, Phase 2, NILEX), as well as broader pipeline announcements, please visit the press release archives in the Lilly.com Newsroom.
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For competitive reasons, some pipeline molecules are not identified.
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How does Lilly determine when a molecule enters a particular phase of clinical development?
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- Lilly considers Phase 1 clinical development to be underway once the first human dose has been given.
- Lilly considers Phase 2 clinical development to be underway once the first efficacy dose has been given.
- Lilly considers Phase 3 clinical development to be underway once the first registration dose has been given.
- Lilly considers regulatory review to be underway when the first submission has been made.
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For competitive reasons, some pipeline molecules are not identified.
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When are molecules listed as “milestone achieved”?
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Molecules are listed as “milestone achieved” during the quarter after the milestone was achieved. For Q1 2021, milestone achievement occurred April 23, 2021 - July 30, 2021.
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For competitive reasons, some pipeline molecules are not identified.
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Why are some molecules listed on the pipeline website in Phase 2 clinical development, but noted as Phase 1 on ClinicalTrials.gov?
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Lilly defines the start of Phase 2 as the first dose in a clinical study for the purpose of evaluating efficacy, whether that occurs in a Phase 1 cohort or a separate Phase 2 study. Some oncology pipeline molecules are considered by Lilly to be in Phase 2 clinical development, although clinicaltrials.gov lists them as Phase 1 based on a Phase 1 study.
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For competitive reasons, some pipeline molecules are not identified.
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