Medicines in Development

MOLECULE & POTENTIAL INDICATION DATA AS OF October 30, 2018

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Regulatory Approval Achieved

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Galcanezumab

migraine prevention

Milestone Achieved

  • Pain
  • Large Molecule
  • NME

Galcanezumab

LY2951742, (CGRP monoclonal antibody), is a large molecule that binds and inhibits the activity of calcitonin gene related peptide (CGRP). LY2951742 is being studied for the prevention of both chronic and episodic migraine.

News (January 1, 2010 - October 30, 2018)

Galcanezumab

migraine prevention

  • Pain
  • Large Molecule
  • Milestone Achieved
  • NME

Regulatory Review

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Ixekizumab

radiographic axial spondyloarthritis

Milestone Achieved

  • Immunology
  • Large Molecule
  • New Indication

Lasmiditan

migraine

Milestone Achieved

  • Pain
  • Small Molecule
  • NME

Lasmiditan

LY573144 (lasmiditan), a small molecule, is an oral 5-HT1F receptor agonist. LY573144 is being studied for the acute treatment of migraine.

Nasal Glucagon

hypoglycemia

  • Diabetes
  • Large Molecule
  • NME

Nasal Glucagon

Nasal glucagon is a large molecule being studied for the treatment of severe hypoglycemia in people with diabetes treated with insulin.

News (January 1, 2010 - October 30, 2018)

Ramucirumab

hepatocellular cancer

Milestone Achieved

  • Oncology
  • Large Molecule
  • New Indication

Ramucirumab

(ra" mue sir' ue mab)

LY3009806 (ramucirumab), a large molecule, is an antiangiogenic therapy. Specifically, it is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. LY3009806 is currently being studied for the treatment of 2nd line hepatocellular carcinoma.

Ixekizumab

radiographic axial spondyloarthritis

  • Immunology
  • Large Molecule
  • Milestone Achieved
  • New Indication

Lasmiditan

migraine

  • Pain
  • Small Molecule
  • Milestone Achieved
  • NME

Nasal Glucagon

hypoglycemia

  • Diabetes
  • Large Molecule
  • NME

Ramucirumab

hepatocellular cancer

  • Oncology
  • Large Molecule
  • Milestone Achieved
  • New Indication

Phase 3

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Abemaciclib

adjuvant breast cancer

  • Oncology
  • Small Molecule
  • New Indication

Abemaciclib

(a be muh sī klib)

LY2835219 (abemaciclib), a small molecule, is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 that inhibits phosphorylation of the Rb tumor suppressor protein and thereby induces G1 cell cycle arrest. LY2835219 is being studied for the treatment of adjuvant breast cancer.

Baricitinib

atopic dermatitis

  • Immunology
  • Small Molecule
  • New Indication

Baricitinib

LY3009104 (baricitinib, formerly known as JAK1/JAK2 Inhibitor) is a small molecule that inhibits the activity of the Janus (JAK) 1 and 2 enzymes. LY3009104 is being studied for the treatment of atopic dermatitis.

Baricitinib

systemic lupus erythematosus

Milestone Achieved

  • Immunology
  • Small Molecule
  • New Indication

Baricitinib

LY3009104 (baricitinib, formerly known as JAK1/JAK2 Inhibitor) is a small molecule that inhibits the activity of the Janus (JAK) 1 and 2 enzymes. LY3009104 is being studied for the treatment of systemic lupus erythematosus.

Dulaglutide 3.0 / 4.5 mg

diabetes

  • Diabetes
  • Large Molecule
  • New Formulation

Dulaglutide 3.0 / 4.5 mg

LY2189265 (dulaglutide), a glucagon-like peptide-1 analog, is a large molecule being studied at investigational doses as a once-weekly treatment for type 2 diabetes.

Empagliflozin

heart failure

  • Diabetes
  • Small Molecule
  • Commercial Collaboration
  • New Indication

Empagliflozin

BI10773 (empagliflozin) is a small molecule that inhibits the sodium glucose co-transporter-2 (SGLT 2). BI10773 is being studied in collaboration with Boehringer Ingelheim as a treatment for chronic heart failure with either preserved or reduced ejection fraction.

News (January 1, 2010 - October 30, 2018)

Empagliflozin

type 1 diabetes

  • Diabetes
  • Small Molecule
  • Commercial Collaboration
  • New Indication

Empagliflozin

BI10773 (empagliflozin) is a small molecule that inhibits the sodium glucose co-transporter-2 (SGLT 2). BI10773 is being studied in collaboration with Boehringer Ingelheim as a treatment for type 1 diabetes.

Flortaucipir F 18

  • Neurodegeneration
  • Small Molecule
  • New Diagnostic

Flortaucipir F 18

(flor tau’ si pir)

Flortaucipir F 18 (formerly known as 18F-AV-1451 or Tau imaging agent) is a small molecule PET imaging agent being studied for the imaging of Tau pathology.

Galcanezumab

cluster headache

  • Pain
  • Large Molecule
  • New Indication

Galcanezumab

LY2951742, (CGRP monoclonal antibody), is a large molecule that binds and inhibits the activity of calcitonin gene related peptide (CGRP). LY2951742 is being studied for the prevention of cluster headache.

Ixekizumab

non-radiographic axial spondyloarthritis

  • Immunology
  • Large Molecule
  • New Indication

Ixekizumab

LY2439821 (ixekizumab) is a large molecule that neutralizes a soluble factor called interleukin-17A (IL-17). LY2439821 is being studied for the treatment of non-radiographic axial spondyloarthritis.

Mirikizumab

psoriasis

  • Immunology
  • Large Molecule
  • NME

Mirikizumab

(mir” i kiz’ ue mab)

LY3074828 (formerly known as IL-23 antibody) is a large molecule that blocks the activity of the cytokine interleukin 23. LY3074828 is being studied for the treatment of psoriasis.

Mirikizumab

ulcerative colitis

  • Immunology
  • Large Molecule
  • New Indication

Mirikizumab

(mir” i kiz’ ue mab)

LY3074828 (formerly known as IL-23 antibody) is a large molecule that blocks the activity of the cytokine interleukin 23. LY3074828 is being studied for the treatment of ulcerative colitis.

Pegilodecakin

pancreatic cancer

  • Oncology
  • Large Molecule
  • NME

Pegilodecakin

LY3500518 (pegilodecakin), a large molecule, is a PEGylated IL-10 designed to activate and enhance anti-tumor immune response in cancer patients. LY3500518 is being studied for the treatment of pancreatic cancer.

Ramucirumab

NSCLC

  • Oncology
  • Large Molecule
  • New Indication

Ramucirumab

(ra" mue sir' ue mab)

LY3009806 (ramucirumab), a large molecule, is an antiangiogenic therapy. Specifically, it is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. LY3009806 is currently being studied for the treatment of first-line, EGFR positive NSCLC.

Solanezumab

preclinical Alzheimer’s

  • Neurodegeneration
  • Large Molecule
  • NME

Solanezumab

(soe" la nez' ue mab)

LY2062430 (solanezumab) is a large molecule that binds to soluble monomeric forms of amyloid ß (Ab) after it is produced. LY2062430 is being studied for its potential to slow the progression of Alzheimer's disease.

Tanezumab

cancer pain

  • Pain
  • Large Molecule
  • Commercial Collaboration
  • New Indication

Tanezumab

(ta nez' oo mab)

Tanezumab, a large molecule, is a humanized monoclonal antibody that inhibits nerve growth factor. Tanezumab is being studied in collaboration with Pfizer for the treatment of cancer pain.

Tanezumab

chronic lower back pain

  • Pain
  • Large Molecule
  • Commercial Collaboration
  • New Indication

Tanezumab

(ta nez' oo mab)

Tanezumab, a large molecule, is a humanized monoclonal antibody that inhibits nerve growth factor. Tanezumab is being studied in collaboration with Pfizer for the treatment of chronic lower back pain.

News (January 1, 2010 - October 30, 2018)

Tanezumab

osteoarthitic pain

  • Pain
  • Large Molecule
  • Commercial Collaboration
  • NME

Tanezumab

(ta nez' oo mab)

Tanezumab, a large molecule, is a humanized monoclonal antibody that inhibits nerve growth factor. Tanezumab is being studied in collaboration with Pfizer for the treatment of multiple pain indications including osteoarthritis pain.

Ultra-Rapid Lispro

diabetes

  • Diabetes
  • Large Molecule
  • NME

Ultra-Rapid Lispro

LY900014 (ultra-rapid lispro) is a novel formulation containing locally-acting excipients to accelerate insulin lispro absorption. LY900014 is a large molecule being studied for the treatment of type 1 and type 2 diabetes

Abemaciclib

adjuvant breast cancer

  • Oncology
  • Small Molecule
  • New Indication

Baricitinib

atopic dermatitis

  • Immunology
  • Small Molecule
  • New Indication

Baricitinib

systemic lupus erythematosus

  • Immunology
  • Small Molecule
  • Milestone Achieved
  • New Indication

Dulaglutide 3.0 / 4.5 mg

diabetes

  • Diabetes
  • Large Molecule
  • New Formulation

Empagliflozin

heart failure

  • Diabetes
  • Small Molecule
  • New Indication

Empagliflozin

type 1 diabetes

  • Diabetes
  • Small Molecule
  • New Indication

Flortaucipir F 18

  • Neurodegeneration
  • Small Molecule
  • New Diagnostic

Galcanezumab

cluster headache

  • Pain
  • Large Molecule
  • New Indication

Ixekizumab

non-radiographic axial spondyloarthritis

  • Immunology
  • Large Molecule
  • New Indication

Mirikizumab

psoriasis

  • Immunology
  • Large Molecule
  • NME

Mirikizumab

ulcerative colitis

  • Immunology
  • Large Molecule
  • New Indication

Pegilodecakin

pancreatic cancer

  • Oncology
  • Large Molecule
  • NME

Ramucirumab

NSCLC

  • Oncology
  • Large Molecule
  • New Indication

Solanezumab

preclinical Alzheimer’s

  • Neurodegeneration
  • Large Molecule
  • NME

Tanezumab

cancer pain

  • Pain
  • Large Molecule
  • New Indication

Tanezumab

chronic lower back pain

  • Pain
  • Large Molecule
  • New Indication

Tanezumab

osteoarthitic pain

  • Pain
  • Large Molecule
  • NME

Ultra-Rapid Lispro

diabetes

  • Diabetes
  • Large Molecule
  • NME

Phase 2

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Abemaciclib

HR+/HER2+ metastatic breast cancer

  • Oncology
  • Small Molecule
  • New Indication

Abemaciclib

(a be muh sī klib)

LY2835219 (abemaciclib), a small molecule, is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 that inhibits phosphorylation of the Rb tumor suppressor protein and thereby induces G1 cell cycle arrest. LY2835219 is being studied for the treatment of hormone receptor positive and HER2 positive metastatic breast cancer.

Baricitinib

alopecia areata

Milestone Achieved

  • Immunology
  • Small Molecule
  • New Indication

Baricitinib

LY3009104 (baricitinib, formerly known as JAK1/JAK2 Inhibitor) is a small molecule that inhibits the activity of the Janus (JAK) 1 and 2 enzymes. LY3009104 is being studied for the treatment of alopecia areata.

BTK Inhibitor

immunology

  • Immunology
  • Small Molecule
  • NME

BTK Inhibitor

LY3337641 (BTK Inhibitor) is a small molecule that inhibits the Bruton's tyrosine kinase. LY3337641 is being studied for the treatment of immune disorders.

D1 PAM

dementia

  • Neurodegeneration
  • Small Molecule
  • NME

D1 PAM

LY3154207 (D1 PAM) is a small molecule that acts as a positive allosteric modulator of the dopamine receptor D1 and is being studied for the treatment of dementia associated with Parkinson's disease.

Dual Amylin Calcitonin Receptor Agonist

diabetes

  • Diabetes
  • Large Molecule
  • NME

Dual Amylin Calcitonin Receptor Agonist

DACRA-042 is a large molecule that acts as a dual agonist of both the amylin receptor and calcitonin receptor and is being studied for the treatment of diabetes.

Merestinib

cancer

  • Oncology
  • Small Molecule
  • NME

Merestinib

(mer es’ ti nib)

LY2801653 (formerly known as c-Met Inhibitor) is a small molecule that has been shown in vitro to be a reversible type II ATP-competitive inhibitor of MET, a receptor for hepatocyte growth factor. Preclinical testing also has shown LY2801653 to inhibit several other receptor tyrosine oncokinases including MST1R, FLT3, AXL, MERTK, TEK, ROS1, and DDR1/2 and the serine/threonine kinases MKNK1/2. LY2801653 is being studied for the treatment of cancer.

Mirikizumab

Crohn's disease

  • Immunology
  • Large Molecule
  • New Indication

Mirikizumab

(mir” i kiz’ ue mab)

LY3074828 (formerly known as IL-23 antibody) is a large molecule that blocks the activity of the cytokine interleukin 23. LY3074828 is being studied for the treatment of Crohn's disease.

N3pG-Aß Monoclonal Antibody

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

N3pG-Aß Monoclonal Antibody

LY3002813 (N3pG-Ab MAb) is a large molecule that binds to deposited amyloid plaque in brain and is being studied for the treatment of Alzheimer's disease.

Olaratumab

pancreatic cancer

Milestone Achieved

  • Oncology
  • Large Molecule
  • New Indication

Olaratumab

LY3012207 (olaratumab), a large molecule, is a human IgG1 monoclonal antibody that binds to the platelet derived growth factor receptor alpha (PDGFRα) and blocks PDGFRα activation. LY3012207 is being studied for the treatment of pancreatic cancer.

Pegilodecakin

NSCLC

  • Oncology
  • Large Molecule
  • New Indication

Pegilodecakin

LY3500518 (pegilodecakin), a large molecule, is a PEGylated IL-10 designed to activate and enhance anti-tumor immune response in cancer patients. LY3500518 is being studied for the treatment of NSCLC.

PI3 Kinase/mTOR Dual Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

PI3 Kinase/mTOR Dual Inhibitor

LY3023414 (PI3 Kinase/mTOR dual Inhibitor) is a small molecule being studied for development in combinations for the treatment of cancer.

Prexasertib

cancer

  • Oncology
  • Small Molecule
  • NME

Prexasertib

(prex” a ser’ tib)

LY2606368 monomesylate monohydrate (formerly known as Chk1 Inhibitor) is a small molecule that preferentially binds to and inhibits checkpoint kinase 1 (Chk1), a global regulator of the mammalian cell cycle and, to a lesser extent, inhibits Chk2. LY2606368 monomesylate monohydrate is being studied for the treatment of cancer.

Tau Deposit Monoclonal Antibody

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

Tau Deposit Monoclonal Antibody

LY3303560 "Tau Deposit Antibody" is a large molecule that binds selectively to tau protein in the brain and is being studied for the treatment of Alzheimer's disease.

TGFß R1 Kinase Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

TGFß R1 Kinase Inhibitor

LY3200882 (TGFß Receptor 1 Kinase Inhibitor) is a small molecule that inhibits the kinase activity of the TGFß receptor 1. LY3200882 is being studied for the treatment of cancer.

Tirzepatide

diabetes

  • Diabetes
  • Large Molecule
  • NME

Tirzepatide

LY3298176 (Dual GIP/GLP-1 Receptor Agonist) is a large molecule that acts as a coagonist for both the gastric inhibitory polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor and is being studied for the treatment of diabetes.

Abemaciclib

HR+/HER2+ metastatic breast cancer

  • Oncology
  • Small Molecule
  • New Indication

Baricitinib

alopecia areata

  • Immunology
  • Small Molecule
  • Milestone Achieved
  • New Indication

BTK Inhibitor

immunology

  • Immunology
  • Small Molecule
  • NME

D1 PAM

dementia

  • Neurodegeneration
  • Small Molecule
  • NME

Dual Amylin Calcitonin Receptor Agonist

diabetes

  • Diabetes
  • Large Molecule
  • NME

Merestinib

cancer

  • Oncology
  • Small Molecule
  • NME

Mirikizumab

Crohn's disease

  • Immunology
  • Large Molecule
  • New Indication

N3pG-Aß Monoclonal Antibody

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

Olaratumab

pancreatic cancer

  • Oncology
  • Large Molecule
  • Milestone Achieved
  • New Indication

Pegilodecakin

NSCLC

  • Oncology
  • Large Molecule
  • New Indication

PI3 Kinase/mTOR Dual Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

Prexasertib

cancer

  • Oncology
  • Small Molecule
  • NME

Tau Deposit Monoclonal Antibody

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

TGFß R1 Kinase Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

Tirzepatide

diabetes

  • Diabetes
  • Large Molecule
  • NME

Phase 1

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Aß42 Antibody

Alzheimer’s

  • Neurodegeneration
  • Large Molecule
  • NME

Aß42 Antibody

"Aß42 Antibody" is a large molecule being studied for the treatment of Alzheimer's disease.

Aur A Kinase Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

Aur A Kinase Inhibitor

"Aurora A kinase Inhibitor" is a small molecule being studied for the treatment of cancer.

Automated Insulin Delivery System (AID)

diabetes

  • Diabetes
  • NME

Automated Insulin Delivery System (AID)

"AID" is an automated insulin delivery system being studied for the treatment of diabetes.

BAFF/IL-17 Bispecific Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

BAFF/IL-17 Bispecific Antibody

"BAFF/IL-17 Bispecific Antibody" is a large molecule being studied for the treatment of autoimmune diseases.

Basal Insulin-Fc

diabetes

  • Diabetes
  • Large Molecule
  • NME

Basal Insulin-Fc

"Basal Insulin-Fc" is a large molecule being studied for the treatment of diabetes.

CXCR1/2 Ligands Monoclonal Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

CXCR1/2 Ligands Monoclonal Antibody

"CXCR1/2 Ligands Monoclonal Antibody" is a large molecule being studied for the treatment of autoimmune diseases.

Dual Amylin Calcitonin Receptor Agonist

diabetes

  • Diabetes
  • Large Molecule
  • NME

Dual Amylin Calcitonin Receptor Agonist

"DACRA-089" is a large molecule being studied for the treatment of diabetes.

ERK Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

ERK Inhibitor

"ERK Inhibitor" is a small molecule being studied for the treatment of cancer.

IDO1 Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

IDO1 Inhibitor

"IDO1 Inhibitor" is a small molecule being studied for the treatment of cancer.

IL-23/CGRP Bispecific Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

IL-23/CGRP Bispecific Antibody

"IL-23/CGRP Bispecific Antibody" is a large molecule being studied for the treatment of autoimmune diseases.

IL-2 Conjugate

immunology

  • Immunology
  • Large Molecule
  • NME

IL-2 Conjugate

"IL-2 Conjugate" is a large molecule being studied for the treatment of autoimmune diseases.

IL-33 Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

IL-33 Antibody

"IL-33 Antibody" is a large molecule being studied for the treatment of autoimmune diseases.

Oxyntomodulin

diabetes

  • Diabetes
  • Large Molecule
  • NME

Oxyntomodulin

"Oxyntomodulin" is a large molecule being studied for the treatment of diabetes.

PD-L1 Monoclonal Antibody + LY Combo

cancer

  • Oncology
  • Large Molecule
  • NME

PD-L1 Monoclonal Antibody + LY Combo

"PD-L1 Monoclonal Antibody + LY Combo" is a large molecule being studied for development in combination for the treatment of cancer.

TIM-3 Monoclonal Antibody

cancer

  • Oncology
  • Large Molecule
  • NME

TIM-3 Monoclonal Antibody

"TIM-3 Monoclonal Antibody" is a large molecule being studied for the treatment of cancer.

Urocortin-2 Peptide Agonist Long Acting

heart failure

Milestone Achieved

  • Diabetes
  • Large Molecule
  • NME

Urocortin-2 Peptide Agonist Long Acting

"Urocortin-2 Peptide Agonist Long Acting" is a large molecule being studied for the treatment of heart failure.

Aß42 Antibody

Alzheimer’s

  • Neurodegeneration
  • Large Molecule
  • NME

Aur A Kinase Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

Automated Insulin Delivery System (AID)

diabetes

  • Diabetes
  • NME

BAFF/IL-17 Bispecific Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

Basal Insulin-Fc

diabetes

  • Diabetes
  • Large Molecule
  • NME

CXCR1/2 Ligands Monoclonal Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

Dual Amylin Calcitonin Receptor Agonist

diabetes

  • Diabetes
  • Large Molecule
  • NME

ERK Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

IDO1 Inhibitor

cancer

  • Oncology
  • Small Molecule
  • NME

IL-23/CGRP Bispecific Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

IL-2 Conjugate

immunology

  • Immunology
  • Large Molecule
  • NME

IL-33 Antibody

immunology

  • Immunology
  • Large Molecule
  • NME

Oxyntomodulin

diabetes

  • Diabetes
  • Large Molecule
  • NME

PD-L1 Monoclonal Antibody + LY Combo

cancer

  • Oncology
  • Large Molecule
  • NME

TIM-3 Monoclonal Antibody

cancer

  • Oncology
  • Large Molecule
  • NME

Urocortin-2 Peptide Agonist Long Acting

heart failure

  • Diabetes
  • Large Molecule
  • Milestone Achieved
  • NME

Pipeline Disclaimer

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 October 30, 2018. Lilly assumes no duty to update this information.

For competitive reasons, some pipeline molecules are not identified; in those instances, only the therapeutic area in which the molecule is being studied is listed.

Property of Eli Lilly and Company.

FREQUENTLY ASKED QUESTIONS

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.

  • Abbreviations & Icons

    β: beta

    NME: new molecular entity

    NILEX: new indication or line extension

      regulatory approval achieved

      milestone achieved

      new to pipeline

  • 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?

    Molecules are grouped by therapeutic area and molecule type (NME or NILEX), but there is no other significance to a molecule’s placement within a phase.

  • What is the significance of the indications listed for each molecule?

    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.

  • Why are some molecules not identified and simply referred to by therapeutic area (e.g., diabetes)?

    For competitive reasons, some pipeline molecules are not identified; in those instances, only the therapeutic area in which the molecule is being studied is listed.

  • How does Lilly determine when a molecule enters a particular phase of clinical development?

    • 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.
  • How does Lilly define First Human Dose?

    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.

  • How does Lilly define First Efficacy Dose?

    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.

  • How does Lilly define First Registration Dose?

    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.

  • How does Lilly define First Submission?

    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).

  • Which molecules include links to press releases and what are the criteria for press release inclusion?

    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.

  • Why are some molecules listed on the pipeline website in Phase 2 clinical development, but noted as Phase 1 on ClinicalTrials.gov?

    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.

  • Why are some molecules in the pipeline followed by a 1 or 2?

    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.

  • What is a commercial collaboration?

    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.

  • What is the difference between a small and large molecule?

    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.