Medicines in Development

MOLECULE & POTENTIAL INDICATION DATA AS OF July 29, 2019

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Regulatory Approval Achieved

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Galcanezumab

Cluster Headache

Milestone Achieved

  • Pain
  • Large Molecule
  • New Indication

Galcanezumab

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

Nasal Glucagon

Hypoglycemia

Milestone Achieved

  • 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 - July 29, 2019)

Ramucirumab

Hepatocellular Cancer

Milestone Achieved

  • Oncology
  • Large Molecule
  • New Indication

Ramucirumab

(ra" mue sir' ue mab)

LY3009806 (ramucirumab), a biologic entity, 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.

Galcanezumab

Cluster Headache

  • Pain
  • Large Molecule
  • Milestone Achieved
  • New Indication

Nasal Glucagon

Hypoglycemia

  • Diabetes
  • Large Molecule
  • Milestone Achieved
  • NME

Ramucirumab

Hepatocellular Cancer

  • Oncology
  • Large Molecule
  • Milestone Achieved
  • New Indication

Regulatory Review

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Connected Care Pre-Filled Insulin Pen

Diabetes

  • Diabetes
  • New Formulation

Connected Care Pre-Filled Insulin Pen

This prefilled insulin pen is part of the integrated insulin management system, which includes a Bluetooth-enabled pen attachment and mobile medical application

Dulaglutide REWIND

  • Diabetes
  • Large Molecule
  • New Indication

Dulaglutide REWIND

LY2189265 (dulaglutide), a glucagon-like peptide-1 analog, is a biologic entity being studied for the reduction of cardiovascular events in adults with type 2 diabetes.

Empagliflozin

Type 1 Diabetes

Milestone Achieved

  • 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.

Empagliflozin + Linagliptin + Met XR diabetes

  • Diabetes
  • Commercial Collaboration
  • New Formulation

Empagliflozin + Linagliptin + Met XR diabetes

"Empa + Lina + Met XR" is a fixed dose combination of Empagliflozin, a sodium glucose co-transporter-2 inhibitor and Linagliptin, a dipeptidyl peptidase 4 inhibitor with metformin-extended release. It is being studied as a treatment for type 2 diabetes in collaboration with Boehringer Ingelheim.

Ixekizumab

Radiographic Axial Spondyloarthritis

  • Immunology
  • Large Molecule
  • New Indication

Lasmiditan

Migraine

  • Pain
  • Small Molecule
  • NME

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 biologic entity being studied for the treatment of type 1 and type 2 diabetes.

Connected Care Pre-Filled Insulin Pen

Diabetes

  • Diabetes
  • New Formulation

Dulaglutide REWIND

  • Diabetes
  • Large Molecule
  • New Indication

Empagliflozin

Type 1 Diabetes

  • Diabetes
  • Small Molecule
  • Milestone Achieved
  • New Indication

Empagliflozin + Linagliptin + Met XR diabetes

  • Diabetes
  • New Formulation

Ixekizumab

Radiographic Axial Spondyloarthritis

  • Immunology
  • Large Molecule
  • New Indication

Lasmiditan

Migraine

  • Pain
  • Small Molecule
  • NME

Ultra-Rapid Lispro

Diabetes

  • Diabetes
  • Large Molecule
  • NME

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

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.

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

  • 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

Chronic Kidney Disease

  • 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 kidney disease.

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 - July 29, 2019)

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.

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 ? (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 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 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 - July 29, 2019)

Tanezumab

Osteoarthitic Pain

  • Pain
  • Large Molecule
  • Commercial Collaboration
  • NME

Tanezumab

(ta nez' oo mab)

Tanezumab, a large molecule, is a 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.

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

Adjuvant Breast Cancer

  • Oncology
  • Small Molecule
  • New Indication

Baricitinib

Alopecia Areata

  • Immunology
  • Small Molecule
  • Milestone Achieved
  • New Indication

Baricitinib

Atopic Dermatitis

  • Immunology
  • Small Molecule
  • New Indication

Baricitinib

Systemic Lupus Erythematosus

  • Immunology
  • Small Molecule
  • New Indication

Dulaglutide 3.0 / 4.5 mg

Diabetes

  • Diabetes
  • Large Molecule
  • New Formulation

Empagliflozin

Chronic Kidney Disease

  • Diabetes
  • Small Molecule
  • New Indication

Empagliflozin

Heart Failure

  • Diabetes
  • Small Molecule
  • New Indication

Flortaucipir F 18

  • Neurodegeneration
  • Small Molecule
  • New Diagnostic

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

Tirzepatide

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.

Abemaciclib

Prostate Cancer

  • Oncology
  • Small Molecule
  • New Indication

Abemaciclib

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 prostate 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.

Basal Insulin-Fc

Diabetes

  • Diabetes
  • Large Molecule
  • NME

Basal Insulin-Fc

LY3209590 "Basal insulin-Fc" is a large molecule comprised of an engineered insulin fused to an Fc domain designed to provide a long-acting basal profile. LY3209590 is being studied for the treatment of diabetes.

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.

Donanemab Alzheimer's

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

Donanemab Alzheimer's

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

IL-33 Antibody Atopic Dermatitis

Autoimmunity

  • Immunology
  • Large Molecule
  • NME

IL-33 Antibody Atopic Dermatitis

Business area: Autoimmunity

LY3375880 "IL-33 Antibody" is a biologic entity that binds to interleukin 33 and is being studied for the treatment of atopic dermatitis.

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.

Olaratumab

Pancreatic Cancer

  • 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.

RET Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

RET Inhibitor

"RET Inhibitor" is a small molecule that inhibits the rearranged during transfection (RET) kinase. It is being studied across multiple tumor types.

TGFß R1 Kinase Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

TGFß R1 Kinase Inhibitor

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

Zagotenemab Alzheimer's

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

Zagotenemab Alzheimer's

Business area: Neuroscience

LY3303560 (Tau Deposit Antibody) is a biologic entity that binds selectively to tau protein deposits in the brain and is being studied for the treatment of Alzheimer's disease.

Abemaciclib

HR+/HER2+ Metastatic Breast Cancer

  • Oncology
  • Small Molecule
  • New Indication

Abemaciclib

Prostate Cancer

  • Oncology
  • Small Molecule
  • New Indication

Automated Insulin Delivery System (AID)

Diabetes

  • Diabetes
  • NME

Basal Insulin-Fc

Diabetes

  • Diabetes
  • Large Molecule
  • NME

D1 PAM

Dementia

  • Neurodegeneration
  • Small Molecule
  • NME

Donanemab Alzheimer's

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

IL-33 Antibody Atopic Dermatitis

Autoimmunity

  • Immunology
  • Large Molecule
  • NME

Mirikizumab

Crohn's Disease

  • Immunology
  • Large Molecule
  • New Indication

Olaratumab

Pancreatic Cancer

  • Oncology
  • Large Molecule
  • New Indication

Pegilodecakin

NSCLC

  • Oncology
  • Large Molecule
  • New Indication

RET Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

TGFß R1 Kinase Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

Zagotenemab Alzheimer's

Alzheimer's

  • Neurodegeneration
  • Large Molecule
  • NME

Phase 1

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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.

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 Acylated

Diabetes

  • Diabetes
  • Large Molecule
  • NME

Basal Insulin Acylated

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

BTK Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

BTK Inhibitor

"BTK inhibitor" is a small molecule being studied for the treatment of cancer.

BTLA Antibody Agonist

Immunology

  • Immunology
  • Large Molecule
  • NME

BTLA Antibody Agonist

"BTLA Agonist Antibody" is a biologic entity being studied for the treatment of autoimmune diseases.

cancer

Oncology

  • Oncology
  • NME

cancer

A chemical entity being studied for the treatment of cancer.

CD200R Antibody Agonist

Immunology

  • Immunology
  • Large Molecule
  • NME

CD200R Antibody Agonist

"CD200R Antibody Agonist" is a large molecule being studied for the treatment of autoimmune diseases.

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.

GDF15 Agonist

Diabetes

  • Diabetes
  • Large Molecule
  • NME

GDF15 Agonist

"GDF15 Agonist" is a large molecule being studied for the treatment of diabetes.

GGG Tri-Agonist Diabetes

Diabetes

  • Diabetes
  • Large Molecule
  • NME

GGG Tri-Agonist Diabetes

Business area: Diabetes

"GGG Tri-Agonist" is a biologic entity being studied for the treatment of diabetes.

GLP-1 Receptor NPA

Diabetes

Milestone Achieved

  • Diabetes
  • Small Molecule
  • NME

GLP-1 Receptor NPA

"GLP-1 Rec NPA" is a chemical entity being studied for the treatment of diabetes.

IDO1 Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

IDO1 Inhibitor

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

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.

O-GlcNAcase Inhibitor Alzheimer's

Neurodegeneration

  • Neurodegeneration
  • Small Molecule
  • NME

O-GlcNAcase Inhibitor Alzheimer's

Business area: Neuroscience

"O-GlcNAcase Inhibitor" is a chemical entity being studied for the treatment of Alzheimer's disease.

Oxyntomodulin

Diabetes

  • Diabetes
  • Large Molecule
  • NME

Oxyntomodulin

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

PACAP38 Antibody

Pain

  • Pain
  • Large Molecule
  • NME

PACAP38 Antibody

"PACAP38 Antibody" is a large molecule being studied for the treatment of pain.

PD-1 Antibody Agonist

Immunology

  • Immunology
  • Large Molecule
  • NME

PD-1 Antibody Agonist

"PD-1 Antibody Agonist" is a large molecule being studied for the treatment of autoimmune diseases.

PD-1/PD-L1 Bispecific Antibody

Cancer

Milestone Achieved

  • Oncology
  • Large Molecule
  • NME

PD-1/PD-L1 Bispecific Antibody

PD-1/PD-L1 Bispecific Antibody is a biologic entity being studied for the treatment of cancer.

SSTR4 Agonist

Pain

Milestone Achieved

  • Pain
  • Small Molecule
  • NME

SSTR4 Agonist

"SSTR4 Agonist" is a chemical entity being studied for the treatment of Pain.

Tau Morphomer

Alzheimer's

Milestone Achieved

  • Neurodegeneration
  • Small Molecule
  • NME

Tau Morphomer

"Tau Morphomer" is a chemical entity being studied for the treatment of Alzheimer's disease.

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.

TRPA1 Antagonist

Pain

Milestone Achieved

  • Pain
  • Small Molecule
  • NME

TRPA1 Antagonist

"TRPA1 Antagonist" is a chemical entity being studied for the treatment of pain.

Aur A Kinase Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

BAFF/IL-17 Bispecific Antibody

Immunology

  • Immunology
  • Large Molecule
  • NME

Basal Insulin Acylated

Diabetes

  • Diabetes
  • Large Molecule
  • NME

BTK Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

BTLA Antibody Agonist

Immunology

  • Immunology
  • Large Molecule
  • NME

cancer

Oncology

  • Oncology
  • NME

CD200R Antibody Agonist

Immunology

  • Immunology
  • 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

GDF15 Agonist

Diabetes

  • Diabetes
  • Large Molecule
  • NME

GGG Tri-Agonist Diabetes

Diabetes

  • Diabetes
  • Large Molecule
  • NME

GLP-1 Receptor NPA

Diabetes

  • Diabetes
  • Small Molecule
  • Milestone Achieved
  • NME

IDO1 Inhibitor

Cancer

  • Oncology
  • Small Molecule
  • NME

IL-2 Conjugate

Immunology

  • Immunology
  • Large Molecule
  • NME

O-GlcNAcase Inhibitor Alzheimer's

Neurodegeneration

  • Neurodegeneration
  • Small Molecule
  • NME

Oxyntomodulin

Diabetes

  • Diabetes
  • Large Molecule
  • NME

PACAP38 Antibody

Pain

  • Pain
  • Large Molecule
  • NME

PD-1 Antibody Agonist

Immunology

  • Immunology
  • Large Molecule
  • NME

PD-1/PD-L1 Bispecific Antibody

Cancer

  • Oncology
  • Large Molecule
  • Milestone Achieved
  • NME

SSTR4 Agonist

Pain

  • Pain
  • Small Molecule
  • Milestone Achieved
  • NME

Tau Morphomer

Alzheimer's

  • Neurodegeneration
  • Small Molecule
  • Milestone Achieved
  • NME

TIM-3 Monoclonal Antibody

Cancer

  • Oncology
  • Large Molecule
  • NME

TRPA1 Antagonist

Pain

  • Pain
  • Small 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 July 29, 2019. 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 listed in alphabetical order by phase in development.

  • 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.

  • When are molecules listed as “milestone achieved?”

    Molecules are listed as “milestone achieved” during the quarter after the milestone was achieved. For Q4 2018, milestone achievement occurred October 30, 2018-February 5, 2019.

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