CLINICAL DEVELOPMENT PIPELINE
Regulatory Review
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GalcanezumabLY2951742, (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 both chronic and episodic migraine.
For more information on galcanezumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
IHC 2017: Lilly's Galcanezumab Demonstrates Positive Long-Term Safety Results for up to 12 Months in Patients with Migraine – September 8, 2017
Lilly's Galcanezumab Significantly Reduces Number Of Migraine Headache Days For Patients With Migraine: New Results Presented At AHS – June 10, 2017
Lilly to Present Late-Breaking Data for Galcanezumab and Lasmiditan at the American Headache Society Annual Scientific Meeting – June 8, 2017
Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine – May 12, 2017
Lilly to Present Data for Galcanezumab for the Prevention of Migraine at the American Academy of Neurology (AAN) Annual Meeting - April 20, 2017 -
Abemaciclib (a be muh sī klib)LY2835219 (abemaciclib), a chemical entity, 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 metastatic breast cancer.
For more information on abemaciclib clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio™ (abemaciclib) as Initial Treatment of Advanced Breast Cancer – October 12, 2017
Lilly MONARCH 3 Study Published In Journal Of Clinical Oncology Demonstrates Benefit Of Verzenio™ (Abemaciclib) Plus NSAI In Advanced Breast Cancer – October 6, 2017
Lilly Receives U.S. FDA Approval of Verzenio™ (abemaciclib) – October 4, 2017
FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer – July 10, 2017
Lilly Builds Upon Body of Data for Abemaciclib with Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival in Advanced Breast Cancer - June 3, 2017
Lilly to Present Results from Pivotal Breast Cancer Study of Abemaciclib and New Portfolio Data at ASCO 2017 – May 17, 2017
Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study of Abemaciclib Demonstrated Superior Progression-Free Survival at Interim Analysis – April 24, 2017
Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study of Abemaciclib Met Primary Endpoint of Progression-Free Survival—March 20, 2017
Lilly Provides Update On MONARCH 2 Phase 3 Trial Of Abemaciclib—August 10, 2016
Lilly And Boehringer Ingelheim Announce Clinical Trial Collaboration In Metastatic Breast Cancer—July 13, 2016
Lilly Announces Results From MONARCH 1 Trial Of Abemaciclib Monotherapy—June 3, 2016
Lilly Announces Webcast To Discuss Abemaciclib Data—May 31, 2016
ASCO Data Underscore Lilly's Diverse Oncology Pipeline And Portfolio—May 18, 2016
Lilly Receives FDA Breakthrough Therapy Designation For Abemaciclib - A CDK 4 And 6 Inhibitor - In Advanced Breast Cancer—October 8, 2015
Lilly Releases Early-Stage Pipeline Data At AACR Annual Meeting 2015—April 20, 2015
Phase 3
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Nasal GlucagonNasal glucagon is a biologic entity being studied for the treatment of severe hypoglycemia in people with diabetes treated with insulin.
For more information on nasal glucagon clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
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Ultra Rapid InsulinLY900014 (LY) 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
For more information on LY900014 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
None during this time period.
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Lanabecestat (lan” a bes’ e stat)LY3314814 (formerly known as BACE - AZD3293), a chemical entity, is an oral beta secretase cleaving enzyme (BACE) inhibitor. LY3314814 is being studied for the treatment of Alzheimer's disease.
For more information on BACE - AZD3293 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
Lilly And AstraZeneca Receive FDA Fast Track Designation For AZD3293, An Investigational Treatment For Early Alzheimer's Disease—August 22, 2016
Diversity Of Lilly's Alzheimer's Disease Pipeline Showcased At The Alzheimer's Association International Conference® 2016 (AAIC® 2016)—July 21, 2016
Eli Lilly And Company And AstraZeneca Announce Continuation Of Pivotal Clinical Trial For People With Early Alzheimer's Disease—April 8, 2016 -
LasmiditanLY573144 (Lasmiditan), a chemical entity, is an oral 5-HT1F receptor agonist. LY573144 is being studied for the acute treatment of migraine.
For more information on LY573144 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
IHC 2017: Lilly's Lasmiditan Significantly Reduces Pain in Patients with Migraine – September 9, 2017
Lilly Announces Positive Results for Second Phase 3 Study of Lasmiditan for the Acute Treatment of Migraine – August 4, 2017
Lilly to Present Late-Breaking Data for Galcanezumab and Lasmiditan at the American Headache Society Annual Scientific Meeting – June 8, 2017 -
Solanezumab (soe" la nez' ue mab)LY2062430 (solanezumab) is a biologic entity 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.
For more information on solanezumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
None during this time period.
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Tanezumab (ta nez' oo mab)Tanezumab, a biologic entity, 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.
For more information on tanezumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab – June 13, 2017
Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab – March 23, 2015 -
Ixekizumab
axial spondyloarthritisLY2439821 (ixekizumab) is a biologic entity that neutralizes a soluble factor called interleukin-17A (IL-17). LY2439821 is being studied for the treatment of axial spondyloarthritis.
For more information on ixekizumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
None during this time period.
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Tanezumab (ta nez' oo mab)Tanezumab, a biologic entity, is a humanized monoclonal antibody that inhibits nerve growth factor. Tanezumab is being studied in collaboration with Pfizer for the treatment of cancer pain.
For more information on tanezumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
None during this time period. -
Tanezumab (ta nez' oo mab)Tanezumab, a biologic entity, 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.
For more information on tanezumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
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EmpagliflozinBI10773 (Empagliflozin) is a chemical entity 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.
For more information on BI10773 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010 - 10/17/2017)
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EmpagliflozinBI10773 (Empagliflozin) is a chemical entity 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.
For more information on BI10773 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
None during this time period.
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GalcanezumabLY2951742, (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.
For more information on galcanezumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
None during this time period.
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Abemaciclib (a be muh sī klib)LY2835219 (abemaciclib), a chemical entity, 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.
For more information on abemaciclib clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
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Abemaciclib (a be muh sī klib)LY2835219 (abemaciclib), a chemical entity, 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 KRAS mutant non small cell lung cancer.
For more information on abemaciclib clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio™ (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer – October 10, 2017
Lilly Releases Early-Stage Pipeline Data At AACR Annual Meeting 2015—April 20, 2015
Abemaciclib - Lilly's Oral CDK 4/6 Inhibitor - Shows Single-Agent Activity In A Phase I Study For Patients With A Specific Type Of Lung Cancer – May 12, 2014 -
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 second-line bladder cancer.
For more information on ramucirumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
Lilly Builds Upon Body of Clinical Evidence for CYRAMZA® (ramucirumab) with Phase 3 RANGE Data Demonstrating Superior Progression-Free Survival in Advanced or Metastatic Urothelial Cancer – September 10, 2017
Lilly Announces Phase 3 RANGE Urothelial Cancer Trial of CYRAMZA® (ramucirumab) Met Primary Endpoint, Improving Progression-Free Survival – May 31, 2017 -
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 first-line gastric cancer.
For more information on ramucirumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
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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.
For more information on ramucirumab clinical studies, click here
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
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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 first-line, EGFR positive NSCLC.
For more information on ramucirumab clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
Rapidly Progressing Advanced Non-Small Cell Lung Cancer Patients Shown to Benefit in New CYRAMZA® (ramucirumab) Phase 3 Subgroup Analysis – October 16, 2017
Early-Phase Immuno-Oncology Studies of Lilly's ALIMTA® (pemetrexed) and CYRAMZA® (ramucirumab) with Merck's KEYTRUDA® (pembrolizumab) Show Encouraging Results in Non-Small Cell Lung Cancer—June 5, 2016
ASCO Data Underscore Lilly's Diverse Oncology Pipeline And Portfolio—May 18, 2016
Lilly To Present CYRAMZA® (Ramucirumab) Data At 2015 ASCO Annual Meeting—May 28, 2015
Lilly, Merck Enter Collaboration Agreement To Research Immuno-Oncology Combination Regimens In Multiple Types Of Cancer—January 13, 2015 -
Flortaucipir F 18 (flor tau’ si pir)Flortaucipir F 18 (formerly known as 18F-AV-1451 or Tau imaging agent) is a chemical entity PET imaging agent being studied for the imaging of Tau pathology.
For more information on Flortaucipir F 18 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
PRESS RELEASES (1/1/2010-10/17/2017)
New Studies Suggest Relationship Between Tau Pathology And Progression Of Alzheimer's Disease—July 27, 2016
Lilly To Showcase Data From Its Alzheimer's Disease Portfolio At The Alzheimer's Association International Conference 2014 (AAIC 2014)—July 8, 2014
Phase 2
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BTK Inhibitor
immunologyLY3337641 (BTK inhibitor) is a new chemical entity that inhibits the Bruton's tyrosine kinase. LY3337641 is being studied for the treatment of rheumatoid arthritis.
For more information on LY3337641 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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MirikizumabLY3074828 (formerly known as IL-23 antibody) is a biologic entity that blocks the activity of the cytokine interleukin 23. LY3074828 is being studied for the treatment of immune diseases including ulcerative colitis and psoriasis.
For more information on LY3074828 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Dual Amylin Calcitonin Receptor AgonistDACRA-042 is a new biologic entity that acts as a dual agonist of both the amylin receptor and calcitonin receptor and is being studied for the treatment of diabetes.
For more information on DACRA-042 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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GIP/GLP-1 Co-Agonist PeptideLY3298176 (GIP/GLP-1 Co-agonist Peptide) is a new biologic entity 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.
For more information on LY3298176 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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BACE InhibitorLY3202626 (BACE Inhibitor), a chemical entity, is an oral beta secretase cleaving enzyme (BACE) inhibitor. LY3202626 is being studied for the treatment of Alzheimer's disease.
For more information on LY3202626 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Merestinib cancer (mer es’ ti nib)LY2801653 (formerly known as c-Met inhibitor) is a chemical entity 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.
For more information on LY2801653 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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PI3 Kinase/mTOR Dual InhibitorLY3023414 (PI3 Kinase/mTOR dual Inhibitor) is a chemical entity being studied for development in combinations for the treatment of cancer.
For more information on LY3023414 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Prexasertib (prex” a ser’ tib)LY2606368 monomesylate monohydrate (formerly known as Chk1 inhibitor) is a chemical entity 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.
For more information on LY2606368 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Baricitinib
systemic lupus erythematosusLY3009104 (baricitinib, formerly known as JAK1/JAK2 Inhibitor) is a chemical entity that inhibits the activity of the Janus (JAK) 1 and 2 enzymes. LY3009104 is being studied for the treatment of systemic lupus erythematosus.
For more information on LY3009104 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Baricitinib
atopic dermatitisLY3009104 (baricitinib, formerly known as JAK1/JAK2 Inhibitor) is a chemical entity that inhibits the activity of the Janus (JAK) 1 and 2 enzymes. LY3009104 is being studied for the treatment of atopic dermatitis.
For more information on LY3009104 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Dulaglutide Investigational DosesLY2189265 (dulaglutide), a glucagon-like peptide-1 analog, is a biologic entity being studied at investigational doses as a once-weekly treatment for type 2 diabetes.
For more information on LY2189265 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Abemaciclib (a be muh sī klib)LY2835219 (abemaciclib), a chemical entity, 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 pancreatic cancer.
For more information on LY2835219 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
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Abemaciclib (a be muh sī klib)LY2835219 (abemaciclib), a chemical entity, 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 squamous NSCLC.
For more information on LY2835219 clinical studies, click here.
NOTE: If you click on the link above it will take you to a site maintained by a third party, which is solely responsible for its content.
Phase 1
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, delayed or 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 17, 2017. 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.
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