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    [{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eli Lilly's Mirikizumab Shows Improved Symptom and Reduces Intestinal Inflammation in Patients with Crohn's Disease in 52-Week Phase 2 Trial","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mirikizumab Improves Fatigue in Patients with Crohn's Disease in Phase 2 Trial","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"D. E. Shaw Research","pharmaFlowCategory":"D","amount":"$535.0 million","upfrontCash":"$60.0 million","newsHeadline":"D. E. Shaw Research Licenses First-in-Class Therapeutic for Immunological Diseases to Lilly","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase I"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lilly's Mirikizumab Helped Patients with Crohn's Disease Achieve Long-Term Remission in Phase 3 Trial","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Lilly's Omvoh\u2122 (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"}]

    Find Gastroenterology Clinical Drug Pipeline Developments & Deals by Eli Lilly

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              Eli Lilly

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              FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

              Details:

              Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

              Lead Product(s): Mirikizumab-mrkz

              Therapeutic Area: Gastroenterology Product Name: Omvoh

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 26, 2023

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              Eli Lilly

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              Lilly's Mirikizumab Helped Patients with Crohn's Disease Achieve Long-Term Remission in Phase 3 Trial

              Details:

              Mirikizumab is an interleukin-23p19 antagonist that is currently indicated for active ulcerative colitis in Japan, Germany, the United Kingdom and Canada and is being developed for the treatment of adults with moderately to severely active Crohn's disease.

              Lead Product(s): Mirikizumab

              Therapeutic Area: Gastroenterology Product Name: LY3074828

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 12, 2023

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              Eli Lilly

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              U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab

              Details:

              LY3074828 (mirikizumab) is a humanized IgG4 mAb that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for psoriasis, ulcerative colitis and crohn's disease. U.S. FDA has issued complete response letter for mirikizumab.

              Lead Product(s): Mirikizumab

              Therapeutic Area: Gastroenterology Product Name: LY3074828

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 13, 2023

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              Eli Lilly

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              D. E. Shaw Research Licenses First-in-Class Therapeutic for Immunological Diseases to Lilly

              Details:

              DES-7114, is an orally administered, highly selective small-molecule inhibitor of the ion channel protein Kv1.3. It has recently completed Phase 1 clinical trials in healthy volunteers and has demonstrated efficacy in preclinical models of inflammatory and autoimmune diseases.

              Lead Product(s): DES-7114

              Therapeutic Area: Gastroenterology Product Name: DES-7114

              Highest Development Status: Phase I Product Type: Small molecule

              Recipient: D. E. Shaw Research

              Deal Size: $535.0 million Upfront Cash: $60.0 million

              Deal Type: Licensing Agreement June 13, 2022

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              Eli Lilly

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              Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study

              Details:

              Mirikizumab (LY3074828) is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune-mediated diseases, including ulcerative colitis and Crohn's disease.

              Lead Product(s): Mirikizumab

              Therapeutic Area: Gastroenterology Product Name: LY3074828

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 24, 2022

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              Eli Lilly

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              Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022

              Details:

              In the placebo-controlled maintenance cohort, the frequency of serious adverse events among patients treated with mirikizumab was numerically lower compared to placebo, and the overall safety profile was consistent with that of the previous mirikizumab studies in UC.

              Lead Product(s): Mirikizumab

              Therapeutic Area: Gastroenterology Product Name: LY3074828

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 14, 2021

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              Eli Lilly

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              Mirikizumab Improves Fatigue in Patients with Crohn's Disease in Phase 2 Trial

              Details:

              Mirikizumab is being studied for UC and CD, two forms of inflammatory bowel disease that can cause serious and debilitating symptoms, and disruptions in daily life.

              Lead Product(s): Mirikizumab

              Therapeutic Area: Gastroenterology Product Name: LY3074828

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 22, 2021

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              Eli Lilly's Mirikizumab Shows Improved Symptom and Reduces Intestinal Inflammation in Patients with Crohn's Disease in 52-Week Phase 2 Trial

              Details:

              Results from the 52-week study showed continued symptom improvement and reduction of intestinal mucosal inflammation in patients with moderately to severely active Crohn's disease after treatment with mirikizumab.

              Lead Product(s): Mirikizumab

              Therapeutic Area: Gastroenterology Product Name: LY3074828

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 12, 2020

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