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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Imeglimin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 24, 2020

            Details:

            Phase 3 TIMES 2 and TIMES 3 trial results demonstrate that Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.

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            Lead Product(s): Imeglimin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sumitomo Dainippon Pharma Co., Ltd

            Deal Size: $21.3 million Upfront Cash: Undisclosed

            Deal Type: Agreement July 30, 2020

            Details:

            Sumitomo Dainippon Pharma has submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.

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            Lead Product(s): Imeglimin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 20, 2020

            Details:

            Two drug-drug interaction studies assessed the effect of repeated co-administration of commonly prescribed medications, metformin or sitagliptin (Januvia®; Merck & Co.), with Imeglimin.