[{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Publication of Imeglimin Clinical Study Results in Clinical Pharmacokinetics","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Poxel"},{"orgOrder":0,"company":"Poxel","sponsor":"Sumitomo Pharma","pharmaFlowCategory":"D","amount":"$21.3 million","upfrontCash":"Undisclosed","newsHeadline":"Poxel Announces Submission of Imeglimin Japanese New Drug Application for the Treatment of Type 2 Diabetes by Sumitomo Dainippon Pharma","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Poxel"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Presents Imeglimin Phase 3 TIMES Results and PXL770 Preclinical Cardio-Renal Results at the 56th EASD Annual Meeting","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Poxel"},{"orgOrder":0,"company":"Amolyt Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amolyt Pharma Announces Phase 3 Clinical Trial of Eneboparatide for the Treatment of Hypoparathyroidism Following Positive End of Phase 2 Meeting with FDA","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Peptide","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Peptide","graph2":"Amolyt Pharma"}]
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AZP-3601 (eneboparatide) targets PTH receptor to safely produce sustained blood levels of calcium and thereby manage the symptoms of hypoparathyroidism, and to limit urine calcium excretion by restoring calcium reabsorption by the kidney, preventing chronic kidney disease.
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.
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.
Two drug-drug interaction studies assessed the effect of repeated co-administration of commonly prescribed medications, metformin or sitagliptin (Januvia®; Merck & Co.), with Imeglimin.