Positive Phase III Data Set Stage For Japan Imeglimin Filing

Partners Poxel and Sumitomo Dainippon confirm Japan filing plans for novel glimin antidiabetic following positive top-line Phase III results, and cast an eye towards market positioning.

Doctor checks blood glucose monitor to meet with diabetic patients.
Imeglimin Edges Towards Japan Filing • Source: Shutterstock

French metabolic disorders company Poxel SA and Asia partner Sumitomo Dainippon Pharma Co. Ltd. (SDP) say they remain on track for a planned Japanese approval submission sometime in 2020 for imeglimin, following new top-line Phase III results for the novel antidiabetic.

The plan could potentially lead to a 2021 launch for the oral glimin class molecule in what may become the first market worldwide for the Merck Serono spin-out's lead asset.

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