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GNS-20I04

Development stage: Phase 1
Lead developer: Genewon Science
Modality: Small Molecules
Administration: Oral

Overview

GNS-20I04 is an improved small molecule drug developed by GenuOne Sciences for the treatment of type 2 diabetes. It is a fixed-dose combination (FDC) of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Classified as an 'improved drug' (개량신약) under South Korean regulatory standards, GNS-20I04 is designed to enhance glycemic control by utilizing two complementary mechanisms: dapagliflozin reduces blood glucose by inhibiting renal glucose reabsorption, while sitagliptin increases insulin secretion and suppresses glucagon release. GenuOne Sciences, a prominent South Korean CDMO, successfully progressed GNS-20I04 through Phase 3 clinical development to regulatory approval, subsequently marketing the product under the brand name Exfolia.

Brand names: Exfolia
Other names: Sitagliptin + Dapagliflozin

Targets

SGLT2 (Sodium-glucose cotransporter protein subunit 2)DPP-4 (Dipeptidyl Peptidase-IV)

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