ZemiStatin (gemigliptin/rosuvastatin FDC) / LG Chem - LARVOL DELTA

In-lab synthesized turn-off fluorescence sensor for estimation of Gemigliptin and Rosuvastatin polypill appraised by Spider diagram, AGREE and whiteness metrics. (PubMed, Sci Rep) - "The aforementioned metrics proved the superiority of the adopted approach over the previously published one regarding eco-friendliness and sustainability. Our devised fluorimetric turn-off sensing method showed high sensitivity, selectivity, feasibility, and rapidity with minimal cost and environmental burden over other sophisticated techniques, making it reliable in quality control labs."

Journal • Diabetes • Dyslipidemia • Metabolic Disorders

Pharmacokinetic and Pharmacodynamic Comparison of Two Formulations of a Fixed-Dose Combination of Gemigliptin/Rosuvastatin 50/20 mg: A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study. (PubMed, Drug Des Devel Ther) - "The FDC of gemigliptin/rosuvastatin 50/20 mg as the bilayer tablet showed equivalent PK and PD properties with the FDC of gemigliptin/rosuvastatin 50/20 mg as the monolayer tablet in healthy subjects. These results suggest that the newly developed bilayer tablet can become an alternative formulation to the commercially available monolayer tablet."

Clinical • Journal • PK/PD data • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A Fixed-Dose Combination Of Gemigliptin And Rosuvastatin Exhibits Similar Pharmacokinetics, Pharmacodynamics, And Safety Compared To That Of A Loose Combination In Healthy Subjects. (PubMed, Drug Des Devel Ther) - "PK, PD, and safety profiles of gemigliptin, its metabolite, and rosuvastatin were similar between FDC and loose combination. The FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) can be used as an alternative to a loose combination, which is expected to improve patient compliance."

Clinical • Journal • PK/PD data • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of fixed-dose comBination therApy with gemigLiptin (50 mg) and rosuvAstatiN (20 mg) Compared with Each monotherapy in patients with type 2 diabetes and dyslipidaemia (BALANCE): A multicentre, randomized, double-blind, controlled, phase 3 trial. (PubMed, Diabetes Obes Metab) - "The FDC of gemigliptin/rosuvastatin is effective and safe at reducing both blood glucose and LDL-C levels and could be a good therapeutic choice for type 2 diabetic patients with dyslipidaemia."

Clinical • Combination therapy • Journal • Monotherapy • P3 data

BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination. (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: LG Chem

Clinical • New P1 trial