Sugarnon (evogliptin) / Dong-A - LARVOL DELTA

Efficacy and safety of a triple fixed-dose combination of empagliflozin, evogliptin and metformin in patients with type 2 diabetes inadequately controlled: a Phase III randomised controlled trial (EASD 2026) - P3 | "The addition of empagliflozin to metformin and evogliptin significantly improved glycemic control and multiple metabolic parameters with a favorable safety profile. These results confirm the clinical efficacy and safety of a triple therapy approach, supporting the use of a single-tablet triple fixed-dose combination of metformin, evogliptin, and empagliflozin to simplify complex treatment regimens and improve outcomes in patients with T2DM."

Clinical • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Response to Letters to the Editor Regarding 'Role of Evogliptin for Intra-Class Therapeutic Interchange in Patients With Type 2 Diabetes Mellitus: Subgroup Analysis From a Multi-Center, Prospective, Observational Study (REVISE Study)'. (PubMed, Endocrinol Diabetes Metab) - No abstract available

Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS) (clinicaltrials.gov) - P2/3 | N=486 | Terminated | Sponsor: REDNVIA Co., Ltd. | Trial completion date: Dec 2026 ➔ Mar 2026 | Suspended ➔ Terminated; The study is terminated due to sponsor's business decision. There were no safety issues influencing this course of action.

Trial completion date • Trial termination • Cardiovascular

Aortic valve stenosis serum IGFBP2 mediates female-specific Evogliptin resistance in valve myofibroblasts. (PubMed, Cell Rep) - "We found that serum insulin-like growth factor binding protein 2 (IGFBP2) mediates Evogliptin resistance in female VICs cultured with female AVS serum through the activation of Rho/ROCK and focal adhesion kinase signaling. Our findings highlight IGFBP2 as a candidate biomarker for stratifying female patients with AVS for Evogliptin treatment, underscoring the need to incorporate sex as a biological variable in determining AVS treatments."

Journal • Cardiovascular • IGFBP2

Methodological Confounders in Evaluating Intra-Class Therapeutic Interchange to Evogliptin: A Closer Look at the REVISE Sub-Analysis. (PubMed, Endocrinol Diabetes Metab) - No abstract available

Journal

Comment on 'Role of Evogliptin for Intra-Class Therapeutic Interchange in Patients With Type 2 Diabetes Mellitus: Subgroup Analysis From A Multi-Centre, Prospective, Observational Study (REVISE Study)'. (PubMed, Endocrinol Diabetes Metab) - No abstract available

Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Role of Evogliptin for Intra-Class Therapeutic Interchange in Patients With Type 2 Diabetes Mellitus: Subgroup Analysis From A Multi-Center, Prospective, Observational Study (REVISE Study). (PubMed, Endocrinol Diabetes Metab) - P=N/A | "Intraclass therapeutic interchange (ICTI) to evogliptin from other DPP-4 inhibitors was an effective and well-tolerated strategy for optimizing glycemic control. These findings suggest that intra-class therapeutic interchange could be an effective and well-tolerated strategy for optimizing glycemic control in a clinical setting. However, given the observational nature of this study, further controlled studies are needed to confirm these findings against a comparator group."

Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Anti-fibrotic effects of evogliptin in fibroblasts derived from post-burn hypertrophic scars. (PubMed, Sci Rep) - "Evogliptin treatment in HTSFs and HNFs treated with transforming growth factor-beta 1 (TGF-β) both inhibited the expression of differentiation markers, including αSMA, TGF-β1, YAP1, TEAD1, and CTGF, thereby reducing fibroblast activation; ECM components, including type Ⅰ collagen, type Ⅲ collagen, and fibronectin; epithelial-mesenchymal transition (EMT) markers, including snail1, slug, twist1, vimentin, and n-cadherin; and TGF-β-mediated signaling molecules, including SMAD2, SMAD3, TAK1, ERK, p38, JNK, AKT, and STAT3. Our results demonstrated that evogliptin exerts its anti-fibrotic activity by inhibiting fibroblast activation, EMT, and ECM synthesis in HTSFs."

Journal • Fibrosis • Immunology • CDH2 • CTGF • DPP4 • SMAD2 • SMAD3 • SNAI1 • SNAI2 • STAT3 • TEAD1 • TGFB1 • TWIST1 • VIM • YAP1

A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS) (clinicaltrials.gov) - P2/3 | N=580 | Suspended | Sponsor: REDNVIA Co., Ltd. | Recruiting ➔ Suspended

Trial suspension • Cardiovascular

Cinchona-Functionalized Crown-Ether-Pinioned Calix[4]arene for a Scalable Asymmetric Organocatalytic Aza-Michael Addition Reaction. (PubMed, Org Lett) - "The catalyst could be recycled up to 25 test cycles without any significant waning in the yield and selectivity. The synthetic application of this approach to DPP-4 inhibitor drugs, such as (R)-sitagliptin and evogliptin, further demonstrates its feasibility."

Journal

Effect of anti-tuberculosis drugs on the pharmacokinetics and pharmacodynamics of novel antidiabetic drugs: A scoping review. (PubMed, Pulmonology) - "RIF co-administration with gemigliptin, evogliptin and canagliflozin requires caution and potential requiring dose adjustments, while saxagliptin, dapagliflozin, ertugliflozin and empagliflozin appear safer alternatives. The limited inclusion of DM patients with TB, restricted to one study with latent TB infection, further reduces generalisability. We developed a clinical decision algorithm to support co-treatment in TB - DM cases, but further dedicated studies are warranted to guide optimal co-treatment."

Journal • PK/PD data • Review • Diabetes • Hematological Disorders • Infectious Disease • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Effectiveness and Safety of Evogliptin in Patients With Type 2 Diabetes Mellitus: A Multicenter, Prospective, Observational Study. (PubMed, Diabetes Obes Metab) - "Evogliptin reduces blood glucose levels and is well-tolerated when used as an add-on, as a switch from other dipeptidyl peptidase 4 inhibitors, or as part of an initial combination therapy in patients with type 2 diabetes mellitus."

Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Circulating biomarkers in serum from aortic valve stenosis patients predict sex-specific drug responses in valve myofibroblasts. (PubMed, bioRxiv) - "Our findings reveal a sex-specific, serum-mediated mechanism of Evogliptin resistance and highlight IGFBP2 as a candidate biomarker for stratifying female AVS patients for Evogliptin treatment. More broadly, these findings underscore the importance of incorporating sex-stratified biomarker analyses into AVS therapeutic development to improve patient-specific treatment recommendations."

Biomarker • Journal • Cardiovascular • IGFBP2

Evogliptin prevents ceramide-induced pyroptosis during calcification via modulation of NLRP3/GSDM-D mediated pathway in Vascular Smooth Muscle Cells. (PubMed, PLoS One) - "Furthermore, MCC950 (NLRP3 inhibitor), disulfiram (GSDM-D inhibitor) and evogliptin significantly downregulated osteogenic and pyroptotic markers including LDH release in both Pi-induced only and CER + Pi-treated VSMCs. Also, the cleavage efficiency of GSDM-D was high in Pi and CER + Pi groups which was reduced with prior treatment of evogliptin. Hence, our data demonstrate that evogliptin alleviates VC by blocking phenotypic transition and associated pyroptosis via modulation of NLRP3/GSDM-D mediated pathway in CER-induced VSMCs."

Journal • Cardiovascular • Inflammation • BMP2 • IL18 • IL1B • NLRP3 • RUNX2

Novel Drug Molecules for Atherosclerosis from Ginkgo biloba, an Endangered Himalayan Herb, Via Pharmacoinformatics Approaches. (PubMed, Curr Pharm Biotechnol) - "The findings highlight the multi-target therapeutic potential of Isoginkgetin in mitigating the initiation and progression of atherosclerosis."

Journal • Atherosclerosis • Cardiovascular • Inflammation • Metabolic Disorders • CYP19A1 • PACERR • PTGS2

Combined Treatment with Evogliptin and Temozolomide Alters miRNA Expression but Shows Limited Additive Effect on Glioma. (PubMed, Int J Mol Sci) - "The co-administration of evogliptin and temozolomide resulted in distinct miRNA profile changes. Nevertheless, both in vitro and in vivo, the added cytotoxicity from the combination was minimal."

Journal • Brain Cancer • Glioma • Oncology • Solid Tumor • DPP4

Comparative efficacy and safety of Evogliptin in type 2 diabetes patients above and below 65 years. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Enhanced Efficacy and Safety of Evogliptin in Older Adults—A Comparative Study in Type 2 Diabetes Patients Aged above and below 65 Years (ADA 2025) - "Evogliptin effectively improves glycemic control, especially HbA1c levels, with minimal adverse effects in elderly T2DM patients following extended treatment. These findings underscore the importance of personalized diabetes management strategies, tailored to patient age and treatment duration, to maximize therapeutic benefits."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of Bone Metabolism and the Efficacy of Evogliptin and Dapagliflozin for Blood Sugar in the Menopause Female Patients with Type 2 Diabetes—A Multicenter Randomized Exploratory Clinical Trial (ADA 2025) - "In postmenopausal patients with T2DM, Evogliptin demonstrated a more favorable safety profile regarding BMD compared to Dapagliflozin. Dapagliflozin resulted in small but significant reductions in BMD or T-score at non-vertebral bone, due at least in part to weight loss. These findings provide evidence for selecting appropriate antidiabetic medications in postmenopausal women with osteoporosis."

Clinical • Diabetes • Metabolic Disorders • Osteoporosis • Type 2 Diabetes Mellitus

A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS) (clinicaltrials.gov) - P2/3 | N=580 | Recruiting | Sponsor: REDNVIA Co., Ltd. | N=867 ➔ 580 | Active, not recruiting ➔ Recruiting

Enrollment change • Enrollment open • Cardiovascular

Determination of absolute bioavailability, absorption, metabolism, and excretion of evogliptin in healthy male subjects using a microtracer method. (PubMed, J Pharm Sci) - "The concomitant oral dosing followed by microtracer IV dosing and the microtracer oral dosing enabled a comprehensive description of evogliptin's absorption, metabolism, and excretion in humans. Evogliptin was safe and well tolerated in healthy subjects."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS) (clinicaltrials.gov) - P2/3 | N=867 | Active, not recruiting | Sponsor: REDNVIA Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • IGF1

Population pharmacokinetic and pharmacodynamic model of evogliptin: Severe uremia increases the bioavailability of evogliptin. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "The developed PK/PD model accurately predicted exposure and the resulting DPP-4 activity of evogliptin in renal impairment. The findings of this study suggest that renal impairment and associated biochemical changes may impact the bioavailability of CYP3A4-metabolized drugs."

Journal • PK/PD data • Chronic Kidney Disease • Nephrology • Renal Disease • CYP3A4

Effect of Evogliptin on the Progression of Aortic Valvular Calcification. (PubMed, J Am Coll Cardiol) - P2 | "This exploratory study did not demonstrate the protective effect of evogliptin on AV calcification. Favorable 18F-NaF PET results and possible suppression of aortic valve calcification with longer medication use in the evogliptin groups suggest the need for larger confirmatory trials. (A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease; NCT04055883)."

Clinical • Journal

Analytical quality by design-based stability-indicating high performance liquid chromatography method for the estimation of evogliptin tartrate in bulk and tablet dosage form. (PubMed, Biomed Chromatogr) - "The drug was sensitive to acidic, basic, oxidative, thermal, and photodegradation resolving six degradation products. Thus, the developed AQbD-based stability-indicating HPLC method is applicable in analyzing evogliptin in bulk, tablet dosage form and stability samples."

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