recoflavone (DA-6034) / Dong-A, GL PharmTech, AJU Pharm - LARVOL DELTA

GL PharmTech's Recoflavone passes phase 3 trials, boosting stock price significantly (Chosun Biz) - "GL PharmTech is showing strength in early trading on the 23rd. It is interpreted that the buying momentum came after news that the company's eye dryness new drug has passed phase 3 clinical trials. As of 9:37 a.m. on the same day, GL PharmTech is trading at 1,419 won, up 327 won (29.95%) from the previous trading day. It soared to the upper limit (the highest daily price limit) immediately after the market opened....With this phase 3 clinical trial demonstrating superiority over the placebo, it has passed the final stage for new drug commercialization."

Commercial • Stock price • Dry Eye Disease

Docking and Molecular Dynamics Studies on Anticancer Activities of Flavonoids as Inhibitors of CDK2 and CDK9. (PubMed, Med Chem) - "We can conclude that Flavone and Recoflavone are promising anticancer lead compounds in the development of new anticancer drugs."

Journal • Oncology • CDK9

Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients (clinicaltrials.gov) - P2 | N=103 | Completed | Sponsor: AJU Pharm Co., Ltd.

New P2 trial • Dry Eye Disease • Ophthalmology

DA-6034 ameliorates hepatic steatosis and inflammation in high fat diet-induced obese mice. (PubMed, J Yeungnam Med Sci) - "DA-6034 also reduced CCR5 expression and the migration of liver macrophages in HFD-fed mice and inhibited CCR2 ligand and CCR4 ligand, which stimulated the migration of macrophages. Overall, DA-6034 attenuates hepatic steatosis and inflammation in obesity by regulating CCR5 expression in macrophages."

IO biomarker • Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • CCR2 • CCR4 • CCR5 • CD8

Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients (clinicaltrials.gov) - P3 | N=396 | Recruiting | Sponsor: AJU Pharm Co., Ltd.

New P3 trial • Dry Eye Disease • Ophthalmology

Efficacy and safety of DA-6034(AJU-S56/GLH8NDE) in patients with dry eye disease: A multicenter, randomized, double-blinded, placebo-controlled phase 2 study (ARVO 2023) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P2 data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Evaluation of the therapeutic efficacy of DA-6034(AJU-S56/GLH8NDE) in a dry eye mouse model (ARVO 2023) - "Purpose The aim of this study is to evaluate the clinical and histological changes which are associated with the reformulated DA-6034(AJU-S56/GLH8NDE) in the cornea, conjunctiva and lacrimal glands from a dry eye mouse model and to compare its efficacy with those of commercial drugs, diquafosol(DQS) and rebamipide(REB) Methods The dry eye animal model, using the NOD.B10. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology • IL1B • IL6 • MMP9 • NFKB1 • NF-κβ • TNFA

A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults. (PubMed, Clin Transl Sci) - "The systemic exposure as measured by area under the concentration-time curve from time of administration up to the time of the last quantifiable concentration (AUC ) after single-day administration of the same dose was 109% higher in Koreans than in Whites. In conclusion, GLH8NDE was safe and well-tolerated in healthy Korean and White male adults at 9-36 mg/day after single- and multiple-day administrations."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Dry Eye Disease • Ophthalmology

A Randomized, Double-blind, Placebo-controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease (clinicaltrials.gov) - P2; N=99; Not yet recruiting; Sponsor: GL Pharm Tech Corporation

Clinical • New P2 trial • Dry Eye Disease • Ocular Infections • Ophthalmology

A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers (clinicaltrials.gov) - P1; N=39; Completed; Sponsor: GL Pharm Tech Corporation; Not yet recruiting ➔ Completed; Trial completion date: Mar 2020 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Dry Eye Disease • Ophthalmology

Evaluation of the therapeutic efficacy of GLH8NDE(DA-6034) in a dry eye mouse (ARVO 2020) - "The treatment with GLH8NDE showed significant improvement in the dry eye mouse model. Also, it was found that GLH8NDE can be a therapeutic candidate which is superior or equivalent to DQS and REB, for dry eye treatment"

Preclinical • IL1B • IL6 • MMP9