ID110521156 / Ildong - LARVOL DELTA

…Unovia, a new drug development subsidiary of Ildong Pharmaceutical, recently demonstrated superior efficacy to competing substances in a phase 1 trial. (Chosun Biz) - "The company is developing a once-daily oral GLP-1 candidate (ID110521156). In a phase 1 trial involving 36 Korean adults, the high-dose (200 mg) group recorded an average weight loss rate of 9.9% (8.8 kg) after four weeks, higher than Eli Lilly’s oral obesity drug Orforglipron (6.4%) or the candidate from Switzerland’s Roche (7.3%)."

P1 data • Obesity

Ildong Confirms Higher Efficacy of Oral Obesity Drug Compared to Competitors [Google translation] (Business Korea) - "The Phase 1 repeated dose trial was conducted on 36 healthy adults divided into three groups of 50mg, 100mg, and 200mg, administered once daily for 4 weeks. As a result, the 50mg group showed an average weight reduction of 5.5%, the 100mg group 6.9%, and the 200mg group an average of 9.9% with a maximum of 13.8%. Notably, 87.5% of the 200mg group reduced their weight by more than 5%, showing a clear difference from the placebo group (0%). Waist circumference decreased by up to 6.9cm, and body fat mass decreased by more than 15%. Lean body mass slightly increased, confirming qualitative improvement beyond simple weight loss."

P1 data • Obesity

Ildong Pharmaceutical Group is pursuing follow-up development work on ID110521156 with the goal of entering global Phase 2 clinical trials next year. [Google translation] (Business Korea) - "The Phase 2 clinical trial dose is expected to be between 100mg and 200mg."

New P2 trial • Obesity

Ildong Pharmaceutical accelerates drug development for metabolic, autoimmune diseases (Chosun Biz) - P1 | N=36 | NCT06063291 | Sponsor: IlDong Pharmaceutical Co Ltd | "In June, at the American Diabetes Association (ADA) meeting held in Chicago, Unovia presented the results of the clinical SAD and MAD studies on ID110521156 in poster format. In the SAD study, ID110521156 showed relatively fewer gastrointestinal side effects compared to other drugs in the GLP-1 class. Additionally, the MAD study confirmed that as the dosage increased, the weight loss efficacy also increased."

P1 data • Obesity

A Phase 1 Study of ID110521156, a Small Molecule Glucagon-Like Peptide 1 Receptor Agonist, in Healthy Subjects (ADA 2025) - P1 | "These results demonstrate that ID110521156 is an orally available, well-tolerated GLP-1RA with an acceptable safety profile in humans. A phase 1 multiple ascending dose study is currently ongoing [NCT06635226]."

Clinical • Late-breaking abstract • P1 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: IlDong Pharmaceutical Co Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: IlDong Pharmaceutical Co Ltd | Active, not recruiting ➔ Completed

Trial completion

Multiple Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: IlDong Pharmaceutical Co Ltd

New P1 trial

Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: IlDong Pharmaceutical Co Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed

Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: IlDong Pharmaceutical Co Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

Single Ascending Oral Dose Phase 1 Study of ID11052 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: IlDong Pharmaceutical Co Ltd

New P1 trial

Ildong Pharmaceutical joins the race to develop GLP-1 type diabetes treatment [Google translation] (Health Korea News) - "Ildong Pharmaceutical is joining the race to develop drugs in the glucagon-like peptide-1 (GLP-1) series, a treatment for metabolic diseases that is gaining sensational popularity....it was confirmed that the Ministry of Food and Drug Safety approved the investigational new drug (IND) and phase 1 clinical trial plan (IND) for Ildong Pharmaceutical's GLP-1 agonist 'ID110521156'...Ildong Pharmaceutical plans to evaluate the tolerability, safety, and pharmacokinetic properties of 'ID110521156' in healthy adults. Depending on the progress of commercialization work such as clinical development, it will be used as an oral drug targeting type 2 diabetes and obesity in the future."

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Discovery of ID110521156, a Small Molecule GLP-1 Receptor Agonist, for the Treatment of Type 2 Diabetes and Obesity (ADA 2023) - "Even semaglutide administrated orally has been developed, it still has limitation as a drug peptide, including high cost, less stability, and low bioavailability. ID110521156 demonstrated no liabilities when tested on a battery of safety pharmacology studies, including cardiovascular, respiratory, and neurobehavioral function assessment. No genotoxicity was observed on Ames, in vitro chromosomal aberration, and in vivo micronucleus test.From these nonclinical study results, ID110521156 might be considered as a potent candidate of small molecule selective GLP-1 receptor agonist to treat type 2 diabetes and obesity."

Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus