Kyungdong Pharmaceutical announced Sept. 2 that it has submitted an investigational new drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of AUL009, a long-acting injectable semaglutide co-developed with AUL Bio.
AUL009 is a microsphere injectable that applies AUL Bio’s proprietary drug-delivery platform, ExTenna, to semaglutide—the active ingredient widely used in GLP-1 obesity and diabetes therapies. The ExTenna technology encapsulates the active drug within biodegradable polymer microspheres, allowing it to be released slowly and consistently in the body. By shifting semaglutide's administration schedule from once weekly to once monthly, the developers aim to reduce patient dosing burdens and significantly improve treatment adherence and convenience.
The upcoming Phase 1 trial will evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of AUL009. Through stepwise dose escalation, researchers will assess dose-dependent safety and drug exposure characteristics to establish optimal dosing levels and refine development strategies for subsequent clinical phases.
Earlier, Kyungdong Pharmaceutical and AUL Bio presented preliminary human pharmacokinetic and safety data for AUL009 at the American Diabetes Association Scientific Sessions (ADA 2026). In that exploratory evaluation comparing AUL009 to existing semaglutide formulations in eight healthy male volunteers, the candidate demonstrated a sustained pharmacokinetic profile, maintaining drug exposure for more than 30 days following a single administration.
"This IND filing will be an important turning point for AUL009 to move into full-scale clinical development, based on the drug-delivery capabilities we have built up and the human pharmacokinetic evaluation results," an official at Kyungdong Pharmaceutical said.
