[Edaily Reporter Kwon Oh Seok ] Peptron, Inc.(087010), an innovative peptide-based drug development company, is set to begin a formal clinical trial for the development of a long-acting obesity treatment administered once a month. (Photo courtesy of Peptron, Inc.) Peptron, Inc. announced on the 25th that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for “PT403,” a semaglutide formulation incorporating the company’s sustained-release platform technology, “SmartDepot™.” This Phase 1 clinical trial will evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of PT403 following a single subcutaneous administration in 22 healthy adults. The trial will be conducted at the Clinical Trial Center of Chungnam National University Hospital and is designed as a randomized, double-blind, placebo-controlled, stepwise dose-escalation study. It will be conducted across three cohorts, with doses gradually increased following review by the Safety Review Committee (SRC). PT403 aims to significantly extend the dosing interval from once weekly to once monthly by combining Peptron, Inc.’s proprietary technology with semaglutide, a leading drug in the global obesity and diabetes market. As the obesity treatment market has recently shifted its competitive focus from weight loss efficacy to “convenience of administration,” PT403 is drawing attention for its use of semaglutide—an active pharmaceutical ingredient (API) already validated through commercialization—to reduce development risks and achieve a once-monthly formulation. Previously, in June, Peptron, Inc. presented the results of PT403’s pilot clinical and preclinical studies at the American Diabetes Association (ADA 2026) conference, demonstrating its pharmacokinetic characteristics and safety profile as a long-acting formulation. This IND filing signifies that the drug has moved beyond the pilot study phase and entered the formal development stage. A Peptron, Inc. spokesperson stated, “The competitive landscape in the global obesity treatment market is shifting toward administration convenience and durability suitable for long-term therapy,” adding, “Following our presentation at ADA 2026, we will further solidify our clinical evidence through this formal clinical trial and accelerate our global development efforts.”
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