Peptron Begins Phase 1 Trial of Once-Monthly Semaglutide 'PT403'

[Financial News] Peptron has begun full-scale development of a long-acting obesity treatment that extends the dosing interval of semaglutide from once a week to once a month. Peptron said on the 25th that it had filed an investigational new drug application with the Ministry of Food and Drug Safety for PT403, a long-acting semaglutide injection that applies its drug-delivery platform SmartDepot.
The trial will evaluate the safety, tolerability and pharmacokinetic characteristics of PT403 after a single subcutaneous dose in 22 healthy adults.
The study is designed as a randomized, double-blind, placebo-controlled trial, with dose escalation carried out step by step across three cohorts. The next dose group will proceed after the safety and tolerability of the previous group have been reviewed.
PT403 is a candidate that applies Peptron's SmartDepot technology to semaglutide, which is used globally as a treatment for obesity and diabetes. The goal is to extend the dosing schedule from once a week to once a month.
In the obesity drug market, competition is intensifying to develop long-acting formulations that not only deliver weight-loss benefits but also reduce dosing frequency and improve convenience and treatment adherence over the long term.
PT403 stands out because it improves the formulation of semaglutide, a drug with established clinical and commercial experience, rather than developing a new active ingredient.
This IND filing follows the preclinical and pilot clinical results for PT403 that were presented in June at the American Diabetes Association 2026. At the time, Peptron announced the results of a pilot study in which PT403 and an existing semaglutide formulation were each administered to eight people, saying it had confirmed early pharmacokinetic characteristics as well as safety and tolerability profiles.
Through this trial, Peptron plans to assess the safety, tolerability and pharmacokinetic characteristics of PT403 in a more systematic way and secure clinical evidence for future global development.
A Peptron official said, "The competitive benchmark in the global obesity treatment market is expanding beyond weight-loss efficacy to product competitiveness suited for long-term treatment, including dosing convenience and treatment persistence." The official added, "PT403 is being developed with the goal of once-monthly dosing by applying SmartDepot technology to semaglutide, which already has extensive clinical and commercial experience."

[email protected] Kang Jung-mo Reporter