Peptron(087010) said on the 25th that it filed an investigational new drug (IND) application with the Ministery of Food and Drug Safety for a phase 1 clinical trial of "PT403," a once‑monthly, long‑acting semaglutide obesity treatment that uses the long‑acting drug platform technology "SmartDepot™." Semaglutide is the active ingredient in "Wegovy," the GLP‑1 obesity drug from Denmark's Novo Nordisk.
The phase 1 trial will evaluate the safety, tolerability, and pharmacokinetic (PK) profile after a single subcutaneous dose of PT403 in 22 healthy adults. It will be conducted at the Chungnam National University Hospital Clinical Trial Center.
PT403 is a long‑acting injectable under development that applies Peptron's SmartDepot technology to semaglutide with the goal of extending the existing once‑weekly dosing interval to once monthly.
In the global obesity drug market, not only weight‑loss efficacy but also "dosing‑interval extension," which reduces the number of administrations to improve the convenience and persistence of long‑term therapy, has recently emerged as a new competitive factor.
PT403 is characterized by the use of semaglutide, which already has accumulated clinical and commercialization experience in the global market, as the active pharmaceutical ingredient (API), rather than being a new obesity drug candidate. Peptron's strategy is to apply the SmartDepot technology to develop it as a once‑monthly formulation.
The trial will systematically evaluate the safety, tolerability, and pharmacokinetic characteristics of PT403.
Peptron previously confirmed PT403's initial pharmacokinetic characteristics and safety/tolerability profile in a pilot study that administered PT403 and an existing semaglutide formulation to eight participants each.
In preclinical results disclosed at the American Diabetes Association (ADA), PT403 showed superior weight‑loss effects in an obese mouse model compared with an existing once‑weekly semaglutide formulation. The company said that in a safety assessment in adults, hallmark gastrointestinal adverse reactions of GLP‑1 therapies, such as vomiting and nausea, were greatly reduced.
PT403 has currently filed patents in about 20 countries and is under development with the goal of obtaining marketing authorization in 2030.
A Peptron official said, "PT403 is being developed with the goal of once‑monthly dosing by applying SmartDepot technology to semaglutide, which has accumulated clinical and commercialization experience in the global market," and added, "Following the ADA 2026 pilot study, we will systematically confirm its safety/tolerability and pharmacokinetic characteristics through this formal trial and secure clinical evidence for global development."