Celltrion

• Designed to address limitations of current GLP-1 therapies by maximizing weight reduction while supporting preservation of muscle mass.
• Comprehensive toxicology studies, including primate studies, are underway as the program enters the final preclinical stage ahead of global clinical development.
• Positioned as a next-generation platform candidate with potential applicability across obesity, diabetes, and broader metabolic disease indications.
• Strategic collaboration with Japan-based Scohia Pharma supports development, with Celltrion expected to lead global development and commercialization.
• Expands Celltrion’s innovative pipeline beyond biosimilars into obesity, ADCs, and other novel therapeutics, reinforcing mid- to long-term growth drivers.

INCHEON, South Korea – Celltrion today announced the initiation of primate toxicology studies for its next-generation obesity drug candidate, CT-G32, representing the final preclinical step prior to global clinical development. The company is advancing the program toward submission of an Investigational New Drug (IND) application in the first half of next year.

CT-G32 is a next-generation obesity candidate designed to simultaneously engage four targets, including GLP-1 (glucagon-like peptide-1), and is being advanced by Celltrion as a potential first-in-class therapeutic. The candidate is intended to address key limitations observed in the current GLP-1 treatment landscape, including variability in patient response, muscle loss, and treatment durability, while enhancing overall weight reduction efficacy.

As the global obesity therapeutics market is projected to exceed USD 100 billion, competition to secure next-generation multi-agonist mechanisms continues to intensify across the pharmaceutical industry. Celltrion aims to position CT-G32 beyond a conventional weight-loss therapy and develop it as a broader metabolic disease platform capable of regulating fat, muscle, and overall energy metabolism.

Under the current toxicology program, Celltrion will assess the safety and toxicity profile of CT-G32 in 252 rats and 48 monkeys. The study is expected to provide critical data to support dose selection and safety evaluation for future clinical trials. In parallel, the company plans to further characterize the candidate’s pharmacokinetic (PK) and pharmacodynamic (PD) profile.

In earlier preclinical studies, CT-G32 demonstrated superior weight reduction at equivalent doses relative to a benchmark candidate previously under development, while also showing preservation of lean body mass, including muscle.

Based on these preclinical findings, Celltrion intends to submit an IND application in the first half of next year and subsequently advance CT-G32 into global clinical development. The company is also evaluating the potential to expand the candidate beyond obesity into additional metabolic disease indications, including diabetes and metabolic dysfunction-associated steatohepatitis (MASH).

To support this program, Celltrion has established a strategic collaboration framework with Japan-based Scohia Pharma and is jointly advancing development activities. Celltrion expects to play a leading role across the full value chain, including preclinical and clinical development as well as global commercialization, in order to strengthen its long-term competitiveness in the global market.

In parallel with its quadruple-action injectable program, Celltrion is also developing a multi-action oral obesity candidate. Through differentiated treatment options across stages of care, the company seeks to maximize portfolio synergies and build a broader presence in the obesity therapeutics market. Research is currently underway to improve stability and bioavailability, with IND submission for the oral candidate targeted for the second half of 2028.

A Celltrion official said, “CT-G32 is being developed as a next-generation candidate intended to address the limitations of current GLP-1-based therapies while extending Celltrion’s reach beyond obesity into broader metabolic disease areas.” The official added, “Leveraging the global development and manufacturing capabilities established through our biosimilar business, Celltrion will continue to expand its innovative pipeline in areas including obesity and ADCs in support of sustainable mid- to long-term growth.”