Celltrion Advances First-in-Class Quadruple-Action Obesity Drug CT-G32 into Primate Toxicology Studies
核心洞察
Celltrion has initiated GLP toxicology studies for CT-G32 (搜索), a first-in-class quadruple-action obesity (搜索) candidate, in 252 rats and 48 monkeys with results expected by year-end.
In preclinical studies, CT-G32 (搜索) demonstrated superior weight reduction and lean body mass preservation compared to triple-targeting agents from global pharmaceutical companies.
The company plans to submit an IND application in the first half of 2026 and targets first patient dosing by Q2 2027, with preclinical results to be presented at a November conference.
Celltrion announced on July 29 that it has commenced primate toxicology studies for CT-G32 (搜索), its next-generation obesity (搜索) drug candidate, marking a significant step toward what the company describes as a first-in-class quadruple-action therapy. The GLP toxicology studies are evaluating the safety and toxicity profile of CT-G32 across 252 rats and 48 monkeys, with results scheduled to be presented at a relevant academic conference in November of this year.
The Korean biopharmaceutical firm plans to submit an Investigational New Drug (IND) application for CT-G32 (搜索) as early as February 2026, with first patient dosing targeted for the second quarter of 2027, pending regulatory approval.
Preclinical Differentiation and Mechanism
CT-G32 (搜索) is designed to engage four distinct targets simultaneously, a mechanism that Celltrion believes will address key limitations of current GLP-1 (搜索)-based therapies. In earlier independent preclinical studies, CT-G32 demonstrated superior weight loss effects compared to triple-targeting agents currently under development by global pharmaceutical companies, while notably preserving lean body mass, including muscle tissue.
"CT-G32 (搜索) is being developed as a next-generation candidate intended to address the limitations of current GLP-1 (搜索)-based therapies while extending Celltrion's reach beyond obesity (搜索) into broader metabolic disease areas," a Celltrion official stated.
The company emphasized that the quadruple-action injection is intended to offer reduced variability in patient response and long-lasting effects while advancing weight reduction efficacy. The toxicology studies now underway are expected to provide critical data to support dose selection and safety evaluation for future clinical trials.
Expanding the Metabolic Pipeline
Beyond the injectable formulation, Celltrion is advancing a multi-action oral obesity (搜索) candidate, with research currently focused on improving stability and bioavailability. The company plans to submit an IND for the oral candidate in the second half of 2028.
Celltrion is also working to develop CT-G32 (搜索) into a broader metabolic platform capable of regulating fat, muscle, and overall energy metabolism. The company is exploring expansion into therapies for diabetes (搜索) and metabolic dysfunction-associated steatohepatitis (MASH (搜索)), and has partnered with Japanese bioventure Scohia Pharma (搜索) to support these efforts. Additionally, Celltrion has begun development of long-acting formulations with extended dosing intervals and therapeutics targeting other metabolic diseases such as sarcopenia (搜索) and diabetes, as part of its life cycle management strategy.
Parallel ADC Pipeline Progress
Celltrion's new drug ambitions extend beyond metabolic disease. The company currently has four candidates in Phase 1 clinical trials: three antibody-drug conjugates (CT-P70, CT-P71, CT-P73) and one multi-antibody drug (CT-P72). All four have entered the patient dosing stage and are progressing smoothly.
Two of the ADC candidates are set to complete Part 1 of their Phase 1 trials within this year, with topline results to be announced sequentially starting from the first half of 2026. CT-P70, the most advanced candidate targeting non-small cell lung cancer (搜索) and colorectal cancer (搜索), aims to enter Part 2 of its trial as early as March 2026. CT-P70 secured FDA Fast Track designation last year, and CT-P71—targeting urothelial carcinoma (搜索), breast cancer (搜索), and prostate cancer (搜索)—received the same designation this year. The company plans to apply for Fast Track designation for two additional Phase 1 candidates within this year.
R&D Investment and Pipeline Growth
Celltrion invested approximately 482.4 billion won in R&D last year alone and plans to maintain its investment levels based on stable cash flow from its biosimilar business. The company is currently developing a total of 25 new drug candidates, with five expected to reach the clinical stage by year-end and eight by next year. Starting in 2028, the number of clinical-stage candidates is projected to more than triple compared to the end of this year.
"Leveraging the global development and manufacturing capabilities established through our biosimilar business, Celltrion will continue to expand its innovative pipeline in areas including obesity (搜索) and antibody drug conjugates to bolster mid- to long-term growth engines," the company official added.
Celltrion has positioned oncology, obesity (搜索) and metabolic diseases, and autoimmune diseases as the core pillars of its new drug development strategy, pursuing both in-house development and external technology acquisition through collaborations with AI deep tech companies and firms specializing in microbiome and antibody therapeutics.