CT-G32 / Celltrion - LARVOL DELTA

Celltrion to unveil obesity drug data this year, first ADC clinical readouts in 2027 (Korea Biomedical Review) - "The company is conducting GLP-compliant toxicity studies in rats and monkeys to determine an appropriate dose and assess safety. It aims to submit an investigational new drug application for a phase 1 trial by February 2027 and begin dosing in the second quarter of the year, subject to regulatory approval....The company is also developing an oral multi-acting obesity drug, with an IND submission targeted for the second half of 2028."

IND • New P1 trial • Preclinical • Obesity

The next wave is scheduled to move toward regulators next year. (Korea Biomedical Review) - "Celltrion said it plans to file investigational new drug applications in early 2027 for an additional antibody-drug conjugate, CT-P74, and an FcRn inhibitor, CT-P77, and that it aims to submit a total of 12 investigational new drug applications for new-drug programs by 2028...Celltrion said it is aiming to file an investigational new drug application for CT-G32 in the second half of 2027..."

IND • Immunology • Obesity • Oncology

Celltrion said Friday it has begun primate toxicology studies for its next-generation obesity drug candidate CT-G32, accelerating its development of a first-in-class therapy with advanced effects. (The Korea Herald) - "According to Celltrion, the toxicology studies, which will evaluate the safety and toxicity profile of CT-G32 in 252 rats and 48 monkeys, are expected to provide critical data to support dose selection and safety evaluation for future clinical trials. The Korean biopharmaceutical firm plans to submit an investigational new drug, or IND, application of CT-G32 in the first half of next year....On top of the injectable obesity drug candidate, Celltrion is also developing a multi-action oral obesity candidate. As relevant research is currently underway to improve the oral obesity treatment’s stability and bioavailability, Celltrion said it plans to submit an IND in the second half of 2028."

IND • Preclinical • Obesity

Celltrion steps into weight-loss market with oral rival to Wegovy, Mounjaro (KED Global) - "The company announced on Wednesday that it is developing CT-G32, an orally administered quadruple-receptor agonist designed to activate four metabolic pathways simultaneously, an approach that would move beyond the GLP-1 and dual-agonist injections, like Wegovy and Mounjaro, that dominate the global obesity drug market....Patent registrations have been completed, and formal preclinical development is planned for 2026."

New molecule • Patent • Preclinical • Obesity