Gluetacs Therapeutics Submits Pre-IND Application to the CDE for GT818, a First-in-Class RSK Bifunctional Degrader, for the Treatment of Advanced Malignant Tumors

ON：2025-09-18 TAGS：GLUETACS THERAPEUTICS

September 18, 2025—Gluetacs Therapeutics announces successful submission of the Pre-IND application to the CDE for GT818, an RSK-targeting bifunctional degrader developed based on its proprietary GlueTacs^® platform. This application marks the formal initiation of clinical development, with concurrent IND submissions to the NMPA and the FDA, and the first patient is expected to be enrolled in early 2026.

GT818 is a first-in-class, orally available RSK-targeting bifunctional degrader independently developed by Gluetacs Therapeutics with global intellectual property rights. Preclinical studies demonstrate that GT818 potently and selectively degrades the pathogenic RSK protein, while also exhibiting a high safety window, pronounced tumor enrichment across multiple solid tumor types, and moderate blood-brain barrier penetration. The drug is intended for the treatment of advanced malignant tumors, including solid tumors such as breast cancer, prostate cancer, non-small cell lung cancer, pancreatic cancer, and colorectal cancer, as well as hematologic malignancies including lymphoma. This milestone marks an important expansion of the company’s therapeutic focus from hematologic malignancies (represented by GT919/GT929) to solid tumor indications (GT818).