Gluetacs Therapeutics Announces FDA IND Clearance for GT818, a First-in-Class RSK Bifunctional Degrader

Release Time:2026-08-31
Publisher:Administration Office

Gluetacs Therapeutics announces that GT818, a first-in-class investigational drug candidate developed by the Company, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced malignancies.

In China, GT818 received clearance from the National Medical Products Administration (NMPA) on July 1, 2026, to initiate clinical trials and is currently being evaluated in a Phase 1 clinical study.

GT818 is the third program to receive clinical trial clearance in both China and the United States, representing another important milestone in the Company’s global development.

About Gluetacs Therapeutics

Gluetacs Therapeutics, focusing on the development of oral small molecule protein degrader, is the first biotech company incubated from ShanghaiTech University, Gluetacs was founded in February 2020, and started to operation in March 2021. It was found by several scientists that have done intensive studies in target protein degradation. The company has independent intellectual property of GLUE degrader and GLUETAC degrader development platform with around 100 patents filed, which has indicated a unique and differentiated technical route and development strategy. The company has established artificial intelligence virtual screening platform, in vitro pharmacodynamics screening platform, pharmacokinetics platform, proteomics platform and in vivo drug pharmacology evaluation platform, and has constructed a complete whole-process drug R&D system. Since launching operations in March 2021, Gluetacs Therapeutics has successfully advanced 3 drug candidates into clinical trial. Gluetacs’ therapeutic focus spans multiple areas including hematologic malignancies, solid tumors, autoimmune diseases, and rare diseases, consistently upholding a patient-centric development philosophy.