Cullgen completes patient enrollment for non-opioid painkiller phase 1 trial

GNI Group announced that its key subsidiary, Cullgen Inc., has completed patient enrollment for the Phase 1 clinical trial of its lead product candidate, CG001419, a novel non-opioid analgesic. This achievement signifies the successful enrollment of the target number of patients for the study.

Cullgen initiated the Phase 1 clinical trial (NCT06636500) in Australia on January 23, 2025, involving healthy volunteers. The trial is designed as a single-center, randomized, placebo-controlled, double-blind, single ascending dose (including food effect study) and multiple ascending dose study, evaluating the safety, tolerability, and pharmacokinetics of CG001419.

According to Yin Luo, chief executive of GNI Group and Cullgen, CG001419, a first-in-class oral pan-TRK protein degradation inducer, offers a new treatment option for acute and chronic pain that is safer and more effective than existing non-opioid analgesics. Cullgen aims to file an IND application with the US FDA by early 2026 and plans to commence Phase 2 clinical trials for CG001419 in the pain management sector. The company anticipates a minor impact on its consolidated financial results for the current period from this matter.