Cullgen's CG001419 non-opioid pain treatment completes successful phase 1 trial

Cullgen Inc., a subsidiary of GNI Group, has successfully completed its phase 1 clinical trial for CG001419, a novel non-opioid analgesic candidate. The trial, conducted in Australia with 78 healthy individuals, evaluated the safety, tolerability, and pharmacokinetics of CG001419 through single and multiple ascending dose studies. Results indicate that CG001419 was well-tolerated across all doses, with no serious adverse events related to the drug reported.

CG001419 is positioned as a potential first-in-class oral pan-TRK protein degradation inducer for pain treatment, addressing the critical need for safer alternatives to opioid analgesics. The positive outcome supports the advancement of CG001419, with an Investigational New Drug (IND) application for a phase 2 clinical trial expected to be filed with the FDA in early 2026.

Cullgen plans to initiate a phase 2 clinical trial in the US in the first half of 2026, targeting acute pain in patients undergoing bunionectomy. In addition to its development as a pain therapeutic, CG001419 is also undergoing a separate phase 1 clinical trial in China for solid tumors. The impact of this development on GNI Group's consolidated earnings for the current fiscal year is expected to be minor.