Cullgen Reports Positive Results from Phase 1 Study of its Novel Non-Opioid Product Candidate CG001419 for Pain

IND filing and initiation of Phase 2 clinical trials on track for 1H 2026

Excerpt from the Press Release:

SAN DIEGO, Dec. 12, 2025 (GLOBE NEWSWIRE) — Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies, today announced the completion of its Phase 1 clinical trial evaluating its lead product candidate, CG001419, a potential first-in-class, oral, pan-TRK protein degrader, which is part of a new class of pain signaling channel modulators for the treatment of pain.

Cullgen’s Phase 1 study (NCT06636500) was a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose/food-effect (with or without food) and multiple-ascending-dose trial that evaluated the safety, tolerability and pharmacokinetic characteristics of CG001419 in 78 healthy volunteers. The study was conducted in Australia after receiving ethics committee approval in early 2025. Results from the study showed that all doses were well-tolerated with no drug-related serious adverse events observed.

“We are very pleased with the positive outcome of this Phase 1 study. CG001419 is an important program as it could provide a new, non-opioid, non-NSAID analgesic therapy option for patients suffering from acute and chronic pain,” commented Ying Luo, Ph.D., Chief Executive Officer of Cullgen. “Given the favorable outcome of this study, we plan to submit an IND for CG001419 in early 2026, and, pending FDA allowance of the IND, initiate a Phase 2 study in acute pain in bunionectomy patients in the United States. In addition to studying CG001419 in pain applications, it is also being studied in a separate Phase 1 clinical trial in China in patients with solid tumors.”

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