Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

Phase 3 Completed 182 enrolled Pharmbio Korea Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to evaluate the analgesic efficacy of PBK\_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.

Timeline

Start: 2022-07-25
Primary completion: 2025-02-28
Completion: 2025-02-28

Outcome

Met primary endpoint

paper Both oliceridine doses demonstrated significant improvement in sum of pain intensity differences over 48 h compared with placebo. PMID 41772803 ↗

Publications

Kim S, Cho BK, Young KW, Sung KS, Lee Y, Ahn JY, Kim BS, Kang C, Lee KB, Park CH, Lee DY, Choi Y, Lee HS. A randomized double-blind placebo-controlled trial of oliceridine, a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. Curr Med Res Opin. 2026 Jan;42(1):151-162. doi: 10.1080/03007995.2026.2632422. Epub 2026 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PBK_L1704	Unknown	0.35 mg	—
Subject	PBK_L1704	Unknown	0.5 mg	—

Indications

No indication recorded.