XG005 for Pain Control in Subjects Undergoing Bunionectomy

Phase 2/3 Completed 450 enrolled Xgene Pharmaceutical Group

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

Timeline

Start: 2023-08-29
Primary completion: 2024-08-29
Completion: 2024-09-30

Outcome

Met primary endpoint

paper as the primary efficacy end point was 132.6 (8.0) vs 286.0 (8.2) (P < 0.0001). PMID 41737923 ↗

Publications

Jiang GL, Evanson JR, Solanki D, D'Aunno D, DeNoia E, Rondon JC, Beaton A, Taber L. Pregabalin naproxencarbil in acute post-bunionectomy pain: a randomized clinical trial. Pain Rep. 2026 Jan 20;11(2):e1424. doi: 10.1097/PR9.0000000000001424. eCollection 2026 Apr.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin naproxencarbil	Small molecule	750 mg	Oral
Subject	Pregabalin naproxencarbil	Small molecule	1250 mg	Oral

Indications

No indication recorded.