Suzetrigine is the first approved selective NaV1.8 channel inhibitor. On January 30, 2025, the U.S. FDA approved Suzetrigine for the oral treatment of moderate to severe acute pain. In two phase III clinical trials (NAVIGATE-1 and NAVIGATE-2), Suzetrigine demonstrated statistically significant improvements in the primary efficacy endpoint, time-weighted sum of pain intensity differences over 48 hours (SPID48), compared with placebo. The least squares mean differences were 29.3 (95% CI: 14.0-44.6; P=0.000 2) and 48.4 (95% CI: 33.6-63.1; P<0.000 1), respectively, confirming its robust analgesic efficacy. Furthermore, owing to its high selectivity for NaV1.8, Suzetrigine exhibited favorable safety and tolerability profiles, with notably lower incidences of nausea, vomiting, and drug dependence compared to conventional opioid analgesics, underscoring its substantial clinical value.