Suzetrigine: First Approval.

Suzetrigine (JOURNAVX™), an oral, non-opioid analgesic that is highly selective for the voltage-gated sodium channel NaV1.8 relative to other NaV channels, is being developed by Vertex Pharmaceuticals Inc. for the management of acute and neuropathic pain. NaV1.8 is expressed in peripheral pain-sensing neurons but is not expressed in the brain. Suzetrigine prevents transmission of pain signals by blocking NaV1.8 channels located along peripheral pain-sensing neurons, inhibiting the normal action potential. On 30 January 2025, suzetrigine was approved for the treatment of moderate to severe acute pain in adults in the USA. Suzetrigine is the first NaV inhibitor to be approved in this new therapeutic class of non-opioid analgesics. This article summarizes the milestones in the development of suzetrigine leading to this first approval for the treatment of moderate to severe acute pain.