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Journavx FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 31, 2025.

FDA Approved: Yes (First approved January 30, 2025)
Brand name: Journavx
Generic name: suzetrigine
Dosage form: Tablets
Previous Name: VX-548
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Pain

Journavx (suzetrigine) is a sodium channel blocker indicated for the treatment of moderate to severe acute pain in adults.

Development timeline for Journavx

DateArticle
Jan 30, 2025Approval FDA Approves Journavx (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
Dec 19, 2024Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy
Jul 30, 2024Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain
Apr 18, 2024Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain
Jan 30, 2024Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain
Aug  3, 2023Vertex Announces Publication of VX-548 Positive Phase 2, Proof-of-Concept Results in New England Journal of Medicine
Jul 22, 2022Vertex Advances VX-548 in Acute and Neuropathic Pain
Mar 31, 2022Vertex Announces Statistically Significant and Clinically Meaningful Results From Two Phase 2 Proof-of-Concept Studies of VX-548 for the Treatment of Acute Pain
Jul 19, 2021Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain

Further information

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