Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Published: May 24, 2025
Suzetrigine (Journavx): A Comprehensive Report on a Novel Non-Opioid Analgesic for Acute Pain Management
1. Introduction
- Overview of Suzetrigine (Journavx): Suzetrigine, marketed under the brand name Journavx™ and formerly identified as VX-548, is a novel, orally administered, non-opioid analgesic.[1] It was approved by the U.S. Food and Drug Administration (FDA) on January 30, 2025, for the treatment of moderate to severe acute pain in adults.[1] Developed by Vertex Pharmaceuticals [2], Suzetrigine is distinguished as a first-in-class selective inhibitor of the Nav1.8 sodium channel.[3] This approval marks a significant milestone, as Suzetrigine is the first new pharmacological class of oral pain medication to be approved in over two decades, offering a new approach to acute pain management.[1]
- The Unmet Medical Need in Acute Pain Management: Acute pain is a prevalent condition, affecting millions of individuals annually and often requiring potent analgesic intervention.3 Historically, opioids have been a cornerstone for managing moderate-to-severe acute pain. However, their use is associated with significant risks, including the potential for addiction, misuse, respiratory depression, and other undesirable side effects.8 The widespread prescription of opioids for acute pain has been identified as a contributing factor to the opioid crisis, a major public health concern.10 This context underscores a substantial unmet medical need for effective analgesics that do not carry the addictive potential and adverse effect profile of opioids.4 Suzetrigine's development directly addresses this need by providing a novel, non-opioid mechanism for pain relief.10 The introduction of an effective non-opioid analgesic like Suzetrigine has the potential to significantly alter clinical practice in acute pain management. Post-surgical pain, for instance, is a common reason for initial opioid prescriptions.10 Data indicate that a high percentage of surgical pa
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/21 | Phase 4 | Recruiting | |||
2025/03/21 | Phase 4 | Recruiting | |||
2025/02/19 | Phase 1 | Completed | |||
2025/02/11 | Phase 1 | Completed | |||
2025/01/14 | Phase 2 | Recruiting | Latigo Biotherapeutics | ||
2024/11/20 | Phase 3 | ENROLLING_BY_INVITATION | |||
2024/10/08 | Phase 3 | Recruiting | |||
2024/05/20 | Phase 1 | Completed | |||
2024/03/28 | Phase 1 | Completed | |||
2023/12/19 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.