JOURNAVX (suzetrigine) · Vertex Pharmaceuticals
JOURNAVX (suzetrigine) is a selective NaV1.8 sodium channel inhibitor indicated for moderate to severe acute pain in adults. First-in-class non-opioid pain medication.
How JOURNAVX Works
Suzetrigine selectively blocks the NaV 1.8 voltage-gated sodium channel, which is found in peripheral sensory neurons like the dorsal root ganglion. By inhibiting these specific channels, the drug prevents the transmission of pain signals, or action potentials, to the spinal cord and brain. The treatment also produces an active metabolite, M6-SUZ, which further contributes to the inhibition of NaV 1.8 channels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-01-30
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
JOURNAVX Approval History
What JOURNAVX Treats
2 indicationsJOURNAVX is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Pain
- Postoperative Pain
JOURNAVX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to JOURNAVX
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Vertex Pharmaceuticals's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07538570 | VX25-548-118 | Ph 4 | recruiting | Evaluation of Pain Treatment After Total Knee Arthroplasty |
| NCT07378865 | VX25-548-021 | Ph 1 | recruiting | Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants |
| NCT07575230 | 025-413 | Ph 4 | enrolling by invitation | Suzetrigine vs Norco-postoperative Mohs Pain |
| NCT07231419 | VX24-548-111 | Ph 3 | recruiting | Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy |
| NCT07570069 | VX24-548-018 | Ph 1 | recruiting | Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants |
| NCT07257133 | 25-004867 | Ph 4 | completed | A Study Of Opioid Avoidance In Surgery Through Integrating Suzetrigine |
| NCT07463430 | Suzetrigine | Ph 4 | enrolling by invitation | Suzetrigine for Non-Mastectomy Breast Surgery |
| NCT06628908 | VX24-548-110 | Ph 3 | recruiting | Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy |
| NCT07525219 | IRB00146434 | Ph 3 | not yet recruiting | Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen |
| NCT07548385 STRIDE-PAIN | STUDY-25-01392 | Ph 3 | recruiting | Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN |
| NCT07539623 SMOOTH-SURG | STUDY-25-00822 | Ph 3 | recruiting | Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery |
| NCT07534709 SPARE | STUDY00008784 | Ph 4 | not yet recruiting | Suzetrigine for Opioid-Free Recovery After Cesarean Delivery |
| NCT07226700 | 2025-1169 | Ph 3 | recruiting | Suzetrigine in Total Hip Arthroplasty |
| NCT06696443 | VX24-548-112 | Ph 3 | active not recruiting | Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN) |
| NCT07357376 | AH-ORTHO-JOURNAVX-01 | Ph 3 | not yet recruiting | Evaluating Suzetrigine for Pain Control Following TKA |
| NCT07355166 | IRB-25-2108 | Ph 4 | not yet recruiting | Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports |
| NCT06774625 | LTG-001-003 | Ph 2 | completed | This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars |
| NCT06887972 | VX24-548-113 | Ph 4 | completed | A Single-Arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Aesthetic or Reconstructive Surgeries |
| NCT06887959 | VX24-548-108 | Ph 4 | completed | A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries |
| NCT05660538 results posted | VX21-548-103 | Ph 2 | completed | Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN) |
| NCT05661734 results posted | VX22-548-107 | Ph 3 | completed | A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain |
| NCT06820307 | VX24-548-019 | Ph 1 | completed | Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants |
| NCT06336096 | VX23-548-017 | Ph 1 | completed | A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine |
| NCT07600697 | 26-0498 | Ph 4 | not yet recruiting | Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery |
| NCT07624526 | 2026P000242 | Ph 4 | not yet recruiting | Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty |
| NCT07672015 | 814697 | Ph 4 | not yet recruiting | Precision Pain Management - A Randomized Clinical Trial Assessing the Efficacy of Suzetrigine on Postoperative Analgesia Among Surgical Patients at Higher Risk for Persistent Postoperative Opioid Use (POU) |
| NCT07654296 | 2026P000126 | Ph 3 | not yet recruiting | Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JOURNAVX FDA Label Details
Indications & Usage
FDA Label (PDF)JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.
JOURNAVX Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for JOURNAVX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 1 active patents
Trial Analysis
- • 22 total trials
- • Stage: Expansion
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment