TheraRadar
Data updated: May 26, 2026

JOURNAVX (suzetrigine)

Sodium Channel Antagonists Trial Activity: Expansion 13 active trials
First-in-Class Breakthrough Therapy Priority Review Fast Track
Pain Approved 2025-01-30

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.

Source: FDA Label • Vertex Pharmaceuticals • Sodium Channel Blocker

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

Vertex Pharmaceuticals Incorporated conducting 12 trials (55%)
34 indications explored (Broad Platform)
pain (7 trials)
diabetic peripheral neuropathic pain (3 trials)
opioid consumption, postoperative (2 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
1
Years on Market

Details

Status
Prescription
First Approved
2025-01-30
Patent Cliff
2040

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Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: SUZETRIGINE

JOURNAVX Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2026
Jan 2026 SUPPL
Label · Labeling
Jan 2025 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity

What JOURNAVX Treats

2 indications

JOURNAVX 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
Source: FDA Label

JOURNAVX Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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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

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UPJOHN
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CELECOXIB
CELECOXIB
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PHARMOBEDIENT
Shared indications:
Acute Pain
COMBOGESIC
ACETAMINOPHEN
1 shared
AFT PHARMS US
Shared indications:
Acute Pain
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Clinical Trial Registry

23 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 not yet 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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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 Acute Pain; Postoperative Pain.

View full patent landscape →
1 OB patents · 1 families · 51 international docs across 36 countries

JOURNAVX Patents & Exclusivity

Latest Patent: Dec 2040
Exclusivity: Jan 2030

Patents (1 active)

US11834441 Expires Dec 4, 2040

Exclusivity

NCE Until Jan 2030
Source: FDA Orange Book

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

  • 13 similar drugs
  • Same target/indication analysis
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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