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suzetrigine

Generic: SUZETRIGINE·Brand: JOURNAVX, Journavx

suzetrigine: developed by 1 company · 14 clinical trials tracked · 1 FDA decision.

suzetrigine evidence translation

What we can confirm

1 FDA record · 14 tracked trials

What it means

Source-backed records connect suzetrigine to VRTX; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could suzetrigine → VRTX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 1 study sponsors
Development Pipeline (2)
Clinical Trials (14)showing 10 most recent

A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Subjects

NCT07570069·Phase 1·VRTX
Completed

Primary endpoint: Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz

Interventionalopen18 enrolledStarted 2026-05Completion 2026-071 site · United StatesVertex Pharmaceuticals Incorporated

A Phase 4, Double-blind, Sequential Cohort Study of Pain Treatment and Recovery After Total Knee Arthroplasty

NCT07538570·Phase 4·VRTX
Recruiting

Primary endpoint: Total Opioid Usage

Interventionalquadruple60 targetStarted 2026-04Completion 2027-012 sites · United StatesVertex Pharmaceuticals Incorporated

The Role of NaV1.8 in Human Pain Models - a Randomized, Placebo-controlled Crossover Microdosing Trial

NCT07511400·Early Phase 1
Completed

Primary endpoint: Pain Intensity: Electrical stimulation

InterventionalRandomizedtriple67 enrolledStarted 2026-04Completion 2026-061 site · AustriaMedical University of Vienna

A Phase 1, Open-label, Single-dose Study Evaluating the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Subjects

NCT07378865·Phase 1·VRTX
Recruiting

Primary endpoint: Total Amount of SUZ in Breast Milk of Lactating Female Participants

Interventionalopen12 targetStarted 2026-02Completion 2027-021 site · United StatesVertex Pharmaceuticals Incorporated

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

NCT07231419·Phase 3·VRTX
Recruiting

Primary endpoint: Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo

InterventionalRandomizedquadruple734 targetStarted 2025-11Completion 2027-0450 sites · United StatesVertex Pharmaceuticals Incorporated

A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Laparoscopic Procedures of the Intraperitoneal or Retroperitoneal Cavities or Arthroscopic Orthopedic Procedures

NCT06887959·Phase 4·VRTX
Completed

Primary endpoint: Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) for Pain Control at the End of Treatment

Interventionalopen47 enrolledStarted 2025-03Completion 2025-1117 sites · United StatesVertex Pharmaceuticals Incorporated

A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Aesthetic or Reconstructive Surgeries

NCT06887972·Phase 4·VRTX
Completed

Primary endpoint: Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global assessment (PGA) for Pain Control at the end of Treatment

Interventionalopen100 enrolledStarted 2025-03Completion 2025-115 sites · United StatesVertex Pharmaceuticals Incorporated

A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects

NCT06820307·Phase 1·VRTX
Completed

Primary endpoint: Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ

Interventionalopen50 enrolledStarted 2025-02Completion 2025-041 site · United StatesVertex Pharmaceuticals Incorporated

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG 001 for Acute Pain After Surgical Removal of Impacted Third Molars

NCT06774625·Phase 2·LTGO
Completed

Primary endpoint: SPID 0-12

InterventionalRandomizedquadruple250 enrolledStarted 2024-12Completion 2025-081 site · United StatesLatigo Biotherapeutics

A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

NCT06696443·Phase 3·VRTX
Active, not recruiting

Primary endpoint: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Interventionalopen455 targetStarted 2024-12Completion 2027-0150 sites · United StatesVertex Pharmaceuticals Incorporated
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE 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. ( 1 )(VRTX)FDA ↗
NDA219209Type 1 - New Molecular EntityPriorityOralTablet

Frequently asked questions

Who is developing suzetrigine?

suzetrigine is being developed by VERTEX PHARMACEUTICALS INC / MA.

How many clinical trials involve suzetrigine?

BioSniper tracks 14 clinical trials involving suzetrigine.

What is suzetrigine's latest FDA decision?

The most recent tracked FDA decision for suzetrigine is Approval for 1 INDICATIONS AND USAGE 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. ( 1 ), dated January 30, 2025.