Journavx

(Suzetrigine)

ApprovedSmall molecule

Vertex Pharmaceuticals

Journavx is one of 170 small molecule programs targeting Pain, Acute Postoperative. It is currently in Approved.

Indications

Total Trials

Active Trials

169

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Pain, Acute PostoperativeEnrolling by invitation

NeuralgiaActive, not recruiting

Diabetic Peripheral Neuropathic PainActive, not recruiting

Total Knee ArthroplastyActive, not recruiting

Analgesic EfficacyRecruiting

Total Hip Arthroplasty (THA)Recruiting

Postoperative Pain ManagementNot yet recruiting

OsteoarthritisNot yet recruiting

Knee Arthroplasty, TotalNot yet recruiting

Pain ControlNot yet recruiting

Pain, Acute PostoperativeApproved

Enrolling by invitation

NeuralgiaPreclinical

Active, not recruiting

Diabetic Peripheral Neuropathic PainPhase 3

Active, not recruiting

Total Knee ArthroplastyApproved

Active, not recruiting

Analgesic EfficacyPhase 3

Recruiting

Total Hip Arthroplasty (THA)Phase 3

Recruiting

Postoperative Pain ManagementApproved

Not yet recruiting

OsteoarthritisApproved

Not yet recruiting

Knee Arthroplasty, TotalApproved

Not yet recruiting

Pain ControlPhase 3

Not yet recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

143 competitors in Osteoarthritis

#DrugCompanyPhaseTrials

Journavx

Vertex Pharmaceuticals

Approved

1 2

Toradol

Roche

Preclinical

1 3

Cataflam

Bayer Aspirin

Enbrel

2 6

Chirocaine

PPurdue Pharma LP

Preclinical

1 7

Lunesta

Akero Therapeutics

Preclinical

1 8

Glucophage

EMD Serono

Preclinical

1 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Protonix

WWyeth-Lederle Vaccines

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Diabetic Peripheral Neuropathic Pain

NCT06696443

ApprovedRecruiting

Pain

NCT07538570

ApprovedNot yet recruiting

Postoperative Pain Management

NCT07355166

Phase 3Not yet recruiting

Opioid Consumption, Postoperative

NCT07654296

Q2 2027

Phase 3Recruiting

Diabetic Peripheral Neuropathic Pain

NCT07231419

Phase 3Recruiting

Peripheral Neuropathy

NCT06628908

Clinical

Trials by Indication[1]

Pain5 trials

RCT: Suzetrigine vs Norco for Post-op Pain

Not yet recruiting·JJacob Lensing·Phase 4·NCT07195669·76 enrolled

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

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT07378865·13 enrolled

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

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT07570069·18 enrolled

Show 2 more trials

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

Recruiting· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Approved·NCT07538570·60 enrolled

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

Completed·MMedical University of Vienna·Phase 1·NCT07511400·67 enrolled

Effectiveness3 trials

A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 4·NCT06887959·47 enrolled

A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 3·NCT05661734·258 enrolled

A Single-Arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Aesthetic or Reconstructive Surgeries

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 4·NCT06887972·100 enrolled

Efficacy and Safety2 trials

Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 3·NCT05558410·1,118 enrolled

This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars

Completed·LLatigo Biotherapeutics·Phase 2·NCT06774625·250 enrolled

Peripheral Neuropathy2 trials

Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

Recruiting· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 3·NCT06628908·1,100 enrolled

Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 2·NCT05660538·194 enrolled

Opioid Consumption, Postoperative2 trials

Multimodal Analgesia Pathway Assessing Role of Suzetrigine for the Reduction of Opioid Use Following Ureteroscopic Surgery

Not yet recruiting·BBrigham and Women's Hospital·Phase 3·NCT07654296·100 enrolled

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)

Recruiting·UUniversity of California, San Diego·Approved·NCT07672015·100 enrolled

18 more indications

Diabetic Peripheral Neuropathic Pain2 trials

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

Active, not recruiting· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 3·NCT06696443·455 enrolled

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

Recruiting· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 3·NCT07231419·734 enrolled

Female1 trial

Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06820307·50 enrolled

Total Knee Arthroplasty1 trial

Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty

Not yet recruiting·UUniversity of Louisville·Phase 4·NCT07219888·140 enrolled

Adult1 trial

Pharmacodynamic Study of 100mg Suzegtrigine vs Placebo in Healthy Male Adults

Completed·LLatigo Biotherapeutics·Phase 1·NCT06972212·20 enrolled

Rib Fracture1 trial

Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

Enrolling by invitation·UUniversity of California, Irvine·Phase 4·NCT07145346·80 enrolled

Surgery1 trial

A Study Of Opioid Avoidance In Surgery Through Integrating Suzetrigine

Not yet recruiting·MMayo Clinic·Phase 4·NCT07257133·40 enrolled

Pain Control1 trial

Evaluating Suzetrigine for Pain Control Following TKA

Not yet recruiting·AAdventHealth·Phase 3·NCT07357376·210 enrolled

Tonsillectomy1 trial

STOP Trial (Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management)

Not yet recruiting·SStanford University·Approved·NCT07821931·58 enrolled

Pain, Acute Postoperative1 trial

Suzetrigine for Non-Mastectomy Breast Surgery: A Non-Randomized, Prospective Study With Historic Controls

Enrolling by invitation·UUniversity of California, San Diego·Approved·NCT07463430·120 enrolled

Pelvic Organ Prolapse1 trial

Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery

Not yet recruiting·UUniversity of California, Los Angeles·Approved·NCT07600697·120 enrolled

Nail Diseases1 trial

Post-operative Analgesia of Nail Unit Procedures: A Prospective Pilot Study Comparing Suzetrigine vs. Oxycodone+Acetaminophen vs. Acetaminophen/Ibuprofen

Not yet recruiting·UUniversity of Miami·Approved·NCT07820969·45 enrolled

Knee Arthroplasty, Total1 trial

Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study

Not yet recruiting·EEndeavor Health·Approved·NCT07796152·100 enrolled

Osteoarthritis1 trial

Project Suzetrigine: The Efficacy and Safety of Suzetrigine (Journavx™) Following Total Ankle Arthroplasty: an Exploratory Prospective Cohort Study

Not yet recruiting·SSoheil Ashkani Esfahani·Approved·NCT07795827·28 enrolled

Postoperative Pain Management1 trial

Suzetrigine Versus Usual-care Opioids for Postoperative Pain After Common Ambulatory Orthopaedic Sports Procedures - A Randomized Control Trial

Not yet recruiting·UUniversity of California, Los Angeles·Approved·NCT07355166·140 enrolled

Total Hip Arthroplasty (THA)1 trial

A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty

Recruiting·HHospital for Special Surgery, New York·Phase 3·NCT07226700·210 enrolled

Analgesic Efficacy1 trial

A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application

Recruiting·WWake Forest University Health Sciences·Phase 3·NCT07525219·80 enrolled

Joint1 trial

A Single-Arm Open-Label Trial Evaluating the Efficacy of Suzetrigine (Journavx) in Multimodal Postoperative Pain Management Following Thumb Basal Joint Arthroplasty

Enrolling by invitation·RRothman Institute Orthopaedics··NCT07723352·100 enrolled

Unspecified1 trial

A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06336096·48 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 30, 2025

JOURNAVX

NDA NDA219209

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Suzetrigine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Suzetrigine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Suzetrigine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219209). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Journavx. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Vertex Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Vertex Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Dec 4, 2040

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11834441Dec 4, 2040

Journavx

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Trials by Indication[1]

Pain5 trials

Effectiveness3 trials

Efficacy and Safety2 trials

Peripheral Neuropathy2 trials

Opioid Consumption, Postoperative2 trials

Diabetic Peripheral Neuropathic Pain2 trials

Female1 trial

Total Knee Arthroplasty1 trial

Adult1 trial

Rib Fracture1 trial

Surgery1 trial

Pain Control1 trial

Tonsillectomy1 trial

Pain, Acute Postoperative1 trial

Pelvic Organ Prolapse1 trial

Nail Diseases1 trial

Knee Arthroplasty, Total1 trial

Osteoarthritis1 trial

Postoperative Pain Management1 trial

Total Hip Arthroplasty (THA)1 trial

Analgesic Efficacy1 trial

Joint1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News