Clinical Trials

Numerous clinical trials spanning Early Phase 1 to Phase 4 evaluate suzetrigine (VX-548) for managing acute postoperative pain following procedures such as transvaginal pelvic reconstruction, Mohs surgery, and ureteroscopy, alongside chronic conditions like diabetic peripheral neuropathic pain and knee osteoarthritis. Sponsored by both commercial entities and academic medical centers, these protocols represent various recruitment statuses, including completed, active not recruiting, enrolling by invitation, and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07624526 NOT_YET_RECRUITING
Knee Arthritis; Knee Osteoarthritis
Emory University
 2026-07 PHASE4
NCT07534709 NOT_YET_RECRUITING
Cesarean Delivery; Cesarean Section; Pain, Postoperative; Opioid Consumption, Postoperative
University of Texas at Austin
 2026-06 PHASE4
NCT07463430 ENROLLING_BY_INVITATION
Pain, Acute Postoperative; Breast Disease
University of California, San Diego
 2026-04-14 PHASE4
NCT07575230 ENROLLING_BY_INVITATION
Cutaneous Tumors; Mohs Micrographic Surgery
Baylor Research Institute
 2025-11-03 PHASE4
NCT07796152 NOT_YET_RECRUITING
Knee Arthroplasty, Total; Post Operative Pain, Acute; Opioid Consumption, Postoperative
Endeavor Health
 2026-09 PHASE4
NCT07226700 RECRUITING
Total Hip Arthroplasty (THA); Total Hip Arthroplasty \(THA\); Total Hip Replacement; Total Hip Replacement Surgery; Total Hip Replacements; Total Hip Replacement Arthroplasty; Suzetrigine; Pain Management; Pain; Nav 1.8; JOURNAVX; Opioid Cessation; Opioid Consumption, Postoperative; Multimodal Analgesia; Randomized Controlled Trial; Randomized Controlled Study; Randomized Controlled Trials
Hospital for Special Surgery, New York
 2025-11-03 PHASE3
NCT07795827 NOT_YET_RECRUITING
Ankle Osteoarthritis; Postoperative Pain; Acute Pain
Soheil Ashkani Esfahani
 2026-10-01 PHASE4
NCT07145346 ENROLLING_BY_INVITATION
Rib Fractures
University of California, Irvine
 2025-11-13 PHASE4
NCT07600697 NOT_YET_RECRUITING
Pelvic Organ Prolapse (POP); Stress Urinary Incontinence (SUI); Postoperative Pain
University of California, Los Angeles
 2026-07-01 PHASE4
NCT07525219 RECRUITING
Analgesic Efficacy
Wake Forest University Health Sciences
 2026-06-22 PHASE3
NCT07672015 RECRUITING
Opioid Consumption, Postoperative
University of California, San Diego
 2026-07-02 PHASE4
NCT06628908 RECRUITING
Diabetic Peripheral Neuropathic Pain
Vertex Pharmaceuticals Incorporated
 2024-10-01 PHASE3
NCT07231419 RECRUITING
Diabetic Peripheral Neuropathic Pain
Vertex Pharmaceuticals Incorporated
 2025-11-21 PHASE3
NCT07378865 RECRUITING
Pain
Vertex Pharmaceuticals Incorporated
 2026-02-13 PHASE1
NCT07548385 RECRUITING
Total Knee Replacement Surgery; Post-operative Pain
Icahn School of Medicine at Mount Sinai
 2026-04 PHASE3
NCT07538570 RECRUITING
Pain
Vertex Pharmaceuticals Incorporated
 2026-04-24 PHASE4
NCT06696443 ACTIVE_NOT_RECRUITING
Diabetic Peripheral Neuropathic Pain
Vertex Pharmaceuticals Incorporated
 2024-12-18 PHASE3
NCT07355166 NOT_YET_RECRUITING
Postoperative Pain Management
University of California, Los Angeles
 2026-09 PHASE4
NCT07654296 NOT_YET_RECRUITING
Opioid Consumption, Postoperative; Multimodal Analgesia; Ureteroscopy; Ureteral Stents; Ureteral Stent-Related Symptoms
Brigham and Women's Hospital
 2026-08-01 PHASE3
NCT07219888 ENROLLING_BY_INVITATION
Osteoarthritis (OA) of the Knee
University of Louisville
 2026-02-09 PHASE4
NCT07539623 RECRUITING
Bariatric Surgery; Cardiac Surgery With Sternotomy; Post-operative Pain
Icahn School of Medicine at Mount Sinai
 2026-05-01 PHASE3
NCT07570069 COMPLETED
Pain
Vertex Pharmaceuticals Incorporated
 2026-05-07 PHASE1
NCT07357376 NOT_YET_RECRUITING
Postoperative Pain Following Knee Arthroplasty
AdventHealth
 2026-03-01 PHASE3
NCT07511400 COMPLETED
Pain; Acute Pain; Healthy Volunteer Study
Medical University of Vienna
 2026-04-21 EARLY_PHASE1
NCT07257133 COMPLETED
Post Operative Pain
Mayo Clinic
 2025-10-20 PHASE4
NCT07195669 NOT_YET_RECRUITING
Pain Control
Jacob Lensing
 2025-10-01 PHASE4
NCT06887959 COMPLETED
Acute Pain
Vertex Pharmaceuticals Incorporated
 2025-03-27 PHASE4
NCT06887972 COMPLETED
Acute Pain
Vertex Pharmaceuticals Incorporated
 2025-03-21 PHASE4
NCT06774625 COMPLETED
Acute Pain, Postoperative
Latigo Biotherapeutics
 2024-12-19 PHASE2
NCT06972212 COMPLETED
Pain Detection; Pain Threshold
Latigo Biotherapeutics
 2025-06-04 EARLY_PHASE1
NCT06820307 COMPLETED
Pain
Vertex Pharmaceuticals Incorporated
 2025-02-25 PHASE1
NCT06834009 COMPLETED
Pain
Vertex Pharmaceuticals Incorporated
 2025-03-10 PHASE1
NCT06336096 COMPLETED
Pain
Vertex Pharmaceuticals Incorporated
 2024-03-28 PHASE1
NCT05661734 COMPLETED
Pain
Vertex Pharmaceuticals Incorporated
 2023-01-09 PHASE3
NCT05660538 COMPLETED
Diabetic Peripheral Neuropathy
Vertex Pharmaceuticals Incorporated
 2022-12-20 PHASE2
NCT05558410 COMPLETED
Acute Pain
Vertex Pharmaceuticals Incorporated
 2022-10-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Suzetrigine (VX-548) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Suzetrigine (VX-548) is a highly selective inhibitor of voltage-gated sodium channel 1.8 (NaV1.8) that potently blocks sodium influx into peripheral sensory neurons, thereby suppressing action potential propagation and nociceptive signal transmission. By inhibiting primary afferent nociception without engaging central pathways, this targeted channel block reduces pain hypersensitivity, providing effective non-opioid analgesia for conditions evaluated in clinical trials, including acute postoperative pain and diabetic peripheral neuropathic pain.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.