Drugs / Suzetrigine
Suzetrigine
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | JOURNAVX | — | 2025-01-30 | fda.gov ↗ |
| Filed | US (FDA) | — | acute pain | 2024-07-30 | “FDA has accepted its New Drug Application (NDA) submission for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain.” vrtx.com ↗ “accepted the NDA submission for suzetrigine for the treatment of moderate-to-severe acute pain” vrtx.com ↗ |
| Filed | US (FDA) | — | acute pain | 2024-04-18 | “Rolling submission for suzetrigine moderate-to-severe acute pain NDA granted by FDA; first module submitted” vrtx.com ↗ |
| Filed | Other | JOURNAVX | acute pain | — | “Health Canada accepted Vertex’s new drug submission for suzetrigine for the treatment of moderate-to-severe acute pain” vrtx.com ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07511400 | Apr → Jun 2026 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 0 | NCT06972212 | Jun 2025 | — | Latigo Biotherapeutics | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT07570069 | May → Jul 2026 overdue | — | Vertex Pharmaceuticals Incorporated | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07378865 | Feb → Aug 2026 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT06820307 | Feb → Apr 2025 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT06420765 | May 2024 → Mar 2025 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT06336096 | Mar → Jun 2024 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05851157 | May → Oct 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05818852 | Apr → Jun 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05704556 | Feb 2023 → Mar 2024 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05635110 | Dec 2022 → Jun 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05560464 | Oct 2022 → Jul 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05541471 | Sep 2022 → Apr 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05455502 | Jul → Sep 2022 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 24 trials · 4 met primary | ||||||
| Phase 2 | NCT06176196 | Dec 2023 → Oct 2024 | radiculopathy | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2 | NCT05660538 | Dec 2022 → Oct 2023 | diabetic polyneuropathy | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2 | NCT05034952 | Aug → Dec 2021 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2 | NCT04977336 | Jul 2021 → Feb 2022 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 314 trials · 2 met primary | ||||||
| Phase 3 | NCT07864896 | Oct 2026 → Jan 2029 expected | — | Hospital for Special Surgery, New York | Recruiting | No outcome recorded |
| Phase 3 | NCT07654296 | Oct → Dec 2026 expected | — | Brigham and Women's Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07839715 | Sep 2026 → Aug 2027 expected | — | Vanderbilt University Medical Center | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07525219 | Jul 2026 → Jul 2027 expected | — | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07539623 | May → Dec 2026 expected | — | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 3 | NCT07548385 | Apr 2026 → Feb 2027 expected | — | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 3 | NCT07357376 | Mar → Jul 2026 overdue | — | AdventHealth | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07231419 | Nov 2025 → Apr 2027 expected | diabetic polyneuropathy | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 3 | NCT07226700 | Nov 2025 → Nov 2027 expected | — | Hospital for Special Surgery, New York | Recruiting | No outcome recorded |
| Phase 3 | NCT06696443 | Dec 2024 → Jan 2027 expected | diabetic polyneuropathy | Vertex Pharmaceuticals Incorporated | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06628908 | Oct 2024 → May 2027 expected | diabetic polyneuropathy | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 3 | NCT05661734 | Jan → Dec 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT05558410 | Oct 2022 → Aug 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 3 | NCT05553366 | Oct 2022 → Dec 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 422 trials | ||||||
| Phase 4 | NCT07843134 | Apr 2027 → Apr 2029 expected | skin cancer | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07866638 | Nov 2026 → Sep 2028 expected | — | University of Alabama at Birmingham | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07600697 | Nov 2026 → Jul 2027 expected | female stress incontinence, pelvic organ prolapse | University of California, Los Angeles | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07821931 | Nov 2026 → Jun 2027 expected | — | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07856654 | Nov 2026 → Dec 2027 expected | pelvic organ prolapse | Aditi Talkad | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07836010 | Nov 2026 → Jan 2028 expected | — | Duke University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07820969 | Oct 2026 → Oct 2028 expected | nail disorder | University of Miami | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07795827 | Oct 2026 → Oct 2027 expected | osteoarthritis | Soheil Ashkani Esfahani | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07829718 | Sep 2026 → Dec 2030 expected | — | Ohio State University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07796152 | Sep 2026 → Dec 2027 expected | — | Endeavor Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07672015 | Jul 2026 → Jun 2027 expected | — | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 4 | NCT07624526 | Jul 2026 → Aug 2028 expected | osteoarthritis, knee | Emory University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07534709 | Jun 2026 → Feb 2028 expected | — | University of Texas at Austin | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07538570 | Apr 2026 → Jan 2027 expected | — | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 4 | NCT07463430 | Apr 2026 → Jun 2027 expected | breast disorder | University of California, San Diego | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07219888 | Feb → Dec 2026 expected | osteoarthritis, knee | University of Louisville | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07355166 | Feb → Jul 2026 overdue | — | University of California, Los Angeles | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07145346 | Nov 2025 → Aug 2027 expected | — | University of California, Irvine | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07257133 | Oct 2025 → Mar 2026 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT07195669 | Oct → Dec 2025 overdue | — | Jacob Lensing | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06887959 | Mar → Oct 2025 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT06887972 | Mar → Oct 2025 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT06774625 Comparator | Dec 2024 → Aug 2025 | — | Latigo Biotherapeutics | Completed | No outcome recorded |
| Phase 3 | NCT07296770 Background | Oct 2026 → Dec 2028 expected | chronic pain syndrome | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07575230 Comparator | Nov 2025 → Dec 2027 expected | skin neoplasm | Baylor Research Institute | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-03-05 | Vertex Pharmaceuticals Incorporated | Results Vertex to Present New Data on JOURNAVX® That Demonstrates Effective Pain Management Following Aesthetic and Reconstructive Procedures vrtx.com ↗
These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. |
| 2025-01-30 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. |
| 2024-12-19 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy vrtx.com ↗
The study met its primary endpoint with statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS). |
| 2024-07-30 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submission for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain. |
| 2024-04-18 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain vrtx.com ↗
Following the positive Phase 3 results in acute pain announced in January 2024, the Food and Drug Administration (FDA) has granted a rolling New Drug Application (NDA) submission for suzetrigine in moderate-to-severe acute pain. |
| 2024-01-30 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain vrtx.com ↗ |
| 2023-12-13 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). |
| 2023-08-03 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Publication of VX-548 Positive Phase 2, Proof-of-Concept Results in New England Journal of Medicine vrtx.com ↗
today announced publication in the New England Journal of Medicine (NEJM) of preclinical data and the results from its Phase 2 proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty and bunionectomy surgeries. |
| 2022-03-31 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Statistically Significant and Clinically Meaningful Results From Two Phase 2 Proof-of-Concept Studies of VX-548 for the Treatment of Acute Pain vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from two Phase 2 proof-of-concept (POC) studies that investigated treatment with the selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty surgery or bunionectomy surgery. |
All press releases naming this drug 15 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | suzetrigine | “The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.” NCT05553366 ↗ |
| Known as | Journavx | “The purpose of this research is to see if a person having an outpatient total knee replacement will have a difference in their pain and the amount of pain medication (opioids)...” NCT07796152 ↗10“Suzetrigine (JOURNAVX), an oral, first-in-class, selective NaV1.8 inhibitor, administered as a 100 mg (2-tablet) loading dose on the evening of surgery, followed by 50 mg every...” NCT07856654 ↗ “Suzetrigine (Journavx) is a first-in-class, oral, non-opioid analgesic that selectively inhibits the voltage-gated sodium channel 1.8 (NaV1.8), a peripheral nociceptive pathway...” PMID 42156226 ↗ May 2026 “Suzetrigine (Journavx) is a newly United States Food and Drug Administration (FDA)-approved, oral non-opioid analgesic that selectively inhibits the NaV1.8 voltage-gated sodium...” NCT07145346 ↗ “This research study is being conducted to see whether adding suzetrigine (Journavx), an FDA-approved non-opioid pain medication, to the standard Enhanced Recovery After Surgery...” NCT07839715 ↗ “Suzetrigine (VX-548, marketed as Journavx™) is a first-in-class, non-opioid analgesic approved by the U.S. Food and Drug Administration (FDA) in January 2025 for the treatment...” NCT07226700 ↗ “Suzetrigine (Brand name: Journavx), a selective inhibitor of NaV1.7/NaV1.8 channels, has emerged as a promising candidate.” NCT07357376 ↗ “Suzetrigine (JOURNAVX®) administered orally consisting of a course that lasts up to a maximum of 14 days.” NCT07624526 ↗ “Journavx (suzetrigine) is a novel non-opioid analgesic that is FDA approved for acute pain management” NCT07195669 ↗ “Suzetrigine (marketed as Journavx in the US)” NCT07511400 ↗ “Drug: Suzetrigine (Journavx)” NCT07866638 ↗ |
| Known as | SUZ | “Drug: Suzetrigine (SUZ)” NCT07145346 ↗ |
| Known as | SUZETRIGINA | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314487 ↗ |
| Known as | VRT-1737548 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314487 ↗ |
| Known as | VX-548 | “Suzetrigine (VX-548, marketed as Journavx™) is a first-in-class, non-opioid analgesic approved by the U.S. Food and Drug Administration (FDA) in January 2025 for the treatment...” NCT07226700 ↗ |
| Known as | VXC-548 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314487 ↗ |
| Action | Inhibit | “highly selective inhibitor of NaV1.8” PMID 37530822 ↗ Aug 2023 |
| Modality | Small molecule | — CHEMBL5314487 ↗ |
| Route | Oral | “The effect of VX-548, an oral, highly selective inhibitor of NaV1.8, on control of acute pain is being studied.” PMID 37530822 ↗ Aug 2023 |