Drugs / Suzetrigine
Suzetrigine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | JOURNAVX | — | 2025-01-30 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
| 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 2026 → Feb 2027 expected | — | Vertex Pharmaceuticals Incorporated | Recruiting | 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 | ||||||
| Phase 2 | NCT06176196 | Dec 2023 → Oct 2024 | radiculopathy | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT05660538 | Dec 2022 → Oct 2023 | diabetic polyneuropathy | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT05034952 | Aug → Dec 2021 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT04977336 | Jul 2021 → Feb 2022 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT07654296 | Aug → Dec 2026 expected | — | Brigham and Women's Hospital | 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 | No outcome recorded |
| Phase 3 | NCT05553366 | Oct 2022 → Dec 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT07672015 | Jul 2026 → Jun 2027 expected | — | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 4 | NCT07600697 | Jul 2026 → Jul 2027 expected | female stress incontinence, pelvic organ prolapse | University of California, Los Angeles | Not yet 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 → Dec 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 |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06774625 Comparator | Dec 2024 → Aug 2025 | — | Latigo Biotherapeutics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07575230 Comparator | Nov 2025 → Dec 2027 expected | skin neoplasm | Baylor Research Institute | Enrolling by invitation | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-05 | Vertex Pharmaceuticals Incorporated | Vertex to Present New Data on JOURNAVX® That Demonstrates Effective Pain Management Following Aesthetic and Reconstructive Procedures vrtx.com ↗ |
| 2025-09-23 | Vertex Pharmaceuticals Incorporated | Vertex Partners with Basketball World Champion Jayson Tatum to Raise Awareness of JOURNAVX®, a Non-Opioid Medicine Approved for the Treatment of Moderate-to-Severe-Acute Pain vrtx.com ↗ |
| 2025-07-14 | Vertex Pharmaceuticals Incorporated | Vertex Named a Premier, Inc. Breakthroughs Innovation Celebration Winner for JOURNAVX™, a First-in-Class Non-Opioid Treatment for Adults With Moderate-to-Severe Acute Pain vrtx.com ↗ |
| 2025-01-30 | Vertex Pharmaceuticals Incorporated | Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain vrtx.com ↗ |
| 2024-12-19 | Vertex Pharmaceuticals Incorporated | Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy vrtx.com ↗ |
| 2024-10-18 | Vertex Pharmaceuticals Incorporated | Vertex to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the American Society of Anesthesiologists Annual Meeting vrtx.com ↗ |
| 2024-07-30 | Vertex Pharmaceuticals Incorporated | Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain vrtx.com ↗ |
| 2024-04-18 | Vertex Pharmaceuticals Incorporated | Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain vrtx.com ↗ |
| 2024-01-30 | Vertex Pharmaceuticals Incorporated | 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 | Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy vrtx.com ↗ |
| 2023-08-03 | Vertex Pharmaceuticals Incorporated | Vertex Announces Publication of VX-548 Positive Phase 2, Proof-of-Concept Results in New England Journal of Medicine vrtx.com ↗ |
| 2022-07-22 | Vertex Pharmaceuticals Incorporated | Vertex Advances VX-548 in Acute and Neuropathic Pain vrtx.com ↗ |
| 2022-03-31 | Vertex Pharmaceuticals Incorporated | 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 ↗ |
| 2021-07-19 | Vertex Pharmaceuticals Incorporated | Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain vrtx.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 48 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 ↗33 |
| Known as | Journavx | “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 20266“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 ↗ “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 ↗ |
| 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 |