PharmaRadar360

PharmaRadar360

PainDrug intelligence

Journavx

Suzetrigine

Selective NaV1.8 sodium channel blocker. Developed by Vertex. Clinical, regulatory, and source evidence are connected below.

Company
Vertex
Target / MOA
NaV1.8 路 SCN10A
Aliases
Journavx
Signals
20
Clinical trials
19
Approvals
0
Evidence sources
20

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

Phase 3 路 ACTIVE_NOT_RECRUITING 路 Vertex Pharmaceuticals Incorporated

clinical trialClinicalTrials.gov

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

Phase 3 路 RECRUITING 路 Vertex Pharmaceuticals Incorporated

clinical trialClinicalTrials.gov

Suzetrigine in TKA

Phase 3 路 RECRUITING 路 Hospital for Special Surgery, New York

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Journavx 路 NDA219209 路 label version 10, effective Oct 2, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.

European Union (EMA)

EMA's medicines data lists no marketing authorisation for this medicine.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA219209 路 VERTEX PHARMS INC 路 first approved Jan 30, 2025

European Union

EMA's medicines data lists no marketing authorisation for this medicine.

    Patents and exclusivity

    What FDA lists (US)

    Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

    NDA219209 (Orange Book)

    1 listed patent, latest expiry Dec 4, 2040
    • US 11834441 路 expires Dec 4, 2040 路 drug substance, drug product, U-4125

    Exclusivity: NCE until Jan 30, 2030 路 Orange Book entry

    Generics and biosimilars

    The Orange Book lists no approved generic (ANDA).

    FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

    Safety

    Boxed warnings and FDA safety communications

    The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

    Boxed warning

    The current US label has no boxed warning.

    FDA Drug Safety Communications

    None on FDA's list names this drug.

    Clinical trials

    Key active studies

    A focused view of recently updated studies 路 19 linked records.

    Phase 3ACTIVE NOT RECRUITINGNCT06696443

    Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

    Vertex Pharmaceuticals Incorporated 路 Updated Oct 19, 2026

    Phase 3RECRUITINGNCT06628908

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

    Vertex Pharmaceuticals Incorporated 路 Updated Oct 15, 2026

    Phase 3RECRUITINGNCT07864896

    Suzetrigine in TKA

    Hospital for Special Surgery, New York 路 Updated Oct 13, 2026

    Phase 4NOT YET RECRUITINGNCT07866638

    Suzetrigine for Analgesiain Arthroscopic Rotator Cuff Repair

    University of Alabama at Birmingham 路 Updated Oct 8, 2026

    Phase 4NOT YET RECRUITINGNCT07856654

    Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management

    Aditi Talkad 路 Updated Oct 2, 2026

    Phase 4NOT YET RECRUITINGNCT07820969

    Post-op Analgesia of Nail Unit Procedures

    University of Miami 路 Updated Oct 1, 2026

    Regulatory timeline

    Approvals and agency activity

    Verified regulatory records in reverse chronological order.

    No regulatory event is available in this snapshot.

    Source evidence

    Where this profile comes from

    Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

    ClinicalTrials.govofficial 路 Latest Oct 19, 202620
    Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.