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NCT06628908Phase 3RECRUITING

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

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Conditions
Diabetic Peripheral Neuropathic Pain
Interventions / Drugs
SuzetriginePlacebo (matched to SUZ)PregabalinPlacebo (matched to Pregabalin)
View on ClinicalTrials.gov ↗
Sponsor
VRTX
Vertex Pharmaceuticals
Gene Therapy
F22/100
Study Details
Enrollment1100 participants
Primary Completion—
Lead SponsorVertex Pharmaceuticals Incorporated
Data Retrieved2026-04-11 02:55:58.035323+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 1,100 participants
Sponsor Catalyst Profile

Vertex Pharmaceuticals (VRTX) is the sponsoring company for this trial. BiotechSign currently grades this company F (22/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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