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Suzetrigine

Phase 3

Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials5
Total Enrollment386
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05661734A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute PainPHASE3 COMPLETED 258 — — Jan 9, 2023Dec 12, 2023Jul 1, 202514 United States
NCT07570069Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy ParticipantsPHASE1 RECRUITING 18 — — May 7, 2026Jul 11, 2026Jun 2, 20261 United States
NCT07378865Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female ParticipantsPHASE1 RECRUITING 12 — — Feb 13, 2026Feb 26, 2027May 13, 20261 United States
NCT06820307Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female ParticipantsPHASE1 COMPLETED 50 — — Feb 25, 2025Apr 29, 2025May 29, 20251 United States
NCT06336096A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of SuzetriginePHASE1 COMPLETED 48 — — Mar 28, 2024Jun 19, 2024Jul 19, 20241 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
Day 15 and Day 30
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCτ) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
Day 15 and Day 30
Total Amount of SUZ in Breast Milk of Lactating Female Participants
From Day 1 up to Day 10
Total Amount of SUZ Metabolite in Breast Milk of Lactating Female Participants
From Day 1 up to Day 10
Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ
Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of SUZ
Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of DRSP and EE in the Absence and Presence of SUZ
Pre-dose up to Day 25 Post-dose
Part B: Maximum Observed Plasma Concentration (Cmax) of NGM Metabolites and EE in the Absence and Presence of SUZ
Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NGM Metabolites and EE in the Absence and Presence of SUZ
Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of NGM Metabolites and EE in the Absence and Presence of SUZ
Pre-dose up to Day 29 Post-dose
Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ
Pre-dose up to Day 43
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ
Pre-dose up to Day 43
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ
Pre-dose up to Day 43
Part B: Cmax of SUZ
Pre-dose up to Day 29
Part B: AUC0-tlast of SUZ
Pre-dose up to Day 29
Part B: AUC0-inf of SUZ
Pre-dose up to Day 29
Secondary Endpoints
Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale
Day 14 or at Pain Resolution, whichever occurs first
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Day 46
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ and its Metabolite in Breast Milk
From Day 1 up to Day 10
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Suzetrigine (SUZ)EXPERIMENTALParticipants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.
SUZ and EfavirenzEXPERIMENTALParticipants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30.
SUZEXPERIMENTALParticipants will receive a single dose of SUZ on Day 1.
Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE)EXPERIMENTALParticipants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25.
Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE)EXPERIMENTALParticipants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29.
Part AEXPERIMENTALParticipants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period.
Part BEXPERIMENTALParticipants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period.
Interventions
NameTypeDescription
SuzetrigineDRUGTablets for oral administration.
EfavirenzDRUGTablet for oral administration.
DRSP/EEDRUGCombination Tablets for Oral Administration.
NGM/EEDRUGCombination Tablets for Oral Administration.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites14

Key Inclusion Criteria: * Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2) * Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating sc...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT07570069Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 2, 2026NCT07570069Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 2, 2026NCT07570069Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07378865primaryCompletionDate: changed
LOWMay 26, 2026NCT07570069primaryCompletionDate: changed
LOWMay 24, 2026NCT07378865studyFirstPostDate: changed
LOWMay 24, 2026NCT07570069studyFirstPostDate: changed
LOWMay 21, 2026NCT07570069NEW_TRIAL: changed
LOWMay 21, 2026NCT07570069NEW_TRIAL: changed