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VX-973

Phase 1

Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: Aug 26, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06615570A Phase 1 Dose Escalation Study of VX-973 in Healthy ParticipantsPHASE1 COMPLETED 30 — — Sep 30, 2024Jul 21, 2025Aug 26, 20251 United States
NCT05866055A Phase 1 Dose Escalation Study of VX-973 in Healthy AdultsPHASE1 COMPLETED 30 — — May 10, 2023Apr 4, 2024May 6, 20241 United Kingdom
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Study Endpoints
Primary Endpoints
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day -1 up to Day 30
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day -1 up to Day 85
Secondary Endpoints
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973
From Day 1 up to Day 30
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973
From Day 1 up to Day 85
Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973
From Day 1 up to Day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Single Ascending DoseEXPERIMENTALParticipants will be randomized to receive a single dose of VX-973 under fasted conditions.
Part B: Multiple Ascending DoseEXPERIMENTALParticipants will be randomized to receive multiple doses of VX-973 under fasted conditions.
Placebo Part APLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to VX-973.
Placebo Part BPLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to VX-973.
Interventions
NameTypeDescription
VX-973DRUGSuspension for oral administration.
PlaceboDRUGSuspension for oral administration.
MidazolamDRUGSyrup for oral administration.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg * Participants of non-childbearing potential * Nonsmoker or ex-smoker for at least 3 months before screening Key Exclusion Criteria: * History of febri...

Countries:United StatesUnited Kingdom
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