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VX-993

Phase 2

Acute Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 1, 2026

Target and mechanism

Molecular targetNaV1.8
Target classIon Channel
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment367

FDA Designations

No designations recorded

Clinical trial landscape

VX-993 · 8 trials · 3 indications

Phase 2 2Phase 1 6
NCT06619847A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a BunionectomyAcute Pain
COMPLETED367 Analytics
NCT06619860Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral NeuropathyDiabetic Peripheral Neuropathic Pain
RECRUITING300 Analytics
PHASE2COMPLETED
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
Acute Pain
NCT06619847367
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PHASE2RECRUITING
Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain
NCT06619860300
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Study Endpoints

Primary Endpoints

Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
From 0 to 48 Hours After the First Dose of Study Drug
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12
From Baseline up to Week 12
Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993
From Day 1 up to Day 14
Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993
From Day 1 up to Day 14
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Metformin in Absence and Presence of VX-993
From Day 1 up to Day 14
Maximum Observed Plasma Concentration (Cmax) of VX-993
From Day 1 up to Day 28
Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993
From Day 1 up to Day 28
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993
From Day 1 up to Day 28
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 16
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 43
Part A: Maximum Observed Plasma Concentration (Cmax) of Midazolam in Absence or Presence of VX-993
Pre-dose up to Day 15
Part A: Maximum Observed Plasma Concentration (Cmax) of 1-Hydroxy-Midazolam in Absence or Presence of VX-993
Pre-dose up to Day 15
Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993
Pre-dose up to Day 15
Part A: Area Under the Concentration Versus Time Curve (AUC) of 1-Hydroxy-Midazolam in Absence and Presence of VX-993
Pre-dose up to Day 15
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Itraconazole
Pre-dose up to Day 27
Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Itraconazole
Pre-dose up to Day 27
Part C: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil
Pre-dose up to Day 27
Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Gemfibrozil
Pre-dose up to Day 27
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Pre-dose up to Day 25

Secondary Endpoints

Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours
At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=50% Reduction in NPRS at 48 Hours
At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=70% Reduction in NPRS at 48 Hours
At 48 Hours After the First Dose of Study Drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VX-993EXPERIMENTALParticipants will be randomized to receive different dose levels of VX-993.
Hydrocodone bitartrate/acetaminophen (HB/APAP)ACTIVE_COMPARATORParticipants will be randomized to receive HB/APAP.
PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to VX-993 and HB/APAP
PregabalinACTIVE_COMPARATORParticipants will be randomized to receive Pregabalin.
VX-993 and MetforminEXPERIMENTALMetformin will be administered to participants as a single oral dose on Day 1 and then co-administered with VX-993 on Day 10. VX-993 dose will be administered every 12 hours (q12h) from Day 5 through Day 14.
Part A: Single Ascending Dose (SAD)EXPERIMENTALParticipants will be randomized to receive a single dose of different dose levels of VX-993.
Part B: Multiple Ascending Dose (MAD)EXPERIMENTALParticipants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.
Placebo Part APLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to VX-993.
Placebo Part BPLACEBO_COMPARATORParticipants will be randomized to receive multiple doses of placebo matched to VX-993.
Part A: MidazolamEXPERIMENTALParticipants will receive a single dose of Midazolam in absence and presence of VX-993.
Part B: ItraconazoleEXPERIMENTALParticipants will receive a single dose of VX-993 on Day 1 and Itraconazole once daily (qd) on Days 7 through Day 15. On Day 10 participants will receive Itraconazole followed by VX-993.
Part C: GemfibrozilEXPERIMENTALParticipants will receive a single dose of VX-993 on Day 1 and Gemfibrozil every 12 hours (q12d) on Days 7 through Day 15. On Day 10 participants will receive Gemfibrozil followed by VX-993.
Part A: PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to VX-993.
Part B: PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to VX-993.

Interventions

NameTypeDescription
VX-993DRUGTablets for oral administration.
HB/APAPDRUGCapsules for oral administration.
Placebo (matched to VX-993)DRUGPlacebo matched to VX-993 for oral administration.
Placebo (matched to HB/APAP)DRUGPlacebo matched to HB/APAP for oral administration.
PregabalinDRUGCapsules for oral administration.
Placebo (matched to pregabalin)DRUGPlacebo matched to pregabalin for oral administration.
MetforminDRUGTablets for Oral Administration.
PlaceboDRUGSolution for IV administration.
GemfibrozilDRUGTablets for Oral Administration.
ItraconazoleDRUGCapsules for Oral Administration.
MidazolamDRUGSolution for Oral Administration.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Key Inclusion Criteria: Before Surgery: * Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block) After Surgery: * Participant is lucid and able to follow comma...

Countries:United StatesCanadaFranceGermanyItalyUnited Kingdom
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

CompanyTickerTrialsLead PhaseDrugs
Fresenius Medical Care AG Sponsored ADRFMS2PHASE3Dialysis
AstraZeneca PLCAZN1PHASE2AZD4144
CalciMedica, Inc.CALC1PHASE2Auxora
Talphera, Inc.TLPH1N/AUndisclosed
SeaStar Medical Holding CorporationICU2 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1 - Flozin
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Recent Changes (Last 90 Days)

MEDIUMJun 28, 2026NCT06619847TRIAL_REMOVED: changed
MEDIUMJun 28, 2026NCT06619847TRIAL_REMOVED: changed
MEDIUMJun 28, 2026NCT06619847TRIAL_REMOVED: changed
MEDIUMJun 28, 2026NCT06619847TRIAL_REMOVED: changed

Frequently asked questions about VX-993

What is VX-993 used for?

VX-993 is an investigational small molecule being developed for the treatment of pain, including diabetic peripheral neuropathic pain and acute pain. It is currently in Phase 2 clinical development for diabetic peripheral neuropathic pain.

What does VX-993 target?

VX-993 targets the NaV1.8 ion channel, a voltage-gated sodium channel involved in pain signaling. By modulating this channel, the drug aims to reduce pain transmission.

Who makes VX-993?

VX-993 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX.

What phase is VX-993 in?

VX-993 is in Phase 2 clinical development. It has completed Phase 1 trials and is currently being evaluated in a Phase 2 study for diabetic peripheral neuropathic pain.

What clinical trials is VX-993 in?

VX-993 has been studied in several clinical trials, including NCT05653323, NCT06226454, and NCT06392659, which were Phase 1 studies in healthy volunteers. The ongoing Phase 2 trial, NCT06619860, is evaluating the drug for diabetic peripheral neuropathic pain.

Is VX-993 the same as any other drug?

VX-993 is a distinct investigational compound developed by Vertex Pharmaceuticals. No alternative names for VX-993 have been reported.