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VX-150

Phase 2

Acute Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: Apr 20, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment493

FDA Designations

No designations recorded

Clinical trial landscape

VX-150 · 6 trials · 4 indications

Phase 2 4Phase 1 2
NCT03764072A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following BunionectomyAcute Pain
COMPLETED250 Analytics
NCT03304522A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber NeuropathySmall Fiber Neuropathy
COMPLETED89 Analytics
NCT03206749A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following BunionectomyAcute Pain
COMPLETED243 Analytics
NCT02660424A Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the KneeOsteoarthritis
COMPLETED124 Analytics
PHASE2COMPLETED
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Acute PainUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
Small Fiber NeuropathyUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Acute PainUnlock trial analytics
PHASE2COMPLETED
A Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the Knee
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose
0 to 24 Hours After First Dose

SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).

Change in Weekly Average of Daily Pain Intensity on the 11 Point NRS
From Baseline at Week 6

Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain.

Time-weighted Sum of the Pain Intensity Difference (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose
0 to 24 hours after the first dose

SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).

Change from baseline in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index pain subscale score at Day 14
from baseline at Day 14
Change From Baseline in Activity Dependent Slowing (ADS) Over Time
From Pre-dose up to 2-hours Post Dose
Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time
From Baseline up to 3 Hours After Dose

Secondary Endpoints

Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose
0 to 48 Hours After First Dose
Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo
From Baseline at 24 Hours After First Dose
Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
From Baseline at 24 Hours After First Dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received placebo matched to VX-150 for 2 days.
VX-150 - Dose Level 1EXPERIMENTALParticipants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
VX-150 - Dose Level 2EXPERIMENTALParticipants received VX-150 1000 mg once daily (qd) for 2 days.
VX-150 - Dose Level 3EXPERIMENTALParticipants received VX-150 500 mg q12h for 2 days.
VX-150 - Dose Level 4EXPERIMENTALParticipants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
VX-150 - Dose Level 5EXPERIMENTALParticipants received VX-150 250 mg qd for 2 days.
VX-150EXPERIMENTAL -
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)ACTIVE_COMPARATOR -
VX-150, placeboEXPERIMENTALSequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2
placebo, VX-150EXPERIMENTALSequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2
VX-548EXPERIMENTALParticipants will be randomized to receive a single dose of different dose levels of VX-548
VX-993EXPERIMENTALParticipants will be randomized to receive a single dose of different dose levels of VX-993.

Interventions

NameTypeDescription
VX-150DRUGCapsules for oral administration.
PlaceboDRUGCapsules for oral administration.
HB/APAPDRUGParticipants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
VX-548DRUGSolution or suspension for oral administration.
VX-993DRUGSuspension for oral administration.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: Before surgery: * Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m\^2) * Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not t...

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

Frequently asked questions about VX-150

What is VX-150 used for?

VX-150 is an investigational small molecule being developed by Vertex Pharmaceuticals for pain-related conditions, including small fiber neuropathy, osteoarthritis, acute pain, and pain generally. It has been studied in Phase 2 clinical trials for osteoarthritis of the knee and acute pain following bunionectomy.

How does VX-150 work?

VX-150 is a small molecule being developed for pain. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here.

Who makes VX-150?

VX-150 is developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker VRTX. Vertex is conducting clinical trials to evaluate the drug's efficacy and safety in pain indications.

What phase is VX-150 in?

VX-150 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in osteoarthritis and acute pain, and is not yet approved by regulatory authorities. It remains an investigational drug.

What clinical trials is VX-150 in?

VX-150 has completed several clinical trials. NCT02660424 studied it in osteoarthritis of the knee with 124 participants. NCT03206749 and NCT03764072 evaluated it in acute pain after bunionectomy with 243 and 250 participants, respectively. NCT05418712 was a Phase 1 microneurography study in healthy participants.

Is VX-150 the same as any other drug?

No alternative names for VX-150 have been reported. It is identified solely by its development code VX-150 in clinical trial registries and by its developer, Vertex Pharmaceuticals.