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VX-548

Phase 4FDA approved 2025

Acute Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Trials Updated: Oct 19, 2026

VX-548 development status

FDA approval Jan 30, 2025 as Journavx
Approval holderVertex Pharms Inc
ApplicationNDA219209
Highest phase Phase 4 (NCT07836010)
Phase scored for VRTXPhase 2
Registered trials 29 across 6 sponsors since Jul 2021

Label indication JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 ) FDA label

VX-548 target and mechanism

ModalitySmall molecule

Also known as Suzetrigine, Suzetrigine (SUZ), SUZ, JOURNAVX

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials20
Total Enrollment5,094

FDA Designations

No designations recorded

VX-548 clinical trials

VX-548 · 20 trials · 5 indications

Phase 3 5Phase 2 4Phase 1 11
NCT07231419Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral NeuropathyDiabetic Peripheral Neuropathic Pain
RECRUITING734 Analytics
NCT06696443Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)Diabetic Peripheral Neuropathic Pain
ACTIVE NOT_RECRUITING455 Analytics
NCT06628908Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral NeuropathyDiabetic Peripheral Neuropathic Pain
RECRUITING1,100 Analytics
NCT05661734A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute PainPain
COMPLETED258 Analytics
NCT05558410Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an AbdominoplastyAcute Pain
COMPLETED1,118 Analytics
PHASE3RECRUITING
Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain
NCT07231419734
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PHASE3ACTIVE NOT_RECRUITING
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
NCT06696443455
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PHASE3RECRUITING
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain
NCT066289081,100
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PHASE3COMPLETED
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
Pain
NCT05661734258
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PHASE3COMPLETED
Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
Acute Pain
NCT055584101,118
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Study Endpoints

Primary Endpoints

Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
From Baseline up to Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Baseline up to Week 54
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
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) SUZ Compared to Placebo
0 to 48 hours After First Dose of Study Drug

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 baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Baseline, Week 12
Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Baseline, At Week 12

Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
0 to 48 Hours After First Dose of Study Drug

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). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
0 to 48 hours After First Dose of Study Drug

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). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

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
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Pre-dose up to Day 35 Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite
Pre-dose up to Day 35 Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Pre-dose up to Day 35 Post-dose
Change in QT interval corrected by Fridericia's formula (QTcF)
From Baseline up to Day 12
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Day 1 to Day 14
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole
Day 1 up to Day 22
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole
Day 1 up to Day 22
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Rifampin
Day 1 up to Day 28
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite in the Absence and Presence of Rifampin
Day 1 up to Day 28
Maximum Observed Plasma Concentration (Cmax) of VX-548
Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Day 1 to Day 31
Time Taken for VX-548 to Reach Maximum Concentration (tmax)
Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2)
Day 1 to Day 31
Apparent Volume of Distribution of VX-548 (Vz/F)
Day 1 to Day 31
Apparent Clearance of VX-548 (CL/F)
Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548
Day 1 to Day 31
Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-548
Days 1 and 19: Pre-dose up to 24 hours post midazolam dose
Maximum Observed Plasma Concentration (Cmax) of Digoxin in the Absence and Presence of VX-548
Days 1 and 19: Pre-dose up to 120 hours post digoxin dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Midazolam in the Absence and Presence of VX-548
Days 1 and 19: Pre-dose up to 24 hours post midazolam dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Digoxin in the Absence and Presence of VX-548
Days 1 and 19: Pre-dose up to 120 hours post digoxin dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Midazolam in the Absence and Presence of VX-548
Days 1 and 19: Pre-dose up to 24 hours post midazolam dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Digoxin in the Absence and Presence of VX-548
Days 1 and 19: Pre-dose up to 120 hours post digoxin dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

Secondary Endpoints

Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (Pooled with data from Study VX24-548-110)
From Baseline up to Week 12
Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score
From Baseline up to Week 52
Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score
From Baseline up to Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Suzetrigine (SUZ)EXPERIMENTALParticipants will be randomized to receive SUZ.
PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to SUZ.
PregabalinACTIVE_COMPARATORParticipants will be randomized to receive Pregabalin.
Hydrocodone bitartrate/acetaminophen (HB/APAP)ACTIVE_COMPARATORParticipants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.
VX-548EXPERIMENTALParticipants will receive VX-548 up to 12 weeks.
Suzetrigine (SUZ): Low DoseEXPERIMENTALParticipants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
Suzetrigine (SUZ): Mid DoseEXPERIMENTALParticipants received SUZ 46 mg tablet qd for 12 weeks.
Suzetrigine (SUZ): High DoseEXPERIMENTALParticipants received SUZ 69 mg tablet qd for 12 weeks.
HB/APAPACTIVE_COMPARATORParticipants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days.
VX-548: Low DoseEXPERIMENTALParticipants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days.
VX-548: High DoseEXPERIMENTALParticipants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
VX-548: Mid DoseEXPERIMENTALParticipants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
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.
Group 1EXPERIMENTALParticipants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.
Group 2AACTIVE_COMPARATORParticipants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.
Group 2BACTIVE_COMPARATORParticipants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
Cohort 1: Severe Renal ImpairmentEXPERIMENTALParticipants will receive a single dose of VX-548 in a fasted state.
Cohort 2: Matched Healthy ParticipantsEXPERIMENTALHealthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.
Cohort 3: Moderate Renal ImpairmentEXPERIMENTALParticipants will receive a single dose of VX-548 in a fasted state.
Cohort 4: Matched Healthy ParticipantsEXPERIMENTALHealthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.
Cohort 1: Mild Hepatic ImpairmentEXPERIMENTALParticipants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14.
Cohort 3: Moderate Hepatic ImpairmentEXPERIMENTALParticipants will receive multiple doses of VX-548 q12h from Day 1 through Day 14.
Arm 1EXPERIMENTALParticipants will receive a single dose of midazolam and digoxin on Day 1 in dosing period 1 followed by VX-548 every 12 hours (q12h) on Days 6 through 23 in dosing period 2. On Day 19, single doses of midazolam and digoxin will be administered with the morning dose of VX-548.
Sequence 1EXPERIMENTALParticipants will receive VX-548 reference tablet (TF1) under fasted condition in dosing period 1, then VX-548 test tablet (TF2) under fasted condition in dosing period 2, and finally VX-548 test tablet (TF2) under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.
Sequence 2EXPERIMENTALParticipants will receive VX-548 TF1 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.
Sequence 3EXPERIMENTALParticipants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.
Sequence 4EXPERIMENTALParticipants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.
Sequence 5EXPERIMENTALParticipants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.
Sequence 6EXPERIMENTALParticipants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF2 under fasted condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Interventions

NameTypeDescription
SuzetrigineDRUGTablets for oral administration
Placebo (matched to SUZ)DRUGPlacebo matched to SUZ for oral administration.
PregabalinDRUGCapsules for oral administration.
Placebo (matched to Pregabalin)DRUGPlacebo matched to Pregabalin for oral administration.
Suzetrigine (SUZ)DRUGTablets for oral administration.
HB/APAPDRUGCapsules for oral administration.
Placebo (matched to HB/APAP)DRUGPlacebo matched to HB/APAP for oral administration.
VX-548DRUGTablets for oral administration.
PlaceboDRUGTablets for oral administration.
Placebo (matched to VX-548)DRUGPlacebo matched to VX-548 for oral administration.
EfavirenzDRUGTablet for oral administration.
DRSP/EEDRUGCombination Tablets for Oral Administration.
NGM/EEDRUGCombination Tablets for Oral Administration.
MoxifloxacinDRUGCapsules for oral administration.
Moxifloxacin PlaceboDRUGCapsules for oral administration.
VX-548 PlaceboDRUGTablets for oral administration.
OmeprazoleDRUGTablets for oral administration.
RifampinDRUGCapsules for oral administration.
MidazolamDRUGSyrup for oral administration.
DigoxinDRUGTablets for oral administration.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites75

Key Inclusion Criteria: * Body weight greater than or equal to (≥)45 kilogram (kg) * Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pa...

Countries:United StatesAustralia
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Competitive Landscape -Acute Kidney Injury 13 trials (matched to "Acute Pain")

Top 1 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2AZD4144
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Recent Changes (Last 90 Days)

LOWOct 19, 2026NCT06696443lastUpdatePostDate: changed
LOWOct 19, 2026NCT06696443lastUpdatePostDate: changed
LOWOct 19, 2026NCT06696443lastUpdatePostDate: changed
LOWOct 15, 2026NCT06628908lastUpdatePostDate: changed
LOWOct 15, 2026NCT06628908lastUpdatePostDate: changed
MEDIUMOct 10, 2026NCT07378865TRIAL_REMOVED: changed
MEDIUMOct 10, 2026NCT07378865TRIAL_REMOVED: changed
MEDIUMOct 10, 2026NCT07378865TRIAL_REMOVED: changed
LOWOct 9, 2026NCT06696443lastUpdatePostDate: changed
LOWOct 9, 2026NCT06696443lastUpdatePostDate: changed
MEDIUMSep 18, 2026NCT07570069TRIAL_REMOVED: changed
MEDIUMSep 18, 2026NCT07570069TRIAL_REMOVED: changed
HIGHSep 9, 2026NCT07378865Status: RECRUITING → COMPLETED
HIGHSep 9, 2026NCT07378865Status: RECRUITING → COMPLETED
LOWSep 3, 2026NCT06696443lastUpdatePostDate: changed
LOWSep 3, 2026NCT06696443lastUpdatePostDate: changed
HIGHAug 18, 2026NCT07570069Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 18, 2026NCT07570069Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about VX-548

What is VX-548 used for?

VX-548 is an investigational small molecule being developed for the treatment of pain, including acute pain and painful lumbosacral radiculopathy. It is being studied in clinical trials for acute pain following surgical procedures such as bunionectomy and abdominoplasty.

Who is developing VX-548?

VX-548 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. Vertex is conducting clinical trials to evaluate the efficacy, safety, and pharmacokinetics of VX-548 in various pain conditions.

What phase is VX-548 in?

VX-548 is in Phase 2 clinical development for the treatment of pain. It has completed Phase 2 trials for acute pain after bunionectomy and abdominoplasty, as well as Phase 1 trials for pharmacokinetics and safety. VX-548 is investigational and not yet approved by regulatory authorities.

What clinical trials has VX-548 been in?

VX-548 has been studied in completed clinical trials including NCT04977336 for acute pain after bunionectomy, NCT05034952 for acute pain after abdominoplasty, NCT05704556 for pharmacokinetics in renal impairment, and NCT05851157 for the effect of food on pharmacokinetics.

How does VX-548 work?

VX-548 is a small molecule that targets pain pathways. It is being developed as a non-opioid treatment option for acute pain and other pain conditions. The exact molecular target of VX-548 has not been disclosed in the available clinical trial information.

Is VX-548 FDA approved?

VX-548 is not FDA approved. It is an investigational drug currently in clinical development by Vertex Pharmaceuticals. The completed trials have evaluated its safety and efficacy, but it has not yet received regulatory approval for any indication.

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